Good morning. My name is Kevin and I’ll be your operator today. Welcome to Moderna’s Fourth Quarter and Full-Year 2021 Earnings Call. At this time, all participants are in a listen-only-mode. Following the formal remarks, we will open the call up for questions. Please be advised that this 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 fourth quarter and full-year 2021 financial results and business update. You can access the press release we 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; David Meline, our Chief Financial Officer; Stephen Hoge, our President; and Paul Burton, our Chief Medical 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 will turn the call over to Stéphane. Stéphane Bancel: Thank you, Lavina. Good morning or good afternoon, everyone. Welcome to our Q4 2021 conference call. Today, I will start by a quick business review of fiscal year ‘21 before Paul walks you through some real-world evidence data. Stephen will then review our clinical programs before David presents our financial results. I will then come back to close to share some thoughts about where we are heading. We are pleased to report today $18.5 billion of revenues for fiscal year 2021 and the GAAP net income of $12.2 billion, translating to a GAAP diluted earnings per share of $28.29 billion, (sic) [$28.29] with a cash balance at the end of the year of $17.6 billion. We announced this morning that we have completed our August 2021 $1 billion share buyback plan, which reduced our average share count during the fourth…

Thank you, Stéphane, and hello, everyone. It is almost exactly three months ago that we first heard about the [Technical Difficulty] And today, we look back on three months that have seen millions of new cases of COVID-19 infection worldwide due to Omicron and a death toll that turned out to be almost 20% higher than that seen during the Delta wave. It is clear that SARS-CoV-2 is a virus capable of making very large evolutionary leaps in its structure and function. And while we are hopeful that we are about to enter a period of relative stability in the northern hemisphere, we believe firmly that a vaccine booster dose that will be required for the fall of 2022 to provide ongoing protection against this virus. We have seen measures taken by the United Kingdom recently to offer an additional booster dose to those at higher risk. And we believe such measures will become more widespread with governments looking to protect their populations from disease later this year and support their healthcare systems. As always, a huge note of appreciation to the frontline workers, the healthcare workers who have continued to immunize us and protect us during this pandemic. Their tireless work has saved millions of lives worldwide. I’m going to review some data today that underpins why we believe an additional booster shot will be required certainly by the fall of 2022. First, let me share with you some data from a study of almost 440,000 individuals in the United States Veterans Administration database, looking at the effectiveness of mRNA-1273, Spikevax used in the primary series vaccination setting. As we know, the mRNA vaccines are extremely safe and effective. And the data here shows the exceptional effectiveness of mRNA-1273. In this well-powered and prospectively designed comparative effectiveness study, mRNA-1273…

Thank you, Paul. Good morning and good afternoon, everyone. On slide 16, I’d like to briefly summarize our COVID-19 booster development strategy for the endemic phase. So, as Paul covered, the strategic rationale for a seasonal booster has three parts. First, we think neutralizing titers will wane, similar to the endemic human coronaviruses, as Paul just described. That decline in neutralizing titers will increase the risk of breakthrough hospitalization in those at higher risk, specifically including older adults and the immune compromised. We think the emergence of new variants of concern will also have the risk of accelerating waning and broadening the risk of breakthroughs to other populations. So, the desired features for our Northern Hemisphere fall and winter 2022 booster are described here. First, we’d like to improve the durability of protection for neutralizing antibodies against Omicron and Omicron mutations to at least six months that will provide full protection through the Northern Hemisphere fall-winter infection season. We’d like to retain the high and durable protection we’ve been seeing with a prototype vaccine against Delta and the ancestral strains. And third, we’d like to broaden cross-protective immunity to the extent possible to increase the potential for protection against a new emergent variant of concern, which could emerge perhaps from the Southern Hemisphere this midyear. So on slide 17, I’ll quickly summarize our strategy for developing an updated booster for fall 2022. We are currently evaluating three different booster strategies in adults age 18 plus. The first, as both Paul and Stéphane have mentioned, is a bivalent booster vaccine, made up of the prototype mRNA-1273 and an Omicron-specific mRNA-1273.529. This bivalent has been called 214. We are also evaluating, as we previously announced, an Omicron-specific booster, mRNA-1273.529. And of course, we will continue to evaluate our prototype booster, mRNA-1273, for…

Okay. Thank you, Stephen. We are providing today the analysis of actual 2021 fourth quarter and full year results along with a view of key drivers of financial performance going forward. 2021 was a transformative year for the Company as it marked the transition from an R&D-focused entity to a commercial stage company. I’m very pleased with our performance, and wanted to thank all of our employees at Moderna for their dedication and response to the many challenges during this unprecedented company scale-up. Turning now to slide 29, starting with an overview of our sales performance. Total product sales in the fourth quarter of 2021 were $6.9 billion, representing 297 million doses delivered to our customers. This compares to sales of $4.8 billion for 208 million doses in Q3 and 199 million doses in Q2. We increased our dose supply in the fourth quarter by 43% compared to Q3 after a relatively stable picture in Q2 and Q3 as we successfully focused on removing bottlenecks in our supply chain network. Sales of our COVID vaccine have shifted in terms of geographic mix over the course of the year, in line with our expectations and the ramp-up of our international manufacturing capabilities. Sales outside the U.S. to the rest of the world were $6.1 billion in the fourth quarter, reflecting 252 million doses. And sales to the U.S. government were $0.7 billion in the fourth quarter, reflecting 45 million doses sold. For the full year, we sold 807 million doses, resulting in product sales of $17.7 billion. We generated sales of $5.4 billion in the U.S. and $12.3 billion with customers in the rest of the world. Approximately 25% of our delivered doses went to low and middle income countries, either through direct sales or facilitated by donations from other customers.…

[Operator Instructions] Our first question comes from Salveen Richter with Goldman Sachs.

Good morning. Thanks for taking my question. Outside of the flu data that we’re going to see this year, we’re going to get personalized cancer vaccine data as well as rare disease data. Could you just speak to, in rare disease, what success would look like and what the regulatory path there could be? And then, for the personalized cancer vaccine, whether we would be able to get a sense of proof of concept this year?

Sure. Thank you for the question, Salveen. So first, in the rare disease space, it’s important to recognize that these are our Phase 1/2 studies, both the PA and MMA study. And I’ll speak to the PA study mostly because, as I said a moment ago, it’s the one that is -- has enrolled its first cohort and is moving forward with enrollment. So, first and foremost, we are going to be looking at safety in these studies, as you’d expect from a Phase 1/2. And so, one of the most important things to establish is, can we continue to dose, unfortunately, very ill people, or children in the case of both of these studies with mRNA, LNPs for up to six months or even longer, if they stay on the open-label extension. And establishing the safety of the platform on chronic dosing repeatedly over 6 to 12 months is an important objective of that part of the study. When it comes to efficacy, again, these are early studies and small in number as usually is the case with rare diseases. And so, I have to be careful about interpreting any of the data from the early clinical reads too concretely. But the things we’ll be looking for, first and foremost, we’ll be looking at the performance of the medicines in terms of preventing clinical outcomes. And so, in the case of propionic acidemia, these will be major metabolic decompensation events or hospitalizations that do happen with some regularity, unfortunately, for those folks who suffer from these rare diseases or disease like PA. And we will also be looking at biomarkers, and so specifically, biomarkers that have correlated with preclinical disease, and perhaps to a lesser extent, with some of the existing transplant-based therapeutic interventions in these diseases. But, it’s…

Our next question comes from Gena Wang with Barclays.

I have two questions. So, the first one is regarding the flu data, the Phase 2 data in early 2022. Can you be a little bit more specific on timing? And what kind of data you think could be fileable that without the need of a Phase 3 trial with the efficacy outcome? The second question is regarding the 1273, U.S., age 12 to 17. In the press release, you said FDA has not concluded on benefit risk profile of 100-microgram primary series. What additional data you would need to provide? And will you need to provide 50-microgram data in order to receive approval?

Great. Thank you, Gena, for both those questions. So first, a clarification on the flu data. We do not believe that the Phase 2 data alone would be fileable. And that’s based on previously published regulatory guidance, not specific guidance to Moderna. But ultimately, we don’t think Phase 2 on flu alone, which is an immunogenicity -- safety immunogenicity study of approximately several hundred, is sufficient for filing. The question is, from a filing perspective, what sorts of Phase 3 studies are necessary and whether or not an accelerated approval is possible based on just safety and immunogenicity or whether we will need to demonstrate efficacy in an independent efficacy study, a Phase 3 efficacy study prior to filing. And those are consultations that have not yet happened with regulators, but will on the back of that Phase 2 data that we expect shortly. It’s important to note that there are precedents for accelerated approvals based just on safety and immunogenicity in a Phase 3 study, which would be a few thousand people. But you always have to then follow up with an efficacy study perhaps post approval. And so, in summary, we expect to have to do an efficacy study in flu at some point. The question is whether or not it would be before or after accelerated approval with a Phase 3 immunogenicity and safety study. That Phase 3 study would follow on the current Phase 2 study, and we don’t think that the Phase 2 study alone is viable. We do intend, as I said previously and as we said before, to try and start those Phase 3 studies, whether they’re efficacy safety immunogenicity study this year. On the question of the 1273 adolescent filing in the U.S., and so the FDA has not provided -- has…

Our next question comes from Matthew Harrison with Morgan Stanley.

I have two clarifications and then a question. So, first one, on flu. Should we expect that when you present to us the Phase 2 data, whether or not you’ll have had those regulatory discussions or be able to talk about potential next steps in terms of what scope of Phase 3 studies you would need? And then, second, on PA, can you give us a sense of how many cohorts you think you need to see before you may be able to provide that initial data? And then, third, just on the timing of COVID revenues this year, I believe at JPM, you had talked more about first half weighting and second half weighting. And it seems like that’s switched. And I’ve gotten just a couple of questions that I thought would be helpful to clarify. Is that mainly because you’re now targeting boosters for the fall, or is there something else happening here in terms of the weighting of the revenues? Thanks.

So, thanks, Matthew. I’ll take the first two questions. So first, on flu, it’s obviously not in our hands alone. We will -- whether we would be able to connect with the FDA and get feedback back. As we all know, the agency globally, but also the agency in the United States, agencies are -- have a lot going on right now. And so, there may be some delays in getting that feedback. So, it is not -- we will probably share the Phase 2 data as we have it. And we will obviously rapidly consult with agencies, but we will not negate on hearing back from agencies before we share that data, and our plans are moving forward. But, if it’s possible to get that response more quickly, obviously, that will be something we’ll share at that time. So I wouldn’t expect it, it’s a short version, of being able to have that agency feedback, but it’s possible, and we’ll keep our fingers crossed that perhaps the agencies can turn that around more quickly. On PA, so the number of dose level cohorts. I think it’s important to say that there are sort of two features here that we’ll be looking at. Obviously, the dose level cohorts, so how many different dose level or dose frequency cohorts that we’re looking at in that study? But also, then the duration of time on that study because the primary objective of the intervention of the PA program particularly is to prevent the major metabolic decompensations. And so, that is also something that requires time to accrue, so that you can understand within an individual patient, whether you’ve changed the rate of those recurring events. And so, it’s a mix of two things. I mean, I think we would probably expect to see two to three dose level cohorts. But also, given the rate of enrollment, that would probably also allow us to accrue approximately a year on drug for many of the early recipients. And that combination, those who’ve been on for a while as well as seeing what dose escalation can achieve perhaps in biomarkers, will be the composite data that we think will allow us to make a determination whether we’ve got the right dose level and whether we’ve got a clear indication and benefit, and obviously, whether or not we’re seeing chronic safety and tolerability, which we will expect. And if we have that data and it feels clear, then we will move to regulatory consultation on the next step to clinical studies, and obviously, update all of you with that information. So, not a concrete number of dose level cohorts, but more a function of both time on drug for the early cohorts and perhaps a second or third dose level cohort of data that will provide us with that clarity. And I’ll turn it over, I think, David for the third question.

Yes. So, in terms of the first half, second half timing, as we’ve looked now at -- as we move into ‘22, what do we see? We see that the emerging market countries of COVAX have indicated that they’re having a lot of challenge to absorb all the product that they’re receiving through donations. And therefore, as we looked at, in particular, the second quarter timing versus the third quarter, we refined that outlook to be, as I described, first half, second half. And then secondly, the second half is certainly, as Stéphane mentioned, we think there’s going to be quite strong booster sales that will cause the second half to be a bit higher than the first half.

Your next question comes from Michael Yee with Jefferies.

We had a two-part question. One was thinking about your COVID boost strategy and the three different strategies you laid out, including the bivalent, which I think is great. Can you just talk about at what point you decide to pick which strategy that would be, and you’re confident that whatever that would be that that would be ready and able to be approved by the FDA to distribute presumably for the fall 2022 booster season, and if that is actually the product that would be in the guidance for 2022? And the second question relates to USA. I know previously you had talked about USA boosting options and purchases. But I can’t actually remember what or where we are for USA for 2022 or for 2023. And maybe just speak to the color about that market. Thank you.

Great, Michael. So I’ll take the first question and perhaps turn it over to Stéphane on the second. So, in terms of the strategy, so the most important thing to start with maybe is that 1273 as a booster already exists. And so, that is a booster candidate. Although we’re evaluating a fourth dose, we’d expect to have that safety data relatively quickly in the immunogenicity data, and we’ve seen strong real-world evidence of mRNA-1273. And so that booster candidate is obviously something that’s well known to markets and could be available quite quickly. We’re evaluating the Omicron-specific and the Omicron-containing bivalent or 214 in two studies that are ongoing right now. Now, the challenge with all of that, and I think it’s where your question is going, is that when you’re trying to evaluate durability, a difference in durability, that takes time. And so, while we’re running these studies, both the Omicron and Omicron-containing bivalent, and we expect to have data in the first half of this year, that would be one month post boost, and we could turn around and establish, we believe, the safety and the potential benefit of those boosters. And we would hope that the bivalent would continue to be even more compelling. The challenge is that it’s going to be very hard to achieve six months of durability data before Q3. And that’s just a function of time. If you boost people now, it will take time to get that day 181 or six-month durability data that we’ve already started to show with our bivalent vaccines. And so, the question then becomes, how do we proceed from a filing perspective if we’re aiming at the fall for 2022? And those are consultations that are ongoing with regulators now. We do have the benefit of…

Kevin, we have time for two additional questions. Thank you.

Okay. Our next question comes from Cory Kasimov with JP Morgan.

First one, I just want to follow up on what you were just discussing and just kind of looking beyond this fall though. And as kind of we think about moving into this endemic phase and how you’re thinking is evolving, regarding the outlook for the commercial marketplace and like 2023 plus, do you expect APAs for larger countries, be it the U.S. or Europe or anywhere else, or do you think you’ll be doing more selling into private markets? In other words, is there any reason not to shift away from an APA structure? And then secondly, just on capital allocation. Recognize your priorities remain the same here. And clearly, with 44 programs in development, new subsidiaries opening around the world, you have enough capital to do many things simultaneously. But how should we think about priorities with nearly 20% of your year-end cash being dedicated to this latest buyback? Is that 15% to 20% range of kind of your balance sheet an appropriate number to be thinking about in the future? Thank you. Stéphane Bancel: So, let me take the first question, Cory, and I’ll turn to David for the buyback question. So, if you look at the countries outside the U.S., they are in, let’s say, non-pandemic markets, they are mostly direct contract with governments anywhere. So, what is it going to look like in terms of shape and form is not very clear. For example, Europe has purchased together the vaccines for the pandemic, which is not the case, let’s say, for seasonal flu, for example. So, will they continue that model for COVID and move to that model for other vaccines or will they go back to a national system is to be seen. But all countries like Japan, Canada and so on are basically…

Sure, yes. Yes. I mean, I guess, what I’d say about the announcement today, I think what you need to think about is a few things as we did. So, why $3 billion, why now? It starts with a few things. One is, as we said, investing internally and externally and ensuring that we have plenty of firepower to allow us to do that. So clearly, where we enter 2022, we’re in a good position to fund all of the opportunities that we think we have, and they’re very compelling. So that’s one. Two is, looking at what visibility we have of additional cash generation for the company. And again, we feel very good about that certainly as we enter 2022. And then thirdly, we look at the valuation levels. And certainly, we think this is quite attractive at these levels. So, combination of all that adds up to an announcement of $3 billion. To your question, should I be filling in the model for that to continue on an ongoing basis? I think it’s a little bit early for us to comment right now on that question. And I’d encourage you just to wait and let’s see how this evolves. But we feel very good about the prospects for the business. I think the statement today is one of a strong confidence that we can achieve all of the objectives that we’ve set out for the Company.

Our last question comes from Tyler Van Buren with Cowen.

On a similar topic of conversation, could you just provide your latest thoughts on future U.S. pricing for Spikevax? Do you expect the future contracts to have pricing that has normalized relative to ex-U.S. countries? And maybe just on a second point to clarify, do you believe that a new variant wave emerging by year-end is necessary to record the vast majority of the $3 billion in APA options? Stéphane Bancel: So, let me start. So, I will not comment on the U.S. pricing for obvious reasons because of our discussions with the governments. I think as we said before, once this goes into a normal private market, we do expect the pricing to be higher. We think the vaccine does not reflect -- sorry, the price doesn’t reflect the value of a vaccine from a pharmacoeconomic standpoint. And I mean, the options, the $3 billion, so there are just different stage -- some are just waiting funding from governments to move into fully signed APAs. Some are things with COVAX that has a place or as for future needs. So, I don’t think they need to be a new variant for some of it to happen, and plus, the U.S. on top of that. But again, we have never managed through a pandemic and through a transition from pandemic to endemic. So, we want to be cautious and prudent. But I think it doesn’t need a new variant for a material chunk, over $3 billion, to move into signed APAs.

Ladies and gentlemen, this concludes the Q&A portion of today’s conference. I’d like to turn the call back to Stéphane for any closing remarks. Stéphane Bancel: Well, thank you very much everybody for joining. I look forward to talking to you in the coming days and weeks, and especially to welcome you at our Vaccine Day, which will be exciting, in March. Thank you.

Ladies and gentlemen, this does conclude today’s presentation. You may now disconnect, and have a wonderful day.