January 22, 2022

The World Stock Markets Tips & Targets, News, Views & Updates

The World Stock Markets Tips & Targets, News, Views & Updates

Novavax, Inc. (NVAX) CEO Stanley Erck Presents at 40th Annual J.P. Morgan Healthcare Conference (Transcript)

Novavax, Inc. (NASDAQ:NVAX) 40th Annual J.P. Morgan Healthcare Conference January 10, 2022 9:00 AM ET

Company Participants

Stanley Erck – President and CEO

Gregory Glenn – President, R&D

John Trizzino – Chief Commercial Officer and Chief Business Officer

Conference Call Participants

Eric Joseph – JPMorgan

Eric Joseph

All right. Good morning, and welcome to the 40th Annual JPMorgan Healthcare Conference. I’m Eric Joseph, senior biotech analyst with the firm. Thanks for joining us. Our next presenting company this morning is Novavax and here to talk to us about the company is CEO, Stan Erck. Quick programming note, there is a Q&A session after the presentation. Feel free to submit a question by clicking to “Ask a Question” icon. With that, Stan, thanks for joining us.

Stanley Erck

Eric, thank you very much, and thank you, everyone, for joining us this morning. I’m pleased to be here today to discuss the incredible progress Novavax has made over recent months as well as our many substantial milestones ahead in 2022. So let’s turn to Slide 2. Before I begin today’s presentation, I need to remind you that we will be making forward-looking statements during the conference, which are based on our current expectations. We encourage you to reference the risk factors in our SEC filings for additional detail.

So let’s turn to Slide 3. Novavax is at a major turning point in its history. Over the past 2 years, we have built a company that is now a key player in the vaccines market. We have used our expertise with our validated and highly efficacious technology platform to make tremendous strides in delivering our protein-based COVID-19 vaccine to the world. Today, we have transitioned into a company that is poised to deliver our vaccines to all 4 corners of the world and we have expedited our progress in the last quarter of the year with broad authorizations and more to come. I’m going to start with an overview of our major recent accomplishments, virtually all of the milestones I’m going to tell you have occurred within the last 30 or so days and will be — or will be happening over the next 2 quarters. We’ve achieved regulatory authorizations for our first vaccine, Novavax 2373 on a global scale. As of today, we have authorizations through the WHO in Europe, in India, in Indonesia and in the Philippines. And over the next 30 to 90 days, we have the potential to expand those authorizations to include the U.S., the U.K., Australia, Canada, Japan, New Zealand, the UAE, Korea, South Africa and others. We began shipping our first product last quarter. And in December, we started vaccinating people in low and middle income countries. In Indonesia, we shipped over 10 million doses, and we’ll deliver another 40 million doses to Indonesia in the coming quarters. And even though we couldn’t travel easily to this country, we were able to capture our first vaccination in these photos on the slide.

In support of our Gobelins, an advanced purchase agreement and our commitment to global equitable access through the COVAX Facility, we are targeting 80 million doses to be shipped by the end of this quarter. And just this morning, we shipped our first product to Europe to help satisfy our APA in Europe. I’m also pleased to report that the initial 27 million dose order from the EU, which is to be shipped in the first quarter, was expanded last week to include an additional 42 million doses for second quarter delivery. Both of these orders are part of the EU’s option to purchase up to 200 million doses. The European orders highlight the importance of making 2373 available in markets that may have otherwise appeared to be served by other vaccines. People simply want a safe and effective protein-based alternative. As you can see, we are executing on all fronts.

Please turn to Slide 4. As a biotechnology company dedicated to developing and commercializing next-generation vaccines we have focused tremendous efforts over the past 2 years on bringing to market 2373. Today, we are incredibly excited by our progress to deliver upon that mission. Through our clinical development of 2373, we’ve demonstrated high efficacy, a favorable safety profile and importantly, strong responses to COVID variants. These data have formed a robust clinical data package resulting in regulatory authorizations covering over 6 billion lives across over 170 countries. To ensure 2373 is widely available to those in need, we’ve built a global manufacturing and supply network that supports over 2 billion annual doses of capacity and will enable us to deliver upon our supply commitments. As we move into 2022, we’re in a position of financial strength to execute on our commercial rollout of 2373 and pursue continued development of our vaccine pipeline.

So let’s turn to Slide 5. Our innovative platform is based on well understood, recombinant protein technology and offers several differentiators. Formulating our vaccine with our proprietary Matrix-M adjuvant has enabled 2373 to offer key benefits in protecting against COVID-19, including high efficacy across diverse populations, strong cross protection against variance, robust responses as a booster and a reassuring tolerability and safety profile. And additionally, we believe our expansive manufacturing and supply network positions us well to address the global nature of the pandemic. This network provides significant capacity to reach those in need around the world. We also believe our vaccine will improve access in hard-to-reach places through its key distribution and administration benefits, including storage and standard refrigeration temperatures and an assigned 9-month shelf life. A 10 dose vial presentation and a ready-to-use formulation with these key differentiating factors in mind, we are confident in 2373 ability to be an important vaccine option in today’s evolving pandemic.

Please turn to Slide 6. We’ve made tremendous progress advancing 2373 toward regulatory approvals. As of today, we’ve received authorization from the World Health Organization, European Commission, Indonesia, India and the Philippines for our product, NUVAXOVID and 2373 manufactured market by Serum Institute, which is being marketed as COVOVAX. These authorized geographies include over 6 billion individuals where vaccine has the potential to reach. In other major markets, we’ve completed 10 additional regulatory submissions, which include an additional 0.5 billion lives. This includes a filing for authorization in South Africa, not reflected on this slide, because we just announced it this morning. We are in active discussions with regulatory authorities and remain focused on gaining additional authorization for 2373. I note that in the U.S. we completed the submission of our final CMC data package to the FDA at the end of 2021. And at the end of this month, we expect to submit our formal request for emergency use authorization which will mark a critical milestone toward making our vaccine available in the U.S.

Please turn to Slide 7. As we pursue additional regulatory authorizations for 2373, we believe there is a significant global market opportunity for our vaccine. We believe 2373’s highly efficacious and well-understood technology provides a critical alternative for primary vaccination to individuals who may be vaccine hesitant or seeking alternative options. For Booster vaccinations, we believe waning immunity and the emergence of variance will fuel an ongoing need for booster doses, and we’re building a body of evidence that our vaccine, which induces broad immune responses to variants, including Omicron will be an important option for boosters. Existing data demonstrates that 2373 is capable of boosting a homologous and heterologous primary vaccination series with a favorable tolerability profile. In pediatric populations, we believe 2373’s overall product profile positions our vaccine as a desirable future alternative in a rollout of pediatric vaccines globally. Through our cumulative commitment in partnership with Serum Institute of 1.1 billion doses to the COVAX facility, our expansion supply network and our favorable distribution storage profile we believe 2373 is an ideal option to address gaps and vaccine access to lower middle and low income countries. And we are committed to ensuring equitable access to 2373 around the world.

Please turn to Slide 8. This slide summarizes an analysis that identifies where significant market opportunity exists for 2373. As you can see, while many countries have achieved relatively high vaccination rates, there remains a significant percentage that are still unvaccinated with about 30% in high-income countries and 46% in upper middle income countries, still needing 3 doses in 2022. In fact, over 90% of the world still needs their first booster dose. We now know that boosting is critical to ongoing protection and generally speaking, boosting recommendations are only now beginning to see universal application. This need provides for a significant opportunity to step into that gap with 2373. Similar to boosting, the pediatric population, those below 18 years of age as we see global policy support for vaccination. We anticipate that 2373 may provide for a safe and effective solution for the vaccination of that population. Combined, primary boost and pediatric vaccination in high and upper middle income countries alone represents approximately 4.8 billion doses needed. We are also supporting the urgent need for vaccination in all these categories, but especially primary vaccination in low-income countries with approximately 6.8 billion doses needed.

Turning to Slide 9. Next, we provide an overview of doses committed to date through our various supply agreements which illustrates the continued strong demand that exists today for our vaccine. Through our supply agreements, we’ve committed approximately 2 billion doses globally, which include doses committed to the COVAX facility in partnership with Serum Institute of over 1 billion doses, bilateral supply agreements with governments around the world, license production by Serum Institute, SK Bioscience and Takeda that have been committed to others and a 110 million dose option for the U.S. government. As of today, we’ve already begun to deliver upon the supply commitments with a global rollout of 2373 currently underway. As I mentioned, late last year, we began shipping doses to low and middle-income countries with 10 million doses already shipped to Indonesia and people there already getting vaccinated with our vaccine. And we will deliver another 40 million doses to Indonesia over the coming quarters. In the first quarter, we expect to see an acceleration in shipments as more authorizations are received. These will include doses to satisfy our APA commitments and doses to support the Covovax facility. And I’m pleased to let you know that today, we began shipping doses into our European distribution hub and today’s news represents the beginning of an accelerating stream of shipments from the transformation of Novavax into a global commercial company.

Turning to Slide 10. We’ve made significant progress in mobilizing our global manufacturing network with sites around the world routinely producing vaccine at commercial scale. Our global manufacturing network includes our partnerships with Serum Institute, SK Bioscience and Takeda. And through this global manufacturing network, we are prepared to deliver an annual capacity of over 2 billion doses. For production of our antigen, we have significant bioreactor capacity through our Novavax owned Czech Republic facility and additional partnerships with global manufacturers. While our regulatory filings to date leverage our manufacturing partnership with Serum Institute starting this quarter, we expect to supplement our submissions with data from additional sites across our supply chain. For our Matrix-M Adjuvant, we have large-scale production underway at both our Novavax suite of site and contract manufacturing sites.

Turning to Slide 11. We continue to execute on our robust clinical development plan for 2373 use in primary, boosting and pediatric vaccination, which I’ll discuss in more detail in the coming slides.

If we move to Slide 12. In the first half of 2022, we expect to generate additional data. For primary vacations, we will collect data to inform 2373 performance against variants in parallel with achieving additional regulatory authorizations and distributing doses in authorized geographies. For Booster vaccinations, we’ll leverage the data that we already have, showing that 2373 provides very high levels of antibodies against both the parent strain, but also against all of the identified variants of interest, including against the Delta and Omicron variants. We’ll collect additional homologous and heterologous boosting data from ongoing and new studies, and we will prioritize pursuing label indications and policy recommendations, leveraging these data. Finally, for pediatric vaccinations, we expect to complete our regulatory filing in the first quarter for a pediatric indication in children ages 12 to 17 as well as initiate studies stepping down into younger age groups. And in the next few slides, I’ll talk in more detail about this clinical development road map, including data generated to date and upcoming milestones to support label expansions.

Turning to Slide 13. This slide summarizes the very robust data that we generated in both of our Phase III trials, what’s remarkable is how consistent they are with each other. In these trials, 2373 showed consistent high levels of efficacy, a well-tolerated safety profile, strong cross protection against variants, complete protection against severe disease, including against all variants that circulated during the studies and strong protection for high-risk populations. These compelling data form the basis of our regulatory filings.

Turning to Slide 14. So I want to talk about the data generated from Novavax led trials and others, demonstrating 2373 strong potential as a booster. Our Phase II study in the U.S. and Australia has recently shown that a third dose induces strong and functional immune responses, including against new emerged variants such as Omicron. I’ll discuss these data in more detail on the following slide. In the CoV-Boost study run by the University of Southampton, showed that 2373 is suitable for use following primary vaccination with mRNA or viral vector vaccines. This builds the case that 2373 can be used as a booster on top of other primary vaccine regimens. And further, we have additional ongoing booster studies through which we expect to generate important data in 2022. This includes our PREVENT-19 Phase III study, which we believe could be label-enabling for both homologous and heterologous boosting indications. And as we expect strong demand for boosters to continue globally, pursuing label indications and policy recommendations for 2373 as a booster will remain a top priority in the first half of 2022.

Turn to Slide 15. As highlighted on the previous slide, we’ve seen encouraging performance against variance through our clinical development of 2373 as a booster in our Phase II U.S. and Australia trial. In that study, we saw that 2373 induces a broad immune response in the face of viral evolution, even though the vaccine uses the prototype version of spike. After 2 doses of the prototype vaccine, we see 100% seroconversion against all variants. The IgG levels against prototype and alpha were associated with protective efficacy of 96% to 100% against prototype and 86% to 94% against alpha in our U.K. and PREVENT-19 Phase III trials. Remember, we saw no cases of severe disease, hospitalization or death with any variance in these studies. And after a third dose at 6 months, there’s a significant increase in IgG against all variants, including Omicron, several fold above what was associated with strong efficacy after 2 doses.

Moving to Slide 16. So additional data from our Phase II U.S., Australia trial showed that we induced robust functional immunity as measured by hACE2 receptor binding blocking antibodies, which is a stringent functional measure of immune responses. After 2 doses, we observed immune responses against all variants. And after a booster at 6 months, we see 100% seroconversion against all variants with the magnitude of immune responses greater than the peak observed after 2 doses, where we saw high levels of efficacy in Phase III trials. These data present an encouraging picture for 2373 use against Omicron and other circulating variants.

Let’s turn to Slide 17. In addition to primary boosting — primary vaccination and boosting, we believe 2373 can play a major role in the pediatric segment globally. In our PREVENT-19 Phase III pediatric expansion. We evaluated 2373 in adolescents age 12 to 17 and initial findings from the study demonstrated functional immune response after 2 doses that are 2.4 to 4x higher than in adults including against the Delta and Omicron variants. We believe these initial findings will support 2373’s future use in pediatric population, and we believe it will provide broad cross protection for adolescents during continued viral evolution. We expect to submit the adolescent data to global regulatory agencies in this quarter.

Turning to Slide 18. With continued viral evolution of COVID-19, we remain agile in our ability to evaluate and address variance as they emerge. On 2373, our prototype vaccine has demonstrated broad cross protection against variants, we understand that a variant specific vaccine may, in some cases, be necessary to best address the evolving pandemic. We initiated development of an Omicron-specific vaccine last month within days of the variant being identified and began GMP manufacturer that same month. Our response to the Omicron variant demonstrates a hallmark of our vaccine, our ability to rapidly develop and scale a strain change, if and when one is needed. We expect to initiate clinical studies in this quarter, and we believe that developing the vaccine through a strained change approach may create a pathway to licensure. While we will be prepared to switch to a variant-strained vaccine based on Omicron, it’s too early to say whether that’s the right approach or whether 2373 generates a sufficiently broad protective response and simply use 2373 as a boost for the foreseeable future. Over time, data will help us answer that question.

Please turn to Slide 19. In parallel with developing our COVID-19 vaccine candidates, we continued to advance our COVID-NanoFlu combination vaccine candidate, which is a major component of our vaccine pipeline. We’ve completed enrollment of our Phase I/II clinical trial and expect to announce data in the first half of 2022. Based on these data, we expect to initiate a Phase II clinical trial for our COVID-NanoFlu combination vaccine that will also include a NanoFlu only arm. We believe data from these studies will be an ultimate step prior to licensure enabling studies.

Please turn to Slide 20. Today, we have a robust vaccine pipeline of respiratory vaccines that have the potential to protect against today’s most serious illnesses. While we remain focused on continued development of 2373 for initial indications, we are optimistic about other areas for future development, including development of combination vaccines to protect against COVID-19, flu and RSV simultaneously.

Please turn to Slide 21. So as you can see from everything I’ve told you this morning, 2022 is going to be a very busy and productive year for Novavax. This slide provides a consolidated view of all of our major milestones for the year. And rather go into the detail again, I want to close with some framing remarks and leave you with some key highlights of all that we’ve accomplished so far. 2021 was a transformational year for Novavax and for the world. Our COVID vaccine has been authorized in over 170 countries, representing over 6 billion lives, and we’re expecting additional authorizations in over 10 markets in the next 30 to 90 days, including in Australia, U.K., Canada, the U.S. We have commitments for up to 2 billion doses in the manufacturing capacity to fulfill all of those orders and more. We’re shipping product where it’s needed most. Over 10 million doses arrived in Indonesia in December. And today, we shipped our first doses to our European hub. And that’s just the beginning. As we continue to fulfill our current committed doses of 69 million doses through quarter 2 for Europe and begin to ship doses to COVAX this quarter. And what is important is that significant demand remains for a vaccine, our estimate is that 4.8 billion doses are needed for primary, boost or pediatric vaccination in high income and upper middle income countries and an additional 6.8 billion doses are needed in lower middle and low income countries. All in all, that means about 12 billion doses of need in the near term. People want a safe and effective protein-based vaccine alternative, and we are delivering. And we’ve made the progress we have to date because of the unwavering support of our partners, including CEPI, Gavi, the U.S. and U.K. governments, and additional governments around the world and our clinical trial participants and Novavax employees. As a company, we are steadfast in our commitment to global equitable access. We will begin shipping doses to the COVAX facility this quarter to help increase vaccination rates around the world, particularly to the low and low to middle income countries who are counting on 2373 and because of its validated technology platform, high efficacy and favorable product and distribution profile.

Thanks for your attention, and now we’ll take your questions. We will pause for about half a minute to set up for Q&A.

Eric, I think we’re all set.

Question-and-Answer Session

Q – Eric Joseph

Okay. Great. Thanks for that presentation. What — so just picking up on products, given that you have an approved vaccine now that’s going out the door. Maybe I can get you to elaborate a little bit further on the numbers of countries where number of individual companies where you’re shipping product to, right? And how that is anticipated to expand over the first half of the year? I think if I heard you correctly, you’re anticipating or you’re guiding to 69 million doses being distributed to countries in Europe through second quarter. I guess how to think about how that’s distributed across numbers of countries, how that might build going forward? And do you expect to be in a position where you’d be guiding in terms of revenue over that time frame, over the first half of this year?

Stanley Erck

Yes. We hope to be able to guide later on. It’s too early in the launch process for me to guide for anything right now other than what we’ve guided toward. We had the 27 million units order in hand, and we were, frankly, pleasantly surprised on December 31, we got a call for the additional 42 million doses just for the second quarter. So that demand is expanding. Those doses will go to the European Union, and the European Union has an algorithm that will determine to what countries they go. So I don’t know what countries, but will cover the 27 countries in Europe. And then in addition, the Gavi shipments will be to their list of low- and middle-income countries, presumably in maybe high-income countries distributed through the Gavi system. So we don’t today can’t tell you what countries those are going to go to. But it’s clearly expanding. And then on top of that, we have advanced purchase commitments in place — large ones in places like the U.K. and Australia and Canada that we’ll start filling once we get authorization.

Eric Joseph

Correct me if I’m wrong, right? But for countries that are — lower middle income countries that are serviced by Gavi, right, they are having coming vaccine both from that facility, but also independently, I believe, also from the sponsors. Do you have a line of sight in terms of — or do you expect Covavax to be supplying lower middle-income countries exclusively through the Gavi facility? Or do they have the ability to, I guess, purchase product independently from Serum give live sight on that?

Stanley Erck

Well, they have — we have options. We have a commitment, as we mentioned, of a total of 1.1 billion doses to COVAX between Serum and ourselves. Of that, Serum has 750 million of those doses. But Serum has the capacity to make additional doses to fulfill APA separately from Gavi. We just want to make sure we fill up all of our commitments to Gavi.

Eric Joseph

Okay. Great. I want to pick up on the trials related to 2373 use as a booster, right? And really just looking for a little more color on the design of the Phase III trial, who is eligible to participate back, I guess, rolling over from PREVENT-19? And just sort of how the mechanics there work in terms of total patient numbers and sort of what the power and considerations are in terms of looking for vaccine production?

Gregory Glenn

Thanks, Eric. Good question. So that is an important trial for us. And as you rightly point out, this is built on top of our Phase III PREVENT trial. And in that trial, we have essentially opened up the enrollment to all the participants. So it’s going to be quite a large trial. That’s in collaboration with the NIAID or NIH sites as well. So large trial. It will allow really all comers to come in. And I think that reflects the real-world situation we’re moving into here. So as we noted, it’s going to cover both homologous and heterologous boosting as well as having some people who have had experience with infection. So we’re rolling that out now. And I think since the size of the trial and the amount of disease that we’re seeing is out there. So we’ll both look at the immunogenicity, which is very important in our view as well as doing surveillance during that phase of the collection of data.

Eric Joseph

Okay. Okay. There have been from the U.K. Phase II study, smaller in size, but there has been some initial data collected with respect to immunogenicity of essentially heterologous and homologous boosting, right, with the mRNA vaccines and also looking at booster use with 2373. Just from those data, do you have a sense of whether — is it possible to have a sense of whether heterologous boost might provide an advantage over homologous or sequential boost? And I guess when your own market research, has there been much appetite right now so far for a heterologous booster regimen?

Gregory Glenn

Yes. Thanks. I’ll take the first half of the question. I think what — if you look at the paper, what the authors, the people who conducted the trial stated is that this is an enabling trial for heterologous boosting, which is how we view it. It obviously had a small trial. It had some deviations from the normal boosting and immunization schedule, et cetera. But we overall viewed it quite promising, showing that we can use our vaccine on top of the mRNA vaccines as well as the adenovector. I’d say the safety profile for our vaccine really look quite good. Again, consistent with our findings in all of our trials. So we think that’s been an important step forward. Obviously, we want to bolster that as we discussed earlier with our own data from our PREVENT trial in the U.S. So with that, I think I’ll turn it to John. We also, just to say, our own boosting data is extremely promising, and we see both homologous and heterologous immunity that looks highly protective with respect to what we had in our Phase III trial. So I think we’re feeling very buoyant about our ability to boost with our 2373 vaccine.

John Trizzino

Yes. Thanks, Greg. So as we teed up in Stan’s presentation, there’s significant opportunity that remaining here for Booster both from initial regimen, right? So remember that primary series going to be the first 2 doses and then we would follow with a booster dose for the third as well as whatever ongoing policy recommendations exist for additional boosting. Specifically to your question about heterologous boosting, we think there’s a significant opportunity there as well. And while some of the data suggest that the homologous boosting for them and for us, frankly, provide for a robust increase in protective levels of antibodies. We’re getting to levels of antibodies that are from the primary series having — showing protective levels as well. So there are 3 elements as we like to think about it relative to a decision that a health care practitioner making a recommendation or the consumer might think about relative to that boosting heterologous would be that, one, getting to this protective level of immunity. Two is the cross reaction to the variant strain; and three, the safety profile, which I think is critically important, both from a reactogenicity standpoint as well as from an AE perspective. So if those 3 things combined is really the basis for why boosting with our product will be received well, and I think we’ll see significant market demand based upon that criteria.

Eric Joseph

Okay. And from a regulatory standpoint, I mean, what is required, I guess, from a vaccine efficacy standpoint to facilitate an expansion for uses of booster, right? I mean we have seen generally protection rates kind of come down with Omicron — depending on the prevalence strain, right, delta being one Omicron being a little more challenging. Is there a sort of a clean clear demarcation as to, I should say the amount of efficacy that you might be able to demonstrate would be dependent on the strain circulating at the time. Is there a clear demarcation of what the vaccine is efficacy would be — need to be demonstrated to facilitate label expansion for booster?

John Trizzino

I think let me take a run at that. I think there’s 2 elements to this, and we’ve talked about this before, right? There’s a regulatory label enabling studies, which Greg talked about quite a bit regarding the PREVENT-19 looking at boosting off of that clinical trial. And so label-enabling in any of the regulatory authorities. But there’s also significant policy decisions that come to play here too in the context of the pandemic. It’s a very dynamic situation. The regulatory authorities and policy centers need to react quickly. And I think with sufficient evidence, both in smaller studies and larger studies, I think you’ll see potentially in the absence of the specific label indication that you’ll sell policy support for the use of certain vaccines under those circumstances.

Eric Joseph

Got it. Great. Okay. Excellent. A question that we frequently get is just how to think about the regulatory outlook in the U.S. and whether in the EUA is still on the table. I guess that is something that you expect to have feedback on — or update the street on — within first quarter. Just how to think about some of the alternatives there? If it isn’t necessarily an open path, what does the BLA time line look like with Nuvaxovid.

Stanley Erck

Well, I think we know that the EUA is available to us now. We know that Peter Marks had in an interview, had stated I think as recently as a month ago, that the EUA process remains open because they felt a strong need for vaccines like a protein-based vaccine. So I think it’s going to remain open to us. I think the process has started. It’s in the FDA’s hands. We’ll get a response from them sometime in February. And I think the process, we’ve harmonized all of our work globally. And so we’ve gotten all the questions we think. We’ve gotten all the questions one could get from 10 or 15 different regulatory agencies, and we’ve responded to them. So we think we’re well prepared and with a solid application. So we’re optimistic, confident that the FDA is going to respond fairly quickly to us.

Eric Joseph

Okay. Got it. Got it. The — picking up on the potential for a COVID flu shot. Just help us think about sort of what the product would ultimately look like there? Would it be — is it — should we think of it primarily as a sort of a booster shot addressing both viruses? Or would you need to study it sort of as a primary vaccination regimen as well for both flu and for COVID-19.

Gregory Glenn

Yes. Thanks, Eric. It’s Greg. So yes, we think it’s going to be something in the order of an annual immunization like flu was in the past. They’re — we think that COVID may get into the same sort of trough or pace that we see with the flu viruses where there’s some continued seasonal presence of COVID with significant disease and evolution of the virus. So flu, as you know, is updated frequently on an annual basis. And our technology allows us to both update flu and COVID quite quickly. So we’re seeing going forward an annual immunization with flu. And we’re in the middle of, as you know, quite an important trial with some dosing regimens. And exactly how that dosing regimen will look like will be defined in our clinical development. We see a great opportunity with COVID and our technology. I think with flu, we’re expecting to get — we’d like to achieve a place where the vaccine actually is outperforming the flu vaccines that have been in the past. And as you know, we completed a Phase III trial before the COVID epidemic came and all those learnings are being consolidated into our current development program for a combination of vaccines.

Eric Joseph

The current focus on advancing NanoFlu as part of the combination, why focused exclusively there as opposed to given the Phase III that you just alluded to, simultaneously pursuing NanoFlu as a flu-only regimen, right? I believe with the potential for an accelerated approval, an initial approval, given the data at hand.

Gregory Glenn

Yes. I think we’re just keeping our options open. We have — this is — COVID, somewhat of a fluid situation, as you know. And we can — we know that our NanoFlu adjuvant and NanoFlu gives us very good cross-reactive responses. So I think it’s really a matter of keeping our options open. Ideally, for the patient encounter — health encounter with a single vaccine that incorporates both pathogens would really be ideal. So it’s a place where we’re keeping our options open for NanoFlu alone as well as a combination vaccine.

Eric Joseph

Okay. Got it. Got it. I think we’ll have to leave it there for time. But I want to thank the Novavax team for their time to presentation and Q&A this morning. I really appreciate it. And thanks, everybody, for tuning in.

Stanley Erck

Thanks, Eric.

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