Q4 2023 Novavax Inc Earnings Call

Operator: Good morning and welcome to Novavax's fourth quarter 2023 financial results and operational highlights conference call. All participants will be in a listen-only mode.

Good morning, and welcome to Novavax fourth quarter, 2023 financial results and operational highlights conference call.

All participants will be in a listen only mode should you need assistance. Please signal a conference specialist by pressing the star key followed by zero.

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 the star key, then one on your touchtone phone.

After todays presentation, there will be an opportunity to ask questions.

Asked a question you May press Star then one on your Touchstone phone to withdraw your question. Please press Star then two.

Operator: To withdraw your question, please press star, then two. Please note, this event is being recorded. I would now like to turn the conference over to Erika Schultz, Senior Director, Investor Relations. Please go ahead.

Please note this event is being recorded.

I would now like to turn the conference over to Erica Schultz.

Erica Schultz: <unk> Director Investor Relations. Please go ahead.

Erika Schultz: Good morning, and thank you all for joining us today to discuss our fourth quarter and full year 2023 operational highlights and financial results. A press release announcing our results is currently available on our website at Novavax.com, and an audio archive of this conference call will be available on our website later today. Please turn to slide two.

Erica Schultz: Good morning, and thank you all for joining us today to discuss our fourth quarter and full year 2023 operational highlights and financial results.

Erica Schultz: 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.

Erica Schultz: 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, 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, Each forward-looking statement contained in this presentation is subject to risk and uncertainties that can cause actual results to differ materially from those projected in such statements. Additional information regarding these factors appears under the heading, Cautionary Notes Regarding Forward-Looking Statements.

Erica 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.

Erica Schultz: Its key strategic priorities operating plans objectives and prospects full year 2024 financial guidance.

Erica Schultz: The amount of impact of <unk> cost reduction plans, its future financial or business performance conditions or strategies, it's 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.

Erica Schultz: And key upcoming milestones.

Erica Schultz: Each forward looking statement contained in this presentation is subject to risks and uncertainties that could cause actual results to differ materially from those projected in such statements.

Erica Schultz: Additional information regarding these factors appears under the heading cautionary note regarding forward looking statements in our 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 Dot S.

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 www.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 or revise any of these statements. Please turn to slide three.

Erica Schultz: <unk> dot Gov and on our website at Www Dot Novavax Dot com.

Erica Schultz: The forward looking statements in this presentation speak only as of the original date of this presentation and we undertake no obligation to update or revise any of these statements. Please turn to slide three.

Erika Schultz: Joining me today is John Jacobs, our president and CEO, who will provide a review of our progress this past year, focusing on our three key priorities looking towards the future. 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. And finally, Jim Kelly, Chief Financial Officer and Treasurer, will provide an overview of our financial results. I would now like to hand over the call to John Jacobs. Please turn to slide four. Thank you, Erika, and thank you, everyone, for joining us.

Erica Schultz: Joining me today is John Jacobs, our President and CEO, who will provide a review of our progress this past year focusing on our three key priorities looking towards the future. Additionally.

Erica Schultz: Additionally, Jon Zaffino, our president and Chief operating Officer will provide an update on our commercial activities and Dr. Phillip Dubowsky President of research and development will discuss our clinical development and pipeline.

Erica Schultz: Finally, Jim Kelly, Chief Financial Officer, and Treasurer will provide an overview of our financial results.

Erica Schultz: I would now like to hand over the call to John Jacobs.

John Jacobs: Please turn to slide four.

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

John Charles Jacobs: I'm pleased to be with you today, along with the members of our executive team, to reflect on our fourth quarter and full year 2023 financial results and operating highlights and to discuss our priorities for 2024. In 2023, we made significant progress in our priorities, strengthening our foundation and helping to position us for success in 24 and beyond. Throughout the year, we kept you updated on the progress we were making against our three priorities, which were number one, deliver an updated product for the fall vaccination season. Number two, reduce our rate of spend, manage our cashflow, and evolve our scale and structure.

John Jacobs: Pleased to be with you today, along with the members of our executive team to reflect on our fourth quarter and full year 2023 financial results and operating highlights and to discuss our priorities for 2024.

John Jacobs: In 2023, we made significant progress on our priorities strengthening our foundation and helping to position us for success in 'twenty four and beyond.

John Jacobs: Throughout the year, we kept you updated on the progress, we're making against our three priorities, which were number one deliver an updated product for the fall vaccination season.

Number two reduce our rate of spend manage our cash flow and evolve our scale and structure and finally number three leverage our technology platform, our capabilities and our assets to drive additional value beyond new Baxter that along.

John Charles Jacobs: And finally, number three, leverage our technology platform, our capabilities, and our assets to drive additional value beyond new backs of it alone. So let's take a look back at 2023 and what we were able to accomplish in these three key areas of focus for Novavax. Under priority one, deliver our updated vaccine for the fall season. All of us at Novavax are very proud that this fall, we delivered on this priority. And in the face of a COVID market that was smaller than we and many others had projected, we were able to achieve $1 billion of revenue for the full year, 23, including fourth quarter total revenue of $291 million.

So let's take a look back at 2023, and what we were able to accomplish in these three key areas of focus for Novavax.

John Jacobs: Under priority one deliver our updated vaccine for the fall season, all of US at Novavax are very proud that this fall we delivered on this priority and in the face of the cobot market that was smaller than we and many others had projected we were able to achieve $1 billion of revenue for the full year 'twenty three including fourth quarter total.

John Jacobs: Revenue of $291 million.

John Charles Jacobs: Despite this success, we also had some disappointment in our U.S. market performance last season. Last season was a transitional season and the first fully commercial one for us in the U.S. market, and we intend to make improvements in key areas for 2024. Later on in our presentation, John Trizzino will discuss this topic in more detail. Priority number two is to reduce our rate of spend, manage our cash flow, and evolve our scale and structure. 2023 was a pivotal year for the COVID market and for Novavax, as it was the first year post-pandemic and represented the first chapter in our new journey as a company post-pandemic. A key priority for Novavax in 2023 was to scale the organization appropriately and reduce our spend to better align with the evolving market opportunity. To that end, we took decisive action to reduce our expenses and our scale. We entered 2023 with approximately $2.5 billion in current liabilities and, over the course of the year, reduced that figure by over $800 million. And with the resolution of the GAVI arbitration, this number should be further reduced by another $500 million.

John Jacobs: Despite this success, we also had some misses.

John Jacobs: And we are disappointed in our U S market performance last season.

John Jacobs: Last season was a transitional season and the first fully commercial one for us in the U S market.

John Jacobs: And we intend to make improvements in key areas for 2024.

John Jacobs: Later on in our presentation, John Casino will discuss this topic in more detail.

John Jacobs: Priority number two reduce our rate of spend and manage our cash flow and evolve our scale and structure.

John Jacobs: 2023 was a pivotal year for the Covid market and for Novavax as it was the first year post pandemic and represented the first chapter in our new journey as a company post pandemic.

John Jacobs: A key priority for Novavax in 2023 was to scale the organization appropriately and reduce our spend to better align with the evolving market opportunity.

John Jacobs: To that end, we took decisive action to reduce our expenses and our scale. We entered 2023 with approximately $2 $5 billion and current liabilities.

John Jacobs: Over the course of the year reduce that figure by over $800 million and with the resolution of the Gavea arbitration. This number should be reduced further by another $500 million.

John Charles Jacobs: In addition, we reduced our total operating expenses by over $1.1 billion in 2023, almost $150 million ahead of our stated target. And finally, under priority three, leveraging our technology platform, our capabilities, and our assets to drive additional value beyond Novavax alone. During 2023, we were able to outline a faster path forward for our flu-COVID combination vaccine program with a potential launch as soon as 2026. We are still on track to initiate a phase three study this fall. And last week, the FDA confirmed the data requirements to achieve accelerated approval. Dr. Filip Dubovsky will provide details later on in the call on this matter.

John Jacobs: In addition, we reduced our total operating expenses by over $1 $1 billion in 2023, almost $150 million ahead of our stated target.

John Jacobs: And finally under priority three leveraging our technology platform, our capabilities and our assets to drive additional value behind it accident alone.

John Jacobs: During 2023, we were able to outline a faster path forward for our flu Covid combination vaccine program with a potential launch as soon as 2026.

John Jacobs: We are still on track to initiate a phase III study this fall and last week. The FDA confirmed the data requirements to achieve accelerated approval Dr. Filip <unk>, who will provide details later on the call on this matter.

John Charles Jacobs: So looking ahead to 2024 and beyond, I'd like to say that with 2023 now behind us, we intend to build upon our successes, learn from our disappointments, and drive towards a successful 2024. In this second chapter of our New Journey post-pandemic, over the next two seasons, our focus will be on share growth in the COVID market, further streamlining our business model, and preparing the market for a successful launch of our combination vaccine, which we anticipate in 2020. When achieved, the launch of our combination vaccine will mark our third and potentially most exciting chapter yet post-pandemic, allowing us to expand beyond a one-product company. When combined with the potential for both organic and inorganic product expansion, this further supports our vision of becoming a leading global vaccine innovator. Filip will give an update on our combination program shortly during the course of this presentation. Before handing it over to the rest of the management team, I want to outline our three main priorities for 2024. So please turn to slide five.

John Jacobs: So looking ahead to 2024 and beyond I'd like to say with 2023 now behind US we intend to build upon our successes learn from our disappointments and drive towards a successful 2024.

John Jacobs: In the second chapter of our new journey post pandemic over the next two seasons, our focus will be on share growth in the COVID-19 market further streamlining our business model and preparing the market for a successful launch of our combination vaccine, which we anticipate in 2026.

John Jacobs: When achieved the launch of our combination vaccine will mark our third and potentially most exciting chapter yet post pandemic, allowing us to expand beyond one for one product company.

When combined with the potential for both organic and inorganic product expansion. This further supports our vision of becoming a leading global vaccine innovator.

John Jacobs: Philip will give an update on our combination program shortly through the course of this presentation before handing it over to the rest of the management team I want to outline our three main priorities for 2024. So please turn to slide five.

John Charles Jacobs: Our first priority is to deliver an updated product for the 24-25 fall vaccination season with a more competitive presentation, broader retail availability, and early availability in the market with the goal of capturing increased share. Our second priority is to independently launch the phase 3 trial of our COVID flu combination vaccine product and showcase more of what our scientific platform is capable of through the generation and sharing of new clinical data. Finally, our third priority is to continue the evolution of Novavax with our eyes firmly on the future opportunity, further reducing our operating expenses and enhancing our process, and while maintaining our capabilities so we can deliver on our intended business objectives.

John Jacobs: Our first priority is to deliver an updated product for the 'twenty four 'twenty five full vaccination season with a more competitive presentation broader retail availability and early avail or availability in the market with the goal of capturing increased share.

John Jacobs: Our second priority is to independently launch the phase III trial of our Covid flu combination vaccine product and showcase more of what our scientific platform is capable for the generation and sharing of new clinical data.

John Jacobs: Finally, our third priority is it.

John Jacobs: <unk> the evolution of Novavax with our eyes firmly on the future opportunity further reducing our operating expenses and enhancing our processes and while maintaining our capabilities. So we can deliver on our intended business objectives.

John Charles Jacobs: We are excited about the prospects ahead of us as we enter the second chapter of our post-pandemic journey. Our base plans, should we succeed in executing them in 24 and 25, promise to place Novavax in a stronger, leaner position, ready to launch our new combination vaccine, and accelerate the company towards profitability and significant growth potential. Now I would like to hand it over to additional members of the team to discuss our results from the quarter in more detail, beginning with John Trizzino on our commercial updates.

John Jacobs: We are excited about the prospects ahead of us as we enter the second chapter of our post pandemic journey.

John Jacobs: Our base plans should we succeed in executing them in 'twenty four 'twenty five promised the place novavax and a stronger leaner position ready to launch our new combination vaccine and accelerate the company towards profitability and significant growth potential.

John Jacobs: Now I would like to hand, it over to additional members of the team to discuss our results from the quarter in more detail beginning with John Trevino for our commercial update John.

John Joseph Trizzino: Thank you, John. Please turn to slide six. As John explained, 2023 was a year of significant change for our business, and we have learned many lessons that are allowing us to better position ourselves for a stronger 24-25 COVID vaccination season. I'd like to focus today's update on how we plan to translate these lessons into action with a goal to grow share in each of our key regions, as well as the changes we've made to our commercial strategy. Please turn to slide 7.

John Trevino: Thank you John Please turn to slide six.

John Trevino: John explained 2020 free was a year of significant change for our business and we have learned many lessons that are allowing us to better position ourselves for a stronger 'twenty four 'twenty five COVID-19 vaccination season.

John Trevino: I'd like to focus today's update on how we plan to translate these lessons into action with a goal to grow share in each of our key regions as well as the changes we've made to our commercial strategy.

John Trevino: Please turn to slide seven.

John Joseph Trizzino: First, I'd like to provide some high-level context on 2023 and the opportunities in 2024. Full-year 2023 product sales were $531 million, which included $251 million in the fourth quarter. Over 90% of that came from APA sales from Europe, Australia, and New Zealand, with the remainder of our product sales in the U.S., Canada, Singapore, Korea, and Taiwan markets.

John Trevino: First I'd like to provide some high level context on 2023 and the opportunities in 2024.

John Trevino: Okay.

John Trevino: Full year 2023 product sales were $531 million, which.

Which includes $251 million in the fourth quarter.

John Trevino: Over 90% of that came from Apa's sales from Europe, Australia, and New Zealand with the remainder of our product sales in the U S, Canada, Singapore, Korea, and Taiwan markets.

John Joseph Trizzino: Importantly, we entered 2024 with over $1 billion outstanding and an expected APA contract value with deliveries planned for 2024 through 2026. In 2024, our XBB remaining product sales include Q1 APA deliveries for Europe and then for the Southern Hemisphere, and APA sales to Australia and New Zealand upon regulatory approval. We also see incremental opportunity for the private market this year in the UK, as well as the potential for CDC to recommend an additional springtime dose for individuals 65 and over, which ACIP is meeting to discuss today. Please turn to slide 8.

John Trevino: Importantly, we entered 2024 with over $1 billion outstanding and expected contract value with deliveries planned for 2024 through 2026.

For 2024 or <unk> remaining product sales include Q1 deliveries for Europe, and then for the southern Hemisphere, and Apa's sales to Australia, and New Zealand upon regulatory approval.

John Trevino: We also see incremental opportunity for the private credit market. This year in the U K as well as the potential for CDC to recommend an additional spring time dose for individuals 65 and over on which ACI P is leading to discuss today.

John Trevino: Please turn to slide eight.

John Joseph Trizzino: As John mentioned earlier, we learned a lot in 2023, which was our first year competing in a dynamic post-pandemic U.S. commercial market. We successfully secured regulatory authorization and approval for our updated vaccine in key markets around the world and made significant deliveries under our APA agreement. In the U.S., several factors related to our five-dose product presentation and our timing-to-market entry impacted our ability to gain market share. However, factors outside of our control, namely the disappointing COVID market size at just over 30 million doses and the fact that the retail channel accounted for over 95 percent of vaccinations, also led to U.S. performance below our expectations.

John Trevino: As John mentioned earlier, we learned a lot in 2023, which was our first year competing in a dynamic post pandemic U S commercial market we.

John Trevino: We successfully secured regulatory authorization and approval for our updated vaccine in key markets around the world and made significant deliveries under our agreements.

John Trevino: Agreements.

John Trevino: In the U S. Several factors related to our five dose product presentation, and our timing to market entry impacted our ability to gain market share.

John Trevino: However factors outside of our control, namely the disappointing COVID-19 market size at just over 30 million doses and the fact that the retail channel accounted for over 95% of vaccinations.

John Trevino: So led to U S performance below our expectations.

John Joseph Trizzino: We continue to believe that the U.S. market holds opportunities for Novavax. In the U.S., we achieved some important milestones that should provide an opportunity for a much better performance in 2024. We built significant levels of awareness for the first time in the U.S. market, over 80 percent aided awareness, and have seen pockets of rapid uptake, wherein some retail outlets we saw up to 10 percent share when we were carried on an even playing field regarding pharmacy processes and availability. For 2024, we are focused on being in the market in early September, which we anticipate as the start of the vaccination season. We also intend to offer our vaccination in a pre-filled syringe and, if approved under full BLA licensure, in pharmacies. We know that in the first post-pandemic season, COVID vaccinations overwhelmingly took place in pharmacies.

We continue to believe that the U S market pulse opportunity for <unk> in the U S. We achieved some important milestones that should provide an opportunity for a much better performance in 2024.

John Trevino: We built significant levels of awareness for the first time in the U S market over 80% aided awareness and have seen pockets of rapid uptake where in some retail outlets. We saw up to 10% sure. When we were carried on an even playing field regarding pharmacy processes and availability.

John Trevino: <unk>.

John Trevino: For 2024, we are focused on being in market in early September, which we anticipate as the start of the vaccination season.

We also intend to offer our vaccination in a pre filled syringe.

John Trevino: And if approved under full BLA licensure.

John Trevino: We know that in the first post pandemic season, Kogan vaccinations overwhelmingly took place in pharmacies. So we have recalibrated and streamlined our customer engagement teams to focus on this channel today.

John Joseph Trizzino: So we have recalibrated and streamlined our customer engagement teams to focus on this channel. Today, we are already leveraging the relationships built this past season and are currently at the negotiating table with the top major retailers who drove 90% of the pharmacy business last season, potentially setting the stage for expanded access to our updated vaccine in the top national and regional retail chains. Additionally, we believe that if we achieve early September delivery, a pre-filled syringe, and BLA approval, we can secure a meaningfully improved market share. We especially see opportunity in the 65-plus segment, which had the highest vaccination rates of 42% last season.

John Trevino: Today, we are already leveraging the relationships built this past season and are currently at the negotiating table with the top major retailers, who drove 90% of the pharmacy business last season potentially setting the stage for expanded access to our updated vaccine and the top national and regional.

John Trevino: Our retail change.

John Trevino: Additionally, we believe that if we achieve early September delivery.

John Trevino: A pre filled syringe and BLA approval, we can secure a meaningfully improved market share, we especially see opportunity in the 65, plus segment, which had the highest rats vaccination rates of 42% last season, and this is where we plan to concentrate our promotion.

John Joseph Trizzino: And this is where we plan to concentrate our promotional spend in an effort to convert that market to Novavax vaccine shots in arms. We are also closely watching the ACIP meeting today, which could potentially result in a recommendation for spring vaccination for high-risk groups, including those over 65, and an increased opportunity to benefit from our updated vaccine. Finally, we are also making important progress on our objective of on-time delivery. We are working closely with the FDA on a rolling submission of our BLS. Please turn to slide 9.

John Trevino: We'll spend in an effort to convert that market to novavax vaccine shots and arms.

John Trevino: We're also closely watching the ACI team meeting today, which will potentially result in a recommendation for spring vaccination for high risk groups, including those over 65% and increased opportunity to benefit from our updated vaccine.

John Trevino: Yes.

John Trevino: Finally, we are also making important progress on our objective of on time delivery. We are working closely with the FDA on a rolling submission of our BLA.

John Trevino: Please turn to slide nine.

John Joseph Trizzino: Now let's talk about markets outside the U.S., starting with Europe, which converts to a commercial market this year for the first time. Our APA with the European Commission ended in 2023, and we are now entering for the first time a commercial market opportunity in which, despite strong competitive pressure from mRNA APAs, we see revenue potential for our Novavax vaccine in Italy, Spain, and France, as well as in the UK. In these markets, our focus will be on delivering a single-dose presentation with timely availability.

John Trevino: Now, let's talk about markets outside the U S, starting with Europe, which converts to a commercial market. This year for the first time.

John Trevino: Our API and the European Commission ended in 2023, we are now entering for the first time, a commercial market opportunity and which despite strong competitive pressure from M. Rnas Apa's, we see revenue potential for our new Baxter B vaccine in Italy.

John Trevino: Pain, and France, as well as in the UK.

John Trevino: In these markets our focus will be on delivering a single dose presentation with timely availability.

John Joseph Trizzino: In the U.K., we are planning for the launch of a private market featuring Novavax a bit. The Health Security Agency recently updated its green book to include our vaccine, and discussions are underway with leading retailers and occupational health providers. We are already seeing interest in potential orders for our new vaccinated vaccine. Finally, Asia Pacific remains an opportunity for us for the next two seasons through the expected deliveries under existing APAs. Overall, our commercial efforts in the Asia Pacific region remain focused on Australia and our largest APA global market, as well as New Zealand, Singapore, and Taiwan.

John Trevino: In the U K, we are planning for the launch of a private market featuring his accident. The health Security Agency recently updated its screen book to include our vaccine and discussions are underway with leading retailers and occupational health providers.

John Trevino: We are already seeing interest in potential orders for our <unk> vaccine.

John Trevino: Finally in Asia Pacific.

John Trevino: It remains an opportunity for us for the next two seasons through the expected deliveries under existing Apa's.

John Trevino: Overall, our commercial efforts in Asia Pacific remained focused on Australia, and our largest E. P. A global market as well as New Zealand, Singapore and Taiwan.

John Joseph Trizzino: We expect approval of our updated vaccine in Australia and New Zealand soon. Finally, in Canada, we continue to execute on our APA. Our efforts are focused on securing NACI recommendation on par with mRNAs and driving awareness of our differentiated vaccine with healthcare providers and consumers. Now, please turn to slide 10.

John Trevino: We expect approval of our updated vaccine in Australia, and New Zealand soon.

John Trevino: Finally in Canada, we continue to execute on our API. Our efforts are focused on securing nasty recommendation on par with mrna and driving awareness of our differentiated vaccine with health care providers and consumers.

John Trevino: Now please turn to slide 10.

John Joseph Trizzino: As John noted, we have made significant changes to our organization, to how we work, to our scope and scale, and to how we are working tirelessly to coordinate the many critical activities needed to be ready for a successful fall season. Across all key areas, from CMC to regulatory to our commercial efforts, we are coordinating our workflows and streamlining our processes, and remaining singularly focused on operational execution for the upcoming 24-25 season in all of our key markets. We continue to believe, and our data indicates, that there is significant demand for Novavax's protein-based vaccine and that Nuvaxavid will play a meaningful role across the U.S., Europe, and the rest of the world. As we focus on the future, we expect continued transformation in our business, with commercial product sales continuing to grow and to contribute to Novavax's total revenue mix over the next two seasons as the pandemic-era APA sales agreements mature and reach their conclusion between now and 2026.

As John noted, we have made significant changes to our organization to how we work to our scope and scale and how we are working tirelessly to coordinate the many critical activities needed to be ready for a successful fall season.

John Trevino: Across all key areas for the CMC to regulatory to our commercial efforts, we are coordinating our workflows and streamlining our processes and remained singularly focused on operational execution for the upcoming 'twenty four 'twenty five season, and all of our key markets.

John Trevino: We continue to believe and our data indicates that there is significant demand for <unk> protein based vaccine and that <unk> will play a meaningful role across the U S Europe and the rest of the world.

John Trevino: As we focus on the future. We expect continued transformation in our business with commercial product sales continuing to grow.

John Trevino: Contribute to another that is total revenue mix over the next two seasons as the pandemic era apa's sales agreements mature and reach their conclusions between now and 'twenty 'twenty six.

John Joseph Trizzino: We believe that the market is migrating towards seasonal combination respiratory vaccines, especially for flu and COVID. Our market research shows that over half of the flu market is anticipated to convert to combination products, and that 25 to 30 percent of health care providers and consumers prefer a protein-based option. And to date, we believe we are ahead of other non-mRNA competition in combo product development. We think we are well-positioned to capture our fair share of that market opportunity by bringing together our technology platform, MatrixM Adjuvant, proven COVID vaccine, and an outstanding flu vaccine candidate with positive phase 3 data to discuss this and other key R&D updates. I would like to hand it over to Philip.

John Trevino: We believe that the market is migrating towards seasonal combination respiratory vaccine, especially for flu and Covid. Our market research shows that over half of the flu market is anticipated to convert to combination products and then 25% to 30%.

John Trevino: Health care providers and consumers prefer a protein based option.

John Trevino: And to date, we believe we are ahead of other non mrna competition a combo product development.

John Trevino: We think we are well positioned to capture our fair share of that market opportunity by bringing together our technology platform.

John Trevino: The matrix M adjuvant.

John Trevino: Proving COVID-19 vaccine and an outstanding flu vaccine candidate with positive phase III data.

John Trevino: To discuss this and other key R&D updates I would like to hand, it over to Philip.

Filip Dubovsky: Thanks, John. Please turn to slides 11 and 12. I want to cover two R&D priorities for 2024. The first priority is the delivery of updated variant vaccines. I will share clinical and real-world evidence about the performance of our XBB-containing vaccine before I update you on our approach for the 24-25 season. Our second priority is launching the next phase of our COVID-influenza combination program. Like John said, the program is on track, and we have received evident guidance on how to achieve accelerated approval. Before I move into my slides, I want to reflect on the data we have accumulated over this past year that continues to support the promise of our nanoparticle and adjuvant technologies. We continue to see broad, long-lived immune responses in our clinical studies while maintaining a favorable reactogenicity profile.

Philip: Thanks, John Please turn to slide 11 and 12.

Philip: I want to cover two R&D priorities for 2020 for the first priority is the delivery of updated bearing vaccines illustrate clinical and real world evidence about the performance of our <unk> containing vaccine before I update you on our approach for the $24 five season.

Philip: Our second priority is launching the next phase of our Covid influenza combination program.

Philip: Like John said the program is on track and we have received guidance of how to achieve accelerated approval.

Philip: Before I move into my slides I want to reflect on the data we have accumulated over this past year.

And that continues to support the promise of our nano particle in adjuvant technology.

Philip: We continue to see broad long lived immune responses in our clinical studies, while maintaining a favorable react with Genesis profile.

Filip Dubovsky: And this has proven to be true for our initial COVID vaccine, our XGB15 vaccine, the R21 malaria vaccine, as well as our experimental COVID influenza combination vaccine. And we've also started to accumulate real-world effectiveness data that show the immune responses seen in our studies translate to disease prevention in the real world. Okay, let's move to slide 13 and review where we are with strain change, starting with a summary of last year's update. Last summer, the strain was updated to XBB1.5, and we ran a clinical study to reconfirm our strain change approach and evaluate the vaccine's performance. The vaccine achieved its co-primary endpoint of inducing robust HPV1-5 neutralization and seroconversion responses. On the left-hand side of the slide are neutralization responses in adults who previously received three or more mRNA vaccines. XGB1-5 responses increased sevenfold with a single boosting dose.

Philip: And this has proven to be true for our initial COVID-19 vaccine our <unk> one five vaccine.

Philip: Our twin malaria vaccine as well as our experimental COVID-19 influenza a combination vaccine.

Philip: And we've also started to accumulate real world effectiveness data that shows the immune responses seen in our studies translate into disease prevention in the real world.

Philip: Kate let's move to slide 13, and review, where we are with <unk>, starting with a summary of last year's update.

Kate: Last summer the strain was updated to excuse me one pipe and we ran a clinical study to reconfirm, our strange change approach and evaluate the vaccines performance.

Kate: Vaccine achieved its co primary endpoint of inducing robust X would be one five neutralization and seroconversion responses.

Kate: On the left hand side of the slide our neutralization responses in adults, who previously received three or more mrna vaccines.

Kate: It should be.

Kate: One five responses increased seven fold with a single boosting dose.

Filip Dubovsky: Also displayed are the neutralization responses to JN1, which is currently the most common circulating variant. As you can see, we had a 5.6 fold response to this forward drift variant, once again demonstrating this vaccine technology can induce a broadly neutralizing response. Now, on the right-hand side of the slide, are local and systemic reactogenicity symptoms. However, despite the study subjects having received a minimum of three prior doses of the mRNA vaccine, our tolerability profile was very favorable, and this has been reported multiple times in academic publications.

Kate: Also displayed or the utilization responses to Jan one which is currently the most common circulating variant.

Kate: As you can see we had $5 six fold response to this forward drift berrien once again, demonstrating this vaccine technology can induce broadly neutralizing responses.

Kate: Now on the right hand side of the slide our local and systemic exactly tendency symptoms.

Kate: Despite the study subjects, having received a minimum of three prior doses of mrna vaccine. Our tolerability profile was very favorable and this has been reported multiple times in academic publications.

Filip Dubovsky: Okay, let's go to slide 14, which depicts how these immune responses translate into clinical effectiveness. On February 1st, the CDC published early season COVID vaccine effectiveness estimates. (Inaudible) This appears favorable for Novavax. However, the Gesson factors are not available, so individual vaccine effectiveness cannot be calculated.

Kate: Okay, Let's go to slide 14, which depicts how these immune responses translate into clinical effectiveness.

On February 1st the CDC published early season, Covid vaccine effectiveness estimates.

Kate: They concluded that the overall adjusted vaccine effectiveness of the three vaccine brands combined with 54% and that included a protection against Jan one which was estimated to account for about 39% of the symptomatic cases.

Kate: This was not a calculated by vaccine manufacturer or platform or the vaccine specific case counts were included in the publication and are depicted on the right hand side of the slide.

This appears favorable for Novavax.

Kate: Some factors are not available so individual vaccine effectiveness cannot be calculated.

Filip Dubovsky: Although this part of the study captures a small number of Novavax cases, we calculated the crude relative rate reduction for our vaccine, which was 75%. The imbalance in the case counts and the relative rate reduction gives us confidence that our vaccine is providing protection. Okay, let's go to slide 15 for this year's variant. Jane 1 is causing the vast majority of diseases globally, including in the U.S. It's depicted on the left-hand side in purple dots.

Although this part of the study captures a small number of Novavax cases, we calculate the crude relative rate reduction for our vaccine which was 75%.

Kate: The imbalance in the case counts and the relative rate reduction gives us confidence our vaccine is providing protection.

Speaker Change: Okay, Let's go to slide 15 for this year's period.

Speaker Change: Gene one is causing the vast majority of disease globally, including in the U S is depicted on the left hand side in <unk>.

Speaker Change: Couple of thoughts.

Filip Dubovsky: As a recombinant protein vaccine company, we make many of the variants and cross-test them against each other. On the right-hand side of the slide is antigenic cartography depicting the antigenic distance between XBB1-5 and JN1, which is over four antigenic units and represents over a 16-fold reduction in immune response. Despite the fact I showed you data that the HBV vaccine induces good immune responses, and those translate into real world protection from the CDC publication, we believe it is appropriate to update the vaccine to protect from future drift variants. Updating will narrow the antigenic distance and should future-proof the vaccine effectiveness when subsequent mutations occur. Therefore, we would advance JN1 into commercial manufacture while continuing to evaluate upcoming variants. Okay, let's go to slide 16 for a brief update on our COVID-influenza combination program. We've been interacting with the FDA on the design of our Phase III program and the Accelerated Regulatory Approval Pathway. We have agreement on the study design, study endpoints, trivalent comparators, and size of the licensure-enabling safety database.

Speaker Change: Is it a recombinant protein vaccine company, we make many of the variance and cross test them against each other.

Speaker Change: On the right hand side of the slide is antigenic cartography depicting the imaging distance between <unk> five and Jay one which is over four antigenic units and represents over 16 fold reduction immune responses.

Despite the fact I showed you data the HPV vaccine induces good immune responses and those translate into real work protection from the CDC publication, we believe it is appropriate to update the vaccine to protect from future drift variance.

Speaker Change: Abating will narrow the antigenic distance future proof the vaccine effectiveness when subsequent mutations occur.

Therefore, we would advance gen one into commercial manufacturer, while continuing to evaluate upcoming variance.

Speaker Change: Okay, Let's go to slide 16 for a brief update of our Covid influenza combination program.

Speaker Change: We've been interacting with the FDA on the design of our Phase III program and the accelerated regulatory approval pathway. We have agreement on the study design study endpoints <unk> competitors and size of licensure, enabling safety database.

Filip Dubovsky: We're still on track to initiate the Phase 3 study in the fall. Based on supportive data from our Phase II study, which is shown on the right-hand side of the slide, we have confidence in achieving the agreed-upon endpoint. The study is designed to compare the immune responses in two age groups, 50 to 65 and greater than 65, to licensed age-recommended influenza vaccines, as well as our own COVID vaccine.

Speaker Change: We're still on track to initiate the phase III study in the call.

Speaker Change: Based on supportive data from our phase II study, which is shown on the right hand side of this slide we have confidence in achieving the agreed upon endpoints.

Speaker Change: The study is designed to compare the immune responses in two age groups.

Speaker Change: 65, and greater than 65 to licensed agent recommended influenza vaccines as well as our own COVID-19 vaccine.

Filip Dubovsky: The granting of accelerated approval will occur after the data is reviewed by FDA and mean and full therapeutic benefit are demonstrated. We're also planning a lot plot consistency study in the fourth quarter of the year, which should enable a regulatory filing in 2025 and potential launch in the 2026 season. Okay, let me hand over to Jim for financial. Thank you, Filip. Please turn to slide 17.

Speaker Change: The granting of accelerated approval will occur after the data is reviewed by FDA and meaningful therapeutic benefit is demonstrated.

Speaker Change: We're also planning a lot lot consistency study in the fourth quarter of the year, which should enable a regulatory filing in 2025 and potential launch in the 2026 season.

Speaker Change: Okay, Let me hand over to Jim for our financial update.

James Patrick Kelly: Thank you Philip.

James Patrick Kelly: Please turn to slide 17.

James Kelly: This morning we announced our financial results for the fourth quarter and full year 2023. Details of our results can be found in our press release issued today and in our 10k filing; please turn to slide 18. We are focused on improving the financial health and performance of Novavax to enable long-term value creation. Toward that goal, I'll share a few of the key themes for 2023 and a look toward 2024 and beyond. For the full year 2023, Novavax recorded total revenue of $1 billion and significantly improved our balance sheet profile by reducing current liabilities by $825 million. In addition, the Gavi settlement announced last week removes the risk of arbitration with Gavi and will further reduce short-term liabilities by over $500 million.

James Patrick Kelly: This morning, we announced our financial results for the fourth quarter and full year 2023.

James Patrick Kelly: Details of our results can be found in our press release issued today and in our 10-K filing.

James Patrick Kelly: Please turn to slide 18.

We are focused on improving the financial health and performance of Novavax to enable long term value creation.

Towards that goal I will share a few of the key themes for 2023, and a look towards 2024 and beyond.

James Patrick Kelly: For the full year 2023, Novavax recorded total revenue of $1 billion and significantly improved our balance sheet profile by reducing current liabilities by $825 million.

James Patrick Kelly: In addition, the gobby settlement announced last week removes the risk of arbitration with coffee and will further reduce short term liabilities by over $500 million.

James Kelly: As we continue to transform Novavax into a more lean and agile organization, we reduced 2023 total operating expenses by $1.1 billion, or 41%, and exceeded our savings targets for R&D plus SG&A by $150 million. As we look to 2024, we are targeting R&D and SG&A expenses of between 700 and 800 million with the intent to drive them below 750 million at the midpoint, if possible, as we continue to [inaudible] We believe this positions us well as we focus our investments to establish new commercial COVID markets and advance our KICK program. Please turn to slide 19.

James Patrick Kelly: As we continue to transform novavax into a more lean and agile organization. We reduced 2023 total operating expenses by $1 1 billion or 41% and exceeded our savings targets for R&D, plus SG&A by $150 million.

James Patrick Kelly: As we look to 2024, we are targeting R&D and SG&A expenses of between 700 and $800 million with the intent to drive them below 750 million midpoint, if possible as we continue to resize our organization.

James Patrick Kelly: We ended 2023 with cash and accounts receivable of $881 million. In addition, as we enter 2024, we have over $1 billion and EPA contract value outstanding with expected deliveries over the next three years.

James Patrick Kelly: We believe this positions us well as we focus our investments to establish new commercial COVID-19 markets and advance our kick program.

James Patrick Kelly: Please turn to slide 19.

James Kelly: Turning to a more detailed view of our 2023 financial results, I will provide commentary on our fourth quarter 2023 financial results, with a specific focus on revenue and COGS. For the fourth quarter of 2023, we recorded total revenue of $291 million compared to $357 million in the same period in 2022. Our product sales of $251 million in the fourth quarter of 2023 were primarily related to APA deliveries to Europe and Canada plus commercial market product sales in the U.S., South Korea, and Taiwan. Grants of $38 million for the fourth quarter of 2023 reflect the realization of the full value of the $1.8 billion U.S. government funding agreement. For the full year 2023, our total revenue of $984 million was consistent with our guidance.

James Patrick Kelly: Turning to a more detailed view of our 2023 financial results I will provide commentary on our fourth quarter 2023 financial results with specific focus on revenue and Cogs.

James Patrick Kelly: For the fourth quarter of 2023, we recorded total revenue of $291 million compared to 357 million in same period in 2022.

James Patrick Kelly: Our product sales of $251 million in the fourth quarter of 2023 were primarily related to EPA deliveries to Europe, and Canada, plus commercial market product sales in the U S South Korea and Taiwan.

James Patrick Kelly: Grants of $38 million for the fourth quarter of 2023 reflect the realization of the full value of the $1 8 billion U S government funding agreement.

James Patrick Kelly: For the full year 2023, our total revenue of 984 million was consistent with our guidance.

James Kelly: In the U.S. market, product sales for the 23-24 vaccination season are now expected to come in below $25 million, which is less than our prior target. That said, we are closely monitoring the potential for the CDC to recommend a spring COVID-19 booster and will assess how that could impact demand and potential sales in the first half of 2024. Our cost of sales for the fourth quarter of 2023 was $155 million as compared to $182 million for the same period in 2022.

James Patrick Kelly: In the U S market product sales for the 'twenty three 'twenty four vaccination season or not.

James Patrick Kelly: Now expected to come in below $25 million, which is less than our prior target.

James Patrick Kelly: That said, we are closely monitoring the potential for the CDC to recommend spring COVID-19, booster and we'll assess how that could impact demand and potential sales in the first half of 2024.

James Patrick Kelly: Our cost of sales for the fourth quarter of 2023 were $155 million as compared to $182 million in the same period in 2022.

James Kelly: These periods include $30 million and $99 million, respectively, related to excess, obsolete, or expired inventory and losses on firm purchase commitments under third-party supply agreements. Please turn to slide 20. We are committed to creating a more lean and agile organization to align with the company's market opportunities. To advance that goal, over the past year, we've reduced our workforce by over 30 percent compared to the first quarter of 2023. We have also reduced our full year 2023 R&D and SG&A by over 500 million compared to the full year 2022. This result was approximately 150 million better than our original target, and we did so while maintaining core business capabilities and progressing our combination vaccine. For 2024, we are targeting combined R&D and SG&A expenses of $700 to $800 million.

These periods include $30 million and $99 million, respectively related to excess obsolete or expired inventory and losses on firm purchase commitments under third party supply agreements.

James Patrick Kelly: Please turn to slide 20.

James Patrick Kelly: We are committed to creating a more lean and agile organization to align with the companys market opportunities to advance cycle over the past year, we've reduced our workforce by over 30% compared to the first quarter of 2023.

James Patrick Kelly: We have also reduced our full year 2023, R&D and SG&A by over $500 million compared to the full year 2022.

James Patrick Kelly: This result was approximately 150 million better than our original target and we did so while maintaining core business capabilities and progressing our combination vaccine program.

James Patrick Kelly: For 2024, we are targeting combined R&D and SG&A expenses of $700 million to $800 million.

James Patrick Kelly: Yes.

James Kelly: In addition, we are prioritizing improvements to our long-term supply chain efficiency, including exploring the sale of our Czech Republic manufacturing facility. Please turn to slide 21, where I'd like to discuss progress on our balance sheet and liability management. During 2023, we will reduce the company's current liabilities by $825 million, and with the recently announced Gavi settlement, we will further reduce current liabilities by over $500 million in 2024. Of note, the Gavi Settlement provides for an equitable resolution of our differences and spreads any remaining liabilities over five years, allowing us to better manage cash flows and make appropriate investments to grow our business. When assessed on a present value and cost to capital basis, we estimate that the cost of the settlement will be in the range of $300 to $400 million. Please turn to slide 22.

James Patrick Kelly: In addition, we are prioritizing improvements to our long term supply chain efficiency, including exploring the sale of our Czech Republic manufacturing facility.

James Patrick Kelly: Please turn to slide 21, where I would like to discuss progress on our balance sheet and liability management.

James Patrick Kelly: During 2023, we reduced the company's current liabilities by $825 million with the and with the recently announced <unk> settlement. We will further reduce current liabilities by over $500 million in 2024.

James Patrick Kelly: Of note. The Godby settlement provides for an equitable resolution of our differences in spreads any remaining liabilities over five years, allowing us to better manage cash flows and make appropriate investments to grow our business.

James Patrick Kelly: When assessed on a present value and cost of capital basis, we estimate that the cost of the settlement to be in the range of $300 million to $400 million.

James Patrick Kelly: Please turn to slide 22.

James Kelly: Now turning to financial guidance with an emphasis on our total revenue. For the full year 2024, we expect to achieve total revenue of between $800 million and $1 billion. Our projected total revenue includes $500 million to $600 million of APA sales based on expected dose delivery schedules, and non-APA-related revenue of $300 to $400 million from a combination of commercial market product sales plus royalties and other revenue from our partner-related activities. We have previously guided to first quarter 2024 expected total revenues of approximately $300 million. Based upon a delay in our Australia XPB regulatory review, we now expect APA sales for both Australia and New Zealand, originally anticipated for the first quarter of 2024, to now occur later in 2024 upon their respective authorizations.

James Patrick Kelly: Now turning to financial guidance with an emphasis on our total revenue.

James Patrick Kelly: For the full year 2024, we expect to achieve total revenue of between $800 million and $1 billion.

James Patrick Kelly: Our projected total revenue includes $500 million to $600 million of EPA sales based on expected dose delivery schedules and.

James Patrick Kelly: And non EPA related revenue of $300 million to $400 million from a combination of commercial market product sales plus royalties and other revenue from our partner related activities.

James Patrick Kelly: We have previously guided to first quarter 2020 for expected total revenues of approximately $300 million.

James Patrick Kelly: Based upon a delay to our Australia X P. B regulatory review, we now expect sales for both Australia and New Zealand originally anticipated for the first quarter of 2024 to now occur later in 2024 upon their respective authorizations as a result, our first.

James Kelly: As a result, our first quarter 2024 total revenue is now expected to be approximately $100 million. If successful in achieving the guidance outlined today, we believe this will support the funding of our operations for the next 12 months. In our 10K filing, you will see that we have provided an update on our going concern disclosure, specifically that this forecast continues to be subject to significant uncertainty related to revenue for the next 12 months. 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. Please turn to slide 23.

James Patrick Kelly: Quarter 2020 for total revenue is now expected to be approximately $100 million.

James Patrick Kelly: If successful in achieving the guidance outlined today, we believe this will support the funding of our operations for the next 12 months.

James Patrick Kelly: In our 10-K filing you will see that we have provided an update on our going concern disclosure specifically that this forecast continues to be subject to significant uncertainty related to revenue for the next 12 months.

James Patrick Kelly: We look forward to sharing additional updates since we seek to improve novavax has 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: Thank you Jim Please turn to slide 23.

John Charles Jacobs: I am proud of the progress we made in 2023 and the opportunities we have identified that should help us to build a stronger business with our key priorities of executing on the 24-25 COVID season, advancing our combination vaccine, and creating a more financially stable organization. We are operating a business in a complex and challenging marketplace that is undergoing significant change but which also offers immense opportunities to positively impact global public health and drive significant value creation in the future. I would like to thank all of our employees for their continued work in advancing our business.

John: I'm proud of the progress we've made in 2023 and the opportunities we have identified that should help us to build a stronger business with our key priorities of executing on the 'twenty four 'twenty five COVID-19 season.

John: Advancing our combination vaccine and creating a more financially stable organization.

John: We are operating our business in a complex and challenging marketplace, which is undergoing significant change, but which also offers immense opportunity to positively impact global public health and drive significant value creation in the future.

John: I would like to thank all of our employees and their continued work in advancing our business together, we remain committed to generating successful performance and value creation for all of our stakeholders.

Operator: Together, we remain committed to generating successful performance and value creation for all of our stakeholders. And with that, we will now take your questions. Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. Should you have a question, please press the star followed by the 1 on your telephone keypad. Should you wish to cancel your request, please press the star followed by the 2. If you are using a speakerphone, please lift the handset before pressing any key.

Speaker Change: And with that we will now take your questions.

Speaker Change: Thank you ladies and gentlemen, we will now begin the question and answer session should you have a question. Please press the star followed by the one on your telephone keypad.

Speaker Change: Should you wish to cancel your request. Please press the star followed we did too.

Speaker Change: Thank you speaker phone please lift the handset before pressing ntt's one moment. Please for your first question.

Operator: One moment, please, for your first question. Your first question comes from the line of Roger Song from Jeffries. Please go ahead. Great. Good morning, everyone.

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

Great.

Roger Song: Good morning, everyone.

Roger Song: Thanks for the update and taking our questions. Maybe start with a few clarifications for the guidance. First is the 1Q 100 million. Given this is not coming from Australia and New Zealand, can you specify what countries these APAs are from? And then for the rest of the – for the entire 2024, 500 to 600 APA are coming out of the entire 1 billion APA outstanding balance. And my question is, do you expect to see new APA beyond this 1 billion in the coming years? If so, where will those countries come from?

Roger Song: Thanks for the update and taking a question maybe start with a few clarification for the guidance for <unk> is <unk> 100 milligram 100 mill.

Roger Song: Yes.

Speaker Change: So given this is not coming from Australia, and New Zealand.

Speaker Change: So can you specify.

Speaker Change: Where what are the countries for those HVA and then for the rest of that for the entire 2024 five to 688.

Speaker Change: It's coming out of the entire one gain in HCA outstanding.

Speaker Change: My question is.

Speaker Change: Do you expect to see new HCA beyond 1 billion in the coming years, if so where will be those country coming from and last the question relates to the revenue guidance.

John Charles Jacobs: And last question related to the revenue guidance is the 300 to 400 million APA 2024 guidance: how much is coming from the U.S.? If you can give us some color around that. Thank you. Thank you, Roger. There are three questions in there.

We have yet to find you a minute.

Speaker Change: Now <unk>.

Speaker Change: For guidance.

Speaker Change: How much is coming from the U S.

Speaker Change: If you can give us on that.

Speaker Change: Color around that thank you.

Speaker Change: Okay. Thank.

Speaker Change: Thank you Roger three questions in there Jim do you want to take Roger's first question on the source of the $100 million in Q1 certainly.

James Kelly: Jim, do you want to take Roger's first question on the source of the $100 million in Q1? Yes, certainly. Hey, good morning, Roger.

James Patrick Kelly: Hey, good morning, Roger.

James Kelly: So when we look at our Q1 guidance for 2024 that we just shared of $100 million, virtually all of that has, in fact, already been shipped. It is APAs to Europe that were delivered in January. So that is the vast majority of the guidance. As you referenced, our prior guidance for the first quarter of approximately $300 million did include expected sales to Australia and New Zealand. Now, as we have shared with all today, the review of our XBB dossier is still ongoing, and so it is our expectation that, upon authorization, we will make those deliveries later this year. Jim Rogers, third question you may want to address as well, just a breakdown of the non-APA revenue and what proportion of that comes from the U.S. if we heard you correctly. Hey, exactly.

James Patrick Kelly: So when we look at our Q1 guidance for 2024 that we just shared a $100 million virtually all of that has in fact already been shipped it was.

Roger Song: It is a P. A's to Europe that were delivered in January so that is the vast majority of the guidance.

Roger Song: As you referenced.

Roger Song: Our prior guidance for the first quarter of approximately $300 million did include expected sales to Australia, and New Zealand now as we have shared with all today.

Roger Song: That review of our <unk> dossier is still ongoing and so it's.

Roger Song: It is our expectation that upon.

Roger Song: <unk> that we will make those deliveries, but later this year.

Speaker Change: And Jim Rogers third question, you may want to address as well just a breakdown of the non IPA revenue and what proportion of that comes from the U S. If we heard you correctly Roger.

Speaker Change: Hey, exactly.

James Kelly: So, Roger, the component of our revenue guidance, and I'll just restate it here, the $800 million to $1 billion, midpoint $900 million is split between APA sales and non-APA revenue. You correctly noted $500 million to $600 million, midpoint $550 million for APAs, and non-APAs $300 to $400. And within that, we have two primary buckets. One is related to royalty and other revenue.

Speaker Change: So Roger the component of our revenue guidance and I'll just restate it here.

Speaker Change: The $800 million to 1 billion midpoint $900 million is split between EPA sales in non <unk> revenue.

Speaker Change: <unk>.

Roger Song: Correct, Lee noted $500 million to $600 million midpoint, $5 50 for <unk> non Apa's 300 to 400 and within that we have two primary buckets. One is related to royalty and other revenue as you might remember we have begun to receive some reimbursement related to our our 'twenty one.

James Kelly: As you might remember, we have begun to receive some reimbursement related to our R21. That income or economics would come in the form of both reimbursement of the matrix we manufacture in support of launch and ongoing sales. And then, finally, also a royalty that we could be eligible for upon those commercial sales. That's a single-digit royalty.

Roger Song: Income our economics would come in the form of both reimbursement.

Roger Song: The matrix, we manufacturer in support of launch and ongoing sales and then finally also a royalty that we could be eligible for upon those commercial sales.

Roger Song: Single digit royalty so that's a component of it and I would say frankly, a small component of it.

James Kelly: So that's a component of it. And I would say, frankly, a small component of it. In the remaining commercial portion, this is virtually all US, Europe, and the UK. And while we have not provided specific breakouts across those, these are exceptionally important markets for us. You heard John Trizzino speak a little bit earlier about how we are prioritizing our focus on these markets to establish them this year. And in the case of Europe, it was an important transition year from APA to commercial markets.

Roger Song: In the remaining commercial portion.

This is <unk>.

Roger Song: Virtually all U S Europe U K and while we have not provided specific breakouts across those.

Roger Song: These are exceptionally important markets for us.

Roger Song: John Trevino speak a little bit earlier about how we are prioritizing our focus in these markets to establish them this year and in the case of Europe.

Roger Song: [noise] transition year from EPA to commercial markets.

John Joseph Trizzino: Thank you, Jim. And then, Roger, the third portion of your question, John Trizzino, perhaps you can answer. I believe Roger was asking, would we expect, after this billion that we noted in remaining APA value, to have future APAs in the years beyond 2026? Yeah, thanks, John. So, APAs, generally speaking, were a function of the pandemic period of time in which we had advanced purchase agreements in place. As we transition to the commercial market, you're going to see a mix of the normal commercial market, as in the US, so payer-driven purchases through retailers. In Europe, it's again a mix between tenders and the private market.

John Trevino: Thank you Jim and then finally, Roger that third portion of your question Jon <unk>, Perhaps you can answer I believe Roger was asking would we expect after this $1 billion that we noted in remaining a P value to have future apa's in the out years beyond 2026.

Roger Song: Yeah, Thanks, John So.

Roger Song: Generally speaking we are a function of the pandemic period of time in which we had advanced purchase agreements in place as we transition to the commercial market, you're going to see a mix of.

Roger Song: Normal commercial market is in the U S. So payer driven.

Roger Song: Purchases through retailers in Europe, it's again, a mixed between tenders and private market.

John Joseph Trizzino: As we're already seeing in the UK, for example, we're going into private market retail and occupational health, and so there's a mix there of what those purchases will be. The traditional APAs will wind themselves down between now and 2026, and then we'll go to the normal commercial market. Thank you, John. Thank you, Roger. Thank you. Thank you. And your next question comes from the line of Eric Joseph from JP Morgan. Please go ahead. Hi, good morning.

Roger Song: We're already sitting in the UK for example, we're going into private market retail.

Roger Song: And occupational health and so there's a mix there of.

Roger Song: Of what those purchases will be the traditional apa's will why themselves down between now and 2026.

Roger Song: And then we will go to the normal commercial markets.

Speaker Change: Thank you John Thank you Roger.

Speaker Change: Thank you.

Speaker Change: Thank you and your next question comes from the line of Eric Joseph from Jpmorgan. Please go ahead.

Eric William Joseph: Hi, good morning.

Eric William Joseph: Thanks for taking the questions and all of the morning, Eric. It's a relief, as it relates to forward guidance. Can you hear me okay?

Eric William Joseph: Thanks for taking the questions and Oliver good morning, Eric as it relates to.

Eric William Joseph: As it relates to forward guidance.

Eric William Joseph: Hear me Okay.

Operator: Weekend. Good morning. Morning. So just a clarification question when it comes to U.S. sales this past quarter, there's an $82 million product sales return accrual item that we noticed. Can you just help reconcile that with recorded product sales for the full year of around $29 million in the U.S.? Is the difference there just, you know, the difference between growth and net sales?

Speaker Change: We can good morning.

Speaker Change: Good morning.

Speaker Change: So just Claire.

Speaker Change: Clarification question when it comes to U S sales this past quarter.

Speaker Change: $82 million product sales return accrual item.

Speaker Change: Let me notice can you just help reconcile that with recorded product sales.

Speaker Change: For the full year of around $29 million in the U S is the difference there just.

Speaker Change: <unk> seen growth in net sales and then is there any concentration of those.

Eric William Joseph: And then, perhaps just one on the development side as it relates to kick and your expectation of an accelerated approval path there? Can you just sort of clarify what gives confidence and being able to pursue a sort of, it sounds like an approval on the basis of immunogenicity, just given that there isn't yet an approved reference tick offering in the market? Thank you. All right, Jim Kelly, why don't you take the first part of that question, then we'll hand it over to Filip to address the question on KIC. Hey, certainly. Good morning, Eric.

Speaker Change: These returns by contracted among bigger contracted pharmacies and then perhaps just one on the development side as it relates to kick in your expectation of accelerated approval path. There can you just sort of clarify what <unk>.

Speaker Change: Gives you a pause.

Speaker Change: Confidence in being able to pursue a sort of it sounds like.

Speaker Change: And.

Speaker Change: An approval on the basis of the Immunogenicity, just given that there isn't yet.

Speaker Change: It approved.

Speaker Change: Reference.

Speaker Change: Offering in the market. Thank you.

Speaker Change: All right Jim Kelly when you take the first part of that question and then we'll hand it over to Philip to address the question on kick he certainly.

James Patrick Kelly: Good morning, Eric So in our feedback today on the U S market, what I shared with folks is that for the 2023 'twenty four season in the U S. We're expecting total revenues for the U S market to be below $25 million.

James Kelly: So in our feedback today on the U.S. market, what I shared with folks is that for the 2023-24 season in the U.S., we're expecting total revenues for the U.S. market to be below $25 million. We did not break out the specific number for the fourth quarter, but given that guidance we just gave you, the vast majority is in the fourth quarter. As you are looking at what folks will find in our 10K, which is a gross to net roll forward, what you have identified is that we have a reserve for returns that are embedded within our financials. That number is just over $90 million. What that means is that we have sales into the channel; those are to our direct purchasers, who in turn sell to retail establishments.

Philip: We did not break out the specific number for the fourth quarter, but given that that guidance. We just gave you. The vast majority is in the fourth quarter. As you are looking at what folks will find in our 10-K, which is a gross to net roll forward. What you have identified is that we have.

Philip: Have a reserve for returns that are embedded within our financial set numbers just over $90 million. What that means is that we have sales into the channel.

Philip: Those are to our direct purchasers they in turn sell to retail establishments and then we make an estimate based on the.

James Kelly: And then we make an estimate based on the shots in arms that we have through IQVIA for what may be eligible, and we estimate would be eligible for a return at the end of the season. It is simply an estimate at this time. We will monitor it closely as the year goes on, but our net revenue, in the case of the United States, for the fourth quarter is a function of that return estimate that you're seeing in our roll forward financials. It is net of that amount.

Philip: The shots in arms that we have through IQ via for what may be eligible and we estimate would be eligible for return upon the end of the season. It is simply an estimate at this time, we will monitor it closely as the year goes on.

Philip: But our net revenue in the case of the United States for the fourth quarter is a function of that return estimate that you are seeing a roll forward financials. It is net of that amount.

James Kelly: Okay, great. That's very helpful. Filip, do you want to take Eric's second question on... Oh, Eric, did you have a follow-up there? No, no, no. That's fine.

Speaker Change: Okay, Great. That's that's very Phil Philip do you want to take Eric second question.

Philip: Oh, Eric did you have a follow up there.

Eric William Joseph: No no no that's fine that's thank you. Thank you yes. The follow up question on the on the development side.

Filip Dubovsky: Thank you. Thank you. The follow-up question on the development. Yeah, we have a couple of lines of evidence to give us confidence.

Philip: Yeah, we have a couple of lines of evidence to give us confidence I mean as you know we had a prior phase III study that was actually granted.

Filip Dubovsky: I mean, as you know, we've had a prior phase 3 study that was actually granted the accelerated approval pathway by the FDA. So we know what endpoints and how we need to achieve those. And certainly, the immune responses that I shared in the slides today would be adequate to achieve the same ones we used in our prior phase 3 study. We also know that the competitors are talking about timelines, which would indicate that they're pursuing an accelerated approval pathway. But I think most importantly, the FDA told us, right? So they reviewed our plans and our study, and what they told us was that if we achieve the agreed-upon endpoints, and we are able to demonstrate meaningful therapeutic benefit, then there's a pathway forward to accelerated approval. Now, they also said that they would have to wait to see the data before they made the final determination.

Philip: Accelerate approval pathway by the FDA, So we know what endpoints and how we need to achieve that certainly the immune responses that I shouldnt slides today would be adequate to achieve the same ones. We used in our prior phase III study. We also know the competitors are.

Eric William Joseph: Talking about timelines, which would indicate they're pursuing accelerated approval pathway, where I think most importantly, the FDA told us.

Eric William Joseph: Alright, so they reviewed our plans and our study and what they told US was that if we achieve the.

Eric William Joseph: <unk> agreed upon endpoints.

Eric William Joseph: And we are able to demonstrate meaningful therapeutic benefit then there's a pathway forward to accelerate approval now. They also said they would have to wait to see the data before they took the final determination by the strength of the immune responses, we're seeing compared to the comparator.

Filip Dubovsky: But the strength of the immune responses we're seeing compared to the comparators, as well as our prior experience with this conference, suggests we have a pathway forward. Thank you, Jim and Philip. Thanks, Eric. Eric, did you have a follow-up? One more follow-up, if I could, on full year, full year 24 guidance, the non-APA portion of that. What, to what extent is, [inaudible] That guidance sort of conditioned on or dependent on additional regulatory or recommendations. U.S., U.K., and Europe. Jim, did you want to take that one? And then John Trizzino can add color if needed.

Eric William Joseph: As well as our prior experience gives us confidence that we have a pathway forward.

Speaker Change: Okay. Thank you Jim.

Speaker Change: Eric.

Speaker Change: Erik did you have a follow up.

Eric William Joseph: One more follow up if I could on on.

Eric William Joseph: Full year full year 'twenty for guidance.

Eric William Joseph: The non API.

Eric William Joseph: A portion of that.

Eric William Joseph: What.

Eric William Joseph: To what extent is.

Eric William Joseph: <unk>.

Eric William Joseph: That guidance sort of condition or dependent on additional.

Eric William Joseph: Regulatory approvals.

Eric William Joseph: Recommendations.

Eric William Joseph: The U S UK and Europe.

Eric William Joseph: Yes.

Eric William Joseph: Jim did you want to take that one John Trevino can add color if needed go out well he certainly.

James Kelly: Go ahead. Well, hey, certainly. So the non-APA revenue guidance, $300 million to $400 million, is virtually all, except for that small portion related to R21, concentrated on the fall vaccination season.

Speaker Change: So the <unk>.

Jim: Non EPA revenue guidance three to 400 million is virtually all except for that small portion related to our 21 concentrated on the fall vaccination season, and so the regulatory authorization, so we'd be supportive of recognizing that.

James Kelly: And so the regulatory authorizations that would be supportive of recognizing that outcome are all linked to our updated variant, speeding the market and regulatory authorizations to support that commercial market performance. Thank you, Jim. Thanks, Eric.

Eric William Joseph: That outcome.

Eric William Joseph: Are all linked to our updated variant speed to market and regulatory authorizations to support that commercial market performance.

Speaker Change: Thank you Jim Thanks, Eric.

Brendan Mychal Smith: Thank you. Your next question comes from the line of Brendan Smith from Cedar Cullen.

Speaker Change: Thank you. Your next question comes from the line of Brendan Smyth with Cowen. Please proceed.

Operator: Hi guys. Thanks very much for taking the questions. Just a quick one from us, actually. Apologies if I missed it in your comments, but I think you mentioned that you saw up to about 10% share in the U.S. in retail outlets where you were carried on an even playing field.

Brendan Smyth: Hey, guys. Thank you very much for taking the questions a quick one from us actually apologize if I missed it in your comments, but I think you mentioned the aesop to about 10% share in the U S.

Brendan Smyth: In retail outlets, where you were carried on an even playing field. Just wondering if you could maybe expand on that a little bit really kind of what that looks like theres something about those areas, where you could expand even further this year and into next year, maybe what your plans for that would look like.

John Joseph Trizzino: Just wondering if you could maybe expound on that a little bit, really kind of what that looks like. If there's something about those areas where you could expand even further this year and into next year, maybe what your plans for that would look like. And then maybe quickly what the important steps between now and a potential approval would look like if you were to prioritize that prefilled syringe and any meaningful differences you'd expect. John Trizzino, do you want to take Brendan's question and maybe discuss what's different in our intentions for 24 versus 23? Yeah, sure. So yeah, that was a great example of the 10%.

Brendan Smyth: And then just maybe quickly.

Brendan Smyth: What kind of the important steps between now and a potential approval would look like if you were to prioritize that pre filled syringe and any meaningful differences you'd expect for that process versus last year.

Brendan Smyth: John do you want to take care of Brennan's question, and maybe discuss what's different and our intentions for 24 versus 23.

John: Yes sure.

John: So that was a great example.

John: 10% and we also had an other instance, where we had a five 4% to 5% share in similar circumstances.

John Joseph Trizzino: And we also had another instance where we had a five, four to 5% share in similar circumstances. You know, we, as we said, we came to the market a little bit late. So vaccinations were underway, and five dose vial created some challenges.

John: We as we said we came to the market a little bit late so vaccinations were underway.

John: And five dose vial created some challenges and so as we look forward.

John Joseph Trizzino: And so as we look forward to this, you know, the benefit of having a well-informed pharmacy population and pharmacists educated is going to help in that regard of timely availability of product. Pre-filled syringes are going to make it much more convenient for use. And so, as we've mentioned, three critical elements here for success in 24 are early September, on time availability of the product in front of the vaccination season, BLA, which is in the process right now through rolling submission, and pre-filled syringes making it easy and convenient use for other pharmacists. We believe that these will make a dramatic difference in what we see as our performance in 24. And John, just a little bit of additional commentary, well said, but I think that 10%, Brendan, that you mentioned in a key retailer, when we say an even playing field, we were still several weeks behind the competition in a five-dose vial, and we were able to achieve that in just a few weeks of being on the market.

John: To this the benefit of having a well informed pharmacy population.

John: Pharmacists are.

John: <unk>.

John: There is going to help in that regard.

John: Timely availability of product.

John: Pre filled syringe is going to make it much more convenient for use and so as we've mentioned.

John: Three critical elements here for success in 'twenty four is early September on time availability of product in front of the vaccination season.

John: <unk>, which is in process right now through rolling submission.

John: And pre filled syringe, making it easy and convenient used for the pharmacies. We believe that these will make dramatic difference in what we see as our performance in 'twenty four.

John: And John just just a little bit of additional commentary well said, but I think that 10% Brendon that you mentioned in a key retailer when we say even playing field. We were still several weeks behind the competition in a five dose vial and we were able to achieve that in just a few weeks being on the market. So we're confident that.

John Charles Jacobs: So we're confident that should we execute on the plans we intend to execute upon, which include a pre-filled syringe, an on-time launch in the marketplace, being on an even playing field when it comes to pharmacy schedulers, that consumers can go in and schedule their shots, which wasn't the case in 2023, in our first year in the U.S. market. And we are encouraged by the early dialogue we had starting this past fall with retailers, and I think it was a surprise to everyone that the COVID market in the United States was over, like John said in our earlier commentary, 95% plus retail, nothing really coming out of the IDNs of the physician offices. So we've recalibrated, reorganized our internal team and our focus on retail, started those conversations in the fall, and we are very encouraged by where those are headed right now, and that makes us more optimistic about it being much better positioned for success in 2024. Thank you. And your next question comes from the line of Mayank Mamtani from V. Riley Securities. Please proceed. Good morning, team.

John: Should we should we execute on the plans, we intend to execute upon which include a pre filled syringe and on time launch in the marketplace being on an even playing field when it comes to the pharmacy schedulers that consumers can go in and schedule their shots, which wasn't the case.

John: 2023, and our first year in the U S market and we have we're encouraged by the early dialogue. We had starting this past fall with retailers and I think it was a surprise to everyone that the COVID-19 market in the United States was over like John said in our in our earlier commentary and 95% plus retail.

John: Nothing really coming out of the <unk> of the physician offices. So we've recalibrated reorganized our internal team and our focus on retail started those conversations in the fall are very encouraged by where those are headed right now and that makes us more optimistic for it to be much better positioned for success in 24. Thank you.

Speaker Change: Great. Thanks, guys.

Speaker Change: Thank you and your next question comes from the line of Matt <unk> from B Riley Securities. Please proceed.

Matt: Good morning team. Thanks for taking my question and appreciate the level of detail, including on the <unk> settlement. So maybe just on the current liabilities.

Mayank Mamtani: Thanks for taking our questions and I appreciate the level of detail, including on the GAVI settlement. So maybe just on the current liabilities section, could you just break out beyond GAVI, what sort of components remain, and how they contribute to the influence on the going concern language and maybe just, you know, the cash outlays you expect in 2024. Then I will follow up. Yeah, and Jim Kelly will take that, Mayank, and I think we're very proud that in the past year we've made a lot of good progress on removing a significant portion of the one-time current liabilities that were a legacy of the pandemic, many of the take or pay contracts or other matters. I'll let Jim Kelly give you more detail on the current liability breakdown. All right.

Matt: Could you just break out beyond <unk>.

Matt: What sort of confidence remain and how they contribute to the influenza on going concern language.

Speaker Change: Maybe just.

Speaker Change: The cash outlays, you expect in 2024 specific need and you get that but I think it would just make that that'd be great and then I have a follow up Jim Kelly will take that Mike and I think we're very proud that in the past year. We've made a lot of good progress on removing.

Speaker Change: A significant portion of the one time current liabilities that were legacy of the pandemic many of the take or pay contracts or other matters I'll, let Jim Kelly gave you more detail on current liability breakdown, Jim Alright, Hey, good morning, Mike.

James Kelly: Hey, good morning, Mayank, and I'm going to reference slide 21 from our presentation for listeners. And, as John noted, hey, we were able to knock down current liabilities by 825 million during 2023. And as we look at the impact of the GAVI settlement, we will be in a position to reduce those liabilities by over 500 million, our balance sheet, and that's really by spreading the remaining, any remaining liability over five years.

James Patrick Kelly: And if I'm going to reference slide 21 from our presentation for listeners.

Jim: So as Sean noted, we were able to knockdown current liabilities by 825 million during 2023 and as we look at the impact of the <unk> settlement, we will be in a position to reduce those liabilities by over $500 million on our balance sheet and Thats really.

Jim: By spreading the remaining any remaining liability over five years so.

James Kelly: So we are actually exceptionally pleased with what that means in terms of predictability of cash flow and marrying that up with our core operating plan. And then with respect to liabilities at 12-31-2023, I'll reference a couple spots. I'll start with the other current liabilities category of 861. So within that, it's approximately 700 million related to GAVI. And so, as just noted, over 500 million of that will move to long-term liabilities as we continue to move forward. And then the remaining components of that were, there are 112 million related to the UK.

Jim: So we are actually exceptionally pleased on what that means in terms of predictability of cash flow and and marrying that up with our core operating plan and.

Jim: Then with respect to liabilities at 12 31 2023.

Jim: I'll reference a couple a couple of spots I'll start with the other current liabilities category of 861, so within that it's approximately $700 million related to coffee and so as <unk> noted.

Jim: Over $500 million of that will move to long term long term liabilities.

Jim: We are continuing to move forward and then the remaining components of that where theres $112 million related to the U K.

James Kelly: We've got some other small refund liabilities related to other APA-related matters, small items. And then finally, there's a facility operating lease in there as well. So those are the components of the 861.

Jim: We've got some other small refund liabilities related to other EPA related matters small items and then finally its theres our facility operating lease in there as well. So those are the components of the <unk>.

Jim: 861.

James Kelly: With respect to AP and accrued, when you look at the 527, we continue to have our Fuji matter outstanding. I think folks have or heard the update. You'll see it.

Jim: With respect to AP and accrued when you look at the 527.

Jim: We continue to have our Fuji matter outstanding I think folks have.

Jim: Heard the update Youll see it we are on a track towards a arbitration hearing in may.

James Kelly: We are on a track towards a arbitration hearing in May. We, of course, feel strongly about the merits of our case and await that outcome. In addition to that, as we look at the remaining components of AP and accrued, they're part and parcel primarily of just the standard business operations of the company.

Jim: We of course.

Jim: I feel strongly about the merits of our case and await that with that outcome.

Jim: In addition to that as we look at the remaining components of AP and accrued.

Jim: Part and parcel primarily of just standard business operations of the company.

James Kelly: And this is one of the things that we're exceptionally proud of. As the years progressed, we have increasingly, I'll call it, cleared the deck of many of these legacy pandemic era manufacturing taker bays. And we're moving much more to a traditional streamlined balance sheet of an operating entity. So hopefully, that helps with the balance sheet. Super helpful. And then just on the monetization of non-core assets, any update on the Czech manufacturing plant would be helpful.

Jim: And this is one of the things that we're exceptionally proud of FSC Euro has progressed, we have increasingly also I'll call. It cleared the deck of many of these legacy pandemic era manufacturing take or pays and we're moving much more to a traditional streamlined balance sheet of operating entity.

Jim: So hopefully that helps with.

Jim: With the balance sheet.

Speaker Change: Super Helpful. And then just on monetization of noncore assets any any update on the Czech manufacturing would be helpful. And then just one more follow up after that.

Mayank Mamtani: And then I'll just do one more follow up. Yeah, go ahead, Jim. Do you want to take the check plant question?

Jim: Yes go ahead, Jim you want to take the checkpoint question, yes, well certainly and.

James Kelly: Yeah, well, certainly. And, um, Mayank, as we continue to drive towards a more lean and agile organization, the supply chain is of exceptional importance to us with that question. And while a, um, certainly a difficult decision, right, to explore this sale, we recognize that it is an area of, um, opportunity for streamlining and improving efficiencies in our supply chain.

Jim: Mike as we continue to drive towards a more lean and agile organization supply chain is something exceptional importance to us with that without question and while a certainly a difficult decision right to explore the sale we recognized that it is an area of.

Jim: <unk>.

Jim: Opportunity for streamlining and improving efficiencies in our supply chain.

James Kelly: Um, we do anticipate leveraging this check plant this year. Uh, it is a part of our network for delivery of doses into Europe and other, I'll call it Europe-reliant, uh, markets that rely on their regulatory authorization. And so we're exceptionally thankful to that team and everything they're doing, uh, to drive, uh, product sales this fall. Uh, we are at the beginnings, via, uh, working with our broker to get indications of interest. It's a great plant and I have every expectation that we will certainly have a robust interest, and we'll keep you posted.

Jim: We do anticipate leveraging this Czech plant. This year. It is a part of our network for delivery of doses into Europe, and other I'll call. It Europe reliant markets that rely on their regulatory authorization.

Jim: So we're exceptionally thankful to that team and everything they're doing to drive product sales. This fall.

Jim: We're at the beginnings via working with our broker to get indications of interest.

Jim: A great plant and.

Jim: Pre expectation.

Jim: That we will we will certainly have a robust interest and we'll keep you posted on that.

Filip Dubovsky: And just last question about the KIC Combo program, integrating what you've learned from the COVID plus and flu monotherapy phase three trials. You know, just what should we look for in these ACIP public meetings for respiratory vaccines that, you know, help sort of build on the recent FDA interactions that you've had. So just if you could lay that out, that would be helpful.

Speaker Change: Great and just last question about the gig combo program integrating what you've learned from the Covid and flu monotherapy phase III trials.

Jim: What should we look for in these ACI public meetings for our respiratory vaccines that.

Jim: Head sort of build on the recent FDA interactions that you've had.

Speaker Change: If you could lay that out that would be helpful. Thanks again for taking our questions.

Filip Dubovsky: Thanks again for taking the time. Yeah, I think that's kind of a tricky question. I mean, you know, we don't have any combination COVID influenza vaccines that have received ACIP approval to date, and we really don't expect them to come up before ACIP for a couple of years at the earliest. So I think we'll have to wait and see. We know there's a lot of interest from public health authorities, both in the US and globally, to reduce the number of jabs to get people protected, and they see it as a way to increase COVID vaccination because people are, in large part, getting their flu vaccine.

Speaker Change: Yes, I think that's kind of a tricky question I mean, we don't have any combination.

Speaker Change: Covid influenza vaccines that have received as CIP approval to date and really don't expect it to come out before ACI.

Speaker Change: For a couple of years at the earliest.

Speaker Change: So I think we'll have to wait and see we know theres a lot of interest from the public health authorities, both in the U S and globally to a reduced number of jobs to get people protected and they see it as a way to increase COVID-19 vaccination because people are in.

Speaker Change: A large getting their flu vaccines. So I think we will see when it happens, but I think that as you know us and other people in the world are pursuing this because we think it's the right way to go forward.

Filip Dubovsky: So I think we will see when it happens. But I think that, as you know, us and other people in the world are pursuing this because we think it's the right way to go forward. Thanks. Thank you. And your last question comes from Alec Stranahan from Bank of America. Please go ahead. Hey guys, good morning. Can you hear me?

Speaker Change: Yes.

Speaker Change: Thank you.

Speaker Change: Thank you and your last question comes from the line of Alex Shanahan from Bank of America. Please go ahead.

Alec Stranahan: Hey, guys. Good morning can you hear me okay.

Alec Stranahan: Okay? We can. Good morning, Alec. Great, thanks for taking my questions. Just two quick ones from me.

Alec Stranahan: We can good morning, Alex.

Speaker Change: Great.

Alec Stranahan: Thanks for taking my questions just two quick ones for me.

Alec Stranahan: Maybe just to put a finer point on the BLA, I guess based on the latest FDA guidance. Is your go-forward assumption that a formal BLA will be required to commercialize your COVID vaccine next fall in the U.S. And maybe if you could walk us through what's going on now and the remaining hurdles to get both the single-dose presentation and the BLA over the finish line, that'd be great.

Alec Stranahan: Maybe just to put a finer point on the BLA I guess based on the latest FDA guidance.

Speaker Change: Is there a go forward.

Speaker Change: <unk> that a formal BLA will be required to commercialize your COVID-19 vaccine next fall in the U S. In.

Speaker Change: And maybe if you could walk us through what's going on now and remaining hurdles to get both the single dose presentation and.

Speaker Change: The BLA over the finish line that'd be great. Thanks.

John Joseph Trizzino: Thanks. John Trizzino, do you want to take Alec's question? Yes. Yeah. So the BLA pathway is what we're pursuing at the moment, but as you stated, there is an option for EUA if that's needed, given timing. The most significant piece of the strategy here is to be on time for market. So whether that be under EUA or BLA will allow us to be present in front of the vaccination season, and allow us to bring our pre-filter into the market for the convenience of the healthcare providers. And so I think those elements are the most significant pieces.

Speaker Change: John do you want to take Alex question.

John: Yes, yes so.

John: The BLA pathway is is what we're pursuing at the moment, but as you stated there is an availability for EUA. If that's needed given timing. The most significant piece of the strategy here is to be on time for market, so whether that'd be under EUA or or BLA will allow us to be president.

John: One of the vaccination season.

Speaker Change: Wow us to bring our pre filled syringe to the market for the convenience of the health care providers.

Speaker Change: And so I think those elements are the most significant piece, we do have a lot of work that's being conducted between our regulatory teams and our CMC teams with with seeber to ensure that there is a sharing of information under this rolling submission. The intent of the rolling submission is to get them as much information as early as possible.

John Joseph Trizzino: We do have a lot of work that's being conducted between our regulatory teams and our CMC teams with CBER to ensure that there is a sharing of information. Under this rolling submission, the intent of the rolling submission is to get them as much information as early as possible to streamline their review process. I can't comment upon regulatory timing, but we're making significant headway in making that possible for the fall season.

Speaker Change: To streamline their review process.

Speaker Change: Can't comment upon kind of regulatory timing, but we're making significant headway and in making that possible for for the fall season. So.

John Joseph Trizzino: So look, we're confident in the data that we're providing. We're confident in that process, and we're confident in the data that we have so far to deliver against those three objectives.

Speaker Change: Look we're confident in the data that we're providing we're confident in that process and we're confident in the data that we have so far to deliver against those three objectives.

John Joseph Trizzino: Thank you, John. Thank you. There are no further questions at this time. I will now. Kind of call over to Mr. John Jacob.

Speaker Change: Thank you John.

Speaker Change: Thank you there are no further questions at this time I will now turn.

Speaker Change: I'll turn the call over to Mr. John Jacob. Thank you. Please proceed.

John Charles Jacobs: Thank you. Please proceed. Thank you, everyone, for joining us today. We wish you a great end to your week. Thank you. That does conclude our conference for today. Thank you all for participating. You may all disconnect.

John Jacob: Thank you everyone for joining us today, we wish you a great close to your week.

Speaker Change: Thank you that does conclude our conference for today. Thank you all for participating you may all disconnect.