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

Operator: Our next question comes from Michael Yee of Jefferies.

Dina Elmonshed: This is Dina on for Mike. Just a quick question on the flu update. So I saw that you guys are doing a Q3 update for the second immunogenicity study and then going on to have data in Q3 with that. But how about the efficacy study from that second infection or that – yeah, that previous infection study? What are your timelines for that? Have that shifted? Are you going to share that? And also on PCV, are you going to be sharing any additional updates on the regulatory path moving forward? Or are you sharing any other updates on lung, et cetera?

Stephen Hoge: First, on the 1010 flu program, as you referenced, we have two ongoing – we have actually three ongoing Phase 3 studies, but two that are continuing to accrue data. We’ll be providing updates on the efficacy study, the P302 study you referenced. And as you know, on our Vaccines Day, we talked about an end-of-season update. And we’ll also be sharing where we are in the pivotal P303 immunogenicity study. And as I said, we’ll be doing that this quarter, and we’re excited to continue to update on the progress in influenza. As it relates to INT, now INT, not PCV, that program, we had a great opportunity to provide an update to you all and everyone at ASCO just a month ago. And we’re going to be, of course, at our R&D Day reprising that.

And also talking to some of the other progress happening in the INT program. We are obviously working hard to get up and running in our non-small cell lung cancer, but we’re really – pivotal studies, but we’re really excited by the start of the first Phase 3 with melanoma study now, and we’ll be providing further updates in a month in New York.

Operator: Our next question comes from Ellie Merle with UBS. Your line is open.

Unidentified Participant: This is Sarah [ph] on for Ellie. Just a follow-up on Tyler’s earlier question. Thinking about COVID volumes going forward, can you give more color on how you’re thinking about first half versus second half? Particularly, any color on your expectation for first half of next year? And then on CMV, any expectation on when you’ll complete enrollment? And how we should think about when we could get data and maybe anything you’re seeing on a blinded basis on the event rate?

Arpa Garay: I’m happy to take the first question and then will hand it over to Stephen on CMV. In terms of how we’re thinking about the first half versus second half going forward, in the first half of the year, sales that we expect will come from the Southern Hemisphere, where it is their fall and winter season. Additionally, in some countries, in the higher-risk populations, there continue to be spring campaigns and boosters, particularly for immunocompromised, elderly and highest-risk patients. So we do anticipate some sales coming in for the high-risk spring boost for the Southern Hemisphere as well as any carryover from late winter of this year into January. The majority of our sales will continue to be expected in the second half of the year, though, as the majority of our sales will be anticipated from the Northern Hemisphere and the fall vaccine campaign.

Stephen Hoge: And on the question of CMV enrollment, yes, we’re really excited by the recent acceleration toward completion of enrollment there. We’re past 80%. We do hope to complete enrollment shortly. We’ve made good progress in the first half of this year, and so we haven’t specifically set a target on that, but we would hope to enroll it for sure this year. Then we will be accruing cases, and I think that’s where it gets very interesting in tracking the CMV Phase 3 program. We’ve already started to accrue cases that we talked about in the Vaccines Day. And as we get to full enrollment, we will have more participants who can contribute cases to our first interim analysis of efficacy, which will be an event-driven analysis, and so not something we can predict the timing of.