Earnings Labs

Moderna, Inc. (MRNA)

Q4 2020 Earnings Call· Thu, Feb 25, 2021

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Transcript

Operator

Operator

Good morning, and welcome to Moderna's Fourth Quarter 2020 Conference Call. [Operator Instructions]. At this time, I would like to turn the call over to Lavina Talukdar, Head of Investor Relations at Moderna. Please proceed.

Lavina Talukdar

Analyst

Thank you, operator. Good morning, everyone, and thank you for joining us on today's call to discuss Moderna's fourth quarter and full year 2020 financial results and business update. You can access the press release issued this morning as well as the slides that we'll be reviewing by going to the Investors section of our website. On today's call are Stéphane Bancel, our CEO; David Meline, our CFO; Stephen Hoge, our President; and Tal Zaks, our Chief Medical Officer. Before we begin, please note that this conference call will include forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Please see Slide 2 of the accompanying presentation and our SEC filings for important risk factors that could cause our actual performance and results to differ materially from those expressed or implied in these forward-looking statements. We undertake no obligation to update or revise the information provided on this call as a result of new information or future results or developments. On Slide 3, please see the important indication and safety information for our COVID-19 vaccine, which has been authorized for emergency use in the United States and many other countries around the world. With that, I will now turn the call over to Stéphane. Stéphane Bancel: Thank you, Lavina. Good morning, or good afternoon, everyone. I hope all of you and your loved ones are in good health. Thank you for taking the time to join our Q4 2020 call. For the call, we propose to start first by looking back to fiscal year 2020 and then looking to fiscal year 2021. For fiscal year 2020, I will share a few slides to summarize the key elements of the year, before David shares with you the 2020 financials and also how…

David Meline

Analyst

Okay. Thank you, Stéphane. Before reviewing the financial section of the slide deck, I want to comment on the approach we've taken sharing this information. This starts with the 3 Cs, these being clear, complete and comprehensible. Today, we are presenting our results primarily on a U.S. GAAP basis. And in individual item level, in some cases, we also provide additional detail to provide greater clarity on underlying trends and to facilitate period-over-period comparisons in line with our 3C goal. Reflecting the continued uncertainties related to the course of the evolving pandemic, along with the many challenges and opportunities we face as a newly globalizing commercial company, we also seek to avoid implying an unrealistic level of precision concerning future financial projections in the face of a range of outcomes. With this background, we are providing today the analysis of actual 2020 results, along with a view of key drivers of the financial framework going forward. We will continue to update and refine this information as business evolves. Turning to Slide 10. I want to briefly remind you about some key accounting changes which we presented on this slide in our Q3 call in October. As a result of the successful transition to a commercial company, following the emergency use authorization by the FDA and Health Canada in December 2020, we began to record product sales. We also began to capitalize inventory based on the expectation these costs would be recoverable through commercialization of our COVID-19 vaccine as opposed to expensing costs directly to R&D in the period incurred. And we also began to capitalize purchases of property and equipment and long-term lease assets as opposed to expensing costs in the period incurred through the lack of alternative use. With this context, let me turn now to Slide 11. Total…

Stephen Hoge

Analyst

Thank you, Stéphane, and good morning, everyone. Today, I want to take you through our current thinking on variance and our strategy to address them. I'll then turn it over to Tal to provide an update on our pipeline. Let me start with a quick overview of our strategy for SARS-CoV-2 variance of concern. Last week, we published a letter in The New England Journal of Medicine with data that confirmed the Moderna COVID-19 vaccine, mRNA-1273, provides neutralizing activity against all variants of concern tested to date. Nonetheless, as recent reports have increased transmission and potential reinfections of the new variants have emerged, out of an abundance of caution, we have announced multiple strategies to try to increase protection against those variants. As has been widely reported, the immune response generated by original strains appears to be relatively weaker against the B.1.351 variant. If or when immunity wanes in the future, this might lead to a gap in protection. We plan to close this potential gap with an update to our vaccine based on the new strains. We anticipate different approaches for 2 distinct populations. For those who have been immunized or infected by the original strains, we anticipate boosting with a variant-specific booster vaccine, either alone or in combination with our vaccine against the ancestral strains. For those who are still naive to SARS-CoV-2 because they have not been previously infected or vaccinated, we anticipate updating our vaccine to provide immunity to both the ancestral strains and the new variants of concern. Now on Slide 25, you can see the clinical trials that are ongoing or planned for our COVID-19 vaccines. For mRNA-1273, the TeenCOVE Phase II/III study in adolescents ages 12 to 17 years is ongoing and recently completed enrollment. The KidCOVE study, Phase II, in pediatric populations…

Tal Zaks

Analyst

Thank you, Stephen. So let me briefly summarize where we are in the rest of our pipeline. We have 4 other vaccine programs that are in clinical trials. The CMV vaccine is on track to start the pivotal Phase III this year. The Zika vaccine is preparing for a Phase II trial that is also expected to begin in this year. And our hMPV/PIV3 vaccine is currently enrolling in toddlers. Our RSV vaccine is being studied in 2 separate trials, 1 in children and 1 in adults. The pediatric trial is enrolling quickly, and the first 3 cohorts in the age de-escalation study have now been fully enrolled. We announced last month that we were taking our RSV vaccine into the adult population, and I'm happy to share that the first participant has since then been dosed in that trial. Just last month, we announced 3 new development programs in infectious disease vaccines. Our influenza vaccine program will evaluate 3 candidates comprising multiple antigen combinations against the 4 seasonal viruses recommended by the WHO, eventually moving 1 candidate into a Phase III trial. Our HIV vaccine program has 2 approaches. mRNA-1644 is a collaboration with IAVI and the Bill and Melinda Gates foundation. It's a novel approach to an HIV vaccine strategy that's designed to elicit broadly neutralizing HIV-1 antibodies. mRNA-1574 is a collaboration with the NIH, and this includes multiple native-like trimer antigens. And finally, for those unfamiliar with the Nipah virus, this is a zoonotic virus transmitted to humans from animals, that is either transmitted in food or through direct human-to-human transmission. It is included in the WHO R&D blueprint list of epidemic threats needed for urgent R&D action. mRNA-1215 is a collaboration with the NIH to develop a Nipah vaccine. We also have 7 clinical proof-of-concept trials…

Operator

Operator

[Operator Instructions]. Your first question comes from the line of Matthew Harrison with Morgan Stanley.

Matthew Harrison

Analyst

I guess, first question, can you discuss the dosing strategy around boosting. And in particular, I think I understand why you're going to start with 50 micrograms, but what you think about the probability of using a lower dose there. And then just secondly, as far as I understand, I think the number of doses that have been signed via APA are higher than the 700 million that you've talked about in terms of manufacturing supply. Can you just talk about what your thoughts are in being able to deliver those additional doses this year?

Tal Zaks

Analyst

Go ahead, Stephen.

Stephen Hoge

Analyst

I'll take the - I'll try and take the first one and then hand it over to Tal as well. And then I think David will obviously take the second. The - so first on 50 micrograms, I'd remind you of a couple of things. So in this case, this is a third dose of a booster. And so I think we're quite optimistic that a substantially lower dose is necessary because the immune system has already been primed and boosted once. And this is just maturing and updating that immune response to new variant. And I'll note that we've shared our Phase II data, which does show that we see at 50 micrograms, even in a primary series, really good neutralizing antibodies. And so I think we're quite optimistic that 50 micrograms or lower will suffice as the third dose booster.

Tal Zaks

Analyst

This is Tal. The only thing I'd add is that, that has scientific precedence. There's been data. I, believe we had already a vaccine that was published a while ago that showed that if you come in months later, you can come in with a much lower dose and that is sufficient to provide a boost. So in the context of wanting to maximize the ability to provide a benefit from whatever given capacity, I think that strategy makes sense. On top of which, as Stephen alluded to, it could be that even 50 micrograms as a priming series could suffice. Recall that our dose at 100 supersedes what you see with natural infection in terms of neutralizing antibodies to begin with. Stéphane Bancel: Thanks, Tal, and Stephen. On the second question, Matthew, as you know, we have been cautious about talking about supply for the year, and we have raised the number as we have understood better the learning curve of the process, as we've had the lots made and being able to see the demonstrated output. I think it's important to always appreciate this is a new technology we have never made and nobody in the world has made at that scale so fast. And so it's important for people to understand, we invested and built the manufacturing capacity, the ability to make 1 billion doses. The piece, having worked myself in manufacturing at commercial scale, and of course, you know Juan Andres, who runs manufacturing - used to run manufacturing for Novartis worldwide, there are so many unknown at this stage that as we learn more, we are upgrading our numbers. As you know, last year, early in the process, we said we feel comfortable we'll get at least 500 million doses of the 1 billion of infrastructure capacity. Then we raised it to 600. With what we have seen out of the U.S. supply chain, the - as you know, Europe is around 3 months behind the U.S. because of when we started building it. We did not have a Norwood-like site in Europe, as you know. We feel good about what's happening in the U.S. The team are doing really a remarkable job. And so we feel comfortable today to up what we call our base case. We feel very comfortable that we will deliver 700 million doses. The team is working extremely hard to get to 1 billion doses. They know that every extra dose we can get out of Moderna supply chain will be used and will help protect people. So you have our full commitment to do everything we can to get as close as we can to 1 billion. But at this stage, what we're saying is we feel very comfortable we can deliver 700 million, base plan. And we are still working through the upside, and I will not bet against the Moderna team to be able to do better. But at this stage, 700 million is the base.

Operator

Operator

Your next question comes from the line of Ted Tenthoff with Piper Sandler.

Edward Tenthoff

Analyst · Piper Sandler.

And just incredible progress over the course of the year. And David, thanks for all the clarity on the quarterly update. I'm wondering, with respect to the $200 million that was booked in the fourth quarter, what is the number of vaccines that is ascribed to that? And then if I may, will we be getting any data from the triplet oncology IO program this year?

David Meline

Analyst · Piper Sandler.

Yes. So the $200 million of revenue was associated with the deliveries that we made to the government in the fourth quarter in the U.S., which was around $17 million.

Tal Zaks

Analyst · Piper Sandler.

And Ted, this is Tal. As it relates to the triplet, I hope so. Data in oncology is a function of when we see responses. And so once we see them and we confirm them, then, of course, that becomes material information that we share. So it's hard to predict, but I would focus on it.

Edward Tenthoff

Analyst · Piper Sandler.

Brilliant. And Tal, wishing you all the best. Thanks for all the hard work.

Operator

Operator

Our next question comes from the line of Salveen Richter with Goldman Sachs.

Salveen Richter

Analyst · Goldman Sachs.

And Tal, I want to second that. Good luck with the path ahead, and you will be missed here. So with regard to variance, which of the 3 approaches for COVID on the four do you think will be optimal here? And do you have updated thoughts on the correlate of protection or trial design? And then separately, should we expect your pricing strategy for 2022 to be in line with 2021? You did mention options. So I'm just curious how we should think about that.

Stephen Hoge

Analyst · Goldman Sachs.

Thank you, Salveen. I'll try and take the first part of that for those questions. So as far as what's optimal, I think we have to run the clinical experiment to know, and that's why you see us taking the 3 approaches. It is entirely possible, maybe even desirable, that 1273 as a third dose is able to boost immunity above a level that would be necessary to provide long-term protection against the new strains. But if you look forward and say at some point in the future, we're going to be perhaps in a regular boosting environment, what would be the ideal vaccine, it seems logical that a vaccine that provides the broadest immunity, so not just against ancestral strains or a boost against the new strains would perhaps be the best mode. And that's where I think the blended approach, so 1273.211 as we announced today might ultimately be the right long-term product. But in the near term, we got to run the clinical experiments to get the answer. Stéphane Bancel: Thanks, Stephen. And on the pricing question, Salveen, at this stage, we have not disclosed any information on pricing. The piece that I can share as just color is, as you know, we have a high efficacy vaccine. Governments understand the ability that we have to move fast on variants. And of course, they care deeply about that ability versus other technologies and other companies. And so in due course, as the 2021 year progress, we'll be sharing more color on the pricing strategy for 2022 when for both of the prime series as well as the variant. It might be the same, it might not be the same. So we'll discuss that in due course. Thank you.

Tal Zaks

Analyst · Goldman Sachs.

And Salveen, this is Tal. Thanks for your kind note. And I wanted to answer your question about the correlate. I think that work continues. It's being primary led by NIH who have access to all our samples as well as the other BARDA funded trials. The current assumption is that we should be able to move even without a correlate, and that is consistent with the recent FDA guidance on the development of a variant vaccine. I think if there does emerge a correlative protection, it will make everybody's life easier, especially those coming up in our footsteps in terms of licensing new vaccines. But I think also, for us, the ability to peg the dose level will be substantially made easier with that. So we continue to work towards that goal. We'll see in the coming months whether when one emerges.

Operator

Operator

Your next question comes from the line of Michael Yee with Jefferies.

Michael Yee

Analyst · Jefferies.

Again, congrats on all the progress. Two questions. One is a variant timing, manufacturing question and one is a competitor question. I guess based on what you described today, can you just kind of walk through the timing of how to develop and what would be needed to get a variant vaccine approved and when you would be able to flip the switch to start making that? That's just question 1 for variant. And then related to that, maybe for Tal, before we let you go, maybe you could comment about how you think about variant vaccines for mRNA versus adeno, particularly with multiple streams in there? How do you think about comparing and contrasting?

Stephen Hoge

Analyst · Jefferies.

So maybe I'll take the first part of it and then hand over to Tal for the second. I think the - so first, on how quickly we think this goes. We've already, I think, demonstrated that we can pretty quickly produce a new batch. And if you look back to when we announced that we started manufacturing, it might be even faster than last year. We do think the clinical program for testing this is pretty straightforward based on the recent FDA guidance and other public comments. It's likely to be in the hundreds of people and immunogenicity and safety as important endpoints there. But ultimately, that will be subject to discussions with the FDA. And so we think we could get to clinical data here relatively quickly. That will be able to demonstrate the potential for a booster vaccine to close a potential gap in immunity. As far as production, that will depend a lot on the demand picture and possibly that data. But as Stéphane noted, our manufacturing systems, really, we believe we could almost copy and paste the new information into those manufacturing systems and proceed very quickly to be updating our vaccine or produce a booster. Tal, do you want to take the second part of that?

Tal Zaks

Analyst · Jefferies.

Yes. That's a softball. Look, the mRNA, the beauty of the mRNA technology is the fact that the immune system doesn't recognize the LMPs per se. It only recognizes the protein that we teach the body to make. And so I believe that our vaccine platform is optimally suited to boost, irrespective of what primary series somebody got, whether it was a protein mRNA or, frankly, an adeno vector. I think the challenge with the adeno vector is for both the initial boost and certainly any work with variants down the road is going to be that the adeno vectors generate significant immunity against the other components of the adenovirus and thus, have the risk of limiting the ability to translate the transgene. And therefore, if you look at the boosting delta, that is how much additional antibody levels do you get from a boost, with adeno vectors, you can get a boost, but the magnitude of that boost is invariably less than the magnitude of the boost you get with an mRNA platform. And that is true just in the first boost. I suspect that if you needed to come with a third dose or a fourth dose or variant-specific vaccines, it would be challenging to get the requisite amount of specific immune recognition towards the new transgene.

Operator

Operator

Your next question comes from the line of Gena Wang with Barclays.

Huidong Wang

Analyst · Barclays.

Tal, good luck with your next journey. It's a big shoe to fill, and you will certainly be missed here. I have two questions regarding the variance and also next-generation COVID vaccine 1283. So for 1283, is it shorter sequence that make freezer storage feasible? And also with the sequence outside of RM sequence - RBM multi sequence? And then the second part of the question is the COVE II variant for the NIH study. I wondering if you can give a little bit more color regarding type of subjects you will enroll, whether it's a vaccine-naive or experienced subjects and also the booster timing.

Stephen Hoge

Analyst · Barclays.

Thank you for the questions, Gena. I'll take the first part of that and then hand it over to Tal to answer the NIH component. So in terms of the mRNA-1283, it is correct. It is - the fact that it is a shorter mRNA does help with the long-term stability and does facilitate, we think, moving that into a refrigerated vaccine. It's not the only feature. As you'll know, we've had advantages on our mRNA platform based on our long history of working in it, for instance, that we're functioning right now already, as has been noted, in a normal freezer for up to 6 months and actually already doing 30 days with mRNA-1273 in a refrigerator post stalling. And so it's a benefit that we're already well on that path, even with just 1273. I think the second part of your question was, is it just the RBM, and 1283 covers both the RBD and the end terminal domain. And as has been widely reported, those are particularly important for neutralizing activity in the immune system against SARS-CoV-2 virus.

Tal Zaks

Analyst · Barclays.

Thanks, Stephen. Gena, thank you for your kind comments. The NIH, I'll defer to my colleagues there to describe their trial in the coming weeks once they launch it. But in essence, the answer is both. They will have arms there that will be testing the new variant vaccine as a boost in those who have been previously immunized on their Phase I trial. And then there will be a component that will test the new vaccine in a primary series.

Operator

Operator

Your next question comes from the line of Cory Kasimov with JPMorgan.

Cory Kasimov

Analyst · JPMorgan.

And all the best to Tal, although it's good to know we'll have you for a couple more quarters. So two questions for me as well. Look, I realize there's not much you can say on pricing beyond 2021. But as we think about your booster strategies that could be less frequent at lower doses as well as the greater supply of vaccines we should have on the market, balanced against the potential waning of the pandemic, are there scenarios where the price per dose could be either materially higher or lower than what we're looking at in 2021? And then my second question is from a modeling standpoint. Should we be assuming anything in the model above and beyond what was talked about today that could be owed to the U.S. government for the initial co-development of your COVID vaccine? Or is that what David was referring to with the royalties that are included as part of your cost of sales? And if so, should we just be assuming a generally stable rate going forward? Are those changed at all? Stéphane Bancel: So there's a lot to unpack here. Let me start maybe on pricing. So it's quite interesting because, as you know, this is public information, there are some vaccines that have been made available to governments at $3 per dose. And as you know, we walked you through our pricing strategy back, I think, in August, on the Q2 call. The Moderna vaccine is priced much higher. And I think it comes down to a few things. And the most important one is efficacy. Governments care about saving lives. Governments care about getting the economies back on their feet. And so what we're hearing from governments, literally almost on a daily basis as we engage with our…

David Meline

Analyst · JPMorgan.

Okay. Maybe then I'd comment on the question about cost of sales. So Cory, what I did try to say early on was that we don't have precision in all cases. In the case of cost of sales, I would say there are puts and takes that we're monitoring, but we gave you the 20%, because we feel confident that, that's the right range, right zone that we're in. And yes, as we move through time, there's going to be more information as we ramp up our factory capabilities and answer some of the other questions. But I think you're good for now with that modeling assumption.

Operator

Operator

Your next question comes from the line of Geoff Meacham with Bank of America.

Geoffrey Meacham

Analyst · Bank of America.

Also I wanted to offer up best wishes to Tal. A question on manufacturing investments, I guess, for Stéphane. So I guess I'll focus on variance with the booster. And clearly, you guys have to fund many assets progressing in the pipeline. But how flexible are your manufacturing investments? I guess the question is, as the cases globally continue to decline, is there a way to scale back some of that capacity should lower volumes become the norm? Stéphane Bancel: Those are great questions. So in terms of the flexibility, as I described in my remarks, the only raw material that is different from let's say mRNA-1273 to mRNA-1273.351 is only the plasmid. The enzymes are the same, the lipid is the same, with the same equipment in the same rooms with the same people. So the flexibility of this technology is really incredible for people that have worked with recombinant, like I used to do at Lilly. And as you know, I trained as a biochemical engineer, doing neutrophil and E. coli production in bioreactors. It is literally, you come a week after we use disposable reactors, you get new consumable plastic bags and so on as your reactor. And here you go again, you just need to change - take a different plasmid. Because we use disposable reactors and not stainless steel reactors you don't have to spend a lot of time doing cleaning, validation because we basically dispose of things. And so the flexibility is quite incredible. You just need a new plasmid. And so because - so it's not a very expensive part of the cost of the total cost of the finished product that is filled in a vial, because you have to make the mRNA, you have to formulate it and you have to…

Operator

Operator

Your next question comes from the line of Hartaj Singh with Oppenheimer & Co.

Hartaj Singh

Analyst · Oppenheimer & Co.

Great. And Tal, I wish you the very best in your future endeavors. The question I have is, we're hearing more and more about some constraints in the raw materials that go into making vaccines, plasmids, things as simple as pipettes, et cetera. Can you just give us some color and visibility on where Moderna is with its partners, Lonza and others, in this regard to 2021 and 2022 supply? And then could that be a rate-limiting step as you think about other modalities? Stéphane Bancel: Thanks. So as we've said all along, which is why we gave a range and not one number for expected supply in the year, I think one number is a very dangerous strategy. As we said, those type of consumables are, of course, important. We are in a regulated business, and we cannot start to make a product until we have all the components, all the raw material, the entire train team and so on and so forth. So we have a lot of - like in an airplane, you have to check a lot of things before you can start the engine. Well, in GMP manufacturing, you have to do the same to ensure the quality and the safety of the product. And so, well, I think the team has done a very good job last year. And as you recall, we started racing against this virus in very early January. And it's in the late January time frame that we started to say, geez, this could turn into a pandemic. And we started to think bigger. And so, one, the team and I spent quite a lot of time as we were starting to think about, okay, how do we go - if we had to make 1 billion doses in '21,…

Operator

Operator

Our next question comes from the line of Simon Baker with Redburn.

Simon Baker

Analyst · Redburn.

Two, if I may, please. Firstly, just going back to cost of goods sold. You've helpfully given us the 20% figure for 2021. But presumably, there will be some degree of variation through quarters. So would it be fair to assume that you will be exiting the year at a figure lower than 20%? And I just wonder if you could give us some color on if that would be meaningfully below 20%. And then moving away from COVID to CMV. You've said that the peak sales potential for the CMV vaccine could be around $2 billion to $5 billion per year. It would seem that HPV is a pretty good road map for the potential in that space and set against that, $2 billion to $5 billion looks quite conservative. So I was just wondering if I'm missing something in that analogy or whether that $2 billion to $5 billion is out of an abundance of caution?

David Meline

Analyst · Redburn.

Yes. Maybe I'll take the first one. On the cost of goods, percent of sales, our advice right now is to assume that's pretty stable through the year, including as we exit the year. So I would recommend you model it consistently. There will be some ups and downs. And the ups and downs are more related to the mix of business and the price levels of the product that necessarily changes in the cost of the produced product. And hence, given that, we get out towards the year-end, we don't have complete visibility on precisely what the book of business and mix will look like of sales, hence, some uncertainty around the precise percentage number. But again, I would advise just treating it as a constant for now. And then as we get better information, we'll give that to you as we move through the year. Stéphane Bancel: Thank you, David. So let me take the CMV question. So a few bit of colors on the $2 billion to $5 billion annual peak sale estimate that we talked about now a while ago. We talked about that as a company that never had run a Phase III at the time, that had never launched a product or get a product approved at the time, that had 0 commercial employee at the time. So we did the analysis with an outside commercial consulting company and with our strategy team and the team here that many of us have commercial experience. So we tend to be cautious, because as a new company we want to make sure that we build credibility and credibility in life has to be earned. And so I will just make the analogy to manufacturing in the sense, we built 1 billion of capacity, and we are very upfront to the financial community about it last year when we did so. But we said, look, given the unknown on raw material supply, given the unknown on yield, we feel comfortable we should get at least 500 million doses out. And then as we learned more, we moved to 600. And as we learned more, we moved it yesterday to 700 million. So do I believe it is possible as we're going to sell more than 5 billion of CMV? Yes, I believe it's possible because it's an incredible unmet medical need. As the world develops, I think the piece one has to be careful about peak sales is peak sales when peak sales slightly up [indiscernible] peak sales 25 years after launch because those vaccines are like annuity-like products. There's, of course, inflation. There's, of course, developing countries that are becoming richer and richer. So is there upside to the number? I believe there's upside to the number. But that's our number right now as a company.

Operator

Operator

Our next question comes from the line of Mani Foroohar with SVB Leerink.

Mani Foroohar

Analyst · SVB Leerink.

Tal, looking forward to chatting with you later on today in our fireside chat, and excited to hear at some point what your next adventure is going to be. A quick and sort of boring financial question. As we - as you guys are pretty clearly going to transition to profitability, cash flow positivity on a - at least in the near term, very durable basis, when would you consider changing your current treatment of your NOL allowances? How would that - how would you communicate that? How would that flow through how you communicate your financials from a modeling perspective? And then secondarily, and maybe scientifically, more interestingly, how do you interpret the data suggesting that at least for the adenoviral approach from J&J, but also from your own data and the other mRNA vaccine, that titers appear to improve over time and cellular immunity improves over time and the gap in efficacy against the so-called South African variance and the ancestral Wuhan variant seems to close. That would suggest to me, the 1273 should have similar efficacy versus the South African and the Wuhan variance. Am I interpreting it the same way you are? Or am I missing something?

David Meline

Analyst · SVB Leerink.

Yes. So maybe I'll cover the first one. On the tax rate, as I said, what happens is we're carrying this net operating loss with a full valuation reserve right now against the deferred tax asset that comes with it. So that will, of course, get released as we start generating pretax income. And it's likely based on the current book of business that we would consume during the year the entire loss carryforward. So that's point one. Point two is from an accounting perspective, what happens is you basically project the full year tax rate, including the consumption of that deferred tax asset. And then you start accounting quarter-by-quarter based on that average of the full year rate. So it actually, from an accounting perspective, doesn't matter, the timing of the release of the NOL, the deferred tax asset and the valuation reserve. So that's why I tried to be clear with the mid-teen percentage, including in Q1, because from an accounting perspective, it will - it would be stable unless we have some other changes that caused the full year rate to change as we move forward. Hopefully, that's clear.

Mani Foroohar

Analyst · SVB Leerink.

That's clear. I misstated my question. I actually meant versus severe disease mortality in terms of the similarity and efficacy alone. I thought of a longer-term follow-up.

Stephen Hoge

Analyst · SVB Leerink.

Sure. Yes. So thank you for that question. So let me take a stab at it. I think we're - as you noted, I mean, we had nearly or essentially 100% of efficacy against severe disease, 94% against moderate or any disease. And I think that gives us great optimism about the current 1273 vaccine that's been authorized is protecting and even if the new strains are slightly more virulent, that we'll be in good shape. I think the question, though, is at some point, you would expect coronavirus immunity to wane. And that's because in all of the human circulating coronaviruses, that's what happens. The durability here has always been a question. Is it 1 year? Is it 3 years? Is it 5 years? I think as you see new strains emerge, like the potentially concerning strains that we've been talking about, particularly in the Republic of South Africa and Brazil, you have to ask the question, is that - what does that look like not just now, but what does that look like 6 months from now, 1 year from now, as we start to move into a mode where we're going to see seasonal epidemics of coronaviruses, which we already see for the other coronaviruses, and you would have to assume will happen with SARS-CoV-2. And it's for that - it's those gaps in immunity that I think we're particularly focused on right now, which is, to what extent do you - to what extent in the future do at-risk populations emerge with increased risk against these new strains? It's not something you can see in the data in the first 30, 60, 90 days post vaccination in the current clinical trials. But it's something that you - we did talk a lot about last year, and I think it's going to continue to be something we have to track closely as we look ahead.

Mani Foroohar

Analyst · SVB Leerink.

That's helpful. I guess that would imply also that it might be useful to look at sero collected from the already vaccinated patients, 180, et cetera, further days out and perhaps perform the same experiment described in the New England Journal of Medicine article. Would you consider disclosing that data? Or do you think it just makes more sense to just move to your novel variant approaches? And just would the clinical data speak for itself?

Stephen Hoge

Analyst · SVB Leerink.

So fair question. I mean, look, I think we will obviously update data on durability of responses across our Phase I, Phase II, Phase III trials as that comes out. And looking forward, it's prudent. And if we can, we will be providing updates as well against the new strains. I think what we're saying about the variants and strategies against it is - I think none of us want to be in a situation where we wait until there are reinfections and increased morbidity and, God forbid, more mortality in a seasonal epidemic, for instance, this winter in the Northern Hemisphere, this coming winter. And then say, okay, now it's time to be boosting people. And so as we're continuing to face an evolving virus that is changing its stripes and perhaps decreasing the durability of our immunity, we're trying to be very proactive with the 3 strategies we described. And I think we'll continue to follow things like the data that you pointed to, which is how are we doing in terms of immunity and blood of people who've previously been vaccinated or previously infected. We'll obviously closely be following reinfections. And then I think we all have to be following very closely what's happening in the southern hemisphere, because as they move into their winter and a potential seasonal spike in the winter as you normally see in temperate climates, it will help us understand to what extent are we still in a - we have to stay ahead in the concerning phase of this epidemic or pandemic or is it a place where we start to get more and more confident that the vaccines have the virus under control.

Operator

Operator

At this time, I'll turn the call back over to Stéphane Bancel for closing remarks. Stéphane Bancel: Well, thank you very much, everybody, for joining us. We look forward to seeing you at our next event on April 14 for Vaccine Day, and I wish everybody to stay safe. Have a great day. Bye.

Operator

Operator

Thank you, ladies and gentlemen, that concludes today's conference call. You may now disconnect.