Q1 2022 Novavax Inc Earnings Call

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Good afternoon, and welcome to the Nova expert quarter doesn't want me to financial results and operational highlights conference call. All participants will be in a listen only mode. Because you need assistance. Please signal conference specialist by pressing the star the Star key followed by zero.

Operator: Thank you for watching. Good afternoon and welcome to the Novavax First Quarter 2022 Financial Results and Operational Highlights Conference Call. All participants will be in a listen-only mode.

Operator: Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then 1 on your touch-tone phone.

After today's presentation there'll be an opportunity to ask questions to ask a question you May Press Star then one on your Touchtone phone to withdraw your question. Please press Star zero.

Please note this event is being recorded.

I'd now like to turn the conference over to Silvia Taylor Senior Vice President of Global Corporate Affairs and Investor Relations. Please go ahead.

Operator: To withdraw your question, please press star then 2. Please note this event is being recorded. I would now like to turn the conference over to Sylvia Taylor, Senior Vice President of Global Corporate Affairs and Investor Relations. Please go ahead.

Good afternoon, and thank you all for joining us today to discuss our first quarter 2022 operational highlights and financial results.

Sylvia Taylor: Good afternoon, and thank you all for joining us today to discuss our first quarter 2022 operational highlights and financial results. A press release announcing our results is currently available on our website at Novavax.com. An audio archive of this conference call will be available on our website later today.

Press release announcing our results is currently available on our website at Novavax Dot com and <unk>.

Oh archive of this conference call will be available on our website later today.

Before we begin with prepared remarks, I need to remind you that we will be making forward looking statements. During this teleconference, which are based on our current expectations and beliefs. For example statements relate into 2022 financial guidance future financial or business performance conditions or strategy, including expectations regarding revenue product demand.

Sylvia Taylor: Before we begin with prepared remarks, I need to remind you that we will be making forward-looking statements during this teleconference, which are based on our current expectations, For example, statements related to 2022 financial guidance. Federal Financial or Business Performance, Conditions or Strategy, including Expectations regarding revenues, product demand, operating expenses, growth margins, cash usage, clinical development of our vaccine candidates, timing the future regulatory and filing, authorizations and actions, and other interstate milestones are forward looking state.

Operating expenses gross margin cash usage clinical development of our vaccine candidates.

I mean, the future regulatory filings authorizations in action and other anticipated milestones are forward looking statements.

<unk> cautions that these forward looking statements are subject to numerous assumptions risks and uncertainties, which change over time and actual results could differ materially from what is described in such statements.

Sylvia Taylor: Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks, and assumptions, change over time, and actual results could differ materially from what is described in such statements. Please turn to slide three. During this call, we will be referring to a non-GAAP financial measure, which is not prepared in accordance with U.S. generally accepted accounting principles.

Please turn to slide three.

During this call we won't be referring to our non-GAAP financial measure, which is not prepared in accordance with U S. Generally accepted accounting principles. The most directly comparable financial measure calculated in accordance with GAAP and a reconciliation of GAAP to the non-GAAP measure is contained in the presentation is available on our website at IR Dot Hill.

Sylvia Taylor: The most directly comparable financial measure calculated in accordance with GAAP and a reconciliation of GAAP to the non-GAAP measure is contained in the presentation and is available on our website at ir.novavax.com, please turn to slide four. Joining me today is Stan Erck, President and CEO, who will provide an overview of recent achievements and our upcoming strategic priorities. Additionally, John Trizzino, Chief Commercial Officer and Chief Business Officer, will provide an update on the status of our global COVID-19 vaccine rollout and our current regulatory progress.

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Please turn to slide four.

Joining me today is Stan <unk>, President and CEO, who will provide an overview of recent achievements and our upcoming strategic priorities. Additionally, John Trevino, Chief Commercial officer, and Chief business Officer will provide an update on the status of our global COVID-19 vaccine rollout and our current regulatory progress.

Dr. Philip Dubowski, Chief Medical Officer will discuss our clinical and regulatory strategy across our pipeline and Jim Kelly Chief Financial Officer, and Treasurer will provide an overview of our financial results Dr. Greg Glenn President of research and development will also be available for the Q&A section at the end of today's call I'd now like to.

Hand, the call over to Stan Please turn to slide five.

Sylvia Taylor: Dr. Filip Dubovsky, Chief Medical Officer, will discuss our clinical and regulatory strategy across our pipeline, and Jim Kelly, Chief Financial Officer and Treasurer, will provide an overview of our financial, Dr. Greg Glenn, President of Research and Development, will also be available for the Q&A section at the end of today's call. I'd now like to hand the call over to Stan.

Stan Erck: Please turn to slide 1. Thank you, Sylvia. And thanks everyone for joining us today to discuss Novavax's first quarter results. We had a landmark start to 2022, reporting today a major milestone for Novavax. Our first ever profitable quarter as a commercial stage company, reporting $203 million in net income and $704 million in total revenue. These accomplishments are the result of continued execution on our strategic objectives, deliver our COVID vaccine globally, advance our pipeline of new strains and combination vaccines. Proud of our strong progress throughout the first quarter.

Thank you Sylvia and thanks, everyone for joining us today to discuss novel vaccine first quarter results.

A landmark start 2022 reporting today, a major milestone for <unk>, our first ever profitable quarter.

Virtual stage company reporting $203 million net income of $704 million in total revenue.

These accomplishments are the result of continued execution on our strategic objectives to deliver a COVID-19 vaccine globally and advance our pipeline of new strange combination vaccine.

Proud of our strong progress throughout the first quarter since the start of the year, we've increased our global impact strengthened our capabilities as a commercial stage vaccine.

Stan Erck: Since the start of the year, we've increased our global impact, strengthened our capabilities as a commercial stage vaccine. I'd like to begin today's call by highlighting the key accomplishments since the start of the year that demonstrate the substantial progress we've made, continued the successful launch of Novavax globally, with vaccinations underway in key markets around the world, secured additional authorization. Full approvals for primary vaccination in adults further solidify our global research. In the U.S., we reached a major milestone in our pathway to EUA with a VRBPAC meeting now set for June 7th following the successful completion of an inspection of our manufacturing site at Serum Institute of India. Our expectation with the VRBPAC meeting is authorization for primary vaccination in adults.

I'd like to begin today's call.

Stan Erck: We have already submitted our adolescent data, and we will be submitting additional data for boosting to the FDA. For additional indications, the timing of review will be a decision the FDA will have to make in the coming... Cheny II X, [inaudible] vicious strategy to pursue an expanded label for our COVID-19 vaccine, including indications for pediatrics. We recognize variants continue to emerge, and we remain ready to pivot and bring the relevant vaccines to market.

The key accomplishments since the start of the year that demonstrate the substantial progress we've made.

We continued the successful launch of the vaccine globally with vaccinations underway in key markets around the world.

We secured additional authorizations and full approvals primary vaccination of adults further solidifies our global research.

Global reach.

In the U S. We reached a major milestone or pathway to <unk> with a <unk> meeting Dow set for June 7th following the successful completion of an inspection of our manufacturing site of service to <unk>.

Our expectation with the <unk> meeting is authorization for primary vaccination in adult we've already submitted our adolescent data and we will be submitting additional data for boosting to the FCA.

For additional indications the timing of review will be a decision the FDA will have to make in the coming weeks.

We continue to execute an ambitious strategy to pursue an expanded label for our COVID-19 vaccine, including indications for pediatrics and boosting.

We recognize various continue to emerge and we remain ready to pivot and bring the relevant vaccine to market.

We are advancing an overgrown monovalent and bivalent option is expected to be in the clothing later this month.

Stan Erck: We are advancing an Omicron monovalent and bivalent option and expect it to be in the clinic later this week. We also advanced our COVID-19 influenza combination vaccine, through a Phase I-II trial, goal to advance this candidate into a phase 2 trial before the end of the year, strong execution of our commercial launch plan and clear line of sight into our opportunities, we are well positioned to achieve our guidance of full year 2022 total revenue between $4 and $5 billion. And with that, John Trizzino will now discuss the commercial launch of Novavax. Thank you, Stan.

We also had been answered COVID-19 influenza combination vaccine through a phase one two trial with the goal to advance this candidate into a phase II trial before the end of the year.

This strong execution of our commercial launch plan.

Your line of sight to our opportunities.

Well positioned to achieve our guidance for full year 2022, total revenue between four and $5 billion.

With that John <unk>, who will now discuss the commercial launch.

It.

Please turn to slide six.

John Trizzino: Please turn to slide 6. Today, I'd like to provide an update on our COVID-19 vaccine rollout. Then, I'll touch on our ongoing efforts to ensure optimal supply and distribution of our vaccine, as well as our regulatory progress. Following the successful initial delivery of our vaccine to Indonesia in the fourth quarter, we've continued the global rollout of Nuvaxovid, our COVID-19 vaccine, and Covovax, the trade name for our COVID-19 vaccine, manufactured and marketed by CIRMIN, to additional key markets.

Today I'd like to provide an update on our COVID-19 vaccine rollout then I'll touch on our ongoing efforts to ensure optimal supply and distribution of a vaccine as well as our regulatory progress.

Following the successful initial delivery of our vaccine to Indonesia in the fourth quarter. We've continued the global rollout of new batch of it our COVID-19 vaccine and Kobo backs. The trade name for our COVID-19 vaccine manufacturer and marketed by serum Institute two additional key markets.

Through the first quarter.

John Trizzino: Through the first quarter, over 42 million doses have been delivered globally, including to the European Union, Canada, South Korea, Australia, New Zealand, and Indonesia. And as Stan mentioned, vaccinations, with Nuvaxavit and Colavax are underway in all of these markets. We continue to receive positive feedback from our customers in market as doses of our vaccine are delivered. While we are pleased with the initial utilization of our vaccine, we expect to see additional pull-through within these markets in the coming months as demand continues with recent surges of COVID around the world. As we look ahead to the second quarter, we expect our shipments to key markets to increase.

Over 42 million doses have been deliberate globally, including to the European Union, Canada, South Korea, Australia, New Zealand and Indonesia.

As Stan mentioned vaccinations.

This new vaccine they didn't cola backs are underway in all of these markets.

We continue to receive positive feedback from our customers in market as doses of our vaccine or delivery.

While we are pleased with the initial utilization of our vaccine we expect to see additional pull through within these markets in the coming months as demand continues with recent surges of COVID-19 around the world.

As we look ahead to the second quarter, we expect our shipments to key markets to increase.

This includes the European Union, where we are fulfilling on our previously disclosed 42 million dose order and as a result, we expect increased product revenue for Q2.

John Trizzino: This includes the European Union, where we are fulfilling a previously disclosed 42 million dose order, and as a result, we expect increased product revenue for Q2. We are collaborating with all of our partners on allocation and delivery schedules and stand ready to ship our vaccine to where it is needed most, ensuring that we reach our shared goal of global equitable access. With emergency use listing granted by the WHO, our vaccine is now available in upwards of 170 countries worldwide, and we have sufficient manufacturing capacity to meet all demands. We believe that our protein-based vaccines' storage attributes, efficacy, and safety make it ideal for most settings, including those where standard cold chain is preferred. In addition, we continue to see low vaccination rates across low-income countries.

We are collaborating with all of our partners on allocation and delivery schedules and stand ready to ship our vaccine to where it is needed most insuring that we reach our shared goal of global equitable access with emergency use listing granted by the W. H O.

Our vaccine is now available in upwards of 170 countries worldwide and we have sufficient manufacturing capacity to meet all demand.

We believe that our protein based vaccine storage attributes efficacy and safety make it ideal for most settings, including those where standard cold chain is preferred.

In addition, we continue to see low vaccination rates across low income countries and although we are prepared to deliver the quantities of $23 73 doses to gaudy under the terms of our supply agreement to date, we have not yet received an order from derby and the timing of quantities of future <unk>.

John Trizzino: And although we are prepared to deliver the quantities of 2373 doses to Gavi under the terms of our supply agreement, to date we have not yet received an order from Gavi and the timing and quantities of future orders to deliver 2373 to the COVAX facility are unclear. In the U.S., where we anticipate getting emergency use authorization in early June, we are engaged in ongoing dialogue with the government for how we will support demand if we are authorized.

Orders totaled.

$23 73 to the Kodak facility are unclear.

In the U S, where we anticipate getting emergency use authorization in early June we are engaged in ongoing dialogue with the government for how we will support demand. If we are authorized we continue to receive input from health care providers health care organizations and consumers across the country, who are awaiting new vacs.

John Trizzino: We continue to receive input from health care providers, health care organizations, and consumers across the country who are awaiting new vaccine choices, and if authorized, ours would be the first protein-based vaccine authorized in the U.S. With this recent progress, we remain encouraged by the long-term prospects for our vaccine domestically. And we remain on track to pursue full approval by filing for BLA in the second half of 2022, setting the stage for commercialization in 2023.

And choices and if authorized ours would be the first protein based vaccine authorized in the U S.

With this recent progress we remain encouraged by the long term prospects for our vaccine domestically and we remain on track to pursue full approval by filing for BLA in the second half of 2022 setting the stage for commercialization in 2023.

Right.

This anticipated timing won't be further informed by our pre BLA meeting with the FDA, where we would expect to gain additional insight into BLA requirements and timing.

John Trizzino: This anticipated timing will be further informed by a pre-BLA meeting with the FDA where we would expect to gain additional insight into BLA requirements and timing. To ensure we are prepared to meet current and future global demand, we remain focused on optimizing our manufacturing activities. To that end, we have begun delivering against our commitment to add additional manufacturing sites into our network in addition to Serum Institute of India. At the end of April, we submitted manufacturing data from our partner, SK Bioscience, to the European Medicines Agency as a supplement to our Conditional Marketing Authorization. And later this quarter, we expect to file a variation to add our Czech Republic site, NovavaxCZ, as well.

To ensure we are prepared to meet current and future global demand, we remain focused on optimizing our manufacturing activities to that end, we have begun delivering against our commitment to add additional manufacturing sites into our network. In addition to serum Institute of India at the.

End of April we submitted manufacturing data from our partner SK Bioscience to the European Medicines agency as a supplement to our conditional marketing authorization. In later this quarter, we expect to file a variation to add our Czech Republic site no vaccine.

Well.

With significant progress made in our commercial launch we believe we are well positioned to continue this execution through the remainder of 2022 and beyond.

John Trizzino: With significant progress made in our commercial launch, we believe we are well positioned to continue this execution through the remainder of 2022 and beyond. To accomplish our objectives, we've rapidly scaled our commercial team with a variety of initiatives underway to support our product launch. Some of these include the following.

To accomplish our object objectives, we've rapidly scaled our commercial team with a variety of initiatives underway to support our product launch.

These include the following implementing customer engagement programs to build product awareness built.

John Trizzino: Implementing customer engagement programs to build product awareness. Building out our European operations with the new office in Switzerland that opened this month, deploying our first-ever unbranded campaign to improve educational awareness around COVID-19 vaccines, and building strategic partnerships with governments and policymakers around the world to promote market access. Now please turn to slide 7. On the regulatory front, we've made tremendous progress to expand the global reach of our vaccine. Since the start of the year, we have gained additional authorizations for both Novavaxovit and Covovax.

Building out our European operations with a new office in Switzerland that opened this month.

Deploying our first ever unbranded campaign to improve educational awareness around COVID-19 vaccines.

And building strategic partnerships with governments and policymakers around the world to promote market access.

Now please turn to slide seven.

On the regulatory front, we've made tremendous progress to expand the global reach of our vaccine.

Since the start of the year, we have gained additional authorizations for both new vaccine and kobo backs.

In total our regulatory efforts to date reflect authorizations or approvals in 41 countries as well as emergency use listing from the W. H O, which represents the potential for our vaccine to reach over 170 countries encompassing over 6 billion lives.

John Trizzino: In total, our regulatory efforts to date reflect authorizations or approvals in 41 countries, as well as emergency use listing from the WHO, which represents the potential for our vaccine to reach over 170 countries, encompassing over 6 billion lives. Now please turn to slide 8.

Now please turn to slide eight.

We have been leveraging data generated from our robust clinical development plan to expand our label around the world for boosting.

John Trizzino: We have been leveraging data generated from our robust clinical development plan to expand our label around the world for boosting additional pediatric populations and the additional populations for primary vaccinations such as the immunocompromised. I will now turn it over to Filip for more on all of this. Filip.

Additional pediatric populations.

And the additional populations for primary vaccination such as the immunocompromised.

I will now turn it over to Philip for more on all of this Philip Thanks John .

Flip to slide nine I wouldn't cover three topics today.

Filip Dubovsky: Thanks, John. Let's flip to slide nine. I want to cover three topics.

First I want to talk about our approach to variance based on our antigen adjuvant technology, our approach may be different from other vaccine.

Filip Dubovsky: First, I want to talk about our approach to variants. Based on our antigen and adjuvant technology, our approach may be different from other vaccines. In our phase 3 studies, our vaccines work well against all variants of circulation. Furthermore, the vaccine induced high levels of variant-specific immune response.

Our phase III studies, our vaccines work well against all variants of strict related.

Furthermore, the vaccine induced high levels of very specific immune responses.

Although it is uncertain, but in omicron based vaccine will be required we're pursuing a sprain change study to gather clinical data on the utility of both <unk> as well as the bivalent approach.

Filip Dubovsky: Although it isn't certain that an Omicron-based vaccine will be required, we're pursuing a strain change study to gather clinical data on the utility of both an Omicron variant as well as a bivalent. Next, I'll touch base on our pediatric data. We feel that our vaccine may have a special role in the pediatric population, based on the parent's familiarity with recombinant protein vaccines, and our favorable tolerability and emergency profile.

Next I'll touch base on our pediatric data, we feel that our vaccine may have a special role in the pediatric population based on the parents familiarity with recombinant protein vaccine and our favorable Tolerability and Immunogenicity profile I'll also share some data from our partners at Serbia, India on how is the vaccine performs in children as young as two years of age and fine.

Filip Dubovsky: I'll also share some data from our partners at the Serb Institute of India on how the vaccine performs in children as young as two years of age. And finally, I'm going to go over some data we presented previously on the combination work and I'll leave the pathway forward for that. Okay, let's skip slide 10, which is a transition slide and go to slide 11 to talk about variant, What's displayed here is the comparison of the clinical efficacy results from our two independent phase 3 studies. You can see the vaccine performed well with an overall efficacy of 90% despite the majority of cases being caused by variants. For match strains, efficacy was between 96% and 100%.

Lee.

Go over some data we presented previously on the combination work.

And Ali the pathway forward for that Okay, Let's skip slide 10, which is transition in Florida and goes to slide 11 to talk about variance.

Filip Dubovsky: And for variant strains, efficacy was 86% to 94% for alpha. In the US and Mexico study, 93% against a basket of all variants of interest and variants of concern. We observe complete protection against severe disease, irrespective of which variants are identified. In the Adelson expansion of the US-Mexico study, only Delta circulated, and the efficacy was 82%.

What's displayed here is the comparison of the clinical efficacy results from our two independent phase III studies as you can see the vaccine performed well with an overall efficacy of 90%. Despite the majority of cases being caused by various format strains efficacy with between 96% to 100% and forbearance Springs efficacy was 86 or 94.

Percent for Alpha and the use of Mexico study, 93% against the basket of all parents have interest in various of concern.

We observed complete protection against severe disease, irrespective of which parents circulated.

The adults and expansion of the U S. Mexico study only delta circulated in the efficacy was 82% I.

I should note that the study was powered for the immunologic effectiveness endpoint. So there were only a very few cases and the confidence intervals overlap the point estimate of the bigger more precise adult cohort.

Filip Dubovsky: I should note that the study was powered for the immunologic effectiveness endpoint, so there were only a very, And the conference intervals overlap the point estimate of the bigger, more precise adult cohort. OK, let's move to slide 12, where I've detailed the variants that circulate and cause disease in the study. As you can see, in the UK, Alpha was circulating, and in the Adelson expansion, Delta was identified very highly.

Okay, let's move to slide 12 please.

Detailed the variance that circular didn't cause disease in the studies.

You can see in the U K alpha with circulating in the adolescent expansion that Delta was about identified variant and the biggest study conducted in the U S. Mexico, we identified seven different variants and despite the majority of these cases being caused by this broad range of variance our efficacy was preserved.

Filip Dubovsky: In the biggest study conducted in the U.S.-Mexico, we identified seven different variants. Despite the majority of these cases being caused by this broad range of variants, our efficacy was preserved. Okay, let's go to slide 13, please, and talk about what we know about how the vaccine works against Omicron. On the left-hand side, we've detailed the immune responses against the MASH prototype strain, as well as a broad range of variants after the initial two-dose primary.

Okay, Let's go to slide 13, please and talk about what do we know about how the vaccine works against Obama crime.

Filip Dubovsky: You can see that 100% of participants generated an antibody response that recognized all variants, including Omicron, BA1, and BA2. On the right-hand side, we've displayed the immune response to the variance after a single, Here you can see a very large bump in antibody response to all variants, including the more contemporaneous Omicron VA1, VA2. In fact, the levels for VA1, VA2 after boost are higher than that seen after two doses of the prototype strain on the left-hand side of the slide.

Filip Dubovsky: And I want to remind you that those levels were associated with 36% protection. OK, let's move to slide 14, where the functional immune responses are displayed. And these are 99% neutralization responses against prototype Delta and Omicron performed by the Matt Freiman Lab in the University of Maryland. Again, on the left-hand side, the response after two doses displayed, and the right-hand side, after six doses. After two doses, the neutralizing response is three-point-fold lower for Omicron compared to protein. This is a relatively small difference.

The left hand side, we've detailed immune responses against the mass prototypes rating as well as a broad range of variance. After the initial two those prime series.

Filip Dubovsky: In fact, for influenza, anything less than a fourfold difference could be considered a matched response. After a third dose, on the right-hand side, the immune response... Gimpley, including Paroma Crockett. This is important because pretty much everyone has been exposed to COVID or has been vaccinated, so these boosted responses have become even more relevant. So based on our variant protection and immune data, we are far from certain that an Omicron-based vaccine is required or will provide material improvement in performance.

Filip Dubovsky: However, this question can be answered with clinical data, so let's move to slide 15. We privilegedly announced we plan to conduct a strain change study to allow us to advance an Omicron-based vaccine. The study will be conducted in previously primed individuals. And, and determine if an Omicron-based vaccine induces better immune responses compared to the original prototype vaccine. It will be the basis of a spreadsheet variation.

You can see that a 100% of participants generated an antibody responses recognized all variants, including Omicron you wanted to be a two on the right hand side, we have despite the immune response to the variance after single boosted six months excuse.

Here you can see a very large bump in antibody response to all variants, including the more contemporaneous omicron NBA <unk> in fact, the levels for <unk> two after boost are higher than that seen after two doses to the prototype strain on the left hand side of the slide and I want to remind you that those levels were associated with 36 arms and protection of Phase III studies.

Okay, let's move to slide 14 please.

Filip Dubovsky: We will also take the opportunity to evaluate a bivalent format to determine if there is a benefit of that approach. The city is scheduled to start this month and top line data will be available in the third quarter. Now let's skip slide 16 and move to slide 17 to talk about our pediatric data. This slide describes our adolescent data, which was an expansion of the U.S.-Mexico Phase III study. We enrolled a total of 2,247 12- to 17-year-olds, and we randomized them two-to-one vaccine-to-procedure.

Where the functional immune responses are displayed.

Filip Dubovsky: The participants were subsequently crossed over and we are now finishing up boosting these children. Let me review the top line results. The licensure-enabling effectiveness endpoint was the demonstration of non-inferior immune responses in adolescents compared to young adults. And in fact, the adolescent neutralizing responses were 1%, were a half-fold higher than adults.

These are 99% utilization responses against prototypes Delta and omicron performed by the <unk> Prime and lab at the University of Maryland again on the left hand side. The response after two doses displayed on the right hand side after six months boost.

After two doses that neutralizing response is three fold lower for omicron compared to profile. This is a relatively small difference in fact for influenza anything within a four fold difference could be considered a matched response.

After our third dose on the right hand side of the immune responses increased significantly including for home a crop. This is important because pretty much everyone, who has been exposed to COVID-19 or it's been vaccinated. So these boosted responses have become even more relevant.

So based on our various protection and immune data we are far from certain that omicron based vaccine is required or will provide material improvement in performance. However, this question can be answered with clinical data so let's move to slide 50.

We've previously announced we plan to conduct a spreadsheet study to allow us to advance it omicron based vaccine. The study will be conducted in previously private individuals.

And.

And determined about Hong Kong based vaccine induces better immune responses compared to the original prototype vaccine.

It'll be the basis of a spreadsheet variation we.

We will also take the opportunity to evaluate a bivalent formats to determine if there is a benefit of that approach.

Reschedule just started this month and topline data will be available in the third quarter.

I'll Skip slide 16, and move to slide 17 to talk about our pediatric data.

This slide describes her Allison data, which was an expansion of the U S. Mexico Phase III study.

A total of 2000 and 247 12 to 17 year olds, and we randomized them two to one vaccine to placebo.

Participants were subsequently crossover and we are now finishing up boosting these children.

Let me review the topline results.

The licensure, enabling effectiveness endpoint was the demonstration of non inferior immune responses in adolescence compared to young adults. This was achieved and in fact, the adolescent realizing responses were one one.

More than half fold higher than adults.

We were also able to measure clinical efficacy, including against Delta and the Tolerability was favorable compared to adults and the main part of the study.

Filip Dubovsky: We were also able to measure clinical efficacy, including against Delta, and the tolerability was favorable compared to adults in the main part of the study. These data are the data that is the basis for approval in India for our vaccine, and it's the basis of the file we have submitted to the regulators in the EU, the UK, Korea, Australia, and New Zealand. The increased magnitude of immune response seen in adolescents is also relevant for the variants.

These data are the data that is the basis for approval in India for our vaccine and is the basis of the pilot we have submitted to the regulators in the EU The U K Korea, Australia, and New Zealand.

The increase in magnitude of immune response seen in adolescence. It's also relevant for the variance. So let's look at that on slide 18.

Jim Kelly: So let's look at that on slide 8. Here we've displayed our end of our responses to variants after two doses in 12th of December. Overall, they are two to three-fold higher than student adults after two doses.

We displayed our antibody responses to variance after two doses in 12 to 17 year olds. Overall, they are two to three fold higher than seen in adults. After two dose series. We believe these data hold promise for broad efficacy in the pediatric population.

Jim Kelly: We believe these data hold promise for broad efficacy in the pediatric population. Okay, let's go to slide 19 and talk about data in younger children collected by our partners at Serum. The study they conducted was an expansion of their Phase 2-3 adult study. It was a randomized blind and placebo-controlled study, and in the pediatric portion, they had three age groups. 12 to 17, 7 to 11.

Okay, Let's go to slide 19, and talk about data in younger children and collected by our partners at serum.

The study they can conduct it was an expansion of their phase three adult study there was a randomized blinded placebo controlled study and in the pediatric portion. They had three age groups 12 to 17, 7% to 11 in two to six year olds.

We've been given permission to share topline Reactogenic city, an antibody the results with you today. The study was conducted with a full dose of vaccine in all age groups five micrographs of antigen and 50 micrograms of matrix. Please turn to slide 20.

Jim Kelly: We've been given permission to share top-line reactogenicity and antibody results with you today. The study was conducted with a full dose of vaccine in all age groups, 5 micrograms of antigen and 50 micrograms of matrix. Dr. DeFly 20. On this slide, we've compared the local solicit symptoms by age group. Adults are in dark blue, 12- to 17-year-olds in light blue.

On this slide we've compared the local solicitor symptoms by age group adults are in dark Blue 12 to 17 year olds in light blue.

700, elevens in purple and two to six year olds in yellow dose what is displayed on the top two in the bottle.

Jim Kelly: 7 to 11s in purple and 2 to 6-year-olds in yellow. Dose 1 is displayed on the top and dose 2 in the bottom. As expected, more reactions were observed after dose 2 compared to dose 1. However, overall, the vaccine was well tolerated, at least as well, if not better, than in adults. The companion slide is slide 21, which is the next slide. This shows the solicited systemic reactions. Once again, dose two was more reactogenic than dose one.

As expected more reactions were observed after dose two compared to dose. One. However, overall the vaccine was well tolerated at least as well if not better than in adults.

The companion slides or slide 21, which is the next slide which shows the solicited systemic reactions. Once again those two was more rapidly I think than does one overall the tolerability profile is favorable compared to adults. The one symptom that increases with decreasing ages fever, and the youngest children about a third reported up year. After the second dose. However, the fevers are short.

Jim Kelly: Overall, the tolerability profile is favorable compared to adults. The one symptom that increases with decreasing age is fever, and the youngest children about a third reported a fever after the second dose. However, the fevers were short-lived, with a median of approximately two days, and the grade three fevers occurred in only 1% of the two to six-year-olds.

Lift with a median of approximately two days and the grade three fevers occurred in only what percent of the two six year olds overall, the vaccine was considered to be well tolerated.

Stan Erck: Overall, the vaccine was considered to be well tolerated. Please turn to slide 22. Here we've displayed the IgG responses at baseline, after one dose and after two doses. Adults are on the left, and the youngest children are on the right.

Please turn to slide 22 here.

Here, we displayed the IGT responses at baseline after one dose and after two doses a delta on the left and the youngest children are on the right.

Our from a validated assay performed in a number of our clinical immunology labs as you can see there's a stepwise increase in immune responses as the H cohort decreases in age.

Stan Erck: The results are from a validated assay performed at the Novavax Clinical Immunology. You can see there's a stepwise increase in immune responses as the age cohort decreases. So overall, we're seeing a favorable tolerability profile and a very significant increase in antibody responses. This sort of profile makes us believe our vaccine may have a special role in children's vaccines. So what's next?

So overall, we're seeing a favorable tolerability profile and a very significant increase in antibody responses in children. The sort of profile makes us believe our vaccine may have a special role in children's vaccinations. So what's next we've agreed upon a pediatric investigational plan in the EU and U K and our IP SP with the FDA has also been agreed to our protocol has been reviewed by the.

Stan Erck: We've agreed upon a pediatric investigational plan in the EU, and our IPSP with the FDA is also. Our protocol has been reviewed by the FDA and we anticipate starting the study this summer. The plant study is a HD escalation study initially looking at 6 to 11 year olds, then 2 to 5 year olds, and finally... Okay, let's skip the transition slide and go straight to slide 24.

The FDA and we anticipate starting to study this summer the plant study as they age Deescalation study initially looking at six to 11 year olds that two to five year olds and finally six months to two year olds.

Okay, let's skip the transition slide go straight to slide 24. Please.

A couple of weeks ago, we presented data from our quadrivalent influenza Covid combination study we conducted the study because in our UK phase III study, we noted even logic interference between influenza vaccine in the induction of anti <unk> antibody with a COVID-19 vaccine.

Stan Erck: A couple of weeks ago, we presented data from our Quadrivalent Influenza COVID combination, conducted the study because in our UK Phase 3 study, we noted immunologic interference between influenza vaccine and the induction of anti-spike antibodies with a COVID vaccine. Subsequently, data has emerged for other vaccine platforms that when even a flu vaccine is given with a third boosting dose of COVID, the immune response to COVID may be reduced by up to a third.

Quickly data has emerged for other vaccine platforms that would even flu vaccine is given with a third boosting dose of COVID-19. The immune response to COVID-19 may be reduced by up to a third.

Isolating the dosage levels of influence the Hemagglutinin and Covid Spike Amgen, we've innovated our way passive issue, let's move to slide 25, and briefly review the study's design.

Stan Erck: By modulating the dosage levels of influenza hemagglutinin and COVID spike antigen, we've innovated our way past... Let's move to slide 25 and briefly review the study's design. The study was a design of an experiment approach, where we had 14 different doses, where we buried the hemagglutinin between 5 and 60 micrograms, and we varied the spike between 2.5 and 22.5 microns.

He was a design of experiment approach, where we have 14 different dosage groups, where where we buried the hemagglutinin between $5 60, microgram and we vary the spike between two 5% and 22.5 micrograms, we held the matrix adjuvant level steady at 50 micrograms.

Stan Erck: We held a matrix adjuvant level study at 50, compared to our standard COVID vaccine with 5 micrograms of spike and our standard quadrivalent influenza vaccine which had 60 micrograms. The Influenza Comparator has 75 micrograms of Matrix M because that was the formulation we used in our successful Phase III Quadrivalent Influenza Study. The immunologic output, as well as the other baseline characteristics, were fed into a mathematical model which predicted the optimal combination.

This was compared to our standard Covid vaccine with five micrograms of Spike in our standard quadrivalent influenza vaccine, which had 60 micrograms of each blue antigen.

The influence of comparator has 75 micrograms of matrix M. Because that was a formulation we used in our successful phase III quadrivalent influenza study.

Output as well as the other baseline characteristics were fed into a mathematical model, which predicted the optimal combination of antigens. Okay findings on slide six first of all all the combinations were tolerable and the residency profile was in line with the influenza vaccine comparator.

Stan Erck: Okay, the findings are on slide 26. First of all, all the combinations were tolerable, and the recogency profile was in line with the influenza vaccine comparator. From an emergency perspective, we confirmed the immunologic interference between hemagglutinin and Spike that we saw in our Phase 3 study. However, we were able to overcome the interference by increasing the spike amplitude. The optimal dose for spike is between 20 and 30 micrograms, while the hemagglutinin can be reduced to 24 to 40 micrograms per strain, suggest an overall antigen dose may be reduced by up to 50% in the combination product.

From an efficiency perspective, we confirmed the hematologic interference between Hemagglutinin as spike that we saw in our phase III study. However, we were able to overcome it and appearances by increasing the spike Amgen and decreasing became gluten the optimal dose for spike between 20, and 30 micrograms, while the hemagglutinin can be reduced to 24% to 40 micrograms per screen. This.

Suggest an overall antigen dose may be reduced by up to 50% and the combination product.

This will be confirmed in a phase II study that we have planned for later this year, we will select a couple of dosage levels using contemporaneous influenza strains and compare it to licensed influenza vaccine, we will take the opportunity to evaluate 75 micrograms of matrix and subsequent plan includes demonstration of clinical efficacy for both the standalone influenza vaccine as well as the combination vaccine.

Stan Erck: This will be confirmed in a Phase II study that we have planned for later this year. We will select a couple of dosage levels using contemporaneous influenza strains and compare it to licensed influenza vaccines, we will take the opportunity to evaluate 75 micrograms of... The subsequent plan includes demonstration of clinical efficacy for both the stand-alone influenza vaccine, well the common, Okay, let me hand it over to Jim to talk about the financial. All right. Thank you, Philip. Please turn to slide 27.

Okay, Let me hand, it over to Jim to talk about the financials.

Alright, Thank you Filipe. Please.

Please turn to slide 27.

This afternoon, we announced our financial results for the first quarter of 2022.

Jim Kelly: This afternoon, we announced our financial results for the first quarter of 2022. I'll begin by providing an overview of our first quarter 2022 total revenue performance, net income, and cash position. Then I'll discuss our quarterly results in additional detail, as well as provide an update on our full year 2022 revenue guide. The first quarter of 2022 marked an important milestone for Novavax, as our initial profitable quarters at commercial stage companies. We recorded $704 million in total revenue, reflecting 57% growth compared to prior years.

I'll begin by providing an overview of our first quarter 2022 total revenue performance net income cash position, then I will discuss our quarterly results in additional detail as well as provide an update on our full year 2022 revenue guidance.

Jim Kelly: 203 million in net income. We ended the first quarter of 2022 with $1.6 billion in cash and had accounts receivable of over $400 million, which positions us well as we continue our global launch of Novavax. Please turn to slide 28 where we'll provide a comprehensive overview of our first quarter financial results. For the first quarter of 2022, Novavax recorded a total revenue of $704 million compared to $447 million in the first quarter of 2021. Total revenue for the period included $586 million in product sales by Novavax.

The first quarter of 2022 marked an important milestone for known events.

Jim Kelly: $19 million of royalties and other revenue, which includes both royalties and adjuvant sales to our licensed partners, and $99 million in grants from the U.S. government. 31 million of exudate doses, so globally marked the first commercial product sales for Novavax. We recorded lower grants revenue in the first quarter of 2022 compared to the prior year, as we materially completed the activities under the CEPI agreement in 2021, do not expect to record incremental revenue under that agreement in 2022, continue to receive funding for our 2373 clinical programs from the U.S. government.

Our initial profitable quarters commercial stage company.

We recorded $704 million in total revenue, reflecting 57% growth compared to prior year and $203 million and net income.

We ended the first quarter of 2022 with $1 6 billion in cash and had accounts receivable of over $400 million, which positions us well as we continue our global launch no vaccine.

Right.

Please turn to slide 28, where we will provide a comprehensive overview of our first quarter financial results.

For the first quarter of 2022 November <unk> recorded total revenue of $704 million compared to $447 million in first quarter of 2021.

Total revenue for the period included $586 million in product sales by Novavax 19 million of royalties and other revenue, which includes both royalties and adjuvant channels to our licensed partners and $99 million in grants from the U S government.

This 31 million the vaccine day dosing soon globally, Mark the first commercial sales for Novavax.

We recorded lower grant revenue in the first quarter of 2022 compared to the prior year as we materially completed the activities under the Sheppy agreement in 2021, and do not expect to record incremental revenue under that agreement in 2022.

We continue to receive funding for $23 73 clinical programs from the U S government.

We entered 2022 with approximately $800 million.

Jim Kelly: We entered 2022 with approximately $800 million of funding outstanding under our U.S. government agreements and expect to record at least $400 million of this amount during 2022, the remainder in 2023. Our cost of sales for the first quarter of 2022 were $15 million at 3% of product sales in the period, discuss this and the concept of reduced cost, and a bit more detail in the next, research and development expenses for the first quarter of 2022 were $383 million, compared to $593 million for the comparable period in 2021, decrease was primarily the result of lower clinical development activities for 2370, and Kapilization. 2373 Manufacturing Costs during the quarter.

Funding outstanding under our U S government agreements and expect to record at least $400 million of this amount during 2022 with the remainder in 2023.

Cost of sales for the first quarter of 2022.

That's 3% of product sales in the period.

I'll discuss this in the concept of reduced cost of sales and a bit more detail on the next slide.

Research and development expenses for the first quarter of 2022% or $383 million compared to $593 million for the comparable period in 2021.

The decrease was primarily the result of lower clinical development activities for $23 73, and the capitalization of $23 73 and manufacturing cost during the quarter.

We expect our full year R&D expenses to be lower than 2021, and then as noted a significant portion of our 2022 R&D costs will continue to be funded by the U S government.

Jim Kelly: We expect our full-year R&D expenses to be lower than 2021, and as noted, a significant portion of our 2022 R&D costs will continue to be funded by the U.S. Government. Initially, we recorded selling general and administrative expenses of $96 million in the first quarter of 2022, compared to $63 million in the first quarter of 2021. The increased quarter-over-quarter was a result of our commercial launch costs associated with November. We expect SG&A costs to continue to rise as we move through 2022, further enhance our commercial capabilities to bring Novavax to markets around the world.

Additionally, we recorded selling general and administrative expenses of $96 million in the first quarter of 2022 compared to $63 million in the first quarter of 2021.

The increase quarter over quarter was a result of our commercial launch cost associated with no accident.

We expect SG&A costs continue to rise as we move through 2022 as we further enhance our commercial capabilities to bring a vaccine to markets around the world.

<unk> continues to maintain its full tax valuation allowance as of the end of the first quarter of 2022.

Jim Kelly: Novavax continues to maintain its full tax valuation allowance as of the end of the first quarter of 2022. The majority of the $3 million tax expense recognized in the period was for income tax expenses related to foreign withholding taxes on royal, For the first quarter of 2022, we recorded a net income of $203 million compared to a net loss of $223 million in the first quarter of 2021.

The majority of the 3 million tax expense recognized in the period was for income tax expenses related to foreign withholding withholding taxes on royalties.

For the first quarter of 2022, we recorded net income of $203 million compared to a net loss of $223 million in the first quarter of 2021.

And finally for our cash position we ended the quarter first quarter of 2022 was one 6 billion in cash.

Jim Kelly: And finally, for our cash position, we ended the first quarter of 2022 with $1.6 billion in cash. Through sales of 2.2 million shares of Novavax Common stock from our at-the-market offerings, we raised net proceeds of $179 million during the first quarter. Please turn to slide 29 where I'll discuss our cost of sales and mortgages, during 2021 and prior to regulatory authorizations for Novavax, certain manufacturing costs were expensed to research and development that would otherwise have been capitalized to inventory, not for the reduced cost of inventory for the period. The full cost of the sales for the first quarter would have been approximately $160 million, or 27% of product sales, at our standard cost.

Pre sales of $2 2 million shares of Novavax common stock.

From our aftermarket offerings, we raised net proceeds of $179 million during the first quarter of 2022.

Please turn to slide 29, where I'll discuss our cost of sales in more detail.

Okay.

Yeah.

During 2021 and prior to regulatory authorizations from the vaccine at certain manufacturing costs were expense to research and development that would otherwise have been capitalized inventory.

If not for the reduced cost of inventory for the period full cost of sales for the first quarter would have been approximately $160 million or 27% of product sales based on our standard costs.

We expect to utilize the majority of our reduced costs inventory during 2022.

Jim Kelly: We expect to utilize the majority of our reduced cost inventory during 2022, are expected to be between 70 and 80 percent. Please turn to slide 30, where we'll provide an overview of our financial guidance for 2022. Today, we are reiterating our full year 2022 total revenue guidance of between $4 and $5 billion. And as a reminder, total revenue reflects all sources, sales and vaccinated by Novavax, grants revenue, royalties, and other revenue.

Our <unk> gross margins on sales to high income countries are expected to be between 70 and 85% of product sales.

Please turn to slide 30.

We will provide <unk> for financial guidance for 2022.

Today, we are reiterating our full year 2022, total revenue guidance of between four and $5 billion.

As a reminder, total revenue reflects all sources, including product sales in the vaccinated by Novavax grants revenue royalties and other revenue.

As John mentioned previously we are prepared to deliver doses of our vaccine to coffee under the terms of our supply agreement.

Jim Kelly: As John mentioned previously, We're prepared to deliver doses of our vaccine to Gavi under the terms of our supply. However, we were recently notified by GAVI of their intent to seek to revise the number and timing of those. To date, Novavax has not received an order from GAVI, and the timing and quantities of future orders to deliver Novavaxabid to the COVAX, are unclear. Although we're not adjusting our full year 2022 revenue guidance, we note that our current guidance assumes successful delivery and conversion. $700 million prepayment to PROC Revenue.

However, we were recently notified by Ghazi of their intent to seek to revise the number and timing of doses.

To date no vaccine is not received an order from coffee and the tiny quantities of future orders and deliver them to vaccinate. The Kodak facility are unclear.

Although we're not adjusting our full year 2022 revenue guidance.

Note that our current guidance assumes successful delivery and conversion of the $700 million prepayment to product revenue.

In the event, we different deliver less a resulting revenue expectations for the year could be affected.

Jim Kelly: In the event we deliver less, our resulting revenue expectations for the year could be affected. We look forward to sharing our progress towards realizing this total.., future. With that, I'd like to turn it over to Stan to discuss our upcoming... Thanks, Jim, and the team for all the presentations. So let's go to slide 31, close it out.

And look forward to sharing our progress towards realizing this totaled.

On our future earnings calls.

That I'd like to turn it over to Stan to discuss our upcoming <unk>.

Yes.

Thanks, Jim and the team for four.

Oh the presentation. So, let's let's go to slide 31 close it out.

I am pleased to report our many achievements started the year.

Stan Erck: Again, I'm pleased to report there are many achievements since the start of the year, reflecting ongoing execution across all of our strategic priorities. Through the remainder of the year, we will build on this momentum to achieve all of our objectives across commercial, regulatory, manufacturing, and our pipeline. We plan to continue the global delivery of our vaccine in collaboration with our partners, drive additional progress toward our full year 2022 revenue target. Regulatory, we are focused on executing our robust clinical development, pursue additional authorizations that expand our vaccine's label and policy recommendations, for Pipeline.

Reflecting ongoing execution across all of our strategic priorities for 2022 through the remainder of the year, we will build on this momentum to achieve all of our objectives across commercial regulatory manufacturing and our pipeline.

Commercial we plan to continue the global delivery or vaccine in collaboration with our partners to drive additional progress toward our full year 2022 revenue targets for regulatory we are focused on executing our robust clinical development plan to pursue additional authorizations that expand our vaccines label.

Policy recommendations.

And for our pipeline, we will seek to advance development of our other vaccine candidates, ensuring our pipeline has the potential to address todays and tomorrows most pressing global health needs for overcrowded variant strain vaccine, we will conduct a clinical trial to ensure we are prepared to deliver our various specific vaccine.

Stan Erck: We will seek to advance development of our other vaccine candidates, ensuring our pipeline has the potential to address today's and tomorrow's most pressing global health, For our Omicron variant strain vaccine, we will conduct a clinical trial to ensure we're prepared to deliver our variant-specific vaccine, as either monovalent or bivalent vaccine as required in the coming months. And for a COVID-19 influenza combination vaccine, we will initiate our phase two trial. Thanks for your attention.

Is it either monovalent are bivalent vaccine as required in the coming months.

And for a COVID-19 influenza combination vaccine, we will initiate our phase III trial. Thanks.

Thanks for your attention I will now turn it over to the operator for <unk>.

Operator: I will now turn it over to the operator for QA. We will now begin the question and answer session. To ask a question, you may press star then one on your touch-tone phone. If you're using a speakerphone, please pick up your handset before pressing the keys.

We will now begin the question and answer session to ask a question you May Press Star then one on your tax concern if youre using a speakerphone. Please pick up your handset before pressing the keys.

To withdraw your question. Please press Star then two.

The first question comes from Roger song from Jefferies. Please go ahead.

Operator: To withdraw your question, please press star then two. The first question comes from Roger Song from Jeffreys, please go ahead. Great. Thank you for the update and congrats for the OneCure revenues and the positive EPS. So a couple of questions from us. So the first one is for the US EUA, this VRBPAC meeting schedule.

Great. Thank you for the update and congrats for.

Or the one cohort revenue standard policy.

A couple of questions from us. So the first one is for that U S UAE, where.

Schedule. So as you mentioned youre still kind of there.

Filip Dubovsky: So as you mentioned, you're still kind of submitting outstanding items requested by the FDA. Just curious, what are those kind of additional data package you need to submit before they can have this VRBPAC and how confident you are you will have this VRBPAC meeting on June 7th? Thank you. This is Filip.

So meeting after the item go quiet.

By the FDA.

Curious what are those kind of there.

Additional data package.

<unk> said that before.

You can have big pack and how confident you are you will have that patent.

On June seven.

Okay.

This is Scott I'll take that so they're not waiting for any new data from us all the data has been submitted.

Filip Dubovsky: I'll take that. So they're not waiting for any new data from us. I mean, all the data has been submitted, and it's just part of the review process. They just are asking questions back and forth and preparing for the VRBPAC. As you know, it's a lift for them as well as for us to prepare for such an open public session. We're very confident.

And it's just part of the review process. They just are asking questions back and forth and preparing for the <unk> as you know.

A lift for them as well as for us to prepare for such a open public session. We're very content you've seen our clinical data, it's very strong and that's the focus of the verb pack I know theres been scheduled we have.

I have a high degree of confidence that we'll have a successful outcome.

Got it okay. That's great. Thank you.

Filip Dubovsky: You've seen our clinical data. It's very strong, and that's the focus of the VRBPAC. Now that it's been scheduled, we have a high degree of confidence that we'll have a successful outcome. Got it.

Point of sharing.

And another question that is for the debt to date at demonstration.

John Trizzino: Okay, that's great. Thank you for the assurance. And another question is for the to-date administration of the Novavax vaccine. We see the delivery is pretty strong, but it seems the real adoption is relatively lower compared to the delivery. So how do you expect the administration will match up for the delivery and sustain the delivery order as you are guided? Yeah, so this is John.

And all of that vaccine, we see the deliberate pretty strong.

Ste.

The real adoption is actually lower compared to the deliberate so how do you expect the administration will match up for the deliberate and sustained delivery are there.

<unk> guided.

Yes. So this is John so yes, we're lagging just a bit but I think what we're seeing is let them pick up week by week.

John Trizzino: So, yes, we're lagging just a bit, but I think what we're seeing is momentum pick up week by week where, you know, we move this product into the European Commission, as well as others, through a variety of distribution locations on a country-by-country basis, and then they have the responsibility to get that product out to the healthcare providers for vaccination. You know, we're two months in, and we're seeing some improvement in trajectory, although we have a bit of work to do from an education standpoint. Some of the unbranded campaigns that we're engaging in Europe, as well as pull-through mechanisms, I'm sure will allow us to catch up in that regard.

You know we move this product into the European Commission as well as others through.

Brian you have distribution locations on a country by country basis, and then they have the responsibility to get that product out to the health care providers for vaccination.

You know we are two months in and we're seeing some improvement in trajectory, although we have a bit of work to do from an education standpoint, some of the unbranded campaign that we're engaging in Europe as well as pull through mechanisms I'm sure will allow us to catch up.

In that regard, we all let's keep in mind, we also have new.

John Trizzino: But let's keep in mind we also have new orders coming from these countries, so they're accepting additional vaccine in the second quarter, in addition to what they received in Q1, and particularly in Europe with the 42 million doses going into Europe in Q2. So I think that there's a confidence in the vaccine. We're seeing improved uptake, and we'll expect to see that through Q2. And if I can chime in, I mean, we really are expecting the label to be expanded in the near future, and that might provide an issue. Yeah, that's true, because so far most of the country only approved for the prime, not even for the booster or pediatrician, pediatrics.

Orders coming from these countries so they're accepting additional vaccine in the second quarter. In addition to what they receive in Q1 and particularly in Europe with a 42 million doses going into Europe in Q2, So I think.

There is a confidence in the vaccine we are seeing improved uptake.

And we will expect to see that through Q2 and Q3.

And if I can chime in I mean, we really are just paying the label to be expanded in the near future.

I'll provide additional opportunity.

Yeah.

Yes sure.

So far yes, most of the country you only got approved for that client not UN boosted.

Still on pediatrics and pediatric.

Okay, Great maybe just one last one if I may is just.

John Trizzino: Okay, great. Maybe just one last one, if I may, is just clarifying for the upcoming Omicron-related data in 3Q, would that be just the monolalane, or you also will report data from the birelane in 3Q? Thank you. So we think we'll be delivering the monovalent for sure. The bivalent might lag by just a little bit, or maybe not. It mostly depends on the speed of enrollment at the site.

Just a clarifying.

They can call me on the call and related.

Data in Q1.

Just the monovalent are you also willing to pull data from <unk>.

Thank you.

So we think we will be delivering them.

Unavailable for sure the bivalent my wagged by just a little bit or maybe not it mostly depends on the speed of enrollment at the site I think we're ready to move forward with both the monovalent as well as the bivalent product.

Filip Dubovsky: I think we're ready to move forward with both the monovalent as well as the bivalent. Thank you. Thank you for taking our questions. The next question comes from Georgi Yordanov from Cowan & Company. Please go ahead.

Yeah.

Excellent. Thank you. Thank you for taking my questions.

Okay.

The next question comes from Georgia, you want or not.

From Cowen and company. Please go ahead.

Hey, guys. Thank you so much for taking my questions and congratulations on the progress in your first quarter of profitability.

John Trizzino: Hey guys, thank you so much for taking our questions and congratulations on the progress in your first quarter of profitability. So maybe just to follow up with some of the questions that were asked, one question that we've been getting is on the APAs, how long can countries delay on setting up a delivery schedule? Is there like something in the contract that kind of like sets a timing until when countries should.., should write, Yeah, so the way those APAs are set up, Yurgi, is that, you know, we and they have some flexibility in scheduling how those doses are shipped into the country, and so we're speaking and coordinating with them on almost a daily basis, and their demand patterns and how they want to bring product into their particular country is communicated amongst us, and then we set those delivery schedules, you know, based upon that, and some of those APAs, as we've talked about before, will be shipping throughout the year and then also into 2023 as well. And is there any update on the UK shipments?

So maybe just to follow up with I guess some of the questions that were asked.

One question that.

We've been getting is on the E. P. A how long can countries delay on setting up a delivery schedule is there like something in the contract, but kind of like a timing until when countries should.

Should kind of set up the schedule and actually accept the doses that are part of the contract.

Do you guys have any update on <unk>.

On those schedules for for example, the U K.

And then the.

To follow up there.

Yeah, so the windows eight P H a.

Our set of your D is that we and they have some flexibility in scheduling how those doses are shipped into the country and so we are speaking and coordinating with them.

Most of the daily basis.

And in there.

Demand patterns and how they want to bring product into the a particular country.

As communicated amongst us and then we set those delivery schedules based upon that and some of those as we've talked about before.

We will be shipping throughout the year and then also into 'twenty two 'twenty three as well.

Got it and is there any update on the U K.

Thanks.

We're still coordinating with the UK about what their delivery schedule is were.

John Trizzino: We're still coordinating with the UK about what that delivery schedule is. We're still waiting on JCVI recommendations to come through on our product and as we've talked about these label expansions will help with all those efforts as well. That's great.

Still waiting on J C V I, a recommendations to come through on a product.

As we've talked about these label expansions will help with all of those efforts as well.

That's great and then.

John Trizzino: And then maybe you can also talk about your preparedness to participate in an eventual booster market this fall. So do you believe you could potentially be able to participate in that market with an Omicron-containing vaccine, just given the timing of results for the upcoming studies? Well, that's our that's our goal. Our goal is to be ready for such a campaign. Now, clearly, we need to have a boosting indication and then we need to have the Omicron strain change to be in place before we, As you know, some of our labels, for instance in Japan, actually carry both homologous and heterologous labels, and their number of countries where the policy bodies have allowed us to be used. Situations, either homologously or heteros.

Also to talk about.

Your preparedness to participate in an eventual booster market. This fall.

Do you believe you could potentially be able to participate in that market, but an army current containing vaccine.

Just given the timing of results for the upcoming studies.

Well, that's our that's our goal our goal is to be ready for such a campaign now clearly we need to have a boosting indication and then we need to have the omicron strain change should be in place before we can do that.

The as you know some of our labels for instance, in Japan actually carry both a homologous and had August boosting indication and there are a number of countries where the policy bodies have allowed us to be used in a boosting situation either homologous Lee our head of all honestly and we're bringing additional data to bear.

John Trizzino: We are bringing additional data to bear in that regard. So that's what we want to do, and that's what we're working towards. Great.

In that regard.

So that's what do we want to do and that's what we're working towards.

Great and then finally on the.

John Trizzino: And then finally, on the COVID flu combination opportunity, congratulations on the data. And to us, given just your technology, you could really be first to market with this product that could provide a major differentiation compared to your competitors. So maybe could you talk about how aggressively do you plan to pursue this program and do you see it as a priority for you in the near term? I guess I can take a crack at that, cover, if I say something which is incomplete or, So yeah, we're pushing as hard as we can. There are a number of innovations, which we haven't talked about, that we're bringing to this product. And the main issue is that blue is unpredictable.

Combination opportunity congratulations on the data.

And towards given just your technology, you can really be first to market with this product that could provide a major differentiation compared to your competitors. So maybe could you talk about how aggressively do you plan to pursue this program and do you see it as a priority for you.

In the near term.

I guess I can take a crack of that and John Kim.

Or if I say, something which is incomplete or incorrect.

So yeah, what we're pushing we're pushing as hard as we can there are a number of innovations, which we haven't talked about that we're bringing into this product.

And the main issue is that blue is unpredictable.

In the clinic.

John Trizzino: And the clinical efficacy study, we want to actually demonstrate that this product is better than licensed comparative. And for that, we need flu to circulate. So I think that that's the one uncertainty is to the timing of when that pivotal clinical efficacy study will occur. I think regarding, you know, commercial opportunity here, it's becoming clear that the key opinion leaders are looking at COVID to be looking like a flu, a seasonal, annual seasonal vaccination.

Clinical efficacy study, we want to actually demonstrate that this product is better than light.

A licensed comparator vaccine and for that we need flew to circulate. So I think that's the one uncertainties to the timing of when that pivotal clinical efficacy study will occur.

Regarding commercial opportunity here.

John Trizzino: And so the combination of these two, and particularly on, you know, our technology platform, our recombinant protein, as well as azjuventive technology seems to fit real well. I think most people will prefer one shot over multiple shots, and so, therefore, and with the data that we have for both, so we've got solid efficacy data off of COVID, obviously, and we also have a successful phase three on our flu vaccine that makes this a strong combination and would expect high demand for this in most high-income country markets. That's great. Thank you so much and congratulations.

Clear of that.

Key opinion leaders are looking at COVID-19 to be looking like a flu or seasonal annual seasonal vaccination and so the combination of these two and particularly on <unk>.

Our technology platform, our recombinant protein.

As well as adjuvant, the technology seems to fit real well.

Most people will prefer one shot over multiple shots and so therefore with the data that we have for both so we've got solid efficacy data off of Covid obviously.

And we also have a successful phase III on a fluke.

Vaccine that makes this a strong combination and would expect high high demand for this.

And most high income country markets.

That's great. Thank you so much and congratulations again.

The next question comes from George Duncan of Cantor Fitzgerald. Please go ahead.

John Trizzino: The next question comes from George Duncan of Cantor Fitzgerald. Please go ahead. Hi. Let's see. This is Charles.

Hi.

Let's see this is Charles thanks folks for taking the question and Dan and team congratulations on a great quarter of progress.

John Trizzino: Thanks, folks, for taking the question. And Stan and team, congratulations on a great quarter of progress. Let's see.

John Trizzino: Had a quick question for John. John, you mentioned in your prepared remarks that you've gotten some favorable feedback from the market regarding the, you know, response to the vaccine. And I guess I'm just kind of wondering what kind of favorable feedback you've gotten in terms of adopters thus far.

Let's see.

Question for John John You mentioned in your prepared remarks that you've gotten some.

Favorable feedback from the market regarding the <unk>.

Response to the vaccine and I guess I'm, just kind of wondering what kind of favorable feedback you've gotten in terms of adopters thus far.

So we continue to hear from our market research as well as anecdotally that there's a high demand for choice in the marketplace.

John Trizzino: So we continue to hear from our market research as well as anecdotally that there's a high demand for a choice in the marketplace. They like the technology platform, they like the safety profile, they like the efficacy profile, and so we're seeing a constant inquiry as to when product is available and where would be availability to get the product. So far, it's a little bit early as far as follow-on to the people that have been vaccinated, but again, we're hearing that they enjoy getting the vaccine, they've seen low rates of reactogenicity, and again, so this isn't a quantifiable approach, but market research and some surveying that we're doing.

They like the technology platform, they like the safety profile they like the efficacy.

He profile and so.

We're seeing.

<unk>.

Okay.

Inquiry as to when product is available and where.

The availability to get the product.

So far it's a little bit early as far as follow on to the people that have been vaccinated.

But again here, where we're hearing that.

They enjoy getting the vaccine they've seen.

Low rates of <unk> initiatives and again, so this isn't.

A quantifiable approach, but market research and some survey that we're doing so we're optimistic about the data inputs that we're getting already where the where the vaccine is business.

John Trizzino: So we're optimistic about the data inputs that we're getting already where the vaccine has been developed. Do you think that, you know, I'll call it, prescribers are aware of and have growing understanding of the kind of relative clinical as well as logistics profile and that that may or may not give an advantage in, say, a future booster campaign? Well, so... You have to keep in mind here that we're not, in many markets, able to promote directly.

Do you think that.

You know I'll call. It prescribers are aware of and have growing understanding.

Kind of relative clinical as well as logistics profile on that that may may or may not give an advantage in in say a ctrip booster campaign.

Well so.

You have to keep in mind here that we're not in many markets able to.

Promote directly so there is what we are trying to do is get people familiar with the various vaccines that are out of the market get familiar that we are in the market.

John Trizzino: So what we are trying to do is get people familiar with the various vaccines that are out on the market, get familiar that we're in the market, but we're not in the normal commercial circumstances where we could be promoting more aggressively about all of the attributes and product profile that we believe are strengths of this product. And so we're doing this through the scientific presentations, we're doing it through any opportunity that we can to make sure people are fully aware of what the characteristics of our vaccines are.

But we're not in the normal commercial circumstances, where we could be promoting more aggressively about all.

All of the attributes.

Product profile that we believe our strengths of this product and so we're doing this through the.

The scientific presentations, we're doing it through.

Any opportunity that we can to make sure people are fully aware of what the characteristics of our vaccine trials.

Charles were partly limited here, but I think we're gaining momentum.

John Trizzino: Charles, we're partly limited here, but I think we're gaining momentum as we're able to get more doses out into the market. Okay that really makes the doses delivered even more impressive to me. Let me ask you a quick question regarding regulatory and you're probably not going to be able to answer these questions rigorously but I guess I'm wondering as you prepare for the upcoming June event VRBPAC meeting, what kind of questions are you anticipating? Are there any key points of debate that you are looking forward to really being able to reconcile?

We're able to get more doses out into the marketplace.

Okay that really makes the doses delivered even more impressive to me. Let me ask you a quick question regarding regulatory and you're probably not going to be able to answer these questions rigorously.

So I'm wondering as you prepare for the upcoming June event for pack meeting what kind of questions are you anticipating.

Are there any key points of debate that you are looking forward to really being able to reconcile.

I guess, that's to me and I think the short answer is no I mean, we've been very open with our data we've published all of our results, but it was very strong it's compelling.

Filip Dubovsky: I guess that's to me, and I think the short answer is no. I mean, we've been very open with our data. We've published all of our results, but it is very strong. It's compelling.

And as the burnt packet is really focused on clinical results.

Filip Dubovsky: And as the VRBPAC is really focused on clinical results, I think that's what we're gonna trot out and share with advisors. We're feeling pretty confident about it. Just putting it into context, we've been approved in 40 other countries and some of those regulatory agencies, for instance Japan, MHRA, EU, Health Canada, TGA, I mean those are rigorous regulatory agencies that have scrutinized our program. Okay. Very good, Filip. Sorry to interrupt you.

That's where we're going to try it out and shared with advisers, but we're feeling pretty confident about this one.

Your next question, but and you're putting it into context, we've been approved you know and in 40 other countries and some of those regulatory agencies for instance, Japan M. H R. E E U Health, Canada T. G. A I mean those are rigorous regulatory agencies have to scrutinize our files.

Okay very good Philips sorry to interrupt two last questions for Jim regarding the last kind of statement out of your presentation on gas copy.

Jim Kelly: Last questions for Jim regarding the last kind of statement out of your presentation on GABI. I guess I'm wondering if they were to renegotiate to zero, I guess, you know, kind of worst case scenario, how could that change, at least qualitatively, how could that change the guidance? Just help me think through that, Matt. You know, Charles, I think it's fair to say you've put forth a highly negative, kind of negative... And Sergio.

Yes, I'm wondering if if they were to renegotiate two zero I guess.

Kind of worst case scenario, how could that change at least qualitatively how could that change the guidance just help me think through that math.

Yeah, Charles I think it's fair to say you put forth a highly negative had a negative scenario.

What we're saying is that it's simply unclear right now.

Jim Kelly: What we're saying is that it's simply unclear. So before we go to perhaps something so negative, what we're simply highlighting is that we're committed to continue working with Gavi to ensure equitable access. And as we, as this becomes clearer, we'll share. I think Jim is precisely right.

Okay before we go to perhaps something some negative we're simply highlighting is that we're committed to continue working with <unk> to ensure equitable access and as we as this becomes clearer we'll share.

Let me add.

Got a little bit I think Jim Jim is precisely right.

Jim Kelly: We can take a disclosure issue that we have here that I think was important for us to be transparent about, but we haven't spent a whole lot of time talking about what upside potential is in multiple markets relative to either the variant strains or bivalent or upside in the U.S. market as we move forward and get introduced into the U.S. market post the VRBPAC meeting. And so I think that there's some pluses and minuses that we're doing here, and we're simply trying to be transparent with this particular disclosure. Yeah, and I'm not trying to set a negative tone.

We can take a disclosure issue that we have here right that I think it was important for us to be transparent about but we haven't spent a whole lot of time talking about what upside potential is in multiple markets relative to either the the variant strains or bivalent or upside in the U S market as we move forward and get introduced.

Juice into the U S market post the.

<unk> meeting and so I think that there is some some pluses and minuses that we're doing here and there were simply trying to be transparent with this particular disclosure.

Yeah, and I'm not trying to set a negative tone I'm just trying to make a very simple overly simplistic mathematical calculation regarding coffee, but I guess what are you reading it right.

Jim Kelly: I'm just trying to make a very simple, overly simplistic mathematical calculation regarding Gavi, but I guess when you renegotiate it could go the other direction as well. Okay, thanks for taking my question. The next question comes from Eric Joseph of J.P. Morgan. Please go ahead. Hey, good evening.

Negotiate it could go the other direction as well okay. Thanks for taking my question.

Thank you Charles.

The next question comes from Eric Joseph of Jpmorgan. Please go ahead.

Hi, good evening, thanks for taking the questions.

Stan Erck: Thanks for taking the questions. Just a couple on the vaccinated commercial. There's been a comment about the expectation of sales increasing. Over the course of the second quarter, was that relative to Q1? I'm just trying to get a sense of where you see demand going relative to Q1. And from what... Q1, we also, we can back into a dose of about $19 a dose. I guess, should we anticipate that price point in our assumptions going forward? Any fluctuation in mix, I guess, right, that might impact ASPs and intestine headquarters as it relates to Novavax? Yeah, Eric, this is Stan.

Just.

A couple on <unk>.

Activate commercial stamina to comment about the expectation.

Sales are increasing.

Over the course of the second quarter was that relative to Q1, I'm just trying to get a sense of where you see.

Demand going relative to Q1 and from what.

Q1, we also we can back into a dose of about $19.

Thank you <unk>.

Dose.

Yes.

So we anticipate that price point, and our assumptions going forward any fluctuation in.

Mix I guess greatly by the impact.

ASP.

In subsequent quarters as it relates to the back to that.

Yes, Terry Stead, So, yes, we expect to an increase in Q2 over Q1.

Stan Erck: So yes, we expect an increase in Q2 over Q1. We have a 42 million dose order to Europe compared to, I think, 27 million the first quarter. And so that in itself is an increase at the same price that we were doing, first quarter, so we expect a fairly substantial increase in the second quarter revenue.

How should we have a 42 million dose orders in Europe compared to I think 27 million the first quarter.

And so that in itself is increasing at the same price that we were doing in the first quarter. So should we expect a fairly.

A substantial increase in the second quarter revenue.

Okay, great and just thinking through some of the scenarios that might take.

Stan Erck: Okay, okay, great. And just thinking through some of the scenarios that might take place with the VRBPAC meeting, is the focus here solely going to be on primary vaccination indication in adults? I'm wondering if there's kind of a potential upside case where the agency might be able to consider a broader application for a pediatric use. Yes, so they've announced that it will be primarily in adults greater than 18 years of age.

Basically your pack meeting.

Is the focus here solely going to be on.

Primary vaccination of indications in adults I'm wondering if there is kind of a potential upside case, where the agency might be able to consider a broader.

Yes.

Application for pediatric use.

Yes, so they've announced that the it'll be primarily an adult score than 18 years of age at the same time they have our adolescent data in hand, and that's the identical package, which has been supplied to the other global regulatory agencies. So they have the data in hand.

Stan Erck: At the same time, they have our adolescent data in hand, and that's the identical package which has been supplied to the other global regulatory agencies, so they have the data in hand. I think it's going to be up to them to decide specifically what questions they ask the advisor. It was for boosting.

It's going to be up to them to decide specifically what questions. They asked the advisory body.

Okay. It was great for boosting they have are boosting data that we're pulling together to submit to the other regulators, we anticipated giving them additional data as well.

Filip Dubovsky: They have our boosting data that we're pulling together to submit to the other regulators. We anticipate giving them additional data. I think it's fair to say that, uh... What gets asked officially during the VRBPAC meeting versus what we submit soon thereafter. That could be a big time, two events.

So I think it's fair to say that.

What gets you asked officially joined <unk> versus what we submit soon thereafter that shouldn't be a big time gap between those two events.

Yes.

Right I mean, the package that we would submit to the.

Filip Dubovsky: That's right. I mean, the package that we would submit to the FDA, for instance, for adolescent, is pretty much identical other than the cover letter that we've submitted to EMA, MHRA. So whether it be addressed there or the following day, I think we're ready for both. Okay, great. And just circling back to the vaccinated sales, I guess for those who are tracking them alongside using third-party data sources, to the extent that those are accurate, I mean, can you just clarify where sort of the point of sale or sales recognition takes place? Is it at doses delivered to a central hub? Is there, you know, consideration for a secondary delivery or shots administered that get factored into when sales are recorded? Yeah, that's a great question.

<unk> for instance for adolescence.

<unk> pretty much identical other than the cover letter then we've submitted to EMA.

Alright.

So so whether it'd be addressed there or the following day I think we're ready for both situations.

Okay great.

Just circling back to the exited sales I guess for those were.

Tracking them along side using third party data sources et cetera.

Those are accurate.

Just clarify where sort of the point of sale or sales recognition takes places it.

Doses delivered to a central hub is there.

No.

Consideration for a secondary delivery or self administered that get factored into when.

Sales are reported.

Okay.

Yeah, that's a great question.

We recognize revenue.

Stan Erck: We recognize revenue on delivery to our customers at their warehouses, that's where they... Okay, great. Thanks for taking all the questions, guys. Congrats on the quarter. The next question comes from Mayank Mamtani from B. Reilly Security. Please go ahead. Good afternoon.

On delivery to our customers that their warehouse and so that's where they take the title.

Yeah.

Okay, great. Thanks for taking the questions guys congrats on the quarter.

The next question comes from Mike <unk> from B Riley Securities. Please go ahead.

Good afternoon, thanks for taking our questions and congrats team on regarding your first profitable quarter. So maybe just.

Jim Kelly: Thanks for taking our questions and congrats to you on recording your first profitable quarter. So, maybe just a follow-up on the prior question, Jim. You know, this process of how revenue is recognized in EU versus shipments that are exported there, can you just help us understand, is there like a timeline lag or an average percentage that needs to get to that facility before, you know, it could get to a subsequent country and recognized as revenue?

Up on the prior question Jim.

This process of how revenue is recognized in EU versus shipments that are exported there.

Can you just help us understand is there like a timeline like ours and average percent data that needs to get to that facility before you know it.

It could get to a subsequent country and recognized as revenue and then a follow up question I had on the revenue guidance the full year guidance was on.

Jim Kelly: And then a follow-up question I had on the revenue guidance, the four-year guidance, was on how much of that $4 to $5 billion, you know, the guidance you issued today, has the U.S. product sales included in there, either as used as, you know, used as primary vaccine series in adults, adolescents, or as boosters? It would be helpful to get some color on that.

How much of that four to 5 billion.

The guidance you issued today.

As the U S product sales.

Included in there either as use us as primary vaccine series and it does so dollar sends out as boosters would be helpful to get some color on that.

Sure sure.

Jim Kelly: Sure, sure. Both good questions. So we have not disclosed a particular cadence of shipments into our facility in the Netherlands, which is from a warehouse units prior to distribution. We haven't communicated a specific expected cycle, from arrival there to distribution out to our customers. Beyond that... We certainly want it to be as quick as possible to have the best shelf life available for our customers.

Good questions.

So the.

We have not disclosed.

Or cadence.

Shipments into our facility in the Netherlands, which is for warehouse units.

So we have been.

<unk> communicated a specific expected cycle time from the arrival there to distribution out to our customers beyond that we certainly wanted to be as quick as possible to tap the best shelf life available for our customers.

And then with respect to your question about the U S government.

Jim Kelly: And then, with respect to your question about the U.S. government and the delivery and the dose. Our.., delivery of doses post-authorization, to be recognized under grant revenue. You might recall that under a $1.8 billion grant.

And the delivery and the dose is.

Our.

Future delivery of doses post authorization are expected to be recognized under grant revenue.

Recall that under our $1 $8 billion.

Operation Warped speed agreement a component of that is earmarked for.

Jim Kelly: Operation Warp Speed Agreement, a component of that is earmarked for doses to be delivered to the U.S. government. Now, we haven't disclosed exactly what percent, or a specific amount, greater than 400 million that I mentioned earlier, Will, will be recognized this year, but it does capture both the U.S. government's funding of our ongoing clinical work and delivery of doses. A reminder, this quarter we recognized 100... Understood.

She has to be.

To be delivered to the U S government no no we haven't disclosed exactly what percent of the or a specific amount of deep greater than 400 million that I mentioned earlier will.

We will be recognized this year, but it does capture both the U S government funding of our ongoing clinical work and delivery of doses. It includes both.

I remind listeners this quarter, we recognized a $100 million.

I understood and could you just give us an update on that incremental 100 million of it Europe that optional EPA, where you are with <unk>.

Jim Kelly: And could you just give us an update on that incremental 100 million with Europe, that optional APA, where you are with that and what's your expectation for this year versus next year? Yeah, so we're still working off the initial orders, and again, Mayank, you know, we're in constant communication with them, but there hasn't been a step into that. Group. Got it. And then just a couple of quick ones for Filip.

And what's your expectation for this year versus next year.

Yeah. So we're still working off the initial orders and.

Again, Mike.

We're in constant communication with them, but.

There hasn't been a step into that.

Expanded 100 billion doses yet but.

Again with the <unk>.

Pediatric label with the booster label and an improved.

Policy support I would reasonably expect that we will continue to see orders coming out of Europe in 'twenty, two and of course in 'twenty three.

Got it and then just.

Filip Dubovsky: This new data coming out of India in pediatrics, how does that inform your dosing strategy for obviously this 5 to 11 year old that you're starting in third quarter but also going down the age group? Anything you learned from that? And then the final question is on, you know, your EUA package is so sort of comprehensive on both clinical modules and CMC. What are the incremental items that will be part of the BLA package that you look to submit in second half? Yeah, so let me, I'll take those sequentially.

A quick one for Philip.

This new data coming out of India and pediatrics.

How does that inform your dosing strategy.

Or obviously this five to 11 year old that youre, starting in third quarter, but also going down the age group.

Any anything you learned from that and then the <unk>.

Final question is on the.

He went packages so sort of comprehensive onboard clinical modules and CMC.

What are the incremental.

The items that will be part of the BLA back is that you look to submit and in second half.

Yeah, So let me.

I'll take them sequentially. So the pediatric data we found a very reassuring.

Filip Dubovsky: So the pediatric data, we found very reassuring. The study design allows for dose adjustment. The Reactor Genicity is too significant in the children. This may not be required.

The study design allows for dose adjustments in case, the Iraqis density is too significant and the children.

This may not be required I mean, what we saw what I shared with you today, a very very good to me from a tolerability perspective, and the right and you just see what was also obviously very good. So it allows us to be reassuring both to the regulators the IRB, so as well as the participants.

Filip Dubovsky: I mean, what I shared with you today looked very, very good to me from a tolerability perspective, and the energy was also obviously very good. So, it allows us to be reassuring, both to the regulators, the IRBs, as well as the participants, in participating in this study. I think, additionally, it may allow us to move a little bit faster through the HD escalation process that is really going to be up to the Safety Monitoring Committee as well as the Regulatory Agency.

Participating in this study I think additionally.

It may allow us to move faster through the H D escalation process that was really up to going to be up to the safety monitoring committee as well as the regulatory agencies.

So overall I think it's good news Ive just de risks the entire endeavor, we're going to maintain the ability to do fractional dosing in case, we do see some reactions, which are severe especially on the youngest kids remember our our goal is to take it out.

Filip Dubovsky: So overall, I think it's good news and just de-risks the entire endeavor. We're going to maintain the ability to do fractional dosing. In this case, we do see some reactions which are severe, especially in the youngest kids. Remember, our goal is to take it down to children six months of age, which is another step down than the data I shared with you today. As far as what's required for the BLA from the clinical perspective, we need to come to an agreement, and this is why we would have the pre-BLA meeting, exactly how much safety data the agency wants before we file a BLA, and also in the U.S. uniquely, a lot plot consistency study needs to be conducted prior to the BLA. And these are very short studies, but we need to make sure that the agency is in agreement with our approach.

Children six months of age, which is another step down in the data I shared with you today as far as what's required for the BLA from a clinical perspective.

We need to come to agreement and this is why we would have at the pre BLA meeting exactly how much safety data. The agency once before we file that BLA and also in the U S. Uniquely a lot lot consistency study needs to be conducted.

Prior to the BLA and these are very short studies, but we need to make sure that the agency is in agreement with our approach for doing that.

Thanks for taking my questions.

Filip Dubovsky: Thanks for taking our questions. The next question comes from Vernon. Vernon Bernardino from H.C. Wainwright, please go ahead.

Yeah.

The next question comes from Vernon.

Bernard Arent Bernardino from H C. Wainwright please yes.

Hi, guys congratulations on the first profitable quarter.

Stan Erck: Hi guys, congratulations on the first profitable quarter. Hopefully you are celebrating that achievement, because it has been some time for some of us to code you for a long time. So my only question really is a follow-up from Charles's question regarding GAVI. Just wondering if you could share perhaps what GAVI is seeing out there and or perhaps what you are seeing out there that could make you at least have a matrix as far as decision making on the rest of your guidance and perhaps where GAVI might go. Yeah, this is Dan.

Hopefully York celebrating that.

Because it has been sometime.

ZIP code you for a long time.

And.

So my only question really as a follow up from.

Question regarding Gabby just wondering if you could share.

<unk> slipped.

He is seeing out there.

Or perhaps what you are seeing out there that could make you.

At least have a metric as far as decision making on.

The rest of your guidance and perhaps what.

We're gathering might go.

Yeah. This is Stan.

Stan Erck: So it's, how are you? Good. Yeah, it's, it's a unclear, marketplace right now in the low and middle income countries, there appears to be lots of inventory that's been shipped to the the main. The vaccine introduction side of the warehouse in many of these low and middle-income countries and the difficulty appears to be getting.., to the youth in the country. And so I think that that's something that's, I don't have a lot of visibility into, but that's.., relayed to us. And so, therefore, they uh...

Thanks Angela.

Are you.

But yeah.

Yeah.

They are unclear.

Marketplace right now in the low and middle income countries. There is there appears to be lots of inventory that's been shipped to the to the main.

Your vaccine introduction side of the warehouse and in many of these low and middle income countries and the difficulty appears to be getting it into the <unk>.

Use the countries so.

That's that's something that I.

I don't have a lot of visibility into but that's what it's been.

Related to us and so therefore they.

That translates into.

Stan Erck: It translates into uncertainty about it, you know. ...demand for our vaccine right now, and so it's, I think, characterized by uncertainty. So I don't know where it's going to go, for the World Middle Income Countries.

Uncertainty about it.

Demand for our vaccine right now and so it's it's I think characterized by the uncertainty so I don't know where it's going to go.

For the low and middle income countries.

We're waiting on.

Stan Erck: We're waiting, on discussions with Gavi to see, what we're going to do with our current... It's, it's, it's.., close that there's uncertainty that's been fairly recent. That's what it is, that's where we're at. As a follow-up, if I could, I know it's a separate disease, influenza, but part of hesitation sometimes is that, you know, if you don't have a severe flu season, and that includes in developing in third world countries, you have less uptake of a vaccine that could potentially protect you, much less save your life. What are you seeing?

Discussions with Gaba B to C.

What we're going to do with our current country. So.

As we disclosed that there is uncertainty that's been fairly recent.

That's what it is like that.

That's where we are.

Okay as a follow up if I could.

No its a separate disease influenza, but.

Part of.

Hesitation, sometimes is that if you don't have a severe flu season.

And that includes in developing and third world countries.

You have less uptake of a vaccine that could potentially protect you much lesser Sandra life what.

What are you seeing I know youre working on a bivalent.

Stan Erck: We're working on a bivalent, but what you're seeing as far as marketing research, you're seeing whether some of this hesitancy is related to the fact that we've not had severe flu seasons for many years now, obviously before the pandemic. Well, yeah, let me comment on that. I think what your assessment is right, fear is a great driver of vaccine use, right? You're preventing a disease, not curing a disease, and so therefore preparation is important.

What you're seeing as far as marketing researchers see.

Weather.

Some of this hesitancy is related to the fact that we've not had severe flu seasons for many years now obviously before the pandemic.

Well, Yeah, let me, let me comment on that I think what your assessment is right fear is a great driver of vaccine used right you're preventing.

A disease not not curing the disease and so therefore preparation is important so I think the issue here burden is is.

Stan Erck: So I think the issue here, Vernon, is what is the best preparation in any particular season for both influenza and COVID? And I think the vaccine is that right prevention. You can't predict in any given year, you know, what the circulating virus rate will be. And so I think that's why you've seen flu vaccine, especially in the U.S., be universally recommended now for many years. And there are some years that are bad and there are some years that aren't as severe.

Is what is the best preparation in any particular season for both influenza and Covid and I think the vaccine is that rate prevention, you can't predict in any.

Any given year, you know what what the circulating virus rate will be and so I think that's why you've seen flu vaccine, especially in the U S. B universally recommended now for many years and there are some years that are bad and there are some years that arent as severe.

Vaccination is important and I think that's going to be true for COVID-19 as well at the moment you have COVID-19 muting.

Stan Erck: But vaccination is important. And I think that's going to be true for COVID as well. At the moment, you have COVID muting the circulation of influenza virus, and that might not be the case.

The circulation of influenza virus.

And that that might not be the case and so when will fluid come back it will likely come back with some vengeance and we need to be prepared for that and we think a combination influenza COVID-19 vaccine is the right strategy.

Stan Erck: And so when will flu come back? It will likely come back with some vengeance, and we need to be prepared for that. And we think a combination influenza-COVID vaccine is the right strategy. Just to pile on from an epi perspective, I mean, really, flu hasn't been around now for a couple of seasons and that means that the population is really susceptible. So, when it does flip over and some minor drift bearing comes into.., population.

Just a just a pilot for my Abbvie perspective, I mean really flew hasn't been around now for a couple of seasons and that means that the population is really susceptible.

So when it does flip over and some minor drift Baron comes into into the population I think we could see quite a severe year and remember that the CDC estimated that the vaccine efficacy. This past year was almost 16%.

Stan Erck: I think we could see quite a severe year. Remember that the CDC estimated that the vaccine efficacy this past year, You know, based on our data, we believe that we have a better. I think that's it. Thanks for taking my question and follow-up, and congrats again on the first profitable quarter. This concludes our question and answer session. I would like to turn the conference back over to Stan Erck for closing remarks.

Based on our data, we believe that we have a better flu vaccine.

I think so thanks for taking my question and follow up and congrats again on the first profitable quarter. Thank you.

Yeah.

This concludes our question and answer session I would like to turn the conference back over to Stan <unk> for closing remarks.

Okay, Thanks, and thanks for everyone for joining in and listening.

Stan Erck: Okay, thanks and thanks for everyone for joining in and listening. Just to close, we're proud of the significant milestones we've reached since the start of 2022, all of which have been made possible through the dedicated efforts of our Novavax team and ongoing collaboration with many of our partners globally. The year ahead, we look forward to continuing to report on additional progress. We've talked about the things that are going on that will be new data coming out this year across our business as we continue the successful commercial launch of our vaccine. Thank you very much, and we'll close. This conference is now concluded. Thank you for attending today's presentation. You may now disconnect. Thank you.

Just to close we are proud of the significant milestones we reached since the start of 2022, all of which have been made possible through the dedicated efforts of our novavax team and ongoing collaboration with many of our partners globally for the year ahead, we look forward to continuing to report on additional progress we've talked about.

Matt.

Things are going on that will be new data coming out this year.

Most of our business as we continue the successful commercial launch of our vaccine.

Thank you very much close.

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

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