Categories Earnings Call Transcripts, Health Care

Novavax Inc. (NVAX) Q2 2020 Earnings Call Transcript

NVAX Earnings Call - Final Transcript

Novavax Inc  (NASDAQ: NVAX) Q2 2020 earnings call dated Aug. 10, 2020

Corporate Participants:

Silvia Taylor — Senior Vice President, Investor Relations and Corporate Affairs

Stanley C. Erck — President and Chief Executive Officer

Gregory M. Glenn — President, Research and Development

John J. Trizzino — Executive Vice President, Chief Business Officer and Chief Financial Officer

Filip Dubovsky — Senior Vice President, Chief Medical Officer

Analysts:

Eric Joseph — JP Morgan — Analyst

Charles Duncan — Cantor Fitzgerald — Analyst

Mayank Mamtani — B. Riley FBR — Analyst

Presentation:

Operator

Ladies and gentlemen, thank you for standing by. And welcome to the Novavax Second Quarter 2020 Financial Operating Results Conference Call. [Operator Instructions] 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, Silvia Taylor. Ma’am, you may begin.

Silvia Taylor — Senior Vice President, Investor Relations and Corporate Affairs

Thank you. Good afternoon, and thank you to everyone who has joined today’s call to discuss our second quarter 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 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 projection. Statements relating to future financial or business performance, conditions or strategy and other financial and business-related matters, including expectations regarding revenue, operating expenses, cash usage 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 would now like to hand the call over to Stan to begin [Technical Issues].

Stanley C. Erck — President and Chief Executive Officer

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 1 clinical data for the Phase 1/2 trial of Novavax CoV2373, our COVID-19 vaccine and are poised to quickly move into Phase 2 this month.

As we hosted a call last week to detail the NVX-CoV2373 Phase 1 clinical data, we’re 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 1 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 will then wrap up and take your questions.

Let’s move to Slide 3. This slide illustrates the significant progress we have made for NVX-CoV2373. As I just mentioned, we identified NVX-CoV2373 as a candidate back in April. After preclinical testing, demonstrated high immunogenicity for NVX-CoV2373 in animal models, our clinical team was then able to start the Phase 1 trial late May, leading to the data released 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 US Department of Defense for $60 million. And we are thrilled to be selected to participate in Operation Warp Speed for which the US government has given us $1.6 billion to develop and manufacture a vaccine.

Slide 4, ensuring global excess of NVX-CoV2373 is a key priority for the Company and we have made significant progress since the beginning of the quarter and building the network of established partners. Recently, we initiated important partnerships for the global development and commercialization of NVX-CoV2373. For Japan, we’ve partnered with Takeda Pharmaceuticals for development, manufacturing and commercialization. Given Takeda’s presence in Japan, we believe they are 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 partnered with the Serum Institute of India for the development and commercialization of NVX-CoV2373 in low-and middle-income countries and India. For those that are not aware, Serum, 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 to support a minimum of 1 billion doses annually from their facilities starting in January of 2021, and we will split the revenue from the sale of product, net of agreed cost 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 the North Carolina and Texas facilities.

In late July, large scale manufacturing began at North Carolina facility for use in the future pivotal Phase 3 trial. And additionally, we entered into manufacturing arrangements with AGC Biologics, a polypeptide group for large-scale production of Novavax’s Matrix-M adjuvant in both US and Europe. Based on our internal manufacturing expertise and the strength of our global partners, we are confident in our ability to produce NVX-CoV2373 on a global scale and ensure widespread access to our vaccine.

Finally, in the second quarter, we were pleased to add Dave Mott to our Board of Directors. Dave 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 to quickly review the Phase 1 — who’ll quickly review the Phase 1 data for NVX-CoV2373 that we reported last week. Greg?

Gregory M. Glenn — President, 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 5, what you could see is that the NVX-CoV2373 is a product of 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 as the full-length protein and combine this with Matrix-M, which is a potent adjuvant, which — for which we have a great deal of clinical experience.

So, let’s turn to the trial on Slide 6. This slide shows the study objectives. The Phase 1 trial evaluated the safety and immunogenicity of the NVX-CoV2373, the spike protein with nanoparticle vaccine with or 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, secondary outcomes included adverse events, wild-type neutralizing antibodies and T-cell responses.

So on Slide 7, we give some detail on the design. It was a randomized observer blinded placebo-controlled trial and it was designed to evaluate the reactogenicity and safety of the NVX-CoV2373. Our focus is on the trial. You can see in the red box, so in Group C and D where we have two doses of our antigen either 5 micrograms and 25 micrograms with the Matrix-M and that was given twice a day 0 to day 21. We compare that to placebo. We also compared to Group B, which did not have the adjuvant and we compared to Group E, which had the adjuvant with our Matrix-M given once followed by placebo at day 21.

So on Slide 8. Just overall, we summarize the conclusions here and again, we provided 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 — I’m sorry, dose independent response, both dosage levels induced high and comparable levels of IgG. So, the trial showed a dose varying effect. The IgG levels compared favorably to those seen in Convalescent Serum that we obtained from the Baylor College of Medicine and we’ve noticed a 100% IgG seroconversion rate. There was an adjuvant required for the UPR [Phonetic] immune response, which was quite clear, so demonstration adjuvant effect was an important finding in this trial.

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With respect to wild-type neutralizing antibodies, they appear to be in the two dose groups numerically superior to what we saw in the Convalescent Serum overall. Both dosage levels again induced a high comparable wild-type hyper neutralizing antibodies. We saw 100% wild-type neutralization and seroconversion rates after the second dose and the neutralization response was tightly correlated with the IgG response. We also looked for T-cells in the preliminary way and we saw that we had polyfunctional CD4 T cells were induced at favor of the Th1 phenotype.

Overall, the Phase 1 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 briefly and look at the 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 is over the log scale. You can see in the far left are the subjects who represent the human convalescent sera and the next row has the placebos. The next row has the 25-microgram dose given at day 0 to day 21 without adjuvant. And then the 5-microgram dose given with Matrix-M adjuvant at day 0 to day 21. 25-micrograms given at day 0 to day 21, and the 25-microgram dose given once a day 21 followed by a placebo. And you can clearly see the difference between the groups in B, were at one and the 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 far on the right there, we have a four Group C, with the second dose, we have a 63,160 ELISA unit titer and that compares to the convalescent sera or the titer or the geometric mean basis was 8,344. So, robust responses, they — overall geometric mean of this is approximately seven-fold higher than the convalescent sera and a robust response.

Going to the next slide. Here we show the wild-type neutralization. This is done through collaboration with 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 sera, 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 a note that there is a tiered response based on in the convalescent sera based on the severity of outcome. And I think our vaccine compares very favorably with the thicker subjects that are in that trial. So, as we mentioned in the results, this correlation between the IgG and [indecipherable] was a very tight correlation.

We also saw 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, in our previous clinical trials where we see a robust T-cell response, CD4 effective memory cell response and it’s a polyfunctional T-cell that has a Th1 phenotype virus.

So overall, if you go to the next slide, we’re of course, we’ve been very buoyed by this result. And just wanted to show how this does fit into our pipelines. You know, we are still very committed to our NanoFlu vaccine program, which you’ve seen in the second bar here, where we had very good results, and over eight co-primary endpoints in March and we expect to continue that development.

So, with that, I’m going to turn this back over to Stan.

Stanley C. Erck — President and Chief Executive Officer

Thanks, Greg. So, we’re now on Slide 11. At the end of the first quarter, we announced successful pivotal Phase 3 results, as Greg just said on the NanoFlu and during the quarter, we added important immunogenicity data, demonstrated the development of robust T cell-mediated responses. We believe these data will further differentiate NanoFlu from leading licensed vaccines. A combination of these results will form the basis for a future BLA submission using the FDA’s accelerated approval pathway.

As part of this effort, we are currently exploring pathways to manufacture product for required lot consistency clinical trial. Phase 2 data from the program have been posted to the online pre-print server mid-archive and Phase 3 data have been submitted to the server as well. It should be up this week with both submitted for peer-reviewed and publication in leading journals.

And finally a quick update on our ResVax vaccine, our Phase 3 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 J. Trizzino — Executive Vice President, Chief Business Officer and Chief Financial Officer

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 are 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 NVX-CoV2373 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 NVX-CoV2373 program and increased employee-related expenses.

As of June 30, 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 I will turn the call back to Stan.

Stanley C. Erck — President and Chief Executive Officer

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 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 US 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?

Questions and Answers:

Operator

Thank you. [Operator Instructions] And our first question comes from Eric Joseph from JP Morgan. Your line is now open.

Eric Joseph — JP Morgan — Analyst

Can you hear me? Thanks for taking the question.

Stanley C. Erck — President and Chief Executive Officer

Yeah, we can Eric.

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Eric Joseph — JP Morgan — Analyst

Great. So, I’ve just been thinking about the upcoming Phase 2 study. Can you talk about whether there are — whether there’ll 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 — are there any endpoints being assessed?

Well, I guess would follow up in the Phase 2 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 in the design so far?

Gregory M. Glenn — President, Research and Development

Hey, Eric, this is Greg. I would introduce you to Filip Dubovsky, our new Chief Medical Officer who is here, and I’ll let — give you a chance to talk to him and I think over the next six months, you and him will have lots of conversations.

Filip Dubovsky — Senior Vice President, Chief Medical Officer

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 — JP Morgan — Analyst

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

Filip Dubovsky — Senior Vice President, Chief Medical Officer

Yes, so half of that — half of the study, so somewhere around…

Eric Joseph — JP Morgan — Analyst

Sorry, excuse me. Got it. Thank you. And then on the manufacturing side, I guess looking across the relationships you have now with merging 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 CMO relationships to get to your target in the US, 100 million doses with OWS and then expanding from there.

Stanley C. Erck — President and Chief Executive Officer

So, there’s inside the US and outside. And so, it’s just a lots 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 pointed out in the US, the capacity is coming primarily from two, right now, from the two Fuji sites and our expectation is, this is for US only that we will be able to supply at least the US needs, which we project could be as high as 500 million to 600 million doses in a year. And we will look to extend that further.

Outside the US, we’ve already — we’ve started, the product facility is getting ready to complete, the reconstruction process, the remodeling process has been going on for three years and we expect engineering runs to start within the next several weeks and then GMP production in large scale at the beginning of the year and we’ll announce some of the other places. As I said in the coming weeks — very shortly. So we expect to have well over a couple billion units of capacity on an annual basis, so.

Eric Joseph — JP Morgan — Analyst

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

Operator

And thank you. And our next question comes from Charles Duncan from Cantor. Your line is now open.

Charles Duncan — Cantor Fitzgerald — Analyst

Thanks for taking the question, Stan and team. Congrats on a really interesting year thus far. I had a couple of questions on the COVID vaccine and then — and then maybe even one on the broader pipeline. First of all, going back to the Phase 2 study that you’ve 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 take a look at and to see whether or not NVX-CoV2373 will work in the older adult population?

Filip Dubovsky — Senior Vice President, Chief Medical Officer

So, this is Filip again. So this — the study we’re planning, we look at two dosage levels on the option that immunosenescence may play a vital role here, but we do have data from the previous work that suggest that the 5-microgram dosage level will likely be the one we end up with. We are looking at the same things we looked at in the first study. We are looking at IgG responses and Matrix responses. And based on that, we’ll pivot data to the FDA for final concurrent with our plans.

Charles Duncan — Cantor Fitzgerald — Analyst

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 1? It would seem to me that it would be the case, but you tell me.

Gregory M. Glenn — President, Research and Development

Yeah, I mean this kind of pre-dates Filip, so I’ll jump in and say, you know, I think that the adjuvant is in some ways the perfect match for immunosenescence. So inducing key health 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 of responses in older adults. So, it is you know the kind of where flu vaccines are going for sure, both results looking for adjuvant to sort of repair immunosenescence.

So we saw that, we — somewhat to my surprise, I was rather staggering — staggered by the fact that there were so little antigen-specific T-cells in the placebo on the day 0 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 in a T-cell response.

So, I’m expecting this to be really a good match for immunosenescence and probably not if any a decrement in the antibody response, we will 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 with the dose, but it appears to us where we are today with the younger adults who were at the peak of immune response. So, given the formulation of dose is probably not going to be likely that we’ll push that up by using a higher dose. But that will expand our safety population very nicely. At the same time, make sure we have no gaps in our dosing strategy.

Charles Duncan — Cantor Fitzgerald — Analyst

Yeah. It’s helpful additional color, Greg. If I could just ask you, 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 3 and clinical study participation or participant enrollment. What do you think you can do to facilitate interest in your program besides demonstrating already having demonstrated pretty, pretty interesting data?

Gregory M. Glenn — President, Research and Development

Well, I think you know, I think that you can see in the last few months the people that are funding are big believers in 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 is some issues around apples to apples comparison. But it does seem like our T-cell and micro immune responses really look robust and 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, 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 because that’s really — we are optimistic. My crystal ball says optimism and — but we have to be focused on execution. So it looks like our data from the functional standpoint is very good.

Charles Duncan — Cantor Fitzgerald — Analyst

And in Japan, does the collaboration with Takeda enable a local clinical study there and/or would that PMDA interaction kind of dovetail on the other Phase 3 results? And then I’ll hop back in the queue.

Gregory M. Glenn — President, Research and Development

That’s the detail we haven’t really disclosed yet. Look, everybody is going to be watching the global trials and those results, and paying attention to that. And so we can’t or at this point don’t know how relevant 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 things start to start up these 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 2 trial in the US and Australia.

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Charles Duncan — Cantor Fitzgerald — Analyst

Thanks for taking my questions.

Gregory M. Glenn — President, Research and Development

Thanks for your interest.

Operator

And thank you. [Operator Instructions] And our next question comes from Mayank Mamtani. Your line is now open.

Mayank Mamtani — B. Riley FBR — Analyst

Good afternoon. Thanks for taking my 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 — in the myalgia and arthralgia rate that we saw. Could you just maybe comment on that qualitatively or quantitatively?

Gregory M. Glenn — President, Research and Development

Yeah, so first of all, we have really covered everything that we saw in — and reported it in the paper in — last week, so there is going to be, you probably had taken a look. There is really close concordance of the details on what we showed in that paper and what we’ve reported. So that’s a — that being said, the T-cell response look to us like it was quite good. We try to match up the reporting axis if you will, with what has been reported in terms of percent of CD4 positive T-cells, and we then have somewhat a 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 will expand that information going forward. But it’s super consistent with what we’ve seen in our previous trials, in 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 you know, turning back to the safety profile, I just think overall, we feel like it’s really a good one. If you look at the — for example, the graph we provided on the local symptoms. The vast majority of subjects have a gray bar or no bar. There is some that have a blue bar. So the gray being mild and the symptoms were collected were 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 scenario of symptoms. I’d like to think of what you’re seeing there as a sort of things you’d associate with generated robust immune response. So again, vaccination one, very quiet, vaccination two, a little more smattering of noise, no particular pattern with severe outcomes of any concern and maybe of course, it’s placebo-controlled. So maybe a little more fatigue, little more muscle myalgia and some headaches. But again, I’ll just say that would be consistent with most of the, many vaccines we see today and we feel like this is a profile that will be, will be acceptable for use.

And you know maybe I hint that the 5-microgram is a little better than the 25-microgram. So, but I wouldn’t make too much of that. So we feel like this is acceptable safety profile and notably, one of the difficult things you have with your vaccine in the context of a pandemic, you are reducing fever in your vaccine, that’s problematic, that creates a management issues and we see no fevers, there is one in the first dose. There is one very low grade fever we recorded, which I can tell people that that means the thermometer was on and working so. But really I think a very good safety profile overall.

Mayank Mamtani — B. Riley FBR — Analyst

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 your safety profile that you just described, any feedback to your next steps here from the FDA yet or is that still — is that [Speech Overlap]

Gregory M. Glenn — President, 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, be ready to go and they are reviewing the data, reviewing our plans and a number of questions. And this will be — they will be the ones to agree that with — we will 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 — we expect to start the Phase 3 [Phonetic] 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 that, but they always have some questions and clarification. So I don’t expect anything should impede our — going forward. But it is of course, important and not assume that they are — they are going to give us their blessing. So, we hope — we expect to hear shortly.

Mayank Mamtani — B. Riley FBR — Analyst

And if I can sneak in one more for John. John, communication cadence regarding some of these stockpiling or distribution arrangement. 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 countries specific arrangements. Could you just comment on that, John?

John J. Trizzino — Executive Vice President, Chief Business Officer and Chief Financial Officer

Yeah. If I think I’m hearing your question the right way you’re, 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 will make that — make that much more clear to everyone. Right now, we’re kind of building you know 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 — against that demand to 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 are making a determination around where those doses will be provided under these various agreements.

So Mayank, stay tuned, there is 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. So more to come, if that answers your question.

Mayank Mamtani — B. Riley FBR — Analyst

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

John J. Trizzino — Executive Vice President, Chief Business Officer and Chief Financial Officer

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 is 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 — B. Riley FBR — Analyst

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

John J. Trizzino — Executive Vice President, Chief Business Officer and Chief Financial Officer

Of course. You’re welcome.

Operator

Thank you. And I’m showing no further questions. I would now like to turn the call back over to Mr. Erck for further comments.

Stanley C. Erck — President and Chief Executive Officer

Yeah, thanks, everybody. It’s been a 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 company is focused on. So you will hear from us. Thank you.

Operator

[Operator Closing Remarks]

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