Vas Narasimhan: Yes, thanks, Mark. So Kisqali, yes, no negative patients were included. On Kesimpta, so first on the ex-US dynamics, I think first it’s important to note, outside of the US, you don’t have the same structure as Part-B for providing an infused medicine. And in many of these healthcare systems, there’s a preference to move patients out of the medical centers and medical homes and more having at-home therapies. So in those key markets, we really see a dynamic. I don’t know the specific shares offhand, but we see a dynamic where we are being a favored class of medicines in some of the large ex-US markets. We have very strong performance in markets like Germany, very strong performance in markets like Japan. And so I think that’s really just a reflection of different dynamics in those markets where there’s a preference for neurologists to provide patients a medicine that’s easy for at-home use.
And we hope over time, as we now move Kesimpta more broadly across Europe and Asia, we have the opportunity to drive significant growth ex-US. In the US, there is different dynamics. Right now, we estimate that the B-cell class share of NBRx is in the mid 50% range, 55%. And over time, we expect that to continue to grow. Kesimpta’s share within the B-cell class is in the high 20s, 27% to 30%, depending on when you look. And we right now are growing with the B-cell class overall. But very much our goal over time is to grow our share of the B-cell class. And that’s something we’re very much focused on. That will take, I think, time for us to achieve, but that’s going to be important if we want to get well beyond the $4 billion guidance we’ve already given.
We think we can get to the $4 billion just by the march of the B-cell class. But if we want to do better, we need to improve our B-cell class share in the US. And that’s something we’re definitely focused on.
Richard Parkes: Thank you.
Vas Narasimhan: Next question, operator.
Operator: Thank you. Your next question comes from the line of Stephen Scala from TD Cowen. Please go ahead.
Stephen Scala: Thank you very much. I’m curious what happens with Entresto IRA price negotiation in 2026 when generics can launch in 2025. It would seem that if there were an Entresto generic, then Entresto would not be eligible for price negotiation. Is that how you see it? And has that come up in price negotiations so far? If yes, then the best case, it would seem, for Novartis would be limited generic competition, maybe even an authorized, which could turn out to be a plus for Entresto revenue. Thank you.
Vas Narasimhan: Yes, thanks, Steve. So it is a valid point. And our position would be if there is a generic that’s launched, that a medicine in our portfolio per the current — the guidance of the IRA would not be eligible at that point in time. So that would be our view. But I think, as you know, there’s many things that are still unfolding with respect to the IRA negotiation. I obviously can’t comment on our approach to the various generic entrants and our approach on how to manage that. I would say that, look for Entresto even beyond in the US, we guide to this 2025, mid-2025 LOE and a IRA. If we were to move, not have a generic enter in 2025, we would be IRA eligible in early 2026. So one way or another, we are going to have Entresto being impacted in this period of time.
What is important to note is, we guide to 5% plus 2023 to 2028 growth, even with Entresto coming out in the US and also coming out in Europe, given the timeline of our RDP in Europe. So I think we feel confident we can grow well beyond the Entresto LOE or IRA, however it ultimately happens in that period. Next question, operator.
Operator: Thank you. Your next question comes from the line of Matthew Weston, UBS. Please go ahead.
Matthew Weston: Thank you very much. Thanks for taking the follow up. It’s a follow up on Pluvicto. Vas, I think at JP Morgan and at the R&D Day, you highlighted PSMAfore filing in 2024. Now it’s the second half of 2024. So can you give us an update? Has anything changed? And also, can you just give us an update on your discussions with regulators? I know there’s been a lot of discussion about the modeled control arm, given the significance crossover. Can you give investors comfort that you’re still confident that it will be acceptable to FDA and regulators around the world?
Vas Narasimhan: Yeah, thanks, Matthew. So we don’t have any updates. The trial continues to accrue events. I mean, based on our current estimates, we think a second half 2024 filing is the right timeline to provide at this point in time. But of course, this will evolve as the events accrue. In terms of our confidence level, nothing has changed. When you look at the overall data set that you saw last year, you saw very impressive gains in our PFS. You saw impressive gains in ORR. You saw a high quality of life improvement, a relatively clean safety profile, even versus ARPI comparator arm. So I think a positive safety profile overall. So we think we have a very compelling case. We think it’s really a matter of getting to that higher resolution, both in terms of the adjusted analysis where we’re already below a hazard ratio of one, as well as a tighter radius around the all comers analysis as well for the OS.
And so this will be, of course, a topic of discussion with the FDA. But we think we can make a very clear and compelling case that this medicine should be offered to patients in the pre-taxane setting. And then we also are continuing, as I mentioned, to move forward rapidly on PSMA addition, as well as Pluvicto in the oligometastatic setting, so we can cover all of our bases. I do think overall as an industry, we’ll learn more with some of the upcoming [adcoms] (ph) from other competitor medicines on how the FDA is thinking about OS crossover and how to manage this. And I’m hopeful that overall patient benefit is what ultimately rules out over some of the statistical pure — pure statistical considerations, given that we are encouraged to utilize crossover in our studies to be patient friendly in an appropriate way.
I think it’s very important we start to be looking at the adjusted analysis. Otherwise, this puts the overall the industry in a very challenging position. Next question, operator.
Operator: Thank you. Your next question comes from the line of Graham Parry, Bank of America. Please go ahead.
Graham Parry: Okay. Thanks for taking the follow-up. I just wanted to dig into some of the moving parts for the guide on generics. You sort of made some sort of high level comments there. But in terms of the ability to manufacture is seen that standard stat in LA. I think to have gotten approval. But is that a restriction a legal one? So is there any litigation around manufacturing, even if the — isn’t around the approval or is that a tech ops consideration? And then on Promacta, I believe there’s no litigation outstanding. You have a sole patent in 2026. So what are the moving parts for timing of the launch there? And is a 2025 or 2026 launch on Promacta even also still a possibility? Thank you.
