Good day, ladies and gentlemen, and welcome to the Novavax Third Quarter Financial Results 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 be given at that time. [Operator Instructions] As a reminder, today’s program is being recorded. I would now like to introduce your host for today’s program, Andrea Flynn, Senior Manager, Investor Relations. Please go ahead.

Thank you, operator. Good morning. This is Andrea Flynn, Senior Manager of Investor Relations at Novavax. I would like to thank everyone for joining today’s call to discuss our third quarter 2015 financial results. A press release and 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 Senior Vice 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 morning, everyone. I expected our call this morning will take a bit longer than our usual quarterly calls I hope you don’t mind. But we are very pleased to discuss the most eventful period in the history of Novavax. During the third quarter, we delivered positive results from five of our key clinical programs, including our RSV F vaccine for older adults, protection of infants by maternal immunization and for pediatrics as well as our seasonal influenza vaccine and Ebola GP vaccine. We also announced earlier this morning that we have initiated a pivotal Phase 3 trial of our RSV F vaccine in older adults. This represents the company’s first Phase 3 trial that is expected to result data roughly a year from now that would be used to file our BLA. Furthermore, with the success of our clinical and product development efforts with RSV in the older adult population, along with our discussions with the FDA and the RSV older adult in the Phase 2 meeting, we believe we will achieve our goal of initiating Phase 3 trial of our RSV F vaccine to protect infants via maternal immunization in the first quarter of 2016. Importantly, our balance sheet remains strong providing us with the capital necessary to aggressively advance our programs to the market maintaining our substantial lead over other competitive efforts. A little over a month ago, we hosted our third Annual Analyst and Investor Meeting, where we received our, where we reviewed our programs in detail. So, for this call, I’ll ask Greg to provide a quick review of our programs, although for obvious reasons, he’ll be talking a bit about this landmark Phase 3 event. Then, Buck will provide an overview of third quarter financial results and finally I will wrap up and then open the line for questions. With that agenda, let me hand the call over to Greg.

Thanks, Stan. Good morning everyone. Thank you for your interest in Novavax. I’ll begin the call this morning with today’s announcement regarding our RSV vaccine program. As Stan mentioned, we are very pleased to announce we have initiated our Phase 3 trial to older adults as we have indicated that we would. We’ve been able to reach this seminal point due to dedication and hard work of our superb team in Novavax through high quality and frequent advice of number of experts in the fields of genetics half the time, and timely in constructive review of our program by the FDA. The trial, known as Resolve is a randomized, observer-blinded, placebo-controlled trials, and this line can grow approximately 11,850 subjects adults 60 years of age and older at 60 sites in the U.S. The primary efficacy objective of the trial is preventing the 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. The trial has been designed based on the Phase 2 results discussed last quarter, in which we were able to describe the RSV attack rate, of vaccine effect with case definitions. As a reminder, the net Phase 2 trial, we followed 1,600 subjects with active surveillance for the 2014/15 U.S. RSV season. We found an overall 4.9% RSV attack rate with elders among which 1.8% had moderate to severe cases as mentioned by multi-symptomatic lower respiratory tract disease. We observed a 64% efficacy against moderate to severe disease associated with lower respiratory tract disease in post ad-hoc analysis. We observed a 44% vaccine effect against overall RSV patients. [Indiscernible] Phase 2 trial was provided to the FDA for review, and subsequently we…

Thank you, Greg, and good morning everyone. Today we announced the financial results for the third quarter and nine months ended September 30, 2015. Summary of financial tables can be found in today’s earnings press release. For the third quarter of 2015, we recorded a net loss of $33.1 million or $0.12 per share. This compares to a net loss of $19.7 million or $0.08 per share in the prior year period. The increase in net loss in the third quarter is primarily the result of increased R&D expenses related to the clinical trials of our RSV F vaccine candidate, and higher employee related costs relative to the same period last year. Revenues for the quarter were $6.5 million compared to $8.2 million for the same period in 2014. This decrease in revenue in the third quarter of 2015 is the results of a lower level of development activities under the HSS BARDA contract as compared to the same period in 2014. For the third quarter of 2015, cost of government contracts revenue decreased 32% to $2.7 million compared to $4 million in the same period of 2014. Consistent with my prior statement on revenue variance, the decrease in cost of government contracts revenue was associated with a lower level of development activities under the HHS BARDA contract in the third quarter of 2015 as compared to the same period in 2014. R&D expenses increased 45% to $27.9 million in the quarter compared to $19.2 million in the same period in 2014. The growth in R&D expenses was primarily due to increased activities related to our ongoing and our planned RSV vaccine clinical trials along with higher employee-related expenses, which includes an increase in non-cash stock compensation expense. G&A expenses increased to $9.1 million in the quarter compared to $4.8 million in the same period in 2014. This increase is primarily due to higher employee-related expenses which included increase in non-cash stock compensation expense as well as growth in pre-commercialization expenses. Increases in employee related expenses, across both for G&A and R&D, are primarily driven by growth in headcount as the company evolves to meet its later stage development and pre-commercialization obligations. As of September 30, 2015, the company has $290.2 million in cash, cash equivalents, and investments on the balance sheet. This concludes my financial review. I’ll now turn the call over to Stan.

Thanks Buck. We’re incredibly pleased to have initiated our Phase 3 trial on older adults today and to review the clinical results we delivered in this third quarter. Initiating this Phase 3 clinical trial and all the results is a significant achievement that creates value for our shareholders and also advances our RSV vaccine towards approval with a potential to have a significant impact on human health. The Resolve trial takes one step closer to bringing the support of vaccine to nice and clear years ahead of other RSV vaccines and all their efforts. We’ll wrap up there and open it up to Q&A. Operator, Q&A please.

[Operator Instructions]. Our first question comes from the line of Cory Kasimov from JPMorgan. Your question please.

Hi, good morning guys. This is Martin [ph] on for Cory. And thanks for taking my questions. I just kind of want to start off with the Phase 3 study design and just wanted to get more clarification on the primary end-point. So, what exactly qualifies as an event for this end-point and how many symptoms the patients need to have to qualify? And how does that compare to the secondary end-points reported in the Phase 2? And I have a follow-up.

Yes, hi, Cory, Greg here, Martin sorry. So, the definition as you know is multi-symptomatic to our respiratory tract disease. These are patient reported symptoms in science. Patient reported symptoms for lower respiratory tract illness include cough, speed of reduction, wheezing and shortness of breath and/or Orthopnea. So, these patients have to have three or more of those symptoms to reach the case that we should, obviously are to be positive by PCR. And that’s pretty much in line with what we, that’s in line with what we observed in the Phase 2 trial. The inclusion of all causes is to include symptoms we described in the Phase 2 trial or upper respiratory disease includes nasal congestion and respiratory infections. And Orthopnea is should add, Orthopnea is defined as 21 breaths per minute. So, what happens I would say, patient calls for, [indiscernible] active impassive surveillance patient calls, they are either able to come in or if they are unable to come in then they have to study the risks, as visit them they go through the CRF questionnaire which is just stated as interim there swapped, provided also taken that’s all inhibited and sort of starters.

Okay, great. Thanks. And then just my follow-up is, what kind of led to the decision to increase the expected enrollment number? Can you give us more detail as far as the lower bout of the confidence interval for the primary as well?

Sure. This as we analyze the data, the data provided by the FDA, they rationalization both on the ordering and rationalization on the end-points we described and the lower bout of confidence intervals. So, for the primary it’s 30%, throughout the 30, more about the confidence interval 30%. And for the secondary it’s 25%. So, we power these studies based on those numbers to have primary objective well and that is of 90%. And the secondary objective to be powered at 85%, that’s we think are very, very conservative numbers.

Yes Martin, this is Stan. I just pointed out that we had previously estimated we’ll be on the 8,000 to 10,000 rate we went to 11,000 more as an insurance policy because we wanted to nail the achievement of our primary end-point and learn. As to Greg said, we are well in excess of 90% which if we have a season that has fewer attack rate or lower attack rate we’re going to be in good shape.

Okay, great. Thanks a lot.

Thank you. Our next question comes from the line of Bill Tanner from Guggenheim Securities. Your question please.

Thanks for taking the questions. Greg, on the 60 sites or maybe just describing the patients and these are going to be community living patients I’m assuming or?

Yes, they are ambulatory generally, we carry them. So they can be both community as well they can be in care centers, they have to be ambulatory and able to either come in. So they’re generally functional, except these are not nursing high-care patients.

Okay. And then, just to be clear, the treatment effect that you would need to see would be as it relates to the primary and the secondary?

Well, because it’s well powered, it’s powered on 64% to test of efficacy that’s because the power is in excess and the lower value of comps defined there is 30%. So, we have this well powered treatment effect that’s why we have to be 64%, highly powered study.

Okay, okay, all right. Thanks very much.

Thank you. Our next question comes from the line of Joel Beatty from Citi. Your question please.

Hi, good morning. Thanks for taking the questions. The first one is just on the status of enrollment in the trial. Do you have all the sites on board and have you began enrolling patients?

Yes. Both the answers are very short ones, yes, yes.

Okay, great. So, I guess another question and what the FDA, where you’re tucked in might be looking for. Do you expect that the vaccine would be approved if the trial just hits the primary end-point or do you expect you also need to hit the secondary end-point?

That’s a good question. We would be approved based on success in the first. It would be within our view augmented with success in the second. But obviously the first end-point is providing the economic cost burden and it impairs with the very keenly supportive of this. The FDA also did know this is more severe and more significant burden of disease it fits in moderate to severe agreements. So, but to answer your question mechanically, the end-points are analyzed in a higher fashion so the primary stands alone, and it’s positive. The alpha error can be brought into the second analysis and if the second analysis is positive these would then be considered for the indication. We do believe in a review sending that if, one were to miss the lower bout of confidence interval that can be still discussed potentially accepted by the FDA. So, there is a fair amount of I think potential for success in both of the areas.

Okay. And then, finally, I noticed that the press release describes the trial is observer-blind and doesn’t use the terminology double-blind. Could you confirm whether or not the patients will know whether they’ve received RSV vaccine or placebo?

Yes, they would not know.

Okay, great. Thanks for taking the questions.

Thank you. Our next question comes from the line of Heather Behanna from Wedbush Securities. Your question please.

Hi guys, congrats on the progress and thanks for taking my question, just a quick question about the RSV rate in general. I know that it’s been pretty consistent from year-to-year. But if you could give us a little bit more color on sort of the sub-group that you’re targeting as far as moderate to severe RSV? And what factors we might want to look for to see, does it correlate with a higher flu or we see more severe cases and the things to look forward is? Give us some confidence in the numbers on the attack rate for your primary end-point?

So, in our trial the attack rate was 1.8% for the moderate to severe. The attack rates were all RSV was 4.9%. We during the running of Phase 2 trial, we get to practice on some of the logistics. We determine that to be our surveillance could be improved especially by those who call but could not come into the clinic. And we would expect to through these modifications of our trial conduct to increase the attack rate simply by catching all the cases that are there. We have built into the as Stan mentioned, we have an insurance policy based on the powering studies, we could withstand a very significant variation in RSV season. However, it’s our view that the RSV is relatively consistent in this range. So, we’re both prepared by the end, the powering of the study the clinical trial interventions for surveillance. And the back team effect frankly, I think we can whether - we’ve powered this study very conservatively for success.

Great. Thanks for the color.

Thank you. Our next question comes from the line of Ed Tenthoff from Piper Jaffray. Your question please.

Great. Thank you very much. And thanks for the update. Any comments first with respect to the number of patients in the elderly study, is this more than we were initially anticipating?

Yes. We were looking at 8,000 to 10,000 through our discussion with the FDA in terms of the end-points that this approach we have powered it up. And so, it would be restate what I already said, this has allowed us to be sure we meet our end-point, very robust as far as power in primary over 90%, and 85% of the secondary.

Okay, great. So, it’s really more an instrument of increasing the power around the change primary?

That’s right. Well, and that’s correct.

Well, and Ed, this is Stan.

Hi, Stan.

Good, how are you? So, when I said we want to be well over 90% power and we said one of the incident one of the attack rate is 1.5% or 1.2% and we want it to be a one-season trial. And so we said it’s worth the investment as insurance to make sure we’re in there, almost any considerable season.

Okay, awesome, makes a lot of sense. Thanks so much.

Thank you. Our next question comes from the line of Kevin DeGeeter from Ladenburg Thalmann. Your question please.

Hi, this is Jake Colby on for Kevin this morning. Thank you for taking my questions. Sorry if I missed this in your prepared remarks earlier, but do you have a status update on the pentavalent program and your timeline for moving that into clinical development?

Yes, so, this is Stan. And so it was sort of lost with all of the other data that we’ve been putting out. But at the end I think Greg mentioned we are putting together plans so that we can run a pentavalent combination vaccine on the second half of next year. We think that’s a very important trial. It’s not in the same critical pathway as license is, getting your feedbacks being approved first. So, we’ve been able to put that after the second half of next year. So, we’re working on it.

Okay. And then one quick follow-up. Do you believe that one formulation would work for both the elderly and new-born populations or would they require different formulation?

Yes, they’re both in development program we determine based on the target profile what was appropriate dose and formulation for each population. And so they’re different.

Okay, thanks.

And just to follow that up, so we’ve got two different products, one for the elderly and 135 microgram dose unadjuvanted. For the maternal we have 120 micrograms with an element adjuvant. And we have yet to determine what the final formulation or the final dosage would be for pediatrics. We’ve got some very positive data from a small trial this year and we’re going to work on once we get both of these Phase 3 trials kicked off by the beginning of the year, then we’ll put together a clinical development plan for pediatrics. And the first trial will be designed to determine whether we have a formulation, what formulation will be with adjuvant or non-adjuvant and what the dose level would be. So, that’s the next trial.

Okay, thank you.

Thank you. Our next question comes from the line of George Zavoico from JonesTrading. Your question please.

Hi, good morning everyone, and thanks for the update, and congratulations on starting the Phase 3 elderly. One of the criteria for the Phase 3 for the elderly, is it going to be that they’re going to be required to get a seasonal flu vaccine as well? And is there indication that if the elderly don’t have a seasonal flu they might have a more, a different kind of RSV response or is it totally unrelated?

So, that’s a good question. So, we of course, we either - they have either had a pre-seating flu vaccine when they’re enrolled and that’s there is a timeframe in which that’s eligible or at the same time, the same visit we offer them a flu vaccine. So we do stratify that. And we are looking and you may recall, we have provided today that surely that there is no interference with the influence in Response. So that’s something we have to study and look - take a look at. We’re not expecting a significant interaction between that and the RSV vaccine, because obviously these are both seasonal flu vaccines and it’ll be oddly convenient to provide the vaccines at the same time or without interference at patients’ convenience. Right now, having flu vaccine in separate arms when they ask for it at the visit, but we have I think I believe a 30 to 45 day window. So we’re starting, so it’s a fairly narrow window and we’re starting now. So, a certain number, of population will already have a flu vaccine and they will offer to those who have not.

If there is a bigger flu season and perhaps then you strain, they may not be well covered by the seasonal flu vaccine. How are you adjusting for any complications that that might occur because of that?

Well, we don’t, there is a fair amount of FDA logic evidence that there isn’t a lot of interaction between flu and RSV itself. So, for example, we saw very few color effects in our first trial. So it can affect the timing of the actual cases to some degree but the way the trial is starting, we stay on that time period as well. So I don’t anticipate that they’re good or bad flu season will necessarily have any effect on the trial. As Stan mentioned, we’ve tried to power this study so that we have some variation in the attack rate, we would be helpful there. We have attempted and we have setup in place, of a little bit better system for catering subjects who need solving the new home limits. So, we’ve invested a fair amount of estimation, we capture everything. In my view, we’ll capture more than we did in the past season because our system is all more robust here.

And of course you’re going to be, when someone comes out of the system of course you have everything in place to determine that this is impact our severe enough flu, I mean?

Right, that’s right. That’s correct. That will be evident since it’s blinded it’ll be evident once we’re unwind. But the PCR multiplex I think there is 20 plus pathogens, higher pathogens that we protect. And we didn’t take flu in the last trial. So and as I mentioned we did not see most in the way of co-infections including flu.

Okay. And then, couple of quick questions on immunization, the maternal sorry. For the maternal immunization early 2016, that’s after the RSV season. So is that likely to start in the southern hemisphere?

Yes. That’s, you picked that timing right. So right now that’s our general plan.

Okay.

And we will have gone through with FDA in Phase 2 meeting. So there is less as you know since this is a two to four year global plan, there is a little less urgency to click the study off in robust way as you list.

Okay. And doing the same question for the quarter variance, you’re going to get guidance in the early part of next year. So, I’m presuming you’re going to try and kick off the Phase 3 for the ‘16/’17 season?

So, George, we just have to wait and see. We’ve - that program has done well, BARDA really likes the data that they saw in the 206 trial that we advanced. But we’ve made some pretty significant advances in the process along the way and the product. So, we’re just having a good thorough analysis of the past forward, I just can’t announce anything until we finish our planning process with BARDA and that will probably come sometime around the first of the year. We’ll let you know.

Okay, great. Thank you very much.

Thank you.

Thank you. Your next question is a follow-up from the line of Bill Tanner from Guggenheim.

Thanks for taking the follow-up. Stan, just a question on, and I apologize maybe little bit unfair to ask but the older RSV, you mentioned, you guys mentioned top-line data second half of next year, BLA filing in 2017. What’s the chances of and obviously a lot of it’s up to when the data comes in and you can file the FDA. But what do you think the probability as of the chances or how do you think about perhaps having that vaccine ready for the 2017 RSV season?

Yes, well that would be on a spectrum of possible outcomes, possible. But I wouldn’t project that right now. I think so, we’re going to end, season is going to end the same time the last trial did which is in April/May. And we just have five times the amount of data that we’re going to be crunching and going through. So I think we announced this one on August 10 or somewhere thereabout. You got to give us a little extra time to go through the data and make sure we’ve got it. So, we’re going to be announcing that data in the fall some time. And we’ll be, you can imagine that that’s our trial for error, you can put to BLA together the both the clinical and CMC package. And we’ll be encouraging the FDA to review as quickly as possible. But, so I think it’s more likely it would be proved sometime in early 2018 or late 2017 but we’ll see.

Okay, great. Thanks very much.

Thank you. [Operator Instructions]. And this does conclude the question-and-answer session of today’s program. I’d like to hand the program back to Stan Erck, CEO for any further remarks.

Thanks. So, this is it. We’ve become a Phase 3 company now. And we’re moving on all cylinders. So we look forward to talking to you at various meetings and reporting back in the next quarter. Thank you.