Moderna, Inc. — 2024 Q1

On the RSV contract. So as you know, we are not allowed to contract until the product is approved by the regulators. But what we are doing, because we can do that, is our medical teams are actively engaged with retail pharmacies, but also IV and hospital networks in terms of making sure the data on the efficacy profile of the product, on safety, and of course, in the PFS and the benefit of PFS in terms of productivity. Those discussions are ongoing literally on a daily basis, including with leadership of those pharmacies. And the next step, of course, is to wait for the FDA approval. Stephen?

Yes, sure. So thanks for the question. So on the 3 additional INT indications, I think the short version of it is they are all adjuvant settings. Similar to our melanoma Phase II results have been so encouraging, where KEYTRUDA has a known benefit and where we still believe that there's an opportunity to improve on that by driving a specific T cell response with INT.

Yes. Maybe I'll take the first one. Thanks, Mike, for the question.

And your question on INT. I think you nailed it, it's a really important topic, and in particular right now, as we think about accelerated approval that we demonstrate the diligence and substantially enroll the confirmatory study. So really all you're waiting for is for that study to mature, it could be several years.

Thanks for both questions. So first on RSV, caveat by saying we have to complete the approval process with FDA. And then at the end of the day, the recommendation really falls to ACIP and the committee members, so I defer to them.

On the question of flu, we are actively engaged right now on the -- with regulators on the process for submission of the flu vaccine. As I mentioned a moment ago, we are also closing in on clinical data from our combination flu COVID vaccine, mRNA-1083. And that obviously has an important role in our engagement with regulators, generally on flu versus flu COVID combination.

So first, on the question of boosting. So far, what we have -- we obviously don't have the efficacy readout. That's the Phase III study is ongoing. But we do expect to have quite substantial durability data on immunogenicity. And it's quite possible that the efficacy data will give us a signal what the core of production could be.

Great. [indiscernible]

Yes, I'm here. Can you hear me?

Right. Sorry for that brief interruption. So Hartaj, thank you for the question. Just to quickly restate what I was saying. The -- all of our respiratory portfolio, RSV, flu, COVID and the flu COVID combo are being developed towards refrigerator stable PFS. And so our mRNA-1083 program, the flu COVID program as well as the flu program are intended to be a refrigerator stable prefilled syringes. As Stéphane mentioned a moment ago, we really view that as the ideal presentation, the helpful presentation for health care providers really around the world to facilitate their delivery of the vaccine to patients.

Gena. It's Stéphane. I'll take the COVID question and then Stephen will talk about INT. So the tender is up to 36 million doses, will depend on a number of countries that apply to the tender through the EU. So this, we'll know at the end of the process. And as it's a tender process so there is no dialogue, we're just entering all the files and all the data, and that's really ongoing. The team is obviously very active on it.

Yes. So we haven't specifically guided to when we expect to complete, obviously, the second and third parts of our 3-part criteria. That being manufacturing readiness, as you can imagine, work is going on around the clock as well as the enrollment we've made great progress, but we have to sustain that progress.

Great. Perfect question. I'll take this first from the third very quickly. So on the function of RSV, we continue working towards the same PDUFA date, and there's no change to that. As you know, there's a lot of work and around the clock work by ourselves, obviously, and folks at the agency.

And I'll take the IP questions. I mean as you know, our COVID-19 vaccine technology, including our lipid nanoparticle delivery system is the result of independent research and development. We have a strong belief that our technology does not impact on the patent asserted by [indiscernible]. We are confident in our position, and we look forward to presenting our case after next year.

Great. I'll start with the INT question on manufacturing, then Stephen can add around [indiscernible]. So we have not provided some capacity numbers of the factory in Marlborough. But of course, as you can assume, we now the size of melanoma market. And we know our stronger data. We [indiscernible] people benefiting from the Phase II data.

Thank you for the clarifying question on flu. So let me just start by saying that independently, we are looking to submit both the flu program and the flu COVID combo program. So that's 1010 and 1083. Obviously, we need to see the 1083 data, and we'll announce that when we have it.

This is Alex Hammond for Geoff Meacham. So on your [ zoster ] vaccine candidate, when should we receive updates on your pivotal strategy? And is there any color you can provide today in terms of your current thinking on the Phase III design?

Yes. Could you describe about the first part of the question was on which program? The zoster?

The zoster, the shingle.

Shingle zoster. So on the [indiscernible] program, we have -- we're obviously very excited by the Phase I data, which was compared against a licensed product, and we saw really strong T cell response in immunogenicity. And generally, we've been in that across our programs. But in that one, it was very encouraging.

Great. So for the 1083 data, yes, on this quarter, and I would say that we're -- we enrolled the majority of the 1083 studies you know last fall. And the 1010 second-generation study. So we talked about the P303 study. The first part of that enrolled over last summer, just a few months before the combo study.

Sure. So with internal markets, obviously, very important, the U.S. is very important, the U.S. and Russia also super important. As we shared before, we found in all the major geographies already. Of course, EU, U.K., Canada, Australia, some countries in Asia, some countries in the Middle East.

So first on the clarification. There's no change to our expectations on when the CMV readout will happen. I think we previously tried to be careful in saying that we expect it to happen this year. And so obviously, by the end of this year, it is meant to say the same thing, but there's no change in our expectations at this point.

Maybe I'll take the first one, Ed. So we obviously know what we're spending, [indiscernible] but at this point, that we are not prepared to disclose. So maybe someday, but not at this time.

Yes. On the expansion indication. Look, at the joint decision, our partnership with Merck has been really strong. We've been building this out. We do like to review those strategically and then bring them forward once we've started them. And so I don't want to get ahead of that because those are our private strategic competition with Merck. But we are not done yet. We will keep adding in the years ahead.

Well, thank you, everybody, for joining in today for a great session. We look forward to seeing you at latest ASCO. Have a great day.