Novavax, Inc. (NVAX) Q2 2022 Earnings Report, Transcript and Summary

Good morning and welcome to Novavax Second Quarter 2022 Financial Results and Operational Highlights Conference Call. All participants will be in listen-only mode. [Operator Instructions] After today’s presentation, there will an opportunity to ask questions. [Operator Instructions] Please note, this event is being recorded. I would now like to turn the conference over to Silvia Taylor, Senior Vice President of Global Corporate Affairs and Investor Relations. Please go ahead.

Good afternoon, and thank you all for joining us today to discuss our second quarter 2022 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. Before we begin with prepared remarks, I need to remind you that this presentation includes forward-looking statements, including information relating to the future of Novavax, its key strategic priorities, plans and prospects for 2022 and financial guidance including revenue and gross margin; the ongoing development of our vaccine candidates, including anticipated timing of trials and results; the scope, timing and outcome of future regulatory filings and actions; the efficacy, safety and intended utilization of our vaccine candidates; the global market opportunities for our vaccine candidates; the future availability of our vaccine candidates and key upcoming milestones. Each forward-looking statement contained in this presentation is subject to risks and uncertainties that could cause actual results to differ materially from those projected in such statements. Additional information regarding these factors appears under the heading Cautionary Note regarding forward-looking statements in the slide deck we issued this afternoon, and under the heading Risk Factors in our most recent Form 10-K and our second quarter Form 10-Q filed with the Securities and Exchange Commission and available at sec.gov and on our website at novavax.com as well as subsequent filings with the SEC. The forward-looking statements in this presentation speak only as of the original date of this presentation and we undertake no obligation to update or revise any of these statements. Please turn to Slide 3. During this conference call, in order to provide greater transparency regarding our operating performance, we refer to certain non-GAAP financial measures that involve adjustments to GAAP results. Any non-GAAP financial measures presented should not be considered to be an alternative to financial measures required by GAAP, should not be considered measures of liquidity and are unlikely to be comparable to non-GAAP financial measures provided by other companies. Any non-GAAP financial measures referenced on this call are reconciled to the most directly comparable GAAP financial measure in a table available in the Investors section of our website at novavax.com. Please turn to Slide 4. Joining me today is Stan Erck, President and CEO, who will provide an overview of recent achievements and our upcoming strategic priorities. Additionally, Dr. Filip Dubovsky, Chief Medical Officer, will discuss our clinical development updates across our pipeline; and John Trizzino, Chief Commercial Officer and Chief Business Officer, will provide an update on the status of our global COVID-19 vaccine rollout, our recent progress in our label expansion and our global commercial strategy. Finally, Jim Kelly, Chief Financial Officer and Treasurer, will provide an overview of our financial results. Dr. Greg Glenn, President of Research and Development, will also be available for the Q&A section at the end of today’s call. I’d now like to hand the call over to Stan. Please turn to Slide 5.

Thanks, Silvia, and thanks to everyone for joining us today to discuss Novavax’s second quarter results. Once again, we have had a very significant quarter of achievements. We continue to take – make the transition into a commercial company, and we continue to see more and more evidence that our vaccine platform is second to none. In the next few minutes, I and my team will share with you some of the many achievements and breakthroughs that are transforming the company. While we do that, let me take a moment to address what is probably the most visible aspect of our earnings report. Our revenue for the quarter came in well below anyone’s projections. And with respect to all of 2022, we’re expecting to fall short of our earlier projections. For the quarter, revenue was $186 million, a significant shortfall from both the first quarter results and as I said, from our expectations. The shortfall was a result of a couple of issues, one of which is short-term, the timing of our shipments to Europe. The other is a broader issue and will take some time to work through, and this is our changes in expectations from two major markets, the U.S. and the COVAX Facility. Globally, and particularly with respect to COVAX, there was a surge in supply. And when coupled with challenges COVAX had with the distribution into low and middle-income countries, this limited the need for them to order contracted product from us and other vaccine manufacturers. In the case of the U.S., I believe we were late to the market, and U.S. vaccination was driven by what was available and shown to work, mRNA vaccines. In addition, now that we are approved for primary vaccination, we are not yet approved for adolescents and boosting, which are critical indications, and we are making our way through this regulatory process. We are hopeful that we can get through this in days and weeks, but the absence of these indications slows the global rollout of our vaccine. Although, there have been and will continue to be many ups and downs in these markets, we are now projecting that we will have no new revenues in 2022 from the U.S. and from COVAX. Originally, we had planned to have revenue from these two markets arising from the sale of 110 million and 350 million doses, respectively. In terms of where we go from here, I’m happy to say that just since July 1, we have filled over $400 million in revenue. While we’re talking about the second quarter to-date, this was such an extraordinary beginning to quarter three that I want to tell you what we have done through today. From an operational standpoint, we have again had one of the most productive and transformation – transformative quarters in our history. In the U.S., immunizations are currently underway with our COVID-19 vaccine, which is the first protein-based vaccine offered to Americans. This followed our emergency use authorization and unanimous recommendation from the FDA’s Advisory Committee, VERPAC and the CDC’s Advisory Committee on the immunization practices. Globally, we continued the rollout of our COVID-19 vaccine. We have authorization in 43 countries. And as of today, we have delivered over 73 million doses around the world. We initiated new studies in adolescents in younger children, and we made progress in expanding our label. We have already received authorizations for boosting in adolescents in markets around the world with more to come. And this past quarter, we announced new data for our [proxy] (ph) vaccines, showing that immune responses to our vaccines have proven to give broad protection against variants, which we think is a unique feature of our recombinant nanoparticle adjuvanted vaccine. We also showed data on our vaccines durability and breadth of response through 12 months. At the same time, we know the market is quickly evolving. And during the quarter, we advanced our Omicron strain vaccine program. I will say it one more time, this is a transformational year for the company, and we’re building on a great vaccine platform. And having said that, we are in a very dynamic environment, we have all the opportunities that having a great product gives us. But as I’ve already said, we also have a number of uncertainties that we are constantly managing. It’s important to note that while some of our delivery schedules have been shifted into 2023, total demand under most APAs remains unchanged. With all this in mind today, we are revising our 2022 full year revenue guidance to $2 billion to $2.3 billion, and we’ll talk more about this during our call today. Through our commercial readiness efforts and global label expansion to-date, we believe we are laying the foundation for a successful transition to a commercial market in 2023 and are poised to play a significant role in the future COVID-19 landscape. With that, I’d now like to hand it over to Fil.

Thanks, Dan. Please skip Slide 6 and jump to Slide 7. Our clinical development program is collecting data to expand our label for additional indications and populations. Today, I’ll discuss clinical updates for three key areas: homologous and heterologous boosting, expansion into younger pediatric populations and the development of our Omicron variant vaccine. Okay. Let’s go to Slide 8 and 9, please. This is data recently made available by the U.S. government and NIH scientists, identifying a [Indiscernible] of protection for our vaccine. This [Indiscernible] protection was identified in our U.S. Mexico Phase 3 study, where a majority of the cases were caused by variants. The study concludes that while both pseudoneutralization and IgG can serve as [Indiscernible] protection, the IgG seems to better predict protective responses. On the bottom of the slide are the antibody levels associated with various levels of protection. This study confirms that IgG is critical to understand the protective efficacy of our vaccines. Now let’s move to Slide 10, please. What’s displayed here is the immune response kinetics from our U.S. Australia study after two-dose priming series a boost at six months and another boost at 12 months. You can see a peak following two doses, which decays over six months; is boosted with a single dose followed by a slower decay over the subsequent six months; and finally, a very good boost with the fourth dose. Okay. Give me a click. Here, I’ve highlighted the antibody levels after the six-month boost are completely remain over the level associated with protection in our Phase 3 study. This gives us confidence we maintain protective immune responses over time. Go to Slide 11, please. Displayed here is antibody kinetics from our U.S. Mexico Phase 3 study. You can see a peak after two doses, which decays through month 11 with a high boost with a single dose achieving a 27-fold increase from the pre-boost levels. Okay, give me a click. And here, what we’ve done is overlay the protective thresholds derived from the U.S. government scientists over our vaccine response. You can see that seven months, this data predicts approximately 88% efficacy. And importantly, after the boost, high immune responses are achieved that are associated with more than 95% protection. Okay. Let’s go to Slide 12. Here, we’ve displayed the immune responses of our prototype vaccine – what our prototype vaccine induces against Omicron BA.1 subvariant using our validated assay. You see a very similar pattern to what you saw in the previous slide. And importantly, after boosting at 11 months, the antibody levels are comparable to the prototype responses we saw in the previous slide. Okay, give me a build. And once again, we’ve applied the government cores protection thresholds. You can see that significant protection can be expected after two doses, and a 95 protective level is predicted after boosting dose that was delivered at 11 months. I remind you that the model was developed from our data in the Phase 3 study, in which the majority of cases were caused by various suggesting relevance for this analysis. Okay. Let’s go to Slide 13. Here on the left side are the immune responses after two doses against prototype, BA.1, BA.2 and BA.5. You can see that 100% of the parts are seroconverted after two doses. On the right-hand side, we display the responses after three doses. After boosting for all the variants, you can see we’ve achieved the levels comparable to those seen in the Phase 3 study that was associated with over 90% protection. Okay. Let’s go to Slide 14. And here we see data in a multi-dimensional presentation of the immune responses from our U.S. Mexico Phase 3 study called antigenic cartography. This method displays the building of the vaccine-induced antibody to recognize variant spike proteins. The prototype is indicated in dark blue. And the closer to the variants appear to the dark blue circle, the better the immunoresponses recognize the variance. Each square in the grid represents a two-fold difference in antibody levels. Thus, two squares represents a four-fold difference. On the left-hand side, we show antibody binding after two doses in the priming series. While there was a 100% seroconversion to all Omicron subvariants after two doses, the antigenic distance between the matched pro-type strain and Omicron subvariants range from 7.9 to 11.8-fold different. On the right-hand side, after single dose, antigenic distance decreases for all of the Omicron variants, with BA.5 decreasing to just 2.9-fold difference, which could be considered a massive response in the influenza language. This analysis leads us to believe that as we immunize with additional doses of our recombinant spike protein vaccine, we minimize antigenic distance and begin to observe a more universal like response against variance. Okay. Let’s turn to Slide 15 for a quick summary. Clearly, we do not know what will emerge after BA.5, so forward DRIP will be a key issue to be addressed for all COVID vaccines. But testing with our technology may be an attractive option as it provides both high levels of antibodies recognizing variants in a durable immune response. Although, it’s not certain a very specific vaccine will provide significant clinical benefit, we are evaluating a number of constructs in clinical studies, and I’ll describe those studies in a couple of slides. But first, let’s move through Slide 16 to Slide 17 and talk about our pediatric development. This is the ongoing placebo-controlled HD escalation study that’s evaluating the safety hemologic effectiveness and clinical efficacy in children six months to 11 years of age. We will evaluate our standard two-dose schedule with a six-month boost. The study has three age bands at 6 to 11, 2 to 5 and 6 months to 23 months, and the vaccine will be evaluated in a stepwise approach. Sentinel cohort in 6 to 11-year-olds has already been enrolled, and after the safety is reviewed, vaccination will continue. The study is ongoing in the U.S., and we plan to expand the study to the countries indicated on slide. So let’s go to Slide 19, my last slide. And this is the ongoing study that will compare the performance of our prototype vaccine to a BA.1 variant vaccine and BA.5 variant vaccine adults, who have received two or more previous doses of mRNA vaccine. Group 1 has been enrolled and will compare our prototype vaccine to BA.1 vaccine as well as BA.1-plus prototype format. We expect top line results towards the end of the third quarter and to initiate Group 2 in the fourth quarter. In this study, we will compare the variant-specific immunoresponses among the trial arms to support a data-driven decision about the utility of variant vaccines as it applies to our adjuvanted recombinant protein technology. If it continues to be deemed desirable, our goal is to have varying vaccines ready for regulatory evaluation in the fourth quarter. Okay. Let me hand it over to John for the commercial perspective.

Thanks, Filip. Now let’s discuss the status of our commercial rollout globally. Turning to the rollout, what I’d like to do is go to Slide 21. Since the start of our commercial launch to date, we and our partners have delivered over 73 million doses of Nuvaxovid and Covovax around the world. As Stan mentioned, this includes over 23 million doses delivered since the start of the third quarter, including 3.2 million doses delivered in the United States. We are pleased to report that our vaccine is now available in 47 states across the U.S. and vaccinations are underway. Our over 73 million doses delivered to date include deliveries by our partners into the licensed territories. Serum Institute of India, SK Bioscience and Takeda have all successfully delivered over 17 million doses to licensed territories since the start of our commercial launch, including in Japan, South Korea, India, Indonesia and Thailand. Receiving booster and adolescent label expansions globally has taken longer than expected and expanding our label is our core commercial priority. When coupled with global oversupply, this drove a shift in demand for our vaccine from the second quarter into the second half of the year and into 2023. It is important to note that our total contracted demand remains mostly unchanged, although after ongoing discussions with Gavi, we no longer expect to receive an order from the COVAX facility in 2022. In the UK, we recently amended our supply agreement, which now includes the purchase of a minimum of 1 million doses and up to an additional 15 million doses, contingent upon receiving supportive policy recommendations from the UK’s policymaking body, JCVI. The agreement also includes an option to purchase up to an additional 44 million doses through 2024. And for Europe, we expect to deliver the remainder of our total order, which is currently 65 million doses from a previous 70 million doses in the second half of this year and into 2023. Next, label expansion. Please turn to Slide 22. For boosting to date, we’ve received authorizations in Australia for homologous and heterologous boosting, authorization in New Zealand and approval in Japan in partnership with Takeda. Additionally, over a dozen policymaking bodies have issued guidance allowing for the use of Nuvaxovid as a homologous and heterologous booster dose in adults, including Australia, Canada, Germany, South Korea and other markets. For boosting, we’ve also completed additional submissions for authorization for boosting in the EU, Great Britain and Switzerland and will submit in the U.S. by the end of this month. For pediatric and adolescent label expansion, today, we are expanding our label into adolescents ages 12 to 17, and we’ve already begun clinical development in pediatrics ages 6 months to 11 years of age to support additional expansions to our label in the months to come. For adolescents, we received authorizations to date in the EU, Australia, India and Thailand in partnership with Serum Institute, and in Japan in partnership with Takeda. Importantly, following the European Commission’s adolescent authorization, at least two naïve tags in the EU have issued recommendations permitting use of Nuvaxovid as a third dose and/or as a heterologous booster in adolescents 12 to 17. We’ve also completed adolescent submissions in the U.S., Great Brain, Canada, Switzerland and New Zealand, Taiwan and the World Health Organization. As I mentioned, beyond adolescents, we also leveraged data from our recently initiated Phase 2b/3 global clinical trial to pursue label expansion in younger children six months of age to 11 years – six months to 11 years of age, positioning us to capture significant market share in 2023. Now please turn to Slide 23. As we continue to supply our vaccine globally, we remain confident in our competitive product profile, including our vaccine’s efficacy, well-tolerated safety profile, durability of protection, and ability to address both current and future variance strains. Recognizing our vaccines utility in the ongoing fight against COVID-19, our commercial efforts are also focused on driving uptake of our prototype vaccine. To that end, we’ve deployed branded and unbranded advertising campaigns in various markets to build awareness and promote broad market access. And finally, we are broadening our global commercial footprint and have established additional offices to execute locally in key markets around the world including our new European regional office in Switzerland and expansion into Asia Pacific currently underway in Australia and Singapore. Looking ahead, we expect to see a transition from the pandemic phase to a more traditional commercial market in 2023 in the U.S. and other key high-income country markets. Now moving on to manufacturing. Regarding manufacturing, over the past two years, we have rapidly built a global manufacturing and supply infrastructure to produce both antigen and adjuvant. Today, we are collaborating with our core partners, and we are manufacturing at a consistent run rate that enables us to produce sufficient supply to meet global customer demand. Our partner, Serum, successfully surpassed multiple regulatory inspections in the quarter and is our primary manufacturing partner for most of our global supply. Our recent progress includes the addition of SK Bioscience to our EU manufacturing network and an expanded agreement with SK Bioscience to support overcrowd manufacturing. SK Bioscience will also manufacture our vaccine in prefilled syringes in addition to Serum Institute in 2023. Therefore, providing widespread availability of a preformulated single-dose prefilled syringe while maintaining 2 to 8 C refrigerated stability and an expectation of up to 12 months of dating. Additionally, we continue to make progress to bring our Novavax CZ facility in the Czech Republic online. We remain on track to add Novavax CZ as a manufacturing node for our European supply, and we now expect to submit to EMA in the third quarter. The combination of Serum Institute, SK Bio and our CZ facility provides for a robust manufacturing infrastructure for supply of COVID vaccine and others into the foreseeable future. We expect that in 2023, with indications achieved for boosting adolescents, children six months of age and older, a bivalent and/or monovalent variant vaccine option and our strong global manufacturing network, we will be poised for success in a commercial market. With that, I’d now like to turn it over to Jim to discuss our financial results.

Thank you, John. Please turn to Slides 24 and 25. I’ll begin by providing an overview of our second quarter 2022 total revenue performance, net income and cash position. Then I’ll discuss our quarterly results in additional detail and provide commentary on our revised full year 2022 revenue guidance. In the second quarter of 2022, we recorded $186 million in total revenue, a net loss of $510 million and we ended the period with $1.4 billion in cash. Please turn to Slide 26, where I’ll provide a comprehensive overview of our second quarter results. For the second quarter of 2022, we recorded total revenue of $186 million compared to $298 million in the second quarter of 2021. Total revenue for the second quarter included $55 million in product sales based on 3 million doses sold by Novavax; $23 million of royalties and other revenue, including the recognition of a $20 million milestone payment from Takeda related to our first commercial sale in Japan; and $108 million in grants revenue from the U.S. government. Branch revenue for the second quarter of 2022 was lower as expected, given the decrease in activities under our agreements with the U.S. government and completion of the CEPI-related activities in 2021. We entered 2022 with approximately $800 million of funding remaining under our $1.8 billion in U.S. government agreements and expect to record at least $400 million of this amount during 2022, with the remainder in 2023. Our cost of sales for the second quarter of 2022 were $271 million. I’ll discuss this in a bit more detail on the next slide. R&D expenses for the second quarter of 2022 were $290 million compared to $571 million for the comparable period in 2021. The decrease in the current quarter was primarily the result of lower clinical development activities for our COVID-19 vaccine, the capitalization of manufacturing costs and a net benefit from previously recognized embedded lease costs for manufacturing supply agreements. We expect our full year 2022 R&D expenses to be lower than 2021. Additionally, we recorded selling, general and administrative expenses of $108 million for the second quarter of 2022 compared to $73 million in the second quarter of 2021. The increase quarter-over-quarter was a result of commercial launch costs associated with our COVID-19 vaccine. We expect our full year 2022 SG&A costs to increase compared to 2021 as we continue to enhance our commercial capabilities for our COVID-19 vaccine. For the second quarter of 2022, we recorded a net loss of $510 million compared to a net loss of $352 million in the second quarter of 2021. And finally, we continue to maintain a full tax valuation allowance, and we ended the second quarter of 2022 with $1.4 billion in cash. Please turn to Slide 27, where I’ll discuss our cost of sales in more detail. Cost of sales for the second quarter of 2022 were $271 million, and this includes $255 million related to excess, obsolete or expired inventory and losses on firm purchase commitments under our third-party supply agreements. The recognition of these costs were driven by a substantial reduction of our expected deliveries to COVAX and a deferral of deliveries to other customers. As a reminder, during 2021 and prior to regulatory authorizations for our COVID-19 vaccine, certain manufacturing costs were expensed to research and development that would otherwise have been capitalized inventory. If not for the reduced cost of inventory for the period, full cost of sales for the second quarter would have been approximately $280 million. We expect to utilize the majority of our reduced cost inventory during 2022. Based on our standard costs, our COVID-19 vaccine gross margins on sales to high-income countries are expected to be between 70% and 85% of product sales. Please turn to Slide 28, where we’ll provide an overview of our financial guidance for 2022. As stated earlier, we are revising our full year 2022 total revenue guidance to $2 billion to $2.3 billion. As a reminder, total revenue reflects all sources, including product sales of Nuvaxovid by Novavax, grant revenue, royalties and other revenue. Our revised guidance takes into account both the demand and market supply dynamics discussed on the call today. We look forward to sharing additional updates as we progress in coming quarters. With that, I’d like to turn it over to Stan to discuss our upcoming strategic priorities.

Thank you, Jim. In the coming months, we will remain focused on achieving our key strategic priorities for 2022 that include continuing delivery of our vaccine globally; maximizing our label with the addition of boosting in adolescent populations; this is critical to access global demand; completing development of our Omicron-containing vaccine and pilot in the fourth quarter; and progressing into Phase 2 for our COVID-19 influenza combination vaccine, all to enable initiation of our Phase 3 study in 2023. I believe that over time, we’re going to show that our vaccine will demonstrate longer-lasting protection than other platforms that will show that used as a booster our vaccine can protect against a broader range of virus variants. It will be easier to use, and it will be amenable to combinations of respiratory viruses, including influenza. If I’m right, these attributes should translate in the long-term to our ability to build a significant share of the recurring COVID market. Thank you for your attention. I’ll now turn it over to the operator for Q&A.

We will now begin the question-and-answer session. [Operator Instructions] Our first question comes from Georgi Yordanov with Cowen and Co. Please go ahead.

Hey, guys. Thank you so much for taking our questions. Maybe for us, can you just help us understand exactly how the contract with the EU works, you had previously said that there were 27 million doses that were scheduled to be delivered in Q1 then 42 million doses for Q2? Does that – the current revenue looks like basically, you failed to deliver those doses? Like can you just explain like how exactly we should expect the revenue to be flowing and why were only 3 million doses delivered this quarter? And then I have a couple of follow-up. Thank you.

Yes. So this is Stan. So actually, we delivered the doses in the first quarter, and then we delivered the doses on the second quarter. All those doses were actually in our warehouse, our distribution center in Europe. And the problem was is we had a – it took longer to get through all of the internal – and what I mean internally, I mean, in-country processes that get the vaccine released and to the customer on time so that we could book it in – by June 30. And unfortunately, June 30 is a non-movable master, and we missed by a few weeks. And so we had actually all those doses got invoiced in July. As I mentioned, we have, I think, since July 1, over $400 million worth of revenue just in that period alone, that belong in the second quarter, but we missed June 30.

So do we expect some – I guess, for Q2, the regional agreement was for 42 million doses? Do you expect to realize or I guess, invoice all of those 42 million doses in Q3 with the exception for [Indiscernible]?

So I think as John mentioned, all of these – so these orders, all the customers want to look and see whether they can get a delivery in the second quarter versus they’re now moving to third or second or fourth. And we’re trying to accommodate all of the customers request by moving doses around. So it’s a bit of a moving target. We don’t see – right now, we don’t see them reducing their orders. What we see is them reduce – what see spreading it out over extra quarter or two. And so that’s what we look at right now. And so it’s hard to say what’s really going to happen there because it’s hard to say what the surge in the fourth quarter is going to will do to those orders and what the use of our vaccine as a booster will do and how quickly that will take up product. So it’s – but we – so it’s moved but we haven’t lost orders yet.

Got it. And then just as a follow-up, I guess, on what you just mentioned, the Q4. Can you talk about – clearly, most jurisdictions are now expecting an Omicron adapter vaccine in the fall. Can you talk about how do you see that regulatory process? Do you believe that – you mentioned you don’t expect any additional revenue in the U.S. Do you believe that you will be able to actually deliver any Omicron-specific doses this year? And how does the regulatory process and just given the fact that you’re not going to have immunogenicity data in time?

Yes. Again, this is complicated times. And I think that what we’re going to see is we’re having, I guess, probably daily discussions about the use of our Wuhan 2373 vaccine, which we have shown today a bit of the data that we’ve generated, which shows that our vaccine as a booster actually is very effective, [Indiscernible] neutralizing the protective levels of antibodies against VA5, VA4, VA1. So there’s a discussion that we’re having as to whether that should be used as a booster, not just in other parts of the world who are also not convinced that maybe having a VA5 bivalent is the way to go. It’s just – it’s not an answered question yet. And in the U.S., we’re having a discussion as to whether we should be shipping – whether they should be buying our 2373 for boosting in the United States. It’s all up in the air. This is August. It’s something that one would hope would be solved by now, resolved by now, but it’s not. And so we’re in the mix of that discussion. We have good data for 2373. We will have a VA5 vaccine. But as you pointed out, it will be later in the quarter. And I’m not sure it’s needed.

Got it. So – so just to confirm, you don’t expect that the Omicron-specific VA5, you’ll be able to deliver that this year.

No, I didn’t say we won’t be able to deliver it this year. It just will be later. It’s not going to be for October usage.

Got it. Thank you.

Thank you so much.

Next question comes from Roger Song with Jefferies. Please go ahead.

Great. Thank you for taking a question. Maybe just a couple clarification. Can you just provide the granularity for this $2 billion to $2.3 billion updated guidance, specifically how much this U.S. government grant will be included? Because last time, I think where you include $400 million. I see that 1Q and 2Q, each quarter, you delivered – you recorded $100 million per quarter. Do we still expect another $200 million in the second half? Also in terms of the product sales understand you say you have new [Indiscernible] delivery order, maybe the outstanding order of another 5 million doses in terms of other countries what is the breakdown between the product sales versus the other like loyalty and the government grant?

Yes. I’ll take care of the product sales to the U.S. government in the second half and that we decided - we’ve sold the government 3.2 million doses that are currently being used. And we decided, without more clarity from the U.S. government, that we’re just not going to put in a forecast. And I’m not sure that’s my expectation, but that’s all we know right now. And so we’re being very conservative on that forecast. For the grant related, I think Jim has that number in his mind.

Yes, so the grant related for the remaining of the year should be just over – or should be over $200 million. When you look at the midpoint of guidance relative to our sales year-to-date, year-to-date total revenue of $900 million would leave approximately $1.25 billion at the midpoint. So I just shared that the grant revenue would be over $200 million. And therefore, the remaining billing would go towards EPAs and royalty income.

Got it. Okay, thank you. And understanding this demand shift and particularly for the Omicron-containing vaccine availability, maybe, Stan, if you can share with us the expectation for the 2023 and beyond. Particularly, you mentioned the commercial market in the high income country, including U.S., EU. And what do you think about the pricing versus the volume or the market share for Novavax against other vaccines?

So well, that’s a very big question. And I don’t think we have a forecast for 2023 that we can share. I do think that maybe John can talk about, it will shift into a commercial market at a different price and a lot of different…

Yes, I think we’re expecting a shift out of the pandemic period into the commercial market in 2023. But I think you’re going to see that taking place at various times for various countries. A couple of things here, and it’s all based upon our assessment of where the market is heading, which is a bit of a challenge, as you can imagine. But a couple of fundamental pieces that we’re confident about. One is that this virus is not going away. There’s going to be a need for at least some annual revaccination. We expect that that’s probably going to look like something greater than the existing influenza market. Could be from anywhere from 25% to 52% market size greater than what the current flu market is. We would also reasonably expect that pricing will vary, again, country by country, but would look a lot like, again, the premium-priced influenza market in the U.S. Proportionately, that will be different in Europe and other countries. As we said in the presentation, there are a number of things that have been obstacles for us in 2022, booster label, adolescent pediatric label and access into the U.S. market. Therefore, all those obstacles, I think, will be cleared as we head into 2023. And I think as we get through 2023 and get the peak non-pandemic, but peak commercial revenue, we should expect to have an expectation in the 20% to 25% market share of that commercial market going forward. Again, all of this is very speculative in nature, but based upon our analysis of the market to date and what we expect the total COVID vaccine marketplace to look like going forward.

Great. Thank you Stan for the color. Maybe just a last one related to the financial guidance. Can we get a sense of the cash flow and the EPS kind of this year maybe beyond? Particularly, I think the moving piece may be related to OpEx. I think you have been saying the OpEx is lower this year versus last year, but to what extent? And also, how should we think about next year and the beyond? Thank you.

Likely best to leave the 2023 to a future conversation as we fully build out our commercial footprint. With respect to current year, you’ve got SG&A that came in at $108 million for the quarter, we do expect that to continue to trend up as we build out our capabilities. R&D, we do expect R&D to be materially lower year-over-year than last year. And of course, that’s went to the factors I mentioned previously. Everything from capping of supply to inventory to, at least for the first half of the year, lower clinical spend. And then finally, some favorability related to lease accounting. And so we think about our cash position at $630 million, which reflected $1.4 billion in cash and a receivable of $200 million, you add to that the feedback we just shared that we have, call it, orders in hand through today’s call in the range of $400 million, we feel good about our cash position as we continue to execute in the back half of 2022.

Great. Thank you. Thank you, Jim. Yes, that’s it. Thank you for taking the question.

Our next question comes from Mayank Mamtani with B. Riley. Please go ahead.

Thanks for taking our questions and difficult numbers to digest there. So maybe just to follow-up on the delivery versus invoicing process. Can you just clarify how does that differ for EU versus ex-EU territories like Canada, Australia and UK? And if you are able to comment on where does the real-time inventory stand right now? And just going back to Jim’s comment on how should we think about this write-down sort of going forward? And if that needs to be modeled into cost of sales going forward? And then I have a couple of follow-ups.

Okay. I’m happy to take, of course, the rev rec piece. And then glad to speak to the $255 million charge we took this quarter in COGS and what it means prospectively. So with respect to our revenue recognition, it’s uniform globally. And in all cases, it is upon transfer of title to our customers, which is uniformly when a customer takes possession of our product at their location. So that’s true in Europe and elsewhere. With respect to the $255 million charge, this is a function of both the COVAX omission of our expectation to deliver against an inventory build that we had otherwise – an investment that we had otherwise been making to supply COVAX for quite some time. In addition to that, as we watch the market dynamics play out with respect to global supply and demand, certain raw materials and semi-finished goods were subject to potential expiry. And so what you are seeing for us this quarter is a reflection of that, call it, recalibration. And it’s – I’m not sure you’re tracking the earnings for our, call it, COVID peers. It’s a very similar story elsewhere as well.

Helpful clarification. Thank you. And yes, that is the case for the two years also. And then on the booster label with EU and also, importantly, with the UK JCVI. Could you, Filip, if you could give some update on how far along we are? And also on the UK shipments, what’s the expectation to – for that to commence? I appreciate the update on the revised contract you have. And just maybe a higher-level question. As you track market share country-by-country, where you do have the booster approval, are there any case studies one could reference to sort of think of Nuvaxovid market share tracking versus the third or fourth booster shot of mRNA vaccine?

Right. So just as far as where we are with the booster indication in Europe and other territories, well, those are in process side. They have all the information. They have the same information. It was evaluated by the regulators in Japan, Australia and New Zealand where we’ve received favorable approvals. And we’re just working through the process. My expectation is that we’ll be hearing news from those regulators in the next handful of days to weeks. We don’t control that process, obviously, they do. What we do know where the data is available, where our vaccine is available alongside other vaccines is that people are making a choice. We are seeing people ask for vaccines in the booster indication, even though we don’t have a label indication in certain territories such as in Korea or Australia, let’s say. Australia recently changed, but when we look at the historic data before we got the label indication there. So we know people are choosing to go there. The exact amount and how frequently they do that, is really a function of the policy recommendations in each territory. So we know where we have relatively good recommendations such as Korea is happening at a very high rate compared to where we have more restricted recommendations, let’s say, in Germany.

Thank you. And my final question on the capital allocation. Given the dynamics you guys talked about for cash burn and revenue recognition cadence how might you be thinking of the convert that might be coming up in February? Could you provide some comments on that, please?

Yes, certainly, certainly. So for folks who are familiar with our balance sheet, there’s a $325 million convert that matures in February of next year. To date, we have not stated a specific intent to do anything with respect to, for example, refinancing or perhaps just simply paying off. We continue to have confidence in our forward-looking ability to deliver on our sales and generate cash flow. And we’ll evaluate our options in the coming months as we think it best serve shareholders and dependent, of course, on capital markets dynamics.

Thanks for taking our questions.

Our next question comes from Eric Joseph with JPMorgan. Please go ahead.

Hi. Good evening. Thanks for taking the questions. I just wanted to pick up on the COGS expectation in the second half, given the write-downs this quarter. If we’re looking at third-party data, there’s still seemingly a fair amount of inventory in the EU that’s yet to be end distributed. So I guess, can you talk a little bit about shelf expectations for Nuvaxovid? How much of the current inventory could roll over into 2023 should we anticipate a significant, I guess, some amount of inventory on hand being at risk in the second half? And then – just coming back to the U.S. revenue piece. If I heard correctly, you don’t anticipate any additional products revenues from the U.S. this year. Nevertheless, I am curious to know whether if additional orders are made, whether they would count against the balance under the BARDA agreement of 110 million doses or whether you might look to move to a more traditional purchasing model sort of outside the existing contracts in earlier time frame for 2023 and beyond. Thanks.

So Eric, there’s a couple of pieces to parse out there. So the revenue and the write-off of products are somewhat related, and so Jim could talk more to that. So any expectation that we would have, inventory that would not be shipped, Jim has already reserved and made an adjustment for that. Any of the product that we expect to ship for the balance of the year will be on top of whatever inventories are sitting there. There are inventories that are our inventory that fall under what Jim’s assessment would be. And then there are inventories that have already been invoiced to the customer. Shipments in Q3 and Q4 and shipments that have been pushed off into Q1 and Q2 of next year will remain unaffected by those inventory levels. In fact, we see this expected wave of additional vaccine boosters taking place in the fall. I think that, that will help reduce some of the existing inventories of product that has been shipped. And then we already have – are planning out what those shipments would be, as I said, for Q3 and Q4 and then what’s ever pushed into 2023. So I think that captures that piece, Jim.

And then maybe shelf life. Currently, we’re at nine months in most markets.

We would expect as we get later on to the year, that shelf life would extend into 11 months, but don’t have that shelf life extension yet.

Exactly. With respect to the charge in the period of $255 million, approximately $150 million of that or $155 million of that related to inventory in various stages. You know you got raw materials, semi-finished and finished goods. The share of that, which we felt could be subject to expiry, we expense. And then with respect to the remaining $100 million, this has to do with unavoidable fixed purchase commitments in future periods where we simply feel we no longer need to secure either manufacturing slots or certain raw materials. And so we took a charge for that as well. So those – that’s the breakdown of components. Now in terms of forward-looking, if we felt like there was more, we would have, of course, reserved for it today. And therefore, when we speak about our expected margins on a go-forward basis and specifically to high income market, I shared that we expect gross margins in the area in the range of 70% to 85% based upon our standard cost. And that certainly continues to be the case.

Okay. Great. Thanks for taking the questions.

Our next question comes from Alec Stranahan with Bank of America. Please go ahead.

Hey, guys thanks for taking our questions. Just two quick ones from us. First, could you talk a bit more about the Phase 3 design for the combo vaccine? Have you reached an alignment with the FDA on endpoints at this point? And how should we think about a ballpark for enrollment to reach a meaningful effect size given the expected attack rate for both viruses? And secondly, and apologies if this was already asked, but curious whether your current APAs include optionality for strain-specific vaccines, should they become available, or whether this would trigger your additional contracts? Thanks.

Well, the first question is for me. So we have not had our pre-Phase 3 meeting with the agency yet for – and I’m assuming you’re talking about the influenza/COVID combination vaccine. And we’re going to do that after we get the results from our next study. Clearly, they are data driven, and they’re going to want to see that data before they can give us final opinions on it. Although people have been running Phase 3 studies against flu for a while, so we have a pretty good idea at least what we’d like to do. But we haven’t commented on any specifics on what that is that looks like.

As far as strain change provisions, there are some of the agreements that will allow for flexibility in strain change. And frankly, that is fine with us, given where we stand in our development activities. That provides for upside opportunity and the ability to ship variant strained product. Now there’s not been a whole lot of clarity on a country-by-country basis as to what they want most specifically and definitively has been the U.S. market seeking at least the bivalent for the mRNA vaccines. But all the conversations we’ve been having with UK, Europe, Australia, New Zealand, Canada, et cetera, there have not been absolute decisions made regarding strain change product.

Thank you.

Our next question comes from Mayank Mamtani with B. Riley.

Thanks for taking my follow-up. Just really quick, we get asked a lot about the time lines for BA.1 specific vaccine, which you have in the clinic and sort of the CMC scale-up process, how that’s kind of progressed? And if you are looking to build any inventory for that versus wanting to work on the BA.5 specific vaccine. Could you just sort of comment a little bit on both data and then the CMC-specific activities for that vaccine?

Yes, it’s Greg here. So the clinical trial, as Filip noted, has been enrolled, and we’re doing the assays. And so we expect towards the end of quarter three, to provide the clinical result, we’re actively working on BA.5. And our expectation is we can have a stockpile of material. However, we have to submit the regulatory package sometime in quarter four. And so after that, we’re not sure what the timing will be, how long it will take the FDA to review that. So what just I would like to kind of recapitulate what Filip said, however, both – and Stan as well, we’re increasingly convinced that our current vaccine is suitable for deployment in the context of a boosting study. As you know, we provide very good data showing that our vaccine induces broadly – antibodies broadly recognized variants, including BA.5 very nicely. And we’re – I think there’s a fair amount of discussion currently with many of the customers on exactly what to do. We think there’s a lot of merits in deploying our current Wuhan vaccine that is authorized and the Minicare is being used as a booster. And obviously, in our data, it is really strongly inducing this broad recognition of antibodies that broadly recognize new variants when we boost. And we think there’s a very strong case for deployment of that vaccine.

Got it. Appreciate you taking the follow up. Thank you very much.

Thank you.

This concludes the question-and-answer session. I would like to turn the conference back over to Stan Erck for closing remarks.

Thank you. Thanks to everyone for joining today’s call. I’d probably close by thanking all of those who made possible the significant progress during the second quarter, including all of our employees, selfless contributions of our trial participants, the continued support from our partners around the world, and we look forward to reporting additional milestones in the coming months. So thanks for being on the call.

The conference has now concluded. Thank you for attending today’s presentation. You may now disconnect.