Earnings Call: Q3 2022

Nov 8, 2022

Afternoon, and welcome to the Novavax Third Quarter 2022 Financial Results and Operational Highlights. All participants will be in a listen only mode. After today's presentation, there will be an opportunity to ask Please note that this event is being recorded. I would now like to turn the conference over to Sylvia Taylor, Executive Vice President and Chief Communication Officer. Please go ahead. Good afternoon and thank you all for joining us today to discuss our Q3 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 total revenue, 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 seen candidates and key upcoming milestones. Each forward looking statement contained in this presentation is subject to risks and uncertainties that could cause actual results 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 ks And our Q3 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. During this call, in order to provide greater 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 most directly comparable GAAP financial measure within the Investors section of our website at novavax.com. Now please turn to Slide 4. Joining me today is Stan Erck, President and CEO, who will provide an update on our recent progress and our upcoming strategic priorities. Additionally, Doctor. Philip Dubovsky, Chief Medical Officer, will discuss our clinical development across our pipeline and John Trizzino, Chief Commercial We'll provide an update of our financial results. Doctor. Greg Glenn, President of Research and Development will also be available for the Q and 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, Sylvia. Good afternoon, and thanks for joining our Q3 earnings call. In addition to the financial report that Jim Kelly will give, Philip will provide our update on important clinical data We are accumulating, which continue to highlight the advantages offered by our adjuvanted protein based vaccine. And following that, John will discuss our commercialization efforts. But first, let me start with the financials. Jim will provide you more details, but the highlights include Revenue for the quarter was $735,000,000 This met our target for the quarter and bring us to $1,600,000,000 in revenue for the 1st 9 months of the year. During the last quarter, we continued to gather data that supports the differentiation of our vaccine. We believe these differences are important and are a predictable consequence of our vaccine technology. When our nanoparticle Antigen is formulated with Matrix M. It generates a very broad and long lived immune response, which we believe As advantage is in the face of the continued emergence of new variants, we believe that these differences will allow us to deploy a vaccine that may not require serial updating and may not require bivalency. Novavax's vaccine has been granted regulatory authorizations globally. In the Q3, we received emergency use authorization from the United States, representing the last major market in which we have obtained authorization for use. Throughout the year, we have been developing data with our many clinical trials across the globe that support the advantages of our vaccine. And together, we believe these advantages will be the basis for the continued long term expansion of our product in markets throughout the world. We now have data supporting Novaxovitz durable immune response that achieves levels associated with protection in our Phase III trials. With the ever mutating COVID virus, we want a vaccine that can stimulate an antibody response across any variants that arises. And while we can't predict the future, we can show that our vaccine has a breadth of response that covers all of the variants that we've measured to date, including alpha, beta, delta and BA1 through 5. This is important for obvious reasons, but it should be pointed out But we don't have any data which suggests that it's a good decision to switch to a BA. Five vaccine given that our current vaccine stimulates levels A BA. 5 antibody that should be protective. Our data also shows show that we have an 82% prevention of infection Over an extended period, and plus, our data continues to provide confidence in the use of our vaccine and its safety its favorable safety and tolerability profile. Our mission must be to remind and educate the regulatory and policy bodies that as a protein based adjuvanted vaccine, Our vaccine is different from what's on the market. As long as we continue to demonstrate that our current vaccine stimulates a relevant immune response Against circulating variants, we believe our current vaccine will be a good choice for ongoing vaccination campaigns. And importantly, It has the added advantage that when you continue to boost with the same vaccine, you continue to see maturation of these responses with the expectation that you'll see more effective and longer lasting responses. When we see data that suggests the need to update our vaccine with a new strain, We will. We will do so with either a monovalent or bivalent vaccine based on data that we then have and relevant policy recommendations at the time. There may be some public health agencies that prefer either a strain change or bivalent vaccine And our plan is to develop in parallel a variant containing monovalent and bivalent plexi. Switching topics. We have mentioned in the past that we have been collaborating with the Serum Institute and Oxford University on a new malaria vaccine that includes our Matrix M adjuvant. I'm very pleased that Adrian Hill of Oxford University presented a very high level summary of Phase III efficacy data at a late breaking session of the Tropical Disease and Malaria Conference in Seattle last week. More detailed safety and efficacy data will be available when approved for publication later this year. Going forward, we believe that we are in a very good position. We have a global manufacturing capacity to Support our planned sales of nabaxovid. This capacity will also support our pipeline vaccine candidates for flu, for combination flu COVID and for malaria. And we now have a global marketing and regulatory presence to support our goals for 2023 beyond. I'll now turn the call, The presentation over to our Chief Medical Officer, Philip Duboski, who will be followed by John Tercino, our Chief Commercial Officer And our Chief Financial Officer, Jim Kelly. We will end with a session of Q and A. Thanks, Dan. Since the last call, we've developed a significant amount of new clinical data. Today, I'm going to review data from Study 307, is our lock to lock consistency study that includes heterologous boosting on top of 2 and 3 doses of mRNA. Then I'll describe preliminary findings from Study 311, Our STRANGE study that evaluated boosted responses to prototype vaccine, omicron BA. 1 vaccine and bivalent vaccine when given on top of 3 doses of mRNA But first, I want to review some findings we have recently disclosed. Please advance to Slide 7. From our UK study, we recently published that our vaccine had 82% efficacy for preventing all infections over 6 months observation period. This was despite the majority of cases being caused by the Alpha variant. Protection from infection is important because if you don't get infected, you can't transmit the virus, You can get sequelae for COVID and you can get long COVID and you can be the source of new variants. In our adult U. S. Mexico Phase 3 study, we achieved the formal regulatory endpoint supporting boosting in the U. S. Population and we demonstrated a durable immune response as well as a broad immune response That includes cross reactive antibody levels directed against Omecon variants that were consistent with levels associated with protection in our Phase 3 studies. And in our adolescent Phase 3 study, we met the regulatory endpoint for boosting in 12 to 17 year olds and showed the immunologic responses to omicron variants were comparable to those associated with protection. Okay, let's go to Slide 8 and talk about Study 307, which is our last to lock consistency study. For this study, I'll discuss data supporting the achievement of our LOTTO LEND point and the magnitude and breadth of the heterologous boosting response. This is still preliminary data and additional immunologic assessment is ongoing. So let's move to Slide 9, please. Study 307 enrolled 911 adults in the U. S. Who had no history of recent COVID infection and who had received 2 or 3 doses of an approved COVID vaccine with the last dose being at least 6 months prior to enrollment. As you can see on this slide, Most of our subjects received 2 or 3 doses of either Moderna or Pfizer. A few received 1 or 2 doses of J and J and a very small number had received 2 doses of Novavax. After enrollment, all subjects were boosted with 1 of 3 different lots of Novavax vaccine and the serum was collected at day 28 for immunologic assessment. Let's move to Slide 10. Demographics show that the 3 lot groups were well balanced. The racial makeup was broadly representative of the general U. S. Population The median interval prior to the Novavax boost was approximately 9 months. Let's go to Slide 11 and look at the primary endpoint. As you can see here, the primary endpoint of non inferior immunogenicity was achieved as measured by anti S IgG titers at day 28. This was the regulatory endpoint confirming consistency of our manufacturing process. Please note the extremely tight confidence intervals here. But let's look at the immune responses following heterologous and homologous boosting on Slide 12, please. Because most of the subjects in this trial received the Novavax vaccine as a heterologous booster, we had the opportunity to evaluate the magnitude and breadth of immunogenicity in different Shown on the far left are IgG responses in a small group of 7 subjects who received 2 doses of Novavax Priming series followed by a single Novavax boost. We're also showing responses for those who received 2 prior doses of Moderna, 2 prior doses of Pfizer and 1 dose of J and J, a superimposed of course of protection threshold, derived by the U. S. Government based on our U. S. Phase III trial and the actual Phase 3 levels we attained in our 2 Phase 3 studies. The post booster levels we saw in this trial matched or exceeded the levels achieved in the Phase 3 efficacy Consistent with what we've seen previously, we observed the highest antibody titers for the homologous Novavax boosting subset. Okay. Let's go to Slide 13 and look at head August boosting on top of 3 doses of mRNA. This is a similar setup The previous slide, but for the groups who received 3 prior doses of Moderna or Pfizer or 2 prior doses of J and J. So a full primary course plus one prior boost. In each of these subsets, the antibody levels exceeded the Phase III levels And for the mRNA recipients, levels were approximately 20% to 30% higher than we saw in the previous slide with priming with just 2 doses of mRNA. The group with 2 doses of J and J had broad conference intervals because of the small sample size. Now let's look at Slide 14 to look at the breadth of immune response. Here we evaluated IgG responses to prototype and to omicron subvariants BA. 1 and 5. We are displaying the 2 doses of Novavax Boosted once with Novavax is a solid bar on the far left hand side of each triplet and that's compared to 3 doses of Moderna or 3 doses of Pfizer boosted once with Novavax. In all cases, IgG titers at cheap levels predicted to be correlates of protection of approximately 88% to 95%. As before, the highest antibody titers against both prototype and variants were in the homologous Novavax boosted subjects. In summary, we believe that 307 findings are important, both because they confirm consistency of manufacturing, which is critical for vaccine licensure in the U. S. And because they showed robust immune responses to prototype and variance after homologous and heterologous boosting with post boosting antibody levels approximating those levels associated with protection So let's move to Slide 15 and talk about the next study. Now I'll review the top line data from Study 311. The study was designed as a strain change study and evaluated the performance of our pleuritide vaccine and omicron BA. 1 vaccine and a bivalent format vaccine when given after 2 and 3 doses of mRNA. So let's go to Slide 16 of the design. The study was conducted in Australia in adults 18 to 64 years of age, the participants received 2 or 3 doses of mRNA and were boosted with either our prototype vaccine, the BA. 1 vaccine or the bivalent vaccine. Today, I will only talk about participants who received 3 prior dose of mRNA and who are boosted at least 90 days after their last dose. Let's look at the demographics on Slide 17. The study groups are well balanced with racial groups representative of the overall Australian population. The participants received their boost a median of 180 days after their last mRNA dose. You can see that Australia did a better job of controlling infection as The large proportion of this group did not have evidence of prior COVID infection. So let's look at the endpoints on Slide 18. The primary endpoint for the strain change portion was pre specified to be in the 3 dose group and participants who had no prior COVID infections. We compared the day 14 neutralizing responses against BA. 1 in the 3 treatment groups. In the first column, we compared BA. 1 neutralization responses after being boosted With BA. 1 vaccine to the BA. 1 responses after being boosted with prototype. This was a strain change endpoint. And because the BA. 1 vaccine responses against BA. 1 were higher than those induced by the prototype vaccine, the study achieved a statistical endpoint allowing for strain change if eventually needed. Let's give it a click. The second column compares the bivalent vaccine to prototype. The responses were similar with the confidence intervals overlapping 1. And the final column compares the bivalent vaccine to the BA. 1 vaccine and the responses were lower for the So as far as the BA. 1 responses go, the data does not support a measurable benefit for the bivalent vaccine. Okay. Let's look at some comparative data on Slide 19. Here we're looking at IgG responses against BA. 1 and all the participants who received 3 prior doses mRNA vaccine. This group most closely resembles the general population. Here the responses were similar between all three vaccines, Although when boosted with our prototype, it was numerically higher by about 15%. Please advance to Slide 20. Here we're looking at IgG responses against prototype, the Wuhan strain. Once again, the responses were statistically comparable with up to a 20% numerical benefit for boosting with the prototype vaccine. Of course, neither prototype nor BA. 1 are in circulation currently. So let's look at forward Slide 21 please. Displayed here is a neutralization response against BA. 5 Functional Pseudoneutralization Assay. BA. 5 is a omicron subvariant that was not in any of the vaccines, but is related to the BA. 1, so we would expect a superior response with BA. 1 vaccine. However, there was no benefit observed for either BA. 1 vaccine nor the bivalent vaccine compared to the prototype vaccine. In fact, the prototype vaccine gave numerically higher responses. This indicates that boosting with our current vaccine is a viable approach and be considered as a future proof strategy for emerging variants. Okay. Let's look at some reactogenicity on Slide 22. When given as a second boost dose for all three formulations, They were similarly well tolerated with patterns consistent with what we've seen previously. Here the most common local reactions are pain and tenderness, the vast majority being none Mild or moderate in severity. Let's go to Slide 23 and look at solicited systemic symptoms and the pattern is also very similar to what we've seen previously with very low rates of Grade 3 events and a negligible fever signal. Okay, let's sum this up on Slide 24. So to sum up, we believe our data supports the continued and future use of NVX-two thousand three hundred and seventy three as a booster. From our U. S. Mexico Phase 3 study using our PERA type vaccine, We've described a durable immune response and a hematologic data indicating that the levels achieved against drifted omicron variants were consistent with levels associated with protection in our Phase 3 studies. Today, I showed you data that when we are used as a heterologous booster after 2 or 3 doses of authorized vaccine, we achieve broad immune responses against drifted omicron variants. And the magnitude of these responses are considered to be protective when applying the NIH U. S. Government codes of protection thresholds. Finally, our study with Omicron BA. 1 vaccine and bivalent vaccine indicated no measurable benefit over our prototype vaccine. So So when we think about what will be causing illness over the next few months, it will not be BA. 5, where there's some variant that is yet to emerge. A vaccine that induces high levels of cross variant responses might be appealing as a way to future proof the ongoing boosting effort. Importantly, the vaccine is currently stocked and can be deployed immediately. Finally, because this is our original vaccine, we have confidence in the pre existing long lived safety database. This might be a feature that's attractive to individuals who are hesitant to be boosted. Okay, let me turn this over to John Trizzino. Thank you, Thank you. Our doses delivered to date also include over 19,000,000 doses by our strategic partners, Serum Institute of India, SK Bioscience and We remain in ongoing discussions with our customers around the world, including the EU, U. S, Canada, UK, Australia and others to ensure optimal supply of doses through the remainder of the year and into 2023. Notably, in the UK, we delivered an initial 1,000,000 doses in the Q3. We are in active discussions with the UK Health Services Agency around supply and continue to provide data to JCVI to support policy recommendations for boosting in adolescence and expect to receive MHRA approval for adult booster imminently. In the EU, we are expanding our presence and Strengthening our partnerships for now and well into the future. To support this, we are in the process of finalizing a revised delivery schedule for the remaining 23,000,000 doses committed under our APA. In the U. S, we remain in ongoing discussions around additional supply of our COVID vaccine now available for boosting of adults 18 and over. Please turn to slide 27. We continue to closely monitor the market landscape and we believe that current global vaccination trends and the upcoming winter respiratory season present an ongoing near term opportunity to drive uptake of our vaccine. In the U. S. According to recent CDC data, Around 39% of adolescents have yet to complete their primary vaccination series. Additionally, around 47% Vaccinated adults have yet to receive a first booster dose. Additionally, in the UK, Germany, France, Italy and Spain, around 48% of adolescents have yet to complete their primary vaccination series and around 20% A vaccinated adults aged 18 to 59 have yet to receive a booster. With authorization now received for primary vaccination in adolescents In the U. S, EU and UK and for a booster dose in adults in the U. S. And EU, Our recent label expansion aligns with this market need. Outside of the U. S. And Europe, we see similar dynamics that present additional near term To expand the portfolio of vaccine options and appeal to those not yet vaccinated or not yet boosted. In fact, we have already begun to see encouraging evidence of healthcare providers and consumers utilizing our vaccine as a booster dose. Based upon available data through October around 60% of new vaccine doses administered globally have been used as a booster. Please turn to Slide 28. Our key focus to capture the near term and long term market opportunity It's to expand our label to include adolescent boosting based upon the compelling data Philip discussed today. And in the U. S. To also include additional booster doses in adults. Alongside this, we will also focus as always on gaining supportive policy recommendations. These efforts will build upon our label expansion to date, which includes authorizations for primary vaccination in adults in over 40 countries authorizations for primary vaccination in adults in the U. S, EU and 11 additional countries. Authorizations for boosting in adults in the U. S, EU and 6 additional countries. Please turn to Slide 29. Looking to the long term COVID-nineteen market opportunity, we expect to see a transition to a commercial market In the U. S. And other key regions in 2023, with clear evidence that the virus is not going away, We expect an ongoing need for annual seasonal vaccination resulting in a recurrent COVID-nineteen booster market. And we believe this opportunity will be larger than the annual influenza market due to COVID-nineteen's greater burden of disease and higher infectivity In the U. S, we believe an annual booster market in 2023 beyond can include around 225,000,000 individuals, which is significantly larger than the annual U. S. Flu market in recent years of 170,000,000 to 190,000,000 individuals. In the UK and the other key markets in the EU, we believe this could be around 250,000,000 individuals. This potential recurring opportunity includes individuals that have already received their first booster dose, as well as individuals that have been fully vaccinated and are eligible to receive a booster. Importantly, beyond these geographies, we believe that a similar sizable and recurring Booster opportunity will also take shape in other key markets including Asia Pacific. Please turn to Slide 30. As we look toward this long term market, we believe our competitive product profile We'll differentiate our vaccine among healthcare providers and drive adoption among consumers. As Philip discussed today, We continue to build on our existing body of clinical evidence with additional data that demonstrate our vaccines key benefits such as its high efficacy, strong durability of immune responses, protection against infection, Favorable safety and reactogenicity profile and importantly its breadth of immune responses against a broad range of variants. We believe these key benefits coupled with our vaccines well established technology platform and favorable transportation and storage profile Create a competitive product offering. Based upon our data generated to date, including initial results announced today For our omicron variant vaccine program, our commercial strategy is to continue deployment of our prototype vaccine. With that being said, as Philip mentioned, we will continue to generate additional data and be prepared to supply a variant specific vaccine if supported by data or requested by our customers. Regarding commercial strategy, please turn to Slide 31. With strong foundational elements in place, we are executing our robust commercial strategy. I'd like to highlight a few of our key commercial priorities that we believe will drive success in 2023 and beyond. First, we are expanding our commercial footprint in priority markets. We have established our EU regional office in Switzerland, are expanding our commercial structure in the Americas including U. S, Canada and Mexico and building our commercial presence in Asia Pacific. In parallel, we will continue to partner with local policy making bodies to advance supportive policy recommendations. This will be critical to ensuring widespread access and capturing a significant share of the anticipated recurring market outlined today. We are also building brand awareness among healthcare professionals and consumers through a comprehensive marketing strategy to communicate our vaccine's strong data and key benefits. In an effort to position Novavax as a key player in the commercial market, we are also developing our commercial network and building relationships with key stakeholders such as pharmacies and purchasing groups. We will be transitioning to single dose vials and expect to make available prefilled syringes in 2023 in order to enable easier administration and lower waste of doses serving as a competitive advantage for our product. We believe ongoing execution of this global commercial strategy, Coupled with our vaccines competitive product profile will support our long term success and solidify our role in the recurring COVID-nineteen market. I will now hand it over to Jim to discuss our financial results for the Q3. All right. Thank you, John. This afternoon, we announced our financial results for the Q3 of 2022. Details of our results can be found in our press release issued today and our 10 Q filing. I will begin by providing an overview of our Q3 2022 total revenue performance, Net income and cash position. Then I will discuss our quarterly results in additional detail as well as provide commentary On our refined full year 2022 revenue guidance. In the Q3 of 2022, we recorded $735,000,000 in total revenue compared to $179,000,000 in the prior year. Total revenue for the Q3 included $626,000,000 in product sales based on 35,000,000 doses sold by Novavax. Grant revenue of $106,000,000 in the Q3 of 2022 includes revenue on the delivery of 3,000,000 doses to the U. S. Government in comparison to $135,000,000 in the prior year. Additionally, we recorded royalty and other revenue in the Q3 of 2022 of 2,000,000 Our cost of sales for the Q3 of 2022 were $435,000,000 I'll discuss this in a bit more detail on the next slide. R and D expense for the Q3 of 2022 were $304,000,000 compared to $408,000,000 for the comparable period in 2021. The decrease was primarily the result of a $98,000,000 benefit from the settlement of the manufacturing agreement. Additionally, we recorded selling, general and administrative expenses of 123,000,000 in the Q3 of 2022 compared to $78,000,000 in the Q3 of 2021. The increase in the period was primarily the result of activities in support of the commercialization of nabexovid. For the Q3 of 2022, we recorded a net loss of $169,000,000 compared to a net loss of $322,000,000 in the Q3 of 2021. And finally, We continue to maintain a full tax valuation allowance and we ended the Q3 of 2022 with $1,300,000,000 in cash. Please turn to Slide 35. Cost of sales for the Q3 of 2022 We're $435,000,000 This amount includes $249,000,000 related to excess obsolete or expired inventory And losses on firm purchase commitments. The recognition of these costs was driven by efforts to align our supply and third party future purchase commitments with anticipated demand for navexovid. If inventory sold for the Q3 was valued at expected standard cost, Adjusted cost of sales for the period would have been approximately $444,000,000 an increase of 9,000,000 as compared to cost of sales recognized. Nabaxavib gross margins on sales to high income countries are expected to be between 70% 85% of product sales. As noted earlier, we are refining our full year 20 As a reminder, total revenue reflects all sources, including product sales of Novaxovid, by Novavax, Grant revenue, royalties and other revenue. We look forward to sharing additional updates as we Progress in the upcoming quarters. With that, I'd like to turn it over to Stan to discuss our upcoming strategic priorities. Thanks, Jim. So if you turn the slide, please. With the strong Q3 reported today, We are pleased with the momentum we're generating across our business. Moving into the end of the year, we are focused on executing against our Key strategic priorities, these include delivering doses globally to achieve our revenue guidance, ongoing expansions to our label In support of policy recommendations for Nuvexavid and initiating our Phase 2 trial for our COVID-nineteen influenza combination vaccine and standalone influenza vaccine by the end of this year, which will enable a Phase 3 efficacy trial expected to start in 2023. So as we prepare for the upcoming winter COVID season as well as 2023 beyond, We believe we are well positioned to be a leading provider of COVID-nineteen vaccines. And as you've heard today, through our data generated to date, We are confident in our prototype vaccines competitive profile, including its durability of immune responses, its ability to address a broad range of variants, its protection against infection and storage and handling benefits. We believe these differentiating factors along with our ongoing label expansion, global manufacturing and supply network Will allow us to capture meaningful share of the recurring COVID-nineteen market. So thanks for your attention. And I'll now turn it over to the operator for Q and A. Thank you. We will now review the question and answer session. And our first question today will come from Roger Stone with Jefferies. Please go ahead. Great. Thank you and congrats for Good quarter. A couple from us. The first one is the variant specific vaccine. So given the data you presented today, Seems the bivalent, have less immunogenicity against the monovalent. So just curious, What is the plan for the variant specific vaccine moving forward, monovalent versus bivalent? And what kind of variants You plan to do moving forward given so we are having new variants almost every once a while? I'll have a couple of follow ups. Thanks. This is Philip. I mean Stan and John both mentioned that we do plan to develop ovarian vaccine as well as a bivalent to real service market as needed. But your observation is right. I mean what we saw is that our responses against BA. 5 were very good. And the Transmission or the amount of infections caused by BA5 is plummeting. So it's less of a relevant Strain for us to pursue. So we're actually shifting plans a little bit and we're pushing forward with a BQ1-1 variant. And we're going to develop that up and take that into the clinic and also formulate that as a bivalent product. Whether Time will tell whether that's required or whether customers want such a vaccine, but the timelines will allow us to bring that really to the market In a time when the Southern Hemisphere should be surging in the Q2 of next year. Great. Thank you. Okay. All right. So the next question relates to the financials. Just curious, what is the I know you're Referring the guidance for second half to the entire year for 2,000,000,000 Just curious, in 4Q so far, what have you been seeing? And what's the preorder looking like? And how did that compare to the 3Q you just reported? Yeah, hi, John Trizzino. We're Confident with our order book at this point through the end of the year and I think that we're being conservatively cautious about what deliveries we think we'll be able to make the end of the year as we get into the holiday season and product being shipped out and received in during that period of time. So I think the guidance is still strong and just adjusting and refining a bit down to on the low end of the range. Awesome. Okay. Maybe just last one for Anast. Just looking ahead for 2023 2024, if I calculate this right, you probably have around like 150 plus APA, 150 plus doses for APA. So just curious, How should we think about the rest of the APA and when they will starts for a few in the coming years. Yes, it's really difficult to predict what 2023 is going to look like and I would hesitate to even whisper at guidance at the moment. I think with the transition to more of a commercial market, Looking at variant strains or bivalent strains as a possibility and then thinking about what those markets will look like in policy recommendations. As I think you've even heard from some of the other manufacturers, it's a little bit challenging to assess at the moment. I think what will happen as we come through the next Couple of months, look at what our book of business looks like and still remain strong, I think we'll have a determination about whether it's existing APAs or incremental business coming into 2023. I think we the messages that I make should be reinforced, which is that the virus is not going away. We still have variant strains emerging. It looks like we're going to have a Southern Hemisphere boosting season as well as Northern Hemisphere in the fall again, and I think this overall market size is going to be larger than the existing flu market. So, while we Would rather not be thinking about the downside of the virus, we have to be prepared and that's what the purpose of the vaccine is. And I think more will come in the next few months. Okay. I look forward to that. Thank you for taking the question and that's all from us. And our next question will come from Georgi Yordonov with Cowen and Company. Please go ahead. Hello, everyone. Congratulations on the progress. So a few on our end. The first one, I guess, for Philip. Not sure if I missed that, but one of the most crucial pieces of data that we thought was missing from this morning's release Was the full increase in neutralization titers for the 3 different products that you looked at, this has been Basically, kind of like the main factor that regulators and scientific community has been looking at. So we thought that that would be interesting to have. And then we have a couple of follow ups. I guess the question is, can you provide that On the call or if not, when can we expect to see it? Yes, we haven't prepared that data for disclosure And I'm not sure we have specific plans of when we would disclose that. I mean the fold increase certainly is interesting. That shows the ability of a product to boost. But in my mind what's actually more relevant is the absolute tires achieved after you boost, because that's going to translate directly into protection, Especially if you think about the breadth that we demonstrated today, I have a lot of confidence that what we have in hand now It's relevant to the currently circulating strains. A point that Greg, my boss, likes to make is we're not claiming this is universal vaccine. We're ambrovigilant and we test each of the new variants that come up to assure ourselves the immune responses that we're inducing are really relevant for that. So I think you're going to have to hold on until we come up with a until we announce a plan of how to announce additional data on this study. Got it. I guess like the only the our issue is that basically a lot of our consultants The, the correlates of antibody protection, is quite problematic in the community and just because we haven't Had enough data, so that's why it will be important to see that data from you specifically to the full increase. Let me just comment on that because I think you know the FANG publication and that wasn't developed by us, that was developed by the NIH and USG In that publication, they found that the better correlate protection for our specific vaccine was actually IgG and that's different from what they found for other vaccines Where they thought that neutralizing antibody was a better quota protection. But I showed you data today on the pseudo NUTS for BA. 5 And those were really comparable among the treatment groups. And that gives us the confidence to believe that our prototype vaccine we have in hand now is relevant to what's circulating. Got it. And then maybe specifically on the FDA label, maybe can you walk us through the steps How do you think you can kind of like remove that restriction is only being used as a first booster? Guess you presented some of the loss consistency data that supports that. So if you can just help us understand the timelines when could we expect that to happen? Yes, that's right. I mean, this is what we were asked to develop and we had been developing It's where it looks like when we use our booster, not only as the first boost, but as the second boost. And that's the data I showed you both from Study 307 And 311 and that data is being prepared now for submission to the FDA. This is kind of a unique position we are in the U. S. As you know, globally, we don't have a label restrictions on the 1st versus second or third or subsequent boosts. Be that as it may, The data is being pulled together and is being prepared for submission. I want to perhaps remind you that some of the studies that the FDA does not like to consider, Like our 1 on 1 study did in fact have multiple boosts in and up to 4 doses and that has been considered by other regulatory agencies. Got it. And then finally, a question just on the commercial side. As we kind of start to think about the Potential commercial market transition in 2023. Maybe John, can you talk about like When does contracting usually start? Have you had any initial conversations? Some of your competitors have mentioned that they are In conversations with the EU and other markets, and specifically for the U. S, Sorry to be too U. S. Centric, but our understanding is in order to be covered by a commercial insurer, You would have to get full approval by the FDA. Can you update us on do you believe you can get there in time for those contract negotiations And where do you stand with the full BLA submission? Yes, Jorgi, those are great questions. Thank you. So Listen, each one of those contract negotiations is kind of different around the globe. Right now, we're still under EU Commission discussions and It could be that through 23 that's the basis for the existing APAs and any reordering that would come. Similarly in other countries like Australia and Canada, we'll have signed a unique contract and we likely expect that those Countries will stay under the existing kind of APA structure with the opportunity for incremental purchases as well. So we're in constant communication around the globe where we're already engaged and talking to those Procurement authorities about what that's going to look like. In the U. S. In particular, we will not have any restrictions with the private payers The government payers with the EUA in place, those are conversations that We've already had and are confident in our positioning while we're under the EUA. So the EUA will have Some very minor implications to us who ultimately will be filing for the BLA during the course of next year, but not having the BLA fully approved I will not restrict us in the full booster campaign. Got it. Thank you so much. And our next question will come from Mayank Mamtani with B. Riley Securities. Please go ahead. Good afternoon, team. Thanks for taking our questions. So maybe just following up on that last, a follow-up question. So, John, in context of doses that are remaining as part of, for example, the U. S. APA, Is there an absolute minimum that you have to satisfy before you kind of work towards a private Commercial payroll kind of setting, is there something that has to happen as part of the APA Before you could play out part with the other vaccines in the private market and then I have a couple of follow ups. Hi, Rick. I don't think I quite caught all that in Mayank, but Are you referring to the ex U. S. APAs or the EUA in the U. S? Excuse me, I was referring to the U. S. APA, the current 110,000,000 doses contract that you have, is there Some sort of a minimum you have to satisfy before we can sort of think of a private market in 2023 and beyond? Yes. No, I mean, while that contract is still in place, I think likely we're going to see a movement to traditional procurement. And again it's really hard to say when, but if we're keying off of what happened this year, You would think that there would be a full vaccination campaign. We'll learn probably early in the year about What that process is going to look like, what strains are being expected, what vaccine format the U. S. Government is going to want. So I think that's why the Comments I made earlier are, let's kind of stay tuned through the balance of the year and into Q1, as we see how that unfolds, whether the U. S. Government We'll fund the purchase of additional vaccine or they will rely on the public private market to take that over during the course 2023. So I think it's stay tuned, but I think likely you're going to see procurement taking place in the commercial market in 2023. Okay. Thank you for clarifying that. And then on the 4th quarter delivery Estimates that you have, it looks like you only need, I think, an incremental 15,000,000 doses to get to that 2,000,000,000 Refined guidance. Can you confirm that what countries you could get that from? Is that basically EU, UK and Australia and New Zealand? Is that essentially the countries and customers that Can you just clarify that? Well, I think the guidance is kind of Clarifying that, I don't think we're going to give specific doses by country, but it will likely be across All of our APA is in varying dose amounts, but we're not going to disclose what those specifics are country by country. Understood. And then on the R and D expenses, just quickly, it looks like it did come Down quarter over quarter, but it was a result of a manufacturing agreement. Can you speak to what leverage you may have going forward As you think about Q4, but also next year and recognizing that you're being very strategic about investing behind Trials and scaling up for the variant specific vaccine? Certainly. When you look at our R and D expenses this quarter, you're correct. There was about a 90 $8,000,000 benefit, so of course that would take you up to about $400,000,000 We do expect some continued decrease in R and D As we bring more of our manufacturing capabilities online, capitalize on the inventory, including our CZ plant. So you'll see some trending down there over time. I would say that in this period as well, We had a bit of an offset of some ins and outs of the benefit from capitalizing our CZ plant. And then we also had some, I'm going to call it R and D related manufacturing activities that we wrote off, that I wouldn't expect in future periods. So, you'd be correct to see a trending down R and D in some future periods. Thanks for taking my questions. And our next question will come from Eric Joseph with JPMorgan. Please go ahead. Hi. This is Hannah on for Eric. Thanks for taking the question. Just a few from us. So first, I was just wondering if you could talk about the impact to your weighted That can occur from migrating new activity to a single administration SIMS format. And relatedly, what would you need to do In terms of additional supplemental approvals to getting that STRANGE product out. And then also just on the RSV front, just wondering how your thoughts You're really hard to hear on the first part of that question. Would you mind just kind of repeating, please? So that was the first part of the question, impact related COGS from the fringe product. And then also what would it take in terms of Submitting approvals for getting that out, getting that product out? Yes. So we would expect for those pre fill syringe impact that we would see that happening later in the second half of the year, specifically in those markets in the Northern Hemisphere. So I think we would Expect to see some reduction in vial size, total amount of doses in vial in Southern Hemisphere, but certainly moving toward And then on RSP, just thoughts on, I'm trying RSV given the success of those profusion competitors. RSV? Yes. Well, I think, look, it's something that of particular keen interest to us. As we've mentioned before, that technology platform for our recombinant protein nanoparticle as well as Adjuvant is robust and beneficial as we're seeing it in our COVID-nineteen vaccine. We've learned Significant lessons over the course of the last couple of years about how to leverage that technology platform. And while there's good data from competition At RSV, I think we have an opportunity to have even better data given our technology platform in the context of multiple doses and the use of our adjuvant. So stay tuned for more details relative to RSV in our pipeline. Okay, great. Thanks for taking the question. And our next question will come from Alex Stranahan with Bank of America. Go ahead. Hey, guys. Thanks for taking our questions. Just a couple from us. First on BA. 5, could you also draw a line between the pseudovirus GMT response that you showed with the prototype nevaxovid For BA. 5 to what you saw in PREVENT-nineteen, just wondering if GMT is declining on an absolute basis and how this may correlate with protection. And similarly, I believe there was also a BA. 5 specific vaccine and bivalent in the Phase 3 study that you presented today. So guidance on when you'd update the markets on that data would be helpful. And secondly, maybe one for Jim. Looking at your debt commitments to CEPI and the convertible note as well as potential for repayments to the UK and Gavi, which Cumulatively, it's not an insignificant amount of cash potentially on the line. Could you just speak to your view on the liquidity heading into next year? I know you're roughly at $1,300,000,000 balance now. Thanks. All right, Alex. And listen, thanks for your question. We ended the quarter with $1,300,000,000 We are looking forward to February of next year as The time when, of course, our convert, the $325,000,000 comes due, we feel like we have ample cash flow to either retire that convert for cash or monitor market conditions, consider what we might do there. When it comes to Gavi, because you mentioned that one and I think it's an important one for clarification. We received 700,000,000 From Gavi, COVAX, related initially for an upfront for our commitment, 350,000,000 doses. And then of course the other 350 upon approval by the World Health Organization. We do not believe Gavi has any right, to a return of that capital. So for that reason, we would put that off to the side. And then with respect to some of the other puts and takes of call it potential returns of capitals, We'll continue to provide updates on our cash flow as we guide into next year, but we go into this We have great confidence in our commercial launch in nabaxovid and what that means for operating cash flow. And maybe just a bit commentary about the pseudo newts, I mean the data I presented you today is preliminary data. That's being confirmed in a validated assay and we'll have those results soon. They'll be more able to compare between the Phase 2 BA. 5 versus the other subvariants in the prototype, it's a bio assay and There's a lot of variability in the results that you can get from that. But still, we were quite pleased to see the levels we got. It was within The levels that are thought to be protected at least by the NIH cause of protection analysis. And our next question will come from Vernon Bernardino with H. C. Wainwright. Please go ahead. Hi, everyone. Thanks for taking my question and congrats on a Fantastic revenue quarter. Just perhaps a question for John. You had mentioned one thing that still remains under In my opinion, it's the advantages that you have for Novaxovid as far as storage and distribution. Now, thinking down the road, that advantage probably is going to continue to be there. What are you seeing as far as competitors and their storage capabilities and what they're changing and what the market may be Thinking as far as down the road in the storage of the mRNA vaccines and After that, how do you think their capabilities as far as manufacturing, which they had initially We've been interested in wrapping up in these territories that are lower income might be Something that helps them out with their commercial viability of mRNA vaccines is changing. Any insights you could provide would be helpful. Thank you. Yes Vernon, good question. As I briefly mentioned in the presentation, we indeed We'll have a significant advantage in the refrigerator stability of our product. And then of course we would be moving to A smaller dose presentation and ultimately to prefilled syringes, which is yet a significant advancement. It's unclear where The competition is going in and we'll remain to see what they're doing. But at least for the moment, we know that they're still shipping frozen multi dose vials That requires storage up and while it's still before it's used a thawing and then a Fairly short durability, I'm sorry, stability of product after it's thought. So we'll continue to see that advantage we think for some period into the future And certainly into for our other partners into low and upper middle income Markets where freezer capabilities are limited is an advantage for us as well. So thanks for pointing that out and We'll have to keep an eye on what happens with whatever they are able or unable to do with mRNA vaccines. And as far as the market dynamic is concerned, are you seeing any difference or changes in the end user as far as They're thinking of and storage and perhaps future needs for mRNA vaccines versus yours? Yes, I think that's our interest in getting to the commercial markets. I think you'll see the healthcare providers then having some more optionality to access an easier to use presentation. And so That's certainly one aspect that we're going to be pursuing in the U. S. And EU markets. Thank you. And this will conclude our question and answer session. I'd like to turn the conference back over to Stan for any closing remarks. Thank you, operator. I appreciate the time everybody has spent taking this call. It's been a very Big and important quarter for us. We've made a lot of advances on every front and look forward to showing you more of the same for the coming quarters. Thank you. The conference is now concluded. Thank you for attending today's presentation. You may now disconnect your lines