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

June 3, 2021

NASDAQ US Health Care conference_presentation 26 min

Earnings Call Speaker Segments

Michael Yee

analyst
#1

Well, thank you, and good morning, and welcome to another great session here at the Jefferies Global Healthcare Conference. Obviously, very pleased to have with us here the CEO of Moderna, Stephane Bancel. Thank you for joining with us. I know it's crazy and busy times for you but certainly exciting times and certainly a lot to talk about. So thanks for being here with us.

Stéphane Bancel

executive
#2

Thank you, Michael, for having me.

Michael Yee

analyst
#3

Let me just start first by talking -- asking you about your perspective on the 2021 outlook for COVID vaccines for Moderna and bridge that into your thoughts and visibility into 2022. This seems to be a big debate, but I'd love to hear your perspective as how that evolves.

Stéphane Bancel

executive
#4

Sure. So '21, from a supply standpoint is really kind of a done deal in a sense. It's impossible now, being June 3, for any manufacturer to add any meaningful manufacturing capacity because of the lead time between CapEx, hiring people, training them, raw materials and so on and so forth. So I think the capacity for the planet is called for 2021. If you look at the environment, as you know, there's been a lot of changes versus what we believed a year ago between the high efficacy of mRNA vaccines, the safety cloud on the adenovirus, the protein vaccine still not authorized in any of the Western countries. And so I think it's really all about delivery right now. So far, we are well on track to the 800 million to 1 billion dose -- 800 million to 1 billion dose number. And as you know, Michael, we've raised that number slowly as we got more and more comfortable for our ability to deliver. We delivered the 100 million dose to the U.S. government by end of Q1; delivered by end of Q2 -- end of May the second 100 million dose; and are well on track to deliver a 500 million dose in the U.S. by end of July. So the team so far is doing great, and we are getting good visibility on yield, on scale up. So I feel cautiously optimistic. I always want to be careful with manufacturing, but I feel cautiously optimistic. We do not have a biologics process like the adenovirus companies that have had manufacturing issues. And if you look at it, I think both Pfizer and Moderna have delivered on their manufacturing commitment. So as I look into '22. So what has really changed, as I shared on the call, Michael, is that in the last couple of months, which is why we decided to increase our capacity to up to 3 billion dose next year, we got a lot of call from governments around the world basically telling us, "Look, guys, we want more mRNA vaccine for this year and for next year." And they were saying, look, there are 4 things we care about as a government is we want the highest-efficacy vaccine to protect as many people as we can. We want good safety profile. We want good manufacturing reliability because, as you know -- and you've seen in the media, when a country orders and set up all vaccination campaign, which is a very big logistics effort, and then they don't get delivery, they are very, very upset. People in the countries are very upset and politicians do not like when their voters are upset. So manufacturing reliability is really important for the countries. And as well I think, having a manufacturing process that came on, it is not the biologics process, is a huge competitive advantage.

Michael Yee

analyst
#5

Yes.

Stéphane Bancel

executive
#6

And last but not least is the speed to variant and to boosters. Because as we all see, the virus keeps evolving. You see now the new lockdown because of Indian variant. And so I don't think this virus is over because there's still so many people that can get infected. As I've said before, we believe the kind of spring/summer time frame in the North, which is the full winter time frame in the South, is going to be very problematic because there's almost no vaccine in the South given the population that's down there. There's very high-density in household because of low GDP per capita versus the North. And so you have a lot of time, several generation family in the same home, cousins and cousins in the same home. And as they get into the winter, they spend more time indoor like we do in the North. And the last piece, what a lot of people that are not familiar with infectious disease, I think, tend to not appreciate is that you have a lot of immunocompromised people in the South because of -- including your HIV and tuberculosis and other disease. And it is not surprising that you've already seen in the South, P1 Brazil -- or I should call it -- is it gamma?

Michael Yee

analyst
#7

Yes. I don't know which Greek letter it is.

Stéphane Bancel

executive
#8

Yes. It's one of the Greek letters. I just remembered that delta is the Indian one because it's the last one. And so as you look at all those things, this is what governments have been telling us. When I get to talk to health minister, prime minister, presidents of countries, "Give me more mRNA vaccine. That's what I want. That's what my people want." And that's a big change. So what we've said is that we are talking about '22 and have already signed countries, like Israel and Switzerland, which were the first one to sign last year. So the same country that were early are early again. And all the countries that have already deals with Moderna, it's 80-plus countries, are negotiating more deals for '22 right now.

Michael Yee

analyst
#9

Okay.

Stéphane Bancel

executive
#10

And countries that did not get Moderna for '21 and are calling now for Moderna vaccine, I'm like, "Guys, I have no more. It's all sold out." They are interested to get booster for '22. And so I think the market dynamic has changed drastically from early last year. No data in the clinic, everybody betting on older technology to a world where people are just following the data and the facts and they just want mRNA vaccines.

Michael Yee

analyst
#11

That's really important. So let me take a couple of those and expand. Number one, do you believe that you -- we don't have -- this is going to be all stockpiling, right? It's all government purchases, right? That the government purchases, if it's all the same people in '21, and more people would need it and more countries would need for '22, that you would be selling more conceptually in '22 than '21 doses?

Stéphane Bancel

executive
#12

Yes. So that's why we are getting the capacity to 3 billion. If I didn't think we're going to sell more, I will not get my team going crazy.

Michael Yee

analyst
#13

Why would a country order less in '22 than '21? Is that even -- that wouldn't happen, would it?

Stéphane Bancel

executive
#14

So yes, a few things to think about, and that's way it gets a bit complicated. You have, first, the young children will be mostly vaccinated next year, some on the tail end of this year, but the bulk will be in '22. So that's...

Michael Yee

analyst
#15

That's new.

Stéphane Bancel

executive
#16

To 11 -- yes, that's new doses and it's 2 doses. The booster is going to be one dose.

Michael Yee

analyst
#17

Okay.

Stéphane Bancel

executive
#18

And so what governments don't know now, because the virus is still evolving quickly, is do they need one boost per person in '22 or 2 boosts? So some governments that are smart are basically buying at least 1 per citizen of a booster, 18 and above teens and young...

Michael Yee

analyst
#19

They buy 2.

Stéphane Bancel

executive
#20

Yes. And some governments are making -- are putting down money to get option that we have a 3-month or 6 months to exercise before delivery. Where they say, "Look, if there is yet another variant of concern in the fall of '22, I want to boost people around their 1-year anniversary, 9 months to 1 year of dosing." Because what I'm also hearing from countries investing -- because there is no data or how long protection will last, especially if you get infected with variants whether the vaccine you got is for the original strain, they're saying -- I mean, the smart countries are saying, "I would rather be 2 months too early than 2 months too late boosting." Because the most threat is going to be, again, lockdown and hospitals exploding.

Michael Yee

analyst
#21

So a demand perspective, the demand from a government purchasing perspective should be at least the same, if not greater number of citizens to be covered -- not doses because I know it's -- so same number of people covered adults, plus pediatrics would get to the same number of people covered. And then Moderna should sell more to more people because you have more capacity and more countries that didn't get the chance to order. So from a citizen's perspective, it should be more in '22 than '21?

Stéphane Bancel

executive
#22

Yes. And there's another aspect that I think people forget, Michael, which is stocks, which is today, there is no stock in the system, meaning we finished making a lot. It's QC-approved, it's on a truck, it goes somewhere.

Michael Yee

analyst
#23

Okay.

Stéphane Bancel

executive
#24

And in the country, it's the same. There is no stock between the wholesaler, hospital, GP's office, pharmacy. And so if you start to factor stock in the channels, which is true of any industry, people are starting to think about how much drug do they need in the channel so that they don't operate hand to mouth? Because people think that for boosting, you might not be having people willing to come to, like, vaccine stadium to just line up and spend another day waiting. That it might be more decentralized in more traditional health care settings, like GPs, pediatricians.

Michael Yee

analyst
#25

Your point is more orders because this was more a one-for-one demand, and they need to have more than just one-for-one because there needs to be convenience to be able to get it, right?

Stéphane Bancel

executive
#26

Correct.

Michael Yee

analyst
#27

Okay. That's another bar.

Stéphane Bancel

executive
#28

And the other piece that people also underappreciate is wastage. There's actually a lot of wastage, which is so sad to see. There's a lot of wastage. Again, think about it, in the early months of the pandemic vaccination phase in the U.S., people will line up a stadium when they would not qualify to get the last dose at the end.

Michael Yee

analyst
#29

How much do you think is wasted, 10% to 20%?

Stéphane Bancel

executive
#30

So it's interesting. If you look at flu -- seasonal flu, which is pretty similar because it's seasonal.

Michael Yee

analyst
#31

We'll get to flu too here, yes, yes.

Stéphane Bancel

executive
#32

It's around 20% to 30% wastage.

Michael Yee

analyst
#33

Okay. So when they're building their models, they're actually having to need to order, make build in a 20% to 30% adjustment factor. Okay. What about pricing philosophically? I would argue it's not the price per dose, but the price per person. And it's a variant, which there's a premium on a variant? Plus...

Stéphane Bancel

executive
#34

Yes. So I believe the price of this market is going up, not down.

Michael Yee

analyst
#35

Going up, not down.

Stéphane Bancel

executive
#36

Yes. And the reason is the following. When we're negotiating at the same time last year, we had no efficacy data and we are in the marketplace with very established players like protein or adenose, and there is a company, which we all know is called AstraZeneca, who was going out there saying, "We will sell for no profit at $3 to $4 per dose." So as you know, Michael, our price outside the U.S. has been $20, $30, depending on the country, the volume and so on. So imagine how funny to us to negotiate with countries telling me, "Hey, Mr. Bancel, why am I buying from you at $25 or $30? I can buy the AZ vaccine at $3."

Michael Yee

analyst
#37

That's off the table now.

Stéphane Bancel

executive
#38

It's off the table, exactly.

Michael Yee

analyst
#39

But more importantly, I don't -- I mean, again, I'd like to be proud of using this analogy that -- does it really matter for 3 or 4 cups of coffee. And there you go drinking the coffee at the same time, when you're talking about 1 year of protection, ballpark. Does that even matter? So if you're telling me that the number of horses in the game has been narrowed down, that you're meeting the 4 criteria of manufacturing, efficacy, safety and variance, I think those are the 4, that you don't see any material pushback to healthy pricing that should be higher, not lower.

Stéphane Bancel

executive
#40

Yes. And there's another piece that's important is there are many players, of course, Pfizer. And the Pfizer management has said on the record on their Q calls that they think that as the market becomes more of a commercial market, prices are going up.

Michael Yee

analyst
#41

They said that, too. Okay.

Stéphane Bancel

executive
#42

And Pfizer, as we all know, is a company that has a tendency to raise prices and push prices up, not down as a company culture. And so I think that's an important piece, also the dynamic of what we are seeing, which is low-cost players are really out of the market because of the issues, and the only other player in mRNA has more tendency to want higher price than our price.

Michael Yee

analyst
#43

Philosophically, I do see the concept of higher pricing, whether that's pricing per person rather than per dose per se, but the value per person will be higher is what you're saying. Now if I'm going to pen you, is that it makes sense that it's -- if it's $25 a day per dose, it's $50 per person. Is that, conceptually, the $50 per person still valid?

Stéphane Bancel

executive
#44

Yes. I don't think the governments are going to go that far. But a premium versus the price of last year is definitely on the table.

Michael Yee

analyst
#45

Okay, okay. And you're not seeing any pushback on that?

Stéphane Bancel

executive
#46

No. Again, people know there are 2 companies that have what they need. And think about how much are wasting on testing. I mean, think about -- I don't know how many test you did.

Michael Yee

analyst
#47

How much is a test? I don't know how much is a test.

Stéphane Bancel

executive
#48

The test last year. Think about the money that was wasted doing testing, and the test numbers are dropping. So people would rather -- especially now that they know there's high-efficacy vaccine.

Michael Yee

analyst
#49

Yes, yes. That's fair, right? So if you can consider the idea of the testing and the price and the scarcity of the product and the attributes, then you're not seeing pushback. Now why has Europe signed a huge deal with Pfizer? Correct me if I'm wrong. I don't think there's any major announcement out of your side. But also the U.S. hasn't signed anything yet. What's going on there?

Stéphane Bancel

executive
#50

So as I said on the Q call a few weeks ago, we are talking to every government who ordered already. Europe is part of those. So I'm not going to comment more on that for obvious regulatory reason. But yes, we are talking to Europe, obviously. And in the U.S., as you recall, the U.S. has a few more options that they have the right to exercise. And so again, when there's something to announce, we'll talk about it. But the U.S. government, as you just look at the data on the CDC website, it's mostly Pfizer and Moderna a vaccine that's being used in this country.

Michael Yee

analyst
#51

Yes, yes.

Stéphane Bancel

executive
#52

So the government is indeed getting ready for boosting.

Michael Yee

analyst
#53

Yes. The U.S. government is good. All right. So you're in talks with both of those, and those are obviously important geographies. Okay. What about variants? What can you say about -- not selling the vaccine, but the demand utilization even beyond '22? And the reason I ask that is because if the number of infections is going down and the vaccines you're using, generally speaking, are blunting the virus and are maybe not 95% effective, but effective in blunting variants, concept of herd immunity or whatnot, don't you think that, that concept means that the demand urgency for people to use it is less? Make a comment about that.

Stéphane Bancel

executive
#54

Sure. So I think it depends on what you believe about the science. So what we believe, as we showed at our vaccine data is that like natural coronavirus infection, protection is going to be 1 to 3 years if you get infected by the same virus, same variant, from what you get vaccinated to what you get infected later. And the 1 to 3 year depends on people's health, age, co-morbidity factors and so on and so forth.

Michael Yee

analyst
#55

But if it was the same strain.

Stéphane Bancel

executive
#56

If it's the same strain.

Michael Yee

analyst
#57

We will have longer protection.

Stéphane Bancel

executive
#58

That's what we believe.

Michael Yee

analyst
#59

Mostly because of memory cells that's...

Stéphane Bancel

executive
#60

Yes. Exactly. We don't have the data yet because we don't have a 1-year Phase III data behind it.

Michael Yee

analyst
#61

By the way, I won't get into the nuance of protection, not against infection, but I'm talking about protection against like severe disease.

Stéphane Bancel

executive
#62

Correct.

Michael Yee

analyst
#63

I saw this whole thing about, "Oh, you don't need to get it because you won't get severe disease. you won't go to the hospital." Like okay, I mean, yes.

Stéphane Bancel

executive
#64

Yes. And so what we believe is that people are going to need boosting in '23 and further. What governments might do, because it's never private payers might who look at return on their investments. And $50 vaccine to prevent Michael to have 2% chance of being hospitalized is a very quick math to do. So that's point number one. Point number two, people have been so traumatized by COVID that I think a lot of people would rather be safe than sorry. If it's one shot at your CVS and you go get back your shot in the August, September, October time frame of '23, let's say. And then as we discussed, Michael, is we are working on the flu vaccine. As we've shared, we have beautiful RSV human data with elevenfold increase of antibodies in single dose. So the Moderna vision is very clear is that we want to bring, every year ,combo vaccines, single dose, that you can get at your pharmacy or at your GP or in your company provided by your employer, where you will have high-efficacy flu vaccine, not the a 20% to 60% efficacy of current vaccine, but high in the 90-plus percent efficacy flu.

Michael Yee

analyst
#65

90%, you're thinking. Okay.

Stéphane Bancel

executive
#66

That's what I think. 90%-plus COVID vaccine with the right variant for that winter. And then we will add RSV as well. So what we want to do is to really give you a shot that you just don't get the key respiratory disease that might get you hospitalized or might get you just sick for a few, few bad days. That's what we want to do.

Michael Yee

analyst
#67

Right. I see what your point is. Your point is let's see what the utilization demand -- the actual demand to get the jabs will be in '22 and '23. We can debate that. You're saying, look, people are traumatized, not a big deal to take another boost. Price isn't a big deal. But if you could combine it with flu, where people do, do flu, 50% of the country does do flu, and it's a lower efficacy, number one, you will have flu -- all right, the point is you bridge them all into one.

Stéphane Bancel

executive
#68

Correct.

Michael Yee

analyst
#69

That's what you're trying to do.

Stéphane Bancel

executive
#70

And my point too is I think the flu market will expand a lot because people know that flu shots don't really work. I know a lot of people that just don't take it. I take it every year.

Michael Yee

analyst
#71

I didn't take it. So there you go. I could be a converter.

Stéphane Bancel

executive
#72

I mean, I take it every year for a long time. But I know a lot of people who don't because, they're like, "It doesn't only work." But if, Michael, I tell you, you can get a flu shot in the same dose as your COVID shot and it's going to be 95% efficacy, I think you might take it.

Michael Yee

analyst
#73

Yes. That would grow the market. Okay. So number one, what flu -- could you have flu data this year? And what is good data? Are there levels, what's good data?

Stéphane Bancel

executive
#74

Yes. So that's a great question. So yes, I believe we will have flu data this year. And flu is a very interesting program to develop from a regulatory standpoint because you have an approvable endpoint, which is neutralizing antibody titer. So if you can show the HA antigen, you can show -- if you do a 40:1 dilution, and you can still show the antibody in the blood serum, that's what the FDA consider clearing the bar.

Michael Yee

analyst
#75

Titer level's above 40.

Stéphane Bancel

executive
#76

40:1 dilution, yes, for the HA antigen. And if you look at Moderna, very old vaccines, the H10 and the H7 vaccine that we did back then. What we showed is we had everybody above 40:1, which is why, Michael, I believe we're going to have a very high efficacy flu vaccine. Remember last year, you and I were having this discussion, the Phase I data of COVID, high neutralizing antibodies, the young people, the elderly. And we saw...

Michael Yee

analyst
#77

That translates to efficacy. Now people understand that now. People understand about how -- now -- but how much more, how much higher could you get versus the traditional protein-based vaccines?

Stéphane Bancel

executive
#78

That's why I think we're going to be in the 95% efficacy. I think it's going to be like...

Michael Yee

analyst
#79

Titer levels of what, hundreds?

Stéphane Bancel

executive
#80

Yes, hundreds.

Michael Yee

analyst
#81

Hundreds.

Stéphane Bancel

executive
#82

And remember, for those of you that are curious, go see back the old clinical data published over 2 vaccine of Moderna. This was old manufacturing technology, Michael. The new process is much better. This was all lipid, not the current lipid in COVID.

Michael Yee

analyst
#83

Yes. And what did you have?

Stéphane Bancel

executive
#84

So we're at the time where, we're above 40.

Michael Yee

analyst
#85

And with the old technology. So you think it'll be higher than that.

Stéphane Bancel

executive
#86

With the old technology, so I cannot wait to see the new vaccine data.

Michael Yee

analyst
#87

And if I go look at the protein-based ones, it's like 40? Or I don't know what other protein, I don't know what level. Okay. So you think that you will have much higher titer levels and that, therefore, that will translate to higher efficacy. Now do you think eventually you would need to run it? Or people would have to believe that titer levels of hundreds are better than a Sanofi flu vaccine?

Stéphane Bancel

executive
#88

No, I think what we'll do is we'll do an efficacy study just to show.

Michael Yee

analyst
#89

Like head-to-head?

Stéphane Bancel

executive
#90

Yes. I don't know whether our placebo or we'll see. We have not disclosed that. But we will, indeed, I think, get quickly to an approvable endpoint so we can get authorization with the titers, because we can on this virus. We could not with COVID. But also at the same time take a bit longer. We'll run an efficacy study so that we can prove to people that taking Moderna shot will get a very good flu shot.

Michael Yee

analyst
#91

Okay. All right. So we'll get an early read-through, higher titer levels, higher efficacy, better than protein-based flu vaccines, that's the next market we could get in June. Question, is that platform amenable to other vaccines that are available out there that many companies are selling? Ironically, if I may advertise our own conference call in 2 weeks, talking about how mRNA could pose a threat to other protein-based vaccines. What other diseases out there that are amenable that you would go after? I guess, RSV and CMV, those are the things you're talking about.

Stéphane Bancel

executive
#92

Yes. So CMV, there is no vaccine on the market. So that's a new market. But I think your question is more around existing products on the market.

Michael Yee

analyst
#93

Existing, yes, sure. Let's start with that.

Stéphane Bancel

executive
#94

Yes. So existing product, flu is an obvious one. But there is no reason that you could not do an HPV vaccine. There is no reason you couldn't do a shingles vaccine. So any of those virus vaccines, you could do. What the technology is not ready to do today is a vaccine against the bacteria. If you think about, let's say, Prevnar, today the technology is not amenable to do a Prevnar-like vaccine using mRNA. But everything else, that is a virus-based infection, the same technology...

Michael Yee

analyst
#95

Shingles is a big one. I mean, I know that's...

Stéphane Bancel

executive
#96

Well, HPV as well. I mean, I think HPV is Merck's #2 product behind KEYTRUDA. When KEYTRUDA goes off patent in '28, HPV becomes Merck's #1 product.

Michael Yee

analyst
#97

Okay. Well, I know the shingles vaccine is huge sales, too.

Stéphane Bancel

executive
#98

Yes. It's billions of dollars as well. So between flu, HPV and shingles, you take a huge chunk of the current vaccine business that is totally amenable with mRNA. Flu is the first one we're going after because we believe that combining flu with COVID with RSV made a beautiful product that a lot of people should want.

Michael Yee

analyst
#99

I don't remember on the pipeline chart. So shingles and Hep-V are, in theory, I'm sure you're working on that, that's the point. These are on the drawing boards?

Stéphane Bancel

executive
#100

We are working on a lot of things, Michael. Now that we know it's working in vaccines, trust me.

Michael Yee

analyst
#101

Absolutely.

Stéphane Bancel

executive
#102

And we have $8 billion of cash. We won't be shy to be aggressive in vaccines.

Michael Yee

analyst
#103

Okay. All right. Last question for you is CMV -- actually, you know what, let me ask you on oncology. I bet you never get a question oncology. We understand that the philosophical idea to work in infectious diseases, respiratory diseases is there. What are you doing in oncology where you -- I mean, you are testing it. What is the problem there? Is it its potency, its target? It's just tough, right? It's tough.

Stéphane Bancel

executive
#104

Yes. So in oncology, as we all know the biology is tougher versus infectious disease or rare genetic disease, where the virus is much more straightforward. Our approach in oncology is we believe that by combining some mRNA medicines to commercial checkpoints, we have no interest to do another PD-1, the market is clouded with PD-1 and more coming. But we believe that by combining mRNA approach to doing things that you cannot do over combinants, that you cannot do with a small molecule, could improve the response rate of the checkpoint monotherapy.

Michael Yee

analyst
#105

Makes sense.

Stéphane Bancel

executive
#106

And that's our approach. We have 5 drugs, not 1. We have 5 drugs in the clinic combined either KEYTRUDA or with [ Diovan ] from AZ, where the approach is exactly the same, it's can you improve the response of that checkpoint monotherapy by adding an mRNA component to basically improve the immune response of a drug.

Michael Yee

analyst
#107

Got it. All right. Well, so fine. A lot on the plate. I got to say I'm excited to see the flu data now, and you kind of fleshed out how to think about in '22 and '23, and the fact that there's only really a couple of players here left on the table. Imagine just in 12 months, and we're sitting here at last year's Jefferies Health Conference, what a different time that was. So congrats on all that progress. And the stock is doing incredibly well. It's $199 right now.

Stéphane Bancel

executive
#108

What?

Michael Yee

analyst
#109

It is. It's up 5% right now. And I just really appreciate the conversation, and congrats on all the work you've been doing. So appreciate it.

Stéphane Bancel

executive
#110

Thanks, Michael, for everything. And I can tell you, next year, there will be a lot of new stuff.

Michael Yee

analyst
#111

I look forward to it. Thank you.

Stéphane Bancel

executive
#112

Great. Thank you. Thank you.

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