Q4 2020 Novavax Inc Earnings Call

Okay.

Ladies and gentlemen.

Operator: Ladies and gentlemen, your conference is scheduled to begin momentarily. Until that time, your lines will again be placed on music hold.

And is scheduled to begin momentarily.

Operator: Thank you for your patience. ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? Ladies and gentlemen, thank you for standing by and welcome to the Novavax fourth quarter 2020 financial results conference call. At this time, all participants are in a listen-only mode.

Until that time your lines will again be placed on music hold.

Operator: After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star zero.

Operator: I would now like to hand the conference over to your speaker today. Ms. Sylvia Taylor, you may begin. Thank you. Good afternoon, everybody.

Thank you for your patience.

Sylvia Taylor: And thank you to all of you who joined today's call to discuss our fourth quarter and full year 2020 operational highlights and financial results. A press release announcing our results is currently available on our website at Novavax.com, and an audio archive of this conference call will be available on our website later today. We're also filing our 10-K this afternoon.

Okay.

[music].

Sylvia Taylor: Joining me today are Stan Erck, President and CEO, who will provide an overview of our progress. Dr. Gregory Glenn, President of Research and Development, who will provide an update on our global clinical trial activity and regulatory pathway. John Trizzino, Chief Commercial Officer and Chief Business Officer, who will update us on our manufacturing scale-up, partnerships, and advanced purchase agreements.

Sylvia Taylor: And Gregory Covino, Chief Financial Officer, who will briefly highlight our financial status. Additionally, Dr. Filip Dubovsky, Chief Medical Officer, will be available for the Q&A section at the end of today's call. Before we begin with prepared remarks, I need to remind you that we will be making forward-looking statements during this teleconference that could include financial, clinical, or commercial projections. Statements relating to future financial or business performance, conditions, or strategy, and other financial and business-related matters, including expectations regarding revenue, operating expenses, cash usage, and clinical development and anticipated milestones, are forward-looking statements within the meaning of the Private Security Litigation Reform Act. Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties that could change over time. With that said, I'd now like to hand the call over to Stan.

Stan Erck: For those of you following the accompanying slides, please turn to slides 9. Thank you, Sylvia, and thank you to everyone for joining us this evening. I'd like to make some opening remarks regarding how we've progressed as a company and reflect on where we're headed in this coming year. And following that, we'll take some time for questions.

Stan Erck: We have completely changed the company in ways that would normally take several years to accomplish. While many businesses in the world have slowed down due to the pandemic, we've done the opposite; everything about our company has changed. Before we get into our presentation, I'd like to thank all of our staff for the non-stop effort that each of them has made for an entire year. I'm afraid to say that I don't see a slowdown anytime soon, but having said that, everyone understands the importance of our mission and can take satisfaction from the accomplishments that have been made so far and know that they are part of a once-in-a-lifetime mission.

Stan Erck: I'd like to start our presentation by recounting for you a short list of what our staff has accomplished since our last annual Early, We've enrolled over 50,000 participants in COVID-19 clinical trials. In the spring of last year, we completed enrollment in a Phase 1-2 trial in the U.S. and Australia. In September and February, we initiated three efficacy trials in the U.S., the U.K., and South Africa, enrolling almost 50,000 participants. We've shown that our vaccine is 96% effective against the original COVID-19 when tested in the UK trial and achieved 86% effectiveness against the UK variant strain in that same trial.

[music].

Stan Erck: In the South African trial, where the so-called triple mutant variant was circulating, we showed that our vaccine was 60% effective at preventing COVID disease in the portion of the study population that was HIV negative. What sometimes gets lost in the discussion of our COVID-19 program is that we also completed a phase three pivotal trial for our nanoflu program and met or exceeded all eight of our primary objectives. We started last year with about 150 employees worldwide. We now have approximately 800 employees globally and will likely exceed 1,000 employees sometime this summer. We started last year without any capacity to manufacture products.

Stan Erck: In the last year, we built a global network of manufacturing sites and partners. In 10 countries, total capacity for COVID-19 vaccines will exceed 2 billion doses on an annual basis by mid-year. At the beginning of last year, we had $80 million in cash and a financial operating horizon of only $6 billion.

Ladies and gentlemen, thank you for standing by and welcome to the Novavax fourth quarter, 'twenty and 'twenty financial results Conference call.

Stan Erck: Contrary to popular belief, we ended the year with over $800 million and continue to build our financial... We have now secured over $2 billion of funding from our partners, including the U.S. government and CEPI and the Bill and Melinda Gates Foundation, and have purchased commitments for our vaccine, representing the potential for several billion dollars in revenue in the next 12 months. The combination of all of these accomplishments...adds capacity and expertise that will be the foundation for Novavax over the long term and, most importantly, gives us the opportunity to provide the world, including countries of all income levels, a safe and effective vaccine that can be used to help end the world's worst pandemic in the last century.

This time, all participants are in a listen only mode.

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

To ask a question during the session you will need to press star one on your telephone please.

Be advised that today's conference is being recorded.

If you require any further assistance, please press star zero and I.

I'd now like to hand, the conference over to your Speaker today Ms. Silvia Taylor you may begin.

Thank you good afternoon, everybody and thank you to all of you who have joined today's call to discuss our fourth quarter and full year 2020 operational highlights and financial results.

Stan Erck: We are excited to share more details today on the progress we made during this historic year. I would now like to hand the call over to Greg Glenn to discuss highlights from our clinical development program for 2020 and the beginning of 2021. Thank you, Stan, and maybe we can turn to slide four. This really has been a remarkable year.

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.

We are also filing our 10-K this afternoon.

Greg Glenn: Over the past 12 months, we've moved rapidly to respond to the COVID-19 pandemic. We first identified a stabilized recombinant folate protein, Novavax CoV-2373, which I will call 2373 for short, as our vaccine candidate. We identified this within one month of the SARS-CoV sequence being published. We also demonstrated the key role of our Matrix M adjunct for induction of potent immune responses when formulated together, and showed that these components elicited highly protective immunity in animal challenge models.

Joining me today are standard <unk>, President and CEO, who will provide an overview of our progress to date, Dr. Gregory Glenn President of research and development, who will provide an update on our global clinical trial activity and regulatory pathway, John Trevino, Chief commercial officer, and Chief business Officer.

Who will update us on our manufacturing scale up partnerships and advanced purchase agreements and Gregory <unk>, Chief Financial Officer, who will briefly highlight our financial status and.

Additionally, Dr. Phillip Dubowski, Chief Medical officer will be available for the Q&A section at the end of today's call.

Greg Glenn: As you will see below, we've moved rapidly through clinical development and now demonstrated the same high level of efficacy in humans. Our scientists are committed to transparency and publication in high-quality, peer-reviewed journals. We know with satisfaction that we've met this goal through multiple manuscripts, a few of which you see here, published in prestigious scientific journals, including the New England Journal of Medicine, Science, and Nature. So moving to slide five. Our recombinant protein subunit-based vaccine, 2373, offers a range of practical benefits, which we expect will optimize and expedite its global distribution. First, our candidate recombinant spike protein was designed to ensure stability and, as a result, can be stored at typical refrigeration temperatures, enabling distribution through standard cold supply.

Before we begin with prepared remarks, I need to remind you that we will be making forward looking statements. During this teleconference that could include financial clinical or commercial projections.

Statements relating to future financial or performance conditions or strategy, and other financial and business related matters, including expectations regarding revenue operating expenses cash usage and clinical development development and anticipated milestones are forward looking statements within the meaning of the private so.

Acuity is litigation Reform Act net.

<unk> cautions that these forward looking statements are subject to numerous assumptions risks and uncertainties, which change over time.

With that I'd now like to hand, the call over to Stan for those of you. Following the accompanying slides please turn to slide three.

Thank you Sylvia and thank you to everyone for joining us this evening.

Greg Glenn: Additionally, its ready-to-use liquid formulation of both the protein and the adjuvant markedly facilitates the administration of the vaccine. The adjuvant matrix M is a critical feature of the 2373 vaccine, which has both an immune-enhancing and dose-sparing effect, allowing us to produce more doses of 2373 with less antigen required per dose. While inducing immunity, that exceeds that seen from a COVID-19 infection.

I'd like to make some opening remarks regarding how we've progressed as a company and reflected where we were headed and this coming year for.

Following that we will take some time for questions.

So the past year has been a whirlwind, we have completely changed the company and ways that would normally take several years to accomplish.

While many businesses and the world have slowed down due to the pandemic we've done the opposite.

Everything about our company has changed.

Before we get into our presentation I'd like to thank all of our staff for the non stop effort and each of them has made for an entire year.

Greg Glenn: On slide six, we provide an overview of our COVID-related clinical trials. The Phase 1-2 safety and immunogenicity trials demonstrated the key role of the adjuvant, dose sparing, and immune responses that were all well in excess of convalescent serum.

I'm afraid to say that I don't see a slowdown and anytime soon.

But having said that everyone understands the importance of our mission and.

And take satisfaction from the accomplishments.

Greg Glenn: The data suggests the hallmark of our vaccine is the induction of high levels of functional immunity and has an excellent safety profile. In addition, this study confirmed the 5-microgram dose of the antigen. I want to note that there are several other immunogenicity trials that have already started or will start soon in India, the Czech Republic, and Japan that will help to extend global access to our vaccine. For today, I'm going to focus on the results of our EFSCI studies. During their course, the dramatic evolution of the virus occurred, and we were first to demonstrate EFSCI against all three major circulating strains.

And made so far and know that they are part of a once in a lifetime mission.

I'd like to start our presentation by recounting for U a shortlist of what our staff has accomplished since our last annual earnings report.

We've enrolled over 50000 participants and COVID-19 clinical trials and.

And the spring of last year, we completed enrollment and a phase one two trial and the U S and Australia.

In September and February we initiated three efficacy trials and.

And the U S. The U K and South Africa enrolling almost 50000 participants.

We've shown that our vaccine is 96% and effective against the original COVID-19, when tested in the U K trial and achieved 86 per cent of theft effectiveness against the U K variant strain and that same trial.

Greg Glenn: This has led to vital insight for public health and a unique opportunity to demonstrate the utility of our technology in the face of an evolving COVID-19 virus. Let's begin by talking about our Phase 3 trial in the UK on slide 7. After initiating our trial in September 2020, with the support of the UK Vaccines Task Force and the NIHR Registry, we were able to rapidly enroll over 15,000 participants, 27% of whom were over the age of 65.

And the South African trial, where the so-called Triple mutant variant was circulated we showed that our vaccine was 60% effective at preventing COVID-19 disease and a portion of the study population that was HIV negative.

What sometimes gets lost in the discussion of our COVID-19 program that we also completed a phase III pivotal trial for our nano flu program and met or exceeded all eight of our primary endpoints.

Greg Glenn: Our top-line interim analysis showed an overall efficacy of 89%. However, during the conduct of this trial, the virus evolved, and against the original COVID strain, similar to the viruses seen in the mRNA trials, we demonstrated best-in-class efficacy of 96%. With the B.1.1.7 variant, the strain that appeared during the trial, we observed an 86% vaccination rate.

We started last year with about 150 employees worldwide.

And we now have approximately 800 employees globally and will likely exceed 1000 employees sometime this summer.

We started last year without any capacity to manufacture product and.

And the last year, we have built a global network of manufacturing sites and partners and <unk>.

And countries, which total capacity for COVID-19, vaccines will exceed 2 billion doses on an annual basis by mid year.

Greg Glenn: This ladder strain is growing in prominence in the U.S., and it's worth noting that U.K. data suggests that 2373 will perform well in the U.S. amid rapid viral evolution that's trending heavily in this direction. Although the primary endpoint has been met, additional cases have been collected, and a final analysis will be available in the coming weeks. Considering the pathway to authorization, we initiated a rolling submission with non-clinical data with NHRA in the UK.

At the beginning of last year, we had $80 million and cash and a financial operating horizon of only six months and.

Contrast, we ended the year with over $800 million and continued to build our financial strength.

We have now secured over $2 billion of funding and where partners, including the U S government and Cepheid and the Bill Gates, the Bill and Melinda Gates Foundation and.

And our purchase commitments for our vaccine representing the potential for several billion dollars and revenue and the next 12 months.

Greg Glenn: We plan to file for authorization by early the second quarter after we have gathered sufficient data from our UK trial and completed CMC requirements. Moving now to our Phase 2B trial in South Africa, we enrolled a diverse study population of about 4,400 participants, including 245 medically stable HIV-positive adults.

It's a combination of all of these accomplishments adds capacity and expertise that will be the foundation for novavax over the long term and.

Most importantly gives us the opportunity to provide the world, including countries of all income levels.

Safe and effective vaccine that can be used to help and the world's worst pandemic and the last century.

We are excited to share more details today on the progress we made during the historic year I would now like to hand, the call over to Greg Glenn to discuss highlights from our clinical development program for 'twenty and 'twenty and the beginning of 2021.

Greg Glenn: We achieved our primary efficacy endpoint in the overall population, demonstrating a significant level of efficacy at 49%, including all participants. It's important to note that 2373 also demonstrated 60% efficacy in the population that was HIV negative, representing 94% of the volunteers. During the conduct of the trials I mentioned earlier, the virus evolved, and during surveillance, the South African B.1.351 variant was widely circulating during our trial, accounting for 93% of sequence cases. Although one-third of the study participants were seropositive at baseline, these antibodies did not seem to prevent infection with 1.351, again suggesting that prior COVID-19 infection may not protect against subsequent infection with the B.1.531 variant.

Thank you Stan and maybe we can turn to slide for this.

And this really has been a remarkable year.

Over the past 12 months, we've moved rapidly to respond to the COVID-19 pandemic. We first identify the stabilized for common that fully protein Novavax, Kobe, 237, and three which I'll call. It two three and seven three for sure.

Is there a vaccine candidate.

We identified this within one month of the Sars Kobe sequence being published.

We also demonstrated the key role of our matrix M. Adjuvant for induction of potent immune responses when formulated together showed that these components elicited highly protective immunity and animal challenge models.

As you will see below we've moved rapidly through clinical development and now demonstrated the same high level of efficacy in humans.

Our scientists are committed to transparency and publication and high quality peer reviewed journals and we know satisfaction. We've met this goal through multiple manuscripts are few what you see here published in prestigious scientific journals, including the New England Journal of Medicine, and science and nature.

Greg Glenn: However, 2.373 did offer significant protection, even though the vaccine was derived from the original COVID-19 strain. This was not unexpected, as a qualitatively better and broader response here reflects the lessons learned from the matrix M adjuvanted nanoflu vaccine that shows, in the face of evolution, we have these appropriate responses. I would like now to direct your attention to slide 9.

So moving to slide five.

Our recombinant proteins and subunit based vaccine to 373 offers a range of practical benefits, which we expect will optimize and expedite its global distribution for.

Or can that recombinant spike protein was designed to ensure stability and as a result can be stored at typical refrigeration temperatures, enabling distribution through standard coal supply chain.

Additionally, it's ready to use liquid formulation of both protein and the adjuvant markedly and facilitates the administration of the vaccine adjuvant matrix M is a critical feature of the two or three seven and three vaccine, which has both and immune enhancing and dose sparing effect allowed us to produce more doses of 2373.

Greg Glenn: We are pleased with the progress we've observed to date with our pre-event Phase III FQ trial in the U.S. and in Mexico, which we conducted in partnership with the NIH and the Coronavirus Prevention Network. Briefly, the study design is a two-to-one randomized trial enrolling over 30,000 subjects. As you can see, the primary endpoint is aligned with our previous trials, and our interim analysis will be done with 72 cases and 144 final events.

And with less antigen required per dose, while inducing immunity that exceeds that seem from a COVID-19 infection.

This greatly augments, our global capacity for vaccine manufacturer and distributions.

On slide six we provide an overview of our COVID-19 related clinical trials. The phase one two safety and Immunogenicity trials demonstrated the key role of the adjuvant dose sparing and immune responses. They were all well in excess of convalescent Sera.

The data suggests the hallmark of our vaccine is the induction of high levels of functional immunity and has an excellent safety profile and.

Greg Glenn: Finally, we are encouraged to discover a highly motivated participant population during the enrollment process, and we believe a 2-to-1 randomized study, as well as the expectation of a crossover element, played a major role in expediting recruitment. If you look at slide 10, we completed enrollment within two months of initiating this event-driven trial in December of 2020. And now we are happy to report we have a diverse study population of 30,000 participants, which is comprised of 20% Latin American, 12% African American, 6% Native American, and 5% Asian American, with approximately 13% of the individuals 65 and older.

In addition, this study confirmed the five microgram dose for the antigen I want to note that there are several over other immunogenicity trials that have already or will be starting soon and India, the Czech Republic, and Japan that will help to extend the global access to our vaccine for.

Good day and for today I'm going to focus on the results of our efficacy studies during their conduct the dramatic evolution and the virus occurred and we were first and demonstrate F. C against all three major circulating strains and.

This has led to vital insight for public health and a unique opportunity to demonstrate the utility of our technology in the face of and evolving COVID-19 virus, let's begin by talking about our phase III trial, and the U K on slide seven.

After initiating our trials September 'twenty and 'twenty with the support of U K vaccines task force and the NIH. Our registry, we were able to rapidly and roll over 15000 participants 27 per cent of whom are over the age of 65.

Greg Glenn: We expect to announce this interim data from the trial in the second quarter, dependent, of course, on the overall attack rate. As of today, we are working to implement a blinded crossover for both our UK phase three and PREVENT-19 trials. In these blinded crossovers, participants will receive active or placebo, opposite to what the participants initially received, while still remaining blinded.

Our topline interim analysis showed an overall efficacy of 89%.

However, during the conduct of this trial the virus evolved and against the original Covid strain similar to the virus has seen and the mrna trials, we demonstrated best in class efficacy of 96%.

With the B, one one and seven variant strain that appeared during the trial, we observed and 86% vaccine efficacy.

This ladder strain is growing and the provenance and the U S and it's worth noting that U K data suggests the 237 hundred <unk> will perform well and the U S. Amid rapid viral evolution, that's trended heavily in this direction.

Greg Glenn: This design ensures the integrity of the blinded studies and enables us to continue following participants for the duration of efficacy and safety. For PREVENT-19, our blinded crossover protocol has been submitted to the FDA, and the updated protocol, including the details of the crossover, have been posted on our website under research.

Although the primary endpoint has been net additional cases have been collected and a final analysis will be available in the coming weeks considering the pathway. The authorization, we initiated a rolling submission with non clinical data with MH array and the U K.

And we plan to file for authorization by early second quarter. After we have gathered sufficient data from our U K trial and completed CMC requirements.

Moving now to our phase two B trial, and South Africa and slide eight.

We enrolled the diverse study population of about 4004 hundred participants, including 245 medically stable HIV positive adults, we achieved our primary efficacy endpoint and the overall population demonstrating a significant level of FC at 49%, including all participants.

Greg Glenn: Regarding our regulatory pathway in the U.S., we are in ongoing discussions with the FDA to align on the data required for initiation of the EUA and continue to provide information to our open IND application. At this time, we expect to complete our EUA filing in the second quarter. Overall, we're very busy on the regulatory front, and we've also begun the rolling submission process with multiple other regulatory authorities, including the European Medicines Agency, Health Canada, the Australian Therapeutic Goods Administration, and New Zealand's MedSafe.

It's important to note that two or three seven and three also demonstrated 60% efficacy and the population there was HIV negative representing 94% other volunteers.

During the conduct of the trials I mentioned earlier, the virus evolved and during surveillance to South Africa and be 1351 variant was widely circulated during our trial accounts for 93% of sequence cases, although one third of the study participants were zero positive baseline. These antibodies did not seem to.

Infection with 1311351 again, suggesting that prior COVID-19 infection may not protect against subsequent infection with the PD, one and 531 billion.

Greg Glenn: We will continue to engage in dialogue with relevant regulators as we complete our pivotal phase three clinical trials in the UK and US, ensuring that we fully address all safety, efficacy, and quality elements required for authorization. As we look to the future for our 2373 clinical program, we'd like to highlight two areas of focus in the coming months. Our six-month boosting protocol taking place in our Phase 1-2 trial in the U.S. and Australia and the development of a variant strain in Canada.

However to three seven and three did offer significant protection, even though the vaccine was derived from the original COVID-19 straight. This is not unexpected as a qualitatively better and broader response here reflects the lessons learned from the matrix M adjuvant and nano flu vaccine that chose in the face of evolution. We have these appropriate responses.

I would like now to direct your attention to slide nine.

We are pleased with the progress we've observed to date with our prevent.

Phase III efficacy trial, and the U S and in Mexico, which we conducted in partnership with the NIH and the Corona virus Prevention network briefly the study design is a two to one randomized trial enrolling over 30000 and subjects.

Greg Glenn: On slide 12, you see that our Phase 1-2 trial in the U.S. and Australia, initiated in May 2020, provided positive data on 2,3,7,3's immunogenicity and safety. The trials continue to offer valuable clinical insights into some participants now receiving a six-month boost dose to examine the production of a functional immune response. Our technology is suitable for boosting and agile enough to enable the rapid development of a bivalent vaccine approach that can address an evolving virus.

You can see the primary endpoint is aligned with our previous trials and an interim analysis will be done with 72 cases and for 144 final events.

Finally, we are encouraged to discover a highly motivated participant population during the enrollment process and we believe the two to one randomized study as well the expectation of a crossover Eldon played a major role and expedite and recruitment.

If you look at slide 10, we can completed enrollment within two months of initiating this event driven trial in December of 'twenty and 'twenty.

And now we are happy to report that we have a diverse study population of 30000 participants which is comprised of 20% Latin American 12 per cent African American six per cent Native American Vivus and Asian American was approximately 13% of the individuals 65 and older. We expect announced this interim data for.

Greg Glenn: On slide 13, as I mentioned, we have also made significant strides in addressing the mutations of COVID-19 arising around the globe, including exploring variant strain vaccines as standalone and bivalent candidates. We are evaluating these candidates in ongoing human primate studies and plan to initiate clinical evaluation of these candidates in mid-2021. We're leveraging the adaptability of both our vaccine technology and the manufacturing process to evolve our strategy alongside the evolution of the virus. So inclusion on slide 14.

And the trial and the second quarter dependent of course on the overall attack rate.

As of today, we are working to implement a blinded crossover for both our U K phase III and prevent 19 trials and.

These blinded crossovers participants will receive active or placebo opposite to what placebos.

Participants initially received while still remaining blinded.

This design ensures the integrity of the blinded studies and enables us to continue following participants for the duration of efficacy and safety for.

For prevent 19 are blinded crossover protocols and submitted to the FDA and the updated protocol, including the details of the crossover had been posted on our website and resources.

So moving ahead to slide 11 regarding our regulatory pathway and the U S. We are and ongoing discussions with the FDA to align on the data required for initiation of a UA and continue to provide information to our open R&D applications. At this time, we expect to complete our EUA filing and the second quarter or.

Greg Glenn: We now have two independent trials demonstrating 2373's high level of efficacy at levels similar to that seen in the best results against the original virus strain and efficacy against two variant strains coming out of the viral evolution. We also see an encouraging safety profile. We're proud of the clinical team, as Stan mentioned, that's achieved these milestones with 2373 to date and look forward to additional data in the coming months, including data from Prevent 19. And with that, I'd like to turn it over to John Trizzino.

We're all we're very busy on the regulatory front and we've also began the rolling submission process with multiple other regulatory authorities, including the European Medicines Agency Health, Canada, Australia, and therapeutic goods administration, and New Zealand's med space, we will continue to engage in dialogue with respective regulators as we complete our our.

It'll phase III clinical trials in the U K and U S. Ensuring that we fully address all safety efficacy and quality elements required for authorization.

John Joseph Trizzino: I would like to bring your attention to slide 15. As you can see from this slide, in the past 12 months, we have built an impressive global supply chain infrastructure that includes both owned and partnered facilities. This network is centered around our own facilities in the Czech Republic and Sweden, partnerships with contract manufacturing organizations in the U.S., Canada, the U.K., and Spain, and license agreements in India, South Korea, and Japan.

As we look to the future for our 237 and three clinical program, we'd like to highlight two areas of focus and the coming months.

Our six month boosting protocol, taking place and our phase one and two trial and the U S and Australia and the development of a variant strains and candidates.

On Slide 12, you see our phase one two trial and the U S and Australia initiated and May 'twenty and 'twenty.

Provided positive data on 237, and threes and Immunogenicity and safety.

The trials continuing to offer valuable clinical insights for some participants now receiving a six month booth dose to examine the production of functional immune response or technical technology is suitable for boosting and agile enough to enable the rapid development of a bivalent vaccine approach that can address and evolving virus on slide <unk>.

John Joseph Trizzino: The combined capacity for our COVID-19 vaccine globally will exceed 2 billion doses on an annual basis when we reach full manufacturing capacity, which is expected by about mid-year. This global supply infrastructure securely positions Novavax as an integral part of the global solution to the COVID-19 pandemic. Let me highlight some of the following important points. Novavax CZ in the Czech Republic is a large-scale, state-of-the-art manufacturing facility that is now producing our vaccine antibodies. Matrix M is now manufactured at multiple sites globally with sufficiently committed raw materials for our adjuvant component of the vaccine.

<unk> as I mentioned and we've also made significant strides and addressing the mutations of the COVID-19 arising around the globe, including exploring variant strain vaccines and Standalone and bivalent candidates. We are evaluating these candidates and ongoing human Primate studies and plan to initiate clinical evaluation in these cash.

<unk> and mid 2021.

Were levied leveraging the adaptability of both of our vaccine technology and the manufacturing processes to evolve our strategy alongside the evolution of the virus.

And so inclusion on slide 14.

We now have two independent trials, demonstrating to three seven and threes high level of FCS and lever levels similar to that scene and the best results against the original virus strain and S. T. He gets to variant strains coming out of the viral evolution.

We also see and encouraging safety profile.

John Joseph Trizzino: The strategic partnership with Serum Institute provides significant and immediate manufacturing capacity that will provide access to low and middle income countries. SK Bio and Takeda Licensing Partnerships offer additional capacity and access to South Korea and Japan, respectively. In addition to the Advance Purchase Agreement in Canada, we have just recently signed an MOU for Expanded Manufacturing Capacity in Canada at their Biologics Manufacturing Center in Montreal. Now on to the next slide, slide 16.

We are proud of the clinical team as Dan mentioned this achieved these milestones with 237 and three to date and look forward to additional data in the coming months, including data from the prevent 19 and with that I'd like to turn it over to John for Zeno.

Thanks, Greg.

And I would like to bring your attention to slide 15, and now as you can see from this slide and the past 12 months, we have built an impressive global supply chain infrastructure that includes both owned and partnered facilities.

This network is centered around our own facilities, and the Czech Republic and Sweden.

Partnerships with contract manufacturing organizations, and the U S, Canada, UK, and Spain, and license agreements and India, South Korea and Japan.

The combined capacity for our COVID-19 vaccine globally will exceed 2 billion doses on an annual basis, when we reach full manufacturing capacity, which is expected by about mid year.

John Joseph Trizzino: What we all have painfully come to know well this past year is that pandemics have no borders, and therefore, our response must be on a global scale. This has mandated that Novavax respond in multiple ways to ensure fair and equitable access globally. First, as a function of our funding partners around the globe that include the U.S. government, CEPI, UK, and BMGF, the Bill and Melinda Gates Foundation, then for the various countries around the globe that expressed an interest in our vaccine, and finally, country-specific manufacturing partners that allowed our technology to provide additional supply into India, South Korea, and Japan.

This global supply infrastructure securely positions novavax as an integral part of the global solution to the COVID-19 pandemic.

Let me highlight some of the following important points.

No other vaccine Z and the Czech Republic is a large scale state of the art manufacturing facility that is now producing our vaccine antigen may.

Matrix M is now manufactured at multiple flights sites globally with sufficiently committed raw materials for our adjuvant component of the vaccine.

The strategic partnership with serum Institute provides significant and immediate manufacturing capacity that will provide access to low and middle income countries.

S K bio and Takeda licensing partnerships offers additional capacity and access and to the into South Korea, and Japan, respectively.

John Joseph Trizzino: So, as you can see on this slide, we have various agreements that have been executed to date, Advanced Purchase Agreements totaling approximately 200 million doses. 110 million doses committed to the U.S. government with the potential for additional procurement. 1.1 billion doses jointly committed by Novavax and Serum Institute to the COVAX facility, and license agreements with Serum Institute, SK Bio, and Takeda. With that, I'll turn it back over to Stan to provide an update regarding our nanoflu program on slide 17. Thanks, John.

In addition to the advanced purchase agreement and Canada. We have just recently signed an Mou for expanded manufacturing capacity in Canada, and they are biologics manufacturing center in Montreal.

Now onto the next slide slide 16.

What we all have painfully come to know well this past year as Theyre Pandemics have no borders and therefore, our response must be on a global scale.

This mandated that none of the extra respond and multiple ways to ensure fair and equitable access globally.

First as a function of our funding partners around the globe that include the U S government Seppi, UK and B M. G F.

Bill and Melinda Gates Foundation, then for the various countries around the globe that expressed an interest and our vaccine and finally country specific manufacturing partners that allowed our technology to provide additional supply into India, South Korea and Japan.

Stan Erck: While we spent the majority of our time and attention this year developing our COVID-19 vaccine candidate, we remain committed to advancing nanoflu through regulatory licensing. We announced the successful completion of our pivotal phase three clinical trial in the first quarter of last year, achieving all primary objectives. Additionally, in November, we published phase two data in clinical infectious diseases. We are, excuse me, we are currently exploring a variety of options related to commercializing nanoparticles. These options include developing one or more combination vaccines. 2373 in NanoFlu, NanoFlu in RSV, and potentially all three.

So as you can see on this slide we have various agreements that have been executed to date.

Advanced purchase agreements totaling approximately 200 million doses.

110 million doses committed to the U S government with the potential for additional procurement.

1.1 billion doses jointly committed by another <unk> and serum Institute to the Kodak facility.

And license agreements with serum Institute S K bio and Takeda.

Stan Erck: Based on data to be generated early this year, the plan is to bring one or more of these candidates into clinical trials later this year. As always, we will publish the results of these studies as they become available. We believe that in the post-pandemic era, seasonal vaccination with combination vaccines will be a large commercial opportunity for our platform. And with that, I will now hand it over to Greg Covino to provide our financial. Thanks, Stan. Hi everybody. If you could please turn to slide 18.

With that I'll turn it back over to stay and to provide an update regarding our nano flue program on slide 17.

Yes, Sean.

While we spent the majority of our time and attention this year developed and our COVID-19 vaccine candidate, we remain committed to advancing nano flow through regulatory licensure, we announced the successful completion of our pivotal phase III clinical trial and the first quarter of last year, achieving all primary objectives. Additionally in November we published phase two data and the clinics.

Infectious diseases, where excuse me we are currently exploring a variety of options related to commercializing nano flow. These options include developing one or more combination vaccines, such as $23 73, and nano flue nano flu and RSV and potentially all three.

Greg Covino: So I think our press release does a pretty good job of running through the highlights of P&L activity quarter over quarter, in addition to laying out fourth quarter and four-year financing activities. So I'm not going to repeat that here. We also just filed our 2020 10-K prior to or during the course of this call, so the 10-K also includes a summary of important business and financing events, including those which occurred subsequent to year end.

Based on data to be generated early this year.

Plans to bring one or more of these candidates in the clinical trials later this year as always we will publish results for these studies as they become available we believe that and the post pandemic era seasonal vaccination with combination vaccines will be a large commercial opportunity for our platform and with that I will now hand, it over to Greg Calvino to provide our final.

For us.

Thanks, Dan Hi, everybody.

Please turn to slide 18, so I think our press release does a pretty good job for running through the highlights.

Greg Covino: In particular, we've included an update on new supply agreements, and John just touched on that in his comments. And we make note of the substantial completion of a new $500 million ATM in January 2021. So I would encourage everyone to please take a look at the 10k. Overall, considering our year-in-cash position of over $800 million, as you saw in the release, and the financing activities subsequent to year end, we believe we are well capitalized and in a solid financial position as we approach the commercial launch of our COVID-19 vaccine. Back to you, Stan.

And our activity quarter over quarter, and addition to laying out fourth quarter and full year financing activity, so I'm not going to repeat that here.

We also just follow that 2020 10-K prior to and during the course of this call. So the 10-K also includes a summary of important business and financing events, including those which occurred subsequent to year end and particular.

And we've included an update on your supply agreements and John just touched on that and his comments and we.

Make note of the substantial completion of a new January 2021, $500 million Ats and so I would encourage everyone to please take a look at the 10-K.

Considering our year end cash position over $800 million that you saw and the release and.

Stan Erck: Okay, turning to slide 19, as we reflect on the extraordinary progress Novavax made in 2020, we remain focused on delivering key clinical and regulatory milestones as well as executing our global manufacturing and commercial plans in collaboration with our partners. In parallel, we will continue to advance dialogue with global regulatory agencies as we seek authorization and licensure for 2375. Before I open the call for questions, I want to thank our entire Novavax team for their incredible contributions.

And the financing activities subsequent to year, and we believe we are well capitalized and and solid financial position as we approach the commercial launch of our COVID-19 vaccine.

Back to you Stan.

Okay, and turning to slide 19, as we reflect on the extraordinary progress Novavax made and 'twenty and 'twenty, we remain focused on delivering key clinical and regulatory milestones as well as executing our global manufacturing and commercial plans and collaboration with our partners and parallel we will continue to advance dialogue with global regulatory.

Tori agencies and will seek authorization and licensure for $23 73.

Before I open the call for questions I want to thank our entire novavax team for their incredible contributions. This year I would also like to thank our various partners a few of which include U S government Seppi, the Bill and Melinda Gates Foundation, and the COVID-19 Prevention network, whose immediate response to the pandemic and continued support.

Stan Erck: I would also like to thank our various partners, a few of whom include the U.S. government, CEPI, the Bill & Melinda Gates Foundation, and the COVID-19 Prevention Network, whose immediate response to the pandemic and continued support helped make possible our accomplishments during the year. Only through these combined efforts have we been able to achieve these outstanding developments and become a part of the global solution to the COVID-19 pande With that, I will now turn it over to the operator for Q&A. Thank you. As a reminder, to ask a question, press the star followed by the number one on your telephone keypad. To withdraw your question, press the pound key.

And make possible our accomplishments during the year only through these combined efforts and we've been able to achieve these outstanding developments and become a part of the global solution to the COVID-19 pandemic.

With that I will now turn it over to the operator for Q&A.

Thank you.

As a reminder, in order to cash flow question Press Star followed by the number one on your telephone keypad.

To withdraw your question price per pound key.

Operator: Please stand by while we compile the Q&A roster. And your first question comes from the line of Kalichi Shakir with Jeffreys. Thank you. Good afternoon, and thank you for taking my questions. Congratulations on all the progress and success over the last year. I guess my first question is just related to your manufacturing. I'm hoping you can provide additional color around your manufacturing where you are there.

Please standby, while we compile the Q&A roster.

And your first question comes from the line of Caliche.

<unk> with Jefferies.

Thank you good afternoon, and thank you for taking my questions. Congratulations on all the progress and success over the last year I guess my first question is just related to your manufacturing I'm, hoping you can provide additional color around your manufacturing and where you are there are you able to provide any color on your monthly production capacity.

Kalichi Shakir: Are you able to provide any color on your monthly production capacity or your ability to stockpile vaccine right now? And, related to that, how quickly would you be able to go from EUA authorization or approval to actually shipping the vaccine? If you could provide any color there, that would be great, and I have one follow-up question.

Or your ability to stockpile vaccine right now and I guess related to that how quickly would you be able to go from EUA authorization for approval to actually shipping vaccine.

If you can provide any color there that would be great and I have one and follow up question.

Stan Erck: Yeah, this is Stan. I'll take that. So we have... As we mentioned, we tend to focus on manufacturing sites that manufacture the ant. That's probably the most complex part of the manufacturing process. And so we've established those in 10 countries, and they are now all making product at GMP scale. They're either doing it, they finish their engineering runs, they're making products at commercial scale, and the cadence of that production process depends in part on how many runs that they put into their schedule.

Yeah. This is stay and I'll take that so we have as we mentioned so we tend to focus on.

<unk> sites that manufacture the antigen.

And that's probably the most complex part of the manufacturing and.

And so we've established sales and in 10 countries and.

And they are now all making product.

At GMP scale, they're either do it and they finished their engineering runs, they're making product and commercial scale and.

And the cadence of that production process.

And in part on how how many runs that day.

Put into their schedule and those runs depend upon making sure we have enough raw material for instance to make all those rooms. So so theres some scrambling to get enough raw materials to make all the plants working at full speed, but I think we're getting there and so the expectation is that debt all of the plants will.

Stan Erck: Those runs depend upon making sure we have enough raw materials, for instance, to make all those runs. So there's been some scrambling to get enough raw materials to make all the plants work at full speed, but I think we're getting there. So the expectation is that all of the plants will be at full scale by April. So in April, May, and June, we should be finishing, filling, and finishing product in advance of regulatory approvals.

Full scale by April So in April May June, we should be finishing facility and finishing.

<unk> and advance of of our regulatory approvals were now filling.

Stan Erck: We're now filling and packaging material, both in the United States and from Korea, and finishing those in Europe and the U.S. So we will have material that will be on the shelf when we have approval for shipping.

And packaging.

Material both of these added stage.

And from Korea.

And and finishing those and <unk>.

Europe and the U S and so we will have material that will be on the shelf when we have approval for shipment.

Stan Erck: Got it, got it. That's very helpful. Thank you. And I guess with respect to your ongoing non-human primate work with your variant vaccines, could we see that data in Q2? And related to that, given your experience with 2373 and non-human primates, what would data predict or suggest as to the immunogenicity and efficacy of your variant vaccine in humans? Your thoughts there would be greatly appreciated. Yo, this is it, thank you.

Got it got it that's very helpful. Thank you and I guess with respect to your ongoing non human primate work with your various vaccine could we see that data in Q2, and I guess related to that given your experience with 27, three and non human primates, what would data for tenders suggest as for the Immunogenicity and efficacy.

And your gearing and vaccine and humans and your thoughts there would be greatly appreciated.

Joe This is oh. Thank you. It has turned out the animal models were quite predictive. So we have very good efficacy and and the.

Greg Glenn: It turned out that the animal models were quite predictive, so we had very good efficacy in non-human primates. So, you know, that's why we use them. They are not perfect models because they're not really disease models, but they are physiologic in that they require vaccine-induced immunity to get to the mucosal surfaces. So, I think it bodes quite well overall. The other animal model I'd point to non-human primates, the baboons, where we did some initial just, you know, sort of safety immunogenicity studies, and they were quite predictive. So, you know, we also like the mouse models. They are all telling us something.

Non human primates so.

It's why we use them all day.

Are not perfect models, because they're not really lease model, but they are a physiologic and that they require a vaccine induced immunity to get to the mucosal surfaces. So I think it's overall bode quite well the other.

Animal model I'd point to a non human primate is the baboons, where we did some initial just you know sort of safety and Immunogenicity studies and they were quite predicted so are.

You know we like also like the mouse models. They all are telling us something nothing is completely aligned with human disease for <unk>.

Greg Glenn: Nothing is completely aligned with human disease, but they've all been informative, and I think they all pointed us to the kind of efficacy we actually saw in the human trial, which is, you know, really remarkable. Yeah, we always, as soon as we have results that we think make sense to publish, we get out to the peer review. We have a really good receptivity with top journals. So quarter two, probably, we'll see

<unk> all been informative and I think they all pointless to the kind of efficacy, we actually saw and the human trial, which is really a remarkable circle.

Yeah, We you know we.

And we always as soon as we have results that are.

We think makes.

Since the publish we get out to the peer view, we have a really good receptivity with high journals so quarter.

Quarter two probably.

We'll see you know we were going to be always at the Beck and call of peer review.

Greg Glenn: We're going to be always at the beck and call of peer review reviewers. So we have great data, great science, and that's not unreasonable. We should have data in that time. Got it.

Reviewers so, but we have great day, though great science and.

That's not unreasonable to expect we should have data and that timeframe.

Got it perfect. Thank you.

Eric William Joseph: Perfect. Thank you. Your next question comes from the line of Eric Joseph with JP Morgan. Good evening.

Your next question comes from the lineup and rate.

Joseph.

P Morgan.

Eric William Joseph: Thanks for taking the questions. I just wanted to get a better sense of where discussions are with FDA on the path to an EUA for 2373. Does the current guidance for potential submission in the second quarter, anticipate filing after having efficacy data from PREVENT-19, or do you still see a path to starting the process on the basis of the UK and South Africa trials? And then, as a follow-up, as it relates to the planned trials with the new variants and biobalance vaccines, I guess with FDA's guidance, sounding like human judicacy would be sufficient for approval. Is the expectation of the trials that you're initiating, would they be sufficient for, or are they intended for registration? Thanks.

Good evening, thanks for taking the questions.

Just wanted to get a better sense of where discussions are with FDA and the path to an EUA for $23 73.

Yes.

Guidance for.

Potential submission and second quarter.

And anticipate filing after having efficacy data from COVID-19, or do you still see a path to start and the project and the basis of the U K and South Africa trials and.

And then secondly, as a follow up.

As it relates to.

The planned trials with the new.

New variants.

And by a balance vaccines, I guess with Fda's guidance.

Finally, and excuse me and gvhd would be sufficient for approval.

There is the expectation for the trials that you're initiating would be would they be sufficient for.

Or the intended for registration.

Filip Dubovsky: Eric, I'll just make a quick comment, and then I'll turn it over to Filip Dubovsky, our Chief Medical Officer. You know, we're operating on the assumption that the UK data could form the basis for an EUA. We have, as you rightly pointed out, a good backup in a large, pivotal trial. So, you know, that's sort of how we're organizing our submission and our submission strategy. So I think with that, I'll let Filip talk a little bit about the various.

And Eric I'll, just make a quick comment and then I'll turn it over to Philip Dubowski, Our Chief Medical Officer, we're operating on the assumption is and the U K data could form the basis for the UA.

We have as you as you rightly pointed out a good backup and a large pivotal trial. So that's sort of that's how we're organizing our submission and our submission strategy. So I think with that I'll, let phillippe talked a little bit about the varian strategy I guess, the other point of other phase III studies as of the end points are alive.

Filip Dubovsky: I guess the other point about the phase three studies is that the endpoints are really aligned between all three of them. So the FDA is well aware of what our endpoints are, and they've seen the protocols from the other studies as well. On to the variant situation.

And between all three of them.

So.

He is well aware of what our endpoints are and I've seen the protocols from the other studies as well.

Onto the variant.

Situation, we've gotten guidance from a.

Filip Dubovsky: We've gotten guidance from a bunch of different global regulators about the approach to getting these things licensed, and no one is suggesting we do efficacy studies. This is all about showing safety.

For a bunch of different and global regulators about approach to getting these things are licensed and no. One is suggesting we do efficacy studies. This is all about showing safety and more importantly.

Filip Dubovsky: But more importantly, non-inferior immune responses to the variant versus the original strain. And that's a strategy we plan to follow. The studies we have in mind do two things. They look at the variants by themselves, as well as in a bivalent format. We think the latter is really where we want to be. We think that the difference between the prototype strain and the current strains that are circulating in South Africa and Brazil represents a very broad range of antigenic spread.

Certainly non inferior immune responses to the variance versus the original strain and as a strategy. We plan to follow the studies, we have in mind do two things they look at the variance by themselves as well as and our bi valent format and we think the latter is really where we want to be at we think that other differences.

Between the prototype strain and the current strains that are circulating and South Africa, and Brazil represent a very broad range of energetic spread and that's really going to capture with our vaccines. We know we can do by rail and easily there's plenty of space and our vaccine for antigen.

Filip Dubovsky: And that's what we're going to capture with our vaccines. We know we can do bivalent easily. There's plenty of space in our vaccine for antigen doses that high. You know, from our phase one and phase two studies, we went up to 25 micrograms without having problems with that. So we think we have a solution here to the problem. Great. Thanks for taking those questions.

Doses that high you know from our phase I Phase II studies, we went up to 25 micrograms without having problems with that so we think we have a solution here for the problem.

Great. Thanks for taking thanks for taking my questions, maybe just a quick follow up.

Eric William Joseph: Maybe just as a quick follow-up. Ace, at this point, can you say anything in terms of regionality where you would be conducting the planned trials with the bivalent candidates? So the different regulators have given us slightly different study designs we need to take into account, and we haven't finalized the exact location where the studies will be executed. Okay, thanks for picking out the questions and congrats on the progress. Your next question comes from the line of Charles Duncan with Cantor Fitzgerald.

And at this point can you say anything in terms of Regionalisation conducting b.

And the.

Planned trials with the bivalent candidate.

So there are different regulators have given us slightly different study designs and when you take into account and we haven't finalized the exact location of the studies will be executed.

Okay. Thanks for the for taking the questions and congrats on the progress.

Eric.

Your next question comes from the line of Charles Duncan with Cantor Fitzgerald.

Yes.

Eric William Joseph: Hi Stan and team, congrats on really executing well on a really difficult year and thanks for taking our questions. I had a question regarding the EUA, you know, filings. I guess in the UK, what is it, can you provide any color on the rate-limiting steps and maybe the same question for the US, especially given the answer that you just gave on the previous question.

Hi.

And Dan and team congrats on really executing well on and really difficult year and thanks for taking our questions I had a question regarding day EUA.

Filings I guess in the in the U K. What is can you provide any color on the on the rate limiting steps and maybe same question for day U S, especially given the answer that you just gave on the previous question.

Charles Duncan: So, yeah, hi Charles, how are you doing? Good. I think that, you know, they both require, you know, similar categories of information, right? Around the CMC and around the clinical.

So yeah, Hi, Charles how are you doing good.

I think that day.

And both require similar cash.

Categories of information around the CMC and around the clinical so just to give you color on the clinical as you know we unblinded because we had a positive interim efficacy that was yes that we met our statistical success criteria. So that represents a final analysis.

Greg Glenn: So just to give you some color on the clinical, as you know, we unblinded because we had a positive interim efficacy that was a yes, that we met our statistical success criteria. So that represents a final analysis. However, we, you know, continue to collect cases in a blinded fashion. And so we'll analyze those, just like you saw with Moderna and Pfizer. It's another sort of second analysis of

We continue to collect cases, and the blinded fashion and so we'll and analyze those just like you saw with Madonna and fires and it's another sort of a second analysis of the of the endpoint cases, so we're doing that and we.

Greg Glenn: So we're doing that, and we expect to finalize most of that data probably in the early April timeframe. And then that would be, shortly thereafter, be submitted to, frankly, both regulators. So that's one piece.

We expect to finalize and most of that data probably in early April.

<unk> timeframe, and then that will be that will shortly thereafter will be submitted to frankly to both regulators. So so that's that's one piece and then the other pieces the pack.

Greg Glenn: And then the other piece is the package around our CMC. So right now, I think those are creating intensive work, and we're looking to try to align both those submissions around the same time to get our MHRA package in. There have been very good partners, lots of communication, so that's been quite helpful.

Package around our CMC, so right now I think you know.

Those are the growth those are you know.

Credit intensive efforts and there we're looking to try to align.

Both of those submissions around the same time to get our and HRA package and they have been very good.

<unk> lots of communication.

So that's been quite helpful and similarly, we'll have that kind of dialogue with the FDA same topics and as I mentioned, we are hoping that the FDA will view the UK package as a as a.

Greg Glenn: And similarly, we'll have that kind of dialogue with the FDA, same topics. And, as I mentioned, we are hoping that the FDA will view the UK package as a potential basis for licensure. But we also are really close on the heels of that information with the US trial.

Potential basis for licensure, but we also are really close on the heels of that information with the with the U S trial and so.

Greg Glenn: And so there could be some hybrid of those two trials, but a very robust package to convince regulators with respect to the safety and efficacy of our vaccine. And what I think makes this, as we've mentioned, so really important is that we have done this in the context of an evolving virus. So that's a tremendously valuable chunk of information, not only for us but the world. But I think regulators will like that as part of our presentation. Okay, that's helpful, Greg. I appreciate that.

There could be some hybrid of those who trials for a very robust package for regulators with respect to safety and efficacy of our vaccine and what I think makes as we've mentioned so a really important as we have done this and the context of evolving virus, that's a tremendously valuable.

Chunk of information and normally for us with world, but I think regulators will will you know like debt as part of our presentation.

Okay. That's that's helpful. Greg I appreciate that second question that I had is regarding the U S prevent 19 trial.

Charles Duncan: The second question that I had is regarding the U.S. PREVENT-19 trial. The neat thing is that you enrolled it very quickly, two-to-one randomization to the experimental arm, but I guess I'm wondering if you think that that may, call it modulate the case rate, if you will, given that the case rate is falling. Could you could see a slightly, you know, slower case rate accrual in that trial? You know, of course, not compromising the. This is Philip.

Thing is that you enroll and very very quickly two to one randomization to the experimental arm, but I guess I'm wondering if you think debt that may.

Call. It modulate the case rate if you will given that the case rate is falling could you could you see slightly.

And a slower case rate accrual in that trial.

And of course, not compromising the actual data.

Filip Dubovsky: We're all aware of the cases across the U.S., and I think we have a couple of things playing in our favor. One of them is that you saw the slide with the geographic diversity and the size of Mexico. So we really did span the United States and, additionally, with the size of Mexico, so we have a good chance of hitting places that are hot. I guess the other advantage we have is just the sheer size of the study. You know, we were able to demonstrate convincing efficacy in a study of only 4,000 individuals in South Africa. Here, we have 30,000.

And we're at this is Philip we're all aware of the and their cases across the U S and I think we have a couple of things playing in our favor one of them is you saw the slide with the geographic diversity and its.

Insights and Mexico, So, we really did spend the United States and.

Additionally, with the size and Mexico. So we have a good chance of hitting places that are hot.

I guess the other advantage. We have is just the sheer size of the study.

And we were able to demonstrate convincing efficacy and a study of only 4000 individuals and South Africa here, we have 30000 and so the case accrual is going to be a lot lot faster.

Filip Dubovsky: So the case accrual is going to be a lot, lot faster. We know that variants are emerging in the U.S. On the other hand, we know that this particular vaccine works against those variants. So we have high hopes of having a pretty robust response. What's going to likely be the critical path activity is actually the safety database.

<unk>.

We know that variance are emerging in the U S and the other hand, we know that this particular vaccine works against those variance. So we have high hopes and having a pretty.

Robust response, whats going to likely be the critical path activities actually the safety database. So we have guidance from the FDA to and we know exactly what they want to see and it's.

Filip Dubovsky: So we have guidance from the FDA, and we know exactly what they want to see. And it's seeing people having two months of safety after their second dose. So that's kind of the target we're thinking about as when we can wrap this up in the optimal package for the FDA. But like Greg said, should we achieve the endpoints earlier, we'll have the interim analysis to bring to the FDA if they're dissatisfied with what we can bring to them from the UK and South Africa. It's great, Filip and Greg.

And have the people having two months safety after their second dose so that's.

And that's kind of the target we're thinking about is when we can wrap this up and the optimal package for the FDA, but like Greg said should we achieve the endpoints earlier, we will have the interim analysis to bring to the FDA.

They are dissatisfied with where we can bring to them from the U K and South Africa.

It's great Philip and Greg and I'll ask question for John and or Stan.

Filip Dubovsky: Last question for John and Stan. You've built a big company quickly in this last year, and I guess I'm wondering if you could provide a little bit of perspective on how you've been able to maintain quality, you know, in terms of standard operating procedures, etc., in terms of clinical conduct, manufacturing, and other aspects of your business as you really establish this company as a potential leader. Well, I'll take the call because the fun part of my job is bringing in new people into the company, interviewing them, and that has been it's been fun because it's really quite an easy place to hire really good people.

Built a big company quickly.

And this last year and I guess I'm wondering if you could provide a little bit of perspective on how you've been able to maintain quality.

In terms of standard operating procedures et cetera in terms of clinical conduct manufacturing and other aspects of your business as you can see really establishes company's potential leader.

Well I'll take the call because as the third part of my job is bringing in recruiting new people into the company interviewing them.

And.

And that has been it's been fun, because it's really quite and.

And the easy place to hire really good people, we have a technology, which is from the very start is clear that that matches the problem and and.

Stan Erck: We have a technology which, from the very start, is clear that matches the problem, and we've had good data all the way back from the earliest primate data. That was probably better data than anybody else had, and so we've got momentum. We've got financial momentum that allows us to go as fast as we can.

And we've got we've had good day to all the way back from the earliest primary data that was probably better data than anybody else had and so we've got.

And now momentum we've got financial momentum.

That allows us to go as fast as we can we've got the we've got the product is clearly.

Stan Erck: We've got a product that is clearly at the top of the list of vaccines for COVID, and then you've got a pipeline that can build on top of that. So it's actually a good part of my. Thanks for taking the question. Your next question comes from the line of Mayank Mamtani with B Raleigh Security.

At the top of list of vaccines for Covid.

And then you've got to you've got a pipeline.

And that can build on top of debt. So it's actually a good part of my job.

Thanks for taking my questions.

Your next question comes from the line of my Young Man.

Tiny with B Riley Securities.

Mayank Mamtani: Hi Dean, thanks so much for taking my question and congratulations on the progress. So maybe just piggybacking on the question addressed before, can you, Greg, maybe comment on the FDA guidance document that was put out just relative to your expectations? I'm, you know, specifically talking about the lower and upper bound that is said there. Just curious, you know, given you start off with a very high level of utilizing titers, how should one think about when, you know, you go in forward and think about bivalence or even boosters specifically?

Hi, Deane. Thanks, so much for taking my question and congrats on the progress. So maybe just piggybacking on the question addressed before.

Can you Greg maybe comment on the FDA guidance document that was put out just relative to your expectations and I'm, specifically talking about the lower and upper bound.

That said there.

Just curious you know given you started off with a very high and utilizing dinos how should one think about when you go and going forward and and think about bivalent or even boosters specifically.

Greg Glenn: Well, there are some details that need to be defined about the assays, but, you know, I think what we have going for us is that our vaccine is highly immunogenic. So, and the other piece we have to give us some insights is that the animal data seem to be really quite predictive for what we need to know. I do think that there are some options we're considering around the assays themselves, exactly what and maybe some negotiation, but I'm not worried that non-inferiority is a relatively low bar, and given that we can come up with the right measures, I think we should be, and we're You know, that does need to be negotiated.

Well there are some details that need to be defined about the assays, but you know I think what we have going for US is our vaccine is highly immunogenic and so.

No.

And.

And the other piece, we have to give us some insights as the animal data seem to be really quite predictive for what we need to know so.

All right.

Do think that there are some options, we're considering round the assets themselves you know exactly what.

And maybe some negotiation, but I'm not worried debt non inferiority and relatively low bar.

And given.

That we can come up with the right measures I think we should be.

And we're not terribly concerned that debt that's something we can cross.

And then.

That does need to be negotiated the neutralizing assays have have been.

Greg Glenn: The neutralizing assays have been, you know, somewhat of a challenge for people to develop. But you know, we're a year into the epidemic, and I'm confident we can come up with a way to take a look at relative immune responses, and NI is a relatively low bar, as I mentioned. So these don't have to be big trials. Actually, Peter Marks, you know, noted that as well.

Sure.

Somewhat of a challenge for people to develop but we're a year into the epidemic and I'm <unk>.

For that we can come up with a weighted to take a look at the relative immune responses and ni is a relatively low bar that I mentioned so these.

These don't have to be big trials.

Peter marks and noted that as well I think it's a very attractive offer to.

Greg Glenn: I think it's a very attractive offer to go the way of flu and allow the strain change mentality to be, you know, taken up by a company. So, you know, how does that boil down to what we might do? Well, we get to do a pivotal trial, you know; it could be the next trial we do is structured to be a pivotal trial, and we won't be doing efficacy, as Filip mentioned. So that, to me, is quite attractive. And I don't know, Filip, if you want to add anything.

And go the way of flu and O L.

<unk> changed mentality.

To be taken up by a company so.

Debt, how does that boil down to what we might do well we get to do pivotal trial you know it could be the next trial. We do is structured to be a pivotal trial and we won't be doing efficacy as Philip mentioned so.

That's for me is quite attractive and I don't know, Phil you want to add anything to it.

When I said there was.

No other FDA guidance, specifically mentioned so its flexibility to have a discussion with them and things are going to be science based.

Filip Dubovsky: The NPA guidance specifically mentions this flexibility to have a discussion with them. These are going to be science-based discussions, and we have our own ideas that we'll bring to the table and see if they can concur with them. And maybe any update you could provide on what all this kind of means in terms of the development of the flu, because the vaccine efficacy study would probably be relatively difficult to conduct. So any update you have on that, just as an extension of the previous question, and then I just have one follow-up. Oh, not really.

For our discussions and we have our own ideas and bill brings to the table and MTV and concur with them.

And maybe any update you could provide would all this kind of means in terms of development and flu because debt.

Vaccine efficacy study would probably be relatively difficult to conduct so any update you have on that.

And he said the extension of the previous question and then I just have one follow up.

Net.

Really I mean, we are as you know and the background, we're thinking about how to do flu was there's some work going on and formulation right now we haven't really announced a trial or for what our clinical plans are yet, but we are extremely interested and as you as you say I mean, one of the things that debt we were.

Greg Glenn: I mean, as you know, in the background, we're thinking about how to do the flu. There's some work going on with formulations right now. We haven't really announced a trial or what our clinical plans are yet, but we're extremely interested. And as you say, one of the things that we were kind of gratified to see with the variant is that we had this theme embedded in our flu data, but only really validated by immunogenicity, that the adjuvant and the nanoparticle had the ability to give a broad, qualitatively broad response. So it made the flu vaccine, you know, able to cope quite well with the strain, the genetic evolution, in this case, of H3N2.

Gratified to see with the variance is that we had this theme.

Embedded in our flu data, but only bolt only really validated by immunogenicity that the adjuvant and the nanoparticle had the ability to give abroad and qualitatively broad response, so it made the the flu vaccine.

Able to cope quite well with the strain.

Genetic evolution and in this case of Ace III and two so we're kind of we're gratified now both to see efficacy with the nanoparticle against the RNA virus like we have that's very high and also this idea that the broad.

Greg Glenn: So we're kind of, we're gratified now both to see, you know, efficacy with the nanoparticle against RNA viruses like we have, that's very high. And also this idea that broad immunity might result in protection against a really major, in this case, this is a major antigenic drift away from neutralizing antibodies, as Philip mentioned, kind of at the extreme of what might be possible, and yet our vaccine seems to be working pretty well against that.

And they might resolve and protection against a really major and this case. This is the major.

Antigenic drift away from neutralize the antibodies and Phil mentioned kind of at the extreme of what might be possible and yet our vaccine and seem to be working pretty well against that so so I do think it does validate the technology the matrix and the boards and matrix M and the science we had around.

Greg Glenn: So I do think it does validate the technology, the matrix M, the importance of matrix M, and the science we had around, you know, inducing immune responses to epitopes that might not normally be well seen in natural infection but are brought out by making the nanoparticle. So, good validation, I would say, with our clinical data. And the final question I had was, in terms of supply in the late 2Q time frame when you are getting close to your filings, any update on what those levels would be at and how would you think about delivering to the US versus ex-US western economies at that point? Not a complicated question.

Inducing immune responses to epitopes that might not normally be well seen and natural infection, but are brought out by making the nanoparticle.

Z. So good good validation I would say with our clinical data.

Thank you and then a final question I had was in terms of.

And our supply in the late <unk> timeframe then.

You are getting close to your filings and any update on what.

And those levels you would be at and then how would you think about delivering the U S versus ex U S western economies at that point.

Well that's it.

Okay.

Stan Erck: It's a complicated answer, I suppose. We plan on being in full production at all of our plants by the May June timeframe. And, and so if we get, and we will have been building inventory to ship, our hope is that we, I think our stated hope is that we'd be able to ship roughly 110 million doses to the U.S. government by July. And that's still our goal.

Complicated question its a complicated answer I suppose.

And as we plan on being in full production and all of our plants.

By the May June timeframe and.

And so if we get.

And we would have been building inventory to ship our hope is that we.

And I think our state and hope is that we'd be shipping.

Be able to ship raw.

The 110 million doses.

And to the U S government by July and.

And that's still our goal so.

And then ex U S is going to be supplied from several different locations outside the U S and the first doses will go into the U K.

Stan Erck: And then XUS is going to be supplied from several different locations outside the U.S., and the first doses will go into the U.K., assuming that they get first approval, and so we've got various sources for that.

Assuming that they have the first approval and so we've got various sources for that.

Great. Thanks for taking my questions team.

Stan Erck: Great. Thanks for taking my questions, James. Your next question comes from the line of Vernon Bernardino with H.C. Wainwright.

Your next question comes from the line of Vernon Bernardino with H C. H C Wainwright.

Vernon Tolentino Bernardino: Hi everyone, and congratulations on the progress. I think it can't be said enough that you guys are being mentioned in the same sentence as much larger and much better financed vaccine players, and you've accomplished a lot in the past year. So congratulations from me also. I just have one question. A lot of my questions have already been asked. Have you considered a strategy of advancing the bivalent COVID vaccine candidate using a BLA pathway for full approval later this year versus going for emergency use authorization? I ask because of the limitations, especially long term, what comes with EUA.

Hi, everyone and congratulations on the progress.

And I think it can't be said enough debt.

You guys are being mentioned in the same.

Sentence as a much larger and much.

A better financed vaccine players and accomplished.

Accomplished a lot and the past year. So congratulations from me also.

I just have one question lot of my questions already been asked.

Have you considered a strategy of Advair.

For advancing the bivalent COVID-19 vaccine candidates using our BLA pathway for full approval later this year versus going for emergency use authorization.

And I ask because of the limitations.

And especially the long term what comes with.

<unk>.

Filip Dubovsky: Yeah, it's an interesting question. But our ability to license the variant is a strange change, and that actually depends on the prototype having a BLA.

Yes.

It's answering question, but our ability to license for Varian as a strained change and that depends actually on the prototype having a BLA. So I think in the first instance, we're going to have to follow the leader and where the variance and b and the timelines that.

Filip Dubovsky: So I think in the first instance, we're going to have to follow the leader with the variants and be in the timelines that that are established by the prototype. And when you do advance a bivalent COVID vaccine, and you anticipate it, the second component will be a variant as part of the strategy and then the original current protein sequence, or how should we look at the bivalent, what comprises the bivalent vaccine?

Better be established by the prototypes vaccine.

And when you do have <unk>.

And it's a bivalent cover the vaccine candidate do you anticipate.

It.

The second component of it will be a variant.

And as part of the strategy and then the original all current.

And as protein sequence or what.

How should we look at the bivalent.

And on what comprises the bivalent vaccine candidates.

Our current concept is just that so so we think that this.

Filip Dubovsky: Our current concept is just that. So, we think that this, the antigenic space, which equals immunologic space between the original strain and where it has evolved to now, is quite broad. And we want to be able to bring an immunologic solution to all antigenic diversity. So right now, the strains that we are seeing in Brazil and South Africa seem to define the extreme where the virus has evolved.

The antigenic space.

Space, which equals hematologic space between the original strength and where it has evolved to now is quite broad and we wouldn't be able to bring a module solution to OLED and.

Diversity.

And.

Right now the strains that were seeing and Brazil, and South Africa seems to define the extreme where the virus has evolved so and the persistence are for us by Valeant will be that sort of a product.

Filip Dubovsky: So in the first instance, our first buy value will be that sort of product. And then the last question I have is, obviously, these proteins, yours is a protein approach, expose themselves to a lot of immune activity, and therefore, there could be many different species of monoclonal antibodies created against them. What do you anticipate as far as the kind of species and kinds of protection that you may see with your COVID vaccine that you perhaps also saw with the RSV and Mandflu vaccine?

And then last question I have is so obviously.

These.

Proteins.

Yes.

<unk> approach.

Expose themselves to a lot of.

Immune.

Activity and therefore, there could be and many different species of monoclonal antibodies antibodies are created against them. What do you anticipate as far as the kind of species and kinds of protection debt.

You may see with your Covid vaccine that perhaps you also saw with the RSV and.

And then a flu vaccine.

Filip Dubovsky: So maybe I can take a crack at that and Greg can mop up. One thing we know is that we form native confirmation trimers, and that really translated in the phase one data that we published into high levels of neutralizing antibody, which means we got the confirmation right, and the immune response we generated against that correct native confirmation works, it's functional. In that publication, we published a correlation between our neutralization response and our IgG response. It was very, very tight, like a Pearson's correlation of 0.94, 0.95.

So maybe I can take a crack of that and Greg can and mop up.

I mean, one one thing we know is that we form native confirmation primers and.

And that really has translated in the phase one data that we published into high levels of neutralizing antibody for screens, who got the confirmation right and the immune response, we generated against other.

Net correct native confirmation.

<unk> works is functional.

And that publication, we publish a correlation between our neutralization of our sponsor and IGT response was very very tight like a person's correlation of nine for nine five and what that told us and said that over the broad range of antibodies. We did induce it was all proportionately Sumatra and neutralizing so.

Filip Dubovsky: And what that told us is that across the broad range of antibodies we did induce, they were all proportionally the same amount of neutralizing. So that gives us a lot of confidence that as we move these bivalent products forward, we can induce the same sort of neutralizing antibody. The animal work Greg described before will tell us in the next handful of weeks, and we know from our efficacy data that it's paid off for us in the clinic.

That gives us a lot of confidence.

That as we move these bivalent product forward, we can induce the same sort of neutralizing antibody. The animal work Greg described for will tell us and the next handful of weeks and.

And we know from our efficacy data.

And it's paid off for us and the clinic and remember in the case of South Africa.

Filip Dubovsky: And remember, in the case of South Africa, that's the case where previous exposure to wild type, so previous infection where the prototype Wuhan strain did nothing to prevent illness with the South African variant, yet our vaccine was able to perform quite well.

That's the case, where previous exposure to wild type so previous infection, where the prototype Wuhan strength did nothing to prevent illness with the south and South African variant and our vaccine was able to perform quite well and that's really we believe a function of that adjuvant we use.

Greg Glenn: And that's really, we believe, a function of the adjuvant. Yeah, that's great. Thank you. Go ahead, Greg. There's nothing really to add. That's a good tip.

Yes, that's perfect.

Go ahead Greg.

Nothing really to add that sense and that's good.

Greg Glenn: There is nothing to mop up. There is nothing to mop up. Yeah, well then, congratulations. And I certainly look forward to that data because of the academic in me. And congratulations on the year-long progress. Thank you. You have no further questions at this time, and I will now turn the call back over to Mr. Stan Erck for any closing remarks. Great Well, you've heard our story. We've had just an unbelievable year. We're a significant company of size in many ways and expect to have an even more remarkable 2021. I look forward to telling you about it. Thank you all for joining us. That's it. And this concludes today's conference call. Thank you for participating, and you may now disconnect. (inaudible)

No nothing to mop up.

Well, then congratulations and I suddenly and look forward to.

And that day.

Data because of the academic and my congratulations on the year long.

Yes.

Thank you.

You have no further questions at this time and I will now turn the call back over to Mr. Stan <unk> for any closing remarks.

Great well you've heard our story, we've had just an unbelievable year.

We're a a.

Significant company of size and many ways and expect to have and.

And even more remarkable 2021 look forward to telling you about it. Thank you all for them for.

For for.

Joining.

That's it.

And this concludes today's conference call. Thank you for participating and you may now disconnect.

[music].