Moderna, Inc. (NASDAQ:MRNA) Q2 2023 Earnings Call Transcript

And as we get enhanced profiles for flu, as Stephen mentioned earlier, from a commercial perspective, we see a tremendous amount of interest in our combination vaccines, both from patients as well as from healthcare systems. So having RSV and flu gives us an incredible opportunity for a combination for the future.

Operator: Our next question comes from Evan Wang with Guggenheim Securities.

Evan Wang: I just want to follow up on COVID. And as we’re thinking ex-US, any details you can share in terms of size orders and market positioning in some of your markets like Japan? And what could change in 2024? And in flu, just great to see the P303 study fully enrolled, Just want some updated thoughts in terms of confidence on hitting on some of the B strain, given some of the competitor updates.

Arpa Garay: I’ll take the first question. From an ex-US perspective, we have signed a minimum commitment with Japan that has been announced. The minimum commitment that we signed with Japan is just to get product into the country as soon as August, and so we’re ready to execute this fall. If their vaccine uptake expands, we do anticipate additional orders coming in from Japan. For the rest of the world, we have advanced purchase agreements that I have outlined already on – in that first column, as well as ongoing conversations with several other international markets, including those in the European Union. In terms of 2024 changes, what we expect outside the US is we expect more and more markets to actually be transitioning from central government procured to more of an endemic commercial market, such as the transition that the US is going through today.

So we do anticipate changes. Most of those changes will be around shifting where the procurement is happening as well as changes in pricing and reimbursement going forward.

Stephen Hoge: The flu question. So, yes, we’re fully enrolled in P303, ahead of schedule on that, and we will provide data shortly on the P303 study this quarter, as we said. As far as the B strains goes, we already updated earlier this year that actually in the P302 study, we achieved non-inferiority in the B strain, you’ll remember. In the P301, we had missed that. And so, we were learning as we went, and we actually made a series of changes into the P303 study that we were confident and remain very confident will provide a benefit in the B strains that will improve immunogenicity there. So I remain quite optimistic that our understanding of science is really strong, we think, best-in-class and that where we will be and when we look at that P303 data [indiscernible] is in a very strong position as it relates to B strains and continue to be in a very strong position as it relates to the A strains.

Operator: Our last question comes from Simon Baker with Redburn.

Simon Baker: Just two questions from me. One was, how has your view of the RSV opportunity changed in light of competitor two-year data and the ASIC recommendation? In what regard do you think that you can achieve best-in-class profile? And the second question was just a little bit more about the CMV Phase 3 enrollment and if you think you’ll be able to get full enrollment by this quarter.

Arpa Garay: I’ll start with the RSV question. In light of the ACIP shared decision-making recommendation as well as some of the data that was shared this year around revaccination, we do anticipate a slower vaccine uptake at the start. In terms of our potential in that market, we do continue to be very confident that we have a best-in-class profile. And as we get additional data from our own vaccine program, we are hopeful that the ACIP recommendation will be brought in and could be – will enable a faster uptick in outer years.