BioNTech SE (BNTX) Earnings Call Transcript & Summary

All right. Good morning, everyone, and actually, good afternoon to you, Ryan. My name is Cory Kasimov, one of the senior biotech analysts at JPMorgan. And welcome to day 3 of our 10th Annual Napa Valley Biotech Forum. It is my pleasure to be here today hosting this discussion with BioNTech, one of the companies that's hopefully going to be a key reason why we're all gathered together in the actual Napa Valley next year. So we have here with us Ryan Richardson, the Chief Strategy Officer and Managing Director from BioNTech. So Ryan, thank you very much for being here. Before we get started with questions, let me just remind everybody, that you're able to contribute to this conversation using that little blue button in the portal to ask a question, and we'll work those into our conversation as we go forward. So Ryan, thanks again. I look forward to this discussion with you today.

And maybe just to kick things off -- and we'll spend some time, first of all, no surprise to anyone. I'm sure talking about COVID-19 and your vaccine and recent developments and kind of how to look at the future, but we will certainly save some time to talk about what you have going on in the rest of the company as well, especially oncology, and there is quite a bit. But maybe to start with the news this morning. Obviously, some encouraging data with BNT162 in kids aged 12 to 15. So in the grand scheme of things, like what does this mean? And maybe more so, what are the next steps to get authorization for the segment of the population?

Yes. And thanks for the invitation, Cory. It's great to be with you, even if we're not in Napa. I think -- yes, I think this is a -- it's another step towards broadening access to our vaccine. The data that we put out today is from the pivotal study and shows very strong efficacy outcomes and safety and tolerability in the 12- to 15-year-old cohort. I think we saw very high efficacy, actually 100%, in prevention of symptomatic COVID -- severe COVID. We saw very robust antibody responses in this cohort, actually more robust than the adult population. And we're going to seek to try to include this in the BLA filing that we submit, hopefully in Q2. That's the plan, for broader market approval for the vaccine. And so I think this is just one step of many to try to broaden access. We had previously gotten approval -- Emergency Use Authorization, I should say, from 16 years up. And following this step, we're going to seek to collect data and present data on in the children -- in children. And actually, that study has already started. So I think it's an important development, one of hopefully many in various different subgroups to broaden access.

And when should we expect data from kids? I mean, do you have a sense, given time lines, what you saw with the adolescents and teens?

Yes. It could be later this year, back end of this year or early next year.

Okay. And is it your expectation, like for the 12- to 15-year-old segment that this is something where you would have authorization prior to next school year and this becomes sort of like a part of the vaccine process ahead of school?

We do plan to submit this data with -- in the upcoming submission. That's the idea. So conceivably, yes. We think we could have approval already with this segment this year and even ahead of fall.

Okay. And then another kind of bigger-picture topic that we've been getting from -- a question we've been getting from folks on a bigger-picture topic is Pfizer's disclosure recently that they're going to go and develop their own messenger RNA platform as well. I guess, I mean, what are your thoughts around that? And did you have -- did BioNTech have discussions with Pfizer to kind of continue this collaboration outside of COVID?

Yes. So first of all, it's important to note we have a really good relationship with Pfizer. And actually it started before COVID. So we did a partnership to develop an mRNA vaccine for seasonal influenza back in 2018. So we had already made the commitment back then that we were going to work with Pfizer. Actually, as part of that deal, because it was our first infectious disease deal, we made the decision to really leverage their infectious disease expertise, and we actually licensed the program to them. So that was already set in motion. And we're actually looking forward to working with them on that program and getting it into the clinic here, hopefully, relatively soon, maybe next year, maybe late this year. But -- so yes, I think on COVID, it's been really a great partnership, continues to be at all levels. I mean, it's really, really a close collaboration with COVID-19. And I think the 2 companies together have been able to achieve what neither company alone could have achieved for COVID-19, both in terms of speed of development, in terms of -- certainly in terms of the number of doses we're now able to produce with manufacturing facilities on both sides of the Atlantic. And I think, long term, for us, BioNTech, the benefit of working with Pfizer is going to become even more apparent as we get into what we think will be a longer-term market and we can leverage their commercialization capability. So I think what we'll make of the statements, I think it's a testament to the fact that mRNA is going to become a big pillar of this industry. We think we're very well placed to lead in that development. I think it's great that Pfizer is going to establish a team of 50 people. Again, it speaks to that opportunity. We've got a team of over 600 in R&D, almost 2,000 in the company. And we've grown -- we've almost actually more than doubled in size over the past 2.5 years. And we're going to continue to invest to stay at the forefront. So I think it's a great partnership. And we may actually even broaden it in the future. We'll have to see how things develop.

Okay. So one of the other recent disclosure came on yesterday, it's great to hear that you can now be able to produce 2.5 billion doses of your COVID vaccine by the end of this year. I'm curious if you think using this capacity, like, to be able to actually ship those doses is dependent on kind of getting booster -- additional booster shots or approval of variant shots? Or is it just the existing vaccine enough and you think there is potentially demand out there for the full 2.5 billion?

Right. Well, so currently, we have 1.4 billion -- a little over 1.4 billion doses contracted or we have signed contracts. And we certainly see more demand even for the current vaccine. I think that's -- those discussions are ongoing with governments around the world. And that's very robust. The demand is still robust, I think, for that. I would look at the potential booster and variant demand as sort of layers on top of that. So I think what is clear is that even without the need for boosters or variant-specific vaccines, there's going to be more need for vaccines than it's currently in our order book. And I think you're seeing as well that -- we're seeing that although there are some regions that have really done well in terms of reserving a lot of capacity, but not all vaccines are seen as perfect substitutes. And I think we compare pretty favorably right now, at least in terms of the data points that we see and the interest level we see in terms of demand for the current vaccine. And we'll have to see how the picture emerges for boosters, variants. We think that it's likely that there will be a need for boosters. There may be a need for variant-specific vaccines. So of course, that would be a multiplier of the ultimate demand level. But -- and for that reason -- I'll just finish by saying, for that reason actually, we've just increased our supply capacity to 2.5 billion. And as we look to 2022, the picture is not fully clear yet, but we've already been discussing whether we might want to even go higher than that in terms of capacity. So that's something we're going to be closely watching over the course of this year.

Okay. So I have some follow-ups on some of these things you made. One though is, over the roughly 1.4 billion doses or a little bit more than 1.4 billion doses that are currently under contract to be distributed, how many of those have actually been distributed to date?

A little over 200 million doses have been distributed worldwide.

Okay. And then -- so it sounds like you think there's still upside to additional contracts. At what point does the market start to get saturated, in your view?

Yes. I think it's a good question, and it's hard to say when that will happen. We're not there yet, I think, is the message I would give you. I think we're still seeing robust demand. To date, those orders have really just been for 2021. And what we're starting to see now is just really kind of recently in the last few weeks are -- is more interested in securing doses for 2022. Some of that is maybe governments that are a little bit behind the curve in their initial orders and they're just looking to secure vaccines -- even the current vaccine. And then there's others that are looking for already kind of seeing a potential need for boosts or variant-specific vaccines who are trying to get ahead of the curve and negotiate orders for that. So we're seeing demand from both angles at the moment. Again, we haven't state -- mentioned anything publicly yet about 2022 and beyond, but we do think that there will be demand coming in for subsequent rounds, even in regions that have fairly large orders in the first round.

Okay. The current planned capacity for '22, correct me if I'm wrong, is 3 billion doses, right?

Well, what we've stated is that we want to -- we hadn't planned capacity as such for 2022. What we stated is that from the 2.5 billion target capacity for this year that we've just recently upgraded to, that we may want to have the ability to even go higher than that. And so we've alluded to the idea that we want to have the ability to flex upwards to 3 billion. That's our sort of current view. But as I stated, it's not a formal target yet. It's still too early, I think, to set a formal target. So we're going to continue to track the situation. We're going to have our first data on a booster, hopefully, over the summer. We think others will also come out with more data. So hopefully, by the summer time and as we go into late Q2, Q3, we'll have a better sense as to both the variant need and also the booster benefit.

Okay. And something you guys talked about on your earnings call yesterday, you talked about, at least to a degree, I think it would be helpful for others to hear the perspective is, I think, in a hypothetical situation, how readily adaptable your manufacturing is, whether it's to go to create a vaccine against a novel variant or strain? Like, how arduous is that process to kind of change up on the fly if it's necessary?

It's quite simple, actually. I think it's -- the process of simply producing going from one variant vaccine to another variant vaccine in terms of production across the whole install base is relatively straightforward. And that's actually one of the advantages of mRNA as a drug class. And it's one of the reasons why we think, to the extent that there will be a need for boosters, we think that mRNA vaccines, in particular, are going to be very well suited to that need. They're much better suited than some of the other modalities.

So the expectation is for a booster. For someone who's been previously vaccinated with whatever vaccine, when they get a boost, it would be a single shot, right?

We're actually going to test -- we are going to test a single first shot boost. We're also in a subset of individuals going to collect data on a fourth shot. So a third and a fourth. It's a relatively small subset of people that we're going to collect data, but we are going to already -- we've already initiated a study to do that here this year.

How much do you think -- once people have been vaccinated -- everyone who's going to be vaccinated in 2021 that gets vaccinated, as you get into subsequent years and, hopefully, the threat of COVID and just kind of like living as we're living now, dissipates, hopefully, to a great degree, but to some degree, how much do you think like people aren't going to be willing to come back in and get revaccinated again and that your vaccination rates ultimately end up along the lines, which we see like a flu shot?

Yes. I think it's a good question, and it's obviously hard to predict it from where we stand today. I think that, certainly, the recognition of this particular pathogen and this disease is off the charts in terms of historical precedent -- recent historical precedent. But what's not clear right now is, will everyone need a boost? How frequently will it be? Maybe that it's just a subset of people that really will require a boost. And maybe that even a further subset of people will require a more frequent boost based on how their immune system performs and how durable their immune system is, right? We already know that we can trace back some of the effects of COVID or at least with some of populations in which COVID really has worst -- has more severe disease. You can trace some of that back to how immune systems perform, right? We see some people's immune system just never really mounts a proper response to the virus. They get overcome very quickly. Some others, they have an immune response but it just lags COVID, and they end up with this prolonged disease. And it may be the case, well, I've to say this is a hypothesis, but that the same would be true post vaccination. Again, some people will require more frequent boosts to have a certain level of protection than others, right? So I think these are the kinds of questions that we want to elucidate in the studies that we've just initiated. And I think over the next 6 to 9 months, we'll know a lot more in terms of how to think about the population and also think about durability of protection.

Okay. I want to work in a couple of portal questions we have here. One says that the EU could really use more messenger RNA vaccines, so could the rest of the world. For this new supply that you've been talking about, what percent is for the U.S. and what percent is for Europe and rest of the world?

Well, the current 1.4 billion doses that have been confirmed that we reported yesterday, 500 million -- so it's actually the largest chunk of those set in for the EU. And we also have 300 million in confirmed orders for the U.S. And then the rest is the rest of the world. We have a couple of other large orders in there, like Japan, we have 144 million doses confirmed. And then the rest is spread out actually over 60 different countries and regions that we're already distributing to. And some that we haven't yet distributed to that we planned to do -- or we plan to do. So it's broad. We're trying to go very broad with distribution. We're going to continue to do that. I do think we'd love to send more doses to the developing world and actually trying to -- we're trying to figure out how to do that. And I do think that, in the next round of contracts, I do think there will be further contracts, some of those will be developing world contracts.

Okay. And then another question from the portal is while it's easy to switch production, what will you do with all the supply for the nonvariant vaccine?

What will we do with the supply? So we're kind of -- we're producing this and then shipping it out kind of in continuous fashion, rather than stockpiling it. So right now, demand exceeds supply, right? So we just can't produce enough, fast enough to satisfy demand. So I don't foresee any massive stockpiling problem. So far, the data points -- the evidence that we have suggests that current vaccine is protective against the variants that have been highlighted and reported. We don't have the full picture of that yet, but we have various bits of analysis and some publications now for the U.K. variant, for example, where we're pretty confident that we have protection with the current vaccine. So I don't -- it's something we'll just -- we'll continue to monitor. And I mentioned that we are going to initiate -- we actually have initiated now studies to look at the South African variant in particular in the human population to develop -- so we have a South African variant vaccine. But because we can switch the production so quickly, I mean, really, we're talking in question a couple of weeks here from a technical perspective, I don't see a huge risk of having massive stockpiles of vaccines that are no longer relevant.

Okay. So I want to follow up on that vaccine, BNT162b2 assay, complicated way of saying the South African variant vaccine. You're evaluating this as both a booster as well as a 2-shot regimen for somebody who's vaccine naive, I guess. What are the anticipated time lines here, best guess, in terms of generating immunogenicity data for that variant vaccine? And then what would the next steps look like for required studies to get to Emergency Use Authorization?

Yes. So we expect to have first data already over the course of the summer, so a couple of months essentially for further safety and immunogenicity data. In terms of the regulatory pathway, we can't say definitively at the moment. So that's something we're still working through with the regulators. We're in discussions with FDA, with EMA, with the U.K. regulator, to try to work out a pathway, right? And I think various regulators have already put out guidance. FDA has put out guidance, EMA has put out guidance. And it's largely consistent. Like, so it kind of spills out a pathway that looks something like a bridge study to the market, relying on safety and immunogenicity, in a relatively small number of patients. So nothing like a 40,000-subject Phase III trial that we just conducted. So that's our current base-case assumption. But I think the important thing really is that we can get that pathway established soon and the fact to support not just the South African variant that we've taken into the study, but any potential variant. Because I think it's a bigger question than just South African. There haven't been any one particular variant. I think, given how widespread this virus is, we think it's likely we're going to have new variants that pose challenges that develop immunoescape mechanisms that are reported in the relatively near future. And so having that pathway in place will allow us to start additional studies very rapidly, hopefully, the bridge version I just described, so that we can bring new vaccines to market in rapid fashion.

Okay. Look, I think I speak for everybody, when I say everyone is very grateful for everything that BioNTech and Pfizer and Moderna, companies like that have done in terms of tackling this pandemic. I think, from a pure investment point of view, one of the big debates and what people are trying to figure out is what is the opportunity for COVID-19 longer term? How sustainable is it? And what are your views on that right now?

So we think there's going to be a market long term. I think it's really hard to estimate the size of that market right now. And so we think that there's going to be a market because the virus is so widespread. It's -- not everyone is going to get vaccinated. And it's so contagious, right? So we think it's going to continue to be -- to pop up and outbreaks for years, again that's highly likely. And we think there's going to be a prolonged interest over years to be prepared for it, to vaccinate the next generation against it, even after the adult population is vaccinated we think. That's why the children -- the adolescent and, ultimately, children will become an important market for this vaccine. And then I think when you get into the question of boosters, how frequently will boosters be required, how widespread, certainly, the variant question. Those are just kind of layers on top, right? And the variant question, in particular, we think, is more like -- that's more of a near- to medium-term driver. With the booster question, obviously being more of a -- that's a longer-term question, right? So how frequent do we need to boost? If you get a third boost, for example, would you -- could you then -- would you need a vaccine every 12 months, every 24, every 5 years, not need one after the third? But we would expect that, after a third dose, you would have a really strong prolonged immune response. And that's just basic immunology, but we'll have to see, right? So that's hard -- sorry, a long-winded answer, I think a way of saying we don't know what the long-term opportunity is, but we do think there will be one. And that's why we're going to conduct so many studies and collect a lot of data.

No. I think it's a very -- actually a very helpful answer and provides good perspective. Another clear lever in all this is, when you think about the number of vaccines that are out there, both at company level with yours and Moderna's and Johnson & Johnson and Novavax, and who knows what happens with AstraZeneca, who knows what happens with like Sanofi vac. So with these many vaccines in play, plus increasing production, like how do you think about pricing trends in future years? And it sounds like -- and to build on that question and not to layer too much onto this, but it sounds like you're already negotiating 2022 contracts. So safe to say that prices probably hold a bit more in '22? And then if there's a decline, it would be after that? Or do you think prices could actually go up?

We're starting from a really low base on pricing. So I think we're starting from a point that is just orders of magnitude below what a normal price would -- what a typical market price would be for an innovative vaccine, and it reflects the situation we're in, right? Of course. And so I think our view on the pricing is, yes, of course, over the -- in the future, there's certainly upside to what is an extremely low price, right? But we also accept that this is not going to be a normal market for a long time, if that work. And -- so I think somewhere in between is where we see the likely scenario. But given we're starting from such a low base, we do think there will be some upside. Hard to predict when that kicks in. It could be medium term. It could be relatively near term. Maybe it's a longer-term increases once -- I think once we're out of the pandemic, certainly, I think there's more room for that. Our focus has been and in the near term will continue to be on volume. And that's one of the reasons we entered into 2 collaborations in the very beginning. And we recognized this is going to be about volume-driven market. We were not going to be able to service that volume on our own. And I think that early, I think, has positioned us very well, right, with what we think is just a really strong profile for our vaccine. And so we're going to focus on volume in the near term. And if there's -- to the extent that there's pricing upside as we -- as the volumes decline, that could compensate, right, I'd say, from a top line perspective. But there's going to be a peak here, and then there's going to be a decline, and there's going to be some stabilization. That's how we see this coming up.

Okay. I mean -- and I certainly appreciate the point on starting from a very low base, but also following up on the other point you made, it's not a normal market. If we're looking at between you, Moderna and Novavax alone, it could be 6 billion, 7 billion doses in the market next year. And when you think about the global population, I just -- that's the part I think where people are trying to piece all of this together and figure out where we go with this. Can you talk a little bit, I think, as we think near term, your guidance yesterday and some of the key assumptions that went into that?

Yes. On the cost side or on the revenue side?

The revenue side more than anything. Yes.

Okay. Yes. Okay. So yes. So the -- so what we said yesterday was we did 2 things. Number one is that we just gave -- we tried to give a picture for what we think from a revenue perspective, if we can deliver the 1.4 billion doses that have been contracted, what we think that, that means for BioNTech's top line next year. And we wanted to do that also to clarify because we have these gross profit sharing arrangements with Pfizer and Fosun, and so we wanted to provide a little more transparency around what we see as an opportunity if we can deliver that vaccine. At the same time, we also raised our target capacity for the year from 2 billion to 2.5 billion doses. So obviously, there's a gap there between the target capacity and the contracted amount currently. I mentioned that the contracting processes are still ongoing in many different countries. And so we do expect there'd be more contracts. But just on the EUR 9.8 billion figure that we put out represents our expected revenue from, again, supplying the 1.4 billion doses that are currently contracted. And that comes in a couple of forms, right? So that comes in direct sales, there's a couple of regions, like Germany, where we have sales force now, where we're booking revenue directly. That also comes from revenue from sales of product to our partners, right? And this is more of a sort of [indiscernible] internal accounting metric, but we need to report it anyway. So it's also on the P&L. And then the big bucket really is for our share of gross profit that we booked, right? And so what that means is that, that EUR 9.8 billion is an estimate, is a blended number that would account in part for what our share of gross profit that we would expect to receive from those signed contracts.

Okay. All right. That makes sense. I want to go back to the topic of the boosting. And we discussed it some -- or Ugur discussed it yesterday on the call a little bit. But your base expectation around how frequently people might need to get boosted at this point, you said just a moment ago, it's kind of an unknown. It's a question you need to answer. Do you think the clarity on this front will come as we start hitting the 1-year vaccination anniversary for those initial volunteers who got into your studies and that will accelerate, of course, over the course of this year? Or do you think these answers are going to be driven more by the added clinical work you're doing?

Yes. I think it's a combination of both. It's probably those 2 things, and it's also probably going to be driven by as to a consensus around -- that comes in from the mountain of work that's going on to -- against COVID, just research work and publications to establish quality protection, right? And then there's already some early data on that that clearly show links to or correlations to antibody titer levels, right, as we mentioned yesterday. And so we think the picture will become much more clear. But already, the early indicators to us suggest that there's likely to be a benefit from a third dose. And we don't know if -- again, we don't know if that's at 6 months, if we don't know if that's at 12 months, but it could -- and we don't know how broad that will be, but we already see some early indicators that suggest it could be 6 to 9 months for some people that there could be a benefit in terms of increased protection. Yes. And it might be that it's not just a simple what's protected -- when are you protected and when you're not, but kind of a curve, right, like a sloping curve, that there might be an opportunity to increase protection dramatically, significantly by reboosting, right? And that's then a trade-off -- if that is true, that's going to trade-off that the public health experts and the regulators are going to have to assess in terms of when it makes sense to go ahead and do that. Again, is it for at-risk populations? Is it more broadly? Is it for people that they just have some indicators that suggest their immune system -- the titer levels are low. Is it more broad-based than that? And I think those are the questions that still have to be answered. But we think -- again, we think it's very likely that there will be a benefit of some protective benefit for -- with the subsequent boost.

Okay. So I guess along those lines, and you've kind of alluded to this a little bit, but how close are you and regulators, the FDA or other regulators, with respect to determining optimal correlates of protection when it comes to trial design? So let's say, like, what do you need to show with respect to neutralizing titers that could be suitable as a surrogate endpoint to get boosters or variant vaccines approved in an expeditious fashion?

Yes. It's a great question. And I don't think we have the answer yet in terms of the biomarkers, right? I don't think we have the answer yet in terms of antibody titer level per se. But I think what we do see, Cory, is that -- in some of the more recent data, we do see differences in terms of actual protection against disease, right? I think Ugur mentioned it yesterday, one of the things that we're particularly focused on is actually protection against infection itself, right? And so evidence of protection against infection, we think, could be a very meaningful thing to look at, especially as long as the pandemic is still ongoing.

Okay. So one thing that sets -- potentially sets BioNTech apart from some of the other vaccine players in the COVID space is access to the China market via your collaboration with Fosun. How do you think about China? How important is that market from a -- when you plan out kind of the rollout of your vaccine on a global basis?

Yes. So we've actually -- again, maybe just real quick in terms of where we are in China. So we have conducted 2 studies in China. We have -- the first was with our b1 candidate. We actually had initiated it before we selected b2. So we did a Phase I study. And now in November, we started a Phase II bridging study for the b2 candidate. And that data is now being collected actually. And we are in the process of submitting for approval in China currently. So we think it could be a significant opportunity. I mean, it's not been factored into our guidance. We don't have a signed contract as such where we have a commitment to purchase the vaccine yet from China. So I think the Chinese market is likely to operate a little bit differently here in the sense that we expect there to be a provincial tendering market and then a private market in China. There, of course, are locally produced vaccines, and those are already being distributed. But as you pointed out, some of our peers have not initiated trials like we have done in the Chinese market. So we think it could be -- it offers real upside for BioNTech. And we're working very closely with Fosun to try to open up that market and deliver our vaccine in large quantities, right? Initially, that would be out of Europe, right? So we have capacity in Europe that we could utilize to set up to send fairly large volumes. Actually, we've committed to 100 million doses. We've committed to close to 100 million -- to send 100 million doses plus if the market is there for that. So we'll have to see how it develops. It's a bit of a different regulatory regime there, but have a really strong emphasis on safety, especially for new modalities. They've been very thorough in their review, and we've basically been working with them continuously now for a while and trying to satisfy their request and hopefully, more to come.

Okay. All right. Great. Look, in our last 10 minutes or so, I want to make sure we cover other aspects of the business. Happy to take other questions via the portal if people have follow-ups on COVID. But as we transition over -- before we get into oncology, to follow up on infectious disease, and I do have an investor question as well. But first, when you think about the success you've had in developing BNT162 in infectious disease and what we've seen some other companies do with mRNA going after infectious disease, how aggressively might BioNTech pivot to pursue this as a key vertical going forward?

We see it as one of our core areas going forward. So I think immuno-oncology clearly is a core area. We have 13 different oncology programs in the clinic today and 14 different trials. And we see infectious disease as sort of the second pillar, right? And we currently have 9 preclinical programs active in infectious disease at BioNTech, along with our partners. So we're also collaborating with The Gates Foundation in infectious disease. We're collaborating with the University of Pennsylvania. And of course, we mentioned Pfizer. So 3 different collaborators. And so I think you're going to see us accelerate our effort in infectious disease. And we're going to look to take more programs into the clinic in the coming years.

Okay. So another portal question that's on this subject. If you don't work with Pfizer on flu, would that be so BioNTech can go it alone? Or would you be interested in finding another strategic partner?

Well, so we're partner with [ Pfizer ] on flu. So that deal has been done, and that's the current arrangement. But like I said, we have 8 other infectious disease areas -- infection disease programs, I should say, outside flu and COVID that are not partnered with Pfizer currently. And so we'll make that decision in terms of how we proceed with those indications on a case-by-case basis, I think. And I think Pfizer is a -- the strategic relationship with Pfizer is an asset for us. We see it as such. They bring tremendous capability to bear, I think -- and it's a great partnership. But we also want to build our own BioNTech company. And we actually want to build our own large global company and build our capabilities alongside our partners. And this partnering model is actually not new. And Pfizer is -- it's obviously the -- our COVID partner, but we have 7 other partners, pharma partners. And in oncology, we leverage partnerships. And we do a similar sort of 50-50 arrangement with a number of them, where we share development costs, we make joint development decisions, but we have a right to commercialize. And actually, if you look at our pipeline today, even where we've partnered, we have a mixture of partner programs and wholly owned assets, mostly wholly owned majority, but there's still some partnered programs as well. But even where we've partnered, we have a right to commercialize in the major markets, like the U.S. and Europe, right, in oncology. So that's the way -- that's the model we've employed to go so broad. And we leverage our partners' capability, right, in development. And eventually, we can do something in commercialization. So I think it's a unique model and it's worked well for us, both with COVID and in oncology. And I think, going forward, I think we're going to have even more flexibility than we've had in the past to choose whether to go alone, right, or to leverage our partners' capability or technology.

Okay. All right. Great. So I guess it's not surprising. But lost in the hyperfocus on COVID is the progress that you guys are making on the oncology front. So maybe to set the stage, we're talking about this in the last, like, 5 to 8 minutes we have here, when it comes to the various candidates you have, so we're not going to get through all of them, is there any one you're particularly excited about, given either the approach, the target or preliminary data you've established? Can you pick one out at this point? Or is it still just more the breadth of it?

I'll pick one. I'll pick one for you. So I'd say CARVac, right, which is our CAR-T program, which we're combining with an mRNA vaccine that encodes the same antigen. And it's -- I mentioned it, number one, because we just started the Phase I trial. And we could already have the data by the end of this year. And this is a CAR-T program against solid tumors, right? So in the past, CAR-Ts work well against some lipid tumors. It's not worked very well against solid tumors. And with this approach, we're really trying to address 2 main obstacles. One is the antigen itself, so we're targeting a novel antigen called CLDN6, came out of our own research, and -- which is highly expressed in cancer tissue, not expressed at all in healthy tissue, right? It's expressed actually in a range of different cancers. So ovarian cancer, it's highly expressed; testicular cancer; about 10% of lung cancers and some others. And so that's novel. The second aspect is actually the persistence challenge is particularly acute in solid tumors, right? So if CAR-T cells don't interact with antigen, they can readily exhaust. And it renders the treatment -- it makes it more difficult to actually have an impact on growing tumors if that happens quickly. So what we can do with this RNA lipoplex technology that we use, which is similar to our FixVac cancer vaccine is by encoding the same antigen of the CAR-T cells of targeting, we can actually amplify them in vivo, which we've done some in the animal models -- in the animal side. This is going to be the first study to evaluate whether we can do that in humans. And we think that could be particularly powerful because it will give us the ability potentially to lower the dose upfront in the CAR-T cells, reduce CRS and toxicities, generally, and then be able to modulate the response or modulate the activity of the CAR-T cells in vivo. And where we want to go with this in vivo cell therapy, and we think that's the -- there's a huge opportunity ahead in that space. And this is one of the several programs and technology areas that we're working on towards that end. This is the first. And so if the data is -- we'll see how this works in humans. We're very -- we think it's really innovative science, combines different aspects of -- combines -- takes our mRNA platform and combines it with the cell therapy approach. And it does work well. In this instance, we think it's an approach that could have a fairly broad platform impact because you could use it -- we think you could use it across different antigen targets for CAR-T therapy.

Okay. Yes, it sounds super cool. So I'm glad you gave that overview of it. I did want to ask, yesterday, you mentioned in your call, the discontinuation of BNT122 in high-risk early-stage non-small cell lung cancer. Can you elaborate on the rationale there? I mean, you alluded to a combination of the pandemic, but also the evolving landscape in lung cancer. Is there any read-through to your other programs with that decision?

No, I don't think so. I think iNeST, which is our individualized cancer vaccine, we still believe has tremendous promise in the adjuvant setting in early-stage cancers. And we really do believe that the ability to target neoantigens in a specific way to harness the patient's own immune system to create really strong T-cell response is that -- that there's a large opportunity in treating a range of cancer with that approach. So it's an important tool in our toolkit, and we're going to continue to study it this year in adjuvant CRC, but most likely in other indications as well going forward. We're still looking at that. So I think this was a particular decision, right, that we made that relates to the highly competitive NSCLC market. I'd also point out we're continuing to improve iNeST, right? So the neoantigen selection algorithms that we use are still improving over the past year. After the acquisition of Neon, we rationalized their models and our models. And actually, we've improved it overall using sort of the benefits from both approaches. So this is a modality that's going to continue to get better over time. And I wouldn't read too much into that particular decision for the rest of the pipeline. It really was a specific decision based on where iNeST is right now and based on the NSCLC adjuvant marketplace.

Okay. Great. And we're down to the last couple of minutes, but I definitely wanted to ask you about your bispecific programs with Genmab. So maybe if you can just set the stage for what we could see this year for BNT311 and 312. What would you view as sort of encouraging data on the next updates we get that would warrant further development and advancement of these programs?

Sure. Right. So 311 and 312, these are 2 bispecific antibodies that -- so the 311 is targeting -- it's a PD-L1x4-1BB. 312 is CD40 4-1BB. We see these both as next-generation checkpoint immunomodulators, with potential across a range of different tumors. We've reported some early data already for BNT311 last year at SITC. We reported early dose expansion data with this bispecific and also a handful of patients. We had 12 patients in the CPI experience in a CLC expansion cohort. Early data, but we already showed responses in checkpoint experience patients, which we thought was very encouraging, especially given this is only a couple of months of data follow-up time. And so this year, the plan is to provide a much broader data set. We've now initiated -- in the process of initiating over 7 expansion cohorts in different tumor types. And in the second half of this year, we'll provide an update on 312. This is the PD-L1x4-1BB. So more mature and much broader data. The CD40 molecule, we haven't yet provided data. So this will be the first data update from that bispecific. And again, here, it's similar concept, similar trial design, it's a basket study. It's a little bit smaller study. This will be a data update also in the second half of the year. And what we're looking for in both cases, right, is we're looking for, of course, safety and tolerability, but we're also looking for evidence of tumor -- antitumor activity. And we've shown that already with the PD-L1 molecule. And so I think a positive outcome here for the CD40 molecule would be signs of activity, including in checkpoint refractory patients. That would be the first instance. So -- or the first signal that would be -- that could merit moving into expansion cohorts.

Okay. All right. Terrific. Well, we are just -- we are out of time. But before we close, I want to ask your favorite Napa wine, what are you going to be buying for everybody next year when we're all in Napa together?

So I'm a big fan of the [indiscernible] 2013. It's one of my favorites. And haven't had it for a while, but I would recommend it.

Perfect. Well, hopefully, we can get there with you sometime soon. So Ryan, thank you very much for taking the time and for all you guys are doing for all of us right now. So really appreciate it. And I look forward to speaking to you again soon.

All right. Thanks, Cory.

All right. Take care.