Novavax Inc (NVAX) 2016 Q2 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Novavax second quarter financial results conference call. (Operator Instructions)

I would now like to introduce your host for today's conference. Ms. Andrea Flynn, you may begin.

Thank you, and good afternoon. This is Andrea Flynn, Associate Director of Investor Relations at Novavax. I would like to thank everyone for joining today's call to discuss our second quarter 2016 financial results. A press release of our earnings is currently available on our website at novavax.com and an audio archive of this call will be available on our website later today.

Joining me on today's call is Novavax's President and CEO, Stan Erck, together with our Senior Vice President of Commercial Operations, John Trizzino; President of Research and Development, Dr. Greg Glenn; and Chief Financial Officer, Buck Phillips.

Before we begin our 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 strategies and other financial and business-related matters including expectations regarding revenue, operating expenses, cash usage and clinical developments 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 will now turn the call over to Stan.

Thanks, Andrea, and good afternoon, everyone. I'm very pleased to report that we are continuing all of the activities necessary for the commercialization of our first product. We remain on track to report data from our Phase 3 clinical trial for our RSV F Vaccine in older adults this quarter.

Across the Company, we are continuing work to assemble a BLA for FDA submission in 2017. We will incorporate all of the support of safety, immunogenicity and efficacy data from our RSV F Vaccine clinical trials as well as CMC and nonclinical data into the BLA. We have received fast-track designation from the FDA and will ask for priority review prior to our BLA submission.

Regarding ex U.S. regulatory activities, I want to remind investors that, as Greg outlined in our last call, we have met with two European national regulatory agencies, the Paul-Ehrlich-Institut in Germany and the Medicines and Healthcare Products Regulatory Agency in the U.K. In both meetings, the older adult and the infant via maternal immunization programs were discussed. Overall, both agencies were supportive of each program including clinical trial designs, trial endpoints and proposed clinical data sets to support future marketing authorization applications. Our goal is to file for marketing approval in Europe shortly after we file our BLA in the U.S.

Our quality and manufacturing groups have been working toward validation of our processes and expanding production. In a very big milestone for our manufacturing and quality groups, next week, we will start our process performance qualification runs, or PPQ, in advance of our first commercial production runs, which will start in 2017.

Last quarter, we signed a lease on 150,000-square foot existing building, about one mile away from our offices that we will customize as our commercial manufacturing site. Our plan is to launch our vaccine from our current GMP manufacturing facility in 2018. In this much larger new facility, we are designing a manufacturing plant that will allow us to expand our current capacity by six-fold. These two facilities are designed to provide product to support sales estimates for launch and for several years beyond product launch. Future manufacturing needs beyond that will depend upon discussions with our global partner.

Our commercial operations team has been hard at work to build disease state awareness within the medical community, the payer community and within U.S. health agencies such as the CDC. In a significant milestone, the ACIP established its first ever working group for RSV, which met in June to discuss the birth of RSV disease in the U.S. This working group began the evaluation process that will ultimately lead to the addition of our FDA-licensed product to the ACIP vaccination schedule.

We're also making significant progress in discussions with potential partners for RSV global commercialization. Our goal is to identify the best pharmaceutical partner to help us achieve regulatory approval and commercial launch globally in parallel with our U.S. launch. We hope to identify the partner and negotiate an agreement sometime later this year after we unblind our Phase 3 data.

So as you can imagine, much of our focus has been on supporting the successful conclusion of our older adult Phase 3 trial and all the supporting activities required to assemble a BLA. Having said that, we also have several other important activities that will create value for the Company. I'll briefly cover a few of these.

With regard to our other Phase 3 trial named Prepare, which is designed to demonstrate protection of infants via maternal immunization, execution remains ongoing with participants enrolled in the United States, South America, Africa and Australia, and we are now working to expand into Central America, Europe and Asia. With ongoing support from the Bill & Melinda Gates Foundation, we expect to continue enrollment in all of these global locations, and we currently expect to report preliminary results in two to four years.

We continue to believe that a combination RSV and flu vaccine represents a very large market opportunity. We have initiated preclinical studies with the vaccine -- with a candidate vaccine and plan to initiate the clinical trial in the first half of 2017. Greg will go on to a little bit more detail later.

And finally, as we did with other emerging viruses like H7N9, Ebola and MERS, we have initiated a program to develop a vaccine to protect against the Zika virus. We have preclinical studies underway and expect to collaborate with a group that has an animal challenge model. We will keep you posted as to progress on this later this year.

So now circling back to our Phase 3 trial announcement that we will make later this quarter, I'm acutely aware that everyone on this call would like to know more about this clinical trial and would like to ask Greg a few questions about the results. But at this time, we are compiling data into a very large clinical trial database that is still blinded to everyone at Novavax. The integrity of this process is our highest priority. And since we initiated this trial at the end of 2015, we have been very clear about its design and objectives. However, we will not disclose any findings or observations until we announce the unblinded results later this quarter.

What I can say is that we are on track and remain confident that we will report preliminary top-line results in the third quarter. That means we expect to have top-line safety, primary endpoints, secondary endpoint results before this quarter ends. We expect to announce immunogenicity data -- easy for me to say, later this year. Greg and I are both excited to be aware -- to be able to discuss our results just as soon as they're available for public dissemination, and we will arrange another call with you when we do.

So as we did last quarter I'm going to have John Trizzino, our Senior Vice President of Commercial Operations, provide an update on our efforts preparing for commercialization of our first product. After John, Greg will discuss our clinical programs, and then Buck will provide an overview of the second quarter financial results. Finally, I'll wrap up and then open the line for questions.

Thanks, Stan, and good afternoon, everyone. As I outlined last quarter, well in advance of a product launch, there are a host of activities that need to take place to prepare the market for a new product. This is especially the case for the launch of the first vaccine for RSV. Therefore, we continue to be deeply and actively involved with policy initiatives, payer and pricing strategy, key opinion leader and health care provider advocacy, and mostly staying focused on delivering the significant health benefits of an RSV vaccine to the older adult target population.

This past May, we launched our disease state awareness campaign to educate health care providers about the burden of RSV disease in older adults highlighted by the launch of our website discoverrsv.com. This website is the first online resource to educate health care providers about the symptoms and burden of disease for RSV in older adults that they should be looking for in their practice.

In addition, we hosted a disease state awareness booth at both the American College of Physicians Internal Medicine Annual Meeting in D.C. in May and the International BIO Conference in San Francisco in June. At both events, interaction with and feedback from physicians highlighted that RSV is underrecognized in their practices.

We plan to host the booth at other upcoming events including the annual meeting of the American Academy of Family Physicians, September 20 through 24 in Orlando; IDWeek, October 26 through the 30 in New Orleans; and the 2016 GSA Annual Scientific Meeting in New Orleans, November 16 through 20. We will also be sponsoring disease state theaters on RSV disease burden in older adults at the Options for the Control of Influenza Conference August 24 through 28 in Chicago; and at IDWeek in New Orleans October 26 through 30.

ACIP, as Stan referred to before, the Advisory Committee on Immunization Practices, is the group that advises the CDC on recommendations for vaccine use. An ACIP recommendation is an important element to broad stakeholder acceptance of an RSV vaccine, and we are committed to supporting the ACIP's efforts with clinical data, pharmacoeconomic studies to verify and document the economic burden associated with RSV in older adults and generation of RSV disease burden evidence.

We are extremely pleased with the ACIP's creation of an RSV working group. This announcement at the June ACIP meeting was accompanied by very important presentations that are now available to the public at the ACIP website. These affirm the seriousness of RSV disease and its burden in older adults.

All of these activities support our commercial strategy in preparation for the launch of our RSV F Vaccine in older adults planned for 2018. As a reminder, RSV infects over 2.5 million older adults every year in the United States alone with an estimated annual cost burden in excess of $28 billion. According to the presentations made at the June ACIP meeting, RSV disease causes approximately 180,000 hospitalizations and 14,000 deaths among older adults that are older than 65 years of age.

Let me close my remarks by once again emphasizing the seriousness of RSV disease in older adults. Of those 2.5 million infections annually, there are almost 900,000 cases that are medically attended each year. That includes either an unscheduled doctor's visit, an ER visit or a hospitalization.

Now let me turn the call over to Greg to provide a quick review of our programs. Greg?

Thanks, John, and good afternoon, everyone. As Stan indicated, I will begin with a brief statement about our RSV F program for older adults. I want to reiterate what Stan said earlier that we are on track to announce data from our Resolve trial this quarter. Surveillance from this trial was completed on May 1 per the trial protocol, and we are in the process of completing sample testing and populating and cleaning the database, ultimately, leading to data space lock and unwinding.

As I have in the past, I'll briefly review the trial design. Resolve is a randomized observer-blinded, placebo-controlled trial that enrolled 11,850 adults 60 years of age and older at 60 sites in the U.S. The primary efficacy objective of the trial is prevention of moderate to severe RSV-associated lower respiratory tract disease, as defined by the presence of multiple lower respiratory tract symptoms and signs. The secondary objective is the prevention of all acute symptomatic RSV respiratory disease. Based on continued execution of the trial, we provide top-line efficacy results from this seminal trial in the third quarter of this year in line with our prior guidance. We expect pivotal efficacy results will support the filing of our U.S. BLA 2017 as well as other global marketing applications.

In addition to Resolve, we also have an ongoing Phase 2 rollover clinical trial of our RSV F Vaccine in older adults. We expect the safety and immunogenicity data from this trial will support discussions with regulatory agencies, advisory committees like ACIP and the payer community as we seek a recommendation for an annual seasonal vaccine in the older adult population.

This trial is a randomized observer-blind placebo -- rollover trial which enrolled the same adults 60 years of age and older who participated in the prior Phase 2 trial known as E201. We have successfully completed enrollment in this trial with 1,330 older adults. The primary endpoint for this trial will evaluate safety in serum anti-F IgG concentrations in response to revaccination in the second RSV season. We're on track to share the results from this trial before the end of the year.

We are also continuing to enroll participants in our Phase 3 trial for infants via maternal immunization known as Prepare. Validating the need for a vaccine, as you may recall, Novavax received a grant of up to $89 million from the Bill & Melinda Gates Foundation to support the development of this RSV F Vaccine for infants via maternal immunization.

The Prepare trial is a randomized observer-blinded, placebo-controlled trial that utilizes the group's sequential design, offering flexibility in trial size that is responsive to the rate of endpoint events and evolving evidence of efficacy while maintaining the integrity of the blinded trial. The primary objective of the Prepare trial is to determine the efficacy of maternal immunization with the RSV F Vaccine against symptomatic RSV lower respiratory tract infection with hypoxemia in infants in the first 90 days of life. As Stan mentioned earlier, participants are being recruited and vaccinated in a number of global clinical sites based on the timing of each region's RSV season.

So while we remain focused on the ongoing RSV Phase 3 trials, we also recognize the value of the pediatric RSV vaccine and remain in communication with regulatory agencies regarding our clinical development plans. We plan to provide guidance on our clinical development plans in the second half of this year.

Now moving forward to our influenza program. During the quarter, we announced the development of a seasonal influenza vaccine based on a hemagglutinin nanoparticle. The seasonal influenza nanoparticle approach builds on the advances and insights achieved with our RSV and other nanoparticle vaccines.

As you may recall, the RSV F Vaccine development leverages the induction of broadly neutralizing antibodies to conserve sites within the F protein, and we adopted that approach in developing our seasonal influenza nanoparticle. As you all know, Novavax pioneered the use of palivizumab-competing antibody as a metric for an infective immune response to RSV. I'm pleased to report we have identified influenza broadly neutralizing antibody and developed a similar influenza specific broadly neutralizing monoclonal antibody competition assay to test the immune responses to our new influenza nanoparticle vaccine.

These advances together led to a presentation at the new approach -- at a Keystone Symposium called New Approaches to Vaccines for Human and Veterinary Tropical Diseases. Here we shared preclinical data from a combination of our RSV F and influenza nanoparticle vaccines, bringing together a vaccine approach that induces broadly neutralizing antibodies against both influenza and RSV and advancing the concept of a combination respiratory vaccine. A vaccine with these attributes covering both influenza and RSV, which together are major causes of serious respiratory infection in older adults and pediatrics, would be an important advance for public health.

The next step in the program will be to conduct a multi-armed Phase 1/2 clinical trial of our seasonal influenza nanoparticles alone and in combination with the RSV F Vaccine, and with and without our Matrix-M adjuvant. We expect to initiate this trial in the first half of 2017.

So with that update of our key programs, I'll now turn the call over to Buck.

Thank you, Greg, and good afternoon, everyone. Today we announced the financial results for the second quarter ended June 30, 2016. Summary financial statements can be found in today's earnings press release.

For the second quarter of 2016, we recorded a net loss of $79.4 million or $0.29 per share. This compares to a net loss of $20.6 million or $0.08 per share in the prior year period. The increase in net loss in the quarter is primarily the result of increased R&D expenses related to the clinical trials and development activities of our RSV F Vaccine candidate relative to the same period last year.

Revenue for the quarter was $2.5 million compared to $14 million in the same period in 2015. This 82% decrease in revenue in the '16 period over the '15 period was driven by three primary factors. The first is the onetime recognition of $7.7 million in revenue in the second quarter of 2015, resulting from the settlement of indirect rates under the HHS BARDA contract for the years of 2011 and 2012. Second, a higher level of BARDA-related activities in the second quarter of 2015 relative to 2016, specifically a Phase 2 quadrivalent seasonal influenza vaccine trial, which was completed in 2015. And last, the recent advances the Company has made in its seasonal influenza nanoparticle program, which have resulted in the wind-down of VLP influenza activities under the BARDA contract.

The decline in BARDA revenue in the second quarter of '16 is partially offset by $1.7 million in revenue recorded under the Bill & Melinda Gates Foundation grant of $89 million. The BMGF revenue is directly related to the Prepare clinical trial. And as we've previously discussed, we should expect an increase in that BMGF revenue in '16, which will correlate to the underlying costs occurred in the Prepare trial itself.

R&D expenses increased 134% to $64.9 million in the quarter compared to $27.7 million in the same period in 2015. The increase in R&D expenses was primarily due to the increase in activities in our ongoing RSV F Vaccine clinical trials and related development activities along with higher employee-related expenses, which include an increase in noncash stock compensation expense. The Resolve trial was the primary contributor to the increase in R&D expenses in the second quarter of 2016.

G&A expenses increased 99% to $14.1 million in the quarter compared to $7.1 million in the same period in 2015. This increase is primarily due to an increase in employee-related expense, which includes an increase in noncash stock compensation expense as well as increases in commercial and pre-commercialization expenses. Increases in employee-related expenses both for G&A and R&D are primarily driven by the growth in headcount necessary to support our expanded project development activities and the maturation of the Company.

One key noncash component of expense growth on a period-over-period basis is the growth in noncash stock compensation expense, which increased to $5.3 million in the quarter from $2.6 million in the prior year period. As of June 30, 2016, the Company had $366.4 million in cash, cash equivalents and investments on the balance sheet.

Early in the year, Novavax completed an issuance of convertible senior notes, strengthening our balance sheet ahead of data from the Phase 3 Resolve trial expected in the third quarter of '16 and in support of discussions of commercialization rights to its RSV F Vaccine franchise outside of North America while minimizing dilution.

This concludes my financial review. I'll now turn the call back over to Stan.

Thanks, Buck. We're incredibly excited about the coming months. Positive data from Resolve will take us one step closer to bringing this important vaccine to licensure years ahead of other RSV vaccine development efforts.

Before I open up the call for questions, I would like to reiterate that our upcoming Phase 3 data readout in older adults on track to be announced this quarter will be a top-line data announcement. We expect to provide data on our primary and secondary endpoints. There are a number of immunogenicity data points that we are working on, and when we will report those results over the remainder of the year. At the risk of being repetitive, we remain blinded for the time being and look forward to announcing unblinded data later this quarter.

Finally, I'd like to announce that we will be hosting our annual Investor and Analyst Day on October 11 in New York City, so mark your calendars. Additional details will be forthcoming shortly. And we'll wrap up here and open it up to Q&A. Operator, Q&A?

(Operator Instructions) And our first question comes from a Bill Tanner of Guggenheim Securities. Sir, your line is now open.

Hi, thanks for the questions. Stan, I had a question for you related to the manufacturing. I think that you said that the existing plant could meet the U.S. or I think you didn't say that -- that's actually going to be my question is, to what extent of the U.S. demand do you think you could actually meet with that plant or peak demand, I guess? Or what kind of market demand do you think you could meet assuming a reasonable uptake?

Yes, I think -- so the plan is, is actually we're going to start making product in 2017, freezing both product, and so that we'll have enough product for 2017 production and 2018 production to satisfy the demand for 2018 launch in the U.S. What we're expecting is, obviously, there will be expansion in the U.S. in 2019 and then initiation of trials -- not trials -- of sales in 2019 in Europe.

That plant plus the beginning production of our new plant will be able to supply the worldwide production. We expect we'll be able to supply worldwide production sales demand during, at least, the first four or five years, which will give us time to decide, when we talk with our partner, how we're going to satisfy demand beyond 2023 or '24.

Okay, that's helpful. And then, just a quick question on Zika. I'm wondering if you could speak to how you see the commercial opportunity being similar or different from what Novavax has done in the past with some of the pandemic things like Ebola or H7N9. And then just a lot of activity, obviously, in the industry trying to develop a Zika vaccine. Maybe give us some color as to where you see Novavax stacking up relative to the competition.

Yes, it's a great question. I wish I had a crystal ball, but I don't. So we're starting on this because I think it's -- we think it's a problem that can be solved with our platform. And so we're doing the early stage preclinical work to show that we got a vaccine that could hold up under an animal challenge, and we're going to watch closely where it goes. I think the entire industry is wondering whether there's either going to be government support for this or whether there's actually a commercial market for this. I don't think there's an answer to that yet. So don't know yet.

Okay. Thank you.

Our next question comes from a Jessica Fye of JPMorgan. Ma'am, your line is now open.

This is [Ryan] on for Jess. I guess on the -- with the shift to the nanoparticle approach for seasonal flu, is there any potential for a new BARDA contract with that technology?

Yes, there is. In fact, we are on very -- we have been and continue to be on very good terms with BARDA. When we found that the work that we were doing brought us out of the scope of the contract that we've been working on, they have asked us to, when we get our clinical data, to come back and propose to them what would be a next-generation vaccine.

Okay. And maybe we could dig a little bit more into the program. Given the number of options that you have in terms of running it just as a flu program or in combination with RSV, how quickly could you start a combination study with those two vaccines?

So we're planning on doing that in the first half of next year. And I think that we're targeting this combination vaccine to what is probably the largest market. It would be a combination flu and RSV vaccine, probably with our Matrix adjuvant and for the older adult population for flu. That will be the first target.

I think that the trial would -- we're going to get a lot of really useful data from this trial because we're going to look at a vaccine for commercial seasonal vaccine for flu with and without RSV, and both of those with and without Matrix. And we'll get some really good data out of that. And that will direct us more to what the Phase 2 trial will be.

Great. Thanks for taking the questions.

And our next question comes from a Ted Tenthoff of Piper Jaffray. Sir, your line is now open.

Thanks very much. Looking forward to the data coming up soon. I just wanted to get a sense from the meeting with ACIP this summer. Did you get any concrete directive sort of coming out of that in terms of what might be required either for a premium pricing? Or is this really a matter of, if it gets approved, they're going to pay for it? What was your sense coming out of the conference?

So this is John Trizzino. We were extraordinarily excited by, first, the formation of the RSV working group. This is a strong indication that they are now pursuing a review of RSV burden, that they are preparing themselves for our licensure. And therefore, once licensed, presentation to ACIP for their recognition in addition to the vaccination schedule. And so having their activity two years ahead of when we would expect to launch is a very strong signal.

The ACIP, since there's no existing vaccine for RSV, the pricing of review is just one element of what they look at and mostly from a pharmacoeconomic analysis perspective. And their mission is to look at safety and efficacy of the vaccine to the burden and then recommending it for the schedule.

So everything is aligned exactly as we hoped it would be. The presentations that were made in the June meeting fully supported the modeling that we've done so far on burden of disease. And there's more work to be done, but we're very well positioned, as I mentioned in my remarks, to have a very good working relationship with the CDC and with the ACIP working group.

Excellent. Thank you very much.

And our next question comes from a Heather Behanna of Wedbush Securities. Ma'am, your line is now open.

Hello. Thank you for taking my questions. This is [Edwin]. I'm on the line for Heather. I know that you can't talk about any of the data, but I'm just curious if you can provide any color on enrollment percentages of adults over 75 or also color on secondary endpoints we will get after the top-line data readout.

Hi. This is Greg here. So you may recall in our protocol, we prespecified around 25% of the subjects would be 75 or older, and we achieved something like 24.8%. So we have that built into the trial. And our secondary endpoint would be acute respiratory disease in RSV positive. So that's how the trial is structured.

Okay. Thank you.

Our next question comes from a Joel Beatty of Citibank. Sir, your line is now open.

Hi. Thanks for taking the questions. I'm not sure if I missed it on the last question, but would you be able to provide the secondary endpoints that you plan to announce this quarter?

The top-line result will be acute respiratory disease, RSV positive.

Preventional.

Sorry?

Preventional.

Yes, preventional. So [B vaccine, Fc]. And the confidence intervals, as you know, we have agreed with the FDA as 25% lower bound confidence interval. So we'll provide the vaccine estimate confidence interval for acute respiratory disease, RSV positive.

Okay. But I guess, regarding the 25%, I think I remember from before it may have been 30% at one point. Is there a distinction there? Or has that changed?

No, no. The primary is the prevention of moderate-severe RSV illness, and there throughout the lower bound of 95% confidence interval of 30%. For the secondary, with acute respiratory disease, we rule out the lower bound north of 25%.

Okay, then the last question. Can you just discuss the delay in the timing for the Phase 2 immunization trial from Q3 to sometime by year end? And also, are the results from the trial something that potential partners would want to see before a partnership?

Yes, we'll talk about the timing. Stan, it's a timing question, but --

He's talking 202.

Yes, 202. He's talking about the rollover trial. We're on track to analyze that, I think with guidance, and they probably will be very interested in that data. So we're -- it's roughly the same time frame as 301, and we're doing the same thing, the analysis, locking the database. It's a smaller trial, so it's 1,330 subjects. So I think the timing in the guidance we've provided has been the second half of 2016, right?

Right. I believe it's correct, (inaudible - microphone inaccessible).

Great. Thank you.

Our next question comes from a Kevin DeGeeter from Ladenburg. Sir, your line is now open.

Hi. Great. Good afternoon. Just two maybe short simple questions for me. As we think about potential business development transactions for the RSV program, given that I guess the limited number of transactions and partnerships in the vaccine space, are there any that jump out that you could point to that's either comparable or instructive to help us think about what potential economic metrics might look like?

That's a good question. I must admit we've looked at all of the partnering deals that have done, and you're right, there are not many precedent vaccine partnerships. But there are a number of the larger deals that have been done on drugs that may have some relevance.

Yes, I think Kevin, and just to support Stan on this, we've actually done an in-depth analysis on what would recognizably be most of the Phase 3 or late-stage development programs that have been partnered over the last several years. And while there are not any vaccines specific that we can point to as precedent deals, we do see a lot of deals for what we would call novel therapeutic opportunities that are opening new market opportunities.

So they're novel, they're differentiated, they're greenfield opportunities. And we kind of see those as maybe the playbook that we'd like to use as we go forward. So the team has been very diligent on reviewing this data set and using that to help guide us in these conversations as we go forward.

Okay, great. And then maybe one more for me then, and then I'll hop back in the queue. Kind of staying in the business development theme, do you think it would be appropriate to include the influenza nanoparticle in upcoming partnering discussions given the potential for inclusion of that in the combination vaccine? Or do you think it is appropriate given the stage of development to keep that separate and wholly owned by Novavax at this time?

I think that's a really good question. I think it represents a nice market opportunity for us in flu, and putting them together, of course, represents -- although we think RSV alone represents the biggest market opportunity for vaccine, putting it together just amplifies that. And I think any partner that we have, of course, they're selling to the same customer, would be interested in talking about both those problems. So some sort of optionality will be in those discussions, I think.

All right. Great. Thanks so much.

Our next question comes from a George Zavoico at JonesTrading. Sir, your line is now open.

Hi. Thanks for taking my question. Hi, everyone. First question, let me address Zika for a second. Because previously, for the other emerging virus vaccines, you've been very, very quick in developing a vaccine that you could take into human trials. The Zika genome was known earlier this spring, and so it's a little bit past your prior record timing to have the vaccine out. Is that partly because -- does that have to do with the vaccine being a little bit more difficult to get an antigen against it? Or is it because most of your focus has been on the RSV and the nanoparticle.

I think it bolstered the focus on our RSV vaccine. As you can imagine, we've got two Phase 3 trials going on. In some respects, it targets a different group within our company because it's really the early-stage discovery group that is working on this, but they're always busy. But as usual, as I'm glad you pointed out, remember that we have had great successes on these other emerging viruses and -- but Zika is now at a point where I think the pace of animal work and where we go from there is accelerating.

Hi, George, it's Greg here. I mean, we also really reengineered the flu nanoparticle program and have really good results to present in South Africa. So I think it's been fit in amongst those strategies. But really focused on executing and getting high-quality data from the RSV Phase 3 programs. But by and large, [we see] we're not as far out.

So a little more detail. Is the Zika vaccine via VLP or a nanoparticle?

It's a nanoparticle. Yes, I think we're, again saying, capitalizing on our experience with RSV, the flu nanoparticles, Ebola. The Ebola vaccine was extremely effective. I think, as a demonstration of the technology, it's really very, very good. So these novel lethal viruses often come with vaccinology challenges. But I think as you pointed out, Zika I believe, is going to be relatively easy from a vaccinology standpoint because historically, the flay-v-virus surface proteins have been hard to make. And we, I think, have solved the difficult technical problem and expect the vaccinology should be straightforward.

Many of the other approaches are genetic-based or vector-based, and I see a lot of limitations. But that having a purified nanoparticle vaccine, having a major [tim] asset in our pocket with the Ebola vaccine, we're able to give a zero 28-day immunization and we have very good -- very high antibodies, neutralize the antibodies and persistent immune responses.

Great adjuvant.

It's a very good adjuvant. And it is a clinical arena where we have a lot of comfort. This is -- I see it as a major public health problem. We have a particular expertise in working in the context of women who might be considering being pregnant and/or pregnant. We've done a lot of work in this area. So from an understanding of how to proceed in the clinical trial setting, I think we could really be seen as rivaling anybody.

So we're quite interested. I think we all believe that it's a big unmet need. There is likely to be persist and I think we can meet the challenge. And so I think we'll update -- we're looking forward to presenting some of the preclinical data at a scientific forum in the near future and making more progress.

Okay, cool. That's reassuring. With regard to the BARDA contract, the one that's expiring in September, do you expect any more revenue from that in 3Q? It's winding down in September, so maybe you will. And what do you expect to be the total that you will have received from them? Because the initial -- I think the initial amount was [196] and it was downsized about [179]. Am I remembering it correctly?

Yes, I think the total contract size that you've mentioned is approximate. To date, over the history of the contract, we've recognized $115 million in revenue under that contract. So George, as we look forward into Q3, I think your expectation should be that we will not recognize any revenue. We might have very de minimis revenue just for contract administrative level work that we do. But your expectation should be that we will have no revenue from that contract in the third quarter.

Okay. And finally -- thanks for that, Buck. And finally regarding the combo vaccine, there's -- I mentioned there's multiple tracks you can take, as you've already pointed out, seasonal vaccine by itself or with the combination. But you're basically starting with a nanoparticle vaccine back at Phase I. Whereas with the VLP vaccine, you're approaching a Phase 3 efficacy vaccine.

So in terms of getting the flu vaccine to market, there's now going to be a little bit of a gap from when we expected the VLP vaccine to hit market and now with a nanoparticle vaccine to hit market. So can you just provide sort of back-of-the-envelope kind of analysis of when we might expect the progression from Phase 1 to Phase 2? And I imagine with the new nanoparticle vaccine, you'd also need to do a Phase 3 efficacy vaccine just like you're doing with the RSV.

Yes, I think that's right. I think that we will proceed. We're going to get a lot of data out of this Phase 1/2 programs that we're going to start next year. And from that data that, it just depends on whether we have to do a -- what kind of dose confirmation study we have to do before we go into a Phase 3. We will know a lot about the types of antibodies that we'll be wanting to generate, and we'll be able to assay them. And the other half of the program, of course, we're going to be doing it with a product that has Phase 3 data and will be soon licensed with the RSV F Vaccine. So part of the vaccine will be an approved product. So that will shorten the timetable from getting to licensure of a combination vaccine. I don't have a specific timetable until I know the data from the next study.

So and then in addition to plus or minus the RSV Vaccine, plus or minus the Matrix-M, you're also going to be doing multiple doses of the nanoparticle vaccine, like you did in the prior trial.

It will be one of your larger Phase 1/2 trials. Yes, we're going to get a lot of good data out of it.

And do you expect that to be Northern Hemisphere or Southern Hemisphere or both? Because I mean, it sounds like you're having a pretty big trial with so many different arms.

Yes, I think (inaudible) to be out of season, so we could evaluate the immunogenicity without the interference from (multiple speakers) --

That's true, okay.

We have that option to be Northern or Southern.

So as you know, we've got multiple times in Australia just for that very reason because of the seasonality of our vaccines themselves. We're very familiar with that process.

Okay. Great. Thank you very much. Look forward to the Resolve's results.

Yes, we do too.

Our next question comes from a Vernon Bernardino. Sir, your line is now open.

Thank you. Yes. Thanks for taking my question. The nanoparticle, the next-gen flu vaccine is definitely intriguing to me. Can you just say again what kind of differentiation or efficacy you might expect from that versus the current flu vaccines?

Yes, I think -- it's Greg here. I think we have learned a lot from the RSV F Vaccine, the palivizumab-competing antibody, that being a broadly neutralizing antibodies in some of the other sites. So all the, I think, tremendous learning we have had from making a purified surface glycoprotein has informed us for Ebola and for flu. And so we've done some of the work, as I've mentioned, and we, I think, presented this data at the Keystone Symposia, where we can induce these broadly neutralizing antibodies. So essentially, we can -- we have a number of them that we identified like palivizumab in terms of their type of activity.

For example, at the conference, we showed we induced broadly neutralizing antibodies against the H3N2, and that include -- what we do is we take the antibodies we've made, the monoclonal antibodies we've made, and show that we can neutralize viruses from multiple decades. And there, we show I think from 1968, '82, '97, 2000s, about 10 different historical strains that this antibody can neutralize that virus. It's derived from our vaccine in animal immunization protocol.

So the same -- we see the same sort of pattern in our RSV Vaccine. And so how does it affect our flu profile? So the flu vaccine could be a vaccine that covers some of the problems we have currently with our current paradigm. That is, we have to make a choice. The public health institution has to make a choice based on surveillance in the year on the strains that are included in the manufacturing format for the coming year. It's possible to miss that.

In other words, the strain between that year may change enough. There's little or no vaccine efficacy into the strain. Another hazard is that the vaccine is made of egg. The virus is isolated and adapted to eggs and those changes that it undergoes to adapt can affect the field efficacy. And so having a vaccine-like RSV, where it's much more stable construct against targeting broadly neutralizing epitopes that are conserved might align to not change the vaccine or not change it frequently and certainly avoid -- potentially avoid the problems with strain changes and mismatches based on manufacturing techniques.

So our expectation is that it could be a better vaccine and that we will learn a tremendous amount from the Phase 1 trial. You may recall, we did a single Phase 1 trial with RSV back in 2010, and frankly, the main learnings from that trial, the Phase 1 trial, where we described the fact that there was broadly neutralizing antibodies from the vaccine and not from infection, was really the trajectory that led us to where we are today.

So lessons learned. It's a very nice technology. The insect cell makes -- here we can make a purified protein that's properly folded. And we could formulate a way to expose these epitopes. And I think it's a very exciting program, the prospect of mixing in with a proven product like RSV. And also adding Matrix-M. I would say what we know about Matrix-M is it does further increase the responses to these broadly neutralizing epitopes in a very elegant way. So those are three, I think, really powerful technologies to bring to a combination of respiratory vaccine, which I needn't tell you commercially it's quite interesting.

So we're excited about this program. We've put a lot of depth into -- we have a lot of depth in flu vaccine internally. And so I think the general group here is really looking forward to getting the Phase 1/2 data this coming year.

Thanks. That would definitely be a highly differentiated vaccine, creating a new paradigm for sure. One follow-up, if I may, and maybe this is a question for Stan. So the RSV program is definitely something whole onto itself and certainly and you -- again, echoing Greg's paradigm as far as treatment is concerned. Now the combination with the flu vaccine is definitely intriguing, but have you considered partnering the RSV vaccine in combination with somebody else's flu vaccine as far as an opportunity is concerned?

Yes, we have, and we have those types of discussions going on in parallel. So the options are open to us. We have thought about that.

Okay. Maybe we can learn some more in the future. Okay, thank you very much for taking my questions. I'm definitely excited and looking forward to the data later this quarter.

Yes. Okay, Vern.

And our last question comes from a Bill Tanner of Guggenheim Securities. Sir, your line is now open.

Yes, thanks. I had a follow-up maybe for you, Buck. If you could give us a sense of the CapEx requirements for -- I guess, the existing facility might need some modification, but then, obviously, the new one. Just some kind of a ballpark investment there. And Stan, as it relates to the partnerships, I'm assuming since this is Novavax's technology, you're probably not really looking for a partner to provide much there.

Yes. So I'll take that. So yes. So as part of this whole global discussion about RSV partnering, we're not at the point where we've decided whether we're going to just expand our own capacity or whether we're going to take our partners' capacity to do that.

The cost of capital, to answer part of Buck's question, it's unanswerable right now because the cost of capital of outfitting that larger facility will be part of the discussions on our partnering. So I think that it's fair to say that both in terms of capital costs and operating costs of future clinical trials and milestone payments, that sort of thing is going to make a fairly dramatic -- our expectations will make a dramatic change in the rate of burn that we have for this program. And so that is being well considered in these discussions.

And as you're thinking about the partners' facilities, I'm assuming that you're thinking about retrofitting them.

Yes, they'd all have to be retrofitted because we use this single-use technology, but it's not so dramatically different that it can't be put in -- retrofitted into one of their facilities. So it's not that different from traditional manufacturing.

Got it. Okay, thank you.

Okay. Thanks, everybody.

Sir, I'm not showing any more questions.

Okay, great, thanks. We'll talk soon.

Ladies and gentlemen, the conference has now concluded. If you would like to hang up your phones, you may now do so. Thank you, and have a great day.