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Novavax, Inc. (NVAX)

Q3 2016 Earnings Call· Thu, Nov 10, 2016

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Transcript

Operator

Operator

Good day, ladies and gentlemen and welcome to the Novavax Third Quarter Financial Results and Investor and Analyst Update Conference Call. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder this conference is being recorded. I would now like to introduce your host for today's conference, Ms. Andrea Flynn, Associate Director of Investor Relations. Ms. Flynn, you may begin.

Andrea Flynn

Analyst

Thank you, operator. 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 third quarter 2016 financial results and to provide an investor and analyst update. A press release of our earnings is currently available on our website at novavax.com. An audio archive of this conference 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 President of Research and Development, Dr. Greg Glenn; Chief Medical Officer, Dr. Louis Fries; Senior Director of Clinical Development, Dr. James Cummings; 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. We have a slightly different agenda for today's call. Buck will start with a quick review of the third quarter financial results, following that we will begin the Investor and Analyst portion of the call with Stan. I'll now turn the call over to Buck.

Barclay Phillips

Analyst

Thank you, Andrea. Good evening, everyone, and thank you for joining today's call. Today we announced financial results for the third quarter ended September 30, 2016. Summary financial statements can be found in today's earnings press release. For the third quarter of 2016 we recorded a net loss of $66.3 million or $0.24 per share. This compares to a net loss of $33.1 million or $0.12 per share in the prior year period. The increase in net loss in the third quarter of 2016 is primarily the result of increased R&D expenses related to the clinical trials and development activities for our RSV F vaccine candidate along with higher employee related costs relative to the same period last year. Revenue for the quarter was $3.2 million compared to $6.5 million for the same period in 2015. This 50% decrease in revenue in the 2016 period over the 2015 period was driven primarily by a higher level of BARDA related activities in the third quarter of 2015. The decline in BARDA revenue in Q3 of 2016 is partially offset by $2.6 million in revenue recorded under the Bill & Melinda Gates Foundation grant of $89 million. The Bill & Melinda Gates Foundation revenue is directly related to the Prepare trial, our Phase 3 trial of the RSV F vaccine to protect infants via maternal immunization. As we have previously discussed, we expect an increase in Bill & Melinda Gates Foundation revenue in 2016 correlating to the costs incurred in the Prepare trial. R&D expenses increased 73% to $53 million in the quarter compared to $30.7 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 includes an increase in non-cash stock compensation expense. G&A expenses increased 50% to $13.6 million in the quarter compared to $9.1 million in the same period in 2015. This increase is primarily due to an increase in employee related expenses which also includes increases in non-cash stock compensation expense as well as an increase in pre-commercialization expenses. As of September 30, 2016 the company had $300.3 million in cash, cash equivalents and investments on the balance sheet. I will provide some detail regarding future expectations for both expenses and cash burn in my section of the investor and analyst portion of this call. This concludes my financial review of the third quarter 2016. I'll now turn the call over to Stan to begin the investor and analyst presentation.

Stanley Erck

Analyst · Jessica Fye with J.P. Morgan. Your line is open

Thanks all for taking the time to dial into our presentation today. As a reminder this is being webcast we do have a slide presentation. So please join us on our website to access those slides. I expect from this crowd that's on the phone to get a lot of credit for the following. I'm not going to make any reference to the presidential campaign and election results today. So, with that, we have a lot of material to cover, so let me get started. On Slide 3, I'll briefly review our agenda for this call starting out I'll provide an overview of the pipeline and path forward and then I'll introduce you to Dr. James Cummings. You have not met James Cummings before and he has got quite a background so I'll spend a minute doing it. He is our Senior Director of Clinical Development who will provide an update on our Zika program. Prior to joining Novavax he enjoyed a 26-year career in the U.S. Army with a proven track record in vaccine, drug and diagnostics development. He was most recently the Director of the Department of Defense Global Emerging Infectious Disease Surveillance and Response Teams where he led bio surveillance for the DOD with laboratories and partners in 71 countries and served as Consultant to the Surgeon General for all medical research and development. He received his M.D. in internal medicine at Georgetown University and completed an infectious disease Fellowship at Walter Reed and the National Capital Consortium. So our Zika program is in very experienced hands. Next Dr. Louis Fries whom you know will review our older adults Phase 3 trial results and provide information on our next steps in that program. As you would imagine, we spent the last eight weeks pouring over the data…

James Cummings

Analyst · George Zavoico with JonesTrading. Your line is open

Thanks Stan. Good afternoon. I'm Dr. James Cummings, the Senior Director of Clinical Development here at Novavax. Tonight I will review the Novavax Zika vaccine program with a background on Zika virus infection and disease, the Novavax Zika vaccine construct and address study strategy and rationale for formulation with a look at key external data followed by concluding remarks. Zika virus is a [indiscernible] virus transmitted by Aedes mosquitoes. It is also sexually spread. 80% of those infected by the Zika virus remain free of symptoms. Some common clinical symptoms of those remaining symptomatic 20% are fever, rash joint pain and conjunctivitis. The less frequent, but more severe outcomes include microcephaly and other fetal abnormalities when pregnant women are infected by Zika virus and Guillain-Barre syndrome. That ranges from generalized muscle weakness to complete paralysis requiring mechanical ventilation. Of note, Zika was added to the priority review voucher program list in April of this year. This map represents the geographic areas of active Zika virus transmission as reported in November from the U.S. Centers for Disease Control. This is a breakdown of the Zika case counts in the United States and its territories. In the U.S. we have over 4000 total cases of Zika infection with 139 of those acquired locally by mosquito transmission and an additional 32 cases transmitted sexually in the U.S. States. There are currently 1005 cases of Zika reported in pregnant women with 25 live born infants with birth defects including microcephaly and 5 pregnancy losses with birth defects as well. In the U.S. territories there are over 30,000 locally acquired Zika cases with 100 travel associated cases reported. Guillain-Barre syndrome had been reported in 45 of these Zika cases. There are over 2200 cases of pregnant women with known Zika virus infection in the U.S.…

Louis Fries

Analyst · Kevin DeGeeter with Ladenburg

Thank you, James. I would like to shift the focus now to our RSV F Vaccine candidate and in particular our activities over the last year with regard to the older adult target population. And so if you could advance the slide 31, I'd like to just take a moment to step back and remind you were now speaking of our baculovirus SF9 insects cell derived recombinant RSV F nanoparticle. That vaccine has previously been shown to induce broadly neutralizing antibodies specific for sites 1, 2, and 4 on the RSV F protein in both animals and much more importantly in humans. It has been shown to induce protection against challenge in several animal models including cotton rats which have been predictive in previous clinical programs addressing RSV as well as baboons. The vaccine has shown efficacy in a Phase 2 trial in older adults that we'll discuss momentarily. It has shown the capacity to reduce serologic evidence of RSV infection in women of childbearing age by approximately 50% in two trials, the results of which confirmed each other and is currently in active investigation in Phase 3 in pregnant women where we've already shown efficient transposable transfer in our Phase 2 studies. I'd like to remind you briefly of the details of our proceeding Phase 2 trial in the older adult population. We did a Phase 2 trial E201 in 1600 older adults 60 years of age and older in the 2014-15 season that was a randomized, observer blind, placebo controlled trial which used 135 mcg unadjuvanted dose of the RSV F vaccine. Those subjects were followed for a year for safety, immunogenicity and efficacy endpoints. In brief, the study showed a very well-tolerated vaccine with a benign safety profile. It induced roughly 5-fold increases in palivizumab competitive antibodies…

Greg Glenn

Analyst · Citi

Thank you, Lou. So what I'm going to do is cover some familiar ground on our vaccine for protection of infants via maternal immunization and talk about our progress and some new data. So if you go to the next slide, so I'll review the competitive landscape briefly, look at some of the key preclinical data which has undergirded this program to remind you why we have confidence in what we're doing and look at the Phase 2 data, again remind us all of some of the key safety immunogenicity results, look at the Phase 3 study design and then we're going to address some of the support for continuance of the maternal trial and the lessons learned. So the next slide as you can see here is a, I'll just touch on this briefly, this is the competitive landscape for RSV vaccines and you can see I think that the highlight here is that we remain the only product that is in a Phase 3 trial state of the development and of course this is our global trial Prepare for the evaluation of the maternal immunization vaccine. So if you go to the next side, just remind you of some f the data that we generated that we think is important. This is the data in cotton rats. Cotton rates were used as the predictive model for the development of the monoclonal antibody palivizumab and the followup product motavizumab and the use of the monoclonal and the challenge with RSV virus and looking at titers of the virus of the lung those assays and those data were predictive for the subsequent trials in which there were five randomized clinical trials showing these antibodies work. And as a reminder they bind to site 2 on the F protein which we…

Barclay Phillips

Analyst

Thank you, very much Greg. To this point, Stan, Jim, Lou and Greg have done a great job laying out our corporate objectives and the scientific rationale and development plans that will be the focus of our R&D activities through the end of 2017. I would like to take the next few minutes to translate those activities into our financial and operating plan. Next slide, before we look ahead, it’s important for us to review our 2016 operating plan and the related financials. In 2016, our operating plan was built around activities supporting RSV, influenza and new product development. As we can see here on slide 82, our primary focus was on the RSV F Vaccine executing both our Phase 3 older adults resolve trial and our Phase 3 infants via maternal trial for repair. In addition, we had the Phase 2 older adult's rollover study and a series of other activities that were ongoing to support the next steps in the development and ultimately our view of the commercialization RSV F vaccine in older adults. We continued our work in influenza which consisted of managing the BARDA contract to its maturity in September of 2016 as well as the important work to transition our seasonal influenza vaccine to the nanoparticle platform from the VLP platform. And as is always our conduct here at Novavax we are always looking for new product opportunities. These operating plans are inherently tied to the financial forecast and ultimately the reported financials we put forth in front of you. Financial plans are simply an economic measure of the operating plan. Next slide, so to do that translation, we are looking a slide here, slide number 83, that contains three key pieces of financial information; a simplified income statement, cash used in operations, and ending…

Stanley Erck

Analyst · Jessica Fye with J.P. Morgan. Your line is open

Thanks Buck. So, you've now heard from the whole team and I think you've heard a lot of excitement about where we are. It’s a lot better place then where we were 60 days ago, when we were surprised by elderly data. I think we’ve got lot of insight, and lot of work. We have a lot of insight into what we think the fix is for that and plus we haven’t skipped a beat on our Phase 3 maternal program. So, we are excited, we're in a good place, we are going to conclude good 2017 and with that I will turn it over to you guys if you guys are still hanging around.

Operator

Operator

[Operator Instructions] Our first question comes from the line of Joel Beatty with Citi.

Joel Beatty

Analyst · Citi

Hi. Good afternoon. Thanks for the extensive presentation and the questions. The first question is regarding the focus and the need for higher immunological response rates and higher affinity immunological responses, will you be able to go back and look at the data from the Phase 3 trial and assess the immunological responses in those patients, you know our early in the piece of ahead events?

Greg Glenn

Analyst · Citi

Yes, hi, Joel, Greg here. So, yes, that I think what we are at now is we’ve developed what we is an important assay and we are beginning to start that work. So, the idea here is we will have several months and by the time we have the serial from the E205 trial, I think we have a very good idea whether or not we will have [indiscernible] and whether these immune measures are going to provide an extra window into the analysis. I will say, Lou alluded to it. We also have some of the analysis being done on the PCA itself and I think again we will be able to share that information in the coming few months. Our goal is to have a definitive picture of the importance of immunogenicity and time to interpret and use these assays for the E205 trial we are again we are looking ways to improve both the quality and quantity of antibody with adjuvants or with one or two dose regimens.

Joel Beatty

Analyst · Citi

Okay, great. And then if I could ask one other question, how is the enrollment in the Prepare trial going, are you able to give a timeline when you are expecting my readout?

Greg Glenn

Analyst · Citi

There are two questions here. As you know, we are not usually, we don’t give guidance on enrollment. I think just, I can say in general the trial is going quite well and we are in discussion with FDA on the interim unwinding and we are thinking towards the end of this year or certainly next year.

Joel Beatty

Analyst · Citi

Sorry, into next year?

Greg Glenn

Analyst · Citi

Yes, next year, next year we could have that result.

Joel Beatty

Analyst · Citi

Okay, thank you.

Operator

Operator

Thank you. Our next question comes from the line of Jessica Fye with J.P. Morgan. Your line is open.

Unidentified Analyst

Analyst · Jessica Fye with J.P. Morgan. Your line is open

Hey, guys, this is Ryan on for Jess, I appreciate you taking our questions. May be, can you help us understand little bit more about the cost cutting, you know those cost savings of $70 million to $100 million seems like a pretty wide range, so could you give us little bit more color on sort of what factors would put you either the high-end or the lower-end of that range?

Stanley Erck

Analyst · Jessica Fye with J.P. Morgan. Your line is open

Yes, Ryan, thank you for the question. I think just to start out, we have spent a lot of time evaluating the operating plan, the consequences of the investments under that plan and we do believe that that range on the call today is an appropriate range to provide guidance for every one through the end of 2017. Obviously, will help to tighten up some of that ranges we get further into the year. I think there are lot of impacts to the estimates that we put together to get to that number. Frankly, one of the key components would be timing of investments in some of these clinical trials and when they occur as well as other investments that would be made alongside the company to build out. So, as Greg mentioned today, sometimes in our explorations to understand the outcomes of these trials we develop a new assay. We have new learnings and new understandings, those can be impacts to our cost as we go forward and we need to be able to explore those. So, it’s a very high level response, but I will leave that with you at this point in time.

Unidentified Analyst

Analyst · Jessica Fye with J.P. Morgan. Your line is open

And high level, I mean at the high-end of that range, does that include some contemplation of starting another Phase 3 study in older adults if you were able to do it next fall?

Stanley Erck

Analyst · Jessica Fye with J.P. Morgan. Your line is open

I think the guidance I have given you today includes the operating plan that we've discussed. So there is not a Phase 3 trial in that guidance.

Unidentified Analyst

Analyst · Jessica Fye with J.P. Morgan. Your line is open

Okay great. Thank you.

Stanley Erck

Analyst · Jessica Fye with J.P. Morgan. Your line is open

In older adults, yes, we continue with the Prepare maternal immunization trial. Thank you, Greg. That's right.

Operator

Operator

Thank you. Our next question comes from the line of Ted Tenthoff with Piper Jaffray. Your line is open.

Edward Tenthoff

Analyst · Ted Tenthoff with Piper Jaffray. Your line is open

Great, thank you very much again thanks for the very thorough update. So we’ll have the Phase 2 data from the elderly patients. When do you think we could get that data? And I appreciate how this is all stitched together with respect to the financial guidance changing going forward. You know what is the most recent guidance in terms of when we should expect data from Prepare?

Stanley Erck

Analyst · Ted Tenthoff with Piper Jaffray. Your line is open

Well I think, hey Ted its Stan. I think what we’ve told you is we’re projecting second half of ‘17 and that's based upon two things. It’s based upon the case rate that we get from now until mid ‘17 and number two, successful discussions with the FDA which we've already initiated. So I don’t think I can get it closer to than some time in the second half.

Edward Tenthoff

Analyst · Ted Tenthoff with Piper Jaffray. Your line is open

I might not have heard that during the presentation. So that’s helpful. And then with respect to Prepare?

Stanley Erck

Analyst · Ted Tenthoff with Piper Jaffray. Your line is open

That was with respect to Prepare. That was maternal immunization.

Edward Tenthoff

Analyst · Ted Tenthoff with Piper Jaffray. Your line is open

So maternal immunization will get an update in the second half of 2017 you said I'm sorry?

Stanley Erck

Analyst · Ted Tenthoff with Piper Jaffray. Your line is open

And we're hoping that will be efficacy view into what that front.

Edward Tenthoff

Analyst · Ted Tenthoff with Piper Jaffray. Your line is open

And in terms of the Phase 2, the new Phase 2 for elderly, sorry?

Stanley Erck

Analyst · Ted Tenthoff with Piper Jaffray. Your line is open

So that, I think at the latest that will be the third quarter.

Edward Tenthoff

Analyst · Ted Tenthoff with Piper Jaffray. Your line is open

That was very helpful and I look forward to hearing more about the Zika program too. So this is really very helpful to help us understand where things are going from here.

Stanley Erck

Analyst · Ted Tenthoff with Piper Jaffray. Your line is open

Thanks Ted.

Operator

Operator

Thank you. Our next question comes from the line of Kevin DeGeeter with Ladenburg.

Kevin DeGeeter

Analyst · Kevin DeGeeter with Ladenburg

Hey, good evening guys. Thanks for the call for the questions. I guess two from me. Just your current thoughts about your potential path forward that would include potential a combination for influenza in light of the data that Lou described earlier in this call describing in the Phase 3 what appears to be a reduction in the potential efficacy benefit of the vaccine in patients co-administered?

Stanley Erck

Analyst · Kevin DeGeeter with Ladenburg

Sure. I think that you have to understand that that this is an instance where influenza vaccine, another manufacturer's influenza vaccine with the variety of components that relatively crude in activated influenza vaccine contains is given simultaneously and in another injection site in the subject receiving RSV F. For our programs going forward we would take a much different approach. We would use a specifically engineered nano particles flu vaccine which had characteristics or formulation characteristics not unlike the RSV F vaccine could be combined with it directly and we would anticipate most likely would be delivered in concert with an adjuvant that would allow both to have a strong immunogenicity. But I think in the case the key take home is that in the combination, in the Novavax combination vaccine we would engineer the doses and the adjuvant combination to make sure that we got strong responses to both. I think we can probably in that instance overcome the interference of the flu component and we would design the vaccine specifically to do that.

Kevin DeGeeter

Analyst · Kevin DeGeeter with Ladenburg

Okay, great. That's really helpful and then maybe one more for me then I’ll get back in the queue. I think this one is probably for Greg. Greg, one of the things we've been trying to just get our mind around is just how to think about the clinical relevance of the PCA assay in the context of this elderly population. The only assay is being used and clinically validated primarily in neonates and in pediatric populations. Are you doing any work to characterize whether or not this is really the right cell I got to be you doing any work to characterize whether or not this is really the right surrogate to be thinking about in the elderly and does the Phase 3 data sort of allow for any analysis on those lines.

Stanley Erck

Analyst · Kevin DeGeeter with Ladenburg

And I think given this is what in the part I was alluding to maybe I can expand on a little bit. So this look at the antibody affinity we think it's quite important and what it's revealed to us is we have what looks like a population that of folks that have RSV type 2 specific immunity and then those that don't. And in those that don't we think that when we induce immunity the PCA measure is not lining up with what we had expected. So in young healthy immune systems when we measured PCA it was high affinity PCA. So in the older docks as I was showing you we have that was we were surprised to observe that we could measure PCA in some vaccines but it had very low affinity. So we think that's a very important window and to what we need to achieve with our immunization. And as Joe asked a little earlier so now we can reflect back with this new measure and look at our E201 our E202 and our E310 sera and see if it meaningfully predicts our ability to indicate a protective immune response. I think it is quite likely since affinity is a known factor for listing good protection, but could be a meaningful window in which to look for immune correlative risk and interpret our formulation data. So we’re quite excited about using this assay and that's why I felt like we want to share with you tonight. We will be looking through. We’ve got a lot of archives here of course. We have a very unique clinical data set and PCR of positive subject. So it’s going to be very interesting over the next few months for us to go through this and do that very analysis.

Kevin DeGeeter

Analyst · Kevin DeGeeter with Ladenburg

Okay, great. Thank you.

Stanley Erck

Analyst · Kevin DeGeeter with Ladenburg

I think to answer your question I think high affinity PCA is very meaningful. You know that we induce in animals that seems what we are inducing in our Prepare study and I think went through us a curveball is the fact that there is the hallmark of the immunosenescence in older adults has manifested itself as an absence of what looks like RSV specific immunity. We assumed that of the many, many years of exposure of the older adult population with prime everybody what we didn't really calculate for was the fact that some of those in fact that memory would be knocked off as maybe with CMV infection to the loss of B cells. So the assay has provided a window in the population we’re in. I think it provides a window and provides real confidence that our unitization in maternal is very, very good and I think it’s going to give us guidance as we select our formulation going forward for older adults.

Kevin DeGeeter

Analyst · Kevin DeGeeter with Ladenburg

Okay great and then just one small clarification on that. I really appreciate the thorough answer. With regard to validating that assay you are going to do that against sera of from an adult population or from..

Stanley Erck

Analyst · Kevin DeGeeter with Ladenburg

Yes.

Kevin DeGeeter

Analyst · Kevin DeGeeter with Ladenburg

Okay thank you.

Stanley Erck

Analyst · Kevin DeGeeter with Ladenburg

We can take our efficacy trials now we have sera, we know the attack rate, we know who got RSD. So we have a set of windows to evaluate the meaning of this assay against the observed efficacy in these three trials. So we’re quite, you know we’re very eager we’re beginning to get into that analysis and we’ll look forward to sharing with you the results in the near future. Anything to add there Lou?

Louis Fries

Analyst · Kevin DeGeeter with Ladenburg

No, I think that the data that we have in hand and the array of samples that we have in hand as Greg said is quite unique. One of the interesting issues about understanding especially in an elderly population who are affected by what in some years for example as in the Phase 3 years relatively infrequent disease is that you don't know in a person who is not sick whether they were exposed or whether they were not exposed or whether they were exposed and resistant to exposure. So here we have the opportunity of looking at the people who got sick and essentially are trying to establish a correlative failure if you will and then contrasting those with matched individuals who were like them in every other way, but did not get sick. So that’s one of the directions that we’re going to be exploring that will take quite a lot of assay where we think it’s going to be illuminating at the end of the day.

Kevin DeGeeter

Analyst · Kevin DeGeeter with Ladenburg

Great, thanks so much.

Operator

Operator

Thank you. [Operator Instructions] Our next question comes from the line of George Zavoico with JonesTrading. Your line is open.

George Zavoico

Analyst · George Zavoico with JonesTrading. Your line is open

Hi, thanks everyone for that excellent update and summary. A couple of questions about Zika first, recently Sanofi received I think $40 million plus BARDA grant, Florida provided $25 million from its own coffers I think to study development of Zika vaccine. Can you tap into any of these external sources for funding?

James Cummings

Analyst · George Zavoico with JonesTrading. Your line is open

Hi thanks for that question. This is James. So certainly we’re looking at multiple lines of external funding from other government sources as well as from BARDA. And at this time, I believe that the BARDA funding for last fiscal have been determined, but we’re looking forward to exploring other opportunities, especially when we have the non-human primate data in hand in January of 2017.

George Zavoico

Analyst · George Zavoico with JonesTrading. Your line is open

Okay, so if it doesn’t work out, you might get it perhaps in 2018 and given the length of time for review.

Barclay Phillip

Analyst · George Zavoico with JonesTrading. Your line is open

Yes, we’re going to work on it. I mean this is – we think the U.S. government is recognizing, this is an important capuchin and we know that there is funding activity going on. So I think we will poised to start to try to obtain that funding in the coming year.

George Zavoico

Analyst · George Zavoico with JonesTrading. Your line is open

And then…

James Cummings

Analyst · George Zavoico with JonesTrading. Your line is open

Fiscal 2018, which starts in October.

George Zavoico

Analyst · George Zavoico with JonesTrading. Your line is open

Okay, and then for RSV again, the Phase 2 study that you’re going to start in next year, this is strictly an immunization study, so you don’t have to worry about what the attack rate is for next year right? But will you also be doing a secondary endpoint – secondary efficacy endpoint like you did with the primary for the first Phase 2 trial?

James Cummings

Analyst · George Zavoico with JonesTrading. Your line is open

Well, we can observe to see whether that there is a significant attack rate or not, but remember we’ll be studying multiple formulations in a relatively small trial. Now the trial will eventually span the RSV season in the southern hemisphere.

George Zavoico

Analyst · George Zavoico with JonesTrading. Your line is open

Okay.

Stanley Erck

Analyst · George Zavoico with JonesTrading. Your line is open

And so yes, we can we can be opportunistic and characterize any respiratory infections that can occur.

James Cummings

Analyst · George Zavoico with JonesTrading. Your line is open

But I think George the key here is when we get these data, we will be using different tools to measure this and was a really cool analysis. We will know a lot more about the type of immune response, each of the arms of the trial gives or nearly have.

Stanley Erck

Analyst · George Zavoico with JonesTrading. Your line is open

I think that’s true and the other thing in the trial will be of a size that we wouldn’t be able to make, draw efficacy conclusions anyway, but we can monitor rate.

George Zavoico

Analyst · George Zavoico with JonesTrading. Your line is open

But given the lack of history of attack rates from year-to-year, this is going to be an interesting endpoint to really figure out to see how frequently you might get an outlier season like you did for your Phase 3?

James Cummings

Analyst · George Zavoico with JonesTrading. Your line is open

Yes, we’re not really in quite a debt. We recognize the importance of that. We’re not really incorporating that. We've scaled back Phase 2. We want to establish in immune response that we think is as predictive of protection and we as mentioned I think we have an archive of information from these three trials that are very, very rich that we think we can learn from before we go back into efficacy study.

George Zavoico

Analyst · George Zavoico with JonesTrading. Your line is open

Okay.

James Cummings

Analyst · George Zavoico with JonesTrading. Your line is open

We also know – I just would also point out that the ACIP has an interest in adults are city surveillance and they began to, they've begun to fund some centers to do older adult surveillance, which is new and represents our interest in the disease burden, in addition to the pediatric surveillance that is going on. So I think we did present our data at ACIP and they have a continued interest in RSV and they recognize that their surveillance is to improve it. So we hope we can take advantage of some of that information that’s going to be generated this year and the coming year.

George Zavoico

Analyst · George Zavoico with JonesTrading. Your line is open

Okay. And you were – also at one point talking about doing impedes trial, moving on a Phase 2 impede something in your future. You didn’t talk so much about that on the call, is that still on the final stages…

James Cummings

Analyst · George Zavoico with JonesTrading. Your line is open

No, in our checklist – it’s in our checklist George. We just haven’t put it on the calendar yet. We are anxious to start a Phase 2 B trial and we could start one next year, we just have to put it on the calendar, so we’re not talking about it yet.

George Zavoico

Analyst · George Zavoico with JonesTrading. Your line is open

Okay, and with regards back to ZIKV, you mentioned the cost for your reactivity, is this, and it sounds to me that you could apply this – bit of approach, you could apply this for dengue. Are you considering dengue as a new opportunity, because you did have the opportunity as one of your financial goals?

James Cummings

Analyst · George Zavoico with JonesTrading. Your line is open

So I think the important thing to note about that quaternary epitope in fact that it can serve across those sleeper [ph] viruses is the fact that it is unlikely to change. So as we look at time and the effects of Zika presenting themselves along with the change in Zika virus, we feel that our target is more of a static target in terms of being around for a long time. Coupling that with Matrix, we're going to have an outstanding fact against that particular virus. And that’s I think the importance of the quaternary epitope.

George Zavoico

Analyst · George Zavoico with JonesTrading. Your line is open

Again Zika, but would you be able to apply it to dengue?

James Cummings

Analyst · George Zavoico with JonesTrading. Your line is open

Yes, it’s possible, but that’s not our first target right now.

George Zavoico

Analyst · George Zavoico with JonesTrading. Your line is open

Yes, yes, of course, just speculating. Now one last question on Zika, and then I'll get back into the queue. I was listening to back in [indiscernible] speak about Zika and even in Brazil, some of the people there are saying that you do not expect the second wave of widespread Zika infections similar like they had last year. So in terms of the [indiscernible] do you expect these kinds of peaks to sort of flatten out over time and this person actually said that maybe by the end of this year by the end of next year, everyone in Puerto Rico for example would be exposed, in which state if we do a trial, would you have to preselect for those who were exposed and having the antibodies already and those who have some antibodies already versus those that have not been exposed, it is just to complicate your planning?

James Cummings

Analyst · George Zavoico with JonesTrading. Your line is open

I think that’s more of a complex question. When one looks at the transmission of Zika virus there are many models out there. Very recently this past Sunday and on 60 Minutes, we heard Dr. Falchuk speak to that and the concern as Zika being of prominence within the United States and other areas for the foreseeable future. So, although there’s many different models out there, I don’t think that we’re looking at Zika as not being an issue for the United States for the next several years. In terms of the population of Brazil or other areas of high transmission, there is historically some evidence that prior flavivirus infection might protect an individual for a period of time after exposure to that flavivirus. But for a virus that's been discovered since 1947, we really have a dearth of information about Zika virus. So more to follow as our [indiscernible] gets better, but many experts in the field project Zika virus to be ongoing for the next several years.

George Zavoico

Analyst · George Zavoico with JonesTrading. Your line is open

Okay, great. Thank you all very much. I’ll be back in queue.

Operator

Operator

Thank you. I’m not showing any further questions at this time. I would now like to turn the call back over to Stanley Erck for any further remarks.

Stanley Erck

Analyst · Jessica Fye with J.P. Morgan. Your line is open

Thanks. Thanks everybody for both being patient with us by when we moved the Analyst Day for a month. We’ve - turns out in retrospect, I’m really glad we did it. We have learned a lot of stuff that we can be a lot more articulate about on this call. And now we’ve got a plan to recite about going forward. So thanks a lot. We’ll look forward to seeing you at various investor meetings in the coming months and reporting data throughout 2017. And with that I will sign off without one political comment.

James Cummings

Analyst · George Zavoico with JonesTrading. Your line is open

Thanks for that Stanley.

Operator

Operator

Ladies and gentlemen, thank you for participating in today’s conference. This concludes the program and you may now disconnect. Everyone have a great day.