Good morning. My name is Kevin. And welcome to Moderna's Third Quarter 2023 Earnings Call. At this time, all participants are in a listen-only mode. Following the formal remarks, we'll open the call up for your questions. [Operator Instructions] Please be advised, today's call is being recorded. At this time, I'd like to turn the call over to Lavina Talukdar, Head of Investor Relations at Moderna. Please proceed.

Thank you, Kevin. Good morning, everyone, and thank you for joining us on today's call to discuss Moderna's third quarter 2023 financial results and business updates. You can access the press release issued this morning as well as the slides that we'll be reviewing by going to the Investors section of our website. On today's call are Stéphane Bancel, our Chief Executive Officer; Stephen Hoge, our President; Arpa Garay, our Chief Commercial Officer; and Jamey Mock, our Chief Financial Officer. Before we begin, please note that this conference call will include forward-looking statements made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Please see Slide 2 of the accompanying presentation and our SEC filings for important risk factors that could cause our actual performance and results to differ materially from those expressed or implied in these forward-looking statements. With that, I'll turn it over to Stéphane. Stéphane Bancel: Thank you, Lavina. Good morning or good afternoon, everyone. Thank you for joining us today. I will start with a quick review of our business for third quarter. Arpa will then give you an update of our commercial progress and plans. Jamey will present our financial results and will explain in detail the one-time charges we announced this morning in our press release. Stephen will then review our clinical programs. And I will share our key priorities for 2024 and 2025 to return Moderna to sales growth and profitability. We delivered $1.8 billion in Spikevax sales of COVID vaccine in the third quarter. Based on trend we are seeing in the U.S. COVID market in recent weeks, we expect our sales for 2023 to be at least $6 billion. We have been preparing for the 2023 fall COVID launch throughout the year, because the U.S. market was pivoting from a pandemic government purchase market to a commercial market. I am very pleased to report that according to IQVIA market data, we have a market share in the U.S. of 45% season to date, compared to 36% for 2022. [And Arpa] (ph) will show you, we even achieved 51% market share last week in the U.S. This commercial performance in the U.S. market shows that Moderna can compete commercially with large established players, [that will prove] (ph) important as we launch RSV 2024 and combo of flu-COVID in 2025. On the cost side of the company, we informed you at R&D Day that it was important for us to resize our manufacturing footprint as the world has moved from a pandemic to an endemic setting. I am pleased that our manufacturing and finance team were able to move fast and resize our manufacturing, so that we can go back to 75% to 80% gross margin levels. This resizing resulted in a charge of $1.6 billion, which Jamey will explain in detail in his section. Now let me turn over to Arpa to walk you through our progress in the U.S. market.

Thank you, Stéphane, and good morning or good afternoon to everyone. Today, I will provide an update on our third quarter performance, our U.S. commercial launch progress and our preparation for our RSV launch next year. Our total sales in the third quarter came in at $1.8 billion, which includes approximately $800 million in international sales and $900 million in U.S. sales. Total sales for the first three quarters of the year were $3.9 billion. Turning now to our expectations for the fourth quarter and full year 2023 outlook. In our international business, we expect an additional $1.1 billion in sales. These sales are based on government contracts and once vaccine doses are shipped and accepted by the customer, they are not returnable. More than half of these sales have already shipped in the fourth quarter. In the U.S., we expect at least $1 billion in sales in the fourth quarter, which would bring U.S. sales to approximately $2 billion for the second half of 2023. This assumes approximately 50 million doses administered in the U.S., which would be similar to the fall season of 2022. With $3.9 billion in sales recorded as of the end of the third quarter, expected fourth quarter sales of $1.1 billion internationally and at least $1 billion in the U.S., our updated sales outlook for 2023 is at least $6 billion. Now turning to the U.S. launch. The data shown here are from IQVIA. As a reminder, IQVIA data only captures the retail channel in the U.S., which includes retail pharmacies and long-term care. I'm first going to share what our weekly market share trends look like and then discuss our cumulative share since launch and how it compares to last year. On the fifth week post launch, for the week ending October 20th,…

Thanks, Arpa, and hello, everyone. Today, I will review our financial performance for the third quarter and provide an updated framework for our full year 2023 financial outlook. Additionally, given we know it's top of mind for investors, we wanted to provide our early thoughts on 2024 and how we're approaching the next couple years. Starting on Slide 15. Total net product sales for the quarter were $1.8 billion, down 44% year-over-year, driven by lower sales volume, and partially offset by a higher average selling price. Product sales were almost evenly distributed between the U.S. market and the rest of the world. We initiated product shipments to customers in mid-September for the fall booster season, following the authorization of our updated COVID-19 vaccine. Cost of sales for the third quarter of 2023 was $2.2 billion compared to $1.1 billion in the prior year. I will provide detailed commentary on the following slides. Research and development expenses were $1.2 billion, which increased by 41% versus the prior year. This increase was driven by our expanded and maturing development pipeline with six products now in Phase 3 studies or pending approval. Selling, general and administrative expenses were $442 million, reflecting an increase of 59% year-over-year. The growth in spending was primarily driven by the buildout of our commercial activities and, in particular, our launch in the U.S. commercial market. The income tax provision in Q3 was $1.7 billion, as we reported evaluation allowance against deferred tax assets of $1.7 billion. Under GAAP accounting rules, we are required to take a reserve, also referred to as evaluation allowance, for deferred tax assets when the current year and cumulative income projection for the next three years is in a loss position. These losses indicate our deferred tax assets may not be fully realized. It's…

Good morning or good afternoon. Today I'll do a quick review of our clinical programs. Many of the details from these programs were shared at our R&D Day in September. I will also review the Phase 3 trial designs for our combination flu and COVID vaccine, mRNA-1083 and the Phase 3 trial design for our INT in non-small cell lung cancer. During R&D Day, we shared the significant progress we've made through the year in advancing our late-stage pipeline, creating the opportunity to have up to 15 product launches in the next five years. Through 2025, and subject to regulatory review and approvals, we anticipate launches for our RSV vaccine, our flu vaccine, a next-generation COVID vaccine, and our combination flu and COVID vaccine. Looking beyond 2025, we have a diverse pipeline of other vaccines, cancer therapies, and rare metabolic disease medicines. We're very excited by the potential benefits these medicines offer across a diverse range of therapeutic areas. Slide 25 is an overview of our respiratory vaccines pipeline. Our leading pipeline includes commercial and Phase 3 programs against COVID, RSV, and flu, as well as earlier-stage next-generation programs in COVID and flu and multiple [combinations] (ph). We recently shared positive topline Phase 1/2 data from our combination flu and COVID vaccine, mRNA-1083. And on the heels of this success, we've started and are rapidly enrolling a Phase 3 study for mRNA-1083 in adults 50 and older. Slide 26 shows the Phase 3 design for mRNA-1083. The Phase 3 study is a randomized, stratified, observer-blind, active-control study evaluating the immunogenicity and safety of 1083 compared to co-administered flu and COVID vaccines. The study will enroll 8,000 participants overall, with two cohorts of 4,000 participants stratified by age 65 years and older and 50 to 64 years of age. Both cohorts…

Thank you. [Operator Instructions] Our first question comes from Gena Wang with Barclays. Your line is open.

Thank you for taking my questions. I have two questions regarding the commercial questions. First, you did mention 2026, you're looking to have a breakeven. And when we take a quick look based on your 2024 and 2025 outlook, it seems the total cost could be in the $8 billion to $9 billion, that range. Could you give us a sense what could be the additional sales if we're using 2024 guidance as a base point? And the second very quickly regarding the manufacturing resizing. After resizing, what is the full capacity regarding doses and what percentage of the manufacturing will be internal in 2024 and 2025?

Maybe I'll take the first one -- first part of the question. So, in terms of 2026, and thanks for the question, let's talk to you about how we're thinking about it. So, we mentioned $4 billion in 2024, approximately $4 billion. And this is all about our late-stage pipeline coming to fruition. So, in 2024, we'll launch RSV, but it's mostly kind of in the second half year sales, and then we'll have a full year in 2025, so that'll provide growth. We will also come to market with flu in 2025. We'll also come to market with a combination of flu and COVID in 2025. Again, depends on timing, but by 2026, we should have a full portfolio. So, we're not going to say what the exact sales numbers are, but you mentioned $8 billion to $9 billion in costs. I'm not exactly sure where you'd get there unless you're assuming a certain sales line on that, but let me go back to what we tried to lay out here. If you assume, for instance, $6 billion in sales, we should have 30% of cost, or $8 billion in sales, we should have 25% of cost. And then, we've said historically in our R&D Day that we need $25 billion overall to make this investment, which should average $5 billion a year. So, hopefully, we're giving you enough pieces without officially guiding any kind of numbers in 2026. But here's what's also important is, if those sales don't come to fruition, we are telling you that we will adjust our expenditures in our investment. So, that's -- we hope that we are -- they will, we are confident in our pipeline, but should it not happen, then we were prepared to adjust our investment. I missed the second part of the question.

Capacity.

Hey, Gina, can you maybe repeat the second part of your question? I apologize. I missed it.

Sure. Basically, after manufacturing resizing, what is the full capacity regarding doses, and what percentage will be internal?

Yeah, thank you for the question. So, we -- as we try to lay out here and are showing you, this capacity is built for volume leverage. So, we at least put $10 billion of sales on that page, and it will require no additional capacity. We will complete, of course, over the next year and a half the UK facility, the Canada facility and Australia facility, but for the respiratory framework, we need no more, at least the $10 billion. I won't project beyond that, but that should answer that question. INT is a little bit different and we are building that and getting that ready for commercial purposes, but we're built for volume leverage moving forward.

Thank you.

Our next question comes from Salveen Richter with Goldman Sachs. Your line is open.

Good morning. Thanks for taking my questions. Two from me here. One is, you provided guidance of about $4 billion between COVID and RSV on the [forward here] (ph) for 2024. Could you just speak to the contribution from each and how you're thinking about flu monotherapy? And the second question is that your financial framework for 2025 includes the ability to flex R&D and SG&A. Are there any parameters you can share on the range of this flexibility and how you would prioritize R&D programs and development? Thank you.

Yeah, thanks, Salveen. I appreciate the question. So, on the $4 billion, we're not going to break out the $1 billion that we attributed to RSV and COVID. All we can say is we've talked about our PDUFA date and that we filed in certain amount of countries across the globe. I will also say, as Arpa mentioned in her prepared remarks that we're super confident in the product profile. We are encouraged by the market and how it's already started from an uptake perspective, and we think we will compete very well in 2024 and beyond. As it pertains to the flexing on our spending for 2025, obviously, I don't know, 80% of our expenses or investments are in R&D, so $4.5 billion for R&D and $1.3 billion for S&A. So that, as I mentioned, 50% of the current spending levels is not committed. So, we have time to make decisions and watch the market to be able to say what amount of registrational trials and what amount of R&D are we going to spend in 2025. So, hopefully that gives you a sense for how much is still the ability to flex. We also have other levers that we can pull, et cetera. SG&A, we also have some flexibility, probably not to the same magnitude, but there is still some amount of flexibility to bring that down from a variable expense perspective. Stéphane Bancel: And Salveen, this is Stéphane. Maybe just to add to Jamey's point on the R&D, as I mentioned in my remarks, if we have to, we will be open, of course, to partnership some of those programs, which is an important way we could flex the R&D number based on where the sales are, as Jamey mentioned, which is if the sales are according to our plan, then we're going to be okay. If the sales are below, we will be very open to partnering. As you know, we've done that in the past. The team knows how to do it. But we will be disciplined about our investments in the business based on where the sales line is.

Thank you. Our next question comes from Eliana Merle with UBS. Your line is open.

Hi, this is Sarah on for Ellie. Thanks so much for taking our question. First, I guess, can you talk about in 2024 again on that $1 billion RSV international sales number? Are you expecting any contribution from flu in '24, and maybe how you're thinking about it into '25? And then, on CMV, can you talk about where you are in cases and how they're tracking versus R&D Day where I think you said a fourth of them were currently tracked? That would be great. Thanks so much.

So, thanks, Sarah. I'll take the first part and then hand it over to Stephen on CMV. So, there is no flu contribution in our 2024 sales outlook of approximately $4 billion. So, in that $1 billion, that is solely RSV and other COVID international sales. We do, as I mentioned in my -- to answering Salveen's question, we do expect to launch flu in our combination products sometime in 2025, and we'll see what we've projected that time.

And on the CMV question, thanks for that. So yes, we did update that we're about a quarter of the way through the case accrual back in R&D Day. I think the next -- we continue to accrue cases at a steady pace. I do think the next update will provide is likely our Vaccines Day in the spring.

Okay, thanks.

Our next question comes from Terence Flynn with Morgan Stanley. Your line is open.

Great. Thanks so much for taking the question. I know GSK has provided an estimate in terms of size of the RSV market, about £5 billion, and Pfizer has given some metrics as well. Given what we're seeing now with these early launches, can you provide us with your assessment of total market size here? And then given some of your comments on competing with larger companies, as you're doing in COVID now, where ultimately do you see your market share shaking out in the RSV space? Thank you.

Thank you for the question. In terms of the total RSV market, as I mentioned earlier, we're excited by the uptake and the consumer awareness of the market overall. And our projections are similar to what both GSK and Pfizer have already guided. In terms of our market share with RSV, we have not yet provided or are ready to provide any forward-looking projections on share, but we are very excited about our strong product profile, both in terms of efficacy, safety, and, as I mentioned, our ready to use pre-filled syringes. So, we will be leveraging the learnings and the success from our COVID commercial launch this year and applying them to RSV next year. Stéphane Bancel: Yes. Just to add to Arpa, Terence, it's Stéphane, the point that Arpa and I made about the market share of COVID is what I think is very important. I think some people believe that because we're a new company in commercials we're not able to compete and I think the market share data that Arpa has shared really show that our U.S. team is able to compete and we will continue to improve things that we are doing, because we are not done improving the [indiscernible] culture as you know us. But the share already moving from 36% last year to 45% cumulative so far in the season, I think it's already a demonstration of what the team is able to achieve. And the season is not over, so that's 51%, so let's see where this one finish when the season is over. But basically, the [differential] (ph) we have, as I mentioned, I've been speaking to pharmacist leadership. And they are all, I think, have a very big workload issue, as you know. There's even strikes in some pharmacy chains in the U.S. as we speak. And you think about the season there, [indiscernible] business for the pharmacy for preparations, and then the flu, and then the COVID. And then, as I mentioned, those two other products, if you just download the label of those products from the FDA website and you look at how many steps they have, it's very complicated. And when you talk to a pharmacy leadership, they don't know how they're going to deal with that type of workload. And so, coming with pre-filled syringe is a tremendous differentiator. We have very good efficacy. We have very good safety profile. We really believe that we have the best in-class product in the market. And [indiscernible], it's going to translate, I think, into a very good effect.

Thank you. Our next question comes from Jessica Fye with JPMorgan. Your line is open.

Hey, guys, good morning. Thanks for taking my question. Just a couple coming back around to one that I think some others were trying to get at, but maybe a little differently. When we think about breakeven in 2026, what are you contemplating in that sales number embedded in your assumption? Does it reflect just respiratory vaccines? Or are you considering INT could be on the market then? And then second, I know you said the percentage of non-retail jobs would grow as the season progresses from where it has been so far this season. Do you believe that the proportion of COVID shots running through the retail channel has shifted at all, bigger picture in 2023 relative to 2022, or should we think of that proportion as remaining similar year-over-year? Thank you.

Yeah. Thanks, Jess, for the question. Again, without getting into too much detail on 2026 in terms of how we think about it, I mean, the best way to keep going back to that late-stage pipeline that we've been talking to you about, RSV, flu, our combination, our next-gen COVID product as well, will all be very much there for the year 2026. And we are confident in all those product profiles and how we will compete. As I mentioned, at 6%, our cost of sales -- at $6 billion, sorry, our cost of sales would be 30%. At $8 billion, our cost of sales would be 25%. And of course, we'll try to improve on that. And that will give us the envelope for how much we can continue to invest in the future products, which we said we'll launch 15 by 2028. That'll be all of our latent product portfolio, that'll be our INT portfolio, that'll be our rare disease portfolio. So, I think that's as much as we can say right now. I just want everybody to know that we are very committed to breaking even in that year, and we have a lot of flexibility, both from a growth standpoint and a discipline investment standpoint.

Great. And I can take the second question on the percentage of non-retail. So, as expected, in 2023, the retailers have been the majority of the market, with more than 90% of the volume during the first few weeks. However, we're now beginning to see a shift towards more non-retail channels, as I had mentioned. We are seeing increased shipments to IDNs, to clinics, to pediatricians, as of the recent weeks. And as I think about full year 2023, I believe the retail mix will be stronger than in 2022 and could land at about 70% to 80% of total vaccinations, whereas in 2022, we saw that the retail channel was only about two-thirds of the mass.

Thank you. Our next question comes from Luca Issi with RBC Capital. Your line is open.

Oh, great. Thanks so much for taking my questions. Maybe circling back on the P&L, I appreciate all the effort on resizing manufacturing and the focus on gross margin, but how should we think about OpEx plus CapEx? As COVID numbers continue to come down, we've seen the BioNTech and Pfizer materially realigning OpEx plus CapEx to their top-line. I believe BioNTech lowered by $600 million this year and Pfizer by $1 billion this year and $2.5 billion next year. However, your OpEx plus CapEx is not materially changed this year and you anticipate that the next year it's going to be generally flat to down. So, can you just maybe comment on why you think that's the right strategic decision for the organization? And then maybe second question on RSV. Obviously, impressive initial launch by GSK and Pfizer and appreciate the differentiations of your product. But what's the latest thinking on whether the vaccine is needed every year or less frequently than that? Is there a scenario where Pfizer and GSK penetrate the market pretty aggressively this year and then you face an uphill battle next year as it turns out that we need a vaccine maybe every other year and not every year? Any thoughts there much appreciated. Thanks so much.

Maybe I'll take the first -- the second part of that question and then hand it over to Jamey for the first. So, on RSV and the need for it, obviously, we're continuing to follow the public health situation in terms of the rate of occurrence of the RSV epidemic this year. At this point, I think we don't have data yet on whether or not it will ultimately be an annual or something less than annual, say every two or three year vaccination regime. I think like everybody else, we'll be looking to our data, the other manufacturers' data, as well as the public health, the epidemiologic data to guide that decision. There are plenty of vaccines for which there is an approach, flu as an example, where there's a seasonal vaccination approach, both because of the benefit offered by the vaccine, but also because of the convenience of just making sure that every season, every year, people are reminded to get that vaccine. So, the ultimate decision on whether this is going to be recommended is not ours, the manufacturer, it will fall to public health officials based on a number of factors, which will include the [indiscernible] and the data we provide, but other factors as well. And we'll work to make sure they have the data they need to make that decision.

And I'll take the first part. Thanks, Luca, for the question. I think the short answer is the opportunity set ahead of us, and we are acting. So, you referenced some of our competitors, so I just want to break that down. I mean, we are super encouraged by the opportunity for additional growth and our ability to impact patients. And we have this 15 products that we think will launch by 2028 or by 2025. We think that's the right thing to do. We have to grow out of our, we have to grow this company and to be able to afford the investment to be able to capture the unparalleled opportunity for this. And I think we are acting, I believe we are acting, and I mentioned everything that we're doing from a cost of sales perspective. And so I think that's very much in line and sized appropriately to have volume leverage when it comes, because it will come. And we are saying in 2024, we can adjust both R&D and SG&A down to a good level, down 6% R&D, down 13%, so, on SG&A. We are largely committed to our registrational trials for 2024. But as I mentioned, we don't have as much flexibility in that particular year, but by 2025, we have even more flexibility. So we're prepared to take action should we need to, but we're very optimistic about the price line that's coming. And hopefully this will just come through growth, and we'll still be able to afford much of this investment. Stéphane Bancel: It's Stéphane. Just maybe adding to Jamey, who said it super well. As you know, we have a platform company. And the [indiscernible] success of those programs we feel very good about. If you just look at with COVID and Phase 3 RSV -- sorry, and Phase 3 for RSV and Phase 3 for flu, we have three out of three positive Phase 3. This is not your industry average. So, we think we can create value and create return on capital for shareholders by investing that capital to high-priority projects that are in late-stage pipeline. As I said, we have the largest late-stage pipeline of any mRNA company. We have six programs right now. And as soon as we launch [indiscernible], which is very, very soon, there's going to be seven programs. We believe the best way to create returns for shareholders is to invest that capital to drive sales growth and profitability.

That's it. Thanks so much.

Our next question comes from Michael Yee with Jefferies. Your line is open.

Hi. Thanks for taking our question. This is Dina on for Mike. I just wanted to get a sense of your assumptions for Q4 COVID jabs and what are you seeing in Q4 right now? How much of that is actually jabs and actual injections versus channel fill? And just to follow-up on that. Now that you've seen sort of half of the 2023 fall season play out, what are your assumptions for 2024 and 2025 for COVID? Are you essentially assuming that the same people who got vaccinated this year will continue to get COVID vaccine every year? Thanks so much.

Thank you for the question. In terms of the fourth quarter '23 jabs, what we saw in 2022 is there was a significant portion, about 45% of the total COVID vaccinations happening in November and December. This year, we're expecting a similar split, likely larger, given that we launched two weeks later into the season in 2023 than we did last year. And what we are hearing from our different non-retail customers as well as our retail pharmacy partners is they are planning vaccination campaigns and marketing efforts to really capture on the November and December months. So, in total, we do anticipate getting to at least 50 million doses this year, and we do believe that November and December will be strong months for us. In terms of 2024, our assumption is everyone who has gotten their booster in 2023 will at least get their booster also in 2024 and beyond. Now, given the higher burden of disease with COVID, as consumers become more understanding of the annual recommendations and as the convenience of getting both flu and COVID becomes more normalized, we do believe over time we'll start to see some increase in the overall COVID market.

Our next question comes from Hartaj Singh with Oppenheimer. Your line is open.

Great. Thank you for my question. I just got a question on the combination programs. And just to give a little bit of -- frame the question, in other therapeutic areas, aside from vaccines for infectious diseases, for example, oncology, monotherapy treatments generally tend to be minority of treatments, 10%, 15%, 20%. Currently, monotherapy vaccines dominate the market in COVID-19 flu. So when you get the combination vaccines going, do you imagine -- does your market research tend to suggest that you would -- again, probably a combination approach might dominate that versus a monotherapy approach, singular vaccines going forward? And then secondly, will the cost of goods sold be any different for the combination versus the monotherapy products? Thank you.

Great. Thank you for the question. So, we do anticipate that our combination vaccine will take a substantial share of the monotherapy vaccines that are available. We have seen in the pediatric vaccine market that upon availability of combinations, you see very strong uptake and conversion from monos to combinations, and we expect a similar trend in the adult market. From our market research, we have heard consistently from consumers that they prefer one shot over multiple shots. From a customer perspective, we are hearing, as Stéphane had mentioned, just with workload issues, one shot saves a lot of time and also helps them to get more patients protective. And from a broader healthcare system and government and payer perspective, we are hearing an increased need to help get greater uptake and compliance in adult vaccinations. And our healthcare authorities believe that combinations can help actually boost the vaccination rate. So, we are very excited about our combination products in the future and think this could really be an inflection point for our mandatory vaccines. Stéphane Bancel: Yes, it's Stéphane. Just to add to Arpa's comments, during COVID, we've been discussing to a lot of -- with healthcare ministers, and the topic of vaccination combination has come a lot. And as you think, especially outside the U.S., where you have a lot of [indiscernible] taking care of people from birth to death, basically, we are very, very interested in combinations. Because they know that if a participant of a country got the vaccine, they got protection against several viruses which prevent hospitalization. As you know, we've done partnership with some countries like the UK, Canada, and Australia. And through those negotiations, the concept of combination was critical in their decision-making. Because as they see their population getting older, they worry that the number of hospitalizations will just go up over time and the ability to prevent that when you see shortages of healthcare workers and as you project those shortages in the future is a key determination of a decision. So, I only think in integrated healthcare system, the drive the [good combo] (ph) will move even faster than actually in commercial markets like the U.S. market.

And, Hartaj, maybe I'll take the cost of sales question. Thank you for it. So this provides a substantial margin expansion opportunity. So, if you think about it, our cost of sales, the smallest portion is our drug substance, so it's our actual mMRA, and that's a very small portion of our overall cost of sales. Everything from drug product in terms of the cost to finish the product and the presentation type, whether it's PFS or a vial or whatever, that now gets cut in half. So, when we sell two, it's a very limited amount of cost increase versus a single presentation. So, it does provide a significant margin expansion opportunity. So, thank you for the question.

Thank you all.

Our next question comes from Evan Wang with Guggenheim Securities. Your line is open.

Hey guys, thanks for taking the question. Appreciate you guys sharing early thoughts on '24 and beyond. For '24 specifically, you talked about some of the contribution from COVID and RSV in terms of split. It sounds like you plan to hit the ground running there in RSV. With international, how are you thinking about the longer-term contribution from COVID as competitor agreements expire? And with flu, with the comments on [marketing] (ph) '25, wondering if you've had any recent conversations with the regulators there in terms of potential approval. Thanks.

Thank you for the question. In terms of our expectations in 2024, we have put about $1 billion across international COVID and RSV. We do anticipate a strong launch in the second half of the year with RSV. And on the international side for COVID, we are continuing to pursue multiple options across a number of countries. In Japan, we will be in a fully commercial market, is our expectation, where we will be competing for the Japanese business. In the EU, we continue to work with countries on agreements to secure our COVID-19 vaccine. As publicly disclosed, the EU has renegotiated their contract with Pfizer earlier this year. So, the EU demand has been substantially satisfied in many markets, but we are hearing from individual member states that they are looking for a second supplier for vaccines. And we are in those discussions right now, both at a country level, but also at a European Commission level to see if a joint procurement agreement can be established in 2024.

And thank you for the flu question. So, as you referenced, we had really strong data out of our P303 Phase 3 study for flu that we released at R&D Day. We're excited about that. We are engaging right now with multiple regulators about the pathway to licensure. I don't have an update about all those conversations because they're happening as we speak, but we will, once we have clarity across all markets on the pathway licensure, provide an update.

Thank you. Ladies and gentlemen, this does conclude the Q&A portion of today's conference -- end of the call itself. You may now disconnect, and have a wonderful day.