Earnings Labs

Moderna, Inc. (MRNA)

Q2 2020 Earnings Call· Wed, Aug 5, 2020

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Transcript

Operator

Operator

Good morning. And welcome to Moderna’s Conference Call. At this time, all participants are in a listen-only mode. Following the formal remarks, we will open the call up for your questions. Please be advised that the call is being recorded. At this time, I’d like to turn the call over to Lavina Talukdar, Head of Investor Relations at Moderna. Please proceed.

Lavina Talukdar

Management

Thank you, operator. Good morning, everyone, and welcome to the Moderna’s second quarter 2020 conference call to discuss financial results and business update. You should 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 Chief Executive Officer; Tal Zaks, our Chief Medical Officer; Stephen Hoge, our President; and David Meline, our Chief Financial Officer. Before we begin, please note that this conference call will include forward-looking statements made pursuant to safe harbor provision 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. 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 are in good health and remain safe. Thank you for joining our Q2 business update. We are committed to building mRNA as a new class of medicines. We model our position to remain the leader in this field. As you know, we believe our mRNA medicines have a potential to address the large and unmet medical needs and to treat diseases that are not addressable by recombinant protein or small molecules. Due to the platform nature of mRNA, we believe our mRNA medicines provide a higher probability of technical success to commercial launch and faster timelines to clinical trials and to the market relative to traditional medicines. We also…

Tal Zaks

Management

Thank you, Stéphane, and good morning, everyone. Let me start with our prophylactic vaccines portfolio, a quick overview of the programs is on slide 7. mRNA-1273, our vaccine against COVID-19 has made very significant progress. The interim results of the Phase 1 trial have now been published in The New England Journal of Medicine. The Phase 2 trial was fully enrolled. And importantly, we recently started Phase 3 trial of 30,000 volunteers in the U.S. Our CMV Phase 2 dose confirmation study remains on track for interim data in the third quarter of this year, and the Phase 3 trial is expected to begin in next year. The Phase 1 trial for Zika is fully enrolled. And I’ll share some data from the 100 and 250-microgram dose cohorts shortly, while we’re preparing for Phase 2. Our Phase 1b age de-escalation study with our combination hMPV/PIV3 vaccine remains on pause with enrollment suspended due to COVID-19 disruptions. And finally, the Phase 1 study with mRNA-1172 against RSV led by our partner Merck is ongoing. So, new is additional data from our CMV and Zika Phase 1 programs. For CMV, these include 12 months immunogenicity data from dose cohorts, 30, 90 and 180-microgram and the safety data from the 300-microgram dose cohort. For Zika, we had disclosed data from the 10 and 30-microgram cohorts. And today, I will show you the safety and immunogenicity data for the 100, 250-microgram dose groups. So, starting with CMV. On slide 9, you will see a table of the solicited adverse events after the third and final vaccination in the highest dose we tested, 300-microgram. The safety and reactogenicity data from this dose is despite side by side with the other lower dose cohorts from the trial. At the 300-microgram dose levels, solicited adverse event reaction…

Stephen Hoge

Management

Thank you, Tal. I’d like to start our discussion on mRNA-1273 value by -- on slide 21, just recapping the scale of the loss that we’ve all been facing. It is remarkable that this pandemic has harmed millions of people already and our hearts go to those who’ve lost loved ones or been made sick themselves. Given the scale of the devastation, it is hard to believe that just seven months ago, none of us have ever heard of SARS-CoV-2 or COVID-19. Globally now, over 18 million people have had confirmed infections with the virus, and almost 700,000 have died. In the U.S., that looks like 4.7 million confirmed cases and 150,000 deaths. And the estimates are that by year-end in the U.S. alone, there could be up to 400,000 deaths in this country. What we’re learning about the virus almost every day is that it may have a number of long-term sequelae beyond the short-term impacts of the disease. So, beyond the pulmonary infection, pneumonia, acute respiratory distress syndrome and pulmonary embolism that we see, there have been increasing reports of other coagulation disorders, cardiac injury and long-term sequelae, as well as disturbing reports of potential long-term neurologic complications and potential inflammatory syndromes in children. Clearly, we’re learning more and more every day about the terrible devastation of this virus. And it’s absolutely imperative that we and others advance the vaccine to try and blunt this pandemic and control these long-term sequelae. So, on slide 22, in trying to assign value to a vaccine during a pandemic such as this, there are a number of approaches, the one of the most established is using incremental cost effective ratios. Using a health economic assessment framework, you usually look just at healthcare costs, really the direct medical costs associated with caring…

David Meline

Management

Sure. Thank you, Stéphane. Turning to slide number 28, in today’s press release, we reported our second quarter unaudited 2020 financial results. We ended Q2 2020 with cash and investments of $3.1 billion compared to $1.7 billion at the end of Q1. The increase is driven by the capital raise in May of this year. Net cash used in operating activities was $130 million for the first half of 2020 compared to $253 million in 2019. The decrease in 2020 is mainly due to deposits of $75 million received as of June 30th, for potential future supply of mRNA-1273. Net cash used in operating activities for the first half of 2019 also included $22 million of in-licensing payments to Cellscript to sublicense certain patent rights. Cash used for purchases of property and equipment was $25 million for the first half of 2020 compared to $18 million in 2019. Total revenue was $66 million for Q2 2020 compared to $13 million for the same period in 2019. Total revenue was $75 million in the first half of 2020 compared to $29 million for the same period in 2019. Total revenue increased for both, the three and six-month periods in 2020 due to increases in collaboration and grant revenue. The collaboration revenue increases were mainly attributable to an increase in revenue in the second quarter, particularly from AstraZeneca. The increases in grant revenue were primarily due to our BARDA agreement related to the development of our vaccine candidate mRNA-1273. Research and development expenses were $152 million for the second quarter of 2020 compared to $128 million for the same period in 2019. Research and development expenses were $267 million in the first half of 2020 compared to $258 million for the same period in 2019. The increases for both, three and six-month…

Operator

Operator

[Operator Instructions] I show our first question comes from the line of Matthew Harrison from Morgan Stanley. Please go ahead.

Matthew Harrison

Analyst

Great. Good morning. Thanks for taking my question. I guess, two for me this morning. First, on manufacturing for 1273, can you give us an update on how much inventory you’ve built so far? And where you are in terms of scaling to that 500 million dose per year run rate that you previously highlighted? And then, second, I was hoping you could comment on some media reports we’ve seen over the last day or two about FDA potentially convening a panel for vaccines in October. And I guess, also comments that there’s going to be real time review of vaccines, and what exactly that means, given the timelines potentially for your Phase 3 study?

Tal Zaks

Management

Matthew, this is Tal. Let me maybe take the second question first, and then I’ll defer to Stéphane to take the first one. Look, I can’t comment on media reports. I think that we have been working very closely with the agency, as I’m sure my colleagues have from other companies to make sure that we’re locked up and give them the greatest -- best visibility we can to our data as it emerges. We continue that dialogue as our Phase 3 is now enrolling. The Phase 3 trial has pretty clear, if you will, interim analyses and this statistical -- robust statistical plan that we have described in the past. But obviously, with the level of unmet need and more and more data emerging to substantiate a potential for benefit as we continue to accumulate safety data on the Phase 3, I’m very happy to see that FDA continues to take a very proactive stance in evaluating for the totality of the clinical data as it emerges. And, as soon as I have any more insights than that, I’ll be more than happy to share it. Stéphane Bancel: Thank you, Tal. And Matthew, on the first question around manufacturing, we will not share inventory numbers at this time. What I can tell you is that as we speak, our teams are making commercial products, receiving the potential approval of mRNA-1273. So, we are literally making products and stockpiling at risk. In terms of the capacity, I’ll confirm what we have said before, which is for 2021, the 500 million dose per year continues to be our base plan, meaning the team has a good sense of how to execute over that plan. And the team continues to work really hard over many different approaches, from new process, equipment to debottleneck, to find a path to 1 billion, which we still consider at this date as an upside. So, the base of 500, it’s your base case and the team is still working hard to figure out how we can get closer to a 1 billion capacity for ‘21 output.

Operator

Operator

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

Ted Tenthoff

Analyst

A question with regard to assumed infection rate for the Phase 3. Obviously, this is going to be somewhat dependent on sort of where you’re enrolling and things like that. So, what can you tell us about the general assumed infection rate and kind of how many infections you may need to see to be able to power the Phase 3 study of that size?

Tal Zaks

Management

It’s a great question. The challenge is that I don’t know how to build those assumptions, given the huge wide variability we see in actual infections rate. So, the number of infections you need to see, correlates to the number of cases required to pass the interim. And as we’ve disclosed, it’s roughly a little over 50 -- a little over 100 and 150 some for first and second interim and then the final. That’s sort of number of cases. And I think the advantage of running a 30,000-subject trial with 15,000 of them getting active vaccine and the rest as the placebo is that the larger that cohort, the more likely you are to see those cases early. But, it’s of course, a direct function of infection rates. I think, sort of if you step back, philosophically, we designed with our partners at NIH such a large trial with the initial goal, not knowing at the time what the infection rates were. You kind of just take a cross country average, you figure you’re going to be able to enrich it somewhat and you make it broad enough so that it’s representative of the diverse population. I think, what we’ve seen is an anticipated acceleration of the timeline to cases, not just by us. But I think by many people out there, recognizing that infection rates currently in the U.S. are actually higher, certainly in the areas in which we’re doing this trial than maybe we would have thought three, four months ago. So, I think the initial projections and people smarter than we have sort of made them was that we had expected to see the cases come in towards the end of the year, or by the end of the year. I think with infection rates, currently, there may be an acceleration of this. But, it’s extremely hard to predict. We, like everybody else, follow these on a daily and weekly moving average. And I don’t think, I’ve got a better crystal ball than anybody else in that domain.

Operator

Operator

Our next question comes from Salveen Richter from Goldman Sachs. Please go ahead.

Salveen Richter

Analyst

So, with regard to the volume agreements that will be executed at a higher price point for smaller versus larger volume orders, how are you delineating between the smaller versus larger internal volumes? And then, secondly, if two different companies developing vaccines for SARS-CoV-2, both use, let’s just say the PRNT50 assays, are those assays identical? So, could you actually look at these programs head-to-head? Stéphane Bancel: Good morning, Salveen. So, I will take the first one and I will turn over to Tal or Stephen for second one. On the volume agreements, we’re disclosing very precise cutoff, because as you can appreciate, there’s a lot of different components that go into getting those agreements to the finish line with potential customers. I think, small is more kind of in 1 millions and large, as you can imagine for bigger countries will be very different ballpark. Stephen, do you want to -- or Tal talk about the PRNT50 assays?

Tal Zaks

Management

Yes. This is Tal. I’ll take a run at that. It’s a great question. I think, all of us are trying to look at them and understand the assays. There are big differences because those assays are not standardized and you’ve seen a range of PRNT50s, you’ve seen assays against live virus, pseudo virus neutralization. What’s clear is that all of these correlate with each other pretty well. But, there also are differences. And I think if you look across, that’s why everybody is trying to sort of report it out as a ratio to the convalescent plasma. The challenge there is, again, there is no standard panel for what the convalescent plasma is. So, everybody’s using different panels of sera. I think, the ballpark estimates are probably roughly comparative. My sense is sort of between half a log and a log of each other, for sure, maybe even tighter than that. But, it’s hard to drill down and get confidence that you’re really comparing apples to apples. And they’re certainly I don’t think identical. People try to set them up in identical ways, but you’re going to have minor variances. There’s also variability in the preclinical models reported. You can see different -- especially in the NHP, you can see people using different inoculums -- or inoculum levels different of severity of infections in the different models and then reporting out protection or not. So, unfortunately, we’re still relatively in the early days. I think, the good news is that you’ve seen for our data pretty robust titers in every which assay you measure as it relates to convalescent plasma. I’m happy for all of us that I think we’re probably not alone. There are going to be other vaccines that also seem to be getting close to that. And so, ultimately, we’ll all get wiser when we see the Phase 3 results over.

Operator

Operator

Our next question comes from Michael Yee from Jefferies.

Michael Yee

Analyst

Two quick ones for me. First, you’re seeing -- or the market is seeing a lot of contracts being deployed both in UK, this morning, also another U.S. contract deployed to J&J. Could you just put into some context for us how we should think about Moderna’s position here and presumption of a diversified stockpile and maybe why or why not there hasn’t been anything to announce just yet? Maybe just make some broad comments about that. And then, the second question, I guess is, since you’ve reported data, there has been obviously a lot of other platforms with data that have come out, both adeno [ph] and protein last night. Maybe just make a comment about how to put that into perspective and the market’s enthusiasm or people’s enthusiasm about those data sets? Stéphane Bancel: Let me talk a bit about contracts and then I will hand over to Tal. So, as you know, Michael, to get to a contract, you need two parties to agree on terms. As I said in my remarks, we are discussing with governments around the world. As you know, we have a longstanding relationship with U.S. government with different agencies, BARDA, DARPA and NIH. The contracts that have been signed so far are contracts, so that actually literally around the world, in all the key regions. And so, as we get to the right place, of course, we will make the right announcement as appropriate. Our understanding is as has been said publically that different governments have different strategies. Some of them want to build a portfolio to manage risk, because, of course, at this stage, nobody knows which vaccine will get approved. Nobody knows the different efficacy, which will be most probably very important, especially for the population at risk, the elderly people with comorbidity factor. To them, the difference in efficacy might be very, very important. And so, I think what we’re seeing is the government’s doing what I think we would do or you would do, if you were running a country, trying to take care of the health of a large group of people, which is to build a portfolio, thinking about both risk of success, performance of a product and so covering the country. So, as you see, a lot of those agreements have options built into them, which I think again, makes a lot of sense as we sit. We want to be part of the solution and make sure that we can be helpful. As we’ve said, we are cautiously optimistic about the good clinical data so far of our vaccine. And we want to make sure we can help as many people as we can around the world, as many governments as we can to protect as many people as we can to kind of stop this pandemic. Tal, can I turn over to you for the second part of question from Michael?

Tal Zaks

Management

Yes. It’s a great question on how the platforms are starting to stack up to each other. I think, our data continues to be as good or better than anything anybody’s recorded, both in terms of what we’re able to show in neutralizing antibodies and in terms of the challenge we do in the non-human primate and the ability to completely eradicate or eliminate the power application of both the lung and the nose. It’s been nice to see Pfizer validating our data in a way with the BioNTech construct. Of course, we’re still very curious to see what they’re taking into Phase 2 and 3, because reportedly they’re taking a different construct than the ones for which they’ve shown data. I think the adeno vectors writ large -- it’s been an interesting story. Initially, it’s pretty clear that there’s less expectation for their ability to boost, given the nature of their platform. And, indeed, the first one -- I don’t think boosted at all. The AstraZeneca Oxford data I think are encouraging and that they can get with a boost apparently to levels of convalescent plasma. Hard to say, very early data, as I think even though they dosed more than 1,000 subjects, they showed data for 10, which they gave a prime boost. So, I’m encouraged by those data and I hope that that’s enough. I suspect that if that ends up being the case, then hopefully for all of us, you will see them sort of be able to reach the minimal bar. But, I’m encouraged by our data and expect that they will translate into -- I’m optimistic that they’ll translate into higher point estimates for efficacy. We saw Novavax data last night, I think any of us who’s been following the field of vaccines, anticipated that a recombinant protein on the right way with a strong adjuvant could be effective. I think, certainly, their neutralizing anybody data are encouraging. And ultimately, I think, the Phase 3 results are going to be required now to really understand fully the point estimate for efficacy as well as a better understanding of the reactogenicity and safety profile of these various approaches. So, in summary, I think the mRNA platforms are clearly there with our data looking great. I think, Novavax did a very nice progress. And I think, adeno vectors, I hope they get there. But, I think they’re going to struggle to boost. And I think, all -- anybody who’s done boost or is able to show a boost is able to show as immunology would anticipate, a very nice potentiation with the booster shot.

Operator

Operator

Our next question comes from the line of Gena Wang from Barclays.

Gena Wang

Analyst

I have two questions. So, the first one is regarding the Phase 3 primary endpoint. Just wondering how do you count infection? I think, according to the clinical trials.gov, it’s basically number of participants with the first occurrence of COVID-19 starting 14 days after second dose. Just wondering, is there a time cutoff, so that every patient will have a same time exposure or will you report as event per 1,000 patent years? And the second question is regarding the Phase 1, Phase 2 data update, hopefully, this month or next month. So, will we see more meaningful number convalescent sera from severe patients using PRNT50 or PRNT80?

Tal Zaks

Management

So, let me take those. I’m not sure we’re going to see a significantly additional data on convalescent plasma. We’re going to look at that when we report out the Phase 2. So, I think it’s premature for me to say one way or another. Regarding your question on Phase 3, I’ll make two points. The primary analysis is just a number of cases. It’s not really -- it’s a slightly different method statistically, but you end up with the same place as I think what you’re referring to as the Pfizer methodology. You will see the number of cases and then the split in those cases, and of course, will describe the timeframe. In terms of counting those cases, you are correct in that the formal counting of cases where you want to see the distribution occurs 14 days after the booster shot, that’s the definition of the primary endpoint. There is, however, a secondary endpoint that will look at the totality of cases that emerge once people start the trial. And of course, I think that could be further supportive evidence, especially its infection rates are so high that indeed we start to see some cases even in the first six weeks. The case definition for us is symptomatic disease. Again, there may be some minor variations between sponsors. I’m not sure everybody’s fully harmonized to the same definition. We’ve been very transparent with the exact definition of our endpoints, so that people can draw their own conclusions and comparisons.

Operator

Operator

Our next question comes from the line of Cory Kasimov from JP Morgan. Please go ahead.

Cory Kasimov

Analyst

Hey. Good morning, guys. Thank you for taking my questions. Two for me as well. First one is on pricing. I appreciate all the thought and detail that went into your prepared comments on the value proposition this morning. But, I guess what I’m wondering is if we see other companies out there currently agreeing to contracts with various governments with price points that appear to range from the low-single-digits to nearly $20 per dose. Doesn’t that make it inherently more difficult for you to try to charge something materially higher than that? And then, second question is probably for Tal. I’m wondering, how difficult is it to maintain the integrity of a Phase 3 blinded trial? When you would suspect a large proportion of the mRNA-1273 treated patients are expected to get common vaccination, adverse events like fever and other symptomatic -- other systemic events where presumably that wouldn’t happen with placebo. Does that matter much in the end in your view? Thanks. Stéphane Bancel: Good morning, Cory. So, it’s Stéphane. I’ll take the first one on pricing and then I’m sure Tal will take the P3 question. So, I think, like in any discussion, Cory, many factors go into arriving on up to an agreement. I would say, first, the totality of data that is available at the time of the discussions, preclinical model, clinical data. Again, given us, also we have a platform, we have the possibility to share public information that has been shared before over dataset. So, I think data is an important one, because I do not think all products are equal. And as Tal said, we would, of course learn much more with Phase 3 data in the fall. Another consideration of course is volume, as we indicated in our remarks. And then, another factor that is important is time of payment, how is the risk distributed between companies, because we discuss in our remarks, like us have started to make products at risk, not knowing if 1273 in our case will be approved or not, and so on -- and there are many more considerations as well. So, I think when you look at the totality of the data, as we’ve shared, we have signed a number of agreements already for potential supply in the $32 to $34 range. And we also said, as volume will increase, we’ll of course integrate that into the analysis. So, we’ll work with the market. But, we also know what we have in terms of product. Tal, do you want to take the P3 question?

Tal Zaks

Management

So, Cory, it’s astute observation. And we and our partners at NIH have thought about this one long and hard. I think, at the end of the day, you’re right, especially after the second dose. First dose, probably people still won’t know it. Second dose, people may intuit whether they’ve got the active one or not. I think, the important pieces here is that the endpoints are pretty hard endpoints and that and I don’t think that you’re going to be less likely to report significant symptoms, if you’ve got placebo or not and the measurement of a PCR test as a PCR test. We have put in place measures to ensure that there’s no sort of quirks of the unblinding. For example, we’re going to be testing by PCR everybody, both on this one and when they come in from the second dose just to make sure that if they do see some mild flu like symptoms, they are clearly attributable to vaccine or it is an infection and we’re not biasing by measuring more frequently in those that cut a vaccine. I think beyond the first couple of days, I don’t expect them to be significant symptoms in anybody. So, I don’t think there’s going to be biasing of any testing. In terms of the asymptomatics, we’re going to look retrospectively anyway and call that based on serology and everybody will get tested. So, I think by making sure that all the objective measures are done on both arms at the same time points, I think we should be in pretty good shape here.

Operator

Operator

Our next question comes from Geoff Meacham from Bank of America. Please go ahead.

Geoff Meacham

Analyst

Hey, guys. Good morning. And thanks for the question. I just had a few. So, what we’ve learned on the value of 1273 is that T cell responses are important as our antibody titers. And so, when you look at the new data today for Zika or for CMV, or really anything going forward, do you think you’ll place more emphasis on optimizing T cell responses just with respect to the platform? And then, just a follow-up on 1273 pricing. When you look at the Phase 3 data, is there a single element that you would say justifies differential pricing, be it T cell or B cell or safety profile, things like that?

Tal Zaks

Management

So, let me take, Geoff, the first question and then, I’ll let Stéphane answer the second. I think, a lot of hay has been made out of T cell responses. Look, T cells are near and dear to my heart, being a medical oncologist. They’re required to cure cancer. I don’t -- I’m not quite sure, they’re as important to cure COVID-19 frankly. I think, what they are is a measure of the quality of the response. So, if you will, the fact that we see the right kind of Th1 helper, I think makes everybody feel good about the antibody responses. But at the end of the day, the best measure of the immune response you’re getting is look at the ability to boost after a prime. That tells you that the immune -- even after dose, once you get the boost, you can see the antibody levels come up quickly. They come up to high levels, they come up with good neutralizing activity, which is a best predictor that should you get infected, the immune system will trigger again in a similar manner. And that’s how the immune system works. I think we’ve had plenty of data from other infectious diseases demonstrating that whenever you try to find a correlative protection, and Merck has done that with y Zostavax years ago, and that’s even a disease where you think T cells matter more, the correlative protection comes up time and again being neutralizing antibody, not T cells. T cells are an adjunct sort of measure of the quality of the response when it comes to these kinds of viruses. And I think, the totality of the data that you’ve seen with SARS-CoV-2 in terms of all the animal models, you can passively transfer antibodies and get protection. So,…

Operator

Operator

Our next question comes from Hartaj Singh from Oppenheimer. Please go ahead.

Hartaj Singh

Analyst

Just a couple quick questions, off the topic of the COVID-19 vaccine. One is, can you just go over quickly, the CMV Phase 3 program, the initiation, the development? And when you’d expect that to readout and potential approval for that product? And then, secondly, in some of our calls with pulmonologists that treat cystic fibrosis, there seems to be a lot of excitement around mRNA therapy for treating cystic fibrosis patients. The belief right now is that it could only treat a minority of those patients. But, our calls seem to suggest that it could treat a majority of the cystic fibrosis patients. Could you talk a little bit to that and where exactly are you with your Vertex collaboration?

Tal Zaks

Management

So, let me start with the Phase 3. I’ll let Stéphane talk about the Vertex collaboration. The Phase 3, as we had previously articulated, I don’t think anything has changed. The trial should follow participants for at least a couple of years. It’ll probably take around 18 months to enroll. And then, you wrap up the data. So, that sort of gives you a sense of the overall duration. We’re on track to start next year. I think, what should be obvious to everybody is, once we have the Phase 2 data, it’s going to require some regulatory interactions and the Phase 2 meeting and so forth. We had gotten feedback in the past from FDA about the primary endpoints, which I think reassured us that it was feasible because we’re looking to prevent primary infection and women of childbearing age not directly looking at outcomes in babies, at least not as part of the Phase 3 program. That being said, obviously, it will require much more detailed discussions with them on the Phase 3 design and the dose and alignment with them prior to start of the Phase 3. So, I hope that that gives you some additional color. I can tell you my sense on Vertex. As a scientist, I’m super excited by the potential for mRNA to -- not be limited by any particular mutation, just from the fundamental science of it. But, I’ll let Stéphane speak to the overall status of the collaboration. Stéphane Bancel: I’ll let Stephen talk about it. He and his team is doing all the work.

Tal Zaks

Management

I think Stephen had to jump off our call. Stéphane Bancel: Sorry. Thank you. So, on Vertex, so as we communicated, I think it was in the Q1 call, Vertex decided to expand the collaboration with Moderna on CF. The joint teams’ discovery have done a really remarkable job in the last few years in term of delivery. As you can imagine, given as well, making the CFTR mRNA is another complicated, given all the things we have done in the current state of the platform and the technology. It is obviously, the challenge entirely in delivery. We look forward to sharing some data soon. Again, it’s a partnership. So, we need to of course align with Vertex on what we believe is the right timing. But, as Tal said, the teams on both sides, I think Vertex and Moderna are very excited about the progress, about the possibility what it will mean for patients. And as we discussed before, if we can find a technology to deliver safely into the lungs and mRNA, obviously, we will be able to use that for obviously disease of lung. And just to remind everybody, the Vertex collaboration is focused on the CFTR gene. And so, the other applications will belong to Moderna from a commercial standpoint.

Operator

Operator

Our next question comes from Alan Carr from Needham & Company. Please go ahead.

Alan Carr

Analyst

Just following on the theme of programs other than COVID-19. You mentioned before that enrollment in a few of these programs is still paused or suspended, because of COVID-19. I’m just kind of wondering, if you’re able to still get prioritized and move forward some of the other programs, such as the rare disease programs, do you feel like you can still keep your eye on the ball in terms of the rest of the non-COVID pipeline at Moderna?

Tal Zaks

Management

So, this is Tal. Let me maybe take a stab at that. I think, the answer is absolutely, yes. And I think, it’s evidenced by the progress that we continue to show for the rest of our pipeline. We’ve expanded the development team quite significantly to go after the COVID-19 vaccine, so that, I think we’ve got very capable teams that are pushing everything else. The fact that we continue to enroll in oncology, it’s seen a little bit of a slowdown, similar to others. And it really depends on the individual center’s data, so who’s enabled and when to treat patient. I think, on the rare disease, not only is our eye on the ball, I think, we’ve -- as we have alluded to in the past, we’re actually using the time to kind of step back and engage deeper with both, investigators and patients and advocates to make sure that when we do restart those programs, because the kids can finally come back in, those programs are better optimized, so that they can -- we can perform better in terms of recruitment and analysis of data on the study. So, we’re continuing to execute across all the fronts. And I think, you’ll see as hopefully the pandemic recedes or as centers figure out how to, despite PPE and social distancing, to continue or restart clinical activities, then, we should come back on line across the board. Stéphane Bancel: Yes. And we just -- to add to Tal’s important comments. When things started to look bad from a global basis in terms of the spread of SARS-CoV-2, we spent quite a long time, I would say in the February timeframe, with the Board and with a team to think about how do we structure the Company, how do we…

Operator

Operator

Our next question comes from George Farmer from BMO Capital Markets. Please go ahead.

George Farmer

Analyst

I’m quite struck by the fact that neutralizing antibody titers don’t really seem to emerge until after the second dose, whereas antibodies in general seem to be elicited after the first injection. How do you think about this? I mean, it seems to be across the board, not just with your vaccine, but with these other vaccines. And, importantly, how would such patients be treated in the Phase 3? Should they come down with COVD, say after the first injection because of not having a sufficient titer going into the second injection?

Tal Zaks

Management

Thanks, George. It’s Tal. Yes, it is interesting. I think, it kind of speaks to basic immunology, which is, if your immune system thinks it clear an infection easy, it doesn’t try too hard. If you come back later and basically show that no, the infection isn’t gone, then it tries harder. And that usually manifests with affinity maturation improvements in the antibody qualities as well as the absolute titers. So, I suspect what you’re seeing is a subtle manifestation of that. Now, the question is though, what happens after just the prime? Yes, you don’t have neutralizing antibodies, but clearly the immune system now reacts differently, once it sees the antigen because you get the boost. And so, it’s an interesting question. Well, what happens if the boost happens not with the vaccine, but with the natural infection? I would suspect, based on sort of first principles that you should see some benefit, you probably -- not the full benefit, you would see if you get infected after the boost, but just by nature of the boosting, you would expect that an infection would also boost in the sense of the immune response would react quicker, more vigorously. And maybe you won’t prevent infection and maybe you won’t even prevent disease. But hopefully, you would prevent a more severe manifestation of disease. Because disease, at least as we understand it in the first phase here is a balance between your immune response and clearing the infection. So, it’ll be very interesting, I think, both for us and for other platforms that use a prime boost to do the secondary analysis of understanding whether we’ve seen any cases in that first month or six weeks and what the distribution of cases are between placebo, and you’re treated. The last piece I’d say that I think also gives me some hope here is the non-human primate where a single dose in the non-human primate can -- or at least the mouse models. The experience with the non-human primate is ongoing. But, in the in the mouse models, we clearly see that even though you don’t see -- you don’t measure the neutralizing antibodies just yet, you are already able to limit viral or abrogate viral replication in the lungs. And so, I think that gives you a sort of immunological readout on the phenomenon describing.

George Farmer

Analyst

And then, along those lines, do we have a view on durability yet, following these -- following both, the nonhuman primates and maybe the mice, if they live long enough. Do you have a sense for how durable the vaccine effect could be?

Tal Zaks

Management

Yes. I do not -- I would make two points on that. First, I don’t think any of us yet understand durability. What is emerging is that if you have mild infection, you’re more likely to have lower levels of antibodies and they’re more likely to wane. That kind of goes with the quality of the immune responses, as I described previously. It’s also -- I mean, let’s not mistake the ability to measure antibodies over time as the Sine qua non of having a memory in an immune response, right? Otherwise, by the time you were my age, you’d be walking around with your blood thick and clotting with antibodies against every infection you’ve ever seen. And yes, I am immune to many things that you are not going to necessarily see high levels of neutralizing antibodies in my blood. It’s more about the memory B cells in the persistence. So, I think that initial level of neutralizing antibodies are what gives us the confidence that we’ve got the right quality of the response and the magnitude is at higher -- higher than what you can see with disease with real infection and convalescent plasma. Now, all that being said, I think it’s obviously reassuring to see the quality of a response by maintaining high neutralizing antibodies. I think, if you look at what the platform is able to induce, it’s pretty evident from the CMV data described earlier this morning that certainly in that instance, with a third boost at six months, look out to a year and you see levels that are still higher than what you had targeted. I think, as it all boils down to the utilization in the context of a pandemic here, if what we have is 12 months of durability, I think that’s a great starting point for us to start protecting the population. And we’ll worry about what happens in year two, three and four when we get to 2022, 2023 on the other side of this pandemic. Over.

Operator

Operator

Our last question comes from Mani Foroohar from SVB Leerink.

Mani Foroohar

Analyst

Couple for me, one quick one from an investor. Could you lay out the economics you guys receive on a commercialized vaccine? How to think about percentages paid out to academic partners and the NIH commercial on economic interest et cetera, just breaking it out, trying to understand what unit margin might be? And then secondarily, as we look at pricing, it’s been commented by co-people here, a couple of analysts regarding pricing in the low single digits to upto just below $20 for example, in larger volume contract. It sounds like we should think as somewhere in that range as par for larger contracts for you guys during the pandemic. But, as you talk about the endemic environment and potentially higher pricing, could you lay out how you expect to realize that pricing and setup where demand will likely decline as the severity of COVID-19 impact globally is reduced during an endemic versus a pandemic period, in a setting where perhaps a half dozen or more vaccines being commercialized by large established players with commercial experience in tender markets such as these will be actively competing on price and volume. So, if you could lay out how you expect to substantially increase your realized price in a setting of increased competition, increased supply and reduced demand? That would be really helpful. Stéphane Bancel: Thank you. Good morning. This is Stéphane. So, this first one is going to be quick because we are not disclosing unit margin per product. On the endemic market, clearly, as we said in our remarks, the competitive dynamics are going to be important. We continue to believe that when you look at the totality of the data, not only across 1273 but across 1273 today that’s public and around the platform that efficacy is going to be an important parameter. We’ve hired people and we continue to have people in the commercial world that comes from large established vaccine players who have relationship with government, who have relationship with people in the channel. And so, we believe that we should be able to establish good commercial programs based on the performance of the product.

Mani Foroohar

Analyst

Great. And as a follow-up, when you -- you’ve talked a couple of things about the CD8 T cell response, T cell biology. Just to clear up, the comment that you -- that across your platform you’ve shown effective T cell response that was directed regarding construct in your cancer portfolio, right, and not at this particular vaccine where we haven’t seen a CD8 T cell response of any measurable level as described in your nonhuman primate or human disclosures thus far. You were talking about the cancer vaccines, right? You weren’t talking about any prophylactic vaccines, so in your CD8 T cell response here?

Tal Zaks

Management

So, this is Tal. That is correct. Although I have to go back because we did disclose some T cells for CMV. I don’t recall, either they were CD8 or just CD4, frankly, off the top of my head. Yes.

Operator

Operator

I show no further questions in the queue. At this time, I’d like to turn the call over to Stéphane Bancel, CEO, for closing remarks. Stéphane Bancel: Thank you very much, everybody, for joining today. Stay safe, and we’ll speak soon.

Operator

Operator

Thank you. Ladies and gentlemen, this concludes today’s conference call. Thank you for participating. You may now disconnect.