Earnings Call Transcript - NVAX Q4 2020

Operator, Operator

Ladies and gentlemen, thank you for standing by, and welcome to Novavax' Fourth Quarter 2020 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. Please be advised that today’s conference is being recorded. I would now like to hand the conference over to your speaker today, Ms. Silvia Taylor. You may begin.

Silvia Taylor, Speaker

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. 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 are also filing our 10-K this afternoon. Joining me today are Stan Erck, 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 Trizzino, Chief Commercial Officer and Chief Business Officer, who will update us on our manufacturing scale-up, partnerships and advanced purchase agreements; 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, condition 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 Securities Litigation Reform Act. Novavax 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 3.

Stan Erck, President and CEO

Thank you, Silvia, 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 are headed in this coming year. Following that, we’ll take some time for questions. The past year has been a whirlwind. 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 has made for the entire year. I don’t see any slowdown on the horizon 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, knowing that they are part of a once-in-a-lifetime mission. I'd like to start our presentation by recounting a shortlist of what our staff has accomplished since our last Annual Earnings Report. We have 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. Between September and February, we initiated three efficacy trials in the U.S., the UK, 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. In the South African trial, which was conducted when the so-called triple-mutant variant was circulating, we demonstrated 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 3 pivotal trial for our NanoFlu program, and met or exceeded all eight of our primary endpoints. We started last year with about 150 employees worldwide, and we now have approximately 800 employees globally, with expectations to exceed 1,000 employees sometime this summer. We started last year without any capacity to manufacture product. In the last year, we have built a global network of manufacturing sites and partners in 10 countries, with a total capacity for COVID-19 vaccines that 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 six months. In contrast, we ended the year with over $800 million and continue to build our financial strength. We have secured over $2 billion of funding from our partners, including the U.S. Government, CEPI, and the Bill & Melinda Gates Foundation, and have purchase 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, it gives us the opportunity to provide the world, including countries of all income levels, with a safe and effective vaccine to help combat the worst pandemic in the last century. 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.

Gregory Glenn, President of Research and Development

Thank you, Stan, and maybe we can turn to Slide 4. 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 identified a stabilized recombinant fully protein Novavax CoV2373, which I'll call it 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 adjuvant for the induction of potent immune responses. The combination showed that these components elicited highly protective immunity in 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 in high-quality peer-reviewed journals, and we have met this goal through multiple manuscripts, a few of which are published in prestigious scientific journals, including the New England Journal of Medicine, Science, and Nature. Moving to Slide 5, 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 has been designed to ensure stability and can be stored at typical refrigeration temperatures, enabling distribution through standard cold supply chains. Additionally, its ready-to-use liquid formulation of both the protein and the adjuvant markedly facilitates vaccine administration. The adjuvant Matrix-M is a critical feature of the 2373 vaccine, which has both an immune-enhancing and dose-varied effect, allowing us to produce more doses of 2373 with less antigen required per dose while reducing immunity that exceeds that seen from a COVID-19 infection. This greatly augments our global capacity for vaccine manufacturing and distribution. On Slide 6, 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 in immune responses, which were all well in excess of convalescent sera. The data suggest the hallmark of our vaccine is the introduction of high levels of functional immunity and has an excellent safety profile. Additionally, this study confirmed the 5-microgram dose for the antigen. I want to note that several other immunogenicity trials have already started or will be starting soon in India, the Czech Republic, and Japan, which will help extend the global access to our vaccine. Today, I’m going to focus on the results of our efficacy studies. During their conduct, the dramatic evolution of the virus occurred, and we were first to demonstrate efficacy against all three major circulating strains. This has led to vital insight for public health and a unique opportunity to demonstrate the utility of our technology amid the evolving COVID-19 virus. Let's begin with 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 in the NIHR registry, we rapidly enrolled over 15,000 participants, 27% of whom were over the age of 65. 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 virus as seen in the mRNA trials, we demonstrated best-in-class efficacy of 96%. For the B-117 variant strain that appeared during the trial, we observed an 86% vaccine efficacy. This latter strain is growing in prominence in the U.S., and it's worth noting that the UK data suggests that 2373 will perform well in the U.S. amid rapid viral evolution trending heavily in this direction. All of the primary endpoints have 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 MHRA in the UK. We plan to file for authorization by early 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 on Slide 8, we enrolled a diverse study population of about 4,400 participants, including 245 medically stable HIV-positive adults. 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 HIV-negative population, representing 94% of the volunteers. During the trials, the virus evolved, and during surveillance, the South African B1.351 variant widely circulated during our trial, accounting for 93% of sequenced cases. Although one-third of the study participants were seropositive at baseline, these antibodies did not seem to prevent infection with the B1.351 again suggesting that prior COVID-19 infection did not protect against subsequent infections with the B1.351 variant. However, 2373 did offer significant protection, even though the vaccine was derived from the original COVID-19 strain. This is not unexpected as a qualitatively better and broader response reflects the lessons learned from the matrix and adjuvant NanoFlu vaccine which show that in the face of evolution, we have appropriate responses. I would like now to direct your attention to Slide 9. We are pleased with the progress we've observed to date with our Phase 3 efficacy 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 2-to-1 randomized trial enrolling over 30,000 subjects. You can see that the primary endpoints align with our previous trials, and interim analysis will be done with 72 cases and 144 final events. Finally, we are encouraged by the highly motivated participant population during the enrollment process, and we believe the 2-to-1 randomized study, as well as the expectation of a crossover, played a major role in expediting recruitment. If you look at Slide 10, we completed the 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, 5% Asian-American with approximately 13% of the individuals being 65 and older. We expect to announce interim data from the trial in the second quarter, depending of course on the overall attack rate. As of today, we are working to implement a blinded crossover for both our UK Phase 3 and PREVENT-19 trials. In these blinded crossovers, participants will receive active or placebo opposite to what the placebo 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 PREVENT-19, our blinded crossover protocol has been submitted to the FDA, and the updated protocol, including the details of the crossover, has been posted on our website under resources. So moving ahead to Slide 11. 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 opening IND application. At this time, we expect to complete our EUA filing in the second quarter. Overall, we are 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. We will continue to engage in dialogue with respect to regulators as we complete our pivotal Phase 3 clinical trials in the UK and U.S., ensuring we fully address all safety, efficacy and quality elements required for authorization. As we look to the future for our 2373 clinical program, we would 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 variant strain candidates. On Slide 12, our Phase 1/2 trial in the U.S. and Australia initiated in May 2020 provided positive data on 2373 immunogenicity and safety. The trial is continuing to offer valuable clinical insights with some participants now receiving a six-month boost dose to examine the production of 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. 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 stand-alone and bivalent candidates. We are evaluating these candidates in ongoing human primate studies and plan to initiate clinical evaluation in these candidates in mid-2021. We are leveraging the adaptability of both our vaccine technology and manufacturing processes to evolve our strategy alongside the evolution of the virus. So in conclusion, on Slide 14, we now have two independent trials demonstrating 2373's high level of efficacy at levels similar to those seen in the best results against the original virus strain and efficacy against two variant strains emerging from viral evolution. We also see an encouraging safety profile. We are proud of the clinical team, as Stan mentioned, that has achieved these milestones with 2373 to date, and look forward to additional data in the coming months, including data from the PREVENT-19 trial. With that, I'd like to turn it over to John Trizzino.

John Trizzino, Chief Commercial Officer and Chief Business Officer

Thanks, Greg. I would like to bring your attention to Slide 15 now. As you can see from this slide, we have built an impressive global supply chain infrastructure that includes both owned and partnered facilities in the past 12 months. This network centers around our own facilities in the Czech Republic and Sweden, partnerships with contract manufacturing organizations in the U.S., Canada, UK, and Spain, and license agreements in 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. This global supply infrastructure securely positions Novavax as an integral part of the global solution to the COVID-19 pandemic. Let me highlight some important points. Novavax CZ in the Czech Republic is a large-scale, state-of-the-art manufacturing facility that is now producing our vaccine antigens. Matrix-M is now manufactured at multiple sites globally with sufficiently committed raw materials for our adjuvant component of the vaccine. The strategic partnership with the 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 in South Korea and Japan respectively. In addition to the advance purchase agreement in Canada, we have 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. 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 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 the Bill and Melinda Gates Foundation, as well as various countries around the globe that expressed an interest in our vaccine and country-specific manufacturing partners that allowed our technology to provide additional supply into India, South Korea, and Japan. As you can see on this slide, we have various agreements that have been executed to date, including advance 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 the Serum Institute to the COVAX facility; and licensing agreements with Serum Institute, SK Bio, and Takeda.

Stan Erck, President and CEO

Thanks, John. 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 licensure. We announced the successful completion of our pivotal Phase 3 clinical trial in the first quarter of last year, achieving all primary objectives. Additionally, in November we published Phase 2 data in Clinical Infectious Diseases. We are currently exploring a variety of options related to commercializing NanoFlu. These options include developing one or more combination vaccines, such as 2373 and NanoFlu, NanoFlu and RSV, and potentially all three. Based on data generated earlier this year, we plan to bring one or more of these candidates into clinical trials later this year. As always, we will publish results of these studies as they become available. We believe that in the post-pandemic era, seasonal vaccination with combination vaccines will present a large commercial opportunity for our platform. And with that, I will now hand it over to Greg Covino to provide our financial results.

Gregory Covino, Chief Financial Officer

Thanks, Stan. Hi, everybody. If you could please turn to Slide 18. Our press release does a good job of running through the highlights of P&L activity quarter-over-quarter, in addition to laying out fourth quarter and full-year financing activities. I'm not going to repeat that here. We just filed our 2020 10-K during the course of this call. The 10-K includes a summary of important business and financing events, including those which occurred subsequent to year-end. We included an update on new supply agreements that John just touched on, and we make note of the substantial completion of a new January 2021 $500 million ATM. I encourage everyone to please take a look at the 10-K. Overall, considering our year-end cash position of over $800 million as mentioned in the release, and the financing activities subsequent to year-end, we believe we are well capitalized and in solid financial position as we approach the commercial launch of our COVID-19 vaccine. Back to you, Stan.

Stan Erck, President and CEO

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 2373. 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 the U.S. Government, CEPI, the Bill and Melinda Gates Foundation, and the COVID-19 Prevention Network. Their immediate response to the pandemic and continued support helped make our accomplishments during the year possible. Only through these combined efforts have we been able to achieve these outstanding developments and become part of the global solution to the COVID-19 pandemic. With that, I will now turn it over to the operator for Q&A.

Operator, Operator

Thank you. Your first question comes from the line of Kelechi Chikere with Jefferies.

Kelechi Chikere, Analyst

Thank you. Good afternoon, and thank you for taking my questions. Congratulations on all the progress 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 or your ability to stockpile vaccines right now? And I guess related to that, how quickly would you be able to go from EUA authorization or approval to actually shipping vaccine, if you could provide any color there, that would be great? And I have one follow-up question.

Stan Erck, President and CEO

Yes. This is Stan. I'll take that. We tend to focus on manufacturing sites that manufacture the antigen, which is perhaps the most complex part of the manufacturing. So we've established those in 10 countries, and they are now all making product at GMP scale. They're either finishing their engineering runs or making product at commercial scale, and the cadence of that production depends on how many runs they have in their schedule. Those runs depend on making sure we have enough raw materials to make all those runs. We’re getting there. The expectation is that all of the plants will be at full scale by April. By April, May, and June, we should be finishing, filling, and finishing product in advance of regulatory approvals. We are now filling and packaging material both in the U.S. and from Korea and finishing those in Europe and the U.S. We will have material on the shelf when we have approval for shipment.

Kelechi Chikere, Analyst

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 I guess related to that, given your experience with the 2373 in non-human primates, what would the data suggest for immunogenicity and efficacy of your variant vaccine in humans? Your thoughts there would be greatly appreciated.

Gregory Glenn, President of Research and Development

Yes. Thank you. It has turned out that the animal models have been quite predictive. So we have very good efficacy in the non-human primates. That’s why we use them. They are not perfect models, but they are physiologic and require vaccine-induced immunity. Overall, they bode well. Another animal model to point to is the baboon, where we did some initial safety and immunogenicity studies, and they were quite predictive. The mouse models have all been informative as well. We are planning to publish our results as soon as we have data that make sense for publication. We have great data and science, and it's not unreasonable to expect we should have data in that timeframe.

Kelechi Chikere, Analyst

Got it. Perfect. Thank you.

Operator, Operator

Your next question comes from the line of Eric Joseph with JPMorgan.

Eric Joseph, Analyst

Good evening. Thanks for taking the questions. I just wanted to get a better sense of where discussions are with the FDA in the path to the 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? As a follow-up, as it relates to the planned trials with the new variants and bivalent vaccines, with the FDA's guidance, is the expectation that the human immunogenicity would be sufficient for approval, and will the trials you’re initiating be for registration?

Gregory Glenn, President of Research and Development

Eric, I'll make a quick comment and then turn it over to Filip Dubovsky, our Chief Medical Officer. We're operating on the assumption that the UK data could form the basis for the EUA. We have a good back-up in a large pivotal trial. So that’s how we're organizing our submission strategy. Filip, can you share a little more about the various strategies?

Filip Dubovsky, Chief Medical Officer

The endpoints of our Phase 3 studies are aligned between all three of them. The FDA is well aware of what our endpoints are. Regarding the variant situation, we've received guidance from various global regulators about our approach to licensing, and no one is suggesting we do efficacy studies. It’s more about showing safety, but importantly, non-inferior immune responses to the variant versus the original strain. We plan to follow up with studies that look at the variants by themselves as well as in a bivalent format. We believe the bivalent format will be where we want to be.

Eric Joseph, Analyst

Great, thanks for taking those questions. As a quick follow-up, can you say anything in terms of regionality where you will be conducting the planned trials with the bivalent candidate?

Filip Dubovsky, Chief Medical Officer

Different regulators have given us slightly varied study designs that we need to take into account, and we haven't finalized the exact locations for the studies.

Eric Joseph, Analyst

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

Operator, Operator

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

Charles Duncan, Analyst

Hi. Stan and team, congrats on executing well in a really difficult year, and thanks for taking our questions. I had a question regarding the EUA filings. Can you provide any color on the rate limiting steps in the UK and the U.S., especially given the answers you just gave on the previous question?

Gregory Glenn, President of Research and Development

Both countries require similar categories of information around CMC and clinical aspects. We unblinded because we had a positive interim efficacy, which means we met our statistical success criteria. So we continue to collect cases in a blinded fashion. We expect to finalize most of that data around early April, and thereafter we will be submitting to both regulators. That's one piece. The other piece is our CMC package. We’re looking to align both submissions around the same time to get our MHRA package in. They've been very good partners, and there’s been a lot of communication.

Charles Duncan, Analyst

Okay, that's helpful. I appreciate that. Second question I had is regarding the U.S. PREVENT-19 trial; you've enrolled it very quickly, but do you think that could modulate the case rate, given that the case rate is falling? Can you see slightly slower case rate accrual in that trial, of course not compromising the actual data?

Filip Dubovsky, Chief Medical Officer

We’re all aware of the cases across the U.S., and the advantages we have include geographic diversity. We have a good chance of hitting areas with high case rates. The size of the study definitely supports faster case accrual. Our vaccine works against the emerging variants, and we’re hopeful about having a robust response. The critical path activity will be the safety database; that’s where we’re focusing our efforts.

Charles Duncan, Analyst

Great. Filip and Greg, last question for John and/or Stan. You’ve built a big company quickly this last year. How have you been able to maintain quality in terms of standard operating procedures in clinical conduct, manufacturing, and other aspects of your business as you establish your company as a potential leader?

Stan Erck, President and CEO

I'll take that. Recruitment has been fun because it’s quite easy to hire really good people here. We have a technology that clearly matches the problem, and we have great data from the earliest primate data, which was better than anyone else had. We now have momentum and financial strength that allows us to go as fast as we can. Our product is clearly at the top of the list of vaccines for COVID, and we have a strong pipeline to build on.

Operator, Operator

Your next question comes from the line of Mayank Mamtani with B. Riley Securities.

Mayank Mamtani, Analyst

Thanks so much for taking my question and congrats on the progress. Maybe just piggybacking on the previous question: can you comment on the FDA guidance document that was put out, relative to your expectations? Specifically talking about the lower and upper bound that is there; curious given you start off with very high neutralizing titers, how should one think about bivalence or even boosters specifically?

Gregory Glenn, President of Research and Development

There are some details that need to be defined about the assays, but our vaccine is highly immunogenic. We have good efficacy data, and we expect that with the right measures, we should meet the non-inferiority standard. The neutralizing assays have been a challenge for test development, but I'm confident we can find solutions. The FDA has indicated flexibility, and we see an opportunity to take the flu strain change mentality into our approach.

Mayank Mamtani, Analyst

Thank you for that. Any updates regarding the development in flu? The vaccine efficacy study would probably be quite difficult to conduct?

Filip Dubovsky, Chief Medical Officer

We haven't announced a trial or our clinical plans yet, but we’re considering how to proceed with flu. We validated the importance of the nanoparticle against RNA viruses. This validation provides encouragement for our flu vaccine development.

Mayank Mamtani, Analyst

Right. Thank you. Finally, in the late 2Q timeframe, when getting close to your filings, could you provide some levels you would be at and delivering to the U.S. versus other Western economies?

Stan Erck, President and CEO

We plan on being at full production at all of our plants by the May-June timeframe. We hope to ship roughly 110 million doses to the U.S. Government by July. The supply for ex-U.S. will come from several different locations outside the U.S. The first doses will go into the UK, assuming they get approval first.

Operator, Operator

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

Vernon Bernardino, Analyst

You guys are being mentioned alongside larger vaccine players, and you've accomplished a lot in the past year, so congratulations. I have just a couple of questions. Have you considered a strategy of advancing the bivalent COVID vaccine candidate using the BLA pathway for full approval later this year instead of going for emergency use authorization, especially considering the limitations that come with EUA?

Filip Dubovsky, Chief Medical Officer

It’s an interesting question, but our ability to license a variant depends on the prototype having EUA. In the first instance, we’ll have to follow the leader with the variances and their timelines.

Vernon Bernardino, Analyst

When you do advance a bivalent COVID vaccine candidate, do you anticipate that the second component will be a variant as part of the strategy as well as the original current protein sequence?

Filip Dubovsky, Chief Medical Officer

Our current concept is just that. We think the antigen space between the original strain and the evolved strains is quite broad, and we want to provide an immunologic solution for all our antigen diversity. The strains emerging in Brazil and South Africa represent the extremes of evolution, and the persistence will likely be as part of the bivalent product.

Vernon Bernardino, Analyst

Could you anticipate the kinds of protection that you may see with your COVID vaccine compared to what you observed with the RSV and NanoFlu vaccine?

Filip Dubovsky, Chief Medical Officer

We formed native confirmation trimers that translate into high levels of neutralizing antibodies. We published a correlation between our neutralizing and IgG response, which was very precise. This evidence gives us confidence that we can induce neutralizing antibodies as we move forward with the bivalent products. Our efficacy data has performed well, and our vaccine is robust against evolving strains.

Gregory Glenn, President of Research and Development

There’s nothing I can add; that’s a good summary.

Vernon Bernardino, Analyst

I certainly look forward to that data because of the academic to, and congratulations on the year-long progress.

Operator, Operator

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.

Stan Erck, President and CEO

Great. Well, you've heard our story. We've had an unbelievable year. We're a significant company of size in many ways and expect to have an even more remarkable 2021. Look forward to telling you about it. Thank you all for joining. That's it.

Operator, Operator

This concludes today's conference call. Thank you for participating, and you may now disconnect.