Brian Ford: First and foremost, thank you so much for the question. We’re really, really excited about this next potential opportunity. As you may recall, back in August, the FDA, in quite a unique move, granted us breakthrough designation at that time and that was off of the first trial. Since then, we read out the second trial, both trials positive and exacerbations, we filed, we announced we filed as of December 27th, and so we are waiting regulatory feedback or feedback from the agency as we speak. We are anticipating, as we said earlier in the pre — setup that we did that we will be launching in 2024, still to be determined whether or not it will be a prior review or not, but we will see.
Paul Hudson: Okay. Thank you. Anything else, Houman? No? Okay. Good. Thanks, Jo. Next question?
Eva Schaefer-Jansen: The next question is from Tim Anderson, [Roche] (ph).
Unidentified Analyst: Thank you. Yep. I have a couple of questions on Beyfortus, if I could. Can you describe the longer term opportunity and how it parses out by geography, meaning US versus ex US? Is this one of those products where it will be most likely, most sales coming from the US as it often is with different products? And then second question is your views of potential competition from Merck, they have this product, clesrovimab, in Phase 3 data in the back part of the year, implies a launch in 2025, also monoclonal. Any first impressions of that product based on what you know today?
Paul Hudson: All right. Thomas, breadth of launch, and some thoughts on that.
Thomas Triomphe: So to the risk of disappointing you, Tim, I might not give you a spreadsheet with a detailed forecast by geography over the coming years. But of course, we are very encouraged by the Q4 launch of this year. As said before, we are doing everything and we’re confident supply will not be an issue. And we’re doing — we’re looking broadly in terms of geography. You have noticed that we just got the registration Beyfortus in China. And we expect to have the registration of Beyfortus in Japan in the coming few months. And we will progressively start launch in China and in Japan at the end of 2024. So but we’re really going as per as we named it, for an all-infant protection, it will be a progressive rollout. Geographies such as China, as you’ve seen it with multiple vaccines, do take time.
So it will be a progressive [solutions] (ph). But the opportunity, if I look at the mid- to long term, could be significant. This year, in 2023, the sales are about two-thirds US, one-third EU, and that might be the perfect presentation for the short term, but again, RSV is everywhere, and we want to go for all geographies progressively one step at a time. For the competition aspect, there are two players, as you know very well. One, which is already licensed. This is about maternal immunization. So I think it’s very clear. The fundamental difference between Beyfortus and maternal vaccines is that Beyfortus is designed to protect all infants, and maternal vaccines cannot by design. And back to the previous question from Luisa, please have a look at the Galicia results.
When there is more than 90% coverage rate in early infant, the impact against hospitalization is impressive from year one. And for the other products, the Merck product is in Phase III. We cannot comment on it. We don’t have data about the Phase III. The only thing I can say that I do believe that the bar has been set in terms of standard of care. And if you look at the profile of Beyfortus, not only in the efficacy, which is impressive as [per the disease data] (ph), but also in terms of safety. And we are talking here about the most fragile part of our population here with the newborn. The safety profile of nirsevimab is just pristine. So I think that’s right, but now let’s look at the Phase 3 results for the Med product.
Paul Hudson: Okay. Thank you. Thanks, Thomas. Thanks, Tim. Next question?
Eva Schaefer-Jansen: The next question is from Peter Welford from Jefferies.
Peter Welford: Hi. Thanks for taking my questions. I’m going to speak first of all, just Beyfortus again if you can. Did you just — when did you comment at all about the phasing? You made a comment the first quarter, you don’t have supply, but I think at the same time, you are delivering doses still to the US, if I’m not wrong, but those sort of carry over. But should we then anticipate, Beyfortus sales dip and then rise again before the winter season? Or I guess, do you have any plans at all for the southern hemisphere, that also we should be considering during those middle three quarters. And just curious, the [specific near 2 million] (ph) that was given, was that the US alone, or is that, across all the regions so far where Beyfortus has been launched?
And then the second question, just one for JB, just on the P&L. The increase in other operating income during the quarter, you referenced in the release something to do with litigation related payments. Wonder how much of that is to do with it, or could you just quantify a bit what it was that that led to the significant increase in the [indiscernible] in the quarter, perhaps relative to expectations? Thank you.
Paul Hudson: Thomas, so maybe some thoughts on Q1, what you can share on phasing and have the distribution of the almost 2 million doses that we put up already in the schedule.
Thomas Triomphe: So first on the first question, the RSV disease is, of course, a very seasonal disease. And therefore, you will see that it will be a cadence if you wish NH countries will have their sales in Q3, Q4. South Hemisphere countries will have their sales in Q1, Q2. Due to the supply limitation and the fact that we are in the progress in the process, sorry, of ramping up supply, I would expect in 2024 that Q3 and Q4 are the key quarters for Beyfortus where you will see, as it was communicated a while ago, some small sales with the delivery of products in January, and we are looking for a couple of countries maybe for South Hemisphere countries. But again, from a significant sales perspective, it’s really about Q4 — Q3 and Q4 for 2024. And back to the point you mentioned, to be very precise, on the approximately 2 million doses of 2023, 2024, so it includes the seasons, i.e., it includes January, February. It’s really total, i.e., US plus Europe.
Paul Hudson: Okay. JB, the other end?
Jean-Baptiste de Chatillon: Yeah. Thank you, Wel. You realize that the ForEx is very visible on the impact on our P&L, but effectively more specifically, we had a few here and there, tens of millions of provisions that we had to pass in Q4, scattered topics, nothing in particular.
Paul Hudson: Okay, good. Thank you. Next question?
Eva Schaefer-Jansen: So the next question is from Richard Vosser, JPMorgan.
Richard Vosser: Hi. Thanks for taking my question. Question on INBRX-101 or the Inhibrx product. I think Inhibrx was highlighting the first readout at the end of ’24. So could you talk through the difference in timing with your second half ’25 timing and whether we will still see some initial data ahead of maybe the final data on the ’25? And then a question on flu, please. Obviously, flu vaccine [indiscernible] and we’ve been hearing about increased competition, I think you’ve referenced it too. So, are we back to a situation of Sort of overcapacity for the for the flu market, outside of high dose and outside of very old adults? So should we expect price pressure going forward? How should we think of the flu seasons going forward? Thanks very much.
Paul Hudson: Okay, good. Maybe, Houman, do you want to comment?
Houman Ashrafian: Yeah. So, Richard, thank you for the question. The short answer is, in terms of operational outcome, we expect the results in ’25. I don’t have any further comment on that, and we look forward to seeing those results. There are other elements to this as we bring the molecule in once the deal closed.
Paul Hudson: Okay, good. Thomas, getting plenty of airtime today. Flu, maybe comments on high dose and the differentiation piece and the thoughts on what it could mean for pricing in standard dose?
