Operator: Thank you. Your next question comes from the line of Florent Cespedes from Societe Generale. Please go ahead.
Florent Cespedes: Good afternoon. Thank you very much for taking my question. On emerging market, you delivered pretty consistent growth quarter-over-quarter. I was just wondering, how confident are you to continue to deliver such growth? Or is there any loss of exclusivity to come in certain countries, notably in China that could impact this growth trajectory? Thank you.
Vas Narasimhan: Yeah. Thanks, Florent. I mean — so we have, I think, very good growth in our international markets. In Europe, of course, we’re currently working on overcoming a number of expiries that we have, you have certainly Lucentis has recently gone off. You have other medicines that have recently gone off as well. And so the European growth has moderated, and then we expect Europe to come back now over the coming years as new medicines launch to replace those expiring therapies. China is seeing very robust growth, double-digit growth, which we continue to see in that market. We will, of course, come up against an Entresto inclusion in the BBP framework, but we expect we’ll be able to manage that. And then with the launches of other medicines, including Cosentyx, Leqvio, to continue the strong growth in China.
Japan is growing double-digit at the moment on the back of the Entresto launch, and we’ll soon be launching Leqvio as well in Japan. So, very dynamic performance in the Japanese market. So with all of those dynamics, we expect the international markets to continue to have very solid growth over the coming years, and that’s driven primarily by the new launches. Next question, operator.
Florent Cespedes: Thank you.
Operator: Thank you. We will now take the next question and the question comes from the line of Seamus Fernandez from Guggenheim Securities. Please go ahead.
Seamus Fernandez: Thanks for the question. So just two. Can you quantify the magnitude of contribution from Kesimpta in the quarter and also just give us a sense of the directional trajectory? And then just a second question we’ve been getting from investors repeatedly on PSMAfore relative to the FDA. Just wondering relative to the Lumakras questions that were raised around that study and trial design, how confident are you that PSMAfore is on track for approval? And can you just update us on the timing of the filing? Thanks so much.
Vas Narasimhan: Yeah. Thanks, Seamus. So on Kesimpta, Harry?
Harry Kirsch: Seamus, I assume the one-time contribution from the revenue deduction, right? So, as you have seen, Kesimpta overall contributed $368 million as growth to the quarter, right, being now close to $660 million total sales. And of that, roughly $110 million is from this revenue deduction true-up. So if you take that out, still significant contribution of roughly $250 million, $260 million, and also still a growth of 86%. Is that answering your question?
Seamus Fernandez: Yeah. Thank you.
Harry Kirsch: Yeah. Good. All right.
Vas Narasimhan: Yeah. On — I’ll allow the second question this time, Seamus. So on PSMAfore, so as I stated, our plan is to file with — when we get to 75% information fraction. And we do feel confident that given the overall data set that we have generated with respect to all of the data you hopefully saw at ESMO and in the earlier presentation that we have a very compelling benefit-risk profile. And we’ll have to then navigate that with the agency with respect to the adjusted OS and the unadjusted OS as well. We’re a little bit in new territory. And so far, FDA, I think, has made a significant shift affecting all cancer drugs with respect to the expectations of OS at the filing with PFS. But I think this is a really unique situation from the other situations that you mentioned.
One, this study was extremely well-designed and well-conducted. And you look at the dropout rates, which were very low because we allow crossover. You look at the timeframe with which we’re collecting the data, you look at the rigor with which we collected the data, and you look at the size of the PFS benefit where you have a doubling of the PFS benefits, significant gains in ORR, significant gains in patient-reported outcomes, a very clear safe — clean safety profile. I think taken together that is a very different profile than maybe what you were referring to. In addition, we have demonstrated OS in another study as well, which I think is an important factor as well when you think about this. Our belief is that with a 75% information fraction, we’ll have collected adequate data to demonstrate the overall profile of the medicine.
We’ll, of course, file it. We’ll deal with the review questions and then manage it from there. But I think based on all of the feedback we’ve heard from physicians and experts, very clear that this is an important medicine that needs to eventually get approved and get out to patients. Moving next slide, please. Next question, operator. Thank you. Thank you, Seamus.
Operator: Thank you. [Operator Instructions] We will now go to the next question, and the question comes from the line of Simon Baker from Redburn. Please go ahead.
Simon Baker: Thank you for taking my question. A slightly bigger picture question. Back in early September, you announced that NIBR was changing its name. I wonder if you could update us on what else is changing beyond the name at NIBR. Thanks so much.
Vas Narasimhan: Yeah. Thanks, Simon. We’re excited about the outlook now for what we call now Biomedical Research within the company. We’ve made a number of changes in our overall R&D strategy. One, we’re focusing very clearly now on four TAs, cardiorenal, neuroscience, oncology, and immunology. And you’ve seen also, I hope, in our filings that we’ve had a significant pruning of the portfolio down to what we believe is now approaching peer median in terms of the size of the portfolio, but that allows us to increase the number of scientists that we have on each one of our projects, which we hope will accelerate the prosecution of those projects, get us to data and readouts quicker, and hopefully get us to more and higher value medicines overall.
So we’ve focused the portfolio and focused our R&D operations. Second, we’ve really created a system now where there is early commercial input, even into research, something that Novartis had not really had between 2002 and last year. So now we have an integrated approach, we call it the RDC continuum, research, development and commercialization. When we enter — when we have a new project that’s going to enter into the portfolio of research that is reviewed by our executive leadership team to make sure we’re all aligned that this is the medicine we want to pursue, it has significant potential. We do allow, of course, the appropriate amount of experimentation within Biomedical Research, but we want that early commercial input to ensure we’re developing medicines that will matter for the world and matter for Novartis.
So there is also improved integration between research, development and commercial. And then, in addition, we’re trying to make research and development as seamless as possible. So now we are increasingly having integrated teams. So if you look at CART and Immunology, if you look at radioligand therapies, in some of our key areas, we’re having integrated research and development teams to ensure that projects move seamlessly Phase 1, Phase 2, no big handoffs, which I think will also enable us to move much faster. Lastly, we’re changing how we measure ourselves. We’re measuring ourselves solely on do we generate medicines in research that advance into late-stage development. If we generate data that’s interesting but not advancing, if we generate data that’s ultimately leading to out-licensed drugs, that’s not the goal of our company.
