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

Stephen Hoge: Maybe I’ll take the first — the second part of that question and then hand it over to Jamey for the first. So, on RSV and the need for it, obviously, we’re continuing to follow the public health situation in terms of the rate of occurrence of the RSV epidemic this year. At this point, I think we don’t have data yet on whether or not it will ultimately be an annual or something less than annual, say every two or three year vaccination regime. I think like everybody else, we’ll be looking to our data, the other manufacturers’ data, as well as the public health, the epidemiologic data to guide that decision. There are plenty of vaccines for which there is an approach, flu as an example, where there’s a seasonal vaccination approach, both because of the benefit offered by the vaccine, but also because of the convenience of just making sure that every season, every year, people are reminded to get that vaccine.

So, the ultimate decision on whether this is going to be recommended is not ours, the manufacturer, it will fall to public health officials based on a number of factors, which will include the [indiscernible] and the data we provide, but other factors as well. And we’ll work to make sure they have the data they need to make that decision.

Jamey Mock: And I’ll take the first part. Thanks, Luca, for the question. I think the short answer is the opportunity set ahead of us, and we are acting. So, you referenced some of our competitors, so I just want to break that down. I mean, we are super encouraged by the opportunity for additional growth and our ability to impact patients. And we have this 15 products that we think will launch by 2028 or by 2025. We think that’s the right thing to do. We have to grow out of our, we have to grow this company and to be able to afford the investment to be able to capture the unparalleled opportunity for this. And I think we are acting, I believe we are acting, and I mentioned everything that we’re doing from a cost of sales perspective.

And so I think that’s very much in line and sized appropriately to have volume leverage when it comes, because it will come. And we are saying in 2024, we can adjust both R&D and SG&A down to a good level, down 6% R&D, down 13%, so, on SG&A. We are largely committed to our registrational trials for 2024. But as I mentioned, we don’t have as much flexibility in that particular year, but by 2025, we have even more flexibility. So we’re prepared to take action should we need to, but we’re very optimistic about the price line that’s coming. And hopefully this will just come through growth, and we’ll still be able to afford much of this investment.

Stéphane Bancel: It’s Stéphane. Just maybe adding to Jamey, who said it super well. As you know, we have a platform company. And the [indiscernible] success of those programs we feel very good about. If you just look at with COVID and Phase 3 RSV — sorry, and Phase 3 for RSV and Phase 3 for flu, we have three out of three positive Phase 3. This is not your industry average. So, we think we can create value and create return on capital for shareholders by investing that capital to high-priority projects that are in late-stage pipeline. As I said, we have the largest late-stage pipeline of any mRNA company. We have six programs right now. And as soon as we launch [indiscernible], which is very, very soon, there’s going to be seven programs. We believe the best way to create returns for shareholders is to invest that capital to drive sales growth and profitability.

Luca Issi: That’s it. Thanks so much.

Operator: Our next question comes from Michael Yee with Jefferies. Your line is open.

Unidentified Analyst: Hi. Thanks for taking our question. This is Dina on for Mike. I just wanted to get a sense of your assumptions for Q4 COVID jabs and what are you seeing in Q4 right now? How much of that is actually jabs and actual injections versus channel fill? And just to follow-up on that. Now that you’ve seen sort of half of the 2023 fall season play out, what are your assumptions for 2024 and 2025 for COVID? Are you essentially assuming that the same people who got vaccinated this year will continue to get COVID vaccine every year? Thanks so much.

Arpa Garay: Thank you for the question. In terms of the fourth quarter ’23 jabs, what we saw in 2022 is there was a significant portion, about 45% of the total COVID vaccinations happening in November and December. This year, we’re expecting a similar split, likely larger, given that we launched two weeks later into the season in 2023 than we did last year. And what we are hearing from our different non-retail customers as well as our retail pharmacy partners is they are planning vaccination campaigns and marketing efforts to really capture on the November and December months. So, in total, we do anticipate getting to at least 50 million doses this year, and we do believe that November and December will be strong months for us.

In terms of 2024, our assumption is everyone who has gotten their booster in 2023 will at least get their booster also in 2024 and beyond. Now, given the higher burden of disease with COVID, as consumers become more understanding of the annual recommendations and as the convenience of getting both flu and COVID becomes more normalized, we do believe over time we’ll start to see some increase in the overall COVID market.

Operator: Our next question comes from Hartaj Singh with Oppenheimer. Your line is open.

Hartaj Singh: Great. Thank you for my question. I just got a question on the combination programs. And just to give a little bit of — frame the question, in other therapeutic areas, aside from vaccines for infectious diseases, for example, oncology, monotherapy treatments generally tend to be minority of treatments, 10%, 15%, 20%. Currently, monotherapy vaccines dominate the market in COVID-19 flu. So when you get the combination vaccines going, do you imagine — does your market research tend to suggest that you would — again, probably a combination approach might dominate that versus a monotherapy approach, singular vaccines going forward? And then secondly, will the cost of goods sold be any different for the combination versus the monotherapy products? Thank you.