Moderna, Inc. (MRNA) Earnings Call Transcript & Summary

November 18, 2021

NASDAQ US Health Care conference_presentation 36 min

Earnings Call Speaker Segments

Michael Yee

analyst
#1

Well, welcome to another great session here at the 2021 Jefferies Global London Virtual and In-person Health Care Conference. I am very honored to have with us here on our virtual fireside chat the CEO of Moderna, Stephane Bancel. Thank you. I appreciate your time here today. Certainly, a very busy and, I don't know, a bit chaotic time period mostly because there are so many things going on all over the world.

Michael Yee

analyst
#2

I would love to just take a step back, Stephane. And maybe just pause and reflect on sort of where you think we are here in the pandemic and the distribution of COVID vaccines for 2021, and how Moderna is evolving into the end of the year -- you just gave guidance, and how that evolves into 2022? This was some, a bit of, I guess, investor debate about what the guidance sort of tells. But I would love to give you an opportunity to sort of talk about that in 2021 and going to 2022. That would be a great place to start.

Stéphane Bancel

executive
#3

Sure. Well, again, thank you, Michael, for having us. It's always a pleasure to talk with you. So if you look at where we are, we set up the year with the aim of making $800 million to $1 billion. We invested with Lonza. We invested in raw materials. And the team has been progressing very nicely. As you know, this is an extraordinary number. In January 2020, when we set out to do this, we have made 0 commercial vaccine, 100,000 dose total for the year. And for people who don't know those orders of magnitude, the entire flu market is around $500 million per year across the industry. So that was kind of a very bold ambition that we set because of the pandemic. We believe now that we should be able to land $700 million to $800 million shipped. The operational hiccup that we went through in Q3 is really around the release of a product and the shipment of a product that are 2 different things. The release is because the supply chain of Moderna has increased complexity tremendously. On making drug substance, we are totally on target. We already made now 900 million doses. So you could see we're going to easily pass 1 billion dose this year in bags, so formulated mRNA in lipids in bags. The bags were north of $700 million. So we're going to be very close to that number by the time the year is there. And the question now, how much can we get released and shipped? The release is a bit behind our plans because I think we underestimated -- and of course, I'm the CEO. It's my mistake. We underestimated the exponential growth of a number of countries and the increased complexity of the supply chain. If you think about the company in Q1 with a U.S. plant making product for 1 customer, the U.S. government, and new plants making product for mostly, well, customer, EU and a bit of Canada, a bit of U.K., a bit of Switzerland. That was kind of it. As we moved into the year, an exponential number of countries each with different requirements, we're moving flexibility of what do you ship where because it's a different product and a different label. It's not interchangeable. And I think we underestimated the people resource head count and all the IT system we needed to be like a well-oiled machine like the big companies. So the good news it's not a technical issue being addressed. We are hiring aggressively. We're building IT systems aggressively. So I only see this as a hyper-growth teething problem that we're going to work out of in the coming couple of years.

Michael Yee

analyst
#4

Let me say 2 points on that, I think. One is that if you do look at the slide, you do have 770 million -- I can't remember the exact number, of vials -- doses in vials that have been made. I don't know -- I'm not sure if the right term is fill finished, right? And literally, it seems from the call, interpreted to be released. Now is that literally someone at the factory has to sign off on all this or it has to get on a plane and get delivered? Literally investors were talking about where was that sort of difference between what's been fill finished in boxes versus what's able to get shipped by December 31. Is that literally planes in delivery?

Stéphane Bancel

executive
#5

So the release part, which is where most of the backlog is, is quality control. And people are physically looking at hundreds of pages of data to be able to sign that this product can be shipped. When the product is released, then it has to be shipped. And the challenge we have with some countries right now is achieving problem at the country level to receive it. So one example were sampling is of -- one of our first COVAX order is for Vietnam. We wasted a lot of time working with Vietnamese customs to get over paperwork back to Moderna so that we can put it on a plane, ship it, then it had to be -- land, received by the customer. And they need to acknowledge taking ownership of a product, custody of a product because it is when -- from a GAAP standpoint, you can declare you have a revenue when shipment is completed.

Michael Yee

analyst
#6

Yes. So think about that. So honestly, the -- if you were to think about the guidance change -- because from a headline perspective, there's a lot of different people involved in the market trying to understand. There's -- some are sophisticated. Some are just seeing, "Okay, well, there's a lower guidance," that the guidance shift of about $20 billion going from -- down to about $15 billion to $16 billion -- $15 billion to $18 billion, excuse me, how much of that is literally just deliveries that would have fallen in November, December to, say, January, February, March, such that every one of those things is literally just sort of a time shift. Is that all that?

Stéphane Bancel

executive
#7

It's most of it. And the reason I say most of it because of the elements we mentioned on the call is priced. And what do I mean by that? It's that, as you know, we have tried to convince the rich countries like the U.S. and Europe to shift some of their deliveries that they don't need right now because they have so much Moderna vaccine, to make room for low-income countries. So one example is, for example, the December shipment to the U.S. government. The U.S. government up to the White House agreed to not receive delivery of that volume in December and to ship that to the African Union. So what does that mean? Because the African Union is at our low-income country price of $7 per dose, you have a -- it's higher price to the U.S. It's more than 100 points. So for the same volume that we're still on track, we're getting less revenue because we're doing the right thing for the world. That revenue will come in '22 to your point.

Michael Yee

analyst
#8

Let me -- I'm going to give you a market perspective on this, any reaction to this. Because the market says, okay, timing of deliveries, that's more logistical thing in concept to supply thing, but the supply will come a month or 2 maybe. Demand, on the demand side equation, yes, it's alluded to that there is a shift in shipping from the U.S., Europe or other higher-priced countries more to COVAX, Africa and other regions because there is plenty of supply. Now to some observers, they think, "Okay, see, there's plenty of supply." Can you -- this then becomes more of a question of, do we have too much vaccine available on shelves at the higher-priced countries? And therefore, combined with the debate about boosting that the demand for more orders at these higher-priced countries, it's more lackluster. Can you maybe comment on that? Because that's a great transition to boosting demand. That case is [ wonderful ].

Stéphane Bancel

executive
#9

Correct. So what I can tell you is from all the discussions I'm having from governments -- and it's almost on a daily basis, I had 2 more this morning, there is no lack of demand. There's no lack of demand for boosters. Actually, if you look at what politicians are trying to do everywhere, it's to make sure people get their booster. And you see already some countries going down in age, like we did in Q1 for the priming series. It's to go down in age for boosters. Because you look at Europe, the cases of COVID are going back up even in countries that have had a good level of vaccination. So cases are going back up for the last 10 days approximately. The WHO had just announced that they are very worried about Europe cases going back up. And so I'm not seeing a softening of demand. What we are seeing is what we knew all along. We knew the U.S. was ordering too much in 2021. I had to speak with the U.S. government for a while. And so I'm very pleased that they released some obligation from us to receive a product later when they're going to need it for more boosting as well as for the younger children who need t he vaccine, and same thing around the world.

Michael Yee

analyst
#10

Right. Look, I -- there's a perception that the U.S. market is the most in terms of volume and relative justified price that, that is an important opportunity for all of these players to justify this. So we...

Stéphane Bancel

executive
#11

Yes. To build on your point, the U.S. is a country where we're getting the lowest price of the OECD countries. There's no OECD countries where the price is as low as the U.S. And because the U.S. population is a couple of hundred million people and when you start getting the children out and people with no vaccines and so on, there are many markets outside the U.S. that to us are much more important from a sales standpoint and profit standpoint than the U.S.

Michael Yee

analyst
#12

Fair enough. So we should change that. So there should be a clarification that perception that actually these are the countries. So talk about 2022 then. If we understand -- and you did -- have given a number for APAs, these advanced purchase agreements, that number, which you can summarize for everyone, is also reflective of a different range of scenarios. Now for some investors, they look at them and they go, "Okay. That's great." But 2 things. One is the number of options to be exercised -- and I'm just giving feedback, was slightly lower than the number previous. So of the 8 billion options previous, have a lot of those transitioned? And number two, literally, and this was partially asked on the call, I mean if people think that there's already plenty of boosting out there, plenty of supply, do they have to actually execute all those orders? Maybe just clarify that for 2022. Literally, people think that's plausible.

Stéphane Bancel

executive
#13

Sure. So let me try to go back to what we said last week. So the APA is signed with upfront payment. That is very important. I believe from everything I'm reading that we are one of the only company or the only company that always get an upfront payment for every APAs. I refuse to sign APAs in the countries that are not willing to put a down payment, and it's a material down payment. That's why if you go back to the cash position of the company, Michael, as you know, we've had cash way ahead of revenues because we had those down payments. And for me, they were very important to see the commitment of those countries.

Michael Yee

analyst
#14

So when you have APAs though for -- what's the number?

Stéphane Bancel

executive
#15

$17 billion for next year.

Michael Yee

analyst
#16

$17 billion, right?

Stéphane Bancel

executive
#17

Yes.

Michael Yee

analyst
#18

You've already received $17 billion of cash?

Stéphane Bancel

executive
#19

No, no, no. We got a percent that we have not disclosed publicly, but it's a double-digit percent that is very material and very important coverage for us to make sure people are serious. And if they were to not take orders, we will cover the cost of a product then sell to somebody else. So that's for the signed APAs. Then the options, we said up to $3 billion. So this number has been, which was not the case before, probabilized. So what we've done to be able to better reflect to people how they should think about the year is you probabilize from options that we think are very high likelihood based on our discussions with the countries on a daily basis. In some that we've said, "Oh, they might have taken the option just to have the optionality, but they maybe have a 20% chance of exercising it." So we counted that into account to those numbers, up to $3 billion. And some, as you mentioned, were options like the COVAX Q2 option was exercised. So it moved compared to the numbers last time from option into APA with down payment. And then the third piece, which I think is going to be also important, is the fall '22 U.S. market. As you know, the U.S. government has ordered product for Q4 and Q1. The U.S. government has no more options from Moderna, from what the Trump administration set up back in the fall of 2020 before we had any data. And I believe it's the same thing for Pfizer. There are no more options set up between Pfizer and the U.S. government. And so think about fall '22 as a normal booster market like the flu. Price, we believe, should be a market price, not a price that was determined, first, before there was any clinical data; two, where Moderna basically provided a discount of $1 billion to the U.S. government to reflect the BARDA grant that we got, that the U.S. payers were made [ well ] from the future purchase of a product. So that takes you to an order of $17 billion to $22 billion for the year. And as we see -- as we said on the call, many discussions ongoing with countries for additional APAs or additional options. We should not forget that what's happening in the world today is countries want mRNA vaccine, even low-income country. Everybody's COVID data is seeing that the mRNA vaccines are superior to the adeno vaccines or like attenuated vaccines like with vaccine from the Chinese. And the second piece that's happening now, which is quite interesting in the last month or 2, is countries are starting to see that the Moderna vaccine provide longer protection of -- longer protection. And as you know, Michael, from the data we showed at the call, you just look at Switzerland, which is an interesting market because it's where Moderna has the highest market share. So if you look at the numbers between Moderna and Pfizer and a bit of J&J, you will see that the rate of hospitalization per 100,000 people, the rate of death after vaccination per 100,000 people is always better with Moderna. So I think as more and more countries see that type of data and start to realize that if you have to boost people, if you have to train people, you're better with Moderna vaccine. And as the world gets out, I think in 2022 where it will be much more market-driven dynamics versus top-down government dynamics, you will see more and more people wanting the Moderna booster.

Michael Yee

analyst
#20

So here, this then shifts to people working -- the biggest development I would tell you that's happening -- and you already know this, over the last couple of months, reflected in stock action for fund managers that are listening right now, is one is that the curve, famous curve, has gone down. People are now going back to work, and there's this perception that the demand for boosting is less because it seems that the pandemic is going away. Part 2 is, "Oh my gosh, someone reports oral pill treatment data," Plan B, I call it. I'd like to say, you don't get a vaccine, Stephane, because you're worried about hospitalization. You get a vaccine because you don't want to get sick. That's why we take the flu vaccine. So -- but the market has reacted. So what do you speak to or how would you speak to this market idea that demand for boosting is not going to be there for '23 or '24? Because these orders are going to fill the shelves for '22. But if nobody's jabbing, then there's this perception that, what difference does it make? Speak to that because that's what happened in the last [ quarters ].

Stéphane Bancel

executive
#21

It's a great question. And I think a lot of people are not familiar enough with this market and are making something that is not correct. So the first one is, if you look at the Pfizer vaccine, you're losing efficacy every month of vaccine too, but the slope is not the same, as has been massively reported. So -- and look at countries like Israel, which was mostly Pfizer on it, how they went back into a Delta wave with a vengeance despite being the country with highest vaccination rate in the world. And so I think -- and it's what you're seeing in Europe, too. Pfizer has higher market share in Europe. So you're going to see the countries with higher Pfizer market share are going to have more break for cases. So I think people do not understand the fact that with time, immunity is going down. Two, and God forbid, we still are not out of the woods in terms of another variant. And so be careful not to assume we are done with COVID. COVID -- SARS-CoV-2 is not leaving the planet. And if you think about it, to your point, the antiviral are a great thing for humanity. There is zero doubt. And if what was described last week and the weeks before by Merck is correct that the real-world evidence, when you look at this in tens of thousands or hundreds of thousands of people screened in term of dose efficacy, it is great for people who get sick. But as you rightly see so, look, through its $500 million per year, Tamiflu has been around for a long time. And why do I get a flu shot every year? Just because I don't want to get sick. Am I worried I'm going to die? No. Do I think I may go to hospital? No. But do I want to spend a couple of days in bed with high fever, actually? No, I don't want to. I just need to -- it's actually on site. We operate as a benefit to our employees. I walk down 2 stairs. I get a shot, like 5 minutes, and I'm fine for the winter. And this is with a vaccine with about 30% to 60% efficacy, true. Now it comes to a world where if you get 90-plus percent efficacy where COVID is, why in the hell would you want to take the risk to get sick? So is it going to help people who don't want to be vaccinated? For sure. Is it going to help the U.S. go out of a pandemic? For sure. And those are good things for the world. But does mean that the entire supply of COVID booster goes away '22? I don't believe so.

Michael Yee

analyst
#22

Do you believe then in the medium term, however you define them, after the holidays, entering the first part of '22, if the vaccine efficacy is declining because of all of the people that got it in the first part of '21 -- you can do math on that, by the first part of '22, those who are not boosted would be amenable to losing protection. And because of the holidays and all these other issues, we will start to see the curve back up. I wouldn't want that, but is that a plausible scenario? Do you think that's going to happen based on science?

Stéphane Bancel

executive
#23

Yes. And I think it's happening in Europe right now. The reason it has not happened in the U.S. is the booster has been approved in the U.S. faster. They were approved for Pfizer first. And as we know, the Pfizer vaccine wane immunity faster. So the bigger agency in the U.S. was the Pfizer vaccinated. And they got the booster first. And so you get a lot of people and you can see in the chart from the CDC. It has a big spike in vaccination for boosters. And now since the Moderna vaccine has been authorized, you could see a big spike in Moderna vaccines. So I think people who want protection are getting boosted as we speak. Those are going to be fine, especially people who've got Moderna, prime, then Moderna booster. If you look at the data from Fauci, where they mix mRNA therapy, because they get the highest neutralizing antibody. They're going to be going further along. People who have Pfizer and Pfizer will potentially, back into the winter, be sick again. That's a big unknown also -- yes.

Michael Yee

analyst
#24

So that's the science, right? Because we're not saying it -- we would not want that to happen. What we're saying is based on science, you believe that the combination of waning immunity, winter -- I would say winter, and other factors would lead the curve to go back up post winter or whatever, and that's just science.

Stéphane Bancel

executive
#25

Yes. And the one example I would use from the real world because we don't have enough longitudinal data on those vaccines. We are living this pandemic as we go, is the OC43 coronavirus, which we spoke about at our Vaccine Day, Michael, which if you look at this virus, which is causing around 10% of hospitalization in the U.S. every year for COVID, the rate of disease in the 65 and above is annual. Older people get sick every year from this virus. So does that mean that vaccine will need a booster every year for people above 65? I don't know yet. It's possible. And that's a piece that we should all be careful about. It's that respiratory viruses don't last as long as other vaccines. And those things mutate because mRNA viruses, unlike DNA virus, HPV and so on, those mutate over time.

Michael Yee

analyst
#26

Yes. Do you -- what percent of people in the U.S. do you think will get a boost in the next 6 to 8 months? Maybe you break it down by those over 65 and those under 65. If you had throw out a number.

Stéphane Bancel

executive
#27

Yes. So I think those above 65, I think it's going to be in the 80-plus percent.

Michael Yee

analyst
#28

80-plus percent, okay.

Stéphane Bancel

executive
#29

I think will get a boost. And if they don't get a boost, as soon as they get friends getting this disease that have been vaccinated, they go run to the CVS to get a boost. And so I think those that have not been boosted now, it's just a matter of time. I have more and more stories that I'm mirroring from people that got the Pfizer vaccine and are getting disease and breakthroughs. And they are saying that, "We have friends," especially on social media. They're getting boosted. And so for those that don't believe the data, they're going to believe if they got one example of their friends and families.

Michael Yee

analyst
#30

Okay. So 80-plus percent. And then some -- what do you think 18 to 65 or maybe 30 to 65.

Stéphane Bancel

executive
#31

So I would go in the -- yes, over the 30 to 65 bracket, like working individuals, who just don't want to get sick -- I mean I've got my booster, obviously. I don't want COVID, and I don't want long COVID. What most people are thinking about is long COVID. And long COVID, there's more and more correlation between EBV, Epstein-Barr virus, the virus that causes mononucleosis, and long COVID. And Dr. Fauci and his team has published that 90% of people with long COVID are EBV-positive. So there's not causation yet. They're working on showing that or not, but there is epidemiology data. And the thesis will be -- or the hypothesis will be when you get COVID infection, you get EBV reactivation in your system because EBV is a DNA virus. Once infected, infected for life. It's in your body. I'm talking about -- I'm EBV-positive. I had mononucleosis as a teenager, and the last thing I want is long COVID because...

Michael Yee

analyst
#32

What percent of people get some form of long COVID? I know there's work around it. What do you think?

Stéphane Bancel

executive
#33

So the number I've read is around 30% of people who got COVID get long COVID, which is an extraordinarily high number. When you think about the fatigue, the brain fogs and so on, those are not good things to have.

Michael Yee

analyst
#34

Okay. Look, that is a good transition into what could happen over the next few months. But importantly, let's take a step back from Moderna platform. That flu data is coming. Now we kind of talked about how they're obviously -- gave out a number for flu vaccine doses around the world. But there's flu data coming. Put into context what we will learn from a Phase I that will inform us of how good your vaccine is versus competitors. I want to start with that.

Stéphane Bancel

executive
#35

Sure. So a few things. I will look at as soon as I get to see the data. One is how does it look in the elderly. It's highly reported that the current flu vaccine don't work very well in the elderly. And so I'm going to want to look at the 50 and above data. I believe they're going to be very strong. As you remember, Michael, in the COVID-19 Phase I data, antibodies in 70-year-old were as good as in 18 years old. That is remarkable in a vaccine. That is not the case of all vaccines, everywhere for COVID. It was not the case of BioNTech and Pfizer vaccine.

Michael Yee

analyst
#36

How are -- the more immunogenicity with the platform, that's part of it.

Stéphane Bancel

executive
#37

Correct. The second thing I want to be looking at is how much antibodies. And the big number that everybody is going to look at is 40:1 on the HA antigen cycle. Why? Because the FDA, for protein vaccine, uses that as a surrogate for efficacy. Unlike for COVID where nobody knew how much antibody we needed, which is why everybody have done a big Phase III study. In the case of flu, because as flu has been going on for a long time and there has been vaccine for a long time, the FDA asked a provable end point of the HA antigen. And if you can show that you dilute the blood of people 40 times, if you can still find the antibody -- neutralizing antibody in the blood after a 40:1 dilution, this is what the FDA considered as enough for efficacy.

Michael Yee

analyst
#38

How will we get above 40? Just to be clear, how do you get above 40?

Stéphane Bancel

executive
#39

Yes, across all age and across all participants. So what does a home run look like to me is all the participants in the Phase I, including the 65 and above, all of them, 100% of them, individually when you get the dots of people, are all above 40:1. That is...

Michael Yee

analyst
#40

Why do proteins -- [ having thought the Sanofi ] data, what would that be in...

Stéphane Bancel

executive
#41

Across different vaccines, you get a big drop in the elderly, and you maybe get 20%, 30%, 40% that are above 40:1 in the elderly group.

Michael Yee

analyst
#42

Can I define 40:1 as zero conversion? Because I know that's like...

Stéphane Bancel

executive
#43

So zero conversion is your base for me, meaning we all have baseline because -- you have been infected by a flu before and vaccinated, Michael. I am as well. You and I have baseline. If we were to take our antibodies today, are not the same. What we want to look is the increase in the baseline. And so that's also very important. If you look at the RSV vaccine, which is [ in various preferred ] vaccine, we showed across the population the increase was around 11x the antibody, when you take the blood before you inject somebody and you take the blood, let's say, a month or 2 months out. That is a very important metric, and we will be measuring that as well for flu, which is...

Michael Yee

analyst
#44

Okay. So 2 end points there. One is how many people get over GMT times 40. That level just titers, just to be clear for people -- like for SARS-CoV-2, where titers are hundreds to 1,000, very much. So if you can get over 40, that would be great. To be clear, we think most -- everybody could get over 40 for mRNA, and that's not necessarily the case for protein, part 1. Part 2 is zero conversion. How do you think about the importance of that? What is good data there?

Stéphane Bancel

executive
#45

So something -- I mean I think a 2 to 4x increase in antibodies will keep you several months out. Of course, more is better, Michael. So I think if you start to see this type of increase, as you think about a 6-month winter season, let's say to go from September to March type of things that we all need, that will be a good baseline to start with. So if I see the variety of that data where there's good zero conversion on an individual basis -- and same, you can look at every participant at different points, and then we can see everybody, including the older people, well above 40:1, that will start to smell like a really good vaccine.

Michael Yee

analyst
#46

So on -- throw out a number for me because I know there's a lot of different flu vaccines. What percent of people over 65 get GMT targets above 40?

Stéphane Bancel

executive
#47

As I say, it depends on the vaccine. And so it's around 30%, 40%.

Michael Yee

analyst
#48

30% to 40%.

Stéphane Bancel

executive
#49

Yes.

Michael Yee

analyst
#50

Okay. All right. Well, that's big. If you can get everyone -- that's the point of going back to the power of the platform, that the immunogenicity of the mRNA is significantly more powerful to reduce the immune response particularly in older people, where that's not as clear with other platforms. By the way, it was seen in COVID. Remember, in those, you saw lower antibody responses in [ other ], remember?

Stéphane Bancel

executive
#51

Yes, and Pfizer vaccine. If you go back -- that's what's a lot of people are missing. If you go back to the Phase I of Pfizer, in the 65 and above, you see around a 60% decrease in antibody titer that got the Pfizer-BioNTech vaccine. But if you look at the Moderna data, which is a point that we internally were jumping around when we saw the data, a 70-year-old will get the same level of neutralizing antibody as an 20-year-old, what I think is unique about the Moderna vaccine.

Michael Yee

analyst
#52

I remember. Now thankfully, because we do want vaccines to work, even though the older people did fall off in terms of titers, they're well above a protective level. So now it's good for Pfizer. Yours are higher, which -- in all age groups, which induces presumably better protection. And that's when you started off the discussion saying that you believe you have better protection. What about -- a lot of people are talking about side effects. Is the dose significantly lower? How do we think about that for flu?

Stéphane Bancel

executive
#53

Yes. So we'll have to see what the dose and the data from the Phase I because I don't know what dose we're going to go into the Phase II/III, which the team is preparing. The only piece we have not put in the FDA file is the dose. We need to add the data, but everything else is ready to go, including the site being prepared. So we're going to be very quickly moving. So I think that the dose will be an important piece. And the dose, it's always the same thing. As you know, in vaccinology, it's -- you need to look at the antibody you get, what tolerability profile you get, and pick a dose where you get enough efficacy for that acceptable profile. Okay. If you think about where the market is going, not the pandemic because we need to prepare for where the market is going, the #1 market, in our opinion, is 50 years old and above. Because we believe -- and the clinical data is very interesting. People that are 50 and above tend to even report less side effects than younger people. And the psychology, when you talk to clinicians, they are very thankful to a vaccine that's working. And so when 25 year old say, "Look, it's a bit [ right ]." And so a 60-year old, a 70-year-old will just go on today and say, "That's fine. I'm just so thankful I can be protected," because for them, the downside is much higher. So I don't know how much is true. I'm just saying you would have heard from doctors...

Michael Yee

analyst
#54

Partially a more dormant immune system, may I say that? I mean...

Stéphane Bancel

executive
#55

Okay. That does work.

Michael Yee

analyst
#56

So look, the point is people -- I want to hear from you. The doses are a lot lower though, and therefore, you -- even at multiplying times 4 strains, the amount of mRNA that's in 1 injection could be 20 micrograms.

Stéphane Bancel

executive
#57

Yes. It could be 20, it could be 50 micrograms.

Michael Yee

analyst
#58

Is that 5 micrograms times 4?

Stéphane Bancel

executive
#59

Exactly. Because also, we should not forget that flu, like COVID-19, people have been primed by vaccines and infection all their life. So all the immunologists believe that people don't need as much mass to create the immune response versus with COVID, everybody was naive.

Michael Yee

analyst
#60

They've never seen it before. So you've got to get up the first time and then you've got to give a second dose. We see...

Stéphane Bancel

executive
#61

A booster, [ all that ] in a booster.

Michael Yee

analyst
#62

With flu, the 4 strains that will either have seen strains related or have seen that. So therefore, it's almost like a boost...

Stéphane Bancel

executive
#63

Yes.

Michael Yee

analyst
#64

The first time they get it. Yes. I get that. So literally, if I make up some doses, it could be like 5 micrograms times 4, which is 20; or 10 micrograms times 4 -- 10 times 4 is 40, and you still have plenty of room within the therapeutic window to give a COVID boost of 25 to 50, where you only got 100 micrograms and people will not be having too much to start. Is that what we...

Stéphane Bancel

executive
#65

Yes. If you agree, what we should not forget is that it's unclear today if you could get 200 or higher with less side effects than the 100 COVID because some of the side effect is because of the antigen. You get so much on one antigen. But if you get a lot of antigens, one for flu, one for COVID, you might be seen at 100-microgram total mass. There will be much lower side effect. We don't know, but we have to see in the clinic. And it's highly possible because we should not forget that vaccines are so efficacious because you make so much antigen.

Michael Yee

analyst
#66

Yes. Okay. Let me end the topic with sort of a bonus question. Cardiovascular data, how to think about upcoming cardiovascular data, the value of that? And then I would say most important, surprising upside next year could be PCV melanoma data, randomized controlled study in resected melanoma, which is not shrinking tumors. This is protecting melanoma from coming back that is plausible that surveillance of antibodies to prevent melanoma. Can you make a comment on those 2?

Stéphane Bancel

executive
#67

Sure. And I will just make the overall comment, Michael, which is between the oncology program as you talked about, cardio with AZ presenting at AHA on November 15, probably the key question is what the data look like? And is AZ, who is one of the best [ pharmaceutical ] company in the world, moving the asset to more clinical trial and to getting ready to get closer to market? And then there's a rare disease program. We have 2 rare disease program dosing in patients as we speak, a third one very soon, autoimmune disease. So if you think about the next 2 weeks to 6 months to 9 months of Moderna, there's going to be a slew of clinical data so -- with [ a few weeks ] as well. So I think it's going to be quite interesting to see the breadth of the platform because most people believe this is a COVID-19 company. No, it's the biggest, largest mRNA platform company which happens to have a pretty good COVID-19 vaccine.

Michael Yee

analyst
#68

Well, let's see what the curve looks like. Let's see what boosting looks like. We talked about that. We've got flu data coming, the cardiovascular data. I'm going to make a big swing as I'm sure AstraZeneca is moving up forward. And then we'll talk about the PCV melanoma data for 2022. Thank you very much, Stephane. Thank you for your time. It's always a pleasure.

Stéphane Bancel

executive
#69

Likewise, Michael. Thank you.

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