Q4 2021 Novavax Inc Earnings Call

Yeah.

Operator: To withdraw your questions, you may press star and. Please also be advised that today's conference call is being recorded. If you should need assistance during today's conference, you can signal an operator by pressing star and then zero. I would now like to hand the conference call over to your speaker today, Sylvia Taylor. You may begin. Good afternoon, and thank you all for joining us today to discuss our fourth quarter and full year 2021 operational highlights and financial results.

Ladies and gentlemen, thank you for standing by and welcome to the Novavax fourth quarter and full year 2021 financial results and operational highlights conference call.

At this time all participant lines are in a listen only mode.

After the speaker's presentation, there will be a question and answer session.

To ask a question you May press Star and then one to withdraw your question you May Press Star two.

Please also be advised that today's conference call is being recorded.

If you should need assistance during todays conference you can signal an operator by pressing star and then zero.

I would now like to hand, the conference call over to your Speaker today Silvia Taylor you may begin.

Good afternoon, and thank you all for joining us today to discuss our fourth quarter and full year 2021 operational highlights and financial results.

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

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

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 relating to future financial or business performance conditions or strategy, including expectations regarding revenue operating expenses cash.

Sylvia Taylor: For example, statements relating to future financial or business performance conditions or strategies, including expectations regarding revenue, operating expenses, cash usage, clinical development of our vaccine candidates, timing of future regulatory filings, authorizations, and actions, and other anticipated milestones are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which may change over time.

You said your clinical development of our vaccine candidates timing of future regulatory filings authorizations and actions and other anticipated milestones are forward looking statements Novavax 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. We encourage you to consult the risk factors discussed in our SEC filings for additional detail.

Sylvia Taylor: We encourage you to consult the risk factors discussed in our SEC filings for additional detail. Joining me today is Stan Erck, President and CEO, who will provide an overview of recent achievements, discuss regulatory updates, and preview 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, supply and manufacturing, as well as address the broader market opportunity for our COVID-19 vaccine.

Joining me today is Stan <unk>, President and CEO , who will provide an overview of recent achievements discuss regulatory updates and preview 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 supply and man.

Sylvia Taylor: Dr. Philip Dubovsky, Chief Medical Officer will discuss recent clinical development 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 would now like to hand the call over to Stan. Please turn to slide 4. Stan?

The factoring as well as address the broader market opportunity for our COVID-19 vaccine Dr. Phillip Dubowski Chief Medical Officer will discuss recent clinical development 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 would now like to hand, the call over to stand Please turn to slide four Stan.

Yeah.

Stan Erck: Thanks, Sylvia, and thanks everyone for joining us today as we discuss the substantial progress made by Novavax in 2021 and into the beginning of 2022. Through continued execution across all areas of our business, today we have rapidly transitioned into a global commercial company, now delivering our COVID-19 vaccine throughout the world. Since making our first submission for authorization in August of last year, we've delivered upon all of our commitments across our entire business, including, and Regulatory.

Thanks, Sylvia and thanks to everyone for joining us today as we discuss the substantial progress made by Novavax in 2021 and into the beginning of 2022.

Through continued execution across all areas of our business today, we have rapidly transition into a global commercial company now delivering our COVID-19 vaccine throughout the world.

So it's making our first submission for authorization in August of last year.

We've delivered on all of our commitments across our entire business, including.

Stan Erck: We have authorizations today from 12 regulatory agencies as well as emergency use listing from the World Health Organization, rapidly expanding access to our COVID-19 vaccine. We are authorized in 38 countries and have emergency use listing from the WHO representing the potential to reach over 170 total countries.

And regulatory we have authorizations today from 12 regulatory agencies as well as emergency use listening from the World Health organization wrapped.

Rapidly expanding access to our COVID-19 vaccine.

We are authorized in 38 countries and have emergency use listening from the WH O representing the potential to reach over 170 total countries.

Stan Erck: Adding this all up, these markets represent six billion lives, commercialization, we've initiated the commercial rollout of Novavax of it. We have shipped our vaccine to the European Union, Australia, Indonesia, and South Korea, and first doses of our vaccine have now been administered in all of these markets. Manufacturing Capacity.

Adding this all up these markets represent 6 billion lives.

And commercialization, we've initiated the commercial rollout of new Baxter, we have shipped our vaccine to the European Union, Australia, Indonesia, and South Korea, and first doses of our vaccine have now been administered in all of these markets.

Manufacturing capacity.

Stan Erck: We've achieved our target of annual capacity of more than 2 billion doses with the ability to meet the current and future global demand for our vaccine. And with respect to clinical data, we have built upon our robust data of clinical evidence, robust body of clinical evidence, and we have generated additional data to support expanded indications and policy recommendations that will drive utilization across our three core targets, primary vaccinations, boosters, and pediatric population. These include new data we announced today demonstrating protection against all COVID-19 infection and durability of efficacy over six months. Booster data demonstrating broad cross-reactivity against variance and adolescent data demonstrating clinical efficacy against variance.

We've achieved our target of annual capacity of more than 2 billion doses with the ability to meet the current and future global demand for our vaccine.

With respect to clinical data, we have built upon our robust data of clinical evidence robust body of clinical evidence and we have generated additional data to support expanded indications and policy recommendations that will drive utilization across our three core targets primary vaccinations boosters.

The pediatric populations.

<unk> include new data, we announced today demonstrating protection against all COVID-19 infection and durability.

Efficacy over six months.

Booster data demonstrating broad cross reactivity against periods and adolescent data demonstrating clinical efficacy against variance.

Stan Erck: With respect to COVID-19 variants, we also demonstrated our ability to rapidly respond to variants of COVID-19. We developed an Omicron-specific variant vaccine, and within weeks of initiating development, we began GMP manufacturing. This serves as an important proof of concept that we can evolve our vaccine as a pandemic evolves with new variants. With all of this momentum over the past 60 days, we are now delivering our protein-based vaccine to the world. And we expect this momentum will only accelerate.

With respect to COVID-19 variance, we also demonstrated our ability to rapidly respond to variance of COVID-19.

We developed and omicron specific variant vaccine and within weeks of initiating development, we began GMP manufactured.

This serves as an important proof of concept that we can evolve or vaccine is a pandemic evolves with bluebird.

With all of this momentum over the past 60 days, we are now delivering a protein based vaccine to the world.

Stan Erck: In 2022, we see significant opportunities for Novavax due to the ongoing urgent need for vaccine globally. These include a global vaccination rate of only 56%. Clearly, we have not yet met the WHO goal of 70% global vaccination, waning immunity over time after vaccination, the continued rise of variants, and pent-up demand for additional vaccine options, especially a protein-based option. All of these factors contribute to the urgency of bringing our vaccine to the market.

And we expect this momentum will only accelerate in 2022 we see significant opportunities for <unk> due to the ongoing urgent need for vaccine globally. These include.

Global vaccination rate of only 56% clearly we have not yet met the WHI goal of 70% global vaccination waning immunity over time after vaccination. The continued rise of variance and pent up demand for additional vaccine options, especially a protein based option.

All of these factors contribute to the urgency of bringing or vaccine to the market.

Stan Erck: With line of sight into all of these factors informing the need for our vaccine today, for the first time, we are providing financial guidance outlining our expectation to achieve full year 2022 total revenue of between $4 and $5 billion. With that, please turn to slide five, where we provide an overview of our regulatory progress to date. Through our focus on expediting our regulatory filing since the first submissions in August 2021, we've now gained authorizations in 38 countries.

With line of sight into all of these factors informing the need for a vaccine today for the first time, we're providing financial guidance.

Outlining our expectation to achieve full year 2022 total revenue of between four and $5 billion.

Okay.

With that please turn to slide five where we provide an overview of our regulatory progress to date.

Through our focus on expediting, our regulatory filing since the first submissions in August 2021, we've now gained authorizations in 38 countries.

Stan Erck: For our product, Novavaxavid, we have received authorizations from all 27 member states of the European Union, Great Britain, Canada, Australia, Singapore, New Zealand, the United Arab Emirates, and, in partnership with SK Bioscience, we also received approval of our BLA in South Korea. For COBOVAX, which is our vaccine manufactured by our partner, Sarah Minstitute, we received authorizations from India, Indonesia, the Philippines, and Bangladesh.

For our product <unk>, we have received authorization from all 27 member states of the European Union, Great Britain, Canada, Australia, Singapore, and New Zealand, the United Arab Emirates and in partnership with SK Bioscience. We also received approval of our BLA to sell that.

South Korea.

Yeah.

<unk>.

Which is our vaccine manufactured marketing by our partner Serum Institute, we received authorizations from India, Indonesia, the Philippines and Bangladesh.

Stan Erck: For both Novavax and Kovavax, we've also received emergency use listing from the World Health Organization representing the potential for our vaccine to reach more than 130 additional countries. In these geographies, Novavax is the first protein-based COVID-19 vaccine authorized for commercial use based on phase 3 data, allowing us to bring to the market an important alternative based on a well-understood technology, with significant regulatory progress made to date. We expect to expand our regulatory authorizations through additional submissions, including making Novavax a bit available in the United States, where we have already filed our request for EUA in January.

For both <unk> and Kobo backs. We've also received emergency use listening from the World Health organization, representing the potential for our vaccine to reach more than 130 additional countries.

In these geographies Novavax has the first protein based COVID-19 vaccine authorized for commercial use based on phase III data, allowing us to bring to the market an important alternative based on a well understood technology.

With significant regulatory progress made to date, we expect to expand our regulatory authorizations through additional submissions, including making <unk> available in the United States, where we have already filed a request for EUA in January .

Stan Erck: As Filip will discuss later on today's call, we are also executing upon a robust clinical development program to make our vaccine more widely available. And with that, I'll now hand it over to John to discuss our progress in delivering doses of our vaccine globally. Thank you, Stan.

As Philip will discuss later on today's call. We are also executing upon our robust clinical development program to make a vaccine more widely available.

And with that I'll now hand, it over to John to discuss our progress in delivering doses of our vaccine globally.

Thank you Stan.

John Trizzino: Novavax continues to build a body of evidence to enhance our highly competitive Nuvaxibid product profile, which demonstrates high levels of efficacy and a reassuring safety profile. Beginning with our positive phase 3 data, we have built upon our clinical package with new data from boosting studies, pediatric populations, and today with data demonstrating our vaccine's ability to protect against infection and its strong durability over time. Taken together, our product profile results in a differentiated vaccine that will help achieve global health policy goals at the same time allow us to satisfy existing and future demand globally.

<unk> continues to build a body of evidence to enhance our highly competitive new accident product profile, which demonstrates high levels of efficacy and a reassuring safety profile.

Beginning with our positive free phase III data, we have built upon our clinical package with new data from boosting studies pediatric populations and today with data demonstrating our vaccine's ability to protect against infection and its strong durability over time.

Taken together our product profile results in a differentiated vaccine that will help achieve global health policy goals and at the same time allow us to satisfy existing and future demand globally.

John Trizzino: As we look to expand access to our vaccine, we've already begun to see supportive policy recommendations for Novaxivid, which is a testament to the robust clinical data package we've generated to date. Ministries of Health and National Immunization Technical Advisory Groups across the European Union at the World Health Organization and in Canada, Australia, and Singapore have published their recommendations for Nuvaxavid as a two-dose primary series, and in some national policy recommendation bodies have recommendations allowing heterologous vaccination and boosting.

As we look to expand access to our vaccine we've already begun to see supportive policy recommendations for novak's Covid, which is a testament to the robust clinical data package, we've generated to date.

Ministries of health and natural amortization technical advisory groups across the European Union at the World Health organization, and in Canada, Australia, and Singapore have published their recommendations for the new vaccinated as a two dose primary series.

And in some national policy recommendation bolt bodies have recommendations, allowing heterologous vaccination and boosting.

John Trizzino: With regulatory authorizations and policy recommendations in hand, we've mobilized our global manufacturing and supply network to execute on the rollout of our first commercial product, Novavaxovit. Since December of last year, we've begun shipping doses around the world, including 9 million doses to Indonesia, 6 million to Australia, 2 million to South Korea, and 27 million doses that have already been delivered to our European distribution center. Shipments are already arriving in individual EU countries, and we expect shipments to continue to additional countries in the EU.

With regulatory authorizations and policy recommendations in hand, we've mobilized our global manufacturing and supply network to execute on the rollout of our first commercial product news accident.

Since December of last year, we began shipping doses around the world, including 9 million doses to Indonesia, 6 million to Australia to millions of South Korea, and 27 million doses that have already been delivered to our European distribution Center.

Okay.

Shipments are already arriving in individual EU countries, and we expect shipments to continue to additional countries in the EU will quickly follow these initial deliveries.

John Trizzino: We'll quickly follow these initial deliveries. As already reported, an additional 42 million dose order commitment is in place for the second quarter, resulting in 69 million total doses for Europe in the first half of 2022. In all of these markets, vaccinations with New Vaxivid have begun. For the COVAX facility, we are collaborating closely with GAVI and our global partners to optimize supply quantities and delivery schedules.

As already reported and additional 42 million dose order commitment is in place for the second quarter, resulting in 69 million total doses for Europe in the first half of 2022 .

In all of these markets vaccinations with new the exited have begun.

For the Comex facility, we are collaborating closely with gaudy and our global partners to optimize supply quantities and delivery schedules and together we are committed to achieving our shared goal of equitable access.

John Trizzino: And together, we are committed to achieving our shared goal of equitable access. Now with regulatory authorization in 38 countries and a WHOEUL, our vaccine has the potential to access more than 170 countries around the globe. This global access is supported by bilateral supply agreements already in process of being shipped, licensed partners Serum Institute, SK Bio, and Takeda Oil Manufacturing. We expect additional approvals in the U.S. and others with immediate product availability, and through our partnership with Seeram Institute, we have already shipped 9 million doses to Indonesia in support of our commitment to equitable access. In the U.S., we further solidified our partnership by extending our funding agreement through 2023.

Now with regulatory authorization in 38 countries and it W. H O E U L. Our vaccine has the potential to access more than 170 countries around the globe. This global access is supported by bilateral supply agreements already in process of being shipped.

License partners see our basic two S K bio and Takeda all manufacturing.

We expect additional approvals in the U S and others with immediate product availability.

And through our partnership with serum Institute, we have already shipped 9 million doses to Indonesia in support of our commitment to equitable access.

Okay.

In the U S. We further solidified our partnership by extending our funding agreement through 'twenty twenty-three with this latest modification to our agreement our $1.8 billion of allotted funding will support additional booster and adolescent booster studies for our vaccine, reflecting the U S governments.

John Trizzino: With this latest modification to our agreement, our $1.8 billion of allotted funding will support additional booster and adolescent booster studies for our vaccine, reflecting the U.S. government's ongoing investment to support expansions of our label. We are appreciative of the ongoing support from the U.S. government, and in the future we see an opportunity to pursue procurement agreements to supply doses to the U.S. The U.S. Department of the U.S. Department of the U.S. Department of the U.S. We are frequently engaged with health ministers, public health authorities, and KOLs around the globe, and it is clear that there is a strong demand for an effective protein-based alternative that is safe, effective, and refrigerator stable to allow for ease of transport and on-site storage.

Ongoing investment to support expansions of our label.

We are appreciative of the ongoing support from the U S government and in the future, we see an opportunity to pursue procurement agreements to supply doses to the U S.

Okay.

We are frequently engaged with health ministers.

Public health authorities and Kols around the globe and it is clear that there was a strong demand for an effective protein based alternative that is safe effective and refrigerator stable to allow for ease of transport and onsite storage.

John Trizzino: In addition, as doses of our vaccine are being received across the globe, we believe consumer choice will play an increasingly important role in driving demand. Through Novavax's reassuring tolerability and safety profile, we are confident that utilization of our vaccine can support preferences over time, building additional demand now and into the future. Please turn to slide six.

In addition, as doses of our vaccine are being received across the globe. We believe consumer choice will play an increasingly important role in driving demand.

Through new vaccine bids reassuring tolerability and safety profile, we are confident that utilization of bar vaccine can support preferences over time building additional demand now and into the future.

Please turn to slide six.

John Trizzino: As we execute on the commercial rollout of Novavaxavid, we have readied our global manufacturing infrastructure with sites around the world consistently producing vaccine at commercial scale. Through our partnership with Serum Institute, as well as our Novavax-owned facilities and other manufacturing partnerships, we have significant bioreactor capacity for antigen production and achieved large-scale production of our Matrix M adjuvant, together supporting our over 2 billion doses of annual capacity. Now please turn to slide not, please turn to slide seven, and evaluating the global market demand for NewVexibid.

As we execute on the commercial rollout of new exited we have readied, our global manufacturing infrastructure with sites around the world consistently producing vaccines at commercial scale.

Through our partnership with serum Institute as well as our Novavax owned facilities and other manufacturing partnerships, we have significant bioreactor capacity for antigen production and achieved large scale production of our matrix M. Adjuvant together supporting our over 2 billion doses of annual capacity.

Now please turn to slide <unk>, Please turn to slide seven.

In evaluating the global market demand for new vaccinated data today.

John Trizzino: Data today, demonstrates continued need for primary vaccination, boosters, and for the pediatric market. There is still a need to increase vaccination rates globally. In fact, data from the CDC show a persistent increase in the mortality rate for the unvaccinated over recent months, reiterating the urgent need to deliver our vaccine globally.

Demonstrates continued need for primary vaccination boosters and four of the pediatric market.

There is still a need to increase vaccination rates globally in fact data from the C. D. C. So a persistent increase in the mortality rate for the unvaccinated over recent months reiterating the urgent need to deliver our vaccine globally.

John Trizzino: These data show that mortality rates are lower for those that receive a booster dose. Also, boosting is necessary to increase protection versus those that have only received the primary series, especially as variants of COVID-19 continue to emerge. We believe this presents an additional opportunity for Novavaxivant to support the fight against the ongoing pandemic, please turn to slide eight, where we provide an overview of the market opportunity across primary, booster, and pediatric indications as well as global opportunities to ensure equitable access to vaccines, for primary vaccination.

These data show that mortality rates are lower for those that receive a booster.

A booster dose.

Also boosting is necessary to increase protection versus those that have only received the primary series, especially as various of COVID-19 continued to emerge.

We believe this presents an additional opportunity for new vaccines a bit to support the fight against the ongoing pandemic.

Please turn to slide eight.

Where we provide an overview of the market opportunity across primary booster and pediatric indications as well as global opportunities to ensure equitable access to vaccine for.

John Trizzino: We believe that New Vaxivic can serve as a desirable alternative for those that remain hesitant and those that want additional vaccine options. We also expect that waning immunity and the continued emergence of variant strains will drive ongoing demand for booster and annual revaccination, and we believe our vaccine is ideally positioned to support this need through its demonstrated ability to produce robust immune responses against variants. In the pediatric populations, we see continued need for a differentiated vaccine option.

Four primary vaccination, we believe that new vaccinate conserve as a desirable alternative for those that remain hesitant and those that want additional vaccine options.

We also expect that waning immunity and the continued emergence of variant strains will drive ongoing demand for booster and annual re vaccination and we believe our vaccine is ideally positioned to support this need through its demonstrated ability to produce robust immune responses against variance.

And the pediatric populations, we see continued need for a differentiated vaccine option. We are encouraged by the positive results from our pediatric expansion and our prevent 19 phase III trial announced earlier this month, which demonstrated our vaccines vast potential to serve as an alternative.

John Trizzino: We are encouraged by the positive results from our pediatric expansion in our Prevent 19 Phase 3 trial announced earlier this month, which demonstrated our vaccine's vast potential to serve as an alternative for pediatric populations. And finally, on a global scale, we see significant gaps in vaccine access, which we believe Nuvaxibib can address through its favorable distribution and storage profile. With that, I'd like to hand it over to Philip to discuss our clinical development plan, an additional detail in recent clinical data for New Vax of it. Thank you, John. Please turn to slide nine.

For pediatric populations.

And finally on a global scale, we see significant gaps in vaccine access, which we believe he is actually we can address through its favorable distribution and storage profile.

With that I'd like to hand, it over to Philip to discuss our clinical development plan and additional detail and recent clinical data for <unk> accident Philip.

Thank you John Please turn to slide nine.

Philip Dubovsky: John outlined the three major areas where we see an opportunity for our vaccine to have an additional impact. We're gathering clinical data to support both label expansion as well as policy recommendations. Let's go to slide 10 and talk about primary vaccination. As John described, we continue to seek emergency use authorization in additional territories for primary vaccines. In parallel, we are reading data from our Phase 3 studies to pursue full approval. We expect to file our BLA in the second half of this year.

John outlined three major areas, where we see an opportunity part of backseat to have an additional impact.

Gathering clinical data to support both label expansion as well as policy recommendations let's.

Let's go to slide 10, and talk about primary vaccination.

As John described we continue to seek emergency use authorization in additional territories for primary vaccination.

In parallel we are readying data from our phase III studies to pursue full approvals.

We expect to file our BLA in the second half of this year.

Philip Dubovsky: We're also gathering additional data so our vaccine can be used for additional populations in a more flexible manner to allow for greater use. Today, I will give a couple of examples, one from our BLA dataset from our UK Phase 3 study and another from a study we recently launched in South Africa, please turn to slide 11. Here's the design of the U.S.

We're also gathering additional data as far as <unk> can be used to pour additional populations and then a more flexible manner to allow for greater use.

Today I'll give a couple of examples one from our BLA data set from our U K phase III study and another from studied we recently launched in South Africa.

Please turn to slide 11.

Philip Dubovsky: Phase 3 study, the U.K. Phase 3 study. It enrolled 15,000 participants, half received vaccine and half received placebo. The primary endpoint was PCR-confirmed mild, moderate, or severe disease beginning seven days after the second dose, future on the slide 12. This slide describes the emergence of variants during the conduct of the study. The cases for the primary efficacy evaluation were collected over three months. During a time window from the 10th of November to the 24th of January, it's marked in the green box. You can see that the majority of cases were caused by the alpha barrier which emerged during the conduct of the study. Now let's go to slide 13.

Here's the design of your Phase III study.

U K basically study enrolled 15000 participants have received vaccine and have received placebo. The primary endpoint with PCR confirmed mild moderate or severe disease, beginning seven days after the second dose.

Please turn to slide 12.

This slide describes the emergence of variance during the conduct of the study the.

The cases for the primary efficacy evaluation were collected over three months.

During a time window from the 10th of November 24th of January it's marked in the Green box.

You can see that the majority of cases were caused by the alphabet, which emerged during the conduct of the study.

Now, let's go to slide 13.

Philip Dubovsky: Here we see the primary efficacy data that was used to obtain approval for emergency use authorization. The data was collected over that three-month period, which represents a median of 55 days of surveillance. There were 10 cases in the vaccine group, 96 cases in the placebo group, with the resultant efficacy of approximately 90%. All the severe cases occurred in a placebo group, but due to low case count, this was not specifically significant. Let's move on to slide 14.

Here, we see the primary efficacy data that was used to obtain approval or emergency use authorization.

The data was collected over that three months period, which represents a median of 55 days surveillance.

There were 10 cases in the vaccine group 96 cases in the placebo group with a resultant efficacy of approximately 90%.

All of the severe cases occurred in the placebo group with you to low case counts this was not statistically significant.

Let's move on to slide 14.

Philip Dubovsky: The data I will present today represents the BLA MA data. The efficacy endpoints were collected over a six-month time period, as marked in the green box on the slide. Alphabet and continue to be the predominant variant during the efficacy collection win. Now let's go to site 15 and look at some data. Here we have displayed high-level safety data. The safety profile is very consistent with previous studies. The event rates are low and balanced between vaccine and placebo group. Severe and adverse events of special interest occurred at very low frequency.

The data will present today represents the BLA and MAA dataset.

Betsy endpoints were collected over six months time period, and as Mark and Green box on the slide.

Alpha variance continues to be the predominant variant during the efficacy collection window.

Now, let's go to slide 15, and look at some data.

Here, we have displayed high level safety data the safety profile is very consistent with previous studies the.

Event rates are low and balanced between vaccine or placebo group Sears severe and adverse events of special interest occurred at very low frequencies.

Philip Dubovsky: So it's 516. Now, here we have the placebo-controlled advocacy data collected over the six-month surveillance period, which represents the median of approximately 100 days of surveillance. There were 24 cases in the vaccine group and 134 cases in the placebo group, which yielded a vaccine efficacy of 82.7%, with a lower bound greater than 73%. This is consistent with what we know about the decay of anybody for this vaccine and for all other COVID-19.

Let's move to slide 16.

Here, we had in the placebo controlled efficacy data collected over the six months surveillance period, which represents a median of approximately 100 days of surveillance.

There were 24 cases in vaccine group and 134 cases in placebo group, which yielded an vaccine efficacy of 82, 7% with lower bound greater than 73%.

This is consistent with what we know about the decay of antibody for this vaccine and for all other vaccines.

Philip Dubovsky: Importantly, in this expanded data set, we had an adequate number of cases to statistically demonstrate vaccine efficacy against severe disease. We saw a vaccine efficacy of 100% with a lower bound confidence interval above zero. Now let's turn to slide seven.

Importantly, since expanded dataset, we had an adequate number of cases.

Physically demonstrate vaccine efficacy against severe disease, we saw a vaccine efficacy of a 100% like a lower bound.

And our ROE above zero.

Now, let's turn to slide 17.

Philip Dubovsky: So this is a graphic representation of the protection. The vaccine group is in blue, while the placebo group is in gray. The vaccine group and placebo group diverge on day zero, which was the day the second dose of vaccine was administered, indicating that efficacy can be observed early in the primary vaccination schedule. Al was going to fly 18 [inaudible] The data on this slide represents our first evaluation of protection against infection. Infection is defined as either circumverting to the N-protein or being PCR positive, thus capturing both symptomatic and asymptomatic cases.

So this is a graphic representation of the protection.

A vaccine group in little while the placebo group isn't great.

The vaccine group and placebo group divergent D zero, which was the second dose vaccine was administered indicating efficacy can be observed early in the primary vaccination schedule.

Let's go to slide 18.

The data on this slide represents our first evaluation of protection against infection.

Infection was designed defined as either converting to the M protein or being PCR positive, that's capturing both symptomatic and asymptomatic cases.

Philip Dubovsky: This analysis includes data collected to expand the data. Overall, there were 36 cases in the vaccine group and 195 cases in the placebo group, which yielded a vaccine efficacy of 82.5% with a tight lower bound of 75%. Okay, let's jump to slide 19 for a quick summary. I've presented data from the extended data cut that will be used to support the BLA MAA or from our UK Phase 3 study. The top line safety continues to be reassuring.

This analysis includes data collected through the extended dataset.

Overall, there were 36 cases in the vaccine group and 195 cases placebo group wish you live at vaccine efficacy of 82, 5%.

Lower bound of 75%.

Okay, let's jump to slide 19 for a quick summary.

I've presented data from the extended data cut that will be used to support the BLA and MAA or from our UK phase III study.

Top line safety continues to be reassuring clinical efficacy was maintained with the expected diminishing as immune responses wane.

Philip Dubovsky: Clinical accuracy was maintained with the expected diminution as the immune response is weighing. Vaccine efficacy against severe disease was preserved with no severe cases throughout the extended surveillance period. The vaccine demonstrated protection from infection, which recapitulates what we saw in our non-human primate studies. And this has potential implications for transmission as well as for prevention of long-term COVID sequelae. If you're not infected, you can't transmit the virus, nor can you hang long COVID.

Vaccine efficacy against severe disease was preserved with no secret cases throughout the extended period.

The vaccine demonstrated protection from infection, which which recapitulates what we saw in our nonhuman.

Primate studies.

And.

This has potential implications for transmission as well as for promotion of long term coats Aquila.

If youre not affected you cannot transmit the virus nor can you hang long COVID-19 .

Philip Dubovsky: Okay, let's turn to slide 20 and talk about the study we began last week. In this study, we're evaluating alternate dosing schedules, and people living with HIV were evaluating both a three-dose schedule and an extended dosing schedule to define the best approach for vaccinating immunocompromise. Additionally, we're comparing our classic zero and 21-day schedule to a zero and 70-day schedule to generate data that will support additional flexibility in how our vaccine is used in the real world. This study began last Friday and is an example of the approach we are taking to expand the reach of our primary vaccination population. Okay, please certify 21 and we'll talk briefly about booths.

Okay, let's turn to slide 20, and talking about the studying we began last week.

In this study we're evaluating alternate dosing schedules.

People living with HIV, we're evaluating both a three dose schedule and an extended dosing schedule to define the best approach for Vaccinating immunocompromised participants. Additionally, we're comparing our classics zero in 'twenty, one basically go to zero and 70 days schedule to generate data that will support additional flexibility in our vaccine is used in the real world.

The study began last Friday and it's an example of the approach we're taking to expand the reach of our primary vaccination populations.

Okay. Please turn to slide 21, and we'll talk briefly about boosting.

Philip Dubovsky: For heterologous boosting, we're encouraged by the policy recommendations in some countries allowing heterologous vaccination and boosting. We continue to collaborate with academic and government groups to gather additional data, and this will be used to, and we will initiate our own studies in the second quarter. For homologous boosting, our initial data and regulatory filings will leverage the USC Australia Phase 2 study, as well as data from the South Africa Phase 2 study. I will detail some of that data in a minute.

Or heterozygous boosting we're encouraged by the policy recommendations in some countries, allowing heterologous vaccination and boosting we continue to collaborate with academic and government groups together additional data and this will be used to and we will initiate our own studies in the second quarter.

For homologous boosting our initial data and regulatory filings, we will leverage the USC, Australia that phase II study as well as data from the South Africa Phase II study.

I will detail some of that data in the next slide.

Philip Dubovsky: We anticipate this will be ready for regulatory submission in the second quarter. Additional data will be coming from our face to be studied where we boosted all the part. And as John mentioned, we have received support from the U.S. government to expand the adolescent study to include boost. Now let's go to slide 22 and review some of the data that will support the initial boosting indication. This is indicative data from our U.S. and Australia phase 2 study.

We anticipate this will be ready for regulatory submission in the second quarter <unk>.

Additional data will be coming from our phase III study, where we boosted all the participants and as John mentioned, we have received support from the U S government to extend the adolescent study to include boosting.

Now, let's go to slide 22, and review some of the data that will support the initial boosting vacation.

This is indicative data from our U S and Australia phase two studies. The first two bars display the wild type Mutualization response after two doses in the U K and U S. Mexico Phase III study.

Philip Dubovsky: The first two bars display the wild-type neutralization response after two doses in the U.K. and U.S.-Mexico phase 3 study. Above the bars are the high levels of efficacy seen against strains closer to the original strain as well as variants. As a reminder, the majority of cases in both studies were determined to be variant, and the third bar is a minor response we saw after a single boosting dose of... You can see that we induced neutralizing responses that were four and a half times higher than that associated with protection in the phase three studies, giving us reason to believe we could have comparable or higher efficacy after a boost. Now please turn to slide 23.

Above the bars are the high levels of efficacy seen it get strange closer to the original strain as well as variance.

As a reminder, the majority of cases in both studies were determined to be variance on.

The third bar is immune response, we saw after a single boosting goes up to six months.

You can see that we induce neutralizing responses that were core and half fold higher merit associated with protection and the phase III studies, giving us reason to believe we could have comparable or higher efficacy after boosting dose.

Now please turn to slide 23.

Philip Dubovsky: The quality of the immune response is equally important as the magnitude of the immune response. This slide displays neutralizing response against prototype, delta, and homotonic area. This is a stringent essay conducted at the Matt Primland Lab in the University of Maryland, which measures 99% of your food.

The quality of the immune responses is equally important as the magnitude of the immune response. This slide displays neutralizing response against prototypes Delta and I'm a comp variance.

This is a stringent assay conducted at the mine frame and lab at the University of Maryland, which means there is 99% utilization.

Philip Dubovsky: La Pan Fide are the result after two doses, mutualizing immune responses that were reserved against all variants. There's a four-fold decrease between the original strain in the Omicron of the area. On the right-hand side, you can see that after a single boost, there was a large increase neutralizing titers against all variants, absolute levels after boosting compared favorably with those seen after two doses. I want to remind you that in our Phase 3 study, we saw 96 to 100% protection against the prototype after two doses, shown here in black on the left-hand side, and 82% against Delta, displayed in blue on the left. Okay, please turn to slide 24 and let's talk about children.

Left hand side are the result, after two doses neutralizing immune responses that were preserved against all variance.

For full decrease between the original strain Microrna variant.

On the right hand side, you can see that after a single boost there was a law of large increase neutralizing titers against all variance.

Absolute levels after boosting compared favorably with OTC after two doses.

I want to remind you that in our phase III study, we saw a 96% to 100% protection against the prototype after two doses shown here in black and white.

On site and 82% against Delta display in Blue on the left side.

Yeah.

Okay. Please turn to slide 24, and let's talk about children.

Philip Dubovsky: We have concluded the study in children 12 to 18 years of age and plan to submit this to our global regulators in the first quarter. In fact, we have already submitted the clinical study report to the regulatory agencies that have mechanisms to accept submission of clinical data in advance of the complete filing. As we have previously detailed, we plan to initiate an age de-escalation study in the second quarter. But let me review a bit of data from our adolescent study to show you why we're so excited about the pediatric indication. Please turn to slide 25.

We've concluded the study in children 12 to 18 years of age and plan to submit this to our global regulators in the first quarter.

Fact, we've already submitted into the clinical study report to the regulatory agencies that have mechanisms to accept submission clinical data in advance of the complete island.

As we have previously detailed we plan to initiate an Ht escalation study in the second quarter, but let me review a bit of data from our adolescent study to show you why we're so excited about the pediatric indication. Please turn to slide 25.

Philip Dubovsky: This slide reviews our adolescent data. Unfortunately, we achieved our primary effective end point, which showed the minor responses in 12 to 18-year-olds were non-imperial to those seeding young adults in the main part of the phase 3. In fact, those responses were 1.5% higher than senior adults. From a regulatory perspective, by achieving this endpoint, the efficacy in the adult portion of the study is deemed to apply to the adult population. Additionally, although the number of cases was modest.

This slide reviews, our adolescent data.

Importantly, we achieved our primary effectiveness endpoint, which of the munis sponsors in 12 to 18 year olds, where not adhere to those seen in young adults in the main part of the phase III study in.

In fact it was.

Responses were one point fivefold higher than seen in adults.

From a regulatory perspective, achieving this endpoint.

As seen in the adult portion of the study is deemed to apply to the adolescent.

Additionally, although the number of patients was modest we saw 8% efficacy against the Delta variant.

Philip Dubovsky: We saw 80% efficacy against the Delta variant. Now let's move to slide 20. Displayed here is the local reactogenicity, comparing 12- to 18-year-olds to the 18- to 25-year-olds. Overall, the adolescents compared favorably to young adults. There was a small increase in mild swelling and redness seen after dose 2, likely because of the girth of teenage arms. All of the events were short-lived with a median duration of one to two days.

Now, let's move to slide 26.

[noise] displayed here, it's the local Reactogenic city, comparing 12 to 18 year olds to the 18 to 25 year olds overall, the adolescence compared favorably to young adults.

Small increase in miles swelling and redness seen after those two likelihood of teenage arms.

The events were short lived because he median duration once you do day two days.

Philip Dubovsky: Now let's turn to slide 27 and look at the solicited, The Felicitic Reactor Genocide was also favourable and prepared well between Adlessons to those in the Underbells, small increase in grade 3 fatigues in teens, however, overall, the rates of all grades of fatigue were lower than in the young adult. All events were short-lived, median duration of one day, except for muscle pain. The reason we're so excited about this data is because the reactogenicity appears favorable compared to the young adults, despite the immune response being significantly higher than seen in the younger adults.

Let's turn to slide 27, and look at those solicit symptoms.

Yeah.

The solicitor Reactogenic City was also favorable and compared well between adolescents to those in young adults. It's a small increase in grade <unk> teams of our overall the rates of all great. Some tea were lower than in the young adult all of them are short lived a median duration of one day, except for muscle pain, which was twofold.

The reason, we're so excited about this data is because they are reacting to that city appears favorable compared to the young adults. Despite the immune response to be significantly higher than <unk> seen in the younger adults.

Philip Dubovsky: This may build well for vaccine evaluation and young children and may help increase vaccine acceptability in the age of, Finally, let's go to slide 28 and look at our near-term pipeline. Displayed here is our Natrium Pipeline. And I want to point out some of the clinical highlights.

This may bode well for vaccine evaluation in young children and May help increase vaccine acceptability in this age group.

Finally, let's go to slide 28, and look at our near term pipeline.

Right.

And here is our near term pipeline.

And I want to point out some of the clinical highlights.

Philip Dubovsky: As we've talked about for Novavax today, we will continue to work on our label and policy expansions, including boosting and pediatric indications, for the Omicron vaccine we have previously stated we have one in development. It still isn't clear if an Omicron vaccine is needed. I've shared data that our vaccines work well against all variants in the U.S. and U.K. Phase 3 studies, and our immune responses against Omicron appear sound, especially after booster.

We've talked about putting a accelerated and we will continue to work on our label and policy expansions, including boosting and pediatric indications.

For the Oregon vaccine. We have previously stated we have one in development.

It still isn't clear economic crime vaccine as needed I've shared data that our vaccine it's worked well against all the variants in the U S and UK phase III studies.

And our immune responses against all Macomb appear sound, especially after at least two beds.

Philip Dubovsky: However, we're in the midst of a GMP campaign that's a manufacturer vaccine and the material will be available toward the end of the first quarter. Our plan is to conduct a strain change study immediately thereafter. In these sorts of studies, you've been licensured by comparing the immune response induced by the Omicron vaccine. The immune responses induced by the Oursions claim.

However, we are in the midst of a GMP campaign to manufacture the vaccine and the material will be available towards the end of the first quarter. Our plan is to conduct a spreadsheet study immediately thereafter.

Philip Dubovsky: It's similar to what's done for influenza when strains change on an annual basis. As far as our combination influenza-COVID study goes, it's complete and being analyzed. As you remember, the study explored a wide range of antigen doses for the combination vaccine, as well as for the quadrivalent influenza vaccine by itself. We expect the results to be available in April, and based on those results, we'll conduct a phase 2 study to confirm the specific formulations that we will take into the federal government. Okay, let me turn it over to Jim to discuss our financial results. Thank you, Filip. Please turn to slide 29.

With the phase II studies to confirm specific formulations that we will take into the pivotal study.

Okay, Let me turn on for Jim to discuss our financial results.

Thank you Phil.

Please turn to slide 29.

Okay.

Jim Kelly: I'll begin with an overview of the full year 2021 total revenue performance and our year in cash position, and then my commentary will focus primarily on our fourth quarter results. For the full year 2021, Novavax recorded total revenue of 1.1 billion, a milestone for the company. This $1.1 billion reflects 141% growth in total revenue year-over-year and consists of $949 million of grant revenue and $198 million of royalty and other revenue.

This afternoon, we announced our financial results for the fourth quarter and full year 2021 I'll begin with an overview of the full year 2021 total revenue performance and our year end cash position and then my commentary will focus primarily on our fourth quarter results.

Jim Kelly: Grant's revenue has been an important source of capital to fund our Novavax-invaded clinical program and scale up of our commercial manufacturing capabilities. During 2021, we recorded grants revenue of $811 million and $135 million from the U.S. government and CEPI, respectively. Under the U.S. government agreements, we have $800 million of funding remaining, and we expect to recognize the majority of this amount during 2022. For 2022, we do not expect to recognize a material amount of grants revenue from CEPI as we've completed the activities funded under this agreement.

For the full year 2021, Novavax recorded total revenue of $1 1 billion a milestone for the company.

This $1 1 billion reflects a 141% growth in total revenue year over year and consist of $949 million of grant revenue and $198 million of royalty and other revenue.

Grants revenue has been an important source of capital to fund our novak's evade clinical program and scale up of our commercial manufacturing capabilities during.

During 2021 we recorded grants revenue of 811 million and $135 million from the U S government and sappy respectively.

Under the U S government agreements, we have 800 million of funding remaining and we expect to recognize the majority of this amount during 2022.

For 2022, we do not expect to recognize a material amount of grants revenue from Sheppy as we've completed the activities funded under this agreement.

Jim Kelly: We ended 2021 with $1.5 billion in cash and received an additional $350 million milestone payment from GAVI in the first quarter of 2022. This means Novavax is well-capitalized as we launch Novavaxavid globally, please turn to slide 30. Turning to our fourth quarter 2021 results, Novavax recorded total revenue of $222 million compared to $280 million in the fourth quarter of 2020. Fourth quarter 2021 royalties and other revenue grew to $127 million compared to $20 million in the prior year and reflect the additional royalties from our licensed partners on their sales to South Korea and Indonesia. Fourth quarter 2021 grants revenue of $95 million compares to $259 million in the prior year. The decline in grants revenue resulted from the completion of the manufacturing scale-up activity funded by CEPI earlier in 2021.

We ended 2021 with $1 5 billion in cash and received an additional 350 million milestone payment from godby in the first quarter of 2022.

This means novavax as well capitalized as we launched <unk> of accident globally.

Please turn to slide 30.

Okay.

Jim Kelly: We recorded total operating expenses of $1 billion in the fourth quarter of 2021, including $963 million for R&D. This reflects a significant increase to R&D expenses as compared to both the same quarter prior year and the third quarter of 2021. This increase was primarily the result of the accelerated recognition of embedded lease expenses tied to our contract manufacturing agreements, and the expensing of Novavax-vid pre-launch inventory that in the future will be capitalized to the balance sheet.

Turning to our fourth quarter 2021 results.

<unk> recorded total revenue of 222 million compared to $280 million in the fourth quarter of 2020.

Fourth quarter 2021, royalties and other revenue grew to 127 million compared to $20 million in the prior year and reflect the additional royalties from our licensed partners on their sales to South Korea and Indonesia.

Fourth quarter 2021 grants revenue of 95 million compares to $259 million in the prior year.

The decline in grants revenue resulted from the completion of the manufacturing scale up activities funded by Sheppy earlier in 2021.

We recorded total operating expenses of 1 billion in the fourth quarter of 2021, including 963 million for R&D.

This reflects a significant increase to R&D expenses as compared to both the same quarter prior year in the third quarter of 2021.

This increase was primarily the result of the accelerated recognition of embedded lease expenses tied to our contract manufacturing agreements.

And the expensing of novak's evade prelaunch inventory than in the future will be capitalized to the balance sheet.

Jim Kelly: Neither of these items impact cash flow in the period, and by dispensing these manufacturing costs in 2021, we expect lower cost-a-good sold expense in future periods. We will revisit the concept of less-than-full-cost COGS on our first quarter call. When seeking to understand the operational run rate for R&D costs during 2021, we believe our Q1 to Q3 R&D expense run rate is a better starting point for estimating future R&D cost trends. We expect our full year 2022 R&D expenses to be lower than 2021, and a significant portion of 2022 R&D costs will continue to be funded by the U.S. government. We recorded general and administrative expenses of 84 million in the fourth quarter of 2021 as compared to 61 million in the fourth quarter of 2020.

Neither of these items impact cash flow in the period and by expensing. These manufacturing costs in 2020 , one we expect lower cost of goods sold expense in future periods.

We will revisit the concept of less than full cost Cogs on our first quarter call.

When seeking to understand the operational run rate for R&D costs. During 2021, we believe our Q1 to Q3 R&D expense run rate is a better starting point for estimating future R&D cost trends.

We expect our full year 2022, R&D expenses to be lower than 2021 and.

And a significant portion of 2022 R&D costs will continue to be funded by the U S government.

We recorded general and administrative expenses of $84 million in the fourth quarter of 2021 as compared to $61 million in the fourth quarter of 2020.

Jim Kelly: This increase to GNA is a result of our support of the Novavaxavid launch, and we expect GNA to continue to grow into 2022 as we further enhance our commercial capabilities to bring Novavaxavid to markets around the world. And finally, for the fourth quarter of 2021, we recorded a net loss of $846 million, as compared to a net loss of $178 million in the fourth quarter of 2020, please turn to slide 31, where we'll provide an overview of our financial guidance for 2022.

This increase to G&A as a result of our support of the <unk> launch and we expect G&A to continue to grow into 2022 as we further enhance our commercial capabilities to bring <unk> to markets around the world.

And finally for the fourth quarter of 2021, we recorded a net loss of 846 million as compared to a net loss of $178 million in the fourth quarter of 2020.

Please turn to slide 31.

Where we will provide an overview of our financial guidance for 2022.

Jim Kelly: As discussed earlier, we expect to achieve full year 2022 total revenue of between $4 and $5 billion. As a reminder, total revenue reflects all sources, including product sales and Novavax evade by Novavax, grants revenue, royalties, and other revenue. We look forward to sharing our progress towards realizing this total revenue guidance and plan to provide additional guidance related to full year 2022 operating expenses on future earnings calls. With that, I'd like to turn it over to Stan to discuss our upcoming strategic priorities. Thanks, Jim.

As discussed earlier, we expect to achieve full year 2022 total revenue of between four and $5 billion.

As a reminder, total revenue reflects all sources, including product sales and Novak surveyed by Novavax.

Grant revenue royalties and other revenue.

We look forward to sharing our progress towards realizing this total revenue guidance and plan to provide additional guidance related to full year 2022 operating expenses on future earnings calls.

With that I'd like to turn it over to Stan to discuss our upcoming strategic priorities.

Stan Erck: We're pleased to report these results of a highly productive fourth quarter reflecting our rapid transition into a global commercial organization. With significant results achieved to date and our expectation of achieving four to five billion dollars of total revenue in this year alone, I'd like to end today's call by providing an overview of our strategic areas of focus for the remainder of 2022. On the commercial front, through 22, we will distribute doses globally to our customers to meet our revenue targets.

Thanks, Jim.

We're pleased to report these results of our highly productive fourth quarter, reflecting a rapid transition into a global commercial organization with significant results achieved to date and our expectation of achieving $4 billion to $5 billion of total revenue in this year alone I'd like to end today's call by providing an overview of our strategic areas of focus.

Stan Erck: On the regulatory and manufacturing fronts, we expect to gain additional authorizations where we have already filed, including in the U.S. We will pursue full approval of our vaccine, including filing our BLA in the second half of 2022. We'll add another manufacturing facility, we'll add additional manufacturing sites to our filings, and we'll manufacture doses to supply all of our current as well as additional demand for 2022. Finally, we will advance clinical development of other vaccine candidates in our pipeline, including continuing clinical development to expand the use of Novavaxavid into additional indications, such as boosters, and into the pediatric population, as well as continuing the development of our Omicron vaccine.

For the remainder of 'twenty two.

On the commercial front through 'twenty, two we will distribute doses globally to our customers to meet our revenue targets.

On the regulatory and manufacturing fronts, we expect to gain additional authorizations, where we have already filed including in the U S. We will pursue full approval of our vaccine, including filing our BLA in the second half of 'twenty two.

Add another manufacturing will add additional manufacturing sites to our filings and were manufactured doses to supply all of our current as well as additional demand for 2022.

And finally, we will develop we will advance clinical development of other vaccine candidates in our pipeline, including continuing clinical development to expand the use of <unk> into additional indications such as boosters and into the pediatric population as well as continuing the development of our omicron vaccine.

And we will advance our COVID-19 influenza combination vaccine, which is a key component of our pipeline, we expect to announce data in April and to initiate a phase II trial that will also include a nano flue standalone arm brings us one step closer to pursuing licensure of our product.

Stan Erck: And we'll advance our COVID-influenza combination vaccine, which is a key component of our pipeline. We expect to announce date in April and to initiate a phase two trial that will also include a nanoflu standalone arm, bringing us one step closer to pursuing licensure of our product. Thanks for your attention. I will now turn it over to the operator for Q&A. Ladies and gentlemen, at this time, we'll begin the question and answer session.

Thanks for your attention I will now turn it over to the operator for Q&A.

Stan Erck: To ask a question, you may press star and then one using a touch tone telephone. To draw your questions, you may press star and two. If you are using a speakerphone, we do ask that you please pick up the handset before pressing the numbers to ensure the best sound quality.

Ladies and gentlemen at this time well begin the question and answer session to ask a question you May Press Star and then one using a touchtone telephone.

John in your question you May press Star two.

If you are using a speaker phone, we do ask that you. Please pick up the handset before pressing the numbers to ensure the best sound quality.

Operator: Once again, that is star and then one to join the question. Our first question today comes from Roger Song from Jeffreys, please go ahead with your question. Great. Thank you for taking the question and congrats for all the progress. So the first question from me is regarding the sales guidance or revenue guidance. I think that's very nice. You provide this $4 to $5 billion overall guidance, but could you provide any comments around the breakdown between the product sales like APA versus the royalty and the grant and other, Yeah, I'll take it. This is Stan.

Once again that is star and then one to join the question queue.

Our first question today comes from Roger song from Jefferies. Please go ahead with your question.

Great.

Thank you for taking my question and congrats for audit progress. So the first question from me is.

Regarding that.

Guidance revenue guidance.

That's very nice you provided support to <unk> overall guidance.

Could you provide any comments along.

The breakdown of the change.

Like <unk>.

Graham.

Yes.

Stan Erck: And the vast majority is related to product sales. And of that, the vast majority of that's related to Novavax product sales. And so we book Novavax product sales, as product is shipped and into the hands of our customers. On our partner sales, such as Serum, we book the portion of the sales that is revenue related to us through royalties. And so it's virtually all product related sales with the exception of the government grants that Jim mentioned would be largely expended in 2022 and on the order of magnitude of what, $600 to $800 million in that range? Of the $800 million, we expect more than half will occur in 2022.

Yeah I'll take it this is Dan and the vast majority is related to product sales.

Of that the vast majority of that is related to the vaccine product sales. So we book.

Stan Erck: Yeah. Okay. So it's product related. Sorry.

The product sales.

As our product has shifted into the hands of our customers on our partner sales such as serum we booked a portion of the sales that is revenue related to us.

Through royalties and so it's virtually all product related sales with the exception of the government grants as Jim mentioned will be largely expanded in 2022 and on the order of magnitude of about $6 million to $800 million.

And that range of $800 million, we expect more than half will occur in 2022, okay.

So it's product related revenue.

Okay.

Okay.

No.

Stan Erck: No. Next question, yep. Sorry, did I miss something? Yeah, no, yeah, that's great.

Next question Yep sorry.

Alright, I misheard it.

Stan Erck: And then regarding the COVID flu combo vaccine data in April this year, so just can you just provide some kind of a, your expectation and what is the go-no-go decision point to move forward into the phase, Yeah, so we go into this trial knowing some things already. We know how our flu, the response to our flu vaccination was, including in a phase three immunogenicity trial. We know from preclinical studies, what we wanted to show was that by putting the COVID and the nanoflu vaccine together is neither one suppressed the immune response to the other.

Yes, no that's great.

Then regarding the cold and flu combo vaccine data in April .

Yeah, So just that.

Yes.

Provide some kind of that.

Our expectation and what is the go no go decision points and move forward into the phase two.

Yes. So we go into this trial, knowing knowing some things already we know how our our fluids. The response to our flu vaccination was and included a phase III Immunogenicity trial, we know from preclinical studies, what we wanted to show was that that by putting the COVID-19 and the nano fluids.

Together is neither one suppress the immune response to the other end in animals, we found that we need to we need to confirm that in humans, but we're pretty confident that those data will be available to us and then we took a.

Stan Erck: And in animals, we found that we need to, we need to confirm that in humans, but but we're pretty confident that those data will be available to us. And then we took a pretty broad range of vaccine arms so that we could we could come to a conclusion on what dose level we want between flu and COVID in various arms. And that'll be really key because it's a more complicated vaccine. And there, you know, we want to make sure we've got the right dose.

A pretty broad range of of vaccine arms. So that we could we could come to a conclusion on what dose level we want.

Between flu and Covid.

<unk> arms and that'll be really key because it's a more complicated vaccine and there you know we want to make sure. We've got the right dose. So that's the point of the phase one two trial I think it will give us information to go into a phase II trial that will confirm the dose selection.

Stan Erck: So that's the point of the phase one, two trial. I think it'll give us information to go into a phase two trial that will confirm the dose selection. And, and that'll be later this year. Great, thank you.

And and that'll be later this year.

Stan Erck: Maybe just one last one from me is the recently, your competitors, the Novavax and GSK, they provide some positive data for their protein based vaccine. And maybe just curious your thoughts around how this will impact your commercial adoption for, Yeah, I don't think it has much impact on us right now. I mean, it's hard for us to tell about a competitive product when we haven't seen the data and we don't know the timing of when they're going to file or enter into the marketplace.

Great. Thank you maybe just one last one from me.

We can play.

Competitors and they'll be on the GSK me provide some positive data that Christine beta vaccine.

Maybe just curious your thoughts around how that will impact you all commercial adoption for all that.

Yeah, I don't think it has much impact on US right now I mean, it's hard for us to tell but a competitive product when we haven't seen the data and we don't know the timing of when they're going to file or enter into the marketplace. So we're we're pretty confident based upon what little we have seen that our our our combination of <unk>.

Stan Erck: So we're pretty confident based upon what little we've seen that our combination of efficacy data and safety data and the fact that we're in the market will give us a good head start on any potential competition. Great, thank you, Sam. That's all from us.

Efficacy data.

And safety data and the fact that we are in the market.

Will will give us a good head start on any any potential competition.

Great. Thank you. Thanks, that's helpful.

Charles Duncan: Our next question comes from Charles Duncan from Cancer Fitzgerald. Please go ahead with your question. Yeah, thanks for taking the question, Stan and team. Congrats on executing well during a challenging environment throughout 21.

Our next question comes from Charles Duncan from Cantor Fitzgerald. Please go ahead with your question.

Yes, thanks for taking the questions Dan and team congrats on executing well during a challenging environment throughout 'twenty one.

Stan Erck: Also, thanks for the sales guidance. I did want to ask you a little bit more detail about that in terms of, you said that it was primarily driven by actual sales of Novavax advided. Could you give us some color on the timing?

Also thanks for the sales guidance.

I did want to ask you a little bit more detail about that.

In terms of.

You said that it was primarily driven by.

So sales have no vaccine.

Stan Erck: Is this a quarterly build? Or would you anticipate bulk of the sales in the first half of this year? And then it to be relatively stable over the course of the... Well, we're not, I'm sorry, Charles, but we're not giving quarterly guidance. And so, so we've, we've come up with, we've got these APAs that are in place, we have manufacturing schedules, which will support them. And it's the timing of our customers and when they want their shipments will determine the quarterly pace of these.

Could you give us some color on the timing is this is this a quarterly build or would you anticipate bulk of the sales in the first half of this year and then it to be relatively stable over the course of the year.

Well, we're not sure.

Sorry, Charles but we're not giving quarterly guidance and so so we've come up with we've got these <unk> that are in place, we have manufacturing schedules, which will support them and it's the timing of our customers when they want their shipments will determine the quarterly pace of these in and of course, there's going to be a.

Stan Erck: And, and, and of course, there's going to be a fairly quick out the door because we've already announced that we've shipped 27 million doses to Europe. And I note that we've shipped 27 million doses to Europe in January. And so, for this, for further distribution to our customers. So, so a lot's gone out the door.

Fairly quick out the door, because we've already announced that we've shipped 27 million doses to Europe and Jeb I note.

We've shipped 27 million doses to Europe in January and so for dish for further distribution to our customers. So so a lot's gone out the door we've got.

Stan Erck: We've got, as, as John also noted, we have a 42 million dose order just from Europe in the second quarter. And, and, but, but as far as further definition of doses and doses by quarter, we're not able to, to provide that guidance right now. Okay, that's cool. We're okay with that.

As John also noted we have a 42 million dose order just from Europe in the second quarter and and.

But as far as further definition of doses and doses by quarter were not.

Not able to provide that guidance right now.

Stan Erck: Regarding the guidance, though, is it dependent on U.S. approval? It doesn't seem like it would be, but is there perhaps the four versus five million or billion dollars dependent on approval and use in the United States? I think the U.S. represents upside potential for us.

Okay, that's cool.

We're okay with that.

Regarding.

The guidance, though is it dependent on U S approval it doesn't seem like it would be but is there perhaps the four versus $5 million.

Sure.

Dependent on approval and using the in the United States.

I think the U S represents upside potential for us.

Stan Erck: Okay. And then relative to the BLA, you mentioned the BLA in Europe and then potential for BLA filing here in the United States. Can you give us a little bit of color on what additional work needs to be done to support a BLA filing here in the U.S.?

Okay, and then relative to the BLA.

You mentioned, the BLA and in Europe , and then potential for BLA filing here in the United States can you give us a little bit of color on.

What additional work needs to be done to support a BLA filing here in the U S. And are you signaling that we should forget about an emergency use authorization and really focus on a BLA.

No is the answer to the last question, but I'll, let Philip shepp in and maybe provide some.

The opinion on.

Sure and just to reiterate we're going.

Philip Dubovsky: And are you signaling that we should forget about an emergency use authorization and really focus on a BLA? No is the answer to the last question, but I'll let Filip step in and maybe provide some, some opinion on. Daniela, just to reiterate, we're going full blast for our EUA. We're in contact with the FDA periodically, you know, to make sure all the questions are answered. So, we're going forward to moving forward with that, and as you know, we don't control the pace they review the filing, but we're going forward to a successful verpacate in the near future.

Pro glass for are you anywhere.

I think like with the FDA.

<unk> you know to make sure all their questions are answered. So we're looking forward to moving forward with that and as you know we don't control the pace. They reviewed the pylon I'm looking forward to a successful grand packet in near future.

The clinical data that's required for the BLA and MAA or very similar where they're really looking for is longer term safety and long term safety of the product the.

Philip Dubovsky: The clinical data is required for the BLA and the MAA Overseas. What they're really looking for is longer term safety and it was a long term safety. The US is different from some territories, including Europe, in that from time to time, they want to lock, lock, and lock.

The U S is different from some territories, including Europe , and then from time to time. They went a lot lot consistency study. So thats an additional small study we would have to conduct to support the U S. BLA as opposed to the MAA.

Philip Dubovsky: So that's an additional small study we would have to conduct to support the U.S. VLA as opposed to the MAAs. Now, all that being said, a condition for us to get the MAAs are, well, we have the successful EUAs first before we move on to the pilot and licensure, and that's a path we're going to be following in the U.S. Okay, that's super. Last quick question is on safety since you brought it up.

Now all that being said it condition for us to get to the MAA as well we have to be successful.

He was first before we move onto the final licensure and that's a path we're gonna be following in the U S as well.

Okay. That's Super last quick question is on safety since you brought it up.

I guess I'm wondering if you've seen any.

Philip Dubovsky: So I guess I'm wondering if you've seen any outsized incidents of my myocarditis in patients or in people who have been vaccinated? And and does that change over time? As you as you track them over over time any any incidents?

Any outsized.

Sedans of.

My myocarditis.

In patients or in people, who have been vaccinated and does it change over time.

As you as he tracked them over over time any any incidents.

Philip Dubovsky: Yeah, so we, of course, take all safety very seriously. And we've previously announced that in any safety database as large as ours, you can expect to see cases in the vaccine and placebo. What I can tell you is that the rates of myocarditis are balanced between the vaccine and placebo. Additionally, you know that our safety has been adjudicated by close to a dozen regulators globally. And if you scrutinize our label, you'll see that we don't have myocarditis as a drug reaction in any of our labels.

So we of course take all safety very seriously and we've previously announced that in any safety database as large as ours you can expect to see cases in the vaccine or placebo.

What I can tell you is that as rates myocarditis or balance between the vaccine or placebo group.

Additionally, you know that our safety has been adjudicated by close to a dozen regulators globally and scrutinize our label, you'll see that we don't have myocarditis or adverse drug reaction in any of our labels now all that being said I have to acknowledge that ours is a relatively small database only roughly 60000 individuals.

Philip Dubovsky: Now, all that being said, I have to acknowledge that ours is a relatively small database, only roughly 60,000 individuals, so as we start selling millions and millions of doses, we'll get a much better ability to understand if there's any risk for myocarditis. Okay, very good. Thank you. That's helpful.

We started selling millions and millions of doses, we'll get a much better ability to understand if there's any risk or myocarditis or not.

Okay very good. Thank you that's helpful. Congrats on the progress last year and into this year.

Yeah.

Philip Dubovsky: Congrats on the progress last year and into this year. Our next question comes from Georgie Jordanoff from Cowanning Company. Please go ahead with your question. Hey everyone, congratulations on all the progress for me as well.

Our next question comes from Georgia, Gordon off from Cowen and company. Please go ahead with your question.

Everyone congratulations.

On all the progress for me as well.

John Trizzino: Just a clarification on the guidance. Is there an expected timeline the countries that have signed the APAs will need to accept doses by? And again, related to the $4 to $5 billion, do you expect the majority of the currently signed APAs to be satisfied this year? Our estimate suggests you could generate $2 to $3 billion in cash flows in the next 12 to 18 months. How do you plan to utilize this cash? What are your thoughts on potential BD opportunities or share buybacks? Hi, John Trizzino here.

Clarification on that.

The guidance is there an unexpected timeline that countries that have signed the a piece when he took symptosis by and.

Again related to the 45 billion do you expect the majority of the currently signed Apa's to be satisfied this year and then as a follow up our.

Our estimates suggest that you could generate $2 million to $3 million in cash flows in the next let's say.

12 to 18 months, how do you plan to utilize this cash.

What are your thoughts on potential BD opportunities orange shared buybacks.

Okay.

John Trizzino: So, yeah, the APAs are behind and backing up all of the expectation for our revenue guidance this year. There are some, we don't typically reveal any kind of detail, timing obligations, but we're, as we've talked about in the presentation, you know, shipping across the board to all of the APAs. And so I think the timing of all the shipments is in line, and we feel real confident about what the APAs are that are supporting the revenue recognition. You know, as far as.

Hi, John .

So yeah, the apa's are behind and backing up all of the expectation for a revenue guidance.

This year.

There are so we don't typically reveal any kind of detail.

Timing obligations, but.

As we've talked about in the presentation.

Across the board to all of the E. P. A is and so I think the timing of all the shipments is in line.

And and we feel real confident about what our what the a P. A's are that are supporting the revenue revenue recognition.

As as far as.

Stan Erck: As far as BD opportunities are concerned, you know, I think I'll probably toss it back to Stan mostly for that, but I think it's probably an expectation, you know, that we would be utilizing our cash in an effective way, but Stan? Thanks. Thanks for tucking that one, John.

As far as BD opportunities are concerned you know I think I'll, probably toss it back to Stan mostly for that but I think it's probably an expectation that.

We would be utilizing our cash in an effective way, but stan.

Stan Erck: So, yes, we do expect to generate cash, and cash will be used for investing in our internal projects like the combination nanofluid and other respiratory parts of our franchise. Part of it will be used to explore BD opportunities, and I think that's where our focus will be. I doubt that our focus will be on stock buybacks in the next 12 months. That's great.

Well, thanks, Thanks for taking that one John .

No.

Yes, we do expect to generate cash and.

And that cash will be used for investors.

Internal projects like the.

The combination nano flu and other respiratory parts of our franchise.

Part of it will be used to explore BD opportunities in.

And I think that's where our focus will be I doubt that our focus will be on stock buyback in the next 12 months.

Philip Dubovsky: And then just a quick follow up. Given that there could potentially be a significant booster market this fall, maybe could you just talk about how do you see yourself prepared to participate in it? Some of your competitors have indicated plans to develop bivalent boosters. Is that something in the plans? And would you be able to generate data to get authorization ahead of the fall? Or given the strong data you've already generated, do you believe the standalone vaccine would be sufficient? Dr. Dubovsky.

That's great and then just a quick follow up given that they could potentially be a significant boost their market. This fall.

Could you just talk about how do you see yourself prepared to participate in that some of your competitors have indicated plans to develop bi valent boosters.

Is that something in the plans and would you be able to generate data to get authorization ahead of default or given the strong data you've already generated do you believe the standalone vaccine would be sufficient.

Philip Dubovsky: Thank you. It's a good question. And, you know, we're, we're obviously building our database both for homologous boosting, including looking at multiple rounds of, The Phase 2 in U.S. Australia has now vaccinated people with a Propordose. And the studies we're planning for heterologous boosting also envision three or four doses in boosting on top of heterologous. So, it really isn't clear to us if a bivalent will be required, clear to us that an Omicron-specific vaccine will be required, but we're gonna be prepared for both.

Dr <unk>.

It's a good question and.

We're obviously building our database both for homologous boosting including looking at multiple rounds of boosting.

The phase two any U S Australia.

Vaccinated people with Evercore doses and the studies were planning for Heterologous boosting also envision.

Three or four doses and boosting and on top of her August vaccination.

So it doesn't it really isn't clear to us if they buy ground will be required.

Clear to us that our AUM across specific vaccine will be required, but we're gonna be prepared for a vote.

Philip Dubovsky: So the initial study design calls for looking at Omicron compared to the original prototype, Wuhan, but how we insert the bivalent product into that study or subsequent study or alternate study, we're deciding on right now. I guess I should say, you know, that our dose, our antigen level is very, very low in our vaccine. And there's not a problem for us to include alternate additional antigens. You can see that from our flu product, which the amount of antigen we have is much, much higher than what we have in the COVID vaccine. So there's not a specific technology limitation for us to have a polyvalent vaccine, including bivalent. This is great, thank you so much.

So are the initial study design calls for looking at Omer com compared to the original prototype.

Burned how we insert the bivalent product into that study or a subsequent study our alternate study we're deciding on it right now.

I guess I should say you know that our dose our antigen level is very very low in our vaccine.

And there is not a problem for us to include ultra and additional antigens are.

You can see that from our flu product, which the amount of Amgen. We have is much much higher than what we have in the COVID-19 vaccine. So this is our specific technology limitation for us to have a polyvalent vaccine, including bivalent vaccine.

Great. Thank you so much.

Yeah.

Philip Dubovsky: Our next question comes from Mayank Mamtani from B. Riley Securities. Please go ahead with your question. Good afternoon, congrats on a productive quarter and thanks for providing helpful 2020 outlook and let me also pass on thanks for the revenue guidance here.

Our next question comes from.

<unk> <unk> from B Riley Securities. Please go ahead with your question.

Good afternoon, congrats on a productive quarter and year end.

Thanks for providing a helpful. Duane Duane the outlook and let me answer by Sun tanks for the revenue guidance there so but first question, causing some confusion.

Jim Kelly: So, but first question, causing some confusion on the fourth quarter numbers, maybe I can ask Jim. So, two part on revenue and cost recognition methodology here. So, as you've recognized stockpile doses on P&L and maybe going forward on balance sheet, could you just clarify, do we still assume manufacturing about two billion doses this year? And more importantly, it would be helpful to understand the OPEX rate. I know you said one Q to three Q to be a better proxy, but obviously people are interested in learning about your cash flow generation this year. So, OPEX is an important part of the equation.

Fourth quarter numbers, maybe I can ask Jim.

<unk> on revenue and cost recognition methodology here so.

As you've recognized stockpiled ore does that P&L and maybe going forward on balance sheet.

Can you just clarify does do we still assume manufacturing about $2 billion this year and more importantly.

It would be helpful to understand the Opex right.

I know you said why don't you take you to be a better proxy, but obviously people are interested in learning about your cash flow generation. This year. So opex is an important part of the equation and then I have a follow up on revenue guidance.

Jim Kelly: And then I have a follow up on revenue guidance. Well, thanks for the question. We anticipated a great deal of interest in the shape of our business as we commercialize Novavaxovid. You know, when when providing guidance on the R&D trend, what we're sharing with you is the R&D trends, whereby we are capitalizing the inventory, meaning that the vast majority of our R&D is clinical activity, and then of course, the manufacturing in support of clinical. And that's very different from what you saw in the fourth quarter, where there was a significant pre-launch inventory that in subsequent periods would find its way onto our balance sheet.

Well. Thanks for the question of course strictly anticipated great tail interests in the.

The shape of our business as we commercialize the vaccinated.

When when providing guidance on the R&D trend.

What we're sharing with you is the R&D trends, whereby we are capitalizing the inventory, meaning that the vast majority of our R&D is clinical activity and then of course the manufacturing in support of clinical and that's very different from what you saw in the fourth.

Quarter.

Where there was a significant prelaunch inventory that in subsequent periods would find its way onto our balance sheet.

Jim Kelly: The shape of R&D when you compare 2022 to 2021, full year, is we expect 2022 to be lower. So hopefully that alone is helpful. We will provide additional cost structure guidance beginning next quarter. And so I'm not going to be able to provide any more details on that today. I will reinforce that we have built up our manufacturing capability to produce up to 2 billion doses in the year. Okay, great.

The shape of R&D when you compare 2022 to 2021 full year is we expect 2022 to be lower so hopefully that that alone is helpful.

We will provide additional cost structure guidance beginning next quarter.

And so I'm not going to be able to provide any more details on that today.

We'll reinforce that we have built up our manufacturing capability to produce up to 2 billion doses in the year.

Okay great.

John Trizzino: And then the second question, maybe for John, you know, in terms of the quality control process that is happening, you know, in the original country, India, where the vaccines are coming from, and then, you know, they get to the particular country, there's a local quality control process, and then subsequently, there's revenue recognition. So can you clarify, you know, different countries have different timing and processes. Can you just clarify what would be the expectation for U.S., for instance, and then how does this all come together for, you know, a statement you put out in third quarter filing of potentially recognizing $7.2 billion in APAs at some point across these different quarters, initial quarters?

And then the second question maybe for John in terms of the quality control process that is happening.

In the original country, India that the vaccines are coming from and then.

They get to that particular country. It is a local.

Quality control process and then subsequently there is revenue recognition. So can you clarify.

Countries have different.

Timing and processes.

Can you just clarify what would be the expectation for U S. For instance, and then how does this.

All come together.

When you put out and put quite a filing up potentially recognizing sand-blind $2 billion in Aps at some point across these different quadrant initial quarters.

John Trizzino: To clarify, I think what you're referencing is a disclosure around performance obligations of $7.2 billion. Is that correct? That's correct. Okay. You know, when you see our K, it will say 8 billion, right? And it's everything from the outstanding amounts under Operation Warp Speed, our order book of APAs, milestones, and adjuvant commitments from our licensed partners. So, there's a number of different items in there.

To clarify I think what you're referencing is our disclosure around performance obligations of $7 2 billion.

Is that correct.

That's correct.

Okay, you know when you see our K. It will it will say 8 billion right and it's everything from the outstanding amounts under operation Warped speed, our order book of Apa's milestones and adjuvant commitments from our license partners. So there's a number of different items in there.

Jim Kelly: And so, as you can tell, it's above our guidance range of 4 to 5 billion. And therefore, you'd expect that we'd meet those obligations in this year into next. Great. And then just a quick follow-up for Phil on the nano flu COVID combo next study. Would that include a bivalent or an omicron-specific construct, this study you're planning for? And then on the great to see the six-month durability data, you know, some cases in the delta wave, are you able to put in context what we may have seen from the, you know, currently very effective EU approved vaccine at that time period? You know, maybe in a comparable wave, because it looks like most of the data was in the alpha wave.

And so as you can tell it's it's above our guidance range of $4 billion to $5 billion and therefore, you would expect that we'd meet those obligations and this year into next.

Great and then just a quick follow up.

No no not a fluke go away.

<unk> next study what would that include.

Our bivalent omicron specific contract.

You're planning for and then on the.

Great to see the six month durability data. Some cases does that mean are you able to put in context, what we may have seen from the.

Currently very effective EUA approved vaccine at that time period.

Maybe in a comparable way because it looks like most of their data wasn't.

Philip Dubovsky: Yeah, so let me take this separately. Right now, our plans, are to not use Omicron in our combination in the Phase 2 study. Now, some of that will depend, you know, what happens as the pandemic evolves. We'll have that vaccine in hand and it certainly wouldn't be a problem to include the Omicron into the quadrivalent study. What we're really looking for is more of a proof of concept and by including the the prototype strain in there we can do a direct immunologic comparison back to the phase 3 studies that were associated with protection both in the UK and the US.

Yes, So let me take those separately right right now our plans.

Hard to not use omicron in our combination.

Phase II study now somebody that all depend what happened as the pandemic evolves, we will have that vaccine in hand, and it certainly wouldn't be a problem to include the omicron into the quadrivalent study what are we looking for is more of a proof of concept and by including their the prototypes training. There. We can do a direct comparison back to them.

The phase III studies that are associated with protection both in the U K the U S.

Philip Dubovsky: Now, as far as I think you're wanting me to speculate on what the durability of protection would be like as alternate strains emerge. And as you know, we don't have any data on that other than the immunogenicity data I shared with you, which show that we have an immune response, which does recognize delta as well as the homocron, as well as a host of other variants.

Now as far as I think you're wanting me to speculate on.

And what the durability of protection would be like as alternate strains emerge.

And as you know, we don't have any data on that other than the Immunogenicity data I shared with you would show that we have a immune response, which does recognize delta as well as the O'connor as well as a host of other variance. If you remember back to the adolescent efficacy data that although we didn't have a lot of cases.

Philip Dubovsky: Now, if you remember back to the adolescent efficacy data, that although we didn't have a lot of cases, that had a good estimate of efficacy against delta, which was 82% in the lower bound of roughly 70%. And I think that's consistent with what the other sponsors have shown in their studies against Delta. Thank you for that. I appreciate you all being here.

I'm.

Good estimate of efficacy against Delta, which was 82% in the lower bound of roughly 75%.

And I think that's consistent with what are the other sponsors have shown and their studies against Delta.

Thank you for that I appreciate you taking our questions.

Philip Dubovsky: Our next question comes from Eric Joseph from J.P. Morgan. Please go ahead with your question. Hi, good evening.

Our next question comes from Eric Joseph from Jpmorgan. Please go ahead with your question.

Eric Joseph: Thanks for taking the questions. Just one confirmatory one to start. Is there anything from your interactions with FDA so far that would suggest that the, The EUA path is not still open. I think a lot of investors are just looking for confirmation that the EUA path with Novavax of it is indeed open, and then secondly, as it relates to the non-clinical BLA requirements and needing to demonstrate law-conficiency runs, does it matter which facilities those are being generated at?

Hi, good evening, thanks for taking the questions just one confirmatory one to start is there anything from your interactions with FDA, so far that would suggest that the.

The EUA path.

Is not still open I think a lot of investors are just looking for confirmation that the EUA path with novak's of it isn't is indeed open.

And then secondly, as it relates to the non clinical BLA requirements and needing to demonstrate law consistency runs does it matter, which facilitated excuse me, which facilities. Those are being generated at is serum sufficient or would you need to conduct those impart using your own supply chain.

Eric Joseph: Is, So, maybe I'll take the second part of the question, and just to make the point that Serum is in fact part of our... And all of our global filings were harmonized to include the product in the manufacturing process out of serum to be part of their filing. Now our application to the FDA includes them as a manufacturer, and therefore the Locked Locked Consistency Study has to be made from material made. Okay.

So maybe I'll take the second part of the question and just to make the point. It is in fact part of our supply chain and all of our global filings have more harmonized here include the product and the manufacturing process out of serum to be to be part of their filing.

Our application to the FDA include serum as a manufacturer and therefore, the lockbox consistency study has to be made for material made from Sir.

Okay.

Uh huh.

Philip Dubovsky: And as far as the first question, it's EUA all the way. I mean, I think both us and the agency are working toward getting an EUA for this project. All right, and maybe just a follow-up to the second question. As it relates to manufacturing, I mean, part of the...

And on the first part.

First question.

All the way I mean, I think both US and agency are working toward are working towards getting an EUA for this product as fast as possible.

Alright, and maybe just a follow up to.

Second question.

As it relates to manufacturing I mean part of the.

Stan Erck: Prior communication was that you were expecting to supplement your, Supplement to regulatory bodies with additional CMC packages. Can you, I guess, is there any updated timing that you might be providing today? No, I think that the first goal was accomplished, and with all the filings, first of all, Filip said that we've harmonized all of our productions, which is really important. Number two, our first filings has been with CIRM because they are there with the volume that can service all of the various EUAs, and right after we get those EUAs, which as you recall has only been within the last weeks, we put together packages to file additional sites such as SK in Korea and our CZ facility, and so those will just be coming in time, they will be supplements to all of our filings. We'd like to have the flexibility to ship virtually anywhere from any of our plants.

Communicate prior communication was that you were expecting to supplement your.

Supplement to regulatory bodies with the additional CMC packages can you I guess is there any updated timing that you might be providing today Tonight.

No I think that the first goal was accomplished.

With all the filings.

First of all Philip said that we've harmonized all of our production, which is really important and number two our first filings has been with sure because they are there with the with the volume to conserve as all of the various eus.

And right after we get those <unk>, which as you recall, it's only been within the last weeks, we put together packages to file additional sites such as S. K in Korea, and our seasonal facilities. So those will just be coming at a time it will be supplements to all of our filings we'd like to have the flexibility to ship virtue.

Really anywhere from any of our plants.

Stan Erck: Okay, just just to clarify, finally, as it relates to just manufacturing when it comes to, you know, plants, the plant in Prague agreements with, Fujifilm Diazenthan, like in terms of making API. I guess what is the what should be the current understanding of the integration of those facilities as part of the supply chain? From all the commentary, everything seems to sound to be very heavily weighted towards serum. I guess they're really.

Okay.

Just just to clarify finally as it relates to just manufacturing when it comes to you know plants the planting.

Prague.

Agreements with.

Fuji film and like US in terms of making a P. I I guess what is the what should be the current understanding of the.

The integration of those facilities as part of the supply chain from all the commentary everything seems it sounds to be very heavily weighted towards serum I guess is there really.

Stan Erck: [inaudible] Effectively, should we be thinking about those other facilities making API that I mentioned earlier kind of factoring into the global supply chain? Yeah, they will. It's just we had to, somebody has to be first.

Effectively should we'd be thinking about.

Those other facilities, making API that I mentioned earlier kind of factoring into the global supply chain.

Yes. They will it's just we had somebody has to be first serum was there and ready and scaled up and producing very large quantities of sks.

Stan Erck: Serum was there and ready and scaled up and producing very large quantities. But SK has made on the order of 100 million doses that will be folded into the supply chain very quickly. And same for Prague.

Made up on the order of 100 million doses that will will.

Before that into the supply chain very quickly and same for Prague.

Stan Erck: And we're working, we continue to work with Fuji. So as I say, it gives us multiple options. We have done what we said we would do two years ago, which is to go from zero manufacturing capacity to this level now, which frankly exceeds 2 billion doses a year. So that gives us a lot of flexibility in terms of supplying any anticipated and unanticipated orders that we get from various governments. We're in good place.

And we're working we continue to work with Fuji So as I say it gives us multiple options. We we have done what we said we would do two years ago, which is to go from zero manufacturing capacity to this level, now, which which frankly exceeds 2 billion doses a year. So that gives us a lot of flexibility.

In terms of supply.

<unk> anticipated and unanticipated orders that we get from from Paresh governments.

Good place.

Stan Erck: Okay, thanks for taking the questions. Once again, if you would like to ask a question, please press star and 1. Our next question comes from David Reisinger from SVB. Please go ahead with your question. Yes, thanks very much and thanks for the updates. So I have a few questions. The first is, could you just discuss the gross margin prospects for the company and how we should think about gross margin? Because there are a lot of partners that you have and, It's difficult to try to estimate what the various cost components would be from the various supply side. The second question is.

Okay. Thanks for taking the questions.

No.

Once again, if you would like to ask a question. Please press star and one on.

Our next question comes from David Risinger from Seb. Please go ahead with your question.

Yes, thanks, very much and thanks for the updates.

So I have a few questions. The first is.

Could you just discuss the gross margin prospects for the company and how we should think about gross margin because there are a lot of partners that you have in it.

Difficult to try to estimate what the various cost components would be.

From the various supply sources.

The second question is.

Jim Kelly: The release indicates that you initiated a phase three booster study. When do you expect to generate data from that trial and files for booster approval in the U.S.? And then the final question is for the Omicron-specific vaccine. For that, when do you plan to submit that for approval in the U.S.? and both as a primary vaccine and also as a booster. Thank you very much. So let me distribute this.

The release indicates that you initiated a phase III booster study.

When do you expect to generate data from that trial and file for booster approval in the U S.

And then the final question is for the <unk> specific vaccine.

For that when do you plan to submit that for approval in the U S and.

Yeah.

As the primary vaccine and also.

As a booster.

Thank you very much.

So a lot of the distributors. So first we will give it to Jim for the App.

Philip Dubovsky: First, we'll give it to Jim for the, to talk about or not talk about our future margins and then turn it over to Filip, if I could, to address the other. So, thanks for the question. And I'll start by saying gross margin as a percent of revenue is a little complicated because you have different price points, right? So, you've got some degree of variability depending on the local market price. So, perhaps easier to view it on in absolute terms.

To talk about are not talk about our future margins.

And then turn it over to Philip if I could just to address the others.

So thanks for the question and I'll start by saying gross margin as a percent of revenue.

It's a little complicated because you have different price points right. So you've got some degree of variability depending on the local market price, so perhaps easier to view it on in absolute terms.

Jim Kelly: So, we expect that we're going to have price or cost per unit in the call at $3 to $5 a dose range. But that said, you heard earlier that we've written off an expense, a fair amount of inventory expense in 2021. And so, what that means is that as we move into 2022, begin to recognize sales and COGS, we're going to have periods of, it's called zero cost or low cost COGS early on as we realize the benefit of the manufacturing expenses that hit R&D in 2021. Okay, I think it's over.

So we expect that we're going to have price or cost per unit in the call. It three to $5 a dose range, but that said.

You heard earlier that we've written off in expense a fair amount of inventory expense in 2021, and so what that means to us that as we move into 2020 to begin to recognize sales in Cogs, we're going to have periods of it's called zero cost or low cost Cogs early on.

And.

As we realize the benefit of manufacturing expenses that hit R&D in 2021.

Okay.

Okay.

Oh.

Philip Dubovsky: And so right now we have the Phase 2 study in Australia and the U.S. which we have in hand as well as the South African study which is also a booster. We know from our interactions with regulators that many consider this adequate to get a forward boosting impact. And we've had discussions with the MHRA, EMA, TGA, and they all seem to have a pathway for us to use that data. Whether that's sufficient for the U.S. isn't clear.

And boosting initially and.

So I guess I'll start so right now we have the phase two study in Australia, and the U S, which we have in hand as well as the South African.

Study, which is also boosting study.

We know from our interactions with regulators that many consider this adequate to get it for boosting indications.

We've had discussions with them they may generate E. M E T G a and they all seem to have a pathway for us to use that data by itself.

That's sufficient for the U S is unclear.

Philip Dubovsky: In case it isn't, we do have the boosting study, which is ongoing from the 301 U.S. study where we boosted it. So that'll be ready in due course. Now, that study is started much later than the other two, but that data wouldn't be available for a while. So in short, it's not really clear, and that's really based on regulatory discussions with the FDA, whether the data that we're planning to file in the first quarter, or the second quarter, sorry, will be adequate to get a boosting indication in the end.

In case it isn't.

You do have the boosting our study which is ongoing among the three of them you are staying where we see those participants so that'll be ready in due course.

That study is started much later than the other two nine data wouldn't be available for a while so in short it's not really clear.

He will be based on regulatory discussions with the FDA and whether the data that we're acquiring in the first quarter and second quarter, sorry will be adequate to get a boosting indication in the U S.

Philip Dubovsky: I think you had a question that was similar to that about timelines of U.S. for Omicron, and we haven't disclosed when that study will be. Okay, and just to quickly follow up on that, will that include, Any assessment of of a booster in that Omicron study that you just mentioned. Yeah, it's a it's it's a we haven't gotten into detail into the design of that study. But in short, we're going to be looking at people, who've been vaccinated with other people's vaccines, primarily because there are no more sero-naive people left in this world. So that's the most relevant population to evaluate the vaccine. The study design we have in mind should be able to fill both data that's required for a boosting indication, as well as for a strain change.

I think I had a question on that was similar to that about timelines of U S for OMA com.

And we haven't disclosed when that study will read out.

Okay.

Okay, and just a quick quickly follow up on that will that include.

Any assessment of.

Of a booster in that Omicron study that you just mentioned.

Yeah.

Yeah, it's it's it's.

We haven't gone into detail into the design of that study.

But in short we're gonna be looking at people.

Who band vaccine with other People's vaccines, primarily because there are no more serial naive people.

Watkins World. So that's the most relevant population to evaluate the vaccine and the study design we have in mind.

Should be able to tow boats.

Data that's required for a boosting indication.

Well and sports game change.

You'll be able to serve all those needs.

Thank you very much.

Okay.

Philip Dubovsky: So it'll be able to serve both. Thank you very much. And ladies and gentlemen, with that, we'll conclude the question and answer session. I'd like to turn the conference call back over to Stan for any closing remarks. Thank you.

And ladies and gentlemen, with that we'll conclude the question and answer session I would like to turn the conference call back over to Stan for any closing remarks.

Stan Erck: I think that people who have been following us for some time will recognize that this has been a very transformational quarter for us. We're a revenue generating company. We've got obligations to support that revenue generation and report on that. We're very excited by this. We've now got manufacturing process that's been approved by virtually the world. We've got regularity to our shipping. We've got good cadence, and we're looking forward to every quarter talking with you more. Thanks very much, and keep your questions coming. Talk soon. Ladies and gentlemen, with that, we'll conclude today's conference call. We do thank you for attending. You may now disconnect your line.

Thank you I think that people who have been following us for some time will recognize that this has been a very transformational.

For us we've.

We're a revenue generating company, we've got obligations to to support that revenue generation and report on that we're very excited by this we've now got manufacturing process, that's been approved by virtually the world.

We've got regularity to our shipping we've got good cadence.

And we're looking forward to every quarter.

Talking with you more.

Thanks, very much and.

Keep your questions Kevin.

Good.

Yeah.

Ladies and gentlemen, with that we'll conclude today's conference call. We do thank you for attending you may now disconnect your lines.