Moderna, Inc. (NASDAQ:MRNA) Q3 2023 Earnings Call Transcript

Stephen Hoge: And on the CMV question, thanks for that. So yes, we did update that we’re about a quarter of the way through the case accrual back in R&D Day. I think the next — we continue to accrue cases at a steady pace. I do think the next update will provide is likely our Vaccines Day in the spring.

Unidentified Analyst: Okay, thanks.

Operator: Our next question comes from Terence Flynn with Morgan Stanley. Your line is open.

Terence Flynn: Great. Thanks so much for taking the question. I know GSK has provided an estimate in terms of size of the RSV market, about £5 billion, and Pfizer has given some metrics as well. Given what we’re seeing now with these early launches, can you provide us with your assessment of total market size here? And then given some of your comments on competing with larger companies, as you’re doing in COVID now, where ultimately do you see your market share shaking out in the RSV space? Thank you.

Arpa Garay: Thank you for the question. In terms of the total RSV market, as I mentioned earlier, we’re excited by the uptake and the consumer awareness of the market overall. And our projections are similar to what both GSK and Pfizer have already guided. In terms of our market share with RSV, we have not yet provided or are ready to provide any forward-looking projections on share, but we are very excited about our strong product profile, both in terms of efficacy, safety, and, as I mentioned, our ready to use pre-filled syringes. So, we will be leveraging the learnings and the success from our COVID commercial launch this year and applying them to RSV next year.

Stéphane Bancel: Yes. Just to add to Arpa, Terence, it’s Stéphane, the point that Arpa and I made about the market share of COVID is what I think is very important. I think some people believe that because we’re a new company in commercials we’re not able to compete and I think the market share data that Arpa has shared really show that our U.S. team is able to compete and we will continue to improve things that we are doing, because we are not done improving the [indiscernible] culture as you know us. But the share already moving from 36% last year to 45% cumulative so far in the season, I think it’s already a demonstration of what the team is able to achieve. And the season is not over, so that’s 51%, so let’s see where this one finish when the season is over.

But basically, the [differential] (ph) we have, as I mentioned, I’ve been speaking to pharmacist leadership. And they are all, I think, have a very big workload issue, as you know. There’s even strikes in some pharmacy chains in the U.S. as we speak. And you think about the season there, [indiscernible] business for the pharmacy for preparations, and then the flu, and then the COVID. And then, as I mentioned, those two other products, if you just download the label of those products from the FDA website and you look at how many steps they have, it’s very complicated. And when you talk to a pharmacy leadership, they don’t know how they’re going to deal with that type of workload. And so, coming with pre-filled syringe is a tremendous differentiator.

We have very good efficacy. We have very good safety profile. We really believe that we have the best in-class product in the market. And [indiscernible], it’s going to translate, I think, into a very good effect.

Operator: Thank you. Our next question comes from Jessica Fye with JPMorgan. Your line is open.

Jessica Fye: Hey, guys, good morning. Thanks for taking my question. Just a couple coming back around to one that I think some others were trying to get at, but maybe a little differently. When we think about breakeven in 2026, what are you contemplating in that sales number embedded in your assumption? Does it reflect just respiratory vaccines? Or are you considering INT could be on the market then? And then second, I know you said the percentage of non-retail jobs would grow as the season progresses from where it has been so far this season. Do you believe that the proportion of COVID shots running through the retail channel has shifted at all, bigger picture in 2023 relative to 2022, or should we think of that proportion as remaining similar year-over-year? Thank you.

Jamey Mock: Yeah. Thanks, Jess, for the question. Again, without getting into too much detail on 2026 in terms of how we think about it, I mean, the best way to keep going back to that late-stage pipeline that we’ve been talking to you about, RSV, flu, our combination, our next-gen COVID product as well, will all be very much there for the year 2026. And we are confident in all those product profiles and how we will compete. As I mentioned, at 6%, our cost of sales — at $6 billion, sorry, our cost of sales would be 30%. At $8 billion, our cost of sales would be 25%. And of course, we’ll try to improve on that. And that will give us the envelope for how much we can continue to invest in the future products, which we said we’ll launch 15 by 2028.

That’ll be all of our latent product portfolio, that’ll be our INT portfolio, that’ll be our rare disease portfolio. So, I think that’s as much as we can say right now. I just want everybody to know that we are very committed to breaking even in that year, and we have a lot of flexibility, both from a growth standpoint and a discipline investment standpoint.

Arpa Garay: Great. And I can take the second question on the percentage of non-retail. So, as expected, in 2023, the retailers have been the majority of the market, with more than 90% of the volume during the first few weeks. However, we’re now beginning to see a shift towards more non-retail channels, as I had mentioned. We are seeing increased shipments to IDNs, to clinics, to pediatricians, as of the recent weeks. And as I think about full year 2023, I believe the retail mix will be stronger than in 2022 and could land at about 70% to 80% of total vaccinations, whereas in 2022, we saw that the retail channel was only about two-thirds of the mass.

Operator: Thank you. Our next question comes from Luca Issi with RBC Capital. Your line is open.

Luca Issi: Oh, great. Thanks so much for taking my questions. Maybe circling back on the P&L, I appreciate all the effort on resizing manufacturing and the focus on gross margin, but how should we think about OpEx plus CapEx? As COVID numbers continue to come down, we’ve seen the BioNTech and Pfizer materially realigning OpEx plus CapEx to their top-line. I believe BioNTech lowered by $600 million this year and Pfizer by $1 billion this year and $2.5 billion next year. However, your OpEx plus CapEx is not materially changed this year and you anticipate that the next year it’s going to be generally flat to down. So, can you just maybe comment on why you think that’s the right strategic decision for the organization? And then maybe second question on RSV.

Obviously, impressive initial launch by GSK and Pfizer and appreciate the differentiations of your product. But what’s the latest thinking on whether the vaccine is needed every year or less frequently than that? Is there a scenario where Pfizer and GSK penetrate the market pretty aggressively this year and then you face an uphill battle next year as it turns out that we need a vaccine maybe every other year and not every year? Any thoughts there much appreciated. Thanks so much.