Novavax Inc Q3 FY2021 Earnings Call

Thanks very much. Good afternoon, everyone, and thank you all for joining us today for our call to discuss our third quarter 2021 operational highlights and financial results. A press release announcing our results 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 today is Stan Erck, President and CEO, who will discuss regulatory updates; additionally, John Trizzino, Chief Commercial Officer and Chief Business Officer, will discuss our manufacturing and supply updates and the market opportunity for our COVID-19 vaccine; and Dr. Filip Dubovsky, Chief Medical Officer, will discuss our clinical developments. Jim Kelly, Chief Financial Officer and Treasurer, will also join today's call to overview our financial results for the third quarter. Additionally, Dr. Greg Glenn, President of R&D, will be available for the Q&A section at the end of today's call. Before we begin with prepared remarks, I need to remind you that we will be making forward-looking statements during this teleconference, which are based on our current expectations and beliefs. For example, statements relating to future financial or business performance, conditions or strategy including expectations regarding revenue, operating expenses, cash usage, clinical development of our vaccine candidates, timing of future regulatory filings and actions and other anticipated milestones are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous assumptions risks and uncertainties, which change over time and actual results could differ materially from what is described in such statements. We encourage you to consult the risk factors discussed in our SEC filings for additional detail. I'd now like to hand the call over to Stan. For those of you following the accompanying slides, please turn to Slide 3.

Thank you, Silvia, and thanks to everyone for joining us today. I'm excited to be here today following an incredibly exciting week for Novavax. This past week, we reached a critical milestone. We received our first authorization for our COVID-19 vaccine in Indonesia. This milestone marks Novavax' first-ever approval of our protein-based COVID-19 vaccine. This approval is based upon demonstrated strong efficacy and a favorable safety profile and represents a significant point in our transformation into a global commercial vaccine company. In addition to receiving our first authorization for 2373, we executed on our regulatory strategy in other global markets, with 9 submissions now filed with regulatory agencies around the world. I would like to acknowledge the tremendous efforts made by the entire Novavax team, express my gratitude for our partners and clinical trial sites for their continued support of our mission and importantly, thank each of our clinical trial participants for their vital contributions made during an unprecedented global pandemic. Only through these collaborative efforts were we able to achieve the significant progress. On today's call, I will discuss these regulatory developments in more detail as well as our key upcoming milestones. Other members of our team will discuss manufacturing and supply updates, updates on clinical developments and financial results for the quarter. With that, I'd like to begin today's call by discussing the tremendous progress we've made to date on the regulatory front. Please turn to Slide 4. We now have our first regulatory authorization in hand with the granting of Emergency Use Authorization for 2373 by Indonesia. Our COVID-19 vaccine will be manufactured and marketed by Serum Institute of India under the brand name of COVOVAX. The first authorization of our COVID-19 vaccine exemplifies our commitment to equitable global access and will fill a vital need for Indonesia, which is the fourth most populous nation on earth and continues to work to procure sufficient vaccine for its population. We expect that initial shipments into Indonesia by Serum will begin imminently. Over the past week alone, we completed submissions to 6 regulatory agencies in the following markets: these include the U.K.'s MHRA, Australia's Therapeutic Goods Administration, Health Canada, New Zealand's Medsafe and the European Medicines Agency, or EMA, where we completed the submission of all documents required for regulatory review. Additionally, today, we completed Novavax' rolling submission to the WHO for Emergency Use Listing of 2373. Our regulatory packages have been harmonized across our filings, which initially leverage our manufacturing partnership with Serum Institute. In the near future, we will supplement our submissions with information from additional facilities across our global supply chain and are confident that our clinical manufacturing data form a strong package for review by regulatory agencies. All these regulatory packages are in addition to those we've previously announced for filings in India, in the Philippines and of course, Indonesia, where we are already approved. These filings and in particular, the WHO EUL listing, will enable our effort to provide doses for global equitable access. We remain diligent in our efforts to complete filings in additional geographies shortly. In the U.S., we expect to submit our complete regulatory package to the FDA before the end of this year. So we've made tremendous progress on the regulatory front. We have harmonized all of our regulatory filing packages and submitted them to multiple agencies around the world, all to advance our shared goal of making our vaccine available as quickly and safely as possible to those in need. While we cannot predict how long regulatory agencies will take to approve these packages, we are prepared to work closely and diligently with all the regulatory authorities to facilitate approval.

Thank you, Stan. Moving to Slide 5. Today, we have a global infrastructure in place to support the manufacturing of 2373 with a supply chain of partners and Novavax-owned facilities spanning the world. This expansive global supply chain includes our partnership with Serum Institute, the world's largest vaccine manufacturer by volume; a state-of-the-art wholly owned manufacturing site in the Czech Republic, also known as Novavax CZ; and in Sweden, Novavax AB; manufacturing at established vaccine makers, including SK Bioscience in South Korea and Takeda in Japan; and additional manufacturing partners around the world that include Biofabri in Spain, FujiFilm in the U.S. and U.K., Mabion in Poland and the National Research Council's Biologics Manufacturing Center in Canada. Over the third quarter, we executed a number of agreements to expand our supply chain and ready our global network for commercialization, and these include collaborating with our partner, Takeda, to support their anticipated annual manufacturing capacity of 250 million doses of 2373, expanding our partnership with Serum Institute to manufacture 2373 and entering into an agreement with Mabion for the large-scale production of 2373 through the year 2026. We have made significant progress in mobilizing our supply chain over recent months. We are routinely producing high-quality product at commercial scale at multiple sites around the world. As of the end of the third quarter, we achieved our goal of a manufacturing capacity of 100 million doses per month. Looking to the months ahead, we expect to achieve a manufacturing capacity of 150 million doses per month by the end of the fourth quarter, with the expectation that we will have a manufacturing capacity in excess of 2 billion annual doses in 2022, inclusive of capacity from our partner, Serum Institute. This significant ramp-up in manufacturing will allow us to not only deliver on our current supply agreements but also support additional demand for our vaccine in 2022 and beyond. Now moving to Slide 6. In addition to dramatically increasing the number of available doses to immunize the world, we expect our vaccine will help address major obstacles during this pandemic and beyond, including global distribution challenges and vaccine hesitancy. Storage at standard refrigeration temperatures allows our vaccine to use the existing vaccine supply chain and will increase access to hard-to-reach areas to improve vaccination rates across the globe. Recombinant protein vaccines are well understood and already in widespread use, having been used for decades. Additionally, we have a robust clinical data package demonstrating our vaccine's favorable safety profile and strong immunogenicity and efficacy against multiple strains of the coronavirus, all of which drives confidence in Novavax' vaccine's ability to help protect against the disease. Now turning to Slide 7. As you can see on this slide, we have several supply and licensing agreements in place to ensure the widespread distribution of our vaccine, maintaining the mindset that access to vaccines should have no borders. Our vaccine network will support our supply commitments globally, including up to over 400 million doses of 2373 through bilateral supply agreements, including doses to the European Commission through our APA executed during the third quarter and our joint commitment with Serum Institute of 1.1 billion doses for the COVAX facility. In addition to supplying 2373 for primary vaccination, we expect the need for boosters will continue in the coming years, and we believe 2373 will play a very important role in this ongoing need. Over the coming months, we will be able to support supply to additional markets in need of boosters across high-, middle- and low-income countries.

Thanks, John. Please turn to Slide 8. What's displayed here is the high-level 2373 clinical development plan. The safety, immunogenicity and efficacy of our vaccine is derived from these studies. All these studies are part of our common clinical regulatory package that's included in our harmonized regulatory filings. This data has been provided to regulatory agencies on an ongoing basis and this is currently being reviewed. Let's skip ahead to Slide 9. This slide highlights our 2 pivotal Phase III studies. The bulk of our safety and efficacy data is derived from these studies. One remarkable feature of our vaccine is the consistent efficacy we've seen. The primary vaccine efficacy estimates are within 1 percentage point of each other, and that's despite the fact these studies were conducted at different times in different populations during a time when different variants emerged. You can see a very high point estimate of efficacy, 96% to 100%, against match strains. These are strains whose sequences are most similar to that included in the vaccine. Additionally, the vaccine works well against variants, not only against alpha, but as we have detailed earlier in our U.S. Phase III study, against all variants that circulated at that time. Importantly, we have complete protection against severe disease, hospitalization and deaths in all of our efficacy studies, and that includes, again, severe disease caused by variants. In the larger U.S. study, our vaccine efficacy was 100% against severe disease. In the smaller U.K. and South African studies, although we couldn't calculate an efficacy because of the low number of cases, all the severe cases were in the placebo group. Finally, our efficacy in high-risk populations, such as the elderly and people with comorbid conditions, is almost identical to that of their overall population. So now let's skip forward to Slide 10, talk about our progress in pediatrics. We expanded our U.S. Phase III study to include over 2,200 12- to 17-year-olds. All the primary vaccination series have been delivered. In fact, all the children have been crossed over and safety and efficacy data collection is ongoing. We expect to have a regulatory package available for global submission in the first quarter. The subsequent pediatric clinical development plan has been agreed to by the FDA, MHRA and EMA and the studies will be initiated after this adolescent study reads out. Okay, let's move on to Slide 11 and talk about boosting. In our Phase II study in the U.S. and Australia, we boosted select cohorts at 6 months and at 12 months and the 12-month doses are just finishing up now. We've previously disclosed that a single dose at 6 months can increase wild-type neutralization as well as IgG antibody levels more than fourfold from their peak after receiving 2 doses. However, more importantly, using a stringent human ACE2 inhibition assay, this measures functional antibodies, we demonstrated that our vaccine can boost responses to alpha, beta and delta 6.6 to 10.8 fold over their peak. We believe this is a strength of our vaccine, likely linked to our adjuvant system. We saw excellent protection in the Phase III studies against variants. Recently, Professor Snape from Oxford presented data that demonstrated that 2373 has a specific strength in inducing cross-variant neutralizing responses. In our South Africa Phase II study, we boosted all participants who initially received 2 doses of vaccine with a third dose at 6 months, and that safety data is maturing. The emergency data from the U.S., Australia, along with the safety data from our South Africa study will serve as the basis of our regulatory filings supporting our boosting indication. Finally, let's move to Slide 12, and I want to update you on the progress of our Australia NanoFlu, our 2373 combination study. As you may know, we recently published an NanoFlu Phase III study this quarter in Lancet ID and the study met its primary endpoints, and we've been given a regulatory pathway for licensure by the FDA. The current study, the combination study, was designed to define the dosage levels in vaccination schedule for our quadrivalent flu HA antigen combined with our COVID antigen. Enrollment is complete. All the first doses have been delivered and the second doses are being currently administered. We believe that much like flu, COVID will continue to circulate. Our flu and COVID vaccine share immunologic attributes that make the vaccine attractive in providing protection against drifted flu strains as well as COVID variants. This data will be available in the first half of 2022.

Thank you, Filip. I'd like to start by saying how happy I am to join the Novavax team at such an important moment and look forward to contributing to our rapid transition to becoming a global commercial company. This afternoon, we announced our financial results for the third quarter of 2021, and I'll provide you with a summary of the key highlights beginning on Slide 13. Today, we reported total revenue for the third quarter of 2021 of $179 million and ended the period with $1.9 billion in cash. This means we are well capitalized as we advance towards the commercial launch of 2373. Turning to our financial results on Slide 14, we compare our third quarter 2021 results through the third quarter of 2020. During the third quarter of 2021, we recorded a net loss of $322 million or $4.31 per share. This compares to a loss of $197 million or $3.21 per share in the prior year. Our third quarter 2021 revenue of $179 million and 14% growth compares to $157 million in the prior year. Our total revenue consists of government contract revenue, grant revenue and royalty revenue. Government contract revenue of $98 million reflects our funding from the U.S. government under Operation Warp Speed, which increased by $55 million in the period as we saw an increase in our 2373 funded activities. Grant revenue of $41 million comes primarily from our CEPI funding agreement and fell by $73 million as that agreement is more oriented towards start-up activities, which are now coming to a close. Finally, royalty revenue of $40 million reflects the Novavax share of sales of our license partners. In this case, SK Biosciences made sales of 2373 antigen component to the Korean government during the period. Total expenses for the third quarter of 2021 were $486 million and are primarily weighted towards our R&D activities in support of 2373, both in total for the quarter, are the primary cause of the year-over-year growth. Following an expected regulatory approval of our vaccine, certain types of expenses that have previously been expensed as R&D will be capitalized to inventory and expensed as cost of goods sold when product is delivered. As noted earlier, we ended the third quarter with $1.9 billion in cash and cash equivalents as compared to just over $800 million at year-end 2020. The primary sources of our increase in cash year-to-date are the $1.2 billion in payments received under advance purchase agreements and over $560 million from the sale of common stock in the first quarter.

Thank you, Jim, and welcome on board. Please turn to Slide 15. It was a tremendous quarter for us at Novavax. Behind the scenes, our over 1,300 employees worked tirelessly to prepare for the delivery of 2373 globally. Over the coming months, obtaining regulatory authorization for our COVID-19 vaccine remains our top priority. This involves continued collaboration and discussion with regulatory agencies with whom we've already completed submissions. In other geographies, we will finalize our packages for filing. We also expect to submit our complete regulatory package to the FDA by the end of 2021. Our first authorization by a regulatory agency is expected to be followed by others over the coming weeks. We are turning swiftly to the work at hand to get product ready to ship on a global basis. Timing and the location will, of course, depend on the timing of various regulatory approvals. We expect to be able to ship doses to Indonesia and hopefully others before the end of the year. That will scale up quickly in the first quarter as we match our APA and COVAX orders with these regulatory approvals. We will initiate our shipments from Serum as the first authorized production center and supplement our regulatory filings with data from our other sites, importantly, including our Czech facility and our partner, SK Biosciences in Korea. Our goal is to reach a cadence of production that will allow Novavax and our partners to have a manufacturing capacity of over 2 billion doses in 2022. As we've indicated before, we will fulfill our commitments to higher-income countries from our APAs signed over the last year, and we expect to supply low- and middle-income countries in partnership with Serum to meet our commitments to COVAX. We believe that our vaccine is ideally suited to address the needs of these countries. In the coming months, we will continue to evaluate 2373 use beyond the 2-dose primary vaccination regimen through our ongoing boosting study and expect to collect data that further supports 2373's vast potential to serve as a booster. Through our favorable reactogenicity and safety profile, consistently high levels of efficacy and well-understood technology, we are confident that 2373 will be an important tool in combating COVID-19 in the years to come. In parallel, we will develop other areas of our robust pipeline. As discussed earlier by Filip, we believe our COVID NanoFlu combination vaccine will be a key component of our pipeline, and we look forward to advancing this candidate through clinical development. We also remain optimistic about areas for future development within our pipeline, including for RSV. Moving into the end of 2021, our mission will continue to drive us forward. We never rest in our quest to protect the health of people everywhere. With that, I will now turn it over to the operator for Q&A.

Again, congrats on all the progress here. Just a couple of questions on my end. First, with the filings that you had over the last couple of weeks, a new development was that you're leveraging SII's manufacturing. Can you help us understand the reasoning and rationale behind that? And I guess, more importantly, what are the gating steps and how quickly will you be able to supplement those applications and potential approvals with manufacturing data from your own sites? And I have one follow-up question there.

Yes. This is Stan. Thanks for the question. The reason for our reliance upon Serum as a partner for this is they have -- we've been working with them for almost 2 years in a variety of areas. We know them really well. They have added capacity specifically for Novavax production over the past year that's staggering, well over -- we're targeting 2 billion capacity. Just at Serum, they'll have that next year. They have fill/finish capacity that's virtually unlimited. We can make many hundreds of millions of doses per month in their facility. All of that came together over the past several months and really helped us to get to the point where we could file with 9 different regulatory filings in the past couple of weeks. I mean this has been tremendous progress, and Serum has been there with us. So the follow-on to your question is what about the rest of our plants. We have data. We're collecting data that we will submit once we get regulatory approval in various territories, and we will supplement those filings with data from Korea, from the Czech Republic, from Spain, et cetera, so we can get them all involved. Our global capacity network is really potent.

Thank you for the update. This is [indiscernible]. I'm calling on behalf of Vernon. We just had a question on -- I guess, we wanted to get more color on the timeline of how long would it take for the WHO and EUL review. And I just also wanted to -- just to confirm that the SII will actually manufacture the vaccine and that's it for me.

Well, I think I answered the second part of the question that SII will be the initial manufacturer. They've already made many tens of millions of doses that are waiting to be shipped. We've -- my team has physically gone over there and touched them. So they're there. The -- I forgot what was the first part of the question?

Obviously, congrats on a ton of recent progress. So maybe just staying with the Serum question. Are you able to comment on the economic arrangement you may have for the developed market specifically if Serum is the manufacturer? And also, are you able to comment on COGS if vaccine doses are coming from Serum versus the Novavax facility? And then I have a follow-up.

Yes. One of the reasons we partnered with them a year ago is because we recognized their capabilities for making large quantities of vaccine. They, in fact, in -- their model is to make vast amounts of vaccine at very low cost, and they've tied that to their target markets, which are all low- and middle-income countries. So that's been their target. Our deal with them is that we agreed to license to them so that they can make product. They have an exclusive license in India to make and sell product. In the low- and middle-income countries of the world, we share profits on that. They'll make the product and distribute it, and we'll share profits; we have not disclosed what the ratio of that is. We've also signed an agreement with them, if we want for them to make product for high-income markets. They would supply us finished product, whether in 1 of 2 ways, either from antigen, the spike protein that they make at Serum or from spike protein that we make in our various sites around the world. We'll have the choice of working -- of having Serum fill and produce it for us, produce the entire product for us or just take our manufacturing network and make our own product all the way through fill/finish and distribute it in high-income countries. It's complicated, but it's a very effective way to reach our strategy of going from zero to two billion overnight.

That's helpful color. And then on the other side of the planet, on the U.S. FDA filing, as we think about the specific requirements you're working through, can you maybe detail how much of what you have today could be applicable to the U.S. FDA filing?

Yes. We made a concerted effort to harmonize all of our filings. We're going to file the same thing in the U.S. as we filed elsewhere. We are in the process of dealing with the FDA. We've been in communication with them this week. We're going to set up a meeting sometime in the foreseeable future. We don't know what date yet, but sometime in the near -- from that, we can give more clarity on the dates that we expect to file the complete package and for the EUA. So that will be coming later this month.

Yes. The analysis is ongoing, and it's made slightly more complicated by our current regulatory filings globally. We need to balance that work out. But we are confident that we'll be able to give the data pulled together and submitted as a variation of our initial file in the first quarter.

Congratulations, Stan and team, for all the recent progress; very good to see. I had a question regarding the EUA filings that I'm sure you won't be able to answer in great detail. But beyond being able to talk about when you might see approvals, I'm wondering if you can characterize next steps and whether or not there would be some kind of interim information that can be press released besides an actual approval as Indonesia kind of came out from out of the blue.

Yes. I'm trying to interpret your question a little bit. We are expecting multiple authorizations this year. For each of these, we're trying to allocate product, both that we have in inventory in the U.S. and Europe and South Korea and in inventory that's being built up at Serum. That allocation process will be complicated because until we know what the -- not only when we get the authorization, but the timing of various regulatory approvals. There won't be much visibility before the actual grant of an authorization. The process is they do the review. They've had the ability to review the clinical safety data for some time now because those have been submitted to the regulatory agencies. So the remaining analysis should be focusing on the CMC section. We could only know how interested they are by the number of questions we get and the responses we get, and whether they think they've got all the answers. There’s not going to be any information going forward about the EUA until it happens. I'm optimistically forecasting that they're going to be working on this quickly. From week to week, we will see results of that.

Okay. Very good. That's helpful. If I could turn to Filip or Greg regarding a couple of clinical questions. First of all, I'm wondering if you have ever seen any cases of myocarditis that you think go beyond that which is seen with the virus with an infection generally. Could you provide some kind of theoretical basis for not seeing any cases or foreseeing cases and perhaps even in contrast with other technologies?

We don't really comment on specific safety signals we've seen or not seen in any of our studies. What we can -- what we all know is that myocarditis is often caused by viral infections, and those occur sporadically throughout the planet. Our data is reviewed by our external safety committee as well as by the NIHD SMB, and they haven't identified any safety signals for us yet.

Last question regarding homologous versus heterologous boost. Wondering if you could provide a little bit of perspective on homologous boost; seems like it should work given the data you've shown so far in 6 months. But do you sense that maybe heterologous boost may be a paradigm that you want to evaluate in the future? Is there at least a theoretical basis for thinking that 2373 could be useful on top of past RNA primary boost?

We've outlined the details of our homologous boosting just today, and we think there's a path forward. We see huge value in boosting on top of other vaccines. We have a safety profile that I think will justify doing that and a posology that makes it convenient to move the vaccine around the world and use in that regard. How well it performs, we'll really be data-driven. We plan some studies in the near future to help define that, including studies we're designing to provide enough data to give us a label indication. We're confident that if you were to stack any homologous or heterologous re-dose regime compared to what we've shown in the Phase II study from the U.S. and Australia, we would come out on top. There's something unique about our ability to induce cross-variant neutralizing antibodies, and that may be part of the story. People shouldn't just think about magnitude of immune response but quality of immune response as well.

I just wanted to circle back on plans to supplement the current filings with CMC packages from your own supply chain. Could this happen before or is it more likely to happen after the anticipated decisions, authorization decisions for regions filed over the past week?

The supplementary filings will be filed as soon as we can. Our team has filed 9 regulatory submissions and we've got a few more countries to go, that's going to consume them. But we'll get the supplements in either around the time of approval or just after. We're talking weeks here, not months, so I don't think there’s going to be much difference. Serum will make the bulk of the production over the next few months. We are going to allocate -- focus on COVAX and make sure they get their allocation. It won't be 100% of our product, but a large portion for the first few months, and then it will shift over to our APAs in large quantities in the second and third quarter. Yes, that's correct. They've made over 1 billion doses of AZ's vaccine and got global approval for that. They also got inspected by the U.K. specifically for Novavax production at their plants and got a GMP certificate that allows them. Their plants are probably some of the most modern in the world and are highly regarded by the regulatory agencies. Yes, they conducted a Phase II, Phase III study comparing a material they manufacture with material we manufactured, and that's part of the regulatory dossier. Reflecting on this conversation, we've really accomplished something as a company in the 12 years that I've been here that is just changing the entire company. The energy that's coming out of the company after all of these regulatory filings and getting the first product approval is a big deal, and the company is energized and we're on our way to truly be a changed company over the coming 12 months. I want to thank you to everyone for joining today's call. We're excited by our progress made to date and believe we are positioned for success in the months to come, and we look forward to reporting on the exciting milestones. This means in the coming months, I'm going to be reporting on exciting milestones in the coming weeks and months ahead of us as we move closer to delivering our vaccine globally. So with that, thank you very much.

Thank you. The conference has now concluded. Thank you all for attending today's presentation. You may now disconnect your lines. Have a great day.