Novavax, Inc. (NVAX) Q4 2020 Earnings Report, Transcript and Summary

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. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today’s conference is being recorded. [Operator Instructions] I would 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. 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.

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 reflected where we are headed in this coming year. Following that, we’ll take some time for questions. So 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 of them has made for entire year. I'm afraid to say that I don't see a slowdown any time 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. I'd like to start our presentation by recounting for you 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% of effectiveness against the UK variant strain in that same trial. In the South African trial, with 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. With 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. 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 product. In the last year, we have built a global network of manufacturing sites and partners in 10 countries with 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 the 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 now secured over $2 billion of funding from our partners, including the U.S. Government and CEPI and the Bill and Gates - The Bill & Melinda Gates Foundation, and have purchased commitments from 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 the safe and effective vaccine that can be used to help in the worst pandemic in 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 2020 and the beginning of 2021.

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 induction of potent immune responses when formulated together showed that these component 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 know with satisfaction, we've met this goal through multiple manuscripts, a few, what you see here published in prestigious scientific journals, including the New England Journal of Medicine Science and Nature. So moving to Slide 5, our recombinant protein subunit-based vaccine 2373 offers the 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 coal supply chains. Additionally, it's ready to use liquid formulation of both the protein and the adjuvant markedly facilitate 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 varying effect, allowing us to produce more doses of 2373 with less antigen required per dose, while reducing immunity that exceed 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 the adjuvant dose bearing and the immune responses, they were all well in excess of convalescent sera. The data suggests the hallmark of our vaccine is the introduction of high levels of functional immunity and has an excellent safety profile. In addition, this study confirmed the 5-microgram dose for the antigen. I want to note that there are several other immunogenicity trials that have already or will be starting soon in India, the Czech Republic and Japan that will help to extend the global access to our vaccine. For day I'm - for today, I'm going to focus on the results of our efficacy studies. During their conduct, the dramatic evolution, the virus occurred and we are first to demonstrate FC 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 in the face of the 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 UK Vaccines Task Force in the NIHR registry, we were able to rapidly enroll 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% with the B-117 variant strain that appeared during the trial, we observed an 86% vaccine efficacy. This latter strain is growing in the 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 that's trending heavily in this direction. All of 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 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 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 the 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 B1.351 variant was widely circulated during our trial accounting for 93% of sequence cases. Although one-third of the study participants were seropositive baseline, these antibodies did not seem to prevent infection with 131 - 1351 again suggesting that prior COVID-19 infection did not protect against subsequent with the B1.531 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 here reflects the lessons learned from the matrix and adjuvant 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. 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 corona virus prevention network. Briefly the study design is a 2-to-1 randomized trial enrolling over 30,000 subjects. You can see, the primary endpoint is aligned with our previous trials and interim analysis will be done with 72 cases and 144 final events. Finally, we are encouraged to discover 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 elders played a major role in expediting recruitment. If you look at Slide 10, we can complete 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 65 and older. We expect to announce this 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, I 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 placebos the participants initially received while still remained in blinded. This design ensures the integrity of the blinded studies and enable us to continue following participate 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 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 began 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 dialog with respect to regulators as we complete our pivotal Phase 3 clinical trials in the UK and U.S. 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 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 a variant stain in candidates. On Slide 12, you see 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 technical - 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, then we have also made significant strides in addressing the mutations of the 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 the manufacturing processes to evolve our strategy alongside the evolution of the virus. So inclusion on Slide 14, we now have two independent trials demonstrating 2373's high level of efficacies 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 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 PRVENT-19. Ad with that, I'd like to turn it over to John Trizzino.

Thanks, Greg. I would like to bring your attention to Slide 15, now. 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, 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 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 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 Serum Institute provides significant and immediate manufacturing capacity that will provide access to low-and middle-income countries. SK Bio and Takeda licensing partnerships offers additional capacity and access into 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. 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 a 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 BMGF, 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. So as you can see on this slide, we have various agreements that have been executed to date. 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 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. While we spent the majority of our time and attention this year developing are 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 the 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 to be generated earlier this year the plans to bring one or more of these candidates in the 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 be a large commercial opportunity for our platform. And with that I will now hand it over to Greg Covino to provide our financial results.

Thanks, Stan. Hi, everybody. If you could please turn to Slide 18. 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 full-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. 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 January 2021, $500 million ATM. So I would encourage everyone to please take a look at the 10-K. Overall considering our year-end cash position 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 solid financial position as we approach the commercial launch of our COVID-19 vaccine. Back to you, Stan.

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 dialog with global regulatory agencies that we will seek authorization in 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, whose immediate response to the pandemic and continued support help make possible our accomplishments during the year. Only through these combined efforts, 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. [Operator Instructions] And your first question comes from the line of Kelechi Chikere with Jefferies.

Thank you. Good afternoon, and thank you for taking my questions. Congratulations on all the progress and suspects 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 vaccine 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.

Yes. This is Stan. I'll take that. So we have, as we mentioned, so we tend to focus on manufacturing sites that manufacture the antigen, that's probably the most complex part of the manufacturing. 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 finished their engineering runs, they’re making product at commercial scale and the cadence of that production process depends in part on how many runs that they’ve put into their schedule. Those runs depend upon making sure we have enough raw materials for instance to make all those run. So there’s 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 that all of the plants will be at full scale by April. So in April, May, June, we should be finishing, filling and finishing product in advance of regulatory approvals. We are now filling and packaging material both in the United States and from Korea and finishing those in Europe and the U.S. And so we will have material that will be on the shelf when we have approval so for shipment.

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

Yes. This is – thank you. It has turned out that the animal models were quite predictive. So we have very good efficacy in the non-human primates. So that's why we use them. They are not perfect models because they're not really disease models, but they are physiologic and that they require vaccine induced immunity to get to the vehicles and services. So I think it's overall bode quite well. The other animal model, I'd point to non-human primate is the baboons, where we did some initial just sort of safety and immunogenicity studies and they were quite predictive. So we like - also like the mouse models. They all are telling us something. 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 really a remarkable circle. Yes, we always as soon as we have results that are - that we think makes sense to publish, we get out to the peer review. We have a really good receptivity with high journals, so quarter two probably, we'll see. We are going to be always at the back-end call of peer review - reviewers. So – but we have great data, great science and that's not unreasonable to expect we should have data in that timeframe.

Got it. Perfect. Thank you.

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

Good evening. Thanks for taking the questions. I just wanted to get a better sense of where discussions are with FDA in the path to in the EUA for 2373. Does the current guidance for potential submission in 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 secondly, as a follow-up. As it relates to the planned trials with the new variance and bivalent vaccines, I guess with FDA's guidance, I mean, the human immunogenicity would be sufficient for approval there, is the expectation of the trials that you're initiating would they be sufficient for or they be intended for registration? Thanks.

Eric, I'll just make a quick comment and then I'll 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, as you rightly pointed out, a good backup in 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 Filip to talk a little bit about the various strategy.

I guess the other point of our Phase 3 studies is that the endpoints are 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. Onto the variant situation, 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, but more importantly, non-inferior immune responses to the variant versus the original strain. And as a strategy, we plan to follow-up. The studies we have in mind do two things. They look at the variance 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 represent a very broad range of energetic spread and that's where we're going to capture with our vaccines. We know we can do bivalent easily. There is plenty of space in our vaccine for antigen doses that high. You know from our Phase 1 and Phase 2 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 - maybe just - thanks for taking those questions. Maybe just as a quick follow-up, A, up to this point, can you say anything in terms of regionality where you would be conducting the planned trials with the bivalent candidate? Thanks.

So the different regulators have given us slightly different study designs we need to take into account and we haven't finalized exact location, where the studies will be executed.

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

Sure, Eric.

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

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

I think that they both require similar categories of information right 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 a yes that we met our statistical success criteria. So that represents a final analysis. However, we continue to collect cases in a blinded fashion and so we'll analyze. So it's just like you saw with Moderna and Pfizer, another sort of second analysis of the endpoint cases. So we're doing that and I - we expect to finalize, most of that data probably in early April timeframe and then that will shortly - that will thereafter will be submitted to frankly to both regulators. So that's, that's one piece and then the other piece is the package around our CMC. So right now I think those have created intensive efforts and there, we're looking to try to align both those submissions around the same time to get our MHRA package in. They've have been very good partners, lot's of communication. So that's been quite helpful. And similarly will have that kind of dialog 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 U.S. trial and so there could be some hybrid of those two trials, but a very robust package to prevent regulators with respect to safety and efficacy of our vaccine. And well, I think makes as we've mentioned, so really important as we have done this in the context of 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. Second question that I had is regarding the U.S. PREVENT-19 trial, new thing is that you enrolled it very, very quickly, 2-to-1 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 you see slightly slower case rate accrual in that trial, of course not compromising the actual data?

This is Filip. We're all aware of the cases across the U.S. and I think we have a couple of things play in our favor. One of them as you saw the slide with the geographic diversity and that insight in Mexico. So we really did span the United States and additionally with the size in 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. We were able to demonstrate convincing efficacy in a study of only 4,000 individuals in South Africa, here we have 30,000, so the case accrual is going to be a lot faster. We know that variance are emerging in the U.S., on the other hand, we know that this particular vaccine works against this variance, so we have high hopes of having a pretty robust response. What's 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 seeing how the people having two-month 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, we could bring to them from the UK and South Africa.

It's great Filip and Greg. Last question for John and/or 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 in terms of standard operating procedures, et cetera., in terms of clinical conduct, manufacturing and other aspects of your business as you - as you really established company as potential leader?

Well, I'll take the call, because the fun part of my job is bringing in and recruiting 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. We have a technology, which is from the very start is clear that matches the problem and we've had a good day all the way back from the earliest primate data, that was probably better data than anybody else had and so we've got a 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 that is clearly at the top of list of vaccines that were COVID and then you got a pipeline that can build on top of that. So it's actually a good part of my job.

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

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 is yet there, just curious given you start off with a very high neutralizing titers, how should one think about when you go and forward and think about bivalence or even boosters specifically?

Well, there are some details that need to be defined about the assays, but I think what we have going for us is our vaccine is highly immunogenic and so we are and the other piece we have to give us some insights is the animal data seem to be really quite predictive for what we need to know. So 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 your non-inferiority is relatively low bar and given that we can come up with the right measures, I think we should be - we are not terribly concerned that's something we can cross. That does need to be negotiated, the neutralizing assays have been somewhat of a challenge for people to develop, but we're a year into the epidemic and I'm confident we can come up with a way to take a look at the relatively new mix boxes and NI because of relatively low bar as I mentioned. So these don't have to be big trials, actually Peter Marks noted that as well. I think it's a very attractive offer to go the way of flu and allow the strain change mentality to be taken out by a company. So that - how does that boiled down to what we might do. Well we get to do a pivotal trial, 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 to what I said there.

The FDA guidance specifically I mentioned is flexibility to have a discussion with them and these are going to science-based discussions and we have our own ideas that will bring to the table and see vacant concur with them.

And maybe any update you could provide what all this kind of means in terms of development in 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?

Not really, we are, as you know, in the background, we're thinking about how to do Flu is there some work going on right now, we have really announced a trial or what our clinical plans are yet, but we are extremely interested. And as you say, I mean one of the things that we were kind of gratified to see with the variant is that we have this team embedded in our flu data, but only really validated by the immunogenesis that the adjuvant and the nanoparticle have the ability to give a broad - qualitatively broad response. So it made the flu vaccine able to cope quite well with the strain genetic evolution in this case of H3N2. So we're kind of - we're gratified now both to see efficacy with the nanoparticle against RNA virus like we have. That's very high and also this idea that the broad immunity might result in protection against a really major in this case, this is the major and antigenic drift away from neutralize the antibodies and mentioned kind of at the extreme of what might be possible, yet our vaccine seems to be working pretty well against that. So I do think it does validate the technology, the Matrix-M, the importance of the Matrix-M and the science, we had around inducing immune responses to epitopes that might not normally be well seen in natural infection that are brought out by making the nanoparticle vaccine. So good validation, I would say, with our clinical data.

Right. Thank you. And the final question I had was, in terms of supply in the late 2Q timeframe when you are getting close to your filings and any update on what 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, it's a complicated - it's not a complicated questions, but a complicated answer I suppose. It is we plan on being at full production at all of our plans by the May-June timeframe 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'll be shipping - be able to ship roughly 110 million doses to the U.S. Government by July and that's still a 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 UK, assuming that they have the first approval and so we've got various sources for that.

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

I think it can 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 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?

Yes. It's a interesting question, but our ability to license a variant is a strange change and that depends actually on the prototype having with EOA. So I think in the first instance, we're going to have to follow the leader with the variance and be in the timelines that will be established by the prototype vaccine.

And when you do advance a bivalent COVID vaccine candidate, do you anticipate it - the second component will be a variant as part of the strategy and then the original current as protein sequence or what, how should we look at the bivalent - what comprises the bivalent vaccine candidate?

Our current concept is just that. So we think that this - the antigen 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 immunologic solution to all our antigen diversity. So right now the strains that we are seeing in Brazil and South Africa seems to define the extreme where the virus has evolved. So in the persistence, of course bivalent will be that sort of a product.

And then last question I have is, so 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 - antibodies accretive 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 perhaps you also saw with the RSV and NanoFlu vaccine?

So maybe I could take a crack at that and Greg can mop-up. I mean, one thing we know is that we formed native confirmation trimers and that really has translated in the Phase 1 data that we published into high levels of neutralizing antibody, which means you got the confirmation right and the immune response we generated against that correct native confirmation is works, its functional. In that publication, we publish a correlation between our utilization response and our IgG response and it was very, very tight like a Christmas correlation of [indiscernible]. And what that told us is there over the broad range of antibodies we did induce, it was all proportionately same amount 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 and remember, in this case of South Africa, that's the case where previous exposure to wild types of 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 and that's really, we believe a function of the adjuvant we use.

Yes, that's great.

There is nothing really to add. That's it. That's a good…

Mop up.

Nothing to mop up.

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

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. Look forward to telling you about it. Thank you all from for joining. That's it.

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