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

Hi, everyone. It's great to see you all on Friday of the conference. I'm Courtney Breen, I'm the U.S. biopharma analyst here at Bernstein. I am privileged today to be sharing the stage with Stephane Bancel, the CEO of Moderna. Stephane has been at the helm of Moderna for the last 13 years. It's been a period of great change and growth for Moderna, and we are thrilled to have him join us for this fireside. We will first kick off with a bit of a talk from Stephane, some slides that he's prepared, and then we'll dive into Q&A. To make sure that this Q&A is as relevant to this audience as possible, please feel free to post additional questions through the pigeon hole, I'll be making sure to check that so that we can make sure that we're answering as many of your questions as possible. But with that, I'll hand over to you, Stephane, and look forward to the conversation.

Thank you so much. Good morning, everybody, and thank you so much for being here on Friday, we really appreciate it. We, of course, will be making forward-looking statements and you can find those on our website or SEC website. As all of you know by now, because of what happened during COVID, we started building Moderna 15 years ago, it is like yesterday on this very interesting premise that we could potentially move medicine into digital medicine because mRNA is an information molecule. I think it's the most profound and important thing about the whole presentation. So if you think about small molecule and large molecule, which I had a chance to learn when I worked at Lilly, [ those aren't ] medicine. You have to relearn in a clinic everything every time, you have to really know how to make the molecule and to build factories for the molecule. With mRNA, if we could make mRNA work, mRNA is the software of life. You send mRNA to the cells, like many of you got a COVID shot and your own cells make a protein, in that case, the spike protein, and then your body does the rest of the job. And that's the notion that was so profoundly new that made me decide to join Moderna. And if you think about what this could do and that's a bit -- we thought about it and what I was asked earlier this morning, why did you decide to resign as the CEO of BioMérieux to go and join Moderna with $2 million in the bank and 1 scientist in the Flagship office or VC, it's because actually of this slide, which is actually the most useful slide I've seen and used for the last 13 years, is we thought if a molecule worked, we will be able to do a lot of drugs that are not doable using recombinant or small molecule. We could do secreted protein, like what biotech and pharma does, we could do transmembrane protein, proteins that are stuck at the surface of a cell is where they need to be to do the biological effect you want. We could do protein inside the cells, which we've done so far. We have in the clinic drugs working with clinical outcome where we change the protein inside mitochondria of patients. So that's why it was really exciting. What we could do for patients because 2/3 of the protein coded in your DNA are protein that are not secreted, meaning they're undruggable using biotechnology. The second piece that was very exciting to me was a notion that we should have a much higher probability of technical success of our drugs versus the industry. Why? First, we code protein that exist in nature, either in your DNA or in viruses. If you think about most small molecule that do not exist in nature, which is why most molecule, you put in a human and you have tox issues. And in our case, the chemistry, the chemicals we put in your body for every product for the mRNA molecule will be 100% the same. When we did the RSV Phase III, not one day as CEO I worried about the safety of RSV vaccine. Why? It's exactly the same chemistry as a COVID vaccine that has been given to billions of people. So that's another piece about the amount of technology that made me think a lot, geez, we could have a technology with very different profile of the safety of the drugs. The third piece that excited me is, what we could do for patients and creating value for investors by going faster. I think for COVID, I don't have to make the point anymore. But because it's a platform, because it's always the same manufacturing process, you don't have to reinvent it every time, and you can scale very quickly because you just change one raw material, overall materials are the same between drug 1, drug 2 and drug 3. That's really the power of this technology. And the icing on the cake, massive capital efficiency because it's all synthetic manufacturing processes, no live cells. So because of that and because mRNA is the information, we say we have to be the platform company that has never really been built before us in biotech. Why? Because we say it will be 0 drug because we'll go out of cash before the first drug can generate cash and we'll go bankrupt, all these companies that will have a lot of drugs. The notion this will be a one drug company made zero scientific sense. So we build from Day 1 for scale saying, how do you do tens and tens and tens of medicines. So with massive investment in science to really be the best technology company in the world, massive manufacturing investment, IT, robotics, and now a lot of investment in AI. We just spoke about probability of technical success. I got to go very fast. You see in blue on the left graph, the industry average of a probability of a drug to be successful in Phase I, Phase II and Phase III. And you see in red, the probability of the Moderna portfolio so far. And we've counted all the drugs, including the drugs we designed that will never move to the next stage. For example, we did a Zika vaccine with H7 Avian flu vaccine years ago. We never wanted to take it to Phase II, so we count as a failure in Phase I in this path because we wanted to be consistent with method used in the [ blues ] because you only get positive if you move to the next stage of the study. We're investing a lot in R&D. And we're now at the scale of our investment that looks like an [ Amgen ] type of investments. We have a very strong pipeline, 28 vaccines, 16 programs in therapeutics like oncology, rare disease. If you look at the vaccines, they address a very large TAM, respiratory vaccine, flu, COVID, RSV and [ others ], it's around $27 billion, $30 billion of TAM and the latent virus, those virus like HPV, like VZV shingles, like HIV that are in your body and once in your body are in your body forever. Of course, a massive long-term health issue, EBV and MS -- EBV and mononucleosis, EBV and cancer, recently more data CMV and cancer. And those virus are very complicated, cannot be done using protein, and we think mRNA is a very important answer for that. In terms of the therapeutics, if you think about the TAM and we talk about cancer, I'm sure, especially ASCO starting this weekend in Chicago, we think we have a technology that is quite unique to be able to individualize the treatment to every person, to amplify the response of a checkpoints like KEYTRUDA. And then rare disease, we think the TAM is north of $10 billion with what we're doing in the liver today. So as I said, because we always thought about building a platform company that can enable all those drugs and maximize impact on patients, maximizing value as a consequence, we built a platform company, we invested a lot in the beginnings in IT. So the company has been cloud-enabled since day 1. We've never had a [ server ] in the company's history. We have invested a lot in our quality of our data, which became very handy when machine learning pre-COVID started deeply in the company in science. We've been doing machine learning since 2016. I mean, of course, now with GPTs, we are doing machine learning everywhere. And also in robotics, we are doing a lot in robotics, and we are doing a lot around 3D printing to be able to accelerate our development. So you see this being applied across the business. We have a lot of examples, I'm happy to talk about them if you're interested. If you look at the pipeline in the last couple of slides, we have up to 15 drugs to launch in the next 5 years. That is an incredible opportunity to impact patients and to create value. And you see that kind of 2 waves of products in front of you across the board. So now we're really known as the vaccine company. I believe we're going to become the biggest vaccine company in the world in that time frame just because of the number of products we have. If you look at the number of products we have in late-stage development in vaccine, it is more than the rest of the industry combined. And those are amazing investments. We invest well in the Phase III study for vaccines, and then you have an annuity of, say, for decades to come. So I think it's a really amazing opportunity. There's a lot of milestones. I won't go through even the whole slide. We should have RSV approved this month, and I know we're at towards the end of the month, so I'm waiting for any news from FDA. We're waiting for the flu plus COVID Phase III data, and we say this should come this quarter. And if it's positive, which I believe it should be because of what we showed in the Phase II and now we have COVID, flu, RSV and the next-gen COVID also positive Phase III, we should be able to potentially have a product available in the market flu plus COVID single dose as early as fall of '25 because you could file late summer, early fall for a voucher, get this for the June 2025 ACIP meeting and get this for the fall season. The CMV Phase III data, our first latent product with 6 mRNA in each vial, which is why pharma has all failed to do a CMV vaccine, they all failed in Phase II, 6 mRNA each vial, we'll have Phase III data in second half of the year. With cancer, I cannot say how excited we are about the data. We think we should be able to file for accelerated approval next year and the rare disease in the liver. Those are the financials you can read that yourself, and I propose to move into questions.

Thank you so much, Stephane. You mentioned a little bit about the premise of where Moderna began and that is built on mRNA and kind of the potential. You then had the catalyst of COVID that really shot you to a revenue-generating company. And now you're at the point of launching a number of respiratory vaccines and this ambition to bring another 15 over the next few years. As you look 10 more years into the future, what does this going to like to you then?

Well, 10 years is a long time. So I mean you we just started 14 years ago. So I think if you look 10 years out, as I said, we will be the largest vaccine company in the world because we have more than 200 viruses that hurt human, 200, we have vaccine against 20 of those. So it's a great opportunity to do more vaccines and then to combine them because, of course, we don't want to have 200 shots. But if you think about vaccines preventing cancer, numbers are all over the place. We believe at Moderna that up to 50% of cancers are caused by viruses. And the latent virus I talked about are the cause of it. Why? Because having a virus in your cells for a long time, it's not good because of inflammation, and we know what the inflammation does over time. And so we think that between going after the respiratory franchise and the latent franchise of vaccines, you could have a largest vaccine company in the world. I think in cancer, we're going to end up being larger than KEYTRUDA in terms of sales because we're going to be able to improve KEYTRUDA everywhere where KEYTRUDA works. The safety profile is the same as KEYTRUDA alone. So if you have a better efficacy for the same tox profile, as you can imagine, the doctors and the patients will be very, very interested. We are seeing our Phase III study is enrolling super-fast. We spoke to some of our doctors and they are telling us they are putting everybody on the study because its high efficacy, 1 in 2 people respond to the drug and seems to have cured from the cancer, and the safety profile is the same with that what they're going to give them anyway, which is KEYTRUDA and it's a clinical trial, it's free and it's like it's not a very hard decision to make in terms of risk/reward trade-off. But I believe we're going to be able to go earlier in disease. As we know, checkpoints are not given in Stage 1 or Stage 2 because of the tox profile that they have. When those drug works, very amazing. But they come with a very heavy tox profile as we know because of the mechanism of the drug. But think about the world in which you could go after Stage I or II cancer with just INT. It's the same chemistry as your COVID shot. So think about the world where you could have potentially a liquid biopsy, which is, I think a technology that is not Moderna related, but it's happening as we speak, and it's improving as we speak. Think about a world where you could have an annual checkup with a liquid biopsy, cancer caught early because you don't have it last year. We make an INT for you and because we don't need KEYTRUDA, I can send to the pharmacy because it's just an intramuscular. And you need maybe 4, 5 shots. Now it's 9 shots, but we have clinical data showing that 4 shots might be enough, but of course, we're going to launch with the 9 shots as a protocol, but we're going to go in the real world, try to reduce that literally. So think about the world where you do an annual blood work and then you get an INT, maybe 3, 4, 5 doses at our local pharmacy, with QR code you show and you have exactly the product for you sent to the pharmacy and next to your home. This is [ untouchable ] by checkpoint. We should as society take cancer to which -- this should become a disease -- as we improve the technology, our understanding of cancer, it should become a disease that most people don't die from.

That's very exciting to hear. And I'm going to build on just one of the points that you made and asked the question because scaling is really important and scaling is tough when you have an individualized asset like an INT. So tell me a little bit about kind of how this future that you just laid out in terms of early stage treatment in cancer might be possible given your platform?

Sure. So I spoke in my intro that because we have a platform, all the products are made in the same reactors, with the same material, all but INT. So these made by the same people, in the same room -- same reactor with same material as COVID and some will be for flu and some will be for rare disease and so on. The only exception is INT because it's individualized. So if you think about it, I don't need big reactors, I need microliter. And so it's all about shrinking. The good news because our manufacturing process is cell free that it's all synthetic, it's all enzymatic, the more you shrink things, the faster the reaction goes because things are just closer to each other. And so if you think about it, the manufacturing process we used for the Phase II study, the one I'm going to give an update at ASCO on Monday was basically a 5-day cycle time on the machine that looks like a big American fridge for the mRNA just to make the mRNA then you put the lipid and then you put in a bag. The MRNA was 5 days. In the new plant we're building in Marlborough, which is a Gen 2 of that technology, it's one day. And it's a much smaller footprint. What we're going to do for the scale of this opportunity to individualize product is to shrink the footprint because in a given room I can put many more machines. If you can shrink the footprint and I can shrink the time I need for one person on that machine, I can increase the throughput tremendously. If you think about it in a Phase II, we are working 5 days a week, and we [indiscernible] one patient a week. Now it's 7 days a week and night, and I need only day, one working day, so I can -- basically, I have 14x simplification just by those 2 things, and we have plenty more examples of things like that, that we're doing. So what a lot of about it is, there's no silver bullet and purely an engineering manufacturing product. So the risk is very, very low. Not everything might be working. I think the current brick wall as I call it internally is around 20 days of needle biopsy to needle first dose. The Phase II was 90 days, we're currently at 60 days. I have a very strong line of sight to around 30 days that I think it will happen by the time we launch, which, as I said, could be next year if we get accelerated approval by the FDA. I think the brick wall right now is around 20 days based on known technology, but we are working internally and with our partners, all our suppliers to invent the future, which is can you go even lower than 20. But today, I have no line of sight less than 20 day, but we're going to keep trying.

Fantastic. So we've touched on some science already, some manufacturing, some engineering. And I think there's also a really big other decision you've made in the last kind of 18 months or so where, in many ways, Moderna is at a point where it's about a commercial show me story. And so you have taken this decision to not only play the CEO role, but also play the Chief Commercial Officer role in delivering on that show me of delivering revenue generation and a competitive commercial market. Tell me a little bit about that decision? Why you took it and how on earth you're doing both of those very simultaneously?

Good. So I took it because we were building commercial and it was being built the pharma way. It's not that pharma does not do things right, it is just that they are not running a platform. The use of technology was also a bit old school at pharma, it was not Moderna. And as I reflected on it, it became very clear that we've done, mostly team has done an amazing job, build a platform from an idea of a drug to animal data to Phase II data, we need to still show the world and with allergy and flu and few approvals coming, I think the skeptics will see in the couple of years that we'll have a lot of products approved. So I think we've done a really good job. We're still improving. It's not finished, and we're always going to keep raising the bar by building an amazing machine for what I call generating assets. I think Moderna has -- and if you get another [indiscernible], and you come visit us, as I should say, there's always open invitation, please see the host Lavina but I think once you get into our factory and you see how we do research, how we do manufacturing with scale, how we do 3D printing to go faster to develop processes, you get a sense about the platform we're building. And our AI, and we're very lucky, again, I should say we're lucky with the cloud because when we build the company, the cloud was just starting, and we build the whole company on the cloud and scale with the cloud. And now we're scaling the company in a big way and GPT's coming, we've just been lucky on the timing With more than 1,000 GPTs already we trained in the company and going up by the day. But the observation I had is, we need to build a commercial machine, I need to build a commercial platform, and it was not being built with a platform mindset. And we tried and we tried and tried to coach and tried to coach and it was not going fast enough. And so I came to the conclusion just before Christmas that the best use of my time in the next number of years was to lead personally the build of the commercial platform because as Stephen Hoge who is the president of the company and has been my partner since early days reflected on that every time we are to build the rest of the company because we started as a research company, we're a research company for 4 years in that we are running research. And then we build manufacturing, and I was very involved because of my background at Lilly and I'm engineer by training, and I worked at factories at Lilly. And then we build together the clinical development team, which he really led and I helped him. We realized that he and I have our sleeves up here to build all those things and to rebuild them and rebuild them. And every time we give a piece to somebody coming from industry to build a replica of what they've seen and experienced. And I think it's interesting that Stephen comes from McKinsey and I gave him research after trying 2 chief scientific officers coming from industry that were giving me a pharma-type science and he's been amazing with the science, [indiscernible] development. And so and Stephen, it's really -- because now manufacturing is really strong and standing with amazing head of manufacturing, but I'm still coaching and raising the bar, and Stephen is running R&D. And so that's part of the asset generation platform and machine that we have. I'm keeping an eye on raising the bar, but I have amazing leaders and it has been mostly built. So we're talking about last 10% of the tail to build there. But on commercial, most of the heavy lifting is ahead of us, and we just need to do it the Moderna way and we're just going to have to sweat it. And so to your second part of your question, how am I doing the both jobs, well, is I have a great team, I didn't go to the JPMorgan conference. It's the first time in 20-plus years. I think Jamie, our CFO, he did a presentation with Lavina, we have a great team. I told them guys I need to go and build the U.S. commercial team, and I didn't get on the plane for JPMorgan. Stephen, as I said, is really running the asset generation machine. [ Jay ], our Head of Manufacturing, he's amazing at raising the bar in manufacturing and he is building the INT. We actually had more than a leader who run the COVID scaleup during the pandemic. We sent him on a 1-month sabbatical when we got the Phase III data of INT. I told him your next climbing of the Everest is called cancer and he's going to have 18 months to build the cancer plan from scratch and he's doing an amazing job. So we have a lot of great people, so I've just realigned my job, as you know, because I have an amazing head of HR as well. So having the team and not doing things like a silly example will give you a sense. There was an industry meeting in Greece for all the CEOs of industry in April, and I was invited like every year, and it's an event I'm not going. You guys deal with industry matter, thank you very much. I'm going to stay behind and I'm going to build the commercial organization. So I've just reprioritize-ed my time very differently because I already believe the most important thing I can do over the next few years is to build an amazing Moderna like commercial engine because I need to catch all the drugs that Stephen is throwing at me.

Absolutely, hopefully [indiscernible] coming. As you think about that commercial machine and kind of this first test, which we will be RSV. What are some of the components that will be critical to deliver on? And particularly when you think about the RSV opportunity, how are you using the effort that you have in hand to run against kind of the opportunity ahead?

Sure. So if you think about it, another innovation that we're bringing in RSV is the prefilled syringe. As you know, the Pfizer product has 9-step of lyophilization process to prepare [indiscernible] steps , you clean your arm, you just do a needle, you inject it, you put a Band-Aid and that's the innovation that's important in a world where there is a lack of labor in pharmacies. You see CVS, who's got a couple of pharmacies recently, last year during the peak COVID season, which is very busy in pharmacy because you have flu and COVID and now RSV vaccine on top of the GLP-1 and Lipitor and everything else. And unlike Walmart store, unlike an Amazon warehouse in the [indiscernible] season, you cannot hire people because you need qualification, it's a regulated business. And a lot of pharmacies are coming easily. And so I think that innovation is going to help a lot. We are hearing it from pharmacies, we're hearing it from independent pharmacists, we're hearing it from hospital network, CEOs and CMOs, I think that's going to be an important feature and then the ability to bundle. And then in '25, I would say, to retrieve a combo. So we're going to start to be a player that has also the ability to bundle products. We don't have the ability when you have one product like COVID and the other guys can bundle their products in the retail channel. But I'm going to start to have this ability a little bit in '24, a lot in '25. I think those are the type of things that's going to help us, and how do we build customer intimacy? We are right now spending a lot of time with the big retailers to think about, okay, how do we help reduce your waste because in a vaccine -- in our business, it's industry practice, I didn't have a season, you return your waste to the manufacturer [indiscernible] network because the products are obviously obsolete, you will use different products next season. But I don't know if you like to spend time returning your Amazon purchases I don't because I mean for pharmacist because to be reimbursed for the product, you have to make sure there is no vial broken that the box is not damaged and then you have to put the bar code and the package and send it back, nobody likes to do it. But we're building EDI networks between us and pharmacy chains so that they can tell us every store based on usage by store what type of product they want, and we're going to manage that for them, so we're putting those in place. We are looking at the size of the box. Why? Because when you go and sweat the details in pharmacy, you realize that which space is really important. And when you have [indiscernible] box like this, which is a Pfizer box size and Moderna box is much smaller that's another advantage that's you have. I'm actually now working with the team, okay, how do we have for, maybe tail of the season or smaller doctor's office or independent pharmacies a smaller box. So we are when I work for COVID and RSV and then flu products, it's a smaller prefilled syringe box. And so there's a lot of things like that, that we're just sweating with the customers, with hospital network is how do we help them educate the doctors. So we're renting a lot of medical content, working directly with CMOs of all the big hospital network. So we're just trying to create that intimacy with the customers to sweat every detail that there is no detail more enough if it matters for us. We change even how we read bar code and the type of information it contained because by spending time in the pharmacy, we realized during the season that after scanning the bar code on one of our product, we have to put information by hand. That's insane. So let's get rid of that because I want the pharmacists when they reorder in the stores they want [indiscernible] on our products because we're an easier to give the consumer that walks into the pharmacy than any other product.

Makes a lot of sense. And you make reference upfront that we're at the 31st of May, and there's obviously a decision coming from the FDA and they're doing work at the moment. Can you speak a little bit about kind of the efficacy, the duration response and kind of any signals you can give on kind of when we might hear from the FDA?

So the FDA is really in their hands, I don't know because I'm not online, Lavina is online and it's last day of May. So all -- I mean we've stopped having questions from FDA a while ago, which is a good sign at the end of the process, every time I've done this thing. When you still have questions and back and forth which is not a good sign that you are converging and closing. So I think we're just running all the processes of approval and so on. If you look at the products, I think it's really hard at this stage because there's no head to head study to be clear, how the different products performing in humans at scale. What we believe is important and there's an important ACIP CDC meeting at the end of June, which is why having the approval before the ACIP meeting is key for us to make decision obviously. CDC cares about having a product that is in your arm. And so if you look at it, it's very rare that CDC recommends a product. It has happened some time but when they have a large set of data showing that the product drastically drives difference in hospitalization. If you look even at COVID, it's interesting between our product and Pfizer, there's no recommendation. If you look at the data, even published by the U.S. government like VA ran a massive study in a real world, showing very different hospitalization rate between the Moderna vaccine and the Pfizer vaccine in millions of people, much less of patients with Moderna, which is not surprising because Moderna dose is 2x the Pfizer dose. So you make twice as much antibody, it's going to last longer. It's just simple biology. But we still have not made recommendation because they don't want to drive worry by the public or the medical professionals. And so what we need from ACIP in June is pretty simple is we need to be recommended for vaccination [indiscernible] I think it will take a year or 2 before there's enough real-world evidence to get a good sense for safety, efficacy and durability on the different vaccines. As you know, flu vaccines were done in different seasons. Pfizer and GSK got a little bit lucky because as we are doing the study, then Omicron happened and everybody went back home, without mask and if you look number of [indiscernible], it just drops, of course, on drug or placebo, there was no cases and your efficacy looks amazing when there's no cases. And so I think we're just going to have to wait. I think on the safety, we might end up having a massive advantage on the Guillain-Barré syndrome. As you know, in our Phase III study, there is no reported case of Guillain-Barré. It was twice the size of the GSK or Pfizer studies. But more importantly, if you look at COVID going back to the platform, if you look at COVID, there is no Guillain-Barré syndrome. If you look at the Pfizer cases reported by the CDC at the February ACIP meeting, they were around 3x higher than GSK. So I don't know about your parents, but for my parents, I would rather them be on the GSK vaccine than on the Pfizer vaccine because, again, we don't really know for efficacy at this stage. But we know for safety, 3x in case of -- even though it's a rare event, as you know, Guillain-Barré is a very, very bad side effect to get. And we believe we might have a case where with Moderna, you might not get Guillain-Barré syndrome on the Moderna platform. That would be a massive differentiator. Again, it will take a year or 2 for the CDC to report at the national level all the safety data. But in year or 2 we might have a nice upside that. In that case, we might get to recommendation because of safety actually. Because those things are just too early to tell, but I kind of like our chances.

Fantastic. That's really helpful to understand. I do want to make sure we get to oncology because of ASCO, but I'm going to take 1 pivot before we get there. And I know there have been some questions that have come through a pigeon hole on this, and it's a highly topical event at the moment. We're seeing your stock price moving a bunch recently in response to the bird flu kind of scenarios that might play out. And yesterday, there were reports on a potential collaboration with the U.S. government in advancing a vaccine candidate. I'll ask you to share what you can on that, I would be sill not to. But I also want to ask you to share, perhaps, what you learned from COVID that might be guiding the way you're thinking about this opportunity differently? And also, as you think about the mRNA platform, may that change over the long term the approach to stockpiling when it comes to these kinds of things because of the rapid nature of an mRNA platform.

All right. Those are all great questions. So let me talk about the virus for a minute. As you know, the medical and public health leaders have been worried for the 28 years I've been in infectious disease about avian flu. When COVID started, I was made aware of the first cases in China between Christmas and New Year in 2019. I assume it was an avian flu that is how my brain was brainwashed for 28 years. And so we, at Moderna started to be worried the first half of 2023 because we had to see in so many countries, in so many mammals species, including wild animals, farm animals, the H5 strain circulating everywhere. And as we know and for all of those that have spent whole carriers in infectious disease that people that are close to animals get infected. And I'm not worried in terms of avian flu that people are directly working close to animals getting infected like what is being reported like in the eye or whatever. I'm not worried about that. What I'm worried a lot about right now, and I have no data is do somebody working close to animals who is immunocompromised because they have HIV because they have cancer because they have some type of diseases has been growing the virus in their body, having a chance -- the virus having a chance to mutate. It's unknowable. It might be 0 cases of people working like this around the world, it might be thousands, I have no idea, I have no data. And the day I'm going to start to worry is if there are cases of somebody not working on the farm reporting flu like symptom of coughing and of fever because it would have come from a human-to-human transmission. And because you will probably a bit like if you look at COVID, it seems we've been cases of COVID as early as October 2019 circulating in China. And that's what I would start to really worry about. So because of the animal situation that I described, last year, in the first half, we decided with the team that it was wise to get an H5 vaccine into the clinic. We started a large Phase I/II study that has been since then on clinicaltrials.gov, nobody looked at it, we didn't advertise it because there was no need to worry anybody for it. We were in a large Phase I/II study where we are looking at those because humans would be naive to a virus, so it is not surprising, you needed a higher dose than a seasonal flu booster, which as we know, we have Phase III data on, much higher dose. And so we need to figure out what is that dose with our mRNA platform, which is the goal of a Phase I. And with the Phase II inside the Phase I by giving a big enough [ n ] to participants for every dose, so that's why we have enough safety database moves right into a Phase III, which we have done many times now with our platform. And the idea was let's get the data so that if something bad happens, we know the dose and COVID timelines to your last question, it will put us in the June 2020 time frame when the issue starts. So think if we had known the dose of COVID on our platform in January 2020, that will have moved the launch 6 months, right, plus because it's flu the FDA believes that there is surrogate points for approval, which is the level of antibodies. That's what they use every year. So the Phase III will be much shorter, basically 29 days post dosing. The study will be smaller. So could I see a 3 more Phase III studies start to finish, I do. So they've been reported and in HHS I made some comments that they're in discussions with us. We potentially work together for a Phase III study of H5. That study, as I said, could be completed in as short as 3 months. So if we were to start it sooner, when we get the dose from Phase I/II, you could see the study completed late summer/early fall. And the other piece of the learning from COVID is the manufacturing capacity, which when COVID happened, we have made 100,000 doses in 2019. And I walked into the office of manufacturing at the time and say how do we make 1 billion doses next year. And if you look at me, it's funny like you realize it's 10,000x more, like you're wasting time, how do we make a billion doses next. And they made 850 million doses. So pretty good or crazy target that I literally picked up [indiscernible]. And so but now it's very different. We have massive scale. We have a plant in Canada that I visited 2 months ago that is almost ready, we have a plant in the U.K. that is being built, we have plant in Australia. So we have big difference, it is not only in the how quickly we can get H5 vaccine approved by FDA, maybe a few months from start of problems versus a year, which was already amazing. And unlike for COVID where we only shipped 20 million doses, the [ saddest ] day for me in 2020 is the day we shipped the product. It was a day after it got approved on the Friday night by FDA, Saturday morning we shipped to CDC, we shipped only 20 million doses because we worked 1 year to make 20 million doses. So now we could literally make 20 million doses in a month. So if you think about a few months, as you do your Phase III [indiscernible] risk if the government want to stop stockpiling. You could have 2 dose for every American by the time you launch your product, but a few months after you start to have first cases of trouble the thing about the world could look so different, we'll be talking about an April launch of a vaccine, if I go back to the 2020 time line that we are all too familiar with, we have doses for everybody. We look quite different. So that's why we're doing all the things we are doing. It's impossible to put a probability on it. It was going to be 0 or 100. And I don't know which one, but I'm preparing for a 100.