Novavax - Earnings Call - Q2 2020

Transcript

Operator (participant)

Ladies and gentlemen, thank you for standing by and welcome to the Novavax Second Quarter 2020 Financial Operating Results Conference Call. At this time, all participants are on listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during this session, you'll need to press star one on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star zero. I would now like to hand the conference over to your speaker today, Silvia Taylor. Ma'am, you may begin.

Silvia Taylor (EVP, Chief Corporate Affairs Officer, and Head of Novavax Sweden)

Thank you. Good afternoon, and thank you to everyone who has joined today's call to discuss our Second Quarter 2020 operational highlight 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 will also post the slides from today's call on our website. Joining me today are Stan Erck, President and CEO, Dr. Gregory Glenn, President of Research and Development, and John Trizzino, Executive Vice President, Chief Business Officer, and Chief Financial Officer. Before we begin with prepared remarks, I need to remind you that we will be making forward-looking statements during this teleconference that could include financial, clinical, or commercial projections.

Statements relating to future financial or business performance, conditions for strategy, and other financial and business-related matters, including expectations regarding revenue, operating expenses, cash usage in 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. I'd now like to hand the call over to Stan to continue.

Stan Erck (President and CEO)

Thanks, Silvia. And thanks to everyone joining us this afternoon. The last few months have been historic for Novavax since identifying our vaccine candidate in March. In just four months, we have garnered over $2 billion in funding for its development. We've secured significant manufacturing capacity, signed several research and manufacturing collaborations with organizations around the world, and most importantly, we delivered positive phase I clinical data for the phase I-II trial of Novavax CoV2373, our COVID-19 vaccine, and are poised to quickly move into phase II this month. As we hosted a call last week to detail the 2373 phase I clinical data, we are going to keep today's call short. In terms of an agenda, I'll start with a high-level review of the numerous achievements for our COVID-19 vaccine in the quarter. Greg will then go over the highlights of the phase I data.

I'll come back to provide some additional updates and to provide a quick update on the rest of our pipeline. John will then review the financials for the quarter. We'll then wrap up and take your questions. Let's move to slide three. This slide illustrates the significant progress we have made for 2373. As I just mentioned, we identified 2373 as a candidate back in April. After preclinical testing demonstrated high immunogenicity for 2373 in animal models, our clinical team was then able to start the phase I trial in late May, leading to the data release last week. Simultaneously, we engaged with various global organizations, leading to approximately $2 billion in funding for our vaccine program. We discussed the CEPI funding of $388 million on our last call, and since then, we have also signed a contract with the U.S. Department of Defense for $60 million.

We are thrilled to be selected to participate in Operation Warp Speed, for which the U.S. government has given us $1.6 billion to develop and manufacture our vaccine. Slide four, ensuring global access of 2373, is a key priority for the company, and we have made significant progress since the beginning of the quarter in building a network of established partners. Recently, we initiated important partnerships for the global development and commercialization of 2373. For Japan, we have partnered with Takeda Pharmaceuticals for development, manufacturing, and commercialization. Given Takeda's presence in Japan, we believe they're an ideal partner for us, and they expect an annual capacity of over 250 million doses of our vaccine. We will be entitled to receive payments for development and commercial milestones, as well as a portion of the proceeds from the vaccine.

We also partner with the Serum Institute of India for the development and commercialization of 2373 in low and middle-income countries and India. For those that are not aware, Serum Institute of India is the world's largest vaccine manufacturer in terms of doses delivered, so we are delighted to partner with them to ensure global access in these geographies. We expect Serum Institute of India to support a minimum of $1 billion annually from their facilities starting in January of 2021, and we will split the revenue from the sale of product and net of agreed costs with them. It is important to note that Novavax retains the rights for the major upper-middle and high-income countries. I also want to highlight our acquisition of Praha Vaccines, now Novavax CZ, during the second quarter.

This transaction includes a biologics manufacturing facility and associated assets, including over 150 employees with significant expertise in vaccine manufacturing in the Czech Republic. This facility alone is capable of providing annual capacity of approximately 1 billion doses of antigen starting in 2021. To complement our efforts at Novavax CZ, we signed an agreement with Fujifilm Diosynth Biotechnologies for production in their North Carolina and Texas facilities. In late July, large-scale manufacturing began at North Carolina facility for use in the future pivotal phase III trial, and additionally, we entered into manufacturing arrangements with AGC Biologics and PolyPeptide Group for large-scale production of Novavax's Matrix-M adjuvant in both the U.S. and Europe. Based on our internal manufacturing expertise and the strength of our global partners, we are confident in our ability to produce 2373 on a global scale and ensure widespread access to our vaccine.

Finally, in the second quarter, we were pleased to add David Mott to our board of directors. David is an established leader, board member, and investor, and we're happy to be able to benefit from his expertise. We also made a number of key new hires and promoted several senior people, strengthening our best-in-class management team. I'll now turn the call over to Greg and quickly review the phase I data for 2373 that we reported last week. Greg.

Gregory Glenn (President of Research and Development)

Thanks, Stan. As we gave a detailed review of the data last week, I'm just going to give a high-level overview today. So on slide five, what you can see is that the 2373 is a product of a technology platform that uses the insect cell and Matrix-M adjuvant. So we are able to take a sequence from a virus such as the spike protein sequence from SARS-CoV-2, manufacture this into a nanoparticle that has the full-length protein, and combine this with Matrix-M, which is a potent adjuvant for which we have a great deal of clinical experience. So let's turn to the trial on slide six. This slide shows the study objectives. The phase I trial evaluated the safety and immunogenicity of the Novavax CoV2373, the spike protein recombinant nanoparticle vaccine, with and without Matrix-M adjuvant.

The primary outcomes were reactogenicity, safety, and lab assessments, and the immunoglobulin and IgG anti-spike protein response in humans. Secondly, the secondary outcomes included adverse events, wild-type neutralizing antibodies, and T cell responses. So on slide seven, we've given some detail on the design. It was a randomized, observer-blind, and placebo-controlled trial, and it was designed to evaluate the immunogenicity and safety of the Novavax CoV2373. Our focus is on the trial you can see in the red box. It's on group C and D, where we had two doses of our antigen, either five micrograms and 25 micrograms, with the Matrix-M, and that was given twice at day zero and 21. We compared that to placebo.

We also compared to group B, which did not have the adjuvant, and we compared it to group E, which had the adjuvant with our Matrix-M given once, followed by placebo at day 21. So on slide eight, just overall, we summarize the conclusions here, and again, we provide a great deal of detail about this last week, but we did see. Let's go to the highlights here. The data demonstrated a dose-dependent response. Sorry, dose-independent response. Both dosage levels induced high and comparable levels of IgG, so the trial showed a dose-sparing effect. The IgG levels compared favorably to those seen in convalescent serum that we obtained from the Baylor College of Medicine, and we noted a 100% IgG seroconversion rate. There was an adjuvant required for the optimal immune response, which is quite clear, so demonstration adjuvant effect was an important finding in this trial.

With respect to wild-type neutralizing antibodies, they appeared to be in the two-dose groups numerically superior to what we saw in the convalescent serum overall. Both dosage levels, again, induced high and comparable wild-type neutralizing antibodies. We saw 100% wild-type neutralization seroconversion rates after the second dose, and the neutralization response was tightly correlated with the IgG response. We also looked for T cells in a preliminary way, and we saw that we had polyfunctional CD4 T cells that were induced that favored the Th1 phenotype. Overall, the phase I trial did demonstrate a reassuring safety and reactogenicity profile. We saw no serious adverse events. All unsolicited adverse events were mild or moderate, and the local systemic reactogenicity was not dose-limiting. So let's just talk to the next slide for briefly and look at some of the highlights of the immunogenicity. We covered this previously, but this is the anti-spike IgG ELISA.

You can see that on the Y-axis. It's on the log scale. You can see in the far left are the subjects who represent the human convalescent serum. The next row has the placebos. The next row has the 25-microgram dose given at day zero and 21 without adjuvant, and then the 5-microgram dose given with Matrix-M adjuvant at day zero and 21, 25 micrograms given at day zero and 21, and a 25-microgram dose given once at day 21, followed by a placebo. You can clearly see that the difference between the groups in B were at one and two doses compared to, say, group D, where they had the equivalent antigen dose. You can see the adjuvant effect was profound. You can also see that there was a great benefit in the second dose, achieving very high levels of anti-spike IgG.

You can see some of the details on the right there. We have for group C, with the second dose, we have a 63,160 ELISA unit titer, and that compares to the convalescent serum where the titer on the geometric mean basis was 8,344. So robust responses. The overall geometric mean of this was approximately seven-fold higher than the convalescent serum and a robust response. Going to the next slide, here we show the wild-type neutralization. This is done through collaboration with the University of Maryland School of Medicine, and again, you can see the graph is organized in the same way. Very similar messages: importance of the adjuvant, importance of the second dose, and with reference to convalescent serum, you're seeing again the vaccine group is in excess of the geometric mean of this group from Baylor College of Medicine.

We did discuss fairly extensively in note that there is a tiered response based on the convalescent serum, based on the severity of outcome, and I think our vaccine compares very favorably with the sicker subjects that are in that trial. As we mentioned in the results, this correlation between the IgG and the microneutralization was a very tight correlation. We also saw a strong T cell response. We won't go into that detail again here. That was a preliminary result, and we're going to expand on those results as we go, but it was consistent with what we've seen in our preclinical programs and our previous clinical trials, where we see a robust T cell response, CD4 effector memory cell response, and it's a polyfunctional T cell that has a Th1 phenotype bias.

So overall, if you go to the next slide, of course, we've been very buoyed by this result and just want to show how this does fit into our pipeline. As you know, we are still very committed to our NanoFlu vaccine program, which you can see in the second bar there, where we had very good results. We've got all of our eight coprimary endpoints in March, and we expect to continue that development. So with that, I'm going to turn this back over to Stan.

Stan Erck (President and CEO)

Thanks, Greg. So we're now at slide 11. At the end of the first quarter, we announced successful pivotal phase III results, as Greg just said, on NanoFlu, and during the quarter, we added important immunogenicity data demonstrating the development of robust T cell mediated responses. We believe these data will further differentiate NanoFlu from the leading licensed vaccines. The combination of these results will form the basis for future BLA submission using the FDA's accelerated approval pathway. As part of this effort, we are currently exploring pathways to manufacture product for a required lot consistency clinical trial. Phase II data from the program have been posted to the online preprint server medRxiv, and phase III data have been submitted to the server as well. It should be up this week, with both submitted for peer review and publication in leading journals. And finally, a quick update on our ResVax vaccine.

Our phase III results of ResVax in pregnant women assessing the impact of vaccination on infants were published in the New England Journal of Medicine at the end of July. We still believe that we can design an efficient pathway to a licensed product over the coming years, and with that, I'll have John provide the financial results.

John Trizzino (EVP, Chief Business Officer, and CFO)

Thank you, Stan. Today, we announced the financial results for the second quarter and first six months of 2020. I'll focus my comments on the quarterly results. So now we're on slide 12, and for the second quarter, we reported a net loss of $17.5 million, or $0.30 per share, compared to a net loss of $39.6 million, or $1.69 per share in the second quarter of 2019. The reduction in net loss is mainly due to increased revenue under the CEPI agreement, partially offset by increased R&D and SG&A expenses. Revenue in the quarter increased $35.5 million from $3.4 million for the same period in 2019. As I just noted, the increase was primarily due to the CEPI agreement. R&D expenses increased 15% to $34.8 million in the second quarter of 2020, compared to $30.4 million in the same period for 2019.

This increase was primarily due to increased development activities for 2373 under the CEPI agreement, partially offset by lower employee-related and other costs and development activities of ResVax. G&A expenses increased 84% to $17.7 million in the second quarter of 2020, as compared to $9.6 million for the same period in 2019. The increase was primarily due to increased professional fees related to the Novavax CZ acquisition and supporting our 2373 program and increased employee-related expenses. As of June 30th, 2020, Novavax had $609.5 million in cash and cash equivalents, marketable securities, and restricted cash. Net cash provided by operations for the first six months of 2020 was $92.5 million, compared to net cash used in operation activities of $80.6 million for the same period in 2019. During this quarter, we further strengthened our balance sheet.

We completed a private placement with RA Capital of a Series A convertible preferred stock for gross proceeds of $200 million and raised $206 million in net proceeds through our ATM offerings. For the six months ending June 30th, our total amount raised is $593 million, and in addition, we secured $2 billion of non-dilutive funding to support COVID vaccine development activities. That concludes my financial review, and now I'll turn the call back to Stan.

Stan Erck (President and CEO)

Thanks, John. So even with all the significant progress so far in 2020, we still have work to do and major milestones ahead in the remainder of the year. Now on slide 13, for our coronavirus program, as I said last week, pending FDA okay, we plan to proceed into a trial of approximately 1,500 people in the U.S. and Australia, which will expand what we've done in the initial part of this trial and extend these results into the older adult population. In parallel, we are making plans for global trials to demonstrate efficacy. Our goal is to initiate our first efficacy trial in September and conduct efficacy trials in multiple countries. We will keep everyone updated as appropriate. As you all know, the space is evolving extremely quickly, and we are moving forward in parallel on multiple fronts.

In the coming weeks, we will continue to update you on manufacturing, supply, and collaboration agreements that we are currently working through. Before I open the call for questions, I would just like to add that to thank all the dedicated employees at Novavax for their huge and tireless efforts since the beginning of the pandemic. Without them, none of this progress would be possible. And with that, I'll turn it back over to the operator for Q&A. Operator.

Operator (participant)

Thank you. As a reminder, to ask a question, you'll need to press star one on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Once again, that is star one if you would like to ask a question. Our first question comes from Eric Joseph from J.P. Morgan. Your line is now open.

Eric Joseph (Executive Director)

Yep. So can you hear me? Thanks for taking the question.

Operator (participant)

Yeah, we can, Eric.

Eric Joseph (Executive Director)

Great. Great, great, great. So I guess in thinking about the upcoming phase II study, can you talk about whether there would be any opportunities in that trial for looking at vaccine efficacy? I know that it would be unblinded and non-randomized, but is there any other endpoints being assessed? Well, I guess would follow up in the phase II allow for any read-on protection? And as you are also thinking about expanding eligibility to include the older adult population, can you just talk about numbers there and whether that's included in the 1,500 patients that you're anticipating and designed so far?

Gregory Glenn (President of Research and Development)

Hey, Eric. This is Greg. I'm going to introduce you to Filip Dubovsky, our new Chief Medical Officer who's here, and I'll let him give you a chance to talk to him. And I think over the next six months, you and he will have lots of conversations.

Filip Dubovsky (Senior VP and Chief Medical Officer)

All right. So the study is actually a randomized study, and half of those subjects will be older than 65 years of age, and the other half less than 65. We are looking at efficacy in this study, but with the size of the study, we're unlikely to get a very robust answer to that question.

Eric Joseph (Executive Director)

Got it. And okay. And just in terms of patient numbers on an older adult population over 65?

Filip Dubovsky (Senior VP and Chief Medical Officer)

Yeah. So half of the study. So 750 above.

Eric Joseph (Executive Director)

Sorry. Excuse me. Got it. Thank you. And then on the manufacturing side, I guess looking across the relationships you have now with Emergent, Fuji Diosynth, can you just talk about where your capacity is now in terms of annual doses and to what extent there are still sort of gaps to fill with additional CDMO relationships to get to your target in the U.S., 100 million doses with OWS, and then expanding from there?

Stan Erck (President and CEO)

There's inside the U.S. and outside, and so it's just a lot happening in real time, Eric, and we'll have some announcements in the fairly near future, being weeks, that will better articulate what the global capacity will be, including that in the United States. As you point out, in the U.S., the capacity is coming primarily from two right now, from the two Fuji sites, and our expectation is for U.S. only that we will be able to supply at least U.S. needs, which we project could be as high as five to 600 million doses in a year, and we'll look to expand that further. Outside the U.S., we've already started. The Prague facility is getting ready to complete the reconstruction process or the remodeling process.

It's been going on for three years, and we expect engineering runs to start within the next several weeks and then GMP production at large scale at the beginning of the year, and we'll announce some of the other places, as I say, in the coming week, very shortly. We expect to have well over a couple billion units of capacity on an annual basis soon.

Eric Joseph (Executive Director)

Got it. Great. Thanks for taking the questions and congrats on the progress.

Operator (participant)

Thank you. Our next question comes from Charles Duncan from Cantor. Your line is now open.

Charles Duncan (Managing Director)

Thanks for taking the questions, Stan and team. Congrats on a really interesting year thus far. I had a couple of questions on the COVID vaccine and then maybe even one on the broader pipeline. First of all, going back to the phase II study that you mentioned, including some older adults, thinking a little bit about immunosenescence and the activity of NanoFlu, I'm wondering what particular metrics do you think will be most interesting to take a look at and to see whether or not 2373 will work in the older adult population?

Filip Dubovsky (Senior VP and Chief Medical Officer)

This is Filip again. The study we're planning, we'll look at two dosage levels on the options that immunogenicity may play a vital role here, but we do have data from the previous work that suggests that the 5-microgram dosage level will likely be the one we end up with. We're looking at the same things we looked at in the first study. We're looking at IgG responses and microneutralization responses. Based on that, I will take the data to the FDA for final concurrence with our plans.

Charles Duncan (Managing Director)

And when you think about the activity of the adjuvant in the NanoFlu program, would you anticipate similar activity that you've seen in the recent phase I? It would seem to me that it would be the case, but you tell me.

Gregory Glenn (President of Research and Development)

Yeah. I mean, this kind of predates Filip, so I'll jump in and say I think that the adjuvant is, in some ways, the perfect match for immune senescence. So inducing T helper responses, especially polyfunctional CD4 effector memory cells, is what we saw in older adults. That's really what's needed to establish high antibody affinity and durability responses in older adults. So it is the kind of where flu vaccines are going for sure, older adults looking for adjuvant to sort of repair immune senescence. And we saw that.

And somewhat to my surprise, I was rather staggered by the fact that there were so little antigen-specific T cells in the placebo and the day zero T cells, and then afterwards how good the T cell response in addition to having, it's harder to show a huge antibody response with flu because there's a lot of previous immunity, but that was a distinctive, and we're seeing it here, that we have a good T cell response. So I'm expecting this to be really a good match for immune senescence and probably not, if any, a detriment in the antibody response we'll see. And that's part of why we're studying it. We don't want to miss some critical gap in immunogenicity by going down the dose. But it appears to us where we are today with younger adults, we're at the peak of immune response.

So given the formulation, the dose, it's probably not going to be likely that we'll be able to push that up by using the higher dose. But that'll expand our safety population very nicely. At the same time, make sure we have no gaps in our dosing strategy.

Charles Duncan (Managing Director)

Yeah. And it's helpful additional color, Greg. If I could just ask you to pull out your crystal ball, and I know you'll be kind of speculating here, but when you think about the competitive environment in terms of the phase III and clinical study participation or participant enrollment, what do you think you can do to facilitate interest in your program besides already having demonstrated pretty interesting data?

Gregory Glenn (President of Research and Development)

I think that you can see in the last few months, the people that are funding are big believers in the technology, so all that funding initially was done based on preclinical work and the past experience of the platform, so it's just our view that our immune response is very, very good, and it seems like the best. There's some issues around apples-to-apples comparison, but it does seem like our T cell and microneutralization responses really look robust in what you would want to go into with an efficacy study, so we're hoping that our efficacy would be high. I think our partners through CEPI, the Gates Foundation, and OWS all have that same perception, and so we're going to be laser-focused. That's why Filip is here on getting our studies started and to demonstrate efficacy, so that's really we're optimistic.

My crystal ball says optimism, but we have to be focused on execution. So it looks like our data from the functional standpoint is very good.

Charles Duncan (Managing Director)

And in Japan, does the collaboration with Takeda enable a local clinical study there or would that PMDA interaction kind of dovetail on the other phase III results? And then I'll hop back in the queue.

Gregory Glenn (President of Research and Development)

That's the detail we haven't really disclosed yet. Look, everybody's going to be watching the global trials and those results and paying attention to that. And so we can't, at this point, don't know how relevant it will be to actual licensure in the specific countries we're working with, but I think we'll have more to say about that in the near future as we start up our next set of trials. Right now, we provided our data to the FDA. We're waiting for them to come back, and that will be important for us to start the phase II trial in the U.S. and Australia.

Charles Duncan (Managing Director)

Thanks for taking my questions.

Gregory Glenn (President of Research and Development)

Thanks for your interest.

Operator (participant)

And thank you. And again, ladies and gentlemen, if you have a question, that is star one. Again, if you'd like to ask a question, that is star one. And our next question comes from Mayank Mamtani. Your line is now open.

Mayank Mamtani (Senior Managing Director and Group Head of Healthcare)

Good afternoon. Thanks for taking our questions, and many congrats again on all the recent progress. And welcome aboard, Filip. Look forward to interacting in future calls. The first question can go to either Greg or Filip. On this NanoFlu publication coming out this week, could you please comment on the specificity on the T cell data and also the safety profile, specifically in the context of muscle and the myalgia and the arthralgia rate that we saw? Could you just maybe comment on that qualitatively or quantitatively?

Gregory Glenn (President of Research and Development)

Yeah. So first of all, we have really covered everything that we saw and reported in the paper in the last week. So, there's going to be. You probably have taken a look. There's really close concordance in the details on what we showed in that paper and what we've reported. So that being said, the T cell response looked to us like it was quite good. We tried to match up the reporting axes, if you will, with what had been reported in terms of % of CD4-positive T cells. And we then have a somewhat limited set of data. We needed to get something done, some subset done in order to file our data with the FDA. So there's really only four subjects, 16 total, four per group, and we'll expand that information going forward.

But it's super consistent with what we've seen in our previous trials and our preclinical arena. So we felt very comfortable sharing that information. And the fact is we're seeing this polyfunctional CD4 cells, which we think is kind of our functional target, and a Th1 phenotype, which is helpful to the FDA as they assess the potential safety of these vaccines. So turning back to the safety profile, I just think overall we feel like it's really a good one. If you look at, for example, the graph we provided on the local symptoms, the vast majority of subjects have a gray bar or no bar. There's some that have a blue bar. So the gray being mild and the symptoms were collected. Where it's blank, they were collected and they said no. So really, I think a pretty good, very good-looking profile there for local reactogenicity.

There is a little bit of local pain and local tenderness, and that's going to be the norm, I think, with any vaccine, but I think it's relatively modest. We have a smattering of symptoms. I like to think of what you're seeing there as the sort of things you'd associate with generating a robust immune response. So again, vaccination one, very quiet. Vaccination two, a little more smattering of noise. No particular pattern with severe outcomes that is of any concern. And maybe, of course, it's placebo-controlled. So maybe a little more fatigue, a little more muscle myalgia, and some headaches. But again, I just say that would be consistent with many vaccines we see today. We feel like this is a profile that will be acceptable for use. And maybe a hint that the 5-microgram is a little better than the 25-microgram.

But I wouldn't make too much of that. We feel like this is an acceptable safety profile. And notably, one of the difficult things you have if you're vaccinating in the context of a pandemic, if you're inducing fevers in your vaccine, that's problematic. That creates some management issues, and we see no fevers. In the first dose, there's one very low-grade fever we recorded, which I tell people that that means the thermometer was on and working. But really, I think a very good safety profile overall.

Mayank Mamtani (Senior Managing Director and Group Head of Healthcare)

That's great. So maybe a quick follow-up to that. Has that data now been looked at by the FDA? And any guidance given the impressive immunogenicity and also the safety profile that you just described? Any feedback to your next steps here from the FDA yet, or is that still stable?

Gregory Glenn (President of Research and Development)

That's good. That's glad you asked. So good point. We did file this with the FDA as soon as we had it ready to go, and they're reviewing the data, reviewing our plans and a number of questions. And they will be the ones to agree that we'll need their agreement that the profile is suitable for moving on into development. So we have not heard from them, but we expect to because we're going to start the phase III. We expect to start the phase III trial in the not-too-distant future. We found them to be super responsive and efficient and, frankly, constructive. So I'm not anticipating some large issue here, but they always have some questions and clarifications, but I don't expect anything should impede our going forward. But it is, of course, important and not assume that they are going to give us their blessing.

So we'll be expecting it shortly.

Mayank Mamtani (Senior Managing Director and Group Head of Healthcare)

If I can sneak in one more for John. John, communication cadence regarding some of these stockpiling or distribution arrangements, how and when can we learn more of the granularity around financial terms? Is that really around the different governments allocating budget and then the downstream effect of what could flow as part of some of these country-specific arrangements? Could you just comment on that, John?

John Trizzino (EVP, Chief Business Officer, and CFO)

Yeah. If I think I'm hearing your question the right way, how are we going to be allocating doses produced? And I think Stan made reference to before that we're going to be coming out with a much more kind of robust global supply plan in the coming weeks that'll make that much more clear to everyone. Right now, we're kind of building the capacity out in a pretty significant and dramatic way with not only the funding support but also other partnering arrangements. I think we're seeing, especially since the release of our data, significant demand for advanced purchase agreements, and we have to balance the growing supply against that demand and make sure we're doing that with kind of a global access and global allocation in mind. So we're being very thoughtful about how we build supply.

We're being very thoughtful and diligent about how we're making a determination around where those doses will be provided under these various agreements, so Mayank, stay tuned. There's more to come, and we're learning something new every day about what's happening as each country is making their decisions about how to stockpile product, and keeping in mind all of the work that we're doing with CEPI from a global allocation standpoint, more to come if that answers your question?

Mayank Mamtani (Senior Managing Director and Group Head of Healthcare)

Any color you could give on pricing, or is it too early? Because really, the economic terms and some of these arrangements is what is missing, right? So I'm just curious.

John Trizzino (EVP, Chief Business Officer, and CFO)

I can't give you any more color other than what we've said before, and that is it's going to be fair pricing. I think there's more work that has to be done and talking with our partners about what that strategy looks like. So again, Mayank, stay tuned. It's an evolving process.

Mayank Mamtani (Senior Managing Director and Group Head of Healthcare)

I appreciate you taking my questions and look forward to the updates. Thank you.

John Trizzino (EVP, Chief Business Officer, and CFO)

Of course. You're welcome.

Operator (participant)

Thank you, and I am showing no further questions. I would now like to turn the call back over to Mr. Erck for further comments.

Stan Erck (President and CEO)

Yeah. Thanks, everybody. It's been nothing less than an exciting quarter for the second quarter, and we're expecting the future to look not much different than what the last quarter has been. So we're focused. We're working hard. We need to get the vaccine, not only clinical data for the vaccine, but we need to make lots of it. And that's what the government is focused on. So you'll hear from us. Thank you.

Operator (participant)

Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.