Moderna, Inc. (NASDAQ:MRNA) 13th Annual Jefferies London Healthcare Conference 2022 Call November 15, 2022 10:50 AM ET
Company Participants
Stephen Hoge – President
Conference Call Participants
Michael Yee – Jefferies
Michael Yee
[Starts Abruptly] for joining us on our next session. Michael Yee, Senior Biotechnology Analyst at Jefferies. Very happy to have up here on the stage the President of Moderna, Stephen Hoge. It’s great to have you. Thanks for being here with us. Obviously, a ton of stuff going on. You just reported earnings. We’re in the middle of some, sort of transition from pandemic to endemic.
I think we were commenting here, I guess, we are an endemic as everyone is doing just fine. And we’ll deal with that, but also of course a lot of important things near term on the platform. And so, I’d love to spend some time talking about obviously where we are with COVID and some of the big platform readouts that are going to happen because I think this is important as perhaps the Moderna story will, obviously have exposure to COVID, but transition to talking about other things.
So, maybe just from a high level, Stephen, you could tell us about Moderna’s view coming out of Q3 earnings where you see the COVID pandemic endemic period now and as we go into 2023, what is your view or company’s view about vaccine demand and vaccine sales?
Stephen Hoge
Great. Well, first of all, thanks Mike for the invite and the chance to be here. It’s an incredible conference. Well, let me start with, sort of where we were maybe in the third quarter call, which is, we’re currently seeing about $18 billion to $19 billion worth of advanced purchase agreement deliveries for calendar year 2022, which is also our fiscal year.
That is – now includes about – there’s about $2 billion to $3 billion worth of deferred revenues, which we’ve moved into 2023, which are entirely related to delays in our fill-finish operations as we launched two products globally. And so, not a change in demand, just product that’s coming after – that’s going to be delivered after December 31 under those original advanced purchase agreements.
As you look to 2023, we all expect that some of what’s been happening in the pandemic phase, including many countries boosting twice a year, will moderate. And I think scientifically, we would expect that to start to approach more of a seasonal market where people are getting a seasonal booster much like they do the flu vaccine. And that’s because hopefully the rates of evolution and infection that we’re seeing come down enough that you really only need it for the winter season when you’re getting together in rooms like this. And hopefully, everybody’s boosted.
And so that will have some effect on expected demand. As it stands right now, we have about $4.5 billion to $5.5 billion worth of contracted sales already. And we disclosed that in the third quarter call. That’s made up of equal parts, the $2 billion, $3 billion of deferrals and another couple of billion dollars’ worth of new advanced purchase agreements for delivery in 2023. But it’s important to say that that $4.5 billion to $5 billion does not include U.S. contracts, which will increasingly be a commercial market or deliveries for the European Union or Japan associated with fall 2023 and actually expanded sales perhaps in Latin America and Asia Pacific.
So, there’s plenty of additional contracting that we expect to happen over the, really the season starts in, sort of December, January, February signing up those agreements. And so, we’ll look to that demand, and you know, we do expect it to still be quite robust. And the reason is that even if we get to a world, we’re only doing a seasonal booster. We’re still talking about a top five killer right now globally, leading to huge amounts of hospitalization and direct healthcare system cost.
And as you look forward, we just don’t see a world where that falls below the Top 10 in the near term. Given the rates of infection hospitalization. Unfortunately, death we’re still seeing across developed economies. So, we think there’s going to be strong demand for the vaccines and boosters because they reduce costs for healthcare systems the same year you deploy them just like the flu vaccine.
Michael Yee
So since it’s also a Wall Street audience and financial audience as opposed to just general, broad, and public, consensus sales used to be according to my check, 14 billion next year versus the [18 and 19] [ph], we’re going to do for 2022, so 14, it’s come way down. You make no [indiscernible], but the analysts have got it down to life, 8.5 now. And what you said is, there is 4.5 to 5.5 of contracts already that does not include any revenue from U.S. or Japan, which I think did about a billion dollars last year, so it may not do the same, but it’s a billion dollar in [type market] [ph], and Latin America.
Stephen Hoge
And European Union deliveries for the fall.
Michael Yee
And European Union – okay. What does that mean? There is no contracting, but they haven’t, you haven’t, have you…
Stephen Hoge
We have not entered into agreements for deliveries to European Union, Japan, or the United States for the fall. [indiscernible] We expect all of those to be markets where there’s a need for a booster vaccine.
Michael Yee
So, zero APAs in those big markets, you’re going to already do 4.5 to 5.5 consensus as [indiscernible]. Now importantly, because you want to try to get the numbers right and people think that it’s a reflection of demand, the United States market it has been publicly disclosed that Pfizer thinks the price could be a $100. Now rather than you specify and that you want to specify on what that – how you guys feel about that price, is there some math around how you guys have thought about? Well, the demand should be x in the United States based on flu demand or just, you know, what do you think the demand should be and I multiply times 100?
Stephen Hoge
Yeah. Well, let me talk about the demand in terms of the volume and price somewhat separately. So, first on demand, what we see is, I think are realistically given the healthcare impact and the cost associated with COVID even this year and we don’t expect to be different next year. We expect that at least high risk adults and probably broadly, there’ll be recommendations for vaccination. And if that happens, it’s in subject to public health officials, then a demand and the volume at least to the size of the current flu market would seem like a reasonable assumption.
Michael Yee
I think I have numbers for this, like 60 million to 80 million out of our 320 million in the United States. [Indiscernible]
Stephen Hoge
It’s actually a little bit higher. Yeah. That’s correct. 60 million, 80 million high risk. That’s correct. And then obviously, it’s also recommended more broadly for healthy adults and others because although you don’t have the same risk of hospitalization, there’s still infection absenteeism and so many employers, including ours, you know, deliver flu vaccines every year.
So, the total global demand for flu vaccines is more in the 600 million doses across developed economies. And, you know, it’s a marker. I’m not going to say whether I think it’s going to be bigger or smaller because I think a lot depends upon the rate of evolution of the virus. And whether we continue to see more death and more hospitalization from COVID than we see with flu, which is the case as it stands right now going into this season.
If that remains the case, then you could argue there’s going to be a demand above that in terms of volume versus below. When it comes to pricing, that’s a little bit more of a complicated one because first I’d say that the kinds of numbers that have been put out there you referenced the Pfizer number, they have tended to be gross pricing. And there are gross to net discounts, particularly in markets like the United States, and so net pricing is probably the more relevant thing for assessing revenue. And that’s where we do not have guidance on what our price will be.
We do believe that as we move into commercial market, endemic market, pricing will match the value of the vaccine. And, you know, other entities in U.S. is a huge market. CMS came out and said they saw the value of the vaccine at $64 for the 2023 calendar year cycle. So, that’s a pricing to value type measure in terms of the prevention of outcomes and costs that would happen there. That doesn’t mean that’s the price that we’re anchored on, but it is a reflection of the value we think the vaccine creates.
A lot will also depend upon whether markets go fully commercial or continue to be in some markets more centralized government procurement or even multinational procurement. So, if Europe continues to procure at larger volumes, there tend to be discounts associated with volume. So, there’s a lot of uncertainties about that price, which makes it a little bit dangerous to guide on it right now.
Michael Yee
Well, just starting with the biggest part, which is U.S. and we’re kind of closed out here on COVID, is I think flu in the United States is around a 100 million doses per year out of 320 million people, about 100. That’s kind of the number. So, if one takes and says, in the future, same amount of people are going to get a booster as flu, I don’t want to make any political or judgments around that, but a 100 million if it was a flu type vaccine.
If it was half of that, that’s 50 million. And if the product was a $100 or less. That’s 5 billion. 50x a $100. So that could be at least a ballpark. [Indiscernible]. For U.S. only. Yeah. Correct. And if you got half of that, that’s 2.5. 5.5 is your number already for [AP] [ph] plus 2.5, you’re kind of at 8. So, there’s your guidance – the consensus. I was just trying to think about the [indiscernible].
Stephen Hoge
I think that’s a – without commenting on the specific assumptions, I think that’s reasonable match. And the market – we believe that the market will be at least the scale of the flu market and a price point that’s more in-line with the value of the vaccines, which globally we’ve been averaging, sort of $30 historically this past year, maybe that holds, maybe it goes up in a place like U.S. And so that gives you a sense of if you multiply a 600 million times those sorts of numbers, you also get the overall global market as an estimate, but ultimately time will tell. And we have to work that out. And that’s the overall market. I’m not talking about Moderna.
Michael Yee
Right. So, I guess, we have to split some of that. I’ve been –that is – a 100 million goes to the flu. I give you, if it was 50%, 50 million. So, just to close out on here, a lot of the investor sense, depending if you’re a generalist, a specialist or whoever you are, it’s like, COVID vaccine demand is falling. That’s bad. Numbers are going down. This can’t be good. Your job is to look at the numbers with the consensus is that [plausible] [ph] to get there rather than just say, oh, the numbers are going down. The demand is going down. The demand is going down, but at some point, there’s a level to where you should see some tail revenues.
Stephen Hoge
Yeah. And for sure. And if you deal with governments who have to pay the healthcare bills, whether it’s a Medicare Advantage Plan or a government in Europe that has a nationalized health care system, they directly bear the costs of not vaccinating people. And they far exceed the cost of vaccination brought to those populations. And so, it is a cost saving measure when CMS says $64 of the value.
They save money at 63. Right. And so, it is, we think reasonable to conclude that it’s in the fiscal interest of these governments to make sure that they’re avoiding costs that are preventable as a result of hospitalization from COVID infection, yeah, including next year. So, we – there is at some point a cold hard, you know, public health and economic logic to why it doesn’t fall.
Michael Yee
So, where we would be right or where there would be upside is if other variants come out, waves come out, people have once again feel the sense that, yeah, the pharmacodynamic value to get these vaccines out there goes up, the numbers I just talked about would be visible if for some reason and we don’t know, but obviously Moderna has a view that my gosh, we’re not really seeing infections, it’s not happening, people wane, and people aren’t incentivized to do that. That’s what would be wrong. I guess, the infections are going up just a little bit.
Stephen Hoge
They’re going up, and they will go up. Look, that is one of the most predictable things in biology, is that respiratory viruses cause infection in the winter, and they cause hospitalization in high risk populations. This is probably the fifth coronavirus pandemic in the last 150 years. You know, we talk about this like, [OC43] [ph] causes the common cold. It’s a beta coronavirus. It was the cause of the Russian flu pandemic of 1890. You know, two to three years of infections, deaths globally.
The effect, if you go back and read the history of those things, people report that they lost their sense of smell and taste during the initial ways of it. It’s a beta coronavirus. It is literally a cousin of SARS-CoV-2. A 140 years later, it still infects people every two to three years. It still leads to hospitalizations in developed economies that are preventable. We’re not getting rid of SARS-CoV-2 for a 140 years. It will hopefully become more manageable like the common cold and other respiratory viruses are, but it’s not going away.
Michael Yee
Okay. So, near-to-medium term, obviously, we’ll get through the fourth quarter. I don’t know. So, Moderna’s view that infections will pick up, people are going to see this, and then we’ll start to get more vaccinations and boosting through the winter. And then we’ll get through 2023 and we’ll wait to see how U.S. starts to play out and what happens there. That’s kind of the timeline for COVID.
Stephen Hoge
Yeah. I totally agree with that. And I do think that unfortunately, infections will go up in the fourth quarter. Generally, infections tend to peak for these viruses in the early January time horizons. People get through the holidays. And I think that there has been fatigue, as we all know, in terms of boosters and vaccination, most people have had four, maybe five doses, but a lot of people had three plus doses of vaccine over the last couple of years. That doesn’t perpetuate forever, right.
The idea of getting boosted every couple of years is hopefully not necessary going forward as it becomes more of a normal flu like market. Also some of that fatigue will be replaced by a [indiscernible].
Michael Yee
There’s fatigue from the initial prime and then the quick boost and then there was change in the strain and so people feel okay.
Stephen Hoge
Some of that will moderate out.
Michael Yee
Right. To will be more of a seasonal, so there’s less of fatigue issue. Now, I don’t want to budget time. There’s some near and medium-term pipeline data that’s important. I would argue on them just a stock analyst that the stock is up a lot recently in part because of first announcement by Merck on the personalized cancer vaccine and then commentary I thought was interesting on the quarterly call and people are anticipating a potential announcement – guidance for readout on your randomized Phase 2 study of the personalized cancer vaccine. Talk about how investors should interpret this Merck opt-in? What data they’ve seen? And what are we waiting for this disclosure of this data? And what it means for you?
Stephen Hoge
Yes. So, I need to be extremely careful about what I say about this as you know, but let me try and cover the best I can in terms of that answer. So, there are a number of catalysts, which I hope we get to the other respiratory viruses as well. Because we do think we have a number of pivotal or nearly pivotal readouts very shortly here, but the cancer vaccine, in particular has drawn a lot of interest.
So that is a personalized cancer vaccine. So, as you know, we’re taking a biopsy of somebody’s tumor and making a drug just for them based on the fingerprint of their cancer and injecting them with it, generating T-cell responses. We’ve shown all this before. And what we chose to do a few years ago is we said, now if we really want to know whether a vaccine can treat cancer, can prevent you from having a recurrence, it can eliminate your micrometastasis.
We need to go into one histology. We chose melanoma. We chose stage three melanoma, adjuvant melanoma. And we need to beat KEYTRUDA. And so you do KEYTRUDA versus KEYTRUDA plus cancer vaccine randomized study. That has been an open label study because it was a Phase 2 study, but we obviously have a primary analysis looking at over a couple years of follow-up.
Michael Yee
Randomized controlled study albeit open label.
Stephen Hoge
Correct. So, completely randomized. And we have enrolled 157 people in that study. And we had per plan and statistical analysis plan, we were waiting till everybody, the last 157th person had at least a year of follow-up, which happened in September of this year. You then go get all those scans. Many people have been in the study for longer than two years. And what you get are, you know, [indiscernible] and hazard ratios and p values associated with whether there’s a benefit there.
Now, that analysis has not been completed. So, what we’re doing is collecting all the final scans, getting all that work done, and we expect, as we’ve said, and continue to guide you, we will have that analysis, statistical analysis and comparison completed this quarter, but along the way, our partner Merck had to make a decision on whether or not they wanted to continue to be in the program independently and had to pay a $250 million milestone if they wanted to continue to do that. And because it was an open label study, they did have access to the raw information that’s coming through the study, relapses in the different arms.
That’s not the hazard ratio. That’s not the cleaned and QC data that we’re now compiling and pulling together, but I think people took notice that Merck had enough conviction to make that $250 million payment and lean in heavily even in how they characterize that payment.
Michael Yee
Why do they have to pay 250 million or opt-in a month before data is going to read-out. Is that a contract thing? Is there a deadline?
Stephen Hoge
So part of its contract related for sure, but as I think they said, they obviously had the information needed to make the decision, and wanted to get going in the relationship. And so I think there’s a quote in their press release from [early of] [ph] their Head of Development being pretty clear that they want to get going and planning for the next stage of this program.
Michael Yee
And they did say on their earnings call, they want to look at lung and other adjuvant areas and move forward. So, what are the scenarios just really quickly? Again, press release is coming soon. It’s very disappointing data. It’s positive and trending in the right way. It’s really good in its stats sig.
Stephen Hoge
Yeah. I think those are the three outcomes. And I think, kind of hard to argue with that.
Michael Yee
I guess, I’m a decent analyst. Okay. Which one is it going to be? But okay.
Stephen Hoge
Yeah. If I – well, I don’t actually have the analysis, I am waiting for it and there’s a new requirement because we are hopeful that it will be the last one. That it will be statistically significant, an impressive hazard ratio reduction. So, improvement over key trued up. It’s important that we make sure we conduct that analysis in the right way. And so both that we’re not sort of sampling as we go, yes, it was an open label study, meaning people know whether they got that vaccine or not. And it’s generally known perhaps for them whether they had a recurrence or not and obviously in the arms.
We don’t want to do anything to bias that analysis until we’ve cleaned all the data in a blinded way and then finalize it. So, the short answer is, we’re trying to do all the right diligence because I think we hope that it is that clear hazard ratio is statistically significant and we can start having a very quick conversation about where do we go from here with regulators.
Michael Yee
Let me put it – that’s what I’m saying. So, this is not a small study. I don’t want to go so far to say, it’s a pivotal. It is a large randomized study. Albeit open label and there might be regulatory rules around being open label. I don’t know why it was open label actually, but well they had to, you could have done a placebo, though, in the placebo arm on top of the KEYTRUDA.
Stephen Hoge
We could have.
Michael Yee
Why was it open label?
Stephen Hoge
Principally because so people were randomized to either receive the vaccine or not, but we weren’t doing a placebo vaccine nation. And so because the investigator would know whether the patient was, you know, receiving that IM injection, it just didn’t and the patient would obviously. It was effectively open label, you couldn’t blind for it. Now, it’s a pretty objective endpoint. This is radiologically confirmed recurrence of disease or otherwise. So, it’s not – it’s about as objective as you get.
Michael Yee
If it’s strong statistically significant – well, first of all, if it’s strong significant data, would you have talked with regulators and see if they would accept that?
Stephen Hoge
Of course. I think it depends on the strength of the data, of course. And there’s by no means any requirement for regulators to take a non – it’s not a pivotal study. It wasn’t set up with registration intent. Yes, it’s a 150 people as an RCT, but it’s entirely appropriate for them to ask us to do confirmatory work. And so, I think that should probably be the baseline assumption, but there is an upside case. And look, regulators are like all of us scientists and respond to data. And we all want to look at that data and then make a decision about what we do now.
Michael Yee
Okay. We’ll wait for that press release shortly. On RSV, if I may go to pivotal, randomized controlled, very large Phase 3 RSV study, GSK and Pfizer have put out data. I think GSK is in one of these rooms around here. And they have reported very strong 80% VE efficacy against severe RSV. I think Pfizer for severe is in the ballpark of that number. And congratulations. We now have an RSV vaccine for people. That is a big thing. And you also have a randomized Phase 3, which is accumulating events and could read out as possibly as early by the end of the year.
Stephen Hoge
Possibly. Yeah.
Michael Yee
That’s what the guidance is [showing] [ph].
Stephen Hoge
We know it’s a huge RSV season, unfortunately. You just need to log on to the public health systems and see that. So, we enrolled 35,000 people internationally, a large portion of that in the United States, but it’s truly global as a study. And we’ve been accruing cases at a pretty fast clip on that study, not so surprisingly. We are looking at the same sorts of endpoints of three symptom disease, which is the severe disease, and two symptom disease. And our first interim analysis will be on 43 cases. We presented what we thought was the power on that analysis.
Michael Yee
71% VE.
Stephen Hoge
Right. Very good. And, you know, it – and then obviously the second one is at 70 cases. And as we’ve said, given the pace of RSV infections are happening in the country and perhaps in our study, it’s not a reasonable to expect that to happen this year, perhaps one or both of those, certainly the first one and possibly the second one. We have to – once we have it, go to a [DSMB] [ph] with that. And again, as was with COVID, and we all kind of learned this, that DSMB may say, looks good, keep going or say, you know, great, let’s unblind, and we’ve got something to talk about here at the first analysis, and that doesn’t necessarily preclude what the answer is in the second.
So, we’ll be looking to both of those. I think we’re really impressed by the success of the other two platforms in terms of developing RSV vaccines. The VEs and the 80% haven’t gone unnoticed because our powering was for a more conservative assumption about [indiscernible].
Michael Yee
Protein adjuvant platforms.
Stephen Hoge
We have tended to see in the COVID space, including, you know, in head-to-head studies like we’re done in the UK, [COVID boost] [ph] that we see very strong, perhaps the best neutralizing titers and T-cell responses. against some of those other platforms. And so, while it’s a different antigen, different context, we’re pretty encouraged and we’re hopeful that we’re going to be at that level or better when we see those VE numbers. And so that actually gives us probably a better chance than not of seeing a benefit in one of the early interim analysis.
Michael Yee
Well, I would think given the numbers of the others, 80% and the VE is 71%, I presume we will stop at the first one. Now stopping could be 72, 73, 74, etcetera, right? We’re looking for to be really nice and competitive at least in the ballpark of 80. Can you comment on what does it mean if you’re 80? What does it mean if you’re 85? What does it mean if you’re 75?
Stephen Hoge
I think any of those numbers, you’ve got a vaccine. First point. All right. And from our perspective, we would be racing forward to filing. And our goal would obviously to be in the first wave of RSV vaccinations that are happening out there. There’s probably a few hundred million people that need to catch up RSV vaccination. Again, these are being studied in variably different populations, but 60 plus and there’s going to be an incredible demand for getting those people protected against seasonal RSV infections.
Whether you do this every year forever, like a like a flu or whether you do it every third year, you know, I think we don’t know yet. Nobody has the data to follow those epidemiologically, but let’s just, whichever one of those it is, we definitely want to be in in the game. Obviously, we would want to have the highest VE, provide the best durability and make the case for our vaccine being the best, but I think you going to be realistic. All of these studies have pretty wide vaccine efficacy estimates right now. Right.
You know, they’re plus or minus, you know, a decent amount. And so it’s pretty likely…
Michael Yee
You are talking about the conference intervals?
Stephen Hoge
The conference intervals on the VE. And so it’s pretty likely that they will overlap and that an honest, you know, sort of scientific characterization in the first wave of this is that it’s going to be hard to tell the difference. Now, as the studies mature and events go up and you go from 40 cases to a couple hundred cases…
Michael Yee
Right, we learn this with COVID. The number does range as you get to the next and third as you get. Right.
Stephen Hoge
So, I think the more likely outcome, most likely outcome just as function of number of cases, and the fact that both of Pfizer and GSK data and ours will be on the early side is that you won’t be able to say there’s a statistical difference even if you get a higher point estimate until a little bit later in the evolution of these studies.
Michael Yee
Right. Well, Wall Street will immediately react. Whatever the point estimate is, 79, 77, 82, that’s fine. You believe that you will be in the zone of those and you will be filing and you will duke it out with them in the commercial market or in the market.
Stephen Hoge
For sure. Yes, we – what we haven’t talked about is the flu study, which is going on too, but so we get from then [Multiple Speakers] You point about [indiscernible] and a commercial market, there are the top three respiratory causes of infection, seasonal infection disease, cost in healthcare systems are our COVID flu RSV for older adults. In all cases, now that we have the RSV data and we don’t have ours yet, but the general proof point, these are preventable costs, and what we want to do is, we want to be the company that provides the solution to all three, both monos and potential combos.
Michael Yee
So, that bridges us into flu. But again, going back to, hey, if we have something in the zone, A, we will work to duke it out commercially. The numbers may change as you go farther out as well. And third is, hey, look, you know, we could potentially do a combination. I know that’s far out for people, but conceptually, that is a strategy. And you believe that you can do that without, let’s say starting with two. By the way, you have COVID RSV, flu RSV, COVID flu, the permutations.
Those are our ongoing and that you believe that that would provide efficacy without the [immunoreactogenicity] [ph] issues or side effects that are bothering some people when they think about that. So, correct that assumption because people do think. I mean, first, they thought that with the flu data. Okay. That’s why the stock went down. And then other people are saying, hey, how you – I felt bad after getting in the COVID. How are we going take too, Steven?
Stephen Hoge
Yeah. Look, I think so, first of all, I stand behind with the three monovalent vaccines first. And we can do portfolio contracting around that too. And we – and it’s important to note that these are all three have one thing in common. They’re seasonal.
Michael Yee
That’s interesting, portfolio contracting. Hey, we do already with the dominant provider…
Stephen Hoge
Respiratory solutions for governments or payers that provide some flexibility between these things based on the epidemiology. So, there’s a collective view there independently for the models. I think on the combos, we have to be, I think we believe that we will be able to find the right dose combinations to make the different combinations work. And over time, we think that healthcare systems will want that because, you know, the administration costs again in the CMS data for a single injection is $40.
Michael Yee
By the way, that 40 goes to the Walgreens, not you. Okay? So, that’s – I know it’s 65 plus 40 is 105, I was thinking [indiscernible].
Stephen Hoge
And you got the cost, several bucks in the vial, I mean, just for the individual [indiscernible]. There’s a huge amount of cost associated with just delivering the shot. And multiply that by three, it’s not in anybody’s interest. If you could take that away through combination, it creates economic value. Frankly, value you could split pretty quickly. That’s approximating the value of some of these vaccines. And so, we do believe over time the right answer is, these are seasonal viruses.
We deliver them for thousands of years. They’re not going away. And what we need to do is find a very cost efficient way of preventing the health outcomes. And that’s where combination comes in, but that doesn’t mean we’re going to get it right in the first. We’re running those combination studies as you said. We’ve actually even started the study for the triple combination of RSV flu COVID. And by all means we expect to get to optimal combinations, but that doesn’t mean that in the first iteration we won’t be titrating the doses against each other and looking at things like reactogenicity to make sure that we get the balance right.
What the data tell us what to do? But we’re pretty confident we already know. Our technology allows us to do combinations. And what we really need to do is, find the right mix of doses to get to the right profile to make that …
Michael Yee
Is there any data yet that has two different strains in one that has been given yet or should I just think about, hey, it’s 50 micrograms, and then this one was 50. So, adding 50 plus 50 to 100, and we have given a 100. It’s not like that math.
Stephen Hoge
So, we actually do have a program from back in the day. hMPV/PIV3, these are two respiratory viruses. They’re number 4, number 5 on our hit list for going after. A combination vaccine that had gone into adults and pediatrics and they’ve looked at 50/50 masses, but 50 micrograms, a 150 micrograms, a 150 micrograms in that Phase 1.
That’s been published and presented, and it’s actually a program that’s evolving to an hMPV RSV combo for pediatrics, which is a population where those two virus are really important. But the short version is, we do already have some data on the combination of different viruses. But I think what we’re going to – what others experience would tell us, other platforms, all platforms, is that whenever you do in combinations, you also need to think about the antigen, what’s the virus, and what’s the, you know, just titrating those doses against each other is something you’ll have to figure out. So…
Michael Yee
Would flu RSV have less reactogenicity because people have either seen that already? Because remember, when you’ve seen the disease before, as with COVID, the reactogenicity is supposed to get lower by the third and the fourth time. I’m not going to survey the audience, but presumably it’s less than the first time we had the prime. Therefore, with flu and with RSV or others from that [same box] [ph] or about flu, people who got flu. But the reaction is, it should be lower because they’ve seen it already.
So, it’s not like adding it up. Oh my God, we’re getting two of them. Flu, there could be lesser excesses. People say and your flu data [indiscernible] close out in the last minute because your flu data is coming. How to interpret the flu data? Because people said, your reactogenicity on your flu data wasn’t low and therefore people got, kind of bearish on your platform. Tell me about the flu data and why you think it would be okay from a tolerability standpoint? [Indiscernible]
Stephen Hoge
Yes. Yes, of course. So, on the flu data, we did see reactogenicity was more online with what we see with a COVID vaccine, the boosters for that study. It was a small study. And so I think we need to go get the data in the thousands of people. We’ve already run two Phase 3 studies right now, and we’ll look to that data to guide us the final answer in reactogenicity. We do expect it, I wouldn’t be surprised if it’s higher, given what we saw on the Phase 1, than what you would see with standard dose flu vaccine.
The real reason we’re pursuing those doses, because you can back off on the doses and back off the reactogenicity, is we want demonstrate superior efficacy. That’s not going to happen in the first phase three, that was an immunogenicity study, but the second Phase 3, which is ongoing right now, which could read-out this season, is a head to head looking at whether we can demonstrate superior efficacy. And I think that’s the calculus that we think based on our conversations [ad boards] [ph] and payers and others that’s worth looking at, which is where the high-risk populations would do better…
Michael Yee
Like the older people. So, to be clear, the strategy initially is while people are looking at reactogenicity, and it may be higher. If you can have higher efficacy, there’s a market there for you to go after. You think your platform will show that there is a head-to-head infection study ongoing and you’re given the full dose and you think you will show better infection rates.
Stephen Hoge
That’s the purpose of that study.
Michael Yee
Alright. Thank you for the summary. We’ve got a lot coming up in the next quarter, two, and three and 2023. So, thank you, Stephen. Appreciate it.
Stephen Hoge
Thank you, Mike.
Michael Yee
Very good.
Question-and-Answer Session
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