Novavax Inc (NVAX) 2020 Q2 法說會逐字稿

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  • Operator

  • Ladies and gentlemen, thank you for standing by, and welcome to the Novavax Second Quarter 2020 Financial Operating Results Conference Call.

  • (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 - SVP of IR & 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 projections.

  • 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 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.

  • I would now like to hand the call over to Stan to begin.

  • Stanley Charles Erck - President, CEO & Director

  • 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 4 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 NVX-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 3. 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 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 U.S. Department of Defense for $60 million.

  • And 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 4. 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 partnered 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 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 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 biologic 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, a 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 at 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 I -- who will quickly review the Phase I data for 2373 that we reported last week.

  • Greg?

  • Gregory M. Glenn - President of Research & 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 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 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 I trial evaluated the safety and immunogenicity of the NVX-CoV2373, the spike protein recombinant nanoparticle vaccine, with or without Matrix-M adjuvant.

  • The primary outcomes were reactogenicity, safety and lab assessments and the immunoglobulin 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 7, we give some details on the design.

  • It was a randomized, observer-blinded, placebo-controlled trial, and it was designed to evaluate the immunogenicity and safety of the NVX-CoV2373.

  • Our focuses on the trial, you can see in the red box.

  • So in groups C and D, where we had 2 doses of our antigen, either 5 micrograms and 25 micrograms with the Matrix-M, and that was given twice, at day 0 and 21.

  • We compared that to placebo.

  • We also compared it 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 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 -- sorry, dose-independent response.

  • Both dosage levels induced high and comparable levels of IgG.

  • So the trial showed a dose-varied effect.

  • The IgG levels compared favorably to those seen in convalescent serum that we obtained from the Baylor College of Medicine, and we've noted a 100% IgG seroconversion rate.

  • There was an adjuvant required for the optimal immune response, which was quite clear.

  • So the demonstration of adjuvant effect was an important finding in this trial.

  • With respect to wild-type neutralizing antibodies, they appeared to be, in the 2 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 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 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 and systemic reactogenicity was not dose limiting.

  • So let's just talk to the next slide for 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, it's on the log scale.

  • You can see on the far left are the subjects who represent the human convalescent sera.

  • The next row has the placebos.

  • The next row has the 25-microgram dose given at day 0 and 21 without adjuvant and then the 5-microgram dose given with Matrix-M adjuvant at day 0 and 21, 25 micrograms given at day 0 and 21 and the 25-microgram dose given once at day 21 followed by placebo.

  • And you can clearly see the difference between the groups in B, where at 1 and 2 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 is 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 -- for group C with the second dose, we have a 63,160 ELISA unit titer, and that compares to the convalescent sera when the titer on the geometric mean basis was 8,344.

  • So robust responses.

  • The overall geometric mean of this was approximately sevenfold 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 a collaboration at the University of Maryland School of Medicine.

  • And again, you can see the graph is organized in the same way and very similar messages, importance of the adjuvants, 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 and 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 sicker subjects that are in that trial.

  • So as we mentioned in the results, this correlation between the IgG and the microneut was a very tight correlation.

  • We also saw a strong T cell response.

  • We won't go into that detail again here.

  • That was the 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, we're -- 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 see in the second bar there, where we had very good results.

  • We've met all of our 8 co-primary end points in March, and we expect to continue that development.

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

  • Stanley Charles Erck - President, CEO & Director

  • Thanks, Dave.

  • So we're now on 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 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 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-reviewed 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 Joseph Trizzino - Executive VP, Chief Business Officer, CFO & Treasurer

  • Thank you, Stan.

  • Today, we announced the financial results for the second quarter and first 6 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 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 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 6 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 6 months ending June 30, our total amount raised is $593 million.

  • And in addition, we secured $2 billion of nondilutive funding to support COVID vaccine development activities.

  • That concludes my financial review, and now I'll turn the call back to Stan.

  • Stanley Charles Erck - President, CEO & Director

  • 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 will -- 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.

  • And as you all know, this 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 and 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

  • (Operator Instructions) And our first question comes from Eric Joseph from JPMorgan.

  • Eric William Joseph - VP & Senior Analyst

  • So can you hear me?

  • Stanley Charles Erck - President, CEO & Director

  • Yes, we can, Eric.

  • Eric William Joseph - VP & Senior Analyst

  • Great.

  • Great.

  • So I guess just in thinking about the upcoming Phase II study, can you talk about whether there are -- whether there'd be any opportunities in that trial for looking at vaccine efficacy?

  • I know that it would be unblinded and nonrandomized.

  • But is there any -- are there any end points 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 have designed so far?

  • Gregory M. Glenn - President of Research & Development

  • 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 6 months, you and he will have lots of conversations.

  • Filip Dubovsky - Senior VP & 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 William Joseph - VP & Senior Analyst

  • Got it.

  • And -- okay.

  • And just in terms of patient numbers on -- in older adult population, over 65.

  • Filip Dubovsky - Senior VP & Chief Medical Officer

  • Yes.

  • So half that, half of the study.

  • So somewhere...

  • Eric William Joseph - VP & Senior Analyst

  • Sorry, excuse me.

  • Got it.

  • 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's still sort of gaps to fill with the additional CDMO relationships to get to your target in the U.S., 100 million doses with OWS and then expanding from there?

  • Stanley Charles Erck - President, CEO & Director

  • So there's inside the U.S. and outside.

  • And so it's just a lot's 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 2 -- right now, from the 2 FUJI sites.

  • And our expectation is that for U.S. only, that we will be able to supply at least the U.S. needs, which we project could be as high as 500 million to 600 million doses in a year.

  • And we'll look to expand that further.

  • Outside the U.S., we've already -- we've started the product facility, which is getting ready to complete.

  • The reconstruction process or the remodeling process has been going on for 3 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 said, in the coming -- very shortly.

  • We expect to have well over a couple of billion units of capacity on an annual basis.

  • So...

  • Operator

  • And our next question comes from Charles Duncan from Cantor.

  • Charles Cliff Duncan - Senior Analyst

  • 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 immune senescence 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 & Chief Medical Officer

  • So this is Filip again.

  • So this -- the study we're planning, and we will look at 2 dosage levels on the off chance that immunosenescence may play a vital role here, but we do have data from the previous work that suggests that 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, looking at IgG responses and microneut responses.

  • And based on that, I will take the data to the FDA for final concurrence with our plans.

  • Charles Cliff Duncan - Senior Analyst

  • And when you think about the activity of the adjuvant and 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 M. Glenn - President of Research & Development

  • Yes.

  • 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 immunosenescence.

  • So inducing T cell 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 the kind of where flu vaccines are going, for sure, older adults looking for adjuvant to sort of repair immunosenescence.

  • And we saw that.

  • We -- in the -- somewhat to my surprise, I was rather staggering -- staggered by the fact that there was so little antigen-specific T cells in the placebo in the day 0 T cells and then afterwards, how good the T cell response in addition to having it.

  • 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 we're expecting this to be really 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 in the dose.

  • But it appears to us, where we are today with the younger adults, that we're at the peak of the immune response.

  • So given the formulation and the dose, it's probably not going to be likely that we'll push that up by using the 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 Cliff Duncan - Senior Analyst

  • That'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 demonstrating -- already having demonstrated pretty interesting data?

  • Gregory M. Glenn - President of Research & Development

  • Well, 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 microneut 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, 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, and -- but we have to be focused on execution.

  • So it looks like our data from a functional standpoint is very good.

  • Charles Cliff Duncan - Senior 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 III results?

  • And I'll hop back in the queue.

  • Gregory M. Glenn - President of Research & Development

  • That's a 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.

  • From this point, don't know how relevant will be the 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 to start up these -- our next set of trials.

  • Right now, we've 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.

  • Operator

  • (Operator Instructions) And our next question comes from Mayank Mamtani.

  • Mayank Mamtani - Research Analyst

  • 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 antalgia rate that we saw.

  • Could you just maybe comment on that qualitatively or quantitatively?

  • Gregory M. Glenn - President of Research & Development

  • Yes.

  • 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 ought to take 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 percent of CD4 positive T cells.

  • And we then have -- it's somewhat a limited set of data.

  • We need it to get something done, some subset done in order to file our data with the FDA.

  • So there's really only 4 subjects, 16 total, 4 per group, and we'll 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 these 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 coming -- 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 had a gray bar or no bar; there's some they 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 would associate with generating a robust immune response.

  • So again, vaccination 1, very quiet vaccination 2, a little more smattering of noise, no particular pattern with severe outcomes that is of any concern and maybe -- and of course, it's placebo-controlled, so maybe a little more fatigue, a little more muscle myalgia and some headaches.

  • But again, I'd just say that would be consistent with most of -- many vaccines we see today.

  • And 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 micrograms.

  • So -- but I wouldn't make too much of that.

  • It's just 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.

  • There's one -- in the first dose, there's 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 - Research 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 the safety profile that you just described?

  • Any feedback to your next steps here from the FDA yet?

  • Or is that still -- is that in your...

  • Gregory M. Glenn - President of Research & Development

  • That's good -- glad you asked, so good point.

  • We did file this with the FDA as soon as we had -- we were 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 that -- 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.

  • And because we're going to start the phase -- we expect to start the Phase II 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 clarifications.

  • But I don't expect anything should impede our going forward.

  • But it is, of course, important and not assumed that they are going to give us their blessings.

  • So we'll see -- we can expect here shortly.

  • Mayank Mamtani - Research Analyst

  • And Greg, if I can sneak in one more for John.

  • John, communication cadence regarding some of the 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 Joseph Trizzino - Executive VP, Chief Business Officer, CFO & Treasurer

  • Yes.

  • 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 advance purchase agreements.

  • And we'll have to balance the growing supply against that demand to make sure we're doing that with kind of a global access and a 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.

  • So more to come, if that answers your question.

  • Mayank Mamtani - Research Analyst

  • Any color you could give on pricing?

  • Or is it too early?

  • Because it was really the economic terms in these -- some of these arrangements is what is missing, right?

  • So I'm just curious...

  • John Joseph Trizzino - Executive VP, Chief Business Officer, CFO & Treasurer

  • I can't give you any more color other than what we've said before, and that is going to be fair pricing.

  • I think there's more work that has to be done in talking with our partners about what that strategy looks like.

  • So again, Mayank, stay tuned, it's an evolving process.

  • Operator

  • And I am showing no further questions.

  • I would now like to turn the call back over to Mr. Erck for further comments.

  • Stanley Charles Erck - President, CEO & Director

  • Yes.

  • Thanks, everybody.

  • And 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'll hear from us.

  • Thank you.

  • Operator

  • Ladies and gentlemen, this concludes today's conference call.

  • Thank you for participating.

  • You may now disconnect.