Moderna CEO Stephane Bancel Talks Fourth Quarter Results

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Moderna rising after the pharmaceutical manufacturer reported 4th quarter revenue that beat estimates. The company saying it captured a greater share of the COVID vaccine market in the fall. What it also expects regulators to approve its 2nd commercial product this year, a vaccine for RSV. CEO Stephane Bancel calling 2023 a, quote, year of transition as we adapted to the endemic market. Stephane, I'm pleased to say, catches up with us again. Stephane, you've been a wonderful friend of this program over the last year or so. It's great to catch up with you again, sir. I just want to go to that market share story around COVID vaccines. How did you do that? Where did that come from?

So a lot of hard work and also being able to communicate to doctors that the 2 mRNA vaccines are not the same. And so if you look at the real-world evidence, we have actually less hospitalization of people on the Moderna vaccine than the other vaccine. We've also been partnering with pharmacies to make sure we get the message out. So the team has done a lot of different activities to ensure that We get the share that we think we deserve. We had 30% share in 2022 and we're very pleased to have 48% share in the fall of 2023.

Stephane, do your investors still ask about COVID vaccines or are they much more interested in, say, a melanoma vaccine or some sort of using this technology to prevent cancer?

I mean, both. If you think about Moderna, there is much more to Moderna than COVID. So on the one hand, they want to understand the COVID sales and how we're going to grow the COVID sales. And layer on that RSV sales and then flu sales, because the respiratory franchise is going to be an anchor to Moderna forever because those viruses are not leaving the planet. But of course, we are very excited about the future. I mean, we have a 9-product in-licensing pipeline, including cancer, but also, you know, rare genetic disease. And so it's a very exciting time for Moderna because they're getting the existing products, but they are looking forward to the sales growth delivered by the pipeline.

So on one hand, when you talk— when you talk about RSV or you talk about COVID there's the question we were talking about regulatory risk, the regulatory boon of, say, the CDC coming out and recommending that everybody get these shots every year or mandating it for certain positions. Are you expecting that to be the case with things like RSV?

I mean, if you think about RSV, it is mostly a risk for the elderly and the very young children. So I think the current guidelines of vaccinations for the elderly makes a lot of sense. And we were all very surprised actually about the number of people who got the RSV shot last year. You know, it was much higher than any analyst had forecasted. So we're very excited because not only we have a great product in terms of efficacy, a very good safety profile, but if a product is approved by the regulators, which could come as early as May 12th, that's the FDA PDUFA date, we could be the only product available to healthcare professionals in a pre-filled syringe. And that's really important. As you know, there's a lot of labor shortage in healthcare professionals, especially very acute in pharmacy retail chains. And if you think about the fall season, the pharmacists are very busy. They have to do their usual work, delivering a lot of products for people and flu shots and COVID shots and now RSV shots. But the 2 products available on the market are pretty tedious. One of them is 9 steps of preparation. The other one is 4 steps of preparation. Well, Moderna, again, if approved, will be the only product that is pre-filled syringe. You take it out of the fridge, you clean the arm, you inject it, you put a Band-Aid, you are done. I really believe that healthcare professionals are going to be delighted with our product.

Stephane, that's what I wanted to ask you. You mentioned COVID, flu, RSV, so many vaccines individuals need to get in the winter. So if you had this one shot, it would save a lot of time. And frankly, it'd be a lot easier probably in appetizing people to actually go out and get it. But what is the timeline? When can we see that actually go to market?

So that's one of the other exciting news coming for '24 is we shared last year the phase 2 data of our COVID plus flu combo in a single dose. We should see this year the phase 3 data based on the platform that we have and what we've seen with COVID With RSV and flu. I expect the phase 3 to be positive. If it is positive, we'll file it to regulators. So you could see this available in pharmacies as early as the fall of '25. So that's another exciting differentiation we will have versus traditional flu players and traditional COVID players.

Stephane, I know we're against the clock with you. You've got a busy morning. I just want to squeeze this in. The RSV shot, what are you learning about the durability of the protection it offers? Because as we understand, based on recent reports coming from you, maybe it doesn't last as long as the competitor and their offering does. It makes me wonder, does that affect approval? Is that going to affect your competition against that competitor as you unroll that one out?

Yeah, actually, if you look at the data, we're very confident about our profile. And if you look at the data of your vaccine, they also wane. And so if you look at what we're going to have in the marketplace, I think it's going to be very, very similar to what's available today. So I don't think that's going to be an issue at all.

Stephane, got to leave it there. We promised that you'd escape at about 7:38, so you can. Stephane Bancel, the Moderna CEO. Thanks, Stephane. Great to catch up. Thank you, sir.

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