Thank you, Operator. Good afternoon. I would like to thank everyone for joining today's call to discuss First Quarter 2018 operational highlights and financial results. A press release of our earnings is currently available on our Web site at novavax.com, and an audio archive of this conference call will be available on our Web site later today.

Joining me on today's call are Stan Erck, President and CEO of Novavax and John Trizzino, Chief Business Officer and Chief Financial Officer. Dr. Greg Glenn, our President of Research and Development, will also be available for the Q&A portion of the call.

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 strategy and other financial and business related matters, including expectations regarding revenue, operating expenses, cash usage and clinical development and anticipated milestones, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act.

Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change overtime. I will now turn it over to Stan to begin today's call..

Thanks, Erika. In the first quarter of this year, we recorded data from key clinical trials over two late stage programs. In our ResVax maternal immunization trial, we reported the first ever efficacy data in a Phase 3 trial for RSV. We've said this before but it bears repeating.

We accomplished this after 16 years of development efforts by the entire vaccine industry. Additionally, earlier in the first quarter, we demonstrated for the second time in consecutive clinical trials that NanoFlu, when compared to the best selling flu vaccine in the older adult market, is a differentiated more broadly immunogenicity flu vaccine.

These are remarkable accomplishments and reflect the importance of the Novavax recombinant nano-particle vaccine platform and the value of our dedicated development teams. So let's talk about the challenges lying ahead of us and what we're doing to address these challenges.

The immediate future of both our RSV and flu programs, rely on interactions with regulatory agencies, which have been and remain very good. So first, let's talk about NanoFlu. In a very large global market that cries for a better vaccine, we're now poised to bring a differentiated vaccine until pivotal Phase 3 trial.

Since we announced results from the Phase 2 trial in January, we have been assembling all of our safety, immunogenicity, manufacturing data and preparing a briefing document to present to the FDA at an end of Phase 2 meeting.

We expect that the outcome of this meeting will be an agreed upon Phase 3 pivotal trial design that utilizes the accelerated approval pathway to support future licensure.

If we get the green light that our Phase 3 trial design could be a straightforward as conducting a non-inferiority immunogenicity clinical trial against the license comparator, which is as efficient and cost effective approach to getting our differentiated seasonal flu vaccine into the U.S. market. Turning to ResVax.

It should be no surprise that our investors, as well as their current potential partners, have all been waiting for us to provide clarity on the pathway and timing for product licensure. That is exactly what we are focusing on.

Let me emphasize that we remain optimistic we have a Phase 3 package, including both safety and efficacy data that can support licensure. We summarized our data at the world vaccine Congress meetings last month, and continue to believe we have achieved an important needed breakthrough for the field of pediatric infectious disease.

The good news is that we are getting the attention of regulatory agencies globally. We have prepared and submitted briefing documents containing our data that provide these agencies with the full ResVax picture available today.

We have now scheduled meetings in May and June in the United States, and four other countries with national regulatory agencies and additional scientific advisors. And expect to come out of those meetings with a clear picture of our options.

Given the high burden of disease of RSV in infants globally combined with the data from the world's first Phase 3 efficacy trial of an RFP vaccine, we expect the discussions that we will have with regulators and KOLs globally will have a very high profile. We'll report on the outcome of our efforts in the third quarter.

Although, my comments have been brief, all of the regulatory planning activities that we said we would do are in process. And we expect to have multiple investor communications later this quarter. Now, I'll turn the call over to John to present a financial overview..

Thank you, Stan. Today, we announced financial results for the first quarter of 2019. A summary of our financial statements can also be found in today's press release. For the quarter, we recorded a net loss of $43.2 million or $0.11 per share compared to a net loss of $46.4 million or $0.14 per share in the first quarter of 2018.

The decrease in net loss was primarily due to decreased development activities of ResVax, partially offset by decreased revenue under the Bill & Melinda Gates Foundation, or BMGF grant agreement. Revenue in the quarter decreased 59% to $4 million compared to $9.7 million for the same period in 2018.

The BMGF grant revenue is their revenue related to operating activities in their prepared trial. And so, therefore, this decrease in revenue is the result of completing enrollment of the prepared trial in the second quarter of 2018.

Related to our net loss for the quarter, R&D incentive decreased 20% to $35.5 million, primarily due to decreased development activities, including lower clinical trial costs of ResVax. And G&A expenses were flat for the quarter at $8.7 million compared to the same period in 2018.

As of March 31, 2019, Novavax had $108.7 million in cash, cash equivalents, marketable securities and restricted cash. Net cash used in operating activities for the first quarter of 2019 was $50.6 million compared to $66.1 million in the first quarter of 2018.

While we typically don't offer guidance on cash usage, we expect our cash used in operating activities to decrease for the subsequent quarters of 2019 as compared to the first quarter of 2019. This is due to the timing of payments in the first quarter of 2019 as the prepared trial expenses wind down this year.

Lastly, we've added $55 million to our cash position in the first quarter from our ATM and expected this will give us more room to evaluate our regulatory pathway for ResVax. This concludes my financial review. I'll now turn the call back to Stan..

Thanks, John. To reiterate, Novavax team remains focused on advancing ResVax and NanoFlu in 2019. We look forward to updating you on our discussions with global regulatory agencies on pivotal licensure pathways for RSV and the use of the accelerated approval pathway for licensure of NanoFlu in the U.S.

I'd like to thank our shareholders for their continued support. We look forward to updating on our progress, both in this quarter and throughout the year.

Operator?.

Thank you [Operator Instructions]. Our first question comes from Joel Beatty of Citi. Your line is now open..

This is Shawn Egan on for Joel. Thank you for taking my questions. My first one, which countries do you have regulatory meetings planned for? I heard the U.S.

But I missed which other countries you have those plans?.

So right now, we've got regulatory meetings in Germany and in the UK, and Spain and Sweden..

And then I have two other questions, one on ResVax and one on NanoFlu. I'll start with ResVax. So you have a little bit more time to digest your data as you're putting together these briefing documents with the various agencies.

Anything about the different markets and geographies that ResVax could potentially be approved? And are there different data points that are more or less important for the different geographies?.

I think we've got Greg Glenn on the phone. I'm not quite sure how to answer the question. But go ahead, Greg..

I think what we're after is generalizable ability of our data. RSV is a global disease. It's both a temperate and tropical disease, so it's really is a universal issue. In our case it would be that the signal we saw for efficacy would be generalized [indiscernible] we have to get licensing.

And I think, you asked a little bit about what we were emphasizing. I think in that context, you look at all-cause effects and they're really quite profound.

And we have these effects that I think pediatricians would care about that is then severe hypoxemia and hospitalizations from any [indiscernible] retract illness in infants, it's really important. We are we have begun to work with WHO and part of that dialogue is pathway to getting a broad approval for the rest as well.

So I think the point is that the data in our view is generalizable and that would be -- the case we made and the effects on the all cause severe respiratory outcome is profound and we think that will drive a lot of the interest in the vaccines..

And then for NanoFlu, I believe in previous calls you've indicated that in the discussions you've had with the FDA that accelerated approval could potentially be available for NanoFlu.

Can you discuss which criteria that were discussed that if met would make this pathway available?.

So it is just -- what you ought to be non-inferior to compare to a licensed vaccine, and vaccines have already been licensed and shown efficacy. And there are [indiscernible] protections to try to compare yourself to and you go head-to-head, you reach out four sprays in your vaccine and you measure the immune response.

And we show that we are -- it's a term I hate this because I think we're better, but it's -- the term is non-inferior. And so -- and that allows you to -- it allows you to get a licensed vaccine and then you make a commitment with the FDA that post licensure as you're marketing the product, you also commit to doing an efficacy trial.

And so you have actual efficacy data down the road. But it really accelerates the process of being able to sell and market product. It's nice to be able to do a clinical trial with the product in the market..

We can refer you to the FDA guidance on accelerated approval in there. So the actual mathematical criteria are based on the geometric means, tighter ratios and share conversion and they have criteria. And we can get you a copy of the FDA guidance on the accelerated approval and licensing, so you can get more familiar with that..

Maybe that can be a little bit more clear.

But are there any criteria that had to be met in the Phase 2 studies in order for the Phase 3 program to be accelerated approval eligible?.

Safety of course, but there are pre-specified endpoints that had to be met you get a win there. But it's our view the data will support a Phase 3 trial. So theprocess right now, to be care, is we've asked for clarity on the accelerated approval pathway and we expect an answer to that very soon.

And then we will file end of Phase 2 data package, which should get us a meeting, a face-to-face meeting with the FDA in July. And that's the point at which we would reach agreement on the Phase 3 trial design, so that we can start in September, October..

Thank you. And our next question comes from Kevin DeGeeter of Oppenheimer. Your line is now open..

Just a few more questions from me, with regards to how you think about communicating the outcome from these multiple regulatory discussions.

Do you envision at least with regard to ResVax completing each of these regulatory discussions before providing an update with regard to FDA, and if you -- do you need to see the minutes before you want to provide some feedback? I'm just wondering you could -- just some granularity might help us focus on how to think about the timelines?.

I'm sure we will want as much granularity as possible and that’s on how we've kept with the dialogue is in the meeting. The meetings are all within -- initial meetings are all within one month of each other. And so we'll be getting various different opinions.

And we haven't decided whether we will -- we would announce one before we had the rest of them. But I think it maybe that we'll assemble data from the five of the conversations and say this is what we think, we're hearing and this is the pathway that we think we'll take to licensure, so this is not going to terrible….

With regard to presentations then, I guess next week European Society for Pediatric Infectious Diseases.

At a high level, we anticipate to demonstrably different part of the data than we saw a few weeks ago or will that cover a lot of comparable ground?.

I think we're going to cover a lot of comparable ground. And every week something new comes up, I think you'll cover a lot of comparable ground that will focus on the efficacy that we receive, the particular efficacy that we've got for the more severe forms of RSV, the more important from a medical standpoint.

And a couple thoughts on why there was an imbalance between the trial outcome versus the trial outcomes in the rest of the world. So those are the types of things we cover.

I don't think it's going to be suddenly different, we do have a little more time to present it, so you always a little bit more data and -- but not to say there won't be exciting presentation, Kevin..

And then just two more real quick ones, if I may, first, just a housekeeping item.

John, can you comment on your share count?.

Current outstanding shares?.

Yes, outstanding shares after we work maybe backwards from $55 million you raised-off of the ATM, including incremental shareholder issuance numbers?.

So we had $55 million raised on 84 million shares and so, total now outstanding shares is 469.5 million shares..

And then just lastly with regards to your very strong relationship with the Gates Foundation. How should we think about a timeline for potential updated scope of ongoing work under that relationship? They continue to provide meaningful financial and non-financial support to the RSV programs.

I guess under the currently defined work plan, what duration of work to be completed and when or what might the criteria be to define a new or expanded work frame?.

Well, as I have said in the past and as you know, the Gates Foundation thinks that we have clinical trial data that fits their mission, meets their needs. Its infant mortality in low income countries the vaccine works, so how to get it licensed.

And so I think we're working with them, put our heads together to define what a pathway to licensure would be just for low and middle income countries, such that we would get WHO pre-qualification. And we're laying out that pathway now.

And if it deems that that is a reasonable pathway with a reasonable cost and a reasonable time point that allows us to get the product into mothers, pregnant mothers in handful of years or less then I think that we could expect that the foundation will push us to do that, and that's a good thing..

And our next question comes from Michael Higgins from [Ladenburg Thalmann]. Your line is now open..

A couple now and I'll get back in the queue, first on NanoFlu.

Should we still look forward to 56 day, 180 day data this quarter? And when we do see that, what are the most important things that you want to see in this longer term from data versus what we've seen before?.

So what we've done with the day six here is look at the KPI responses, which is by using two assays, the egg based assay plus the FDA will judging us on terms of immunogenicity, and [VLP] which is assay that uses recombinant proteins and we think reflect -- closely reflects what happens in the nature and what we need to protect against.

And also Bill confirmed that with the use of microneutralization and that is another type of assay that was a functional assay. So that data together, we think is going to be important and it show that the responses are consisting. We're in the process of submitting abstracts to the high-end meetings and to present the data in full.

So I don't think, at this point, we're ready to go through that information.

For the assays, you'll see data from and again, just to be clear, though, generally speaking, the accelerated approval will be based on day 28 immunogenic comparison and license comparator and that of course compares that you mentioned tighter ratios and the field conversion.

I think we mentioned earlier on the call that those criteria for success in those trials are outlined in the FDA accelerated approval guidance we've been looking at that….

So it sounds like we'll see that data in this fall.

Is that fair?.

Sounds about right. We haven't announcement schedule or the meeting but we are hoping….

We're kind of losing you there, but happy to have you on the phone nonetheless.

And from the Phase 2, is it this fall to look for more information on how NanoFlu looks against the commercial trivalent flu vaccine?.

It's about right in those standards.

John, you want to chime in on the timing?.

So I think we're somewhere late September, early October..

And that conference is ongoing?.

So that’s start of the trial, so it's a cohesive trials -- we vaccinate people on day zero, we draw blood 28 days later and then you run the assays -- you collect and run the assays. And so you won't get data until the first quarter..

The data from the Phase 2 against the commercial trivalent flu vaccine smooth actually to believe that was late September [Multiple Speakers]….

We probably [indiscernible] on that.

Are you asking when we're going to published detailed data?.

Right, when we're going to see some more information on how it looks against the commercial vaccine..

Well, I think we gave the high level in our press release. And Greg, you're going to have to….

Yes, I'd say -- I just think it's -- we're submitting the abstracts and that's about the right time frame, I think September, October time frame for that information to be talked about in detail. We also feel that it's worthy of a high end publication. The timing of those submission and acceptances are hard to predict.

But I think that's our plan, so abstract for high end scientific conferences, position of the data. And we -- at this point, I don't have a specific confidence to which we have this -- we'll have the data at this point but it's good data. And I think we're very excited about the program.

And I think the fact that we think that this can move into an accelerated approval is a sign of what we think of our data..

Okay. All right, that's very helpful. It sounds like we'll have some new flow this summer on ResVax and in the fall it accept again with NanoFlu. And just one last question or two here. Can you give us an update on cash runway? And then one last follow-up after that….

So, Michael, we don't give specific guidance on cash runway. I think we've indicated in the former scripts that we expect to see cash used in the business decrease over the coming quarters off of the $108 million of cash we have on hand today. So I think $109 million. So I think that's that as much guidance as we intend to give at this point..

And Stan, I believe you've noted in your prepared remarks that you're expecting to have several investor communications this quarter? I assume that's on ResVax?.

I expect as investor communications on both of those vaccines..

Thank you. And our next question comes from Eric Joseph of JP Morgan. Your lien is now open..

This is Turner on for Eric, thanks for taking my question. So I just was curious on NanoFlu. It sounded like previously you get feedback from FDA in the second quarter and maybe got pushed back to the third quarter now.

So I was wondering, is there any reason as to why? And then number two, does that potentially impact the planned start of the studying? And I suppose is there any importance to starting the study in the fall ahead of the flu season? Or if it's delayed would that potentially be impact the potential results?.

Yes, well, if it were delayed it could impact the results but I don't think it'll be a delay. I think we had said previously that we'll be filing the Phase 2, end of Phase 2 package for the meeting. There is a statutory seven days that the FDA has to -- to have the meeting. I think we said it'll be June, July, which covers over both quarters.

I think it's more likely that it will be a July meeting. So the third quarter versus the second, so it's not a dramatic change. And yes, there's plenty of time to allow us to execute clinical trial in September, October timeframe..

Thank you. And our next question comes from George Zavoico of B. Riley FBR. Your line is now open..

Just following on from that last question with regarding the FDA and ResVax and NanoFlu.

Is that going to be one meeting where we talk about both vaccines, or you have to do separate meetings for, one for ResVax and one for NanoFlu?.

No, separate -- very separate meetings….

And with regard to NanoFlu.

The non-inferiority, does it have to be non-inferior for all four strains or not?.

Yes, that's our expectation. Although, I believe that there was a vaccine approved were three out of the four were non-inferior and one was inferior and got licensed..

So there may be a little leeway?.

Yes, there is..

And with regard to the -- what you mentioned about the Bill & Melinda Gates Foundation, it implies that there might be a different path to registration in low to middle income countries versus U.S. and Europe, and the wealthier Asian countries.

Is it possible that that might happen that you might see this flu, the ResVax vaccine approved with a backing of BMGF earlier than in Europe, supposing you have to do a Phase 3….

We are on all cylinders running in all countries high income and low middle and we want to see what we're going to get. And so we don't think it's a bad thing to introduce a product in large population markets, the price will be very different.

But with the backing of Gates and others going there, I think for nothing else it gets the product where it needs to be to save lives. And number two, I think it will demonstrate maybe help push along in the high income countries, they're reading of how the vaccines work.

So I think there's no negative thing about going into a lower middle income country, particularly [Multiple Speakers]….

I wasn't implying that, and I agree with you completely getting it to market no matter where is a good thing. I'm just wondering if that scenario was a possibility, and the answer is yes. And regarding the registration packages you're sending to the regulatory agencies.

It sounds like pretty much you can just copy the same one to all of them as you implied that this is not a whole lot of difference in what message you're trying to get across regarding the efficacy of the vaccine. But the one difference may be that in the EU, for example, you didn't take the alpha hit there for the informational analysis.

So as far as the EU is concerned, it's a successful prepare trial.

Is that correct? And are you just going to go straight to registration, possibly go straight to registration there without having you to talk about another Phase 3 trial?.

So that's the question we're going to ask, which you're right. And in fact, we plan and back plan and going back to the U.S. and asking them to revisit that issue as well. So we're going to -- these are all legitimate questions for us to ask. I don't think there's anything that's casting concrete.

This is -- and try to emphasize, this is a huge global healthcare problem, nobody's been successful with any Phase 3 efficacy trials. They haven’t gotten in the Phase 3 efficacy trail. And we've demonstrated efficacy and above all. We've demonstrated safely. And there's no safety benefit ratio. There's no issue with safety. So any efficacy is a plus.

And we're very confident going into these places. And I think it will -- will make it -- will make them think twice before they take a non-thoughtful pathway to thinking about approval and what we need to do further. So there wasn't a very elegant way of saying it but we think we have a licensable product..

And finally, I have a question about your share count. I mean, it's well over $450 million now and you're trading under a buck. You've been there for a couple months now. With regard to any reverse split or anything like that.

Any plans for that? You haven't been there for very long, and you could have some significant results coming in decisions where the FDA -- they could bring you back over a buck.

So are you thinking about, or going to wait?.

In fact you missed an 8-K that we filed. So we are doing a reverse split. It will happen on May 8th. And we decided we didn't want to have to deal with -- we want to be so focused on all of these opportunities we have in flu and RSV that we didn't want to be dealing with -- anything with NASDAQ.

And so we took book to bill in a while back and said we're going to do a reverse, and so we're doing a big one. So it's a 20:1, 1:20 and it will take us completely out of that ballpark..

I mean NASDAQ gives you a leeway there for several months, at least a year I think, right?.

They gave six months, there's no reason not to do it. I am now convinced, I've been a non -- I've been the guest of split most of career and I'm now convinced. Most people will talk about companies to do a reverse, typically go down following their [indiscernible] it's not universally true.

And I believe that most of those companies continue to go down, because they're trying to solve the problem when a company didn't have a bright light ahead of them. We have two late stage clinical products that have efficacy data, that have strong data. And we think that this reverse split will help us get back to the investor base [indiscernible]..

In addition to available shares that would allow us in fact the right time to make an additional raise, George. And also there's some important dates for the Russell rebalancing that's coming up that's important to who's holding our stock. So for those three reasons, we thought it was the right time to make a decision to do the reverse flip.

So it wasn't simply based upon being below a dollar, because you're absolutely right. You have at least six months to cure that. But for these three reasons, collectively, it was important for us to make this move now..

So basically you want to get this part out of the way by [indiscernible] said and then concentrate just solely on ResVax and NanoFlu, and I worry about….

That's exactly right, George..

And is there any fluctuations you will take the hit and hope plan for results giving you the rebound?.

Well, yes, let's be very clear, George. As I'd say, we don't expect to take it.

I think this move is important for the shareholders, shareholder value and it's important for the company, our ability to raise additional funding to support ResVax and to support NanoFlu, and also I think important for positioning with the institutional investment community.

So I think for multiple reasons, it's important for our overall strategy and what we're trying to do for the balance of the year..

Thank you. And ladies and gentlemen, this does conclude our question-and-answer session. I would now like to turn the call back over to Stan Erck for any closing remarks..

And I just like to read it -- I guess I don't have any closing remarks other than the fact that we look forward to talking to you more during this quarter about the events that we've got on our plate right now. So thanks, and for thanks sitting through the conversation..

Ladies and gentlemen, thank you for participating in today's conference. This conclude today's program. You may all disconnect. Everyone, have a great day..