Good day, ladies and gentlemen and welcome to the Novavax First Quarter 2017 Earnings 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. As a reminder, this conference call is being recorded. Now I would like to introduce your host for today’s conference Buck Phillips, Chief Financial Officer and Treasurer. Please go ahead.

Thank you, operator. This is Buck Phillips, I’m the Chief Financial Officer and Treasurer here at Novavax. Before we start our formal business, I would like to recognize Andrea Flynn, Novavax’s Director of Investor Relations, who is typically with us on this call, but will be unable to join us today. We’d like to congratulate Andrea and her husband Mark on the arrival of their brand new baby girl, Sydney. Okay, starting the call, I’d like to thank everyone for joining today’s call to discuss our first quarter 2017 financial results. A press release of our earnings 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. 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. 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’ll now turn the call over to Stan to begin today’s discussion.

Thanks Buck. So good afternoon everyone. Thanks for taking the time to dial-in to our call today. As usual I’ll begin the call with an overview and Greg will provide an update on our pipeline and then next Buck will review our financial results and after that I’ll open it up to Q&A. So first, I’d like to take a few minutes to set the tone of our communications for the rest of this year and beyond. Starting in the third quarter of last year, following the release of our Phase 3 RSV trial data in older adults. We made a delivered decision to hold back on press releases another pubic communication until we're able to take the time to start through our very large set of clinical data, an exhaustive review of published literature and meetings with KOLs. The goal of conducting this throw analysis we look to E301 trial, another previous trial is to better understand some very important questions including what is the impact of our vaccine and various measures of immune response and how does it differ when an adjuvant is used. What is the impact of the second dose of vaccine? How to immune response is differ in older adults compared to a younger population and for the analysis of all of our RSV clinical trial samples can we identify the factors that are useful indicators of a reduction of risk of RSV disease. Our goal was to answer these questions and apply our learnings to the unblinding of data from our current Phase II trial in older adults which we call our E-205 trial. I am pleased to say, so we are on track to meet or beat our commitment to announce top line results from this trial in the third quarter. Also when…

Thanks Stan and good afternoon to everyone on the call. Let me begin with an update on our prepared trial, the Phase II trial of our RSV vaccine that's designed to demonstrate protection of infants by maternal immunization to a number of 90 days flat. I want to remind you all that RSV is the most common cause of lower respiratory tract infections and the leading viral cause of severe lower respiratory tract disease in infants and young children worldwide. Despite the induction of post infection newly we could infection in lifelong [indiscernible] and currently there is no approved RC that is available. The Prepare trial supported by a grant of up to $89 million from the Bill and Melinda Gates Foundation. Their trials randomize, observable blinded, placebo controlled trial that group sequential design offering flexibility in trial size that is responsive to the rate of endpoint event and evolving evidence of efficacy, while maintaining and integrity of the blinded trial. The trial includes a single injection of our aluminum adjuvant RSV F Vaccine given between 28 and 36 weeks of estimated gestational age. The primary objective of the Prepare trail is to determine the efficacy of maternal immunization with the RSV F Vaccine against symptomatic RSV lower respiratory tract infection with an objective measure of medical significant, in the infants through minimum of the first 90 days of life. Participants are being recruited and vaccinated at global clinical sites based in the timing of each region’s RSV season. And the trial will include a minimum of approximately 4,600 participants. We are complete in the second year of outside the industry enrollment in South Africa, Australia, New Zealand, Argentina and Chile. All the manufacturing may decline in the trial of the monitors in unblended matter by daily Data Safety Monitoring…

Thank you Greg, today we announced financial results for the first quarter ended March 31, 2017. Summary financial statements can be found in today's earnings press release. We recorded a net loss of 43.9 million or $0.16 per share for the first quarter of 2017. This compares to a net loss of $77.3 million or $0.29 per share in the prior year period. Revenue for the quarter was 5.7 million compared to 4.2 million for the same period in 2016. This 35% increase in revenue in the 2017 period over the 2016 period was driven primarily by higher revenue recorded under the Bill and Melinda Gates Foundation grant of 89 million. As discussed in our prior calls the BMGF revenue is directly related to the operating activity in the prepare trial our Phase III trial of the RSVF vaccine to protect infants via maternal immunization. We are continuing to expect an increase in BMGF revenue in 2017 relative to 2016 which relates to the continue ramp in enrollment and increased level of activities in the prepare trial. Our R&D expenses decreased 45% to 37.7 million in the quarter compared to 69 million in the same period in 2016. The decrease in R&D expenses was primarily due to the decrease in RSV vaccine clinical trial activity in Q1 of 2017 relative to Q1 of 2016. Specifically the fully enrolled older adults Phase II and Phase III studies in the first quarter of 2016. We also experienced lower employee related costs in the first quarter of '17 relative to the first quarter of '16. G&A expenses decreased 16% to 8.9 million in the quarter compared to 10.5 million in the same period in 2016. This decrease is primarily due to lower professional fees for preclinical commercialization activity. As of March 31, 2017…

Thanks Buck. So we all remain excited about our pipeline and our prospects for 2017 and beyond. And look forward to updating you on progress throughout the year and we I'll wrap it up here and open up to Q&A. Operator Q&A please.

[Operator Instructions] And our first question is from the line of Joel Beatty with Citi. Your line is open, one moment.

My first question is, do you anticipate the results from the analysis of the E-205 study to lead to changes in those things being needed for the maternal RSV vaccine?

No I don’t think so. It won't make any difference for the maternal vaccine at all I don’t think. So it will be just to determine what we think going forward with the elderly will be.

And then just last one question. Can you talk a little bit about the information you planned to collect from the informational analysis of the Prepare trail and how it’s difference from interim analysis? Thanks.

Hi Joe, it’s Greg. The informational analysis will have provided the indication of the potential efficacy here at the trial's primary endpoint and we’re going to use it and to provide planning information, so we can deploy resources and an expeditious way for our development program. So we can’t use it to change either the conduct of the trial or the protocol based in these analyses and because of this limitation it carries no statistical costs or Type 1 error. And we should note that this is be done by the unblinded by the DSMB and we simply will get a yes or no answer. So the interim analysis is obviously different and it’s in the protocol for some time and there as I think we’ve provided earlier. The former interim analysis we're defining success and can also the trial conduct, it is conducted with the Type 1 error cost and the fixed interim analysis will be conducted after medium of 3,000 women have been enrolled.

Okay. Speaking -- you mentioned that you could get a yes/no answer. Will you be able to get like pin points of where the primary endpoint is trending or is it just limited to those yes/no answer?

Yes. As a probabilistic statistical approach and we won’t be pin pointing any efficacy number.

Okay. Thank you for taking the questions.

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

Great. Thank you very much. Actually in the past [technical difficulty].

I can’t hear you Ted.

Sorry. Can you hear me better?

Better.

Okay. Just what needs to be done for the Phase 1 studies for the Zika vaccine and the flu [ph] vaccine?

Look, the Zika vaccine were building the R&D, we’ve got some formulation studies and we’re expecting -- we’re getting guidance that we'll be able to start the trial in the lateral part of this year. With flu, it’s really kind of the same activity, we’re building the R&D for that, and we have some manufacturing and some pre-clinical study that are going go into that. So similar activities, pre-clinical package, talk/study package and the manufacturing PNC package have been built for both of those programs, we expect to start again towards the end of this year.

And how [indiscernible]?

Well, it’s a relatively small study in the Phase 1 safety and immunogenicity studies.

And the other magnitude with couple of hundred people each.

Great. Thanks so much. looking forward to the data.

Thank you. And our next question is from the line of Bill Tanner with Cantor Fitzgerald. Your line is now open.

Thanks for taking the questions. Greg, I have a couple for you. This as relates to the 205 data when it comes out, I don’t know if you can put some numbers around what would be good results, I guess, especially by comparison with some of the Phase 2 or the Phase 2 data that you released couple of years ago. And just as thinking about obviously couple of either unadjuvanted or adjuvanted with two different adjuvants and one or two doses. I mean it seems like sort of the Occam's Razor is the Matrix-M and two doses would be the best. So just kind of curious what you're looking for there in terms of getting the best response maybe with the least side effects, just couple of those two questions, thanks.

So you pinned down what we're going to look at, the safety immunogenicity is going to be compared to the reference formulation we've been using in the older adult program since really our Phase I trial, it was also used in the Phase II and Phase III. So you know I think when we give the call we’ll give some detail on what we've learned from the Phase III trial in terms of what we think matters. So you can tell then I don’t have numbers to give you on the kind of movement we're looking for. I think you'll find the analysis quite interesting and think we're looking forward to that. So yes Matrix-M you know in the two dose regimen is going to be of great interest to us and I think you pinned it down. We'll use the immunogenicity and safety data and again compared to your reference formulation to see what we select going forward and in the context of our Phase III analysis around the rich reduction with our immune response.

And you know as it relates to the antigenicity, how does that inform you in terms of going into a pivotal. I know the last, the other pivotal, the last trial I think it seemed to be beset by the problem of, the attack rate was lower. So these are maybe two sides of the same coin and one of them you want to make sure that you've got good immunogenicity and the other you want to make sure that you've got a good handle on what the attack rates for the two sides of the trial appropriately is that kind of the way to look at it?

I think we're looking to move the needle in an appropriate fashion for immunogenicity and I think our view of a clinical trial is we can adapt to the type of event driven trial that we have in maternal, so it can be an event driven maybe multi-season or [indiscernible] designed to allow have an event driven trial and avoid some of the quirks of the seasonality of RSV. We also expect in the coming months to be able to share some very significant epidemiology data through conversation with KOL and new studies and I think that together with our consultation with KOL is what'll have the better guidance on our plan forward.

And then maybe just the last question, as I must confess I haven't not very conversant in malaria vaccinology, so I guess I would think that that's either been looked at quite extensively in either cracked or maybe it’s been intractable, so maybe if you could sort of briefly profile where do you think the Novavax vaccine has a better shot?

That's a great question so there has been a lot of work done and people and old gray heads in this company had their finger in some of that work in previous iterations to their jobs. But there is a vaccine that's showing efficacy it was a vaccine using, I would say, suboptimal antigen in adjuvant and we were able to -- the program at the Jenner Institute is using that as a comparator with the mind that they need to have an improvement over that formulation. So it’s the vaccine that you would use the immune response to block the infection and you know the testing is going on in animals and then they do a human challenge study. So we're quite excited about the results, the adjuvants seems to be really important, that is given along with the antigen as they discovered there at the institute.

And our next question comes from the line of George Zavoico with JonesTrading. Your line is open.

A couple of quick questions I hope. The Southern hemisphere season when does that start and when does that end? And compared that to northern hemisphere so how far are we in the southern hemisphere season?

So just the U.S. for example it does, it's somewhat regional. But roughly speaking it's November to March, so around five months. In the Southern hemisphere, its more or less mirrors that, so roughly speaking it's April to August. And so reference to the Phase II trial we wanted to make sure that the incidents of new RSV infections which do induce immune response would not confound our ability to interpret our immunogenicity results which measure similar outcome. So that was why the Southern for that trial.

When all is said and done with the trial do you expect to have a pretty good geographical balance between Northern and Southern hemisphere?

Now you are talking about out material trial, and yes. We have both regional and local knowledge of RSV seasons in all these sites and as you probably know it’s such a prominent pediatric disease that the pediatric -- the clinicians there well aware of what the onset of the season is. So we have an important customized algorithm for the local sites to use, to taking into account both the onset and the termination as RSV.

And we're running the elderly now, you are talking about considerable amount of data, hope it's going to be logical as well as efficacy and safety of your own vaccine. That suggest that -- can you do this respectively and somewhat retrospectively with your Phase II data, but you suggest that now a lot of the data is known. So you put this trial and the list that you are doing in the RSV space and context that what was known previously in terms of the epidemiology and attack rate? We all know it has a big burden, but you seem to be providing for the first time or as close to the first time, number that can be applied to this.

I think we are going to have a very detailed presentation to come that will include some of the work on epidemiology some of additional conversations we've had with KOLs on epidemiology and then analysis of a very large body of data from our E-205 and E-301 trial and because I said all that would give us a lens on how to interpret the formulation selection we've made and hatch a plan forward. If could beg your difference, I think we'll get into that in some detail in the near future here.

I appreciate that, but I was just asking in terms of context, this sounds like there is a lot of considerable amount of information that nobody really had handle on before.

You are correct, that’s correct. We have charted new waters and we have learned a lot and I think it's been very instructive for us as far as the path forward.

Regular flu vaccine, the VLC that you are working with before, that was -- that included -- and the VLC included the newer amenities as well as the Matric portions. The new vaccine is only going to be [indiscernible]. And one of these issues that you talked about before, I was providing more universal sort of or durable protection, if they were anti-immunity antibodies which was develop as well. So I guess, this is now fallen off the table as it were with the new vaccine. Is that correct, this year it's just [Multiple Speakers]?

Yes. As we said the stability and immunogenicity of once now much more pure product is better. And so we recognized there are some value in immunogenicity [ph] respond. But the ancillary responses we are getting or broadly neutralizing and they’re quite protective, at least in each animal model. So we felt that those tradeoffs and then frankly, the critical component for this is the Matrix-M adjuvant which does a number of thing, it advances the immunogenicity overall, it seems to highlight the broadening neutralizing antibody epitopes quite nicely so you get more induction of that type of the immune response. And so given all that, we felt that the product going forward with the best choice with the many that went into that decision would be an HA [ph] based flu nanoparticle with Matrix-M.

And this is going to be applicable to all people? Elderly and younger people?

Yes. Right now, we’re targeting the older adults. We want to be competitor or superior to the currently licensed products they are targeting older adults. That’s our first goal, one would presume that if it works well in that population, it could be extended to other populations, but our focus is to get into the older adult with our vaccine.

Okay. And a question about the CMC for the Zika and the flu. Are you still [indiscernible] or have you vacated those?

Yes. So have completed the Zika manufacturing and we are building pre-clinical use of the rest of the package around that for the R&D and flu manufacturing is ongoing.

I think, George, it’s Stan. So the flu is -- actually we've made some dramatic improvements in the process in terms of purity and yields, and really quite pleased with where that’s going right now. So we’re in the process of making GMP material. This is now May that will be released in the summer.

Okay. Cool. And then finally one last question on the malaria vaccine. Are these the same folks that were working on the GSK vaccine that we saw the results on?

They have been working on the GSK vaccine, right. And they are, as you probably know the field studies have been promising, they've got some limitations and a big appetite to improve the efficacy of those vaccines. So I’m a believer in the vaccine that has been made, I think it's a big accomplishment in a very tough area, I also believe that the vaccine could be improve and [indiscernible] good taking good strides in that direction.

They're developing data that compares ours or -- Matrixes [indiscernible]. I believe we will, I think the data's going to come out pretty soon in humans and so we'll let them determine the timing of that, but I think we look quite favorable.

Are you contributing is there something to the Welcome Trust or are they purchasing it?

Well it's -- I don't Buck are we selling it to them or giving it to them?

They are purchasing it, in small amounts.

Small amounts.

Okay. Terrific, thank you that's it for me.

Thank you, and our next question comes from the line of Jessica Fye with JPMorgan, your line is open.

Hey guys this is Ryan on for Jess, appreciate you taking our question. Stan, I think earlier in your opening remarks you said you're pleased with enrollment activities and it sounds like there's a number of sites coming online so I know that you're not going to make too comments on it specifically, but you know does that -- sounds like you guys are at least are on track and maybe it sounds like you guys are even a little bit ahead of your expectations? Is that a fair interpretation of your opening remarks?

Yes, as my opening remarks said we don't comment on numbers of cases and vaccines, but we've opened up this figure where the first year was mostly I would say learning the operations of how to do something that's pretty complex, you got a mom and you got a kid being born, you got to follow everybody and just getting that set up in the U.S. and South Africa which is where we started was a big effort and it's really rolled into a second year that's manifold times enrollees over what the first year was and I expect the same will occur in the third year. So it's going well, we're projecting that we will have enough cases by the end of this year to do the informational analysis and for the interim analysis by the end of '18 which could lead us to a great place by the end of '18, so it's going fine.

Okay, great and Buck maybe a quick question on the cash burn reduction versus '16 you know you said you guys are probably closer to the $105 million and is there any additional sort of in the pushes and pulls that are kind of putting you towards that, is that the Phase I studies for the seasonal flu and Zika studies or how do we think about sort of some of those factors that are impacting that you putting you closer to that end of the range?

I think when we came out at the beginning of the year we provided a range as you know on the 2016 earnings call on February 28th, we actually upped the range for greater savings relative to last year's burn, I think as we work through the year and we get quarters behind us, we're able to get greater granularity and visibility on what that total year number will be. We do some conservative planning around here, so obviously as we execute against that conservative planning and look for other ways to save some money, we do save that money, I will state that the Phase I Zika and the Phase I Influenza trial are included in the guidance that I provided, the cash burn guidance so those expenses are included.

Okay, great, thanks for taking my questions.

Thank you, and ladies and gentlemen this concludes our Q&A session, I will turn the call back to Stan Erck, President and CEO for his final remarks.

Okay, so thanks for listening, number one. Number two, I have said it in the beginning I am excited about the rest of the year. We are going to have a lot of things to talk about, data and progress and it's nice to be in this point again and so we look forward to coming around and seeing some of you folks as we get on the road as well, looking forward to. So thank you.

Ladies and gentlemen, thank you for participating in today's conference. This concludes the program and you may all disconnect. Have a wonderful day.