Novavax, Inc. (NVAX) Q4 2016 Earnings Report, Transcript and Summary

Good day, ladies and gentlemen and welcome to the Novavax Fourth Quarter and Full Year 2016 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a Q&A session and instructions will follow at that time. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to turn the conference over to Ms. Andrea Flynn, Associate Director, Investor Relations. You may begin.

Thank you, operator, and good afternoon. This is Andrea Flynn, Associate Director of Investor Relations at Novavax. I would like to thank everyone for joining today’s call to discuss our fourth quarter and full year 2016 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; 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’ll now turn it over to Stan to being today’s call.

Good afternoon, everyone. And thanks for taking the time to dial-in to our call today. As we hosted a detailed earnings and investor and analyst call back in November, we plan to keep our comments relatively brief today. I’ll begin the call with the short introduction and then Greg will provide an update on our pipeline. And then following that Buck will review our financial results and then I’ll it open it up to Q&A. As we noted last quarter, we continue to believe that there is a multibillion dollar opportunity for our RSV F Vaccine franchise, and we still expect to enjoy the advantage of being the RSV vaccine in the market. Our global Phase 3 RSV clinical trial in infants via maternal immunization continues to gain momentum as we enroll participants in multiple countries around the world to take advantage of both the Northern and Southern hemisphere RSV seasons. Execution of this Phase 3 trial is a key focus in 2017. As we mentioned earlier, we’ve been in discussions with the FDA regarding conducting an informational analysis by year-end. While there is no specific agreement yet, our discussions to date lead us to believe we will be allowed to conduct the analysis, and we believe the analysis will provide an indication of the vaccine’s potential efficacy against the primary endpoint. As a reminder, the primary endpoint is the incidence of RSV lower respiratory tract infection with hypoxemia in infants through 90 days of life. We will provide an update once we have more specific information in agreement with the FDA. With respect to our RSV program in older adults, you likely saw that last month we initiated a Phase 2 trial to evaluate one and two dose formulations, vaccine formulations with and without our proprietary Matrix-M adjuvant, and also with and without aluminum adjuvant. We continue to believe that this study will give us important information regarding both the quantity and quality of the antibody responses that we can achieve. Greg will provide further details on these analyses in his comments. RSV vaccination in older adults is a very large market opportunity and remains a key focus and strategic interest of our Company. Finally, we are also moving forward with two programs based on our recombinant nanoparticle vaccine technology, a Zika vaccine and a seasonal nanoparticle flu vaccine. With that, I’ll now turn the call over to Greg to review the pipeline in detail.

Thanks, Stan, and good afternoon to everyone on the call. I’ll start with an update on our Phase 3 trial of RSV named Prepare, which is designed to demonstrate protection of infants by maternal immunization. As reminder, the Prepare trial is supported by a grant of up to $89 million from the Bill & Melinda Gates Foundation whose goal is to reduce global infant mortality through an infected RSV vaccine. The Prepare trial is a randomized, observer-blinded, placebo controlled trial that utilizes a 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 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 hypoxemia in the infants through minimum of 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. This trial will include a minimum of 4,600 participants. As we previously noted in November, we finished year one in U.S., South Africa, Australia, New Zealand and Chile. In the year two, we’re in the process of adding multiple Northern and Southern hemisphere sites. Enrollment in Southern hemisphere is progressing well, and we’re excited to carry that momentum forward to new sites. As a reminder, we will follow maternal participants for nine months and the infants for one year after they are born. As we’ve discussed previously, this trial is being monitor by Data Safety Monitoring Board that is out of necessity unblinded. The DSMB’s primary mandate is to look over evolving aggregate safety data. To do this, it reviews the data monthly in unblinded fashion during enrollment. Today, this group has met many times and the former recommendations made by the DSMB after review of the data, each meaning have been to continue the trial without operation. That means there have been no apparent safety concerns and no advisement to modify or hold the trial. As Stan mentioned, our discussion with the FDA to-date lead us to believe, we will be allowed to conduct an information analysis as early is the end of 2017, which will provide us an indication on the vaccine’s potential efficacy as to primary endpoint. We look forward to providing an update, once we have more specific information in agreement with the FDA. I’ll now move on to our RSV program in older adults. As Stan mentioned, in January, we initiated a Phase 2 clinical trial in this population, which we refer to as E205. The objective of this trail is to assess the safety and immunogenicity of one and two dose regimens of the RSV F Vaccine with or without aluminum phosphate or proprietary Matrix-M adjuvant. This trial is a randomized, observer-blinded, placebo-controlled trial that has enrolled 300 older adults in the southern hemisphere. We’re conducting this trial in the southern hemisphere to avoid the ongoing RSV season in the northern hemisphere and to ensure that the immunogenicity results from the trail are solely resulting from the vaccine and not from natural infection from circulating virus. We expect the trial will determine the effect of adjuvantation and/or a two dose regiments on the quality and quantity of the RSV related immune response in older adults. The top line results from the study are expected in the third quarter of 2017. Results from this trial will be interpreted in the context of our learnings from the previous RSV F Vaccine Phase 2 and Phase 3 studies, as well as the ongoing epidemiology studies and our discussions with KOLs. We expect to use the 205 results in augmented epidemiology data to map out our path forward for this important vaccine, and are considering older adult population or initially working in high-risk population. Moving now to a brief update of our current status of the Resolve Phase 3 trial of RSV F Vaccine in older adults from which we announced data last September. We continue to analyze the data from the Resolve trial in order to better understand these results and to map a path forward for this important program in the older adult population. Our efforts include analyses of existing immunogenicity and efficacy data, and the application of new assays to test the archived samples. We have also undertaken external epidemiologic studies to further understand the attack rate, healthcare burden and seasonality of RSV disease in older adults. As I mentioned earlier, we expect these analyses to provide important information and context when we review the results from the ongoing E205 clinical trial in older adults. Taken together, the data from the current Phase 2 and the evaluation of our Phase 3 data as well as other past clinical trials in older adults will help us determine our next steps. Now, moving to our Zika vaccine program, we are conducting non-human primate challenge studies with colleagues at Harvard. Data analyses from our first study show that does responses reduction in the peak Zika viremia of up to 94% by vaccine induced antibodies and suggested levels of immune response that Novavax candidate could provide sterile immunity and desired outcome. We’ve conducted follow-up formulation studies to suggest that we can achieve higher immunogenicity through relatively simple formulation improvement. Such new vaccine formulations are being evaluated as we continue to conduct IND-enabling pre-clinical studies including studies both in non-human primates and other animal models. Our goal is to initiate a Phase 1 clinical trial of our Zika envelope dimer nanoparticle vaccine candidate later this year. Finally, regarding flu, as you know, we continue to develop recombinant nanoparticle version of our flu vaccine. This construct should have a number of advantages over our previous VLP vaccines including purity and stability, and importantly we believe the ability to simulate broadly neutralize the antibodies. We’re targeting the product profile that could be adjuvant with our Matrix-M adjuvant and that could compete with Sanofi’s high dose vaccine in the elderly market. Our preclinical studies have shown that our nanoparticle flu vaccine candidate does indeed elicit broadly neutralized antibody and it’s our goal to move this program into a Phase 1 clinical trial by the end of this year. So, with that, I’ll now turn the call over to Buck to review our financials. Thank you.

Thank you, Greg, and good afternoon, everyone. Today, we announced the financial results for the fourth quarter and full year ended December 31, 2016. Summary of financial statements can be found in today’s earnings press release. My comments today will focus on the results for the fourth quarter. We recorded a net loss of $57.1 million or $0.21 per share for the fourth quarter of 2016. That compares to a net loss of $78.8 million or $0.29 per share in the prior year period. The decrease in net loss in the fourth quarter is primarily the result of decreased R&D expenses related to the RSV clinical trials and development activities. Revenue for the fourth quarter was $5.4 million compared to $5.9 million for the same period in 2015. This 8% decrease in revenue in the 2016 period over the 2015 period was driven primarily by a higher level of BARDA related activities and associated revenue in Q4 of 2015 relative to Q4 of 2016. The decline in BARDA revenue in Q4 of 2016 was partially offset by $4.5 million in revenue recorded in the period under the Bill & Melinda Gates Foundation grant of $89 million. The BMGF revenue is directly related to the operating activity in the Prepare trial, our Phase 3 trial of the RSV vaccine to protect infants via maternal immunization. We expect the increase in The Bill & Melinda Gates grant Foundation revenue in 2017 correlating to the continued ramp in enrollment and increased level of activities in the Prepare trial. R&D expenses decreased 33% to $51.1 million in the quarter compared to $75.9 million in the same period in 2015. The decrease in R&D expenses was primarily due to the decrease in RSV vaccine clinical activity in Q4 2016 relative to Q4 2015, specifically the RSV Phase 3 trial in older adults and the Phase 2 rollover trial in older adults, which were both initiated in the fourth quarter of 2015 and completed in the fourth quarter of 2016. G&A expenses decreased 6% to $8.3 million in the quarter compared to $8.9 million in the same period in 2015. This decrease is primarily due to the corporate restructuring as announced in November of 2016. As of December 31, 2016, the Company had $235.5 million in cash, cash equivalents and investments on the balance sheet. On our Analyst and Investor Day webcast in November of 2016, we estimated a 2017 reduction in cash burn of between $70 million and $100 million relative to the 2016 cash burn. Today, we will update that guidance, guiding to a further reduction in cash burn and narrowing the range of the estimate. Today, Novavax estimates a reduction in cash burn, which we define as cash used in operating activities plus cash used in capital expenditures of $80 million to $105 million in 2017 relative to 2016. I would like to say that we are currently operating at the higher end of this range. And I hope to provide additional update on our future quarterly earnings call in or on our first quarterly earnings call in May of this year. This concludes my financial review. I’ll now turn the call back over to Stan.

Thanks Buck. We remain excited about our pipeline and our prospects for 2017 and beyond. We look forward to updating you on our pipeline progress throughout the year. To remind everyone, we are midway through a pivotal Phase 3 trial in maternal immunization. We will have the database path forward for our older adult program and the initiation of two new important clinical programs, a big year of execution. And on top of all this, we continue to keep our partners, our potential partners informed as we get new data. There remains a lot of interest in our RSV program. So, with that, let me turn it over to questions.

Thank you. [Operator Instructions] Our first question comes from the line of Jessica Fye from J.P. Morgan. Your line is now open.

Thanks for taking my questions. First one is just Buck. Can you repeat the decline in cash burn year-over-year and clarify, when you say you are at the higher end of that, do you mean higher or higher reduction in burn? And then second, love to hear any more color on the ongoing dialog with the FDA about potential sigma [ph] interim on Prepare. It sounds like you’ve had some encouraging conversations but no final answer yet. Is that what we’re supposed to take from that? Thank you.

Jess, thanks for your question. There is grins around the room, because we had this discussion about my guidance before we got on the call. So, my guidance is an increase. So, the savings in burn 2017 versus 2016 has been increased $80 million to $105 million. When I say, we’re operating at the higher end of that range, we’re operating closer to a $105 million decrease in burn year-over-year versus an $80 million decrease in burn year-over-year.

Jessica, it’s Greg. You did summarize decisions with FDA, we have had some encouraging feedback from them but we have ongoing discussions and at that point, I think we will share, once we gotten through that, share more specific information.

Our next question comes from the line of Joel Beatty from Citi. Your line is now open.

I have two questions on the Phase 3 trial. So, the first is, can you tell us any information about the enrollment progress; how many patients are enrolled now or how many are expected to be enrolled at interim look? And then, the second question is, with the interim look, will that be primarily adjusted, primary endpoint or could you also include a look at biomarkers or immunogenicity and binding and things like that?

So, on the first, we -- I think the only thing we’d really say about enrollment is tracking with our expectations. The analysis, the informational analysis will be done on the primary, so we won’t be looking at biomarkers. So, we would be looking at obviously infants, reduction of RSV, PCR positive, infants who have hypoxemia and through 90 days of life.

Our next question comes from the line of Edward Tenthoff from Piper Jaffray. Your line is now open.

So, thanks for the update, actually a lot of data coming yet this year. With respect to the Zika program, can you give us sort of an update on where things are there, both from a need standpoint and sort of from the government view? Is this still -- I mean, I have my own views on this but where is your view in terms of how high of a priority does it going to be this year and going into next year?

Well, in respect to medical need, it is convenience to be a vaccine problem. As you know, it’s sexually transmitted; it’s a neurotropic virus. So, those who are pregnant could potentially be infected. You may know, if your wife happens to be pregnant that there is lot of attention paid to exposure, testing for exposure because the outcome is very bad. I think we have roughly 40 or so primary Zika infection in these birth defects in U.S., that’s very serious problem. So, the question will be, will it wax or vein, [ph] we know that the virus resides in A grafts. So, during the colder non-mosquito season, we know, there is some persistence of the virus. So, we’re of the view that that’s going to be continued to be a problem. But we’re going to monitor this very carefully. So, I don’t think there’s ever been a precedent like this with respect to a virus causing such severe outcome Guillain-Barré and birth defects. So, I think that the government seems to be quite committed to seeing the vaccine pull through but I’ll let Stan talk to that area. Do you want to make any comments on where government funding might be with Zika?

So, as always, you’re always in a better position with data, not only in non-human primate but also the Phase 1 data. And so, we want to get to that point. There are indications, looking to getting some funding for Phase 1 and we’ll look beyond that to the borders of the world. So, it’s early and of course a product with data makes it that way much easier.

May we ask what your view is?

Yes. I mean, I have a similar view to that. I don’t think this is going away by any means. And the importance of opinion U.S. soil and obviously severity of the birth defects is pretty important. So, I’m very interested in this program.

Great, thank you. So, are we.

Our final question comes from the line of Kevin DeGeeter from Ladenburg. Your line is now open.

Hey, good afternoon guys. Thanks for taking my questions. Just another go at the interim -- potential interim analysis with regards to the maternal study. If there is agreement in the future with FDA to take that look, is there a minimum level of enrollment or number of patients that you think you wanted to have enrolled before taking that look or is it really once FDA gives you a green light, if you come to agreement, you’ll just ahead and take the look?

Yes. I think we’re in negotiation with the FDA, I think in principal, yes, of course there would be a minimum number of enrollees. But I can’t describe that any more than just that we are in discussions with the FDA.

And then just on a little bit higher level, can you just talk about your increased learning with regard to the epidemiology of RSV infections, particularly kind of going back to the older adult population and just what that may mean when you think about evaluating the 205 study and any potential roads forward in the future with regard to the RSV vaccine in that population?

Yes. So, there’s a lot happening on that topic internally and externally. So, we have set up several studies to help us with health econ, and those are -- I think some of that information will be available this summer. So, obviously, when we see our E205 results, it’s going to be a very important time for us to make an assessment of the immunogenicity, what we think it means in light of the assays and the new analyses and the epidemiology. So, some of the internal information should be available for us to review. I’d also note the CDC took on global -- U.S. surveillance for older adults as well, as you know, they have a well-established surveillance program for infants. So, today, I don’t have any new and hot information. But, we expect to in the context of making decisions about going forward, they have additional informative information on the disease burden, assessment of the syndrome that we’ve made a primary endpoint, those type of topics. So, I think we’ll have more information later in the year. It will be very interesting to know. As far as I’m aware, the CDC is not showing their older adults events real time. So, we are going to be actively watching for when they’ll be providing that data. You may know, there is a meeting in Holland called ReSViNET. I know you like to go to meetings. And that probably will be discussed to some degree, the older data. But at this point, I don’t have any new information beyond looking towards the summer when we think we will have some additional data.

That now concludes our Q&A session. I would now like to turn the call back to Stan Erck, President and CEO, for any further remarks.

Okay. As promise, we kept the meeting concise. But, I think we see four data points coming out this year that in the second half of the year that should all be meaningful. Look forward to talking to you in relatively near future, and thank you.

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