Q1 2026 Novartis AG Earnings Call

Speaker #1: Forward-looking statements that involve known and unknown risks, uncertainties, and other factors. These may cause actual results to be materially different from any future results, performance, or achievements expressed or implied by such statements.

Speaker #1: For a description of some of these factors, please refer to the company's Form 20F and its most recent quarterly results on Form 6K that respectively were filed with and furnished to the U.S.

Speaker #1: Securities and Exchange Commission. Before we get started, I also want to echo Sharon, please limit yourselves to one question at a time, and we will cycle through the Q as needed.

Speaker #1: And with that, I will hand across to Vas.

Speaker #2: Thank you, Sloan, and thanks everyone for joining today's call. So if we go to slide 4, as you saw this morning, we delivered a strong start to the year across our priority brands and launches, which is really where our focus is at the moment.

Speaker #2: These brands and launches are what's going to drive our mid to long-term growth and where we believe now we have demonstrated that they're strong momentum behind these medicines.

Speaker #2: The sales for the quarter you saw that those growth drivers were up 34% in constant currency, our base business was largely stable, but we did see significant GX erosions as we've guided to.

Speaker #2: And McCool will go through some of the dynamics for that over the course of the rest of the year. On core opink, we were down 14%, driven by the sales decline as well as the increased investments in R&D, which we also guided to.

Speaker #2: When you look at some of the pipeline highlights, a number of important highlights, including the continued progress for Rapsodo across a number of indications, Unalimab received a breakthrough therapy designation, and priority review in Sjögren's disease, as well as a few other important milestones, which we'll go over over the course of the call.

Speaker #2: Importantly, we're maintaining our full-year sales and core operating guidance for the year. Now moving to the next slide, when you look at those growth drivers in a little bit more detail, that 34% was driven in particular by very strong performance we saw in Kiscali, Fluvicto, Kisimpta, Lekvio, driven by our strong launch overseas, particularly in China, and the continued performance of Semlux.

Speaker #2: So I'll look forward to going through now some of the dynamics for each of our key brands over the course of the remaining slides.

Speaker #2: Now moving to slide 6, in quarter 1, Kiscali grew 55%. And as you know, Kiscali now is has a lot of momentum both in early breast cancer and metastatic breast cancer, and given our global launches, we're starting to see a pickup in the ex-U.S.

Speaker #2: markets. Now focusing in on the U.S., you can see our NBRX share now in the early breast cancer setting is very strong, 65% plus 2% now versus prior quarter.

Speaker #2: In addition, in metastatic breast cancer, we have 47% NBRX and 41% TRX. So taken together, we're in a very strong position in metastatic and early breast cancer.

Speaker #2: And when we look at that data in more detail, we see that Kiscali has a strong position not only in the overlapping segment with our competitor in early breast cancer, but also in our unique segment, particularly the Node 1 high risk and the Node 0 high risk patients.

Speaker #1: Nation and priority review, in Sjogren's disease, as well as a few other important milestones which we'll go over over the course of the call.

Vasant Narasimhan: Nation and priority review in Sjögren's disease, as well as a few other important milestones which we'll go over over the course of the call. Importantly, we're maintaining our full year sales and core operating guidance for the year. Moving to the next slide. When you look at those growth drivers in a little bit more detail, that 34% was driven in particular by very strong performance we saw in Kisqali, Pluvicto, Kesimpta, Leqvio, driven by our strong launch overseas, particularly in China, and the continued performance of Scemblix. I'll look forward to going through now some of the dynamics for each of our key brands over the course of the remaining slides. Moving to slide 6. In Q1, Kisqali grew 55%. As you know, Kisqali now is...

Vasant Narasimhan: Nation and priority review in Sjögren's disease, as well as a few other important milestones which we'll go over over the course of the call. Importantly, we're maintaining our full year sales and core operating guidance for the year. Moving to the next slide. When you look at those growth drivers in a little bit more detail, that 34% was driven in particular by very strong performance we saw in KISQALI, PLUVICTO, KESIMPTA, LEQVIO, driven by our strong launch overseas, particularly in China, and the continued performance of SCEMBLIX. I'll look forward to going through now some of the dynamics for each of our key brands over the course of the remaining slides. Moving to slide 6. In Q1, KISQALI grew 55%. As you know, KISQALI now is...

Speaker #1: Importantly, we're maintaining our full-year sales and core operating guidance for the year. Now moving to the next slide, when you look at those growth drivers in a little bit more detail, that 34% was driven in particular by very strong performance we saw in Kigali, Plovicto, Kisimpta, Lekvio driven by our strong launch overseas, particularly in China.

Speaker #2: And going forward, our focus will be very much continuing to expand Kiscali's utilization in those early breast cancer populations. Now turning to the ex-U.S., I think one of the markets that we're keenly focused on is our performance in Germany, where we saw outstanding performance in quarter 1.

Speaker #2: You can see in early breast cancer, our shares are approaching 80% now in Germany. Overall, we were growing 50% in constant currencies in the first quarter.

Speaker #1: And the continued performance of Zemblog. So I'll look forward to going through now some of the dynamics for each of our key brands over the course of the remaining slides.

Speaker #1: Now, moving to slide six, in Q1, Kisqali grew 55%. And as you know, Kisqali now has a lot of momentum, both in early breast cancer and metastatic breast cancer.

Speaker #2: We have continued metastatic breast cancer leadership across our key markets with 50% NBRX share. And we also see growth accelerating now as we have more EBC launches across a range of markets, 69 countries, and we're reimbursed now in 40 of those markets.

Vasant Narasimhan: has a lot of momentum, both in early breast cancer and metastatic breast cancer. Given our global launches, we're starting to see a pickup over in the ex-US markets. Focusing in on the US, you can see our NBRX share now in the early breast cancer setting is very strong, 65% +2% now versus prior quarter. In addition, in metastatic breast cancer, we have 47% NBRX and 41% TRX. Taken together, we're in a very strong position in metastatic and early breast cancer. When we look at that data in more detail, we see that Kisqali has a strong position, not only in the overlapping segment with our competitor in early breast cancer, but also in our unique segment, particularly the node one high risk and the node zero high risk patients.

Vasant Narasimhan: has a lot of momentum, both in early breast cancer and metastatic breast cancer. Given our global launches, we're starting to see a pickup over in the ex-US markets. Focusing in on the US, you can see our NBRX share now in the early breast cancer setting is very strong, 65% +2% now versus prior quarter. In addition, in metastatic breast cancer, we have 47% NBRX and 41% TRX. Taken together, we're in a very strong position in metastatic and early breast cancer. When we look at that data in more detail, we see that KISQALI has a strong position, not only in the overlapping segment with our competitor in early breast cancer, but also in our unique segment, particularly the node one high risk and the node zero high risk patients.

Speaker #1: And given our global launches, we're starting to see a pickup, over in the ex-US markets. Now focusing in, in on the US, you can see our NBRX, share now in the early breast cancer setting, is very strong.

Speaker #2: Some of the other markets we're paying close attention to in the U.K., we have 78% early breast cancer, and we have a strong early start in China, where we do have now NRDL listings.

Speaker #1: 65% plus 2% now versus prior quarter. in addition, in metastatic breast cancer, we have 47% NBRX and 41% TRX. So taken together, we're in a very strong position in metastatic and early breast cancer.

Speaker #2: So looking ahead, Kiscali is a brand we expect to have continued strong momentum over the course of this year. So turning to slide 7, Kisimpta had also a solid quarter, 26% growth, head of both the MS and B-cell markets.

Speaker #1: And when we look at that data in more detail, we see that Kigali has a strong position not only in the overlapping segment with our competitor in early breast cancer, but also in our unique segment, particularly the node one high risk and the node zero high risk patients.

Speaker #2: In the U.S., we saw a 21% TRX growth versus prior year. That was 2 points ahead of the market and 1.5 points B-cell class share increase versus prior year.

Speaker #2: Importantly, when we look at our NBRX market share, both in the overall market, we reached 17%, and the B-cell class, we reached 28%. So we're gaining share versus our B-cell class competitors as well as the older drugs that still nearly the majority of patients are taking in the U.S.

Speaker #1: And going forward, our focus will be very much continuing to expand Kigali's utilization in those early breast cancer populations. Now turning to the ex-US, I think one of the markets that we're keenly focused on is our performance in Germany, where we saw outstanding performance, in quarter one.

Vasant Narasimhan: Going forward, our focus will be very much continuing to expand Kisqali's utilization in those early breast cancer populations. Now turning to the ex-US, I think one of the markets that we're keenly focused on is our performance in Germany, where we saw outstanding performance in Q1. You can see, in early breast cancer, our shares are approaching 80% now in Germany. Overall, we were growing 50% in constant currencies in Q1. We have continued metastatic breast cancer leadership across our key markets with 50% NBRX share. We also see growth accelerating now as we have more EBC launches across a range of markets in 99 countries, and we're reimbursed now in 40 of those markets.

Vasant Narasimhan: Going forward, our focus will be very much continuing to expand KISQALI's utilization in those early breast cancer populations. Now turning to the ex-US, I think one of the markets that we're keenly focused on is our performance in Germany, where we saw outstanding performance in Q1. You can see, in early breast cancer, our shares are approaching 80% now in Germany. Overall, we were growing 50% in constant currencies in Q1. We have continued metastatic breast cancer leadership across our key markets with 50% NBRX share. We also see growth accelerating now as we have more EBC launches across a range of markets in 99 countries, and we're reimbursed now in 40 of those markets.

Speaker #1: You can see, in early breast cancer, our shares are approaching 80% now, in Germany. Overall, we were growing 50% in constant currencies, in the first quarter.

Speaker #2: Overall, we continue to see a significant runway for Kisimpta. I think a lot of that performance in the U.S. is down to strong operational execution, we've gotten much better, I think, at targeting the right patient groups, the right physician groups, as well as honing our messaging around the unique benefits of Kisimpta as a self-administered monthly therapy.

Speaker #1: We have continued metastatic breast cancer leadership across our key markets with 50% NBRX share. And we also see growth accelerating now as we have more EBC launches across a range of markets, 69 countries and reimbursed now in 40 of the markets.

Speaker #2: So excited about that. And we also continue to progress now our Q every two months dose Kisimpta, which we're looking forward to reading out next year.

Speaker #1: Some of the other markets we are paying close attention to are the UK, 78% early breast cancer, and we have a strong early start in China, where we have energy listings.

Vasant Narasimhan: Some of the other markets we are paying close attention to are the UK. We have 78% early breast cancer, and we have a strong early start in China, where we have. We also expect the hormone-sensitive approval in H2. There we expect the hormone-sensitive indication to increase the total patient pool available to Pluvicto by 75%. A substantial expansion, and one that I think will enable us to get the next inflection of growth for Pluvicto. You can see here at the bottom of the slide some of the data on the number of sites, over 830 sites now prescribing in the US, 580 in the ex-US.

Vasant Narasimhan: Some of the other markets we are paying close attention to are the UK. We have 78% early breast cancer, and we have a strong early start in China, where we have. We also expect the hormone-sensitive approval in H2. There we expect the hormone-sensitive indication to increase the total patient pool available to PLUVICTO by 75%. A substantial expansion, and one that I think will enable us to get the next inflection of growth for PLUVICTO. You can see here at the bottom of the slide some of the data on the number of sites, over 830 sites now prescribing in the US, 580 in the ex-US.

Speaker #2: Now in the ex-U.S. setting, 31% constant currency growth, strong growth in Europe. We estimate one in six MS patients now are in Kisimpta. We see 79% of patients that are coming on to Kisimpta either as naive or first switch in the EU5.

Speaker #1: So, looking ahead, Kigali is a brand we expect to have some strong momentum over the course of this year. Slide seven—Kisimpta had a solid quarter, 26% growth, in both the MS and B-cell markets.

Speaker #1: In the US, we saw 21% TRx growth—versus ahead of the market—and a 1.5-point B-cell class share increase versus prior year. Importantly, when we look at our NBRx market share, both in the overall market at 17%, and in the B-cell class, we reached 28%.

Speaker #2: We also have continued NBRX leadership at 9 out of 10 major markets. We do find in general, outside of the U.S., a strong interest in self-administered medicines that can get patients out of the hospital or out of needing ongoing visits for infusions.

Speaker #1: We're gaining share growth, versus our B cell class competitors as well, the, older drugs that, still, nearly the majority of patients are taking in the US.

Speaker #2: So very amenable to Kisimpta's profile. And we see an opportunity for continued expansion with two-thirds DMT treated patients continuing to not be on a B-cell therapy in our key markets.

Speaker #1: Overall, we continue to see a significant runway, for Kisimpta. I think a lot of that performance in the US is down to strong operational execution, we've gotten much better, I think, at targeting, the right patient groups, the right physician groups, as well as honing our messaging around the unique benefits of Kisimpta as a self-administered monthly, therapy.

Speaker #2: Now moving to slide 8, Fluvicto continued its strong rollout, particularly driven by the pre-tax day in MCRPC setting. We saw strong demand, and we also saw good progress on our ex-U.S.

Speaker #2: rollout. Starting with the U.S., we saw the U.S. sales grow 76% in the quarter with over 70% of that business now coming from the pre-tax day in setting.

Speaker #1: So excited about that. And we also continue to progress now. Our Q, every two months dose, Kisimpta, which we're looking forward to reading out next year.

Speaker #2: And that's coming from a mix of urologists and community oncologists. Right now, we estimate about over 60% of our NBRXs are coming from the community.

Speaker #1: Now on, in, in the ex-US setting, 31% constant currency growth, strong growth, in Europe. We estimate one in six MS patients now are, in Kisimpta.

Speaker #2: And I think that demonstrates we've now successfully made RLT a medicine that can be prescribed in the community settings for patients who prefer to access care in the community.

Speaker #1: We see 79% of patients that are coming onto Kisimpta either as naive or first switch, in the EU5. We also have continued NBRX leadership at nine out of 10 major markets.

Speaker #2: Outside of the U.S., we saw 48% growth with NBRXs up 92%. This was driven by strong EU uptake, but also I think a notable solid start in Japan, where we're seeing very strong interest in Fluvicto.

Speaker #1: We do find in general, outside of the US, a strong, interest in self-administered medicines that can get patients out, of the hospital or out of needing ongoing visits for infusions.

Speaker #1: So, very amenable to Kisimpta's profile. And we see an opportunity for continued expansion, with two-thirds of DMT-treated patients continuing to not be on a B-cell therapy in our key markets.

Speaker #2: So we're excited about that. And the initial stages of a launch as well in China, as a reminder, we have manufacturing sites that are being built and getting up to speed now in Japan and China, which will allow us to serve the Asian markets.

Speaker #1: Now moving to slide eight, Plovicto, continued its strong rollout, particularly driven by the pre-tax day and CR, MCRPC setting. We saw strong demand, and we also saw good progress on our ex-US rollout.

Speaker #2: So diving in a little bit deeper to think about some of those growth drivers, a key element of our story is driving depth in the existing sites.

Speaker #2: And expansion into urology, that continues, and I think we're making good progress on that front. And then we also expect the hormone-sensitive approvals in the second half.

Speaker #1: Starting with the US, we saw the US sales grow 76%, in, in the quarter with 70, over 70% of that business now coming from the pre-tax day, setting.

Speaker #2: There, we expect the hormone-sensitive indication to increase the total patient pool available to Fluvicto by 75%. So a substantial expansion. And one that I think will enable us to get the next inflection of growth for Fluvicto.

Speaker #1: And that's coming from a mix of, urologists and community, oncologists. Right now, we estimate about over 60% of our NBRXs are coming from the community.

Speaker #1: And I think that demonstrates we've now successfully made RLT a medicine that can be prescribed, in the, in the community setting, for patients, in, who prefer to access care in the community.

Speaker #2: You can see here at the bottom of the slide some of the data on the number of sites. So over 830 sites now prescribing in the U.S., 580 in the ex-U.S.

Speaker #2: I think that all just gives us confidence now that we've been able to make RLT standard that's available now broadly in the communities that we serve.

Speaker #1: Outside of the US, we saw 48% growth with NBRXs up 92%. This was driven by strong EU uptake, but also, I think, a notable solid start in Japan, where we're seeing very strong interest, in Plovicto.

Speaker #2: And also sets us up well for the future radioligand therapy portfolio over the coming years. Now moving to slide 9, left you had a really strong quarter.

Speaker #1: So we're excited about that. And the initial stages of a launch as well in China, as a reminder, we have manufacturing sites that are being, built and getting up to speed now in Japan and China, which will allow us to serve the Asian market.

Speaker #2: And that was driven primarily by our performance outside of the U.S., with strong growth in China, as well as in Europe and Japan. Now first, let's start with the U.S., where we saw 31% growth in the quarter.

Speaker #1: So, diving in a little bit deeper to think about some of those growth drivers, a key element of our story is driving depth in the existing sites.

Speaker #2: We continue to outpace the advanced lipid-lowering market. But I think in the U.S., the next inflection point we would expect is when we get the outcomes data in the first part of next year, with in the secondary prevention setting.

Speaker #1: And expansion into urology, that continues, and I think we're making good progress on that front. And then we also expect the hormone-sensitive approvals, in the second half.

Speaker #2: And that'll be an important milestone for us. Now when you think about some of the other data, the highlights we're seeing, we're seeing that we are expanding in the Medicare Part B population, up 11 points versus prior year.

Speaker #1: There, we expect the hormone-sensitive, indication to increase the total patient pool available to Plovicto, by 75%. So a substantial, expansion, and one that I think will enable us to get the next inflection of growth for Plovicto.

Speaker #2: That's about two-thirds of our current business. And we also see that our TRXs are consistently up 41% versus prior year. So I think all heading in the right direction, consistent steady growth across the U.S.

Speaker #1: You can see here at the bottom of the slide some of the data on the number of sites. So over 830 sites now prescribing in the US, 580 in the ex-US.

Speaker #2: in the buy-and-build segment. Outside of the U.S., 106% constant currency growth. That was led by China. The NRDL listing unlocked significant demand. It is early days, so I think we'll have to see how the coming quarters evolve in China.

Speaker #1: I think that all just gives us confidence now that we've been able to make RLT, standard that, that's available now broadly, in the communities that we serve.

Speaker #1: And also sets us up well for the future radioligand therapy portfolio over the coming years. Now, moving to slide nine, let’s view—had a really strong quarter, and that was driven primarily by our performance outside of the US, with strong growth in China as well as in Europe and in Japan.

Vasant Narasimhan: I think that all just gives us confidence now we've been able to make RLT a standard that's available now broadly in the communities that we serve and also sets us up well for the future radioligand therapy portfolio over the coming years. Moving to slide 9. Leqvio had a really strong quarter, and that was driven primarily by our performance outside of the US, with strong growth in China as well as in Europe and Japan. Now first, let's start with the US, where we saw 31% growth in the quarter. We continue to outpace the advanced lipid-lowering market. I think in the US, the next inflection point we would expect is when we get the outcomes data in the first part of next year with in the secondary prevention setting. That'll be an important milestone for us.

Vasant Narasimhan: I think that all just gives us confidence now we've been able to make RLT a standard that's available now broadly in the communities that we serve and also sets us up well for the future radioligand therapy portfolio over the coming years. Moving to slide 9. LEQVIO had a really strong quarter, and that was driven primarily by our performance outside of the US, with strong growth in China as well as in Europe and Japan. Now first, let's start with the US, where we saw 31% growth in the quarter. We continue to outpace the advanced lipid-lowering market. I think in the US, the next inflection point we would expect is when we get the outcomes data in the first part of next year with in the secondary prevention setting. That'll be an important milestone for us.

Speaker #2: So really understand how much of this was a bolus versus a steady demand. But I think the early benchmarks that we're looking at suggest very strong demand in China and something that we're excited about for our future siRNA portfolio.

Speaker #2: Now lastly, in terms of evidence-based for Lekvio, I mentioned the importance of the outcomes trials, but we also are advancing toward we received an FDA approval for adolescents in two specific rare disease indications and that will be important as well from a long-term pediatric exclusivity standpoint.

Speaker #1: Now first, let's start with the US, where we saw 31% growth, in the quarter. We continue to outpace the advanced lipid lowering market, but I think in the US, the next inflection point we would expect is when we get the outcomes data in the first part of next year, with, in the secondary prevention setting.

Speaker #1: And that'll be an important milestone for us. Now, when you think about, some of the other, data, the highlights we're seeing, we're seeing that we are expanding in the Medicare Part B population, up 11 points versus prior year.

Speaker #2: Lekvio is included in the ACC and AHA guidelines, and I think many of you likely saw that the guidelines highlight aggressive lipid management now, even at younger ages for patients.

Speaker #2: So I think that really points to not just statin use, but adding statin and PCSK9 use wherever possible. So I think that all points to a positive outlook for the medicine.

Vasant Narasimhan: Now, when you think about some of the other data, the highlights we're seeing, we're seeing that we are expanding in the Medicare Part D population up 11 points versus prior year. That's about two-thirds of our current business. We also see that our TRXs are consistently up 41% versus prior year. I think all heading in the right direction, consistent, steady growth across the US in the buy-and-bill segment. Outside of the US, 106% constant currency growth. That was led by China. The NRDL listing unlocked significant demand. It is early days, so I think we'll have to see how the coming quarters evolve in China to really understand how much of this was a bolus versus a steady demand.

Vasant Narasimhan: Now, when you think about some of the other data, the highlights we're seeing, we're seeing that we are expanding in the Medicare Part D population up 11 points versus prior year. That's about two-thirds of our current business. We also see that our TRXs are consistently up 41% versus prior year. I think all heading in the right direction, consistent, steady growth across the US in the buy-and-bill segment. Outside of the US, 106% constant currency growth. That was led by China. The NRDL listing unlocked significant demand. It is early days, so I think we'll have to see how the coming quarters evolve in China to really understand how much of this was a bolus versus a steady demand.

Speaker #1: That's about two-thirds of our current business. And we also see that our TRXs, are consistently up 41% versus prior year. So I think all heading in the, in the right direction, consistent steady growth across the US in the buy and build segment.

Speaker #2: Now moving to the next slide. Semlix was up 79%. I think really outstanding performance for this brand, both in the U.S. and ex-U.S. We see in the U.S.

Speaker #1: Outside of the US, 106% constant currency growth. That was led by China. The NRDL listing unlocked significant demand. It is early days, so I think we'll have to see how the coming quarters evolve in China, to really understand how much of this was a bolus versus a steady demand.

Speaker #2: very strong performance in the frontline setting and outside the U.S., both second and third line and frontline now starting to pick up. Let's take each of those in sequence.

Speaker #2: So first, in the U.S., now we've reached 31% first line NBRX share. You can see the steady climb upwards in the graph. So very excited about that.

Speaker #1: But I think the early benchmarks that we're looking at suggest very strong demand in China, and something that we're excited about, for our future SIRNA portfolio.

Speaker #2: And hopefully soon we'll be consistently the leader in NBRX NBRX unit of brand scripts in the United States. When you look at the we're also leader across all lines now with 42% shares.

Vasant Narasimhan: I think the early benchmarks that we're looking at suggest very strong demand in China, and something that we're excited about for our future SIRNA portfolio. Now lastly, in terms of evidence base for Leqvio, I mentioned the importance of the outcomes trial. We received an FDA approval for adolescents in two specific rare disease indications, and that will be important as well from a long-term pediatric exclusivity standpoint. Leqvio is included in the ACC and the AHA guidelines. I think many of you liked the thought that the guidelines highlight aggressive lipid-lowering management now, even at younger ages than the patient study really points. It's not just statin, it's adding statin and PCSK9 as well as possible. I think that all points to a positive outlook for the medicine.

Vasant Narasimhan: I think the early benchmarks that we're looking at suggest very strong demand in China, and something that we're excited about for our future SIRNA portfolio. Now lastly, in terms of evidence base for LEQVIO, I mentioned the importance of the outcomes trial. We received an FDA approval for adolescents in two specific rare disease indications, and that will be important as well from a long-term pediatric exclusivity standpoint. LEQVIO is included in the ACC and the AHA guidelines. I think many of you liked the thought that the guidelines highlight aggressive lipid-lowering management now, even at younger ages than the patient study really points. It's not just statin, it's adding statin and PCSK9 as well as possible. I think that all points to a positive outlook for the medicine.

Speaker #1: Now lastly, in terms of evidence-based for left view, I mentioned the importance of the outcomes trials, but we also are advancing to where we received an FDA approval for adolescents in two specific, rare disease indications, and that will be important as well from a long-term effectivity standpoint.

Speaker #2: So I think that also demonstrates the breadth of interest in Semlix. Outside of the U.S., we grew 68%. That's driven primarily by our third line leadership, 73% share across our key markets.

Speaker #1: Left view is in the ACC and ADA guidelines. I think many of you likely saw that the guideline aggressively looked at management now, even at younger-age patients.

Speaker #2: But we are seeing early line indications now starting the indications starting to advance we're approved in 63 countries. You can see in the chart here that the NBRX share in the first line in Japan, we've already reached 50%.

Speaker #1: I think that really points to not just that and statin and PCSK9 use possible. So I think that all points to a positive outlook for, for the medicine.

Speaker #1: Now moving to the next slide. 79%, I think really outstanding performance for this brand, both in the US and ex-US. we see in the US very strong performance in the frontline setting, and outside of the US, both second and third line and frontline now starting to pick up.

Speaker #2: In Germany, we're seeing early traction as well with 11% NBRX in the front line. And of course, for the long-term outlook for the brand, our goal is to make this the standard of care in the frontline setting across all major geographies.

Speaker #1: Let's take each of those slides in sequence. Of course, in the US now, we've reached 31% first line NBRX share, you can see the, the steady climb upwards in the graph.

Vasant Narasimhan: Now moving to the next slide. Symbicort up 39%, I think really outstanding performance for this brand both in the US and ex-US. We see in the US very strong performance in the front line setting and outside US, both second, third line and front line now starting to pick up. Let's dig into those in sequence. First, in the US now we've reached 31% first line NBRX share. You can see the steady climb upwards in the graph. Very excited about that. Hopefully soon we'll be consistently the leader in NBRX NBRX new to brand scripts in the United States. We're also leader across all lines now with 42% share, I think that also demonstrates the breadth of interest in Symbicort.

Vasant Narasimhan: Now moving to the next slide. Symbicort up 39%, I think really outstanding performance for this brand both in the US and ex-US. We see in the US very strong performance in the front line setting and outside US, both second, third line and front line now starting to pick up. Let's dig into those in sequence. First, in the US now we've reached 31% first line NBRX share. You can see the steady climb upwards in the graph. Very excited about that. Hopefully soon we'll be consistently the leader in NBRX NBRX new to brand scripts in the United States. We're also leader across all lines now with 42% share, I think that also demonstrates the breadth of interest in Symbicort.

Speaker #2: And as you can see in the data, we're well on our way to deliver that goal. Now moving to slide 11. Now Cosentyx had a broadly stable quarter, and we were impacted by some of the one-time effects that we had in the prior quarter in 2025.

Speaker #1: So very excited about that. And I hopefully soon we'll be consistently the leader in NBRX, NBRX new to brand scripts in the United States.

Speaker #2: So when you net out those effects, we would estimate that our global sales growth was about 2% in the U.S. We were roughly flat to 1% growth.

Speaker #1: when you look at, the, the, we're also leader across all lines now with 42% shares. So I think that also demonstrates the breadth of, interest in SAMLEX.

Speaker #2: So I think that indicates that we're stable. And I think set up well now as a new indications come online for Cosentyx. And that's and that's going to be very very important to ultimately achieve our peak sales goal.

Speaker #1: Outside of the US, we grew 68%. That's driven primarily by our third line leadership, with a 73% share across our key markets. But we are seeing early line indications now starting—the indications starting to advance. We're approved in 63 countries.

Speaker #2: So when you look at some of the data, when you look at the hydradenitis, suppurativa, NBRX naive share, you can see here pretty consistently around 50%.

Speaker #1: You can see in the chart here that the NBRX share in the first line in Japan, we've already reached 50%. In Germany, we're seeing early traction as well with 11% NBRX in the front line.

Speaker #2: We did see a slight dip in January because of the degree of verification and the availability of biosimilars. But we see that now climbing back up.

Vasant Narasimhan: Outside of the US, we grew 68%. That's driven primarily by our 3rd line leadership, 73% share across our key markets. We are seeing early line indications starting to advance. We're approved in 63 countries. You can see in the chart here that the NBRX share in the 1st line in Japan, we've already reached 50%. In Germany, we're seeing early traction as well with 11% NBRX in the 1st line. Of course, for the long-term outlook for the brand, our goal is to make this the standard of care in the 1st line setting across all major geographies. As you can see in the data, we're well on our way to deliver that goal. Now moving to slide 11.

Vasant Narasimhan: Outside of the US, we grew 68%. That's driven primarily by our 3rd line leadership, 73% share across our key markets. We are seeing early line indications starting to advance. We're approved in 63 countries. You can see in the chart here that the NBRX share in the 1st line in Japan, we've already reached 50%. In Germany, we're seeing early traction as well with 11% NBRX in the 1st line. Of course, for the long-term outlook for the brand, our goal is to make this the standard of care in the 1st line setting across all major geographies. As you can see in the data, we're well on our way to deliver that goal. Now moving to slide 11.

Speaker #1: And of course, for the long-term outlook for the brand, our goal is to make this the standard of care in the frontline setting across all major geographies.

Speaker #2: So we expect to be stable in that 50% range. Importantly as well for IV patient share, we see steady growth up to now 14%.

Speaker #1: And as you can see in the data, we're well on our way to deliver that goal. Now moving to slide 11. Now, Cosentyx had a broadly stable quarter, and we were impacted by some of the one-time effects that we had in the prior quarter in 2025.

Speaker #2: And so both of these will continue to be important. We are hoping that the HS market continues to develop, not just for Cosentyx, but as we'll address later, Remibrutinib now will also have a readout later this year in HS.

Speaker #1: So when you net out those effects, we would estimate, that our global sales growth was about 2% in the US. We were roughly flat to 1%, growth.

Speaker #2: So we want to see this market expand so the patients who need better therapies are getting them. Outside of the U.S., we were up 3%.

Speaker #2: That's primarily driven by growth in Europe and emerging markets. We continue to see competitive pressures in China, with multiple local NRDL entrants and so there's a long list of competitors that we have.

Speaker #1: So I think that indicates that we're stable. And I think set up well now as a new indications come online for Cosentyx, and that's and that's going to be very, very important to ultimately achieve our peak sales goal.

Vasant Narasimhan: Cosentyx had a broadly stable quarter, we were impacted by some of the one-time effects that we had in the prior quarter in 2025. When you net out those effects, we would estimate that our global sales growth was about 2%. In the US, we were roughly flat to 1% growth. I think that indicates that we're stable, I think set up well now as the new indications come online for Cosentyx. That's gonna be very, very important to ultimately achieve our peak sales goal. When you look at some of the data, when you look at the hidradenitis suppurativa NBRX naive share, you can see here pretty consistently around 50%.

Vasant Narasimhan: Cosentyx had a broadly stable quarter, we were impacted by some of the one-time effects that we had in the prior quarter in 2025. When you net out those effects, we would estimate that our global sales growth was about 2%. In the US, we were roughly flat to 1% growth. I think that indicates that we're stable, I think set up well now as the new indications come online for Cosentyx. That's gonna be very, very important to ultimately achieve our peak sales goal. When you look at some of the data, when you look at the hidradenitis suppurativa NBRX naive share, you can see here pretty consistently around 50%.

Speaker #2: And we've had very strong share performance in China now over many years. But our goal will be to maintain now share and hopefully can stabilize as well the performance in China over the coming quarters.

Speaker #1: So when you look at some of the data, when you look at the hydradenitis, superativa, NBRX, naive share, you can see here pretty consistently around 50%.

Speaker #2: We continue to advance to new indications importantly, the PMR submission happened across geographies, and we expect the FDA approval in the second half. And we also received FDA approval for the pediatric HS indication, and we completed EMA submission as well.

Speaker #1: We did see a slight dip in January because of the degree of verification and the availability of biosimilars. But we see that now climbing back up.

Speaker #1: So we expect to be stable in that 50% range. Importantly as well for IV patient share, we see steady growth up to now 14%.

Speaker #2: So all on track on that 12. I wanted to just say a few words on our renal portfolio by talking about each of the key brands.

Speaker #1: And so both of these will continue to be important. We are hoping that the HS market continues to develop, not just for Cosentyx, but as we'll address later, Remibrutinib now will also have an, a readout later this year in HS.

Vasant Narasimhan: We did see a slight dip in January because of the re-verification and the availability of biosimilar. We see that now climbing back up, so we expect to be stable in that 50% range. Importantly as well, for IV patient share, we see steady growth up to now 14%. Both of these will continue to be important, and we are hoping that the HS market continues to develop, not just for Cosentyx, but as we'll address later, remibrutinib now will also have a readout later this year in HS. We wanna see this market expand so the patients who need better therapies are getting them. Outside of the US, we were up 3%. That's primarily driven by growth in Europe and emerging markets.

Vasant Narasimhan: We did see a slight dip in January because of the re-verification and the availability of biosimilar. We see that now climbing back up, so we expect to be stable in that 50% range. Importantly as well, for IV patient share, we see steady growth up to now 14%. Both of these will continue to be important, and we are hoping that the HS market continues to develop, not just for Cosentyx, but as we'll address later, remibrutinib now will also have a readout later this year in HS. We wanna see this market expand so the patients who need better therapies are getting them. Outside of the US, we were up 3%. That's primarily driven by growth in Europe and emerging markets.

Speaker #2: So first, let's talk about FebHalta. Sales were up 103% in quarter one, with NBRX leadership now both in PNH and C3G. In PNH at the moment, we're seeing 50% NBRX share, as well as important and significant contributions from some of our key ex-U.S.

Speaker #1: So we want to see this market expand so the patients who need better therapies are, are getting them. Outside of the US, we were up 3%.

Speaker #1: That's primarily driven by growth in Europe and emerging markets. We continue to see competitive pressures in China, with multiple local NRDL entrants and, and so there's a long list of competitors that we have and we've had very strong share performance in China now over many years.

Speaker #2: markets. In C3G, 56% NBRX share, and we're now approved in 46 countries. So both of those indications really having solid and consistent performance. Now importantly, in Igen, I think we believe our uptake in U.S.

Speaker #1: But our goal will be to maintain now, share and hopefully can stabilize as well as performance in China over the coming quarters. We continue to advance to new indications, importantly the PMR submission, happened across geographies and we expect the FDA approval in the second half.

Speaker #2: patients will continue to build and with patients with persistent proteinuria and glomerular inflation. So inflammation. So here we're a later line therapy. But I think very important was the two-year phase three applause, Igen data, which was published in the New England Journal.

Vasant Narasimhan: We continue to see competitive pressures in China, with multiple local NRDL entrants, there's a long list of competitors that we have. We've had very strong share performance in China now over many years. Our goal will be to maintain now share and hopefully can stabilize as well as performance in China over. Continue to advance the new indications. Importantly, the PMR submission, it happened across geographies, and we expect the FDA approval in the second half. We also received FDA approval for the pediatric HS indication, and we completed EMA submission as well. All on track on that front. Moving to slide 12, I wanted to just say a few words on our renal portfolio by talking about each of the key brands. First, let's talk about Fabhalta.

Vasant Narasimhan: We continue to see competitive pressures in China, with multiple local NRDL entrants, there's a long list of competitors that we have. We've had very strong share performance in China now over many years. Our goal will be to maintain now share and hopefully can stabilize as well as performance in China over. Continue to advance the new indications. Importantly, the PMR submission, it happened across geographies, and we expect the FDA approval in the second half. We also received FDA approval for the pediatric HS indication, and we completed EMA submission as well. All on track on that front. Moving to slide 12, I wanted to just say a few words on our renal portfolio by talking about each of the key brands. First, let's talk about Fabhalta.

Speaker #1: And we also received FDA approval for the pediatric, HS indication. We've been completed, EMA submission as well. So all on track on that front.

Speaker #2: It showed an impressive slowing in kidney function decline of 49% versus placebo. And a reduction in progression to kidney failure by 43%. The FDA has granted us priority review for the traditional approval.

Speaker #1: Now, moving to slide 12. I wanted to just say a few words on our renal portfolio by talking about each of the key brands.

Speaker #2: So I think that just indicates the strength of the FebHalta data in Igen. For Venrafia, we see steady U.S. uptake and growth in a very competitive field.

Speaker #1: So first, let's talk about FebHalta. Sales were up 103%, in quarter one, with NBRX leadership now, both in PNH and C3G. In PNH at the moment, we're seeing 50% NBRX share, as well as important and significant contributions from some of our key ex-US markets.

Speaker #2: I think is all that we know. That launch is ongoing. We've about 11% NBRX share. We see a significant market expansion opportunity with most patients still on supportive care.

Speaker #1: In C3G, 56% NBRx share, and we're now approved in 46 countries. So both of those indications are really having solid and consistent performance. Now, importantly, in IgAN, I think we believe our uptake in US patients will continue to build, with patients with persistent proteinuria and glomerular inflammation.

Speaker #2: And as that market grows, we hope to Venrafia will ultimately benefit as a really effective and safe vascular agent endothelial agent. And we do expect traditional FDA approval to drive future growth.

Vasant Narasimhan: Sales were up 103% in Q1 with NBRX leadership now both in PNH and C3G. In PNH at the moment, we're seeing 50% NBRX share, as well as important and significant contributions from some of our key ex-US markets. In C3G, 56% NBRX share, and we're now approved in 46 countries. Both of those indications, really having solid and consistent performance. Now importantly, in IgAN, I think we believe our uptake in US patients, will continue to build with patients with persistent proteinuria and glomerular inflation, so inflammation. I think very important was the 2-year Phase III APPLAUZE-IgAN data, which was published in the New England Journal.

Vasant Narasimhan: Sales were up 103% in Q1 with NBRX leadership now both in PNH and C3G. In PNH at the moment, we're seeing 50% NBRX share, as well as important and significant contributions from some of our key ex-US markets. In C3G, 56% NBRX share, and we're now approved in 46 countries. Both of those indications, really having solid and consistent performance. Now importantly, in IgAN, I think we believe our uptake in US patients, will continue to build with patients with persistent proteinuria and glomerular inflation, so inflammation. I think very important was the 2-year Phase III APPLAUZE-IgAN data, which was published in the New England Journal.

Speaker #2: You saw in the quarter we toplined the aligned data and we do expect to submit that data to FDA and EMA in the first half.

Speaker #1: So, inflammation. So here we're at a later line therapy. But I think very important was the two-year phase 3 APPLAUSE-IgAN data, which was published in The New England Journal.

Speaker #2: We will present that data in full. And while we didn't reach statistical significance, we feel confident that the data is compelling. We'll allow that full approval to ultimately happen.

Speaker #1: It showed an impressive slowing in kidney function decline of 49% versus placebo, and a reduction in progression to kidney failure by 43%. The FDA has granted us priority review for the traditional approval.

Speaker #2: Now moving to slide 13. Now Rapsodo TSU launched off to a strong start in the U.S. And we have the early steps now to begin the rollout as well outside of the U.S.

Speaker #2: And I think when you look at the profile we're building pipeline and appeal potential, significant medicine here that could address a range of different dermatology and immunology indications.

Speaker #1: So I think that just indicates the strength of the FebHalta data, in Igen. for Venrafia, we see steady US uptake and growth in, in a very competitive field.

Vasant Narasimhan: It showed an impressive slowing in kidney function decline of 49% versus placebo and a reduction in progression to kidney failure by 43%. The FDA has granted us priority review for the traditional approval. I think that just indicates the strength of the Fabhalta data in IgAN. For abelacimab, we see steady US uptake and grow in a very competitive field, I think as all of you know. That launch is ongoing. We have about 11% NBRX share. We see a significant market expansion opportunity with most patients still on supportive care. As that market grows, we hope that abelacimab will ultimately benefit as a really effective and safe vascular agent, endothelium agent. We do expect traditional FDA approval to drive future growth.

Vasant Narasimhan: It showed an impressive slowing in kidney function decline of 49% versus placebo and a reduction in progression to kidney failure by 43%. The FDA has granted us priority review for the traditional approval. I think that just indicates the strength of the Fabhalta data in IgAN. For abelacimab, we see steady US uptake and grow in a very competitive field, I think as all of you know. That launch is ongoing. We have about 11% NBRX share. We see a significant market expansion opportunity with most patients still on supportive care. As that market grows, we hope that abelacimab will ultimately benefit as a really effective and safe vascular agent, endothelium agent. We do expect traditional FDA approval to drive future growth.

Speaker #2: So starting with the CSU launch, the U.S. uptake we see 3,000 prescribers to date. Across allergists and dermatologists, now prescribing the medicine. 6,000 patient starts.

Speaker #1: I think as all of you know, that launch is ongoing. We have about 11% NBRX share. We see a significant market expansion, opportunity with most patients still on supportive care.

Speaker #1: And as that market grows, we hope to Venrafia will ultimately benefit as a as a really, effective and safe and, vascular agent endothelin agent.

Speaker #2: And we're seeing very positive feedback on the speed of the onset of action. And we estimate an NBRX share now of 24%, which I think is very good in these early phases of launch.

Speaker #1: And we do expect traditional FDA approval to drive future growth. You saw in the quarter we toplined the ALIGN data, and we do expect to submit that data to FDA and EMA in the first half.

Speaker #2: We are having early access wins, but I would say that access will build over the course of the year. So it will take us the full year to get to where we want to ultimately get to from an access standpoint.

Speaker #1: we will present that data in full. And while we didn't reach statistical significance, we feel confident that the data is compelling. We'll allow that full approval to ultimately happen.

Speaker #2: And that'll be important as well because that's what allows us to bridge from three drugs to ultimately paid scripts. So that'll be a steady uptake over the course of the year, not a fast inflection.

Speaker #1: Now moving to Now Rapsodo, is TSU launched off to a strong start in the US. and we have the early steps now to begin the rollout as well outside outside of the US.

Speaker #2: And then outside of the U.S., the China commercial launch and the European EC approval that we've received will enable us to hopefully have a solid launch to Rapsodo in the second half of the year.

Vasant Narasimhan: You saw in the quarter we top-lined the ALIGN data. We do expect to submit that data to FDA and EMA in H1. We will present that data in full. While we didn't reach statistical significance, we feel confident that the data is compelling will allow that full approval to ultimately happen. Moving to slide 13. Now Rhapsido, CSU launch off to a strong start in the US. We have the early steps now to begin the rollout as well outside of the US. I think when you look at the profile we're building, pipeline and uphill potential, significant medicine here that could address a range of different dermatology and immunology indications.

Vasant Narasimhan: You saw in the quarter we top-lined the ALIGN data. We do expect to submit that data to FDA and EMA in H1. We will present that data in full. While we didn't reach statistical significance, we feel confident that the data is compelling will allow that full approval to ultimately happen. Moving to slide 13. Now Rhapsido, CSU launch off to a strong start in the US. We have the early steps now to begin the rollout as well outside of the US. I think when you look at the profile we're building, pipeline and uphill potential, significant medicine here that could address a range of different dermatology and immunology indications.

Speaker #1: And I think when you look at the profile we're building, pipeline and appeal potential, significant medicine here that could address a range of different dermatology and immunology indications.

Speaker #2: We did also have the positive SINDU readout primary endpoint in chronic inducible urticaria. We saw significantly higher rates of complete responses versus placebo across all three SINDU types first time medicine is delivered that well tolerated with a favorable safety profile.

Speaker #1: So starting with the CSU launch, the US, uptake we see 3,000 prescribers, to date, across allergists and dermatologists, now prescribing the medicine. 6,000 patient starts.

Speaker #2: We're on track now for the FDA approval in the first subtype of SINDU and FDA submission of the other two types in the second half.

Speaker #1: And we're seeing very positive feedback on the speed of the onset of action. And we estimate an NBRX share now of 24%, which I think is very good in these early phases of launch.

Speaker #2: Now building on the overall profile for Rapsodo, when you look at the next slide, slide 14, we did release as well the phase two results for Remibrutinib in food allergy to support a fast-acting oral option for these patients.

Vasant Narasimhan: Starting with the CSU launch, the US uptake, we see 3,000 prescribers to date across allergists and dermatologists now prescribing the medicine. 6,000 patient starts, and we're seeing very positive feedback on the speed of the onset of action. We estimate an NBRX share now of 24%, which I think is very good in these early phases of launch. We are having early access wins, but I would say that access will build over the course of the year. It will take us a full year to get to where we want to ultimately get to from an access standpoint. That'll be important as well because that's what allows us to bridge from free drugs to ultimately paid scripts. That'll be a steady uptake over the course year, not a fast inflection.

Vasant Narasimhan: Starting with the CSU launch, the US uptake, we see 3,000 prescribers to date across allergists and dermatologists now prescribing the medicine. 6,000 patient starts, and we're seeing very positive feedback on the speed of the onset of action. We estimate an NBRX share now of 24%, which I think is very good in these early phases of launch. We are having early access wins, but I would say that access will build over the course of the year. It will take us a full year to get to where we want to ultimately get to from an access standpoint. That'll be important as well because that's what allows us to bridge from free drugs to ultimately paid scripts. That'll be a steady uptake over the course year, not a fast inflection.

Speaker #1: We are having early access wins, but I would say that access will build over the course of the year. So it will take us the full year to get to where we want to ultimately get to from an access standpoint.

Speaker #1: And that'll be important as well, because that's what allows us to bridge from three drugs to ultimately paid scripts. So that'll be a steady uptake over the course of the year, not a fast inflection.

Speaker #2: We also are on track now to initiate the phase three study. You can see here on the left the data that we read out.

Speaker #2: The 100 milligram dose provided 86.7% responders, which I think is very impressive result. Our modeling indicates that the 75 milligram DID would be the appropriate dose for the patients moving forward.

Speaker #1: And then, outside of the US, the China commercial launch and the European EC approval that we've received will enable us to hopefully have a solid launch through Rapsodo in the second half of the year.

Speaker #1: We did also have the positive, Sindhu readout, primary endpoint, in chronic inducible urticaria. We saw a significantly higher rates of complete responses versus placebo across all three Sindhu types first time, medicine is delivered that.

Speaker #2: So that's the dose we've taken forward into the phase three study. Our focus will be a multi-allergen prevention study. So I think that's really exciting across a broad range of age, 12 years all the way up to 65 years.

Vasant Narasimhan: Outside of the US, the China commercial launch, and the European EC approval that we've received will enable us to hopefully have a solid launch for Rhapsido in H2. We did also have the positive CIndU readout, primary endpoint, in Chronic Inducible Urticaria. We saw significantly higher rates of complete responses versus placebo across all three CIndU types. First time a medicine has delivered that. Well-tolerated with a favorable safety profile. We're on track now for the FDA approval in the first subtype of CIndU and FDA submission of the other two types in H2.

Vasant Narasimhan: Outside of the US, the China commercial launch, and the European EC approval that we've received will enable us to hopefully have a solid launch for Rhapsido in H2. We did also have the positive CIndU readout, primary endpoint, in Chronic Inducible Urticaria. We saw significantly higher rates of complete responses versus placebo across all three CIndU types. First time a medicine has delivered that. Well-tolerated with a favorable safety profile. We're on track now for the FDA approval in the first subtype of CIndU and FDA submission of the other two types in H2.

Speaker #1: Well tolerated with a favorable safety profile. We're on track now for the FDA approval in the first, subtype of Sindhu. And FDA submission of the other two types in the second half.

Speaker #2: And as I mentioned, anticipate initiation in the second half. This has the potential to address a significant unmet need, 3.5 million high-risk eligible patients across major markets.

Speaker #2: So very excited to add this to the indication list hopefully for Rapsodo. Now moving to slide 15. Also in the quarter, we completed the acquisition of Avidity adding three late-stage medicines for neuromuscular disease.

Speaker #1: Now building on the overall profile for Rapsodo, when you look at the next slide, slide 14, we did release as well the phase two results, for Remibrutinib in food allergy to support, a fast-acting oral option for these patients.

Speaker #2: And then just wanted to highlight two data points from the quarter. We did release the one-year results for Delzota, our DMD Exxon 44 skipping medicine.

Speaker #1: We also have are on track now to initiate the phase three study. You can see here on the left the data that we, we read out.

Vasant Narasimhan: Building on the overall profile for Rhapsido, when you look at the next slide 14, we did release as well the phase two results for remibrutinib in food allergy to support a fast-acting oral option for these patients. We also are on track now to initiate the phase three study. You can see here on the left the data that we read out. The 100-milligram dose provided 86.7% responders, which I think very impressive result. Our modeling indicates that the 75 milligram DID would be the appropriate dose for the patients moving forward. That's the dose we've taken forward into the phase three study. Our focus will be a multi-allergen prevention study.

Vasant Narasimhan: Building on the overall profile for Rhapsido, when you look at the next slide 14, we did release as well the phase two results for remibrutinib in food allergy to support a fast-acting oral option for these patients. We also are on track now to initiate the phase three study. You can see here on the left the data that we read out. The 100-milligram dose provided 86.7% responders, which I think very impressive result. Our modeling indicates that the 75 milligram DID would be the appropriate dose for the patients moving forward. That's the dose we've taken forward into the phase three study. Our focus will be a multi-allergen prevention study.

Speaker #1: The 100 milligram dose, provided 86.7% responders, which I think is very impressive results. Our modeling indicates that the 75 milligram DID would be the appropriate dose for the, the patients moving forward.

Speaker #2: Which was presented at the muscular dystrophy association to a standing ovation, which I think shows the impact that this medicine could have for these patients.

Speaker #2: You can see here the creatine kinase declines, which are remarkable and you can I think really experts have opined that this is really a revolution with this medicine.

Speaker #1: So that's the dose we've taken forward into the, the phase three study. our, our focus will be a multi-allergen prevention study, so I think that's really exciting across a broad range of age, 12 years all the way up to 65 years.

Speaker #2: We're excited to also build after this a range of additional Exxon skipping medicines for DMD. We are expecting the submission now in the first half as we've worked through some of the additional CMC topics to make sure that the file is fully submission ready.

Speaker #1: And as I mentioned, anticipate initiation in the second half. This has the potential to address a significant unmet need, 3.5 million high-risk eligible patients across major markets.

Speaker #2: And then with Deldisiran, we had the final results for the phase one two study, Mirena trial published in the New England Journal. Those are results you all know well.

Speaker #1: So very excited to add this to the indication list hopefully for Rapsodo. Now moving to slide 15. Also in the quarter, we completed the acquisition of Avidity, adding three late-stage medicines for neuromuscular, disease.

Speaker #2: But I think highlight the excellent profile that we've seen with this medicine. And we're on track for the phase three readout for the Harbor study in the second half.

Vasant Narasimhan: I think that's really exciting across a broad range of age, 12 years all the way up to 65 years. As I mentioned, anticipate initiation in the H2. This has the potential to address a significant unmet need, 3.5 million high-risk eligible patients across major markets. Very excited to add this to the indication list, hopefully for Rhapsido. Now moving to slide 15. Also in the quarter, we completed the acquisition of Avidity, adding 3 late-stage medicines for neuromuscular disease. I just wanted to highlight 2 data points from the quarter. We did release the 1-year results for delpacibart zotadirsen, our for our DMD exon 44 skipping medicine, which was presented at the Muscular Dystrophy Association to a standing ovation, which I think shows the impact that this medicine could have for these patients.

Vasant Narasimhan: I think that's really exciting across a broad range of age, 12 years all the way up to 65 years. As I mentioned, anticipate initiation in the H2. This has the potential to address a significant unmet need, 3.5 million high-risk eligible patients across major markets. Very excited to add this to the indication list, hopefully for Rhapsido. Now moving to slide 15. Also in the quarter, we completed the acquisition of Avidity, adding 3 late-stage medicines for neuromuscular disease. I just wanted to highlight 2 data points from the quarter. We did release the 1-year results for delpacibart zotadirsen, our for our DMD exon 44 skipping medicine, which was presented at the Muscular Dystrophy Association to a standing ovation, which I think shows the impact that this medicine could have for these patients.

Speaker #1: And then just wanted to highlight two data points from the quarter. We did release the one-year results for Delzoda, our DMD exon 44 skipping medicine, which was presented at the Muscular Dystrophy Association to a standing ovation, which I think shows the impact that this medicine could have for these patients.

Speaker #2: Now moving to slide 16. I didn't want to say a word on the pipeline readouts for the rest of the year. We have quite a bit happening and we're excited about that.

Speaker #2: So in the first half, I already mentioned the Rapsodo SINDU positive readout. We did have Yanalimab readout and warm autoimmune hemolytic anemia, which did not meet statistical significance.

Speaker #2: So it won't be taking that forward. But we don't expect that to be a read-through to ITP where we already have positive second-line data.

Speaker #1: you can see here the creatine kinase declines, which, are remarkable, and you can, I think really experts have, have opined that this is really a, a revolution with this medicine.

Speaker #2: And we'll look forward to the first-line data in the second half. We also have data in-house now for Vodaplan, which confirms our approach for the phase three study based on that data we feel very comfortable taking the 10 milligram dose now forward into the pivotal phase three readout.

Speaker #1: We're excited to also build after this, a range of additional Exon skipping medicines for DMD. We are expecting the submission now in the first half as we've worked through some of the additional CMC topics to make sure that the file is fully submission ready.

Vasant Narasimhan: You can see here the creatine kinase declines, which are remarkable. You can, I think really experts have opined that this is really a revolution with this medicine. We are excited to also build after this a range of additional exon-skipping medicines for DMD. We are expecting the submission now in H1 as we work through some of the additional CMC topics to make sure that the file is fully submission-ready. With deldisiran, we had the final results for the phase 1/2 study MARINA trial published in the New England Journal. Those are results you all know well, but I think highlight the excellent profile that we've seen with this medicine, and we're on track for the phase 3 readout for the HARBOR study in H2. Moving to slide 16.

Vasant Narasimhan: You can see here the creatine kinase declines, which are remarkable. You can, I think really experts have opined that this is really a revolution with this medicine. We are excited to also build after this a range of additional exon-skipping medicines for DMD. We are expecting the submission now in H1 as we work through some of the additional CMC topics to make sure that the file is fully submission-ready. With deldisiran, we had the final results for the phase 1/2 study MARINA trial published in the New England Journal. Those are results you all know well, but I think highlight the excellent profile that we've seen with this medicine, and we're on track for the phase 3 readout for the HARBOR study in H2. Moving to slide 16.

Speaker #2: We are in collaboration with our partner PTC. And I'm discussing the best next steps for that medicine, including further interactions as well with the FDA.

Speaker #1: And then with, Deldisiran, we had the final results for the phase one two study Marina trial published in the New England Journal. Those are results you all know well.

Speaker #1: But I think highlight the excellent profile that we've seen with this medicine. And we're on track for the phase three readout for the Harbor study in the second half.

Speaker #2: And we'll keep everyone apprised as we continue to progress that medicine forward. We also are on track as well for the FSHD biomarker cohort readout as well.

Speaker #1: Now, moving to slide 16. I didn't want to say a word on the pipeline readouts for the rest of the year, of the year.

Speaker #2: Our plan would be to ultimately disclose that data after we've had any discussions with FDA to understand better if the data meets the standard for an accelerated approval.

Speaker #1: We have quite a bit happening, and we're excited, about that. So in the first half, I already mentioned the Rapsodo Sindhu, positive readout. We did have Unalimab readout in warm autoimmune hemolytic anemia, which did not meet statistical, significance.

Speaker #2: We do not have that data in-house yet, but we do expect it over the course of the remainder of the first half. Other important readouts include the, of course, the Pelicarson readout, which I'm sure we can discuss, the Remibrutinib MS readout, which will have two replicate studies, the Deldisiran DM1 study, which I also have mentioned, and then we've accelerated now the Rapsodo HS program into the second half of this year.

Speaker #1: So it won't be taking that, forward. But we don't expect that to be a read-through to ITP where we already have positive second-line data.

Vasant Narasimhan: I did wanna say a word on the pipeline readouts for the rest of the year. We have quite a bit happening, and we're excited about that. In H1, I already mentioned the Rhapsido CIndU positive readout. We did have adalimumab readout in warm autoimmune hemolytic anemia, which did not meet statistical significance. We won't be taking that forward. We don't expect that to be a read-through to ITP, where we already have positive second-line data, and we'll look forward to the first-line data in H2. We also have data in-house now for votoplam, which confirm our approach for the phase three study. Based on that data, we feel very comfortable taking the 10-milligram dose now forward into the pivotal phase three readout.

Vasant Narasimhan: I did wanna say a word on the pipeline readouts for the rest of the year. We have quite a bit happening, and we're excited about that. In H1, I already mentioned the Rhapsido CIndU positive readout. We did have adalimumab readout in warm autoimmune hemolytic anemia, which did not meet statistical significance. We won't be taking that forward. We don't expect that to be a read-through to ITP, where we already have positive second-line data, and we'll look forward to the first-line data in H2. We also have data in-house now for votoplam, which confirm our approach for the phase three study. Based on that data, we feel very comfortable taking the 10-milligram dose now forward into the pivotal phase three readout.

Speaker #1: And we'll look forward to the first-line data in the second half. We also have data in-house now, for Vodaplan, which confirm our approach for the phase three study based on that data we feel very comfortable taking the 10 milligram dose now forward into the pivotal phase three readout.

Speaker #2: That study enrolled extremely quickly. It's a very exciting because that will give us another or a first oral option for patients with HS. We also have our QCZ484 SIRNA for hypertension phase two data reading out.

Speaker #1: We are, in collaboration with our partner PTC, now discussing the best next steps for that medicine, including further interactions as well with the FDA, and we'll keep everyone apprised as we continue to progress that medicine forward.

Speaker #2: And then lastly, VHB RALS TRM2 antibody reading out as well in the second half. So with that, I will hand it over to Mukulti.

Speaker #1: We also are on track as well for the FSHD biomarker cohort readout, as well. Our, our plan would be to ultimately disclose that data after we've had any discussions with FDA to understand better if the data meets the standard for an accelerated approval.

Speaker #3: Thank you very much, Vas. And good morning, good afternoon, everyone. I will now take you through our financial results for the first quarter, which as Vas mentioned, were strong despite significant US generic entries.

Vasant Narasimhan: We are in collaboration with our partner PTC now discussing the best next steps for that medicine, including further interactions as well with the FDA. We'll keep everyone apprised as we continue to progress that medicine forward. We also are on track as well for the FSHD biomarker cohort readout as well. Our plan would be to ultimately disclose that data after we've had any discussions with FDA to understand better if the data meets the standard for an accelerated approval. We do not have that data in-house yet, but we do expect it over the course of the remainder of the H1.

Vasant Narasimhan: We are in collaboration with our partner PTC now discussing the best next steps for that medicine, including further interactions as well with the FDA. We'll keep everyone apprised as we continue to progress that medicine forward. We also are on track as well for the FSHD biomarker cohort readout as well. Our plan would be to ultimately disclose that data after we've had any discussions with FDA to understand better if the data meets the standard for an accelerated approval. We do not have that data in-house yet, but we do expect it over the course of the remainder of the H1.

Speaker #3: As always, my comments refer to growth rates in constant currencies unless otherwise noted. Slide 18, please. Our Q1 results as expected were impacted by UXGX erosion, with sales down 5% and core-opping down 14%.

Speaker #1: We do not have that data in-house yet, but we do expect it, over the course of, of the remainder of the first half. Other important readouts include the, of course, the Pelacarson readout, which I'm sure we can discuss, the Remibrutinib MS readout, which we'll have two replicate studies, the Deldisiran DM1, a study which I also have mentioned, and then we've accelerated now the Rapsodo HS program into the second half of this year.

Speaker #3: Worth noting is that we did have a positive gross unit in our base from Q1 last year that also had a negative impact on the overall quarterly growth rate.

Speaker #1: That study enrolled extremely quickly. So very excited because that will give us another or a first oral option for patients with HS. We also have our QCZ484 SIRNA, for hypertension, phase two data, reading out.

Speaker #3: Core margin in Q1 declined 4.1%. This was mainly due to higher R&D investments as well as the impact of generics on the gross margin.

Vasant Narasimhan: Other important readouts include, of course, the palovarogene readout, which I'm sure we can discuss, the remibrutinib MS readout, which brought two replicate studies, the deldisiran DM1, a study which I also have mentioned. We've accelerated now the Rhapsido HS program into the H2 of this year. That study enrolled extremely quickly. Very excited, because that will give us another, a first oral option for patients with HS. We also have our QCZ484 siRNA for hypertension, phase two data reading out. Lastly, VHB, our RALS TRIM2 antibody reading out as well in the H2. With that, I will hand it over to Mukul.

Vasant Narasimhan: Other important readouts include, of course, the palovarogene readout, which I'm sure we can discuss, the remibrutinib MS readout, which brought two replicate studies, the deldisiran DM1, a study which I also have mentioned. We've accelerated now the Rhapsido HS program into the H2 of this year. That study enrolled extremely quickly. Very excited, because that will give us another, a first oral option for patients with HS. We also have our QCZ484 siRNA for hypertension, phase two data reading out. Lastly, VHB, our RALS TRIM2 antibody reading out as well in the H2. With that, I will hand it over to Mukul.

Speaker #1: And then lastly, VHB, our RALS, TREM2 antibody reading out as well, in, in the second half. So with that, I will hand it over to Mukulti.

Speaker #3: These results were fully in line with our internal expectations in how we see 2026 P&L phasing through the year panning out. Most importantly, our growth drivers continue to show very positive growth momentum something that Vas has shared earlier on in the presentation with growing at 34% in Q1.

Speaker #1: Thank you very much, Vas. And good morning, good afternoon, everyone. I will now take you through our financial results for the first quarter, which has Vas mentioned.

Speaker #1: We're strong despite significant US genetic entries. As always, my comments refer to growth rates in constant currencies unless otherwise noted. Slide 18, please. Our Q1 results as expected were impacted by UXGX erosion, with sales down 5% and co-opting down 14%.

Speaker #3: Slide 19, please. What's great to see is that our continued focus on free cash flow generation has paid off in Q1. The lower core-opping was compensated by favorable working capital movement.

Mukul Mehta: Thank you very much, Vas. Good morning, good afternoon, everyone. I will now take you through our financial results for the first quarter, which as Vas mentioned, were strong despite significant US Gx entries. As always, my comments refer to growth rates in constant currencies unless otherwise noted. Slide 18, please. Our Q1 results, as expected, were impacted by US Gx erosion, with sales down 5% and core operating income down 14%. Worth noting is that we did have a positive gross net in our base from Q1 last year that also had a negative impact on the overall quarterly growth rate. Core margin in Q1 declined 4.1%. This was mainly due to higher R&D investments as well as the impact of generics on the gross margin.

Mukul Mehta: Thank you very much, Vas. Good morning, good afternoon, everyone. I will now take you through our financial results for the first quarter, which as Vas mentioned, were strong despite significant US Gx entries. As always, my comments refer to growth rates in constant currencies unless otherwise noted. Slide 18, please. Our Q1 results, as expected, were impacted by US Gx erosion, with sales down 5% and core operating income down 14%. Worth noting is that we did have a positive gross net in our base from Q1 last year that also had a negative impact on the overall quarterly growth rate. Core margin in Q1 declined 4.1%. This was mainly due to higher R&D investments as well as the impact of generics on the gross margin.

Speaker #3: And this brought back the free cash flow broadly in line with previous year quarter one. A strong cash flow continues to support our reinvestment into our business, including Bolton, M&A as well as gives us the opportunity to return capital to our shareholders through dividends and share buybacks.

Speaker #1: Worth noting is that we did have a positive gross unit in our base from Q1 last year that also had a negative impact on the overall quarterly growth rate.

Speaker #1: Co-margin in Q1 declined 4.1%. This was mainly due to higher R&D investments, as well as the impact of generics on the gross margin. These results were fully in line with our internal expectations in how we see 2026 P&L phasing through the year panning out.

Speaker #3: Slide 20, please. We remain committed to our balanced shareholder-friendly capital allocation strategy. Alongside an increased R&D in the first quarter, we closed the average acquisition.

Speaker #1: Most importantly, our growth drivers continue to show very positive growth momentum something that Vas has, shared earlier on in the presentation with growing at 34% in Q1.

Speaker #3: And we also announced two early-stage deals to support our oncology and immunology disease franchises. On the other hand, for the return to capital return of capital to our shareholders front, we did pay 9.1 billion in dividend in March and April as previously announced.

Speaker #1: Slide 19, please. What's great to see is that our continued focus on free cash flow generation has paid off in Q1. The lower cor the lower co-opting was compensated by favorable working capital movement.

Mukul Mehta: These results were fully in line with our internal expectations and how we see 2026 P&L phasing through the year panning out. Most importantly, our growth drivers continue to show very positive growth momentum, something that Vas has shared earlier on in the presentation with growing at 34% in Q1. Slide 19, please. What's great to see is that our continued focus on free cash flow generation has paid off in Q1. The lower core operating income was compensated by favorable working capital movement, and this brought back the free cash flow broadly in line with previous year Q1. A strong cash flow continues to support our reinvestment into our business, including bolt-on M&A, as well as gives us the opportunity to return capital to our shareholders through dividends and share buybacks. Slide 20, please.

Mukul Mehta: These results were fully in line with our internal expectations and how we see 2026 P&L phasing through the year panning out. Most importantly, our growth drivers continue to show very positive growth momentum, something that Vas has shared earlier on in the presentation with growing at 34% in Q1. Slide 19, please. What's great to see is that our continued focus on free cash flow generation has paid off in Q1. The lower core operating income was compensated by favorable working capital movement, and this brought back the free cash flow broadly in line with previous year Q1. A strong cash flow continues to support our reinvestment into our business, including bolt-on M&A, as well as gives us the opportunity to return capital to our shareholders through dividends and share buybacks. Slide 20, please.

Speaker #3: And in addition, we continue to progress with our up to 10 billion share buyback program. This program still has around 6.1 billion remaining and is targeted to complete end of 2027.

Speaker #1: And this brought back the free cash flow broadly in line with previous year previous year quarter one. A strong cash flow continues to support our reinvestment into our business, including Bolton, M&A, as well as as well as gives us the opportunity to return capital to our shareholders through dividends and share buybacks.

Speaker #3: Slide 21. With that, I'll move to the guidance piece. So with our Q1 results, we are now reaffirming our full year 2026 guidance. We continue to expect 2026 to have low single-digit sales growth and low single-digit decline in core operating income.

Speaker #1: Slide 20, please. We remain committed to our balanced shareholder-friendly capital allocation strategy. Alongside an increased R&D in the first quarter, we closed the average acquisition, and we also announced two early-stage deals to support our oncology and immunology disease franchises.

Speaker #3: Worth noting is that this is the year we are growing the top line of the company through the largest LOE period that the company has seen.

Speaker #3: Core net financial expense will be around 1.7 billion and core tax rate would be about 16.5%. And these two parameters are consistent with our previous estimates.

Speaker #1: On the other hand, for the return-to-capital return of capital to our shareholders front, we did pay 9.1 billion in dividend in March and April as previously announced.

Speaker #3: Slide 22, please. We continue to expect 2026 to be a year of two halves. H1 growth will be impacted by a tough previous year base following US generic entries for Entresto, Promact, and Tasigna, mid-last year.

Mukul Mehta: We remain committed to our balanced shareholder-friendly capital allocation strategy. Alongside an increased R&D, in Q1, we closed the Avidity acquisition, and we also announced two early-stage deals to support our oncology and immunology disease franchises. On the other hand, for the return of capital to our shareholders front, we did pay $9.1 billion in dividend in March and April, as previously announced. In addition, we continue to progress with our up to $10 billion share buyback program. This program still has around $6.1 billion remaining, and is targeted to complete end of 2027. Slide 21. With that, I'll move to the guidance piece. With our Q1 results, we are now reaffirming our full year 2026 guidance.

Mukul Mehta: We remain committed to our balanced shareholder-friendly capital allocation strategy. Alongside an increased R&D, in Q1, we closed the Avidity acquisition, and we also announced two early-stage deals to support our oncology and immunology disease franchises. On the other hand, for the return of capital to our shareholders front, we did pay $9.1 billion in dividend in March and April, as previously announced. In addition, we continue to progress with our up to $10 billion share buyback program. This program still has around $6.1 billion remaining, and is targeted to complete end of 2027. Slide 21. With that, I'll move to the guidance piece. With our Q1 results, we are now reaffirming our full year 2026 guidance.

Speaker #1: And in addition, we continue to progress with our up to $10 billion share buyback program. This program still has around $6.1 billion remaining, and it's targeted to complete by the end of 2027.

Speaker #3: And with that, in the base, we had guided H1 sales to decline low single-digit and core-opping to decline low double digits. With our Q1 results now in the bag, we are on track to meet that guidance with Q2 sales expected to decline low single-digit and core-opping expected to decline high single-digit to low double digit.

Speaker #1: Slide 21. With that, I'll, move to the guidance piece. So with our Q1 results, we are now reaffirming our full year 2026 guidance. We continue to expect 2026 to have low single-digit sales growth and low single-digit decline in co-operating income.

Speaker #1: Worth noting is that this is the year we are growing the top line of the company through the largest LOE period, that the company has seen.

Speaker #3: In half two, the impact of the US generic entries in the base will start to minimize. And this will allow strong growth of our priority brands and launches to show through the overall P&L.

Speaker #1: Core net financial expense will be one will be around 1.7 billion, and core tax rate would be about 16.5%. And these, these two parameters are consistent with our previous estimates.

Mukul Mehta: We continue to expect 2026 to have low single-digit sales growth and low single-digit decline in core operating income. Worth noting is that this is the year we're growing the top line of the company through the largest LOE period that the company has seen. Core net financial expense will be around $1.7 billion, and core tax rate would be about 16.5%. These two parameters are consistent with our previous estimates. Slide 22, please. We continue to expect 2026 to be a year of two halves. H1 growth will be impacted by a tough previous year base following US generic entries for Entresto, Promacta, and Tasigna mid-last year. With that in the base, we had guided H1 sales to decline low single digits and core op inc to decline low double digits.

Mukul Mehta: We continue to expect 2026 to have low single-digit sales growth and low single-digit decline in core operating income. Worth noting is that this is the year we're growing the top line of the company through the largest LOE period that the company has seen. Core net financial expense will be around $1.7 billion, and core tax rate would be about 16.5%. These two parameters are consistent with our previous estimates. Slide 22, please. We continue to expect 2026 to be a year of two halves. H1 growth will be impacted by a tough previous year base following US generic entries for Entresto, Promacta, and Tasigna mid-last year. With that in the base, we had guided H1 sales to decline low single digits and core op inc to decline low double digits.

Speaker #3: And hence, we continue to expect H2 sales growth of mid-single-digit and core-opping growth of mid to high single-digit. And that brings us to our full year guidance.

Speaker #1: Slide 22, please. We continue to expect 2026 to be a year of two halves. H1 growth will be impacted by a tough previous-year base, following US generic entries for Entresto, Comarch, Tenta, Cigna, mid-last year.

Speaker #3: Next slide, please. If exchange rates remain at late April levels, we expect positive plus 2% impact on full year sales and positive 1% on full year core operating income.

Speaker #1: And with that, in the base, we had guided H1 sales to decline low single-digit and co-opting to decline low double digits. With our Q1 results now in the bag, we are on track to meet that guidance with Q2 sales expected to decline low single-digit and co-opting expected to decline high single-digit to low double digit.

Speaker #3: As a reminder, updated exchange rate assumptions are published monthly on our website. And then that concludes my remarks, and I'll hand it back to Vas.

Speaker #2: Great. Thank you, Mukul, and welcome as well, Mukul, for his first quarter here as CFO is up to a tremendous start. So overall, we've delivered a strong start in 2026 across our priority brands and launches.

Speaker #1: In half two, the impact of the US genetic entries in the base will start to minimize. And this will allow strong growth of our priority brands and launches to show through the overall P&L.

Speaker #2: And we remain fully confident with our mid to long-term growth outlook. We continue to advance our pipeline, completed the ability acquisition, and are well set up for multiple readouts in the second half.

Mukul Mehta: With our Q1 results now in the bag, we are on track to meet that guidance, with Q2 sales expected to decline low single digits and core op inc expected to decline high single digit to low double digit. In H2, the impact of the US generic entries in the base will start to minimize, This will allow strong growth of our priority brands and launches to show through the overall P&L. Hence, we continue to expect H2 sales growth of mid-single digit and core op inc growth of mid to high single digit. That brings us to our full-year guidance. Next slide, please. If exchange rates remain at late April levels, we expect +2% impact on full-year sales and +1% on full-year core operating income. As a reminder, updated exchange rate assumptions are published monthly on our website.

Mukul Mehta: With our Q1 results now in the bag, we are on track to meet that guidance, with Q2 sales expected to decline low single digits and core op inc expected to decline high single digit to low double digit. In H2, the impact of the US generic entries in the base will start to minimize, This will allow strong growth of our priority brands and launches to show through the overall P&L. Hence, we continue to expect H2 sales growth of mid-single digit and core op inc growth of mid to high single digit. That brings us to our full-year guidance. Next slide, please. If exchange rates remain at late April levels, we expect +2% impact on full-year sales and +1% on full-year core operating income. As a reminder, updated exchange rate assumptions are published monthly on our website.

Speaker #2: Remain on track to deliver our full year guidance. And we'll also look forward to those readouts, which could enable us to raise our mid to long-term growth outlook.

Speaker #1: And hence, we continue to expect H2 sales growth of mid-single-digit and co-opting growth of mid to high single-digit. And that brings us to our full year guidance.

Speaker #2: So with that, we can open the line for questions, Sharon.

Speaker #4: Thank you. To ask a question, you will need to press star one and one on your telephone and wait for your name to be announced.

Speaker #1: Next slide, please. If exchange rates remain at late April levels, we expect positive plus 2% impact on full year sales and positive 1% on full full year co-operating income.

Speaker #4: Please limit yourself to one question and return to the queue for any follow-ups. To withdraw your question, please press star one and one. We will now go to our first question.

Speaker #1: As a reminder, updated exchange rate assumptions are published monthly on our website. And then that concludes my remarks, and I'll hand it back to Vas.

Speaker #4: And the first question today comes from the line of Peter Verdult from BNP Paribas. Please go ahead.

Speaker #5: Yeah. Thanks, Peter Verdult, BNP. Just one question, just a deep dive, please, Vas, on HS. Could you perhaps you talked about MBRX during the presentation, but could you talk about current volume price dynamics for Cosentyx in HS, the target clinical profile for Rapsido in HS, and how, if the data is positive, you would intend to position both assets in the market?

Speaker #2: Great. Thank you, Mukul, and welcome as well, Mukul, for his, first quarter here as, CFO is up to a tremendous start. So overall, we've, delivered a strong start in 2026, across our priority brands and launches.

Speaker #2: And we remain fully confident with our mid to long-term growth outlook. We continue to advance our pipeline, completed the ability acquisition, and are well set up for multiple readouts in the second half.

Mukul Mehta: That concludes my remarks, and I'll hand it back to Vas.

Mukul Mehta: That concludes my remarks, and I'll hand it back to Vas.

Speaker #5: Thank you.

Vasant Narasimhan: Great. Thank you, Mukul, and welcome as well, Mukul, for his Q1 here as CFO. He's off to a tremendous start. Overall, we've delivered a strong start in 2026 across our priority brands and launches, and we remain fully confident with our mid to long-term growth outlooks. We continue to advance our pipeline, completed the Avidity acquisition, and are well set up for multiple readouts in the H2, remain on track to deliver our full-year guidance, and we'll also look forward to those readouts which could enable us to raise our mid to long-term growth outlook. With that, we can open the line for questions, Sharon.

Vasant Narasimhan: Great. Thank you, Mukul, and welcome as well, Mukul, for his Q1 here as CFO. He's off to a tremendous start. Overall, we've delivered a strong start in 2026 across our priority brands and launches, and we remain fully confident with our mid to long-term growth outlooks. We continue to advance our pipeline, completed the Avidity acquisition, and are well set up for multiple readouts in the H2, remain on track to deliver our full-year guidance, and we'll also look forward to those readouts which could enable us to raise our mid to long-term growth outlook. With that, we can open the line for questions, Sharon.

Speaker #2: Yeah, Peter. Absolutely. So overall, with Cosentyx, we've had stable growth to net across our indication suite this year. So I think we've been able to manage things pretty well.

Speaker #2: We remain on track to deliver our full-year guidance, and we also look forward to those readouts, which could enable us to raise our mid- to long-term growth outlook.

Speaker #2: So with that, we can open the line for questions, sir.

Speaker #2: So overall, with this is primarily we saw very solid volume growth in the quarter with HS. More of the headwinds that we saw were with some of the older indications.

Speaker #3: Thank you. To ask a question, you will need to press star one and one on your telephone and wait for your name to be announced.

Speaker #3: Please limit yourself to one question and return to the queue for any follow-ups. To withdraw your question, please press star one and one. We will now go to our first question.

Speaker #2: But nothing notable in terms of increased growth to net for Cosentyx in the quarter. And when you think about Remibrutinib, the phase two data indicated, I think, impressive well, early, but impressive results in disease management.

Speaker #3: And the first question today comes from the line of Peter Sedolt from BNP Pariba. Please go ahead.

Vasant Narasimhan: Thank you. We will now go to our first question. The first question today comes from the line of Peter Verdult from BNP Paribas. Please go ahead.

Operator: Thank you. We will now go to our first question. The first question today comes from the line of Peter Verdult from BNP Paribas. Please go ahead.

Speaker #2: I think we'll ultimately have to see how the phase three results play out. But the ambition would be to play as we have with Remibrutinib and CSU and plan to do with Sindu is to hopefully have an oral option that could be placed ahead of biologics and so clearly having two medicines would be helpful.

Speaker #2: Yeah. Thanks, Peter. BNP. just one question, just a deep dive, please, Vas, on HS. Could you perhaps you talked about MBRX during the presentation, but could you talk about current volume price dynamics for Cosentyx in HS, the target clinical profile for Rapsido in HS, and how, if the data's positive, you would intend to position both assets in the market?

Speaker #2: We would have the oral option and then ultimately the biologic option as well. But I think this is really dependent on the data set.

Speaker #2: Thank you.

Peter Verdult: Yeah, thanks. Peter Verdult, BNP. Just one question, just a deep dive, please, Vas, on HS. You talked about NBRX during the presentation, but could you talk about current volume price dynamics for Cosentyx in HS, the target clinical profile for Rhapsido in HS, and how, if the data is positive, you would intend to position both assets in the market? Thank you.

Peter Verdult: Yeah, thanks. Peter Verdult, BNP. Just one question, just a deep dive, please, Vas, on HS. You talked about NBRX during the presentation, but could you talk about current volume price dynamics for Cosentyx in HS, the target clinical profile for Rhapsido in HS, and how, if the data is positive, you would intend to position both assets in the market? Thank you.

Speaker #4: Yeah, Peter. absolutely. So overall, you know, with Cosentyx, we've had stable, I'd say, growth to net, across our indication suite. this year. So I think we've been able to manage things, pretty well.

Speaker #2: This is a heterogeneous population, and we're going to have to see how the data looks before we can fully define the positioning. Next question.

Speaker #4: Thank you. Your next question comes from the line of Sachin Jain from Bank of America. Please go ahead.

Speaker #4: So, overall, you know, with, this is primarily we saw very solid volume growth in the, in the quarter with, HS. More of the headwinds that we saw were with some of the, older indications.

Speaker #6: Hi there. I actually have a follow-on to the prior question on HS if I may. So you sort of commented, Vas, but what's your target efficacy profile relative to existing biologics?

Vasant Narasimhan: Peter. Absolutely. Overall, you know, with Cosentyx, we've had stable, I'd say gross to net, across our indication suite, this year. I think we've been able to manage things pretty well. Overall, you know, this is primarily we saw very solid volume growth in the quarter with HS. More of the headwinds that we saw were with some of the older indications. But nothing notable in terms of increased gross to nets for Cosentyx in the quarter. Now, when you think about remibrutinib, the phase 2 data indicated, I think, impressive, well, early but impressive results in disease management. I think we'll ultimately have to see how the phase 3 results play out.

Vasant Narasimhan: Peter. Absolutely. Overall, you know, with Cosentyx, we've had stable, I'd say gross to net, across our indication suite, this year. I think we've been able to manage things pretty well. Overall, you know, this is primarily we saw very solid volume growth in the quarter with HS. More of the headwinds that we saw were with some of the older indications. But nothing notable in terms of increased gross to nets for Cosentyx in the quarter. Now, when you think about remibrutinib, the phase 2 data indicated, I think, impressive, well, early but impressive results in disease management. I think we'll ultimately have to see how the phase 3 results play out.

Speaker #4: but no-nothing notable in terms of an increased growth to net, for Cosentyx in the quarter. And when you think about Remibrutinib, the phase two data indicated, I think, impressive, or, well, early, early, but impressive results, in disease management.

Speaker #6: Just given the phase two was hard to interpret with the inverse dose response and varied placebo-adjusted rates, and then in your mind, is HS or MS likely a bigger indication?

Speaker #4: I think we'll ultimately have to see how the phase three results, play out. But the ambition would be to play as we have Remibrutinib in CSU and plan to do in Sindhu is to hopefully have an oral option that could be placed ahead of biologics and so clearly having two medicines would be would be helpful.

Speaker #6: Thank you.

Speaker #2: Yeah. I mean, I think I don't know if I have the details, Sachin. We may have to follow up with you on our expectations on the phase three study of the the design in HS.

Speaker #2: But I would still say it's all really going to depend in terms of your second part of your question, the overall data profile that we see.

Speaker #4: We would have the oral option and, ultimately, the biologic option as well. But I think this is really dependent on the data set.

Speaker #2: I think clearly, if Remy and MS proves itself both in relapse rate and disability progression to be better than the anti-CD20s, then, of course, the opportunity here is massive.

Speaker #4: This is a heterogeneous population, and we're going to have to see how the data looks before we can fully define the positioning. Next question.

Vasant Narasimhan: The ambition would be to play as we have with remibrutinib and CSU and plan to do with CIndU, is to hopefully have an oral option that could be placed ahead of biologics. Clearly having two medicines would be helpful. We would have the oral option and ultimately the biologic option as well. I think this is really dependent on the data set. This is a heterogeneous population, and we're gonna have to see how the data looks before we can fully define the positioning. Next question.

Vasant Narasimhan: The ambition would be to play as we have with remibrutinib and CSU and plan to do with CIndU, is to hopefully have an oral option that could be placed ahead of biologics. Clearly having two medicines would be helpful. We would have the oral option and ultimately the biologic option as well. I think this is really dependent on the data set. This is a heterogeneous population, and we're gonna have to see how the data looks before we can fully define the positioning. Next question.

Speaker #2: I think if it's in line or ultimately a little bit worse, then I think HS could be a similarly sized indication. And we know the HS market is growing.

Speaker #3: Thank you. Your next question comes from the line of Satya Jain from Bank of America. Please go ahead.

Speaker #5: hi there. I actually have a follow-on to the prior question on HS if I may. so you sort of commented, Vas, but, what's your target efficacy profile relative to existing biologics?

Speaker #2: We've guided it to be a $5 billion market, growing certainly the potation potential is there to be much larger. And it might be that a safe and effective oral option would be really attractive.

Speaker #5: Just given the phase two was hard to interpret with the inverse dose response and varied placebo, adjusted rates. and then in your mind, is HS or MS likely a bigger indication?

Speaker #2: So I think it's really going to be dependent on that MS readout to understand the size of the MS opportunity. But I think it's exciting that we have two shots on goal with Remy to add to what's two already very compelling indications that we have going forward.

Vasant Narasimhan: Thank you. Your next question comes from the line of Sachin Jain from Bank of America. Please go ahead.

Operator: Thank you. Your next question comes from the line of Sachin Jain from Bank of America. Please go ahead.

Sachin Jain: Hi there. I actually have a follow-on to the prior question on HS, if I may. You sort of commented, Vas, but what's your target efficacy profile relative to existing biologics? Just given the phase 2 was hard to interpret with the inverse dose response and varied placebo-adjusted rates. In your mind, is HS or MS likely a bigger indication? Thank you.

Sachin Jain: Hi there. I actually have a follow-on to the prior question on HS, if I may. You sort of commented, Vas, but what's your target efficacy profile relative to existing biologics? Just given the phase 2 was hard to interpret with the inverse dose response and varied placebo-adjusted rates. In your mind, is HS or MS likely a bigger indication? Thank you.

Speaker #5: Thank you.

Speaker #4: Yeah. I mean, I think I don't know if I have the details such in that we may have to follow up with you on, you know, our expectations on the phase three study of the design, in, in HS.

Speaker #2: But we'll get back to you on your question on HS. Next question.

Speaker #4: Thank you. Your next question. Comes from the line of Richard Foster from JP Morgan. Please go ahead.

Speaker #4: But I, I would still say it's all really gonna depend in terms of your second part of your question. The overall data profile that we see.

Speaker #7: Hi. Thanks for taking my question. Question about China. You referenced competition for Cosentyx. But we also saw much lower growth in general in China, across Q1.

Speaker #4: I think clearly if, if Remy and MS proves itself both, in relapse rate and disability progression to be better than the anti-CD20s, then, of course, the, the opportunity here is, is massive.

Vasant Narasimhan: I mean, I think I don't know if I have the details, Sachin. We may have to follow up with you on, you know, our expectations on the Phase III study, the design, in HS. I would still say it's all really gonna depend in terms of your second part of your question, the overall data profile that we see. I think clearly if Remi and MS proves itself both in relapse rate and disability progression to be better than the anti-CD20s, then of course, the opportunity here is massive. I think if it's in line or ultimately a little bit worse, then I think HS could be a similarly sized indication. We know the HS market is growing. We've guided it to be a $5 billion market growing. Certainly, the potential is there to be much larger.

Vasant Narasimhan: I mean, I think I don't know if I have the details, Sachin. We may have to follow up with you on, you know, our expectations on the Phase III study, the design, in HS. I would still say it's all really gonna depend in terms of your second part of your question, the overall data profile that we see. I think clearly if Remi and MS proves itself both in relapse rate and disability progression to be better than the anti-CD20s, then of course, the opportunity here is massive. I think if it's in line or ultimately a little bit worse, then I think HS could be a similarly sized indication. We know the HS market is growing. We've guided it to be a $5 billion market growing. Certainly, the potential is there to be much larger.

Speaker #7: Despite the strong start for Lekveo. So should we expect more slower international growth for Entresto, Cosentyx going forward? And slower overall China development? Or can Lekveo continue to post drag China growth to double digits?

Speaker #4: I think, if it's in line or, ultimately a little bit worse, then I think HS could be a similarly sized indication. And we know the HS market is growing.

Speaker #4: We've guided it to be a $5 billion market, growing certainly the potation potential is there to be much larger. And it might be that a safe and effective oral option, would be really, attractive.

Speaker #7: And I have one quick linked question on Lekveo. How much of the peak do you think can come from China given the strong start?

Speaker #4: So I think it's really gonna be dependent on that MS readout to understand the size of the MS opportunity. But I think it's, it's exciting that we have two shots on goal with two with Remy to add to what's two already very compelling indications that we have going forward.

Speaker #7: Thanks very much.

Speaker #2: Yeah. Thanks, Richard. So overall, the dynamics in China, we've seen a stabilization in the early part of this year. I don't think we're back to the pre-2025 growth levels, but we do see a stabilization overall in the market as well and in our key segments.

Speaker #4: But we'll get back to you on your question on, on HS. Next question.

Vasant Narasimhan: It might be that a safe and effective oral option would be really attractive. I think it's really gonna be dependent on that MS readout to understand the size of the MS opportunity. I think it's exciting that we have two shots on goal with Remi to add to what's two already very compelling indications that we have going forward. We'll get back to you on your question on HS. Next question.

Vasant Narasimhan: It might be that a safe and effective oral option would be really attractive. I think it's really gonna be dependent on that MS readout to understand the size of the MS opportunity. I think it's exciting that we have two shots on goal with Remi to add to what's two already very compelling indications that we have going forward. We'll get back to you on your question on HS. Next question.

Speaker #3: Thank you. Your next question comes from the line of Richard Foster from JP Morgan. Please go ahead.

Speaker #2: And so we feel confident that our China business can be in that high single digit to low double digit growth range. So that's been positive overall.

Speaker #5: Hi. Thanks for taking my question. question about, China. Y-y-you referenced competition for Cosentyx. But we also saw much lower growth in general, in China across Q1, despite the strong start for Lekveo.

Speaker #2: I think but there's no question it won't get back to the really high growth rates we saw a few years ago. We also see a higher number of competitors entering in in each segment as well, which is something we have to just be ready for when we do launch in China.

Vasant Narasimhan: Thank you. Your next question comes from the line of Richard Vosser from JP Morgan. Please go ahead.

Operator: Thank you. Your next question comes from the line of Richard Vosser from JPMorgan. Please go ahead.

Speaker #5: So you know, should we expect more, slower international growth for Entresto, Cosentyx going forward? And slower overall China development? Or can Lekveo continue to post, drag China growth to double digits?

Speaker #2: Nonetheless, very large market, highly attractive, and I think you've seen the strong performance that we've had. I think for Lekveo, I've guided that Entresto can be a billion-dollar medicine across its indications.

Richard Vosser: Hi. Thanks for taking my question. A question about China. You referenced competition for Cosentyx.

Richard Vosser: Hi. Thanks for taking my question. A question about China. You referenced competition for Cosentyx.

Richard Vosser: We also saw much lower growth in general in China across Q1 despite the strong start for Leqvio. You know, should we expect more slower international growth for Entresto, Cosentyx going forward and slower overall China development? Can Leqvio continue to post drag China growth to double digits? I have one quick linked question on Leqvio. You know, how much of the peak do you think can come from China given the strong start? Thanks so much.

Richard Vosser: We also saw much lower growth in general in China across Q1 despite the strong start for LEQVIO. You know, should we expect more slower international growth for Entresto, Cosentyx going forward and slower overall China development? Can LEQVIO continue to post drag China growth to double digits? I have one quick linked question on LEQVIO. You know, how much of the peak do you think can come from China given the strong start? Thanks so much.

Speaker #5: And I have one quick, linked question on Lekveo. You know, how much of the peak do you think can come from China given the strong start?

Speaker #2: And certainly, we have the aspiration to make Lekveo as big or bigger than Entresto over time. It's early days. I think understanding the trajectory of how we get there, but I would say we see very solid demand for the medicine.

Speaker #5: Thanks very much.

Speaker #4: Yeah. Thanks, Richard. So your overall, the dynamics in China, we've seen a stabilize stabilization, in the early part of, of this year. I, I don't think we're back to the pre-2025 growth levels, but we do see a stabilization overall in the market as well and in our key segments.

Speaker #2: And I think if we could make it in the range of Entresto, that would be a success.

Speaker #4: Thank you. Your next question comes from the line of Simon Baker from Rothschild. Please go ahead.

Speaker #4: And so we feel confident that our China business can be in that high single digit to low double digit growth, range. So that's been that's been positive overall.

Speaker #8: Thank you, very much, for taking my question. And I will stick to the warm. Taking up on your offer, Vas, could you give us your updated levels of confidence on the timing and outcome of the Pelicast and Horizon study?

Vasant Narasimhan: Yeah, thanks, Richard. Overall, the dynamics in China, we've seen the stabilization in the early part of this year. I don't think we're back to the pre-2025 growth levels, but we do see a stabilization overall in the market as well and in our key segments. We feel confident that our China business can be in that high single digits to low double-digit growth range. That's been positive overall. I think there's no question it won't get back to the really high growth rates we saw, you know, a few years ago. We also see a higher number of competitors entering in each segment as well, which is something we have to just be ready for when we do launch in China.

Vasant Narasimhan: Yeah, thanks, Richard. Overall, the dynamics in China, we've seen the stabilization in the early part of this year. I don't think we're back to the pre-2025 growth levels, but we do see a stabilization overall in the market as well and in our key segments. We feel confident that our China business can be in that high single digits to low double-digit growth range. That's been positive overall. I think there's no question it won't get back to the really high growth rates we saw, you know, a few years ago. We also see a higher number of competitors entering in each segment as well, which is something we have to just be ready for when we do launch in China.

Speaker #4: I think but there's no question it won't get back to the really high growth rates we saw, you know, a few years ago. We also see a higher number of competitors entering in, in each in each segment as well, which is something we have to just be ready for when we do launch in China.

Speaker #8: Thanks so much.

Speaker #2: Yes, I mean, so I don't think I have anything new to add, unfortunately, because we don't have any new information. But I think we, of course, continue to make sure that the study is on track.

Speaker #4: Nonetheless, very large market, highly attractive. And I think you've seen the strong performance that we've had. You know, I think for Lekveo, you know, I've guided that Entresto can be a billion-dollar medicine across its indications.

Speaker #2: No change in our expected readout. We do expect a readout in the early part of the second half of the year. So no change with respect to that.

Speaker #4: And certainly, we have the aspiration to make Lekveo as big or bigger than Entresto over time. It's early days. I think understanding the trajectory of how we get there.

Speaker #2: I think if we get a positive result overall, that regardless of the relative risk reduction, we'll find a way to ultimately launch the medicine.

Vasant Narasimhan: Nonetheless, very large market, highly attractive, and I think you've seen the strong performance that we've had. You know, I think for Leqvio, you know, we have guided that Entresto can be a billion-dollar medicine across its indications, and certainly, we have the aspiration to make Leqvio as big or bigger than Entresto over time. It's early days, I think, understanding the trajectory of how we get there, but I would say we see very solid demand for the medicine, and I think if we could make it in the range of Entresto, that would be a success.

Vasant Narasimhan: Nonetheless, very large market, highly attractive, and I think you've seen the strong performance that we've had. You know, I think for LEQVIO, you know, we have guided that Entresto can be a billion-dollar medicine across its indications, and certainly, we have the aspiration to make LEQVIO as big or bigger than Entresto over time. It's early days, I think, understanding the trajectory of how we get there, but I would say we see very solid demand for the medicine, and I think if we could make it in the range of Entresto, that would be a success.

Speaker #4: But I would say we see very solid demand for the medicine. And I think if we could make it in the range of Entresto, that would be a success.

Speaker #2: I think what will be really looking for is, are there either the 90 milligram prespecified subgroup or other subgroups where we can really demonstrate a significant benefit for patients?

Speaker #3: Thank you. Your next question comes from the line of Simon Baker from Rothschild. Please go ahead.

Speaker #2: But I think we'll help with the uptake but we have no insight yet as to what that would be. We've modeled it extensively; we continue to believe that we've done the right study and are fully powered for a 20% relative risk reduction in the 70 milligram per DL and higher patient population, and a 25% relative risk reduction in the 90 milligram per DL patient population.

Speaker #6: Thank you very much for taking my question. And I will stick to the warm. Taking up on your offer, Vas, could you give us your updated levels of confidence on the timing and outcome of the Pelicast and Horizon study?

Vasant Narasimhan: Thank you. Your next question comes from the line of Simon Baker from Rothschild. Please go ahead.

Operator: Thank you. Your next question comes from the line of Simon Baker from Rothschild. Please go ahead.

Speaker #6: Thanks so much.

Speaker #4: Yes, Simon. So, I, I, I don't think I have anything new to, to, to add, unfortunately, because we don't have anything, any new information.

Speaker #2: As a reminder, the median level in the study is 108. So we definitely have enrolled the right patient group. And so we'll ultimately have to see I think some of the other dynamics that will be important is cardiovascular versus stroke and how those different elements contribute to the primary outcome.

Simon Baker: Thank you very much for taking my question, and I will stick to the one. Taking up on your offer, Vas, could you give us your updated levels of confidence on the timing and outcome of the Pelacarsen HORIZON study? Thanks so much.

Simon Baker: Thank you very much for taking my question, and I will stick to the one. Taking up on your offer, Vas, could you give us your updated levels of confidence on the timing and outcome of the Pelacarsen HORIZON study? Thanks so much.

Speaker #4: But I think we, of course, continue to, make sure that the study's on track. No change in our expected readout. We do expect a, a readout, in the early part of the second half of, of the year.

Speaker #4: so no, no change with respect to that. I think if, if we get a positive result overall, that's regardless of the of the relative risk reduction, we'll find a way to ultimately, launch the medicine.

Speaker #2: We do have a MACE4 endpoint here. So we do include stroke and I think some of the recent literature would suggest stroke is going to be an important element of the story for LPA.

Vasant Narasimhan: Yeah, Simon. I don't think I have anything new to add, unfortunately, because we don't have any new information. I think we, of course, continue to make sure that the study is on track. No change in our expected readout. We do expect a readout in the early part of the H2 of the year. No change with respect to that. I think if we get a positive result overall, that regardless of the relative risk reduction, we'll find a way to ultimately launch the medicine. I think what we'll be really looking for is, are there either the 90-milligram pre-specified subgroup or other subgroups where we can really demonstrate a significant benefit for patients that I think will help with the uptake.

Vasant Narasimhan: Yeah, Simon. I don't think I have anything new to add, unfortunately, because we don't have any new information. I think we, of course, continue to make sure that the study is on track. No change in our expected readout. We do expect a readout in the early part of the H2 of the year. No change with respect to that. I think if we get a positive result overall, that regardless of the relative risk reduction, we'll find a way to ultimately launch the medicine. I think what we'll be really looking for is, are there either the 90-milligram pre-specified subgroup or other subgroups where we can really demonstrate a significant benefit for patients that I think will help with the uptake.

Speaker #2: So we'll see how that unfolds. So exciting, but we'll also have to see. I do want to highlight as well that as I've articulated in the past, this will be a slow-building market simply because we need the testing rates to get much higher.

Speaker #4: I think what we'll really be looking for is, are there either the 90-milligram prespecified subgroup, or other subgroups, where we can really demonstrate a significant benefit for patients?

Speaker #4: But I think we'll help with the uptake, but we have no insight yet as to what, what that'd be. We've modeled it extensively, we continue to believe that we've done the right study, and are fully powered for a 20% relative risk, risk reduction in the 70-milligram per DL and higher patient population, and a 25% relative risk, risk reduction in the 90-milligram per DL patient population.

Speaker #2: So this will be assuming it all plays out as we hope, a multiple iterations. But our DII235 is ready to go into phase three studies, which could be a once-yearly LPA injection.

Speaker #2: So we're quite excited about that as well to be ready. Lastly, I would note that ACC and AHA have now added that everybody in the United States should receive an LPA test once in their life.

Speaker #4: As a reminder, the median level in the study is 108. so we, we definitely have enrolled the right patient group. And so we'll ultimately, you know, have to see I think some of the other dynamics that will be important is cardiovascular versus stroke.

Vasant Narasimhan: We have no insight yet as to what would that be. We've modeled it extensively. We continue to believe that we've done the right study and are fully powered for a 20% relative risk reduction in the 70 milligram per DL and higher patient population and a 25% relative risk reduction in the 90 milligram per DL patient population. As a reminder, the median level of the study is 108, we definitely have enrolled the right patient group. We'll ultimately, you know, have to see. I think some of the other dynamics that will be important is cardiovascular versus stroke and how those different elements contribute to the primary outcome. We do have a MACE-4 endpoint here, we do include stroke.

Vasant Narasimhan: We have no insight yet as to what would that be. We've modeled it extensively. We continue to believe that we've done the right study and are fully powered for a 20% relative risk reduction in the 70 milligram per DL and higher patient population and a 25% relative risk reduction in the 90 milligram per DL patient population. As a reminder, the median level of the study is 108, we definitely have enrolled the right patient group. We'll ultimately, you know, have to see. I think some of the other dynamics that will be important is cardiovascular versus stroke and how those different elements contribute to the primary outcome. We do have a MACE-4 endpoint here, we do include stroke.

Speaker #2: And I think fortunate milestone to hopefully get testing rates up and to start to build the market over time. So thanks for the question.

Speaker #8: Thanks so much.

Speaker #4: Thank you. Your next question comes from the line of Matthew Weston from UBS. Please go ahead.

Speaker #4: and how those different elements contribute to the, primary outcome. We do have a, a MACE4 endpoint here. So we do include stroke and I think some of the recent literature would suggest stroke is gonna be an important element of the story for LPA.

Speaker #9: Thank you. My question is about Rapsido. Vas, now that we're heading to EU approval, Rapsido is going to be one of the first pricing discussions for a multibillion-dollar product since MFN.

Speaker #4: so we'll, we'll see how that unfolds. So, exciting, but we'll also have to see. I do wanna highlight as well that as I've articulated in the past, this will be a slow building market simply because we need the testing rates to get much higher.

Speaker #9: So assuming that you've had some early discussions with European governments are you seeing countries inclined to pay higher prices for innovation in Europe?

Speaker #4: So this will be, assuming it all plays out as we hope, a multiple iterations. But our DII235 is ready to go into phase three studies, which could be, once yearly, LPA injections.

Vasant Narasimhan: I think some of the recent literature would suggest stroke is going to be an important element of the story for Lp(a). We'll see how that unfolds. Exciting, but we'll also have to see. I do want to highlight as well that as I've articulated in the past, this will be a slow-building market simply because we need the testing rates to get much higher. This will be, assuming it all plays out as we hope, a multiple iteration. Our DII235 is ready to go into phase three studies, which could be a once yearly Lp(a) injection. We're quite excited about that as well to be ready.

Vasant Narasimhan: I think some of the recent literature would suggest stroke is going to be an important element of the story for Lp(a). We'll see how that unfolds. Exciting, but we'll also have to see. I do want to highlight as well that as I've articulated in the past, this will be a slow-building market simply because we need the testing rates to get much higher. This will be, assuming it all plays out as we hope, a multiple iteration. Our DII235 is ready to go into phase three studies, which could be a once yearly Lp(a) injection. We're quite excited about that as well to be ready.

Speaker #2: Yeah. Thanks, Matthew. So first, it's important to note Rapsido only has an MFN impact for Medicaid, because the approval happened before the signing of our MFN agreements.

Speaker #4: So we're quite excited about that as well, to be ready. Lastly, I would note that ACC and AHA have now added that everybody in the United States should receive an Lp(a) test once in their life.

Speaker #2: Our first launch that will have I think clear MFN-related implications across all segments in the US would be Unalimab. So I think that's just one clarification.

Speaker #4: and I think that's a milestone to hopefully get testing rates up and to start to build the market over time. So thanks for the question.

Speaker #2: Nonetheless, I'll still answer the question in terms of the ongoing discussions with governments. We are engaging with governments across Europe as well as in Japan to hopefully get to a better place.

Speaker #6: Thanks so much.

Speaker #3: Thank you. Your next question comes from the line of Matthew Weston from UBS. Please go ahead.

Speaker #2: I think we're not seeing the progress that we had hoped to see at the pace that we had hoped to see. So I think there has to be some urgency here.

Vasant Narasimhan: Lastly, I would note that ACC and AHA have now added that everybody in the United States should receive an Lp(a) test once in their life. I think those are milestones to hopefully get testing rates up and to start to build the market over time. Thanks for the question.

Vasant Narasimhan: Lastly, I would note that ACC and AHA have now added that everybody in the United States should receive an Lp(a) test once in their life. I think those are milestones to hopefully get testing rates up and to start to build the market over time. Thanks for the question.

Speaker #7: Thank you. My question's about Rapsido. Vas, now that we're heading to EU approval, it Rapsido's gonna be one of the first pricing discussions for a multibillion-dollar product since MFN.

Speaker #2: Because I do expect across the industry, there will be difficult decisions companies will have to take in terms of how they launch or ultimately progress medicines.

Simon Baker: Thanks so much.

Simon Baker: Thanks so much.

Speaker #2: We're already in a situation where depending on how you look 30 to 40 percent of medicines in Europe available in the US don't ultimately come to Europe.

Simon Baker: Thank you. Your next question comes from the line of Matthew Weston from UBS. Please go ahead.

Operator: Thank you. Your next question comes from the line of Matthew Weston from UBS. Please go ahead.

Speaker #7: So assuming that you've had some early discussions with European governments are you seeing countries inclined to pay higher prices for innovation in Europe?

Speaker #2: You could have that number grow, in general, significant delays for introduction of medicines into the European Union. So there's a lot of work to do.

Matthew Weston: Thank you. My question's about Rhapsido. Vas, now that we're heading to EU approval, Rhapsido is going to be one of the first pricing discussions for a multi-billion dollar product since MFN. Assuming that you've had some early discussions with European governments, are you seeing countries inclined to pay higher prices for innovation in Europe?

Matthew Weston: Thank you. My question's about Rhapsido. Vas, now that we're heading to EU approval, Rhapsido is going to be one of the first pricing discussions for a multi-billion dollar product since MFN. Assuming that you've had some early discussions with European governments, are you seeing countries inclined to pay higher prices for innovation in Europe?

Speaker #4: Yeah. Thanks, Matthew. So first, it's important to note Rapsido, only has an MFN impact for Medicaid, because the approval happened before the signing of our MFN agreement.

Speaker #2: We certainly have I think proposals to all the key governments and most important in my mind are Japan and Germany but we haven't seen the progress that we need to see.

Speaker #4: Our first launch that will have, I think, clear MFN-related implications across all segments in the US would be Unalimab. So I think that's just one clarification.

Speaker #2: So this is something we'll have to continue to advocate for over the next year because I think it's really a 2027 story. Where you start to see the impact of MFN on launches in Europe.

Speaker #4: Nonetheless, I'll still answer the question in terms of the ongoing discussions with governments. We are engaging, you know, with governments across Europe as well as in Japan to hopefully get to a, a better place.

Vasant Narasimhan: Thanks, Matthew. First, it's important to note Rhapsido only has an MFN impact for Medicaid because the approval happened before the signing of our MFN agreement. Our first launch that will have, I think, clear MFN-related implications across all segments in the US would be abelacimab. I think that's just one clarification. Nonetheless, I'll still answer the question in terms of the ongoing discussions with governments. We are engaging, you know, with governments across Europe as well as in Japan to hopefully get to a better place. I think we're not seeing the progress that we had hoped to see at the pace that we had hoped to see.

Vasant Narasimhan: Thanks, Matthew. First, it's important to note Rhapsido only has an MFN impact for Medicaid because the approval happened before the signing of our MFN agreement. Our first launch that will have, I think, clear MFN-related implications across all segments in the US would be abelacimab. I think that's just one clarification. Nonetheless, I'll still answer the question in terms of the ongoing discussions with governments. We are engaging, you know, with governments across Europe as well as in Japan to hopefully get to a better place. I think we're not seeing the progress that we had hoped to see at the pace that we had hoped to see.

Speaker #2: Next question.

Speaker #4: Thank you. Your next question comes from the line of James Gordon from Barclays. Please go ahead.

Speaker #4: I think we're not seeing the progress that we had hoped to see, the pace that we had hoped to see. So I think there has to be some urgency here.

Speaker #10: Hello. I'm James Gordon from Barclays. Thanks for taking the question. The question was on hormonal breast cancer. So Russell accepts to have terogesterone as a US approval for adjuvant hormonal breast cancer.

Speaker #4: because I do expect across the industry, there will be difficult decisions. Companies will have to take in terms of how they launch or ultimately progress, you know, medicines.

Speaker #10: Well, before the UN because they've used the PRV. And they suggested this could be an $11 billion-plus product across adjuvant and second line. But mostly an adjuvant.

Speaker #4: We're already in a situation where depending on how you look 30 to 40 percent of medicines in Europe, a-available in the US, don't ultimately come to Europe.

Speaker #10: So that seems to assume big broad uptake. I think the logic is that that could be used instead of someone using an aromatase and a CDK4 for some of the patients.

Speaker #4: You could have that number grow, you have in general, significant delays for introduction of medicines, into the European Union. So there's a lot of work to do.

Vasant Narasimhan: I think there has to be some urgency here, because I do expect across the industry, there will be difficult decisions companies will have to take in terms of how they launch or ultimately progress, you know, medicines. We're already in a situation depending on how you look, 30% to 40% of medicines in Europe, available in the US that don't ultimately come to Europe, you could have that number grow. You have, in general, significant delays for introduction of medicines into the European Union. There's a lot of work to do. We certainly have, I think, proposals to all the key governments. The most important in my mind are Japan and Germany, but we haven't seen the progress that we need to see.

Vasant Narasimhan: I think there has to be some urgency here, because I do expect across the industry, there will be difficult decisions companies will have to take in terms of how they launch or ultimately progress, you know, medicines. We're already in a situation depending on how you look, 30% to 40% of medicines in Europe, available in the US that don't ultimately come to Europe, you could have that number grow. You have, in general, significant delays for introduction of medicines into the European Union. There's a lot of work to do. We certainly have, I think, proposals to all the key governments. The most important in my mind are Japan and Germany, but we haven't seen the progress that we need to see.

Speaker #10: So based on what you know about hormonal breast cancer, do you think that's plausible? Do you think even from the end of this year, you could see some pressure on CDK4 use because people instead would just do a third?

Speaker #4: We certainly have, I think, proposals to all the key governments, and most important in my mind are Japan and Germany. But we haven't seen the progress that we need to see.

Speaker #10: So any thoughts on that, please?

Speaker #4: So this is something we'll have to continue to advocate for over the next year because I think it's really a 2027 story. Where you start to see, the impact of MFN on launches, in Europe.

Speaker #2: Yeah. We don't see that in the same way. I mean, what we expect continue to expect is that physicians will want to use something to ultimately impact the hormonal access and then subsequently the cell cycle-dependent kinase access, especially for patients that we were talking about here which are patients that are no zero, no one, no two, no two or more, and have other risk factors that indicate they have a higher risk of recurrence of breast cancer.

Speaker #4: Next question.

Speaker #3: Thank you. Your next question comes from the line of James Gordon from Barclays. Please go ahead.

Vasant Narasimhan: This is something we'll have to continue to advocate for over the next year, because I think it's really a 2027 story where you start to see the impact of MFN on launches in Europe. Next question.

Vasant Narasimhan: This is something we'll have to continue to advocate for over the next year, because I think it's really a 2027 story where you start to see the impact of MFN on launches in Europe. Next question.

Speaker #8: Hello. I'm James Gordon from Barclays. Thanks for taking the question. the question was on hormonal breast cancer. So what should we expect to have geodestrogen as a US approval for adjuvant hormonal breast cancer?

Speaker #2: So that's point one. That's all of our market research suggests that. And I think part of the reason the major oral surge companies are partnering with us to do combination studies is they ultimately see it in a similar way as well.

Speaker #8: Well, before the UN, 'cause they've used the PRV. And they're suggesting this could be an $11 billion-plus product across adjuvant and second line, but mostly in adjuvant.

Vasant Narasimhan: Thank you. Your next question comes from the line of James Gordon from Barclays. Please go ahead.

Operator: Thank you. Your next question comes from the line of James Gordon from Barclays. Please go ahead.

Speaker #8: So and, and that seems to assume big, broad uptake. I think the logic is that that could be used instead of someone using an aromatase and a CDK4 for some of the patients.

Speaker #2: I can't comment on patients who are very early or less high-risk early breast cancer patients. We used to call them kind of stage one.

James Gordon: Hello, I'm James Gordon from Barclays. Thanks for taking the question. The question was on hormonal breast cancer. Roche looks set to have giredestrant that's US approval for adjuvant hormonal breast cancer well before the UN because they've used the PRV. They're suggesting this could be an $11 billion-plus product across adjuvant and second line, but mostly in adjuvant. That seems to assume big broad uptake. I think the logic is that that could be used instead of someone using an aromatase and a CDK4 for some of the patients. Based on what you know about hormonal breast cancer, do you think that's plausible? Do you think is it even from the end of this year, you could see some pressure on CDK4 use because people instead would just do a SERD? Any thoughts on that, please?

James Gordon: Hello, I'm James Gordon from Barclays. Thanks for taking the question. The question was on hormonal breast cancer. Roche looks set to have giredestrant that's US approval for adjuvant hormonal breast cancer well before the UN because they've used the PRV. They're suggesting this could be an $11 billion-plus product across adjuvant and second line, but mostly in adjuvant. That seems to assume big broad uptake. I think the logic is that that could be used instead of someone using an aromatase and a CDK4 for some of the patients. Based on what you know about hormonal breast cancer, do you think that's plausible? Do you think is it even from the end of this year, you could see some pressure on CDK4 use because people instead would just do a SERD? Any thoughts on that, please?

Speaker #8: So, based on what you know about hormonal breast cancer, do you think that's plausible? Do you think, is it even possible that from the end of this year, you could see some pressure on CDK4 use because people instead would just do a third?

Speaker #2: I think that would be a separate topic that you can talk to our competitor about. But that's not something that we see. I would also say that it is not a straightforward thing to replace established therapies like aromatase inhibitors that have been used for decades.

Speaker #8: So a-any thoughts on that, please?

Speaker #4: Yeah, we don't see that in the same way. I mean, what we expect—and continue to expect—is that physicians will want to use something to ultimately impact the hormonal axis, and then separately the cell cycle-dependent kinase axis, especially for patients we were talking about here, which are patients that are node zero, node one, node two, node two or more, and have other risk factors that indicate they have a higher risk of recurrence of breast cancer.

Speaker #2: So I think this is something that will take time. I think when you look at the data in almost any class of drug, when you're trying to replace a very established therapy, it requires a lot of education and a lot of work.

Speaker #2: And that ramp will come up over time. So we don't view this as having an impact on the Kisqali outlook. Particularly now that in the first-line setting, it seems clear that CDK4/6 will remain the standard of care for the remainder of Kisqali's lifecycle.

Vasant Narasimhan: Yeah. We don't see that in the same way. I mean, what we expect, continue to expect is that physicians will want to use something to ultimately impact the hormonal access and then subsequently dissolve cyclin-dependent kinase access, especially for patients that we're talking about here, which are patients that are node zero, node one, node two or more and have other risk factors that indicate they have a higher risk of recurrence of breast cancer. That's point one. That's all of our market research suggests that. I think part of the reason the major oral SERD companies are partnering with us to do combination studies is they ultimately see it in a similar way as well. I can't comment on patients who are very early, or less high-risk early breast cancer patients.

Vasant Narasimhan: Yeah. We don't see that in the same way. I mean, what we expect, continue to expect is that physicians will want to use something to ultimately impact the hormonal access and then subsequently dissolve cyclin-dependent kinase access, especially for patients that we're talking about here, which are patients that are node zero, node one, node two or more and have other risk factors that indicate they have a higher risk of recurrence of breast cancer. That's point one. That's all of our market research suggests that. I think part of the reason the major oral SERD companies are partnering with us to do combination studies is they ultimately see it in a similar way as well. I can't comment on patients who are very early, or less high-risk early breast cancer patients.

Speaker #4: so that's point one. That's a-all of our market research, suggests that. And I think part of the reason the major, surge oral surge companies are partnering with us to do combination studies is they ultimately see it, in a similar way as well.

Speaker #2: Our focus very much is on CDK2, CDK2/4, CDK4 to make sure that we can lifecycle Kisqali. You saw us bring in Picovation, which we think has the opportunity to be a pan-mutant PIK3CA that has the ability to avoid some of the toxicity profiles that we've seen with hyperglycemia and off-target toxicities.

Speaker #4: I can't comment on patients who are very early, or less high-risk early breast cancer patients. We used to call them kind of stage one.

Speaker #4: I think they that would be a separate topic that you can talk to our competitor about. But that's not something that, that we see.

Speaker #2: So that could be an exciting medicine that hopefully might be able to be used broadly in the approximately 50% of patients who have those mutations over time.

Speaker #4: I would also say that, it is not a straightforward thing to replace established therapies like aromatase inhibitors that have been used for decades. so I think this is something that will take, take time.

Speaker #2: And then developing the combination drug studies, which we continue to do with the oral surge companies.

Speaker #4: I think when you look at the data and almost any class of drug, when you're trying to replace a very established therapy, it requires a lot of education and a lot of work in that ramp will, will come up over time.

Vasant Narasimhan: We used to call them kind of stage one. I think that would be a separate topic that you can talk to our competitor about, but that's not something that we see. I would also say that it is not a straightforward thing to replace established therapies like aromatase inhibitors that have been used for decades. I think this is something that will take time. I think when you look at the data in almost any class of drug, when you're trying to replace a very established therapy, it requires a lot of education and a lot of work, and that ramp will come up over time.

Vasant Narasimhan: We used to call them kind of stage one. I think that would be a separate topic that you can talk to our competitor about, but that's not something that we see. I would also say that it is not a straightforward thing to replace established therapies like aromatase inhibitors that have been used for decades. I think this is something that will take time. I think when you look at the data in almost any class of drug, when you're trying to replace a very established therapy, it requires a lot of education and a lot of work, and that ramp will come up over time.

Speaker #10: Thank you.

Speaker #4: Thank you. Your next question comes from the line of Michael Lyston from Jeffrey's. Please go ahead.

Speaker #4: So, you know, we don't view this as having an impact on the Kisqali outlook. Particularly now that in the first-line setting, it seems clear that CDK4/6 will remain the standard of care for the remainder of Kisqali's life cycle.

Speaker #11: Oh, thank you. Last question for you on avidity. So diatherapeutics presented the achieved data recently with a splicing correction at month 3 to 11 at a higher rate than we've seen with daldesiron.

Speaker #11: And they also showed positive trends in MDHI, where I think we haven't seen any data for daldesiron. Can you elaborate on how this data fits with your decision to pursue avidity as opposed to other assets?

Speaker #4: Our focus very much is on CDK2, CDK2/4, CDK4 to make sure that we can life cycle Kisqali. You saw us bring in Picovation, which we think has the opportunity to be a pan-mutant PIK3CA that has the, ability to avoid some of the toxicity profiles that we've seen with hyperglycemia and off-target toxicities.

Vasant Narasimhan: You know, we don't view this as having an impact on the Kisqali outlook, particularly now that in the first line setting it seems clear that CDK4/6 will remain the standard of care for the remainder of Kisqali's life cycle. Our focus very much is on CDK2/4, CDK4 to make sure that we can life cycle Kisqali. You saw us bring in Pikavation, which we think has the opportunity to be a pan-mutant PIK3CA that has the ability to avoid some of the toxicity profiles that we've seen with hyperglycemia and off-target toxicities. That could be an exciting medicine that hopefully might be able to be used broadly in the approximately 50% of patients who have those mutations over time.

Vasant Narasimhan: You know, we don't view this as having an impact on the KISQALI outlook, particularly now that in the first line setting it seems clear that CDK4/6 will remain the standard of care for the remainder of KISQALI's life cycle. Our focus very much is on CDK2/4, CDK4 to make sure that we can life cycle KISQALI. You saw us bring in Pikavation, which we think has the opportunity to be a pan-mutant PIK3CA that has the ability to avoid some of the toxicity profiles that we've seen with hyperglycemia and off-target toxicities. That could be an exciting medicine that hopefully might be able to be used broadly in the approximately 50% of patients who have those mutations over time.

Speaker #2: Yeah, absolutely. I think obviously, the way biomarker data splicing correction data ultimately correlates with function is to be determined. And I think this is obviously a complex topic given that the target here is in the nucleus.

Speaker #4: So that could be an exciting medicine that hopefully might be able to be used broadly in the approximately 50% of patients who have those mutations over time.

Speaker #2: And so it's definitely something where you're going to have different profiles for the different drugs given that we're comparing here an SIRNA versus an ASO versus other technologies that are being deployed.

Speaker #4: And then developing the combination drug studies, which we continue to do with the oral surge companies.

Speaker #3: Thank you.

Speaker #2: Okay.

Speaker #2: When we look at the data set that ultimately was published in the New England Journal of Medicine, very clear that you saw compelling data with the hand-opening time.

Speaker #3: Thank you. Your next question comes from the line of Michael Lyston from Jeffrey's. Please go ahead.

Speaker #2: We saw functional endpoints going in the right direction. And so we saw everything the way we would expect it. And we have the opportunity here with a fully enrolled, fully powered phase three study that's going to read out well ahead of the competition.

Speaker #6: Oh, thank you. Last question for you on avidity. So diatherapeutics presented the achieved data recently with a splicing correction at months 3 to 11 at a higher rate than we've seen with daldesiron.

Vasant Narasimhan: Developing the combination drug studies, which we continue to do with the oral SERD companies.

Vasant Narasimhan: Developing the combination drug studies, which we continue to do with the oral SERD companies.

James Gordon: Thank you.

James Gordon: Thank you.

Speaker #6: And they also showed positive trends in MDHI, where I think we haven't seen any data for daldesiron. Can you elaborate on how this data fits with your decision to pursue avidity as opposed to other assets?

James Gordon: Thank you. Your next question comes from the line of Michael Leuchten from Jefferies. Please go ahead.

Operator: Thank you. Your next question comes from the line of Michael Leuchten from Jefferies. Please go ahead.

Speaker #2: And I think once that happens, would make it harder for accelerated approvals to ultimately happen in the field as historical precedents have shown. So I think being first to market with a key first-to-market medicine with a key with a compelling profile is going to be very attractive.

Michael Leuchten: Thank you. Vas, question for you on Avidity. Dyne Therapeutics presented the achieve data recently with a splicing correction at month 3 to 11 at a higher rate than we've seen with deldisiran, and they also showed positive trends in MDHI, where I think we haven't seen any data for deldisiran. Can you elaborate on how this data fits with your decision to pursue Avidity as opposed to other assets?

Michael Leuchten: Thank you. Vas, question for you on Avidity. Dyne Therapeutics presented the achieve data recently with a splicing correction at month 3 to 11 at a higher rate than we've seen with deldisiran, and they also showed positive trends in MDHI, where I think we haven't seen any data for deldisiran. Can you elaborate on how this data fits with your decision to pursue Avidity as opposed to other assets?

Speaker #4: Yeah. Absolutely. You know, I think obviously, the way biomarker data, splicing correction data, ultimately correlates with function is, is to, to be, determined. And I think this is obviously a complex topic given that the target here, is in the nucleus.

Speaker #2: And then I would also say that with the avidity acquisition, we have not only DM1, but we also have the opportunity to be the first medicine, even if we need to complete the phase three study, in FSHD.

Speaker #4: And so it's, it's definitely something where you're gonna have different profiles for the for the different drugs given that we're comparing here an SIRNA versus an ASO, versus, other technologies that are being deployed.

Speaker #2: So we'd be first to market DM1, first to market FSHD. And now we're increasingly excited as well about the opportunity we're seeing in the pipeline to address more forms of DMD as well as apply the technology of antibody oligo antibody oligonucleotides, whether SIRNAs or ASOs, to our own internal pipeline.

Vasant Narasimhan: Yeah, absolutely. You know, I think obviously the way biomarker data, splicing correction data ultimately correlates with function is to be determined. I think this is obviously a complex topic given that the target here is in the nucleus. It's definitely something where you're gonna have different profiles for the different drugs given that we're comparing here an siRNA versus an ASO versus other technologies that are being deployed. You know, when we look at the data set that ultimately was published in The New England Journal of Medicine, very clear that you saw compelling data with the hand opening time. We saw functional endpoints going in the right direction. We saw everything the way we would expect it.

Vasant Narasimhan: Yeah, absolutely. You know, I think obviously the way biomarker data, splicing correction data ultimately correlates with function is to be determined. I think this is obviously a complex topic given that the target here is in the nucleus. It's definitely something where you're gonna have different profiles for the different drugs given that we're comparing here an siRNA versus an ASO versus other technologies that are being deployed. You know, when we look at the data set that ultimately was published in The New England Journal of Medicine, very clear that you saw compelling data with the hand opening time. We saw functional endpoints going in the right direction. We saw everything the way we would expect it.

Speaker #4: You know, when we look at the, the data set that we that ultimately was published in the New England Journal of Medicine, very clear that you saw compelling data with the hand-opening time.

Speaker #4: We saw functional endpoints going in the right direction. and so we saw everything the way we, we would expect it. And we have the opportunity here with a fully enrolled, fully powered phase three study that's gonna read out well ahead of the competition.

Speaker #2: So taken together, we think that was the right decision. And everything that we've seen since completing the acquisition continues to confirm that. Next question.

Speaker #4: Thank you. Your next question comes from the line of Graham Parry from Citigroup. Please go ahead.

Speaker #4: And I think once that happens, would make it harder for accelerated approvals to ultimately happen in the field as, as historical precedents have shown.

Speaker #10: Great. Thanks for taking my questions. So on remibusenib in MS, you've now had three trials read out with Norvagio control arm. Giving a pretty good view on the analyzed relapse rate in that population.

Speaker #4: So I think being first to market with a, a key, a key, first-to-market medicine with a key, with a compelling profile, is gonna be very attractive.

Vasant Narasimhan: We have the opportunity here with a fully enrolled, fully powered Phase 3 study that's gonna read out well ahead of the competition. I think once that happens, would make it harder for accelerated approval to ultimately happen in the field as historical precedents have shown. I think being first to market with a first to market medicine with a key, with a compelling profile is gonna be very attractive. Then I would also say that, you know, with the Avidity acquisition, we have not only DM1, but we also have the opportunity to be the first medicine, even if we need to complete the Phase 3 study in FSHD. We'd be first to market DM1, first to market FSHD.

Vasant Narasimhan: We have the opportunity here with a fully enrolled, fully powered Phase 3 study that's gonna read out well ahead of the competition. I think once that happens, would make it harder for accelerated approval to ultimately happen in the field as historical precedents have shown. I think being first to market with a first to market medicine with a key, with a compelling profile is gonna be very attractive. Then I would also say that, you know, with the Avidity acquisition, we have not only DM1, but we also have the opportunity to be the first medicine, even if we need to complete the Phase 3 study in FSHD. We'd be first to market DM1, first to market FSHD.

Speaker #4: And then I would also say that, you know, with the, the de-avidity acquisition, we have not only DM1, but we also have the opportunity to be the first medicine, even if we need to complete the phase three study, in FSHD.

Speaker #10: So to what extent can you compare that data to your blinded data in the remibusenib phase three relapsing MS trials? And to the extent that you can comment, does that give you any increased confidence in the ability to meet the endpoint?

Speaker #4: So we'd be first to market DM1, first to market FSHD. And now we're increasingly excited as well about the opportunity we're seeing in the pipeline to address more forms of DMD as well as apply the technology of antibody oligo antibody oligonuclease ties, whether SIRNAs or ASOs, to our own internal pipeline.

Speaker #10: And also, could you just reconfirm that this stage you're not seeing any drug-induced liver injury or high elevations of ALT in the blinded data?

Speaker #10: Thank you.

Speaker #2: Yeah, thanks, Graham. So I don't have any comment on the ARR data. I'm not up to speed on any blinded views that we have or have not taken on the ARR data.

Speaker #4: So, taken together, we think that was the right decision. And everything that we've seen since completing the acquisition continues to confirm that. Next question.

Speaker #2: But we do track the blinded safety data quite carefully. And I think all of the data that we've looked at and that I've also seen indicate that we don't see any contribution if we assume that the historical rates that we've seen with teraflunomide in historical studies for liver drug-induced liver injury enzyme elevations, etc., that there is no contribution from the remibusenib arm because all we see in the blinded data would be consistent with what one would see from having teraflunomide in the studies.

Vasant Narasimhan: Now we're increasingly excited as well about the opportunity we're seeing in the pipeline to address more forms of DMD, as well as apply the technology of antibody oligonucleotides, whether siRNAs or ASOs, to our own internal pipeline. Taken together, we think that was the right decision. Everything that we've seen since completing the acquisition continues to confirm that.

Vasant Narasimhan: Now we're increasingly excited as well about the opportunity we're seeing in the pipeline to address more forms of DMD, as well as apply the technology of antibody oligonucleotides, whether siRNAs or ASOs, to our own internal pipeline. Taken together, we think that was the right decision. Everything that we've seen since completing the acquisition continues to confirm that.

Speaker #3: Thank you. Your next question comes from the line of Graham Parry from Citigroup. Please go ahead.

Speaker #7: Great. Thanks for taking my questions. so on remibusenib in MS, you've now had three trials read out with an orbagio control arm. giving a pretty good view on the analyzed relapse rate in that population.

Speaker #7: So to what extent can you compare that, that data to your blinded, data in the remibusenib phase three relaxing MS trials? and to the extent, that you can comment, d-does that give you any increased confidence confidence in the ability to meet the endpoint?

Speaker #2: So that gives us a high degree of confidence given that all these patients have now are well past three months where normally you would see any liver injury showed up.

Vasant Narasimhan: Thank you.

Vasant Narasimhan: Next question.

Vasant Narasimhan: Next question.

Vasant Narasimhan: Thank you. Your next question comes from the line of Graham Parry from Citigroup. Please go ahead.

Operator: Thank you. Your next question comes from the line of Graham Parry from Citigroup. Please go ahead.

Speaker #2: So it gives us a high degree of confidence in the safety profile for remibusenib. It's clean and consistent with what we've seen in CSU, in SINDU, in the phase two HS study, in the phase two food allergy study.

Graham Parry: Great. Thanks for taking my questions. On remibrutinib in MS, you've now had three trials read out with an Aubagio control arm, giving a pretty good view on the annualized relapse rate in that population. To what extent can you compare that data to your blinded data in the remibrutinib phase three relapsing MS trials? And to the extent you can comment, does that give you any increased confidence in the ability to meet the endpoint? And also, could you just reconfirm that this stage you're not seeing any drug-induced liver injury or high elevations of ALT in the blinded data? Thank you.

Graham Parry: Great. Thanks for taking my questions. On remibrutinib in MS, you've now had three trials read out with an Aubagio control arm, giving a pretty good view on the annualized relapse rate in that population. To what extent can you compare that data to your blinded data in the remibrutinib phase three relapsing MS trials? And to the extent you can comment, does that give you any increased confidence in the ability to meet the endpoint? And also, could you just reconfirm that this stage you're not seeing any drug-induced liver injury or high elevations of ALT in the blinded data? Thank you.

Speaker #7: and also, could you just reconfirm that this stage you're not seeing any drug-induced liver injury or high elevations of ALT in the blinded data?

Speaker #2: So now we have a pretty large portfolio of studies that have indicated the clean profile of remibusenib. But no insights so far on ARR.

Speaker #7: Thank you.

Speaker #4: Yeah. Thanks, Graham. So I don't have any comment on the, ARR data. I'm not up to speed on, on, any blinded views that we have or have not taken on the ARR data.

Speaker #2: And I think we'll obviously read out the studies this summer and we'll see where we are.

Speaker #4: But we do track the blinded safety data for quite carefully. And I think all of the data that we've looked at and that I've, I've also seen indicates that we don't see any, any contribution if we assume that there.

Speaker #4: Thank you. Your next question comes from the line of Thibault Boutherin from Morgan Stanley. Please go ahead.

Speaker #11: Yeah. Thank you very much. So my question is just on Rapsido. The previous communication was that we should see limited sales in Q4 last year, Q1 this year, because of the free scripts before we see a step up in Q2.

Speaker #4: Rates that we've seen with teraflutamide in historical studies for liver drug-induced liver injury enzyme elevations, etc. the n there is no contribution from the remibusenib arm because all we see in the blinded data would be consistent with what one would see from having, teraflutamide in the studies.

Vasant Narasimhan: Yeah. Thanks, Graham. I don't have any comment on the ARR data. I'm not up to speed on any blinded views that we have or have not taken on the ARR data. We do track the blinded safety data quite carefully. I think all of the data that we've looked at and that I've also seen indicates that we don't see any contribution if we assume that the historical rates that we've seen with teriflunomide in historical studies for drug-induced liver injury, enzyme elevations, et cetera, there is no contribution from the remibrutinib arm. Because all we see in the blinded data would be consistent with what one would see from having teriflunomide in the study.

Vasant Narasimhan: Yeah. Thanks, Graham. I don't have any comment on the ARR data. I'm not up to speed on any blinded views that we have or have not taken on the ARR data. We do track the blinded safety data quite carefully. I think all of the data that we've looked at and that I've also seen indicates that we don't see any contribution if we assume that the historical rates that we've seen with teriflunomide in historical studies for drug-induced liver injury, enzyme elevations, et cetera, there is no contribution from the remibrutinib arm. Because all we see in the blinded data would be consistent with what one would see from having teriflunomide in the study.

Speaker #11: And actually, we saw quite decent sales in the first two quarters. So I guess the question is how much stocking have we seen so far?

Speaker #4: That gives us a high degree of confidence, given that all these patients now are well past three months, where normally you would see any liver injury show up.

Speaker #11: And should we still expect a step up in Q2 as we bridge to paid scripts? And in general, if you could help us with the dynamic in terms of bridge, for the rest of the year.

Speaker #4: So it gives us a high degree of confidence in the safety profile for remibusenib. It's clean and consistent with what we've seen in CSU, in SINDU, in the phase two HS study, in the phase two food allergy study.

Speaker #2: Yeah, absolutely. I would say first on stocking, we've seen stocking levels that are in line with what we've seen historically for brands. So I don't think there's a significant anything that's out of what we would expect from a stocking perspective.

Speaker #4: So now, you know, we have a pretty large portfolio of studies that have indicated the clean profile of remibusenib. But no insights so far on, on ARR.

Vasant Narasimhan: That gives us a high degree of confidence given that all these patients are now well past three months, where normally you would see any liver injury showed up. It gives us a high degree of confidence the safety profile for remibrutinib is clean and consistent with what we've seen in CSU, in CIndU, in the phase two HS study, in the phase two food allergy study. Now, you know, we have a pretty large portfolio of studies that have indicated the clean profile of remibrutinib. No insights so far on ARR, and I think we'll obviously read out the studies this summer and we'll see where we are.

Vasant Narasimhan: That gives us a high degree of confidence given that all these patients are now well past three months, where normally you would see any liver injury showed up. It gives us a high degree of confidence the safety profile for remibrutinib is clean and consistent with what we've seen in CSU, in CIndU, in the phase two HS study, in the phase two food allergy study. Now, you know, we have a pretty large portfolio of studies that have indicated the clean profile of remibrutinib. No insights so far on ARR, and I think we'll obviously read out the studies this summer and we'll see where we are.

Speaker #2: I think when you look at the early data, as I mentioned, 6,000 patient starts, 3,000 prescribers, about a quarter of the top CSU physicians prescribing the medicine.

Speaker #4: And I think we'll obviously read out the studies this summer, and we'll see where we are.

Speaker #3: Thank you. Your next question comes from the line of Thibaut Batherin from Morgan Stanley. Please go ahead.

Speaker #2: So that's all, I think, in the right direction. We think that the early script data probably has to be interpreted carefully because we are using sampling and bridge programs.

Speaker #6: Yeah. Thank you very much. So my question is just on Rapsido. The previous communication was that we should see limited sales in, in Q4 last year, Q1 this year, because of the, free scripts, before we see a step up in, in Q2.

Speaker #2: And as payer coverage expands, we will start to see the conversion from free to paid. But that's going to be a stepwise process over the course of the year.

Speaker #2: We have some early access wins: ESI, Signum, Optum, and we have been able to secure first-line post-antihistamine coverage across those commercial plans. So I think overall, that gives us confidence.

Vasant Narasimhan: Thank you. Your next question comes from the line of Thibault Boutherin from Morgan Stanley. Please go ahead.

Operator: Thank you. Your next question comes from the line of Thibault Boutherin from Morgan Stanley. Please go ahead.

Speaker #6: And actually, we saw quite decent sales in the first two quarters. So, I guess, question is how much how much stocking have we seen so far?

Speaker #6: And should we still expect a step up, in Q2 as we bridge to paid scripts? and in general, if you could help us, with the dynamic in terms of bridge, for the rest of the year.

Thibault Boutherin: Thank you very much. My question is just on Rhapsido. The previous communication was that we should see limited sales in Q4 last year, Q1 this year, because of the free scripts, before we see a step up in Q2. Actually, we saw quite decent sales in the first two quarters. I guess the question is, how much stocking have we seen so far? Should we still expect a step up in Q2 as we bridge to paid script? In general, if you could help us with the dynamic in terms of bridge for the rest of the year.

Thibault Boutherin: Thank you very much. My question is just on Rhapsido. The previous communication was that we should see limited sales in Q4 last year, Q1 this year, because of the free scripts, before we see a step up in Q2. Actually, we saw quite decent sales in the first two quarters. I guess the question is, how much stocking have we seen so far? Should we still expect a step up in Q2 as we bridge to paid script? In general, if you could help us with the dynamic in terms of bridge for the rest of the year.

Speaker #2: But I would expect it to be a steady increase in these initial months, not a hockey stick, simply because it does take time to get all of that in place.

Speaker #4: Yeah, absolutely. I would say, first, on stocking—we've seen stocking levels that are, you know, in line with what we've seen historically for brands.

Speaker #2: And then ultimately start bridging patients. We would expect then to see an acceleration in 2027 as we then have the payer coverage in place.

Speaker #4: So I don't think there's a significant anything that's out of, out of what we would expect from a stocking perspective. I think when you look at the early pers—the early data, as I mentioned, 6,000 patient starts, 3,000 prescribers.

Speaker #2: And then we're well too to have a significant launch. It wouldn't change our long-term outlook as we've guided. We think this can be a very large medicine in CSU alone.

Speaker #4: About a quarter of the top CSU physicians, prescribing the medicine. So that's all, I think, in the right direction. We think that the early script data probably has to be interpreted, you know, carefully because we are using sampling and bridge programs.

Speaker #2: And then when you add SINDU on top and then hopefully MS, hopefully HS, and then down the line additional indications, food allergy, etc., we have a really exciting path ahead of us for the medicine.

Vasant Narasimhan: Yeah, absolutely. I would say first on stocking, we've seen stocking levels that are, you know, in line with what we've seen historically for brands. I don't think there's a significant, anything that's out of what we would expect from a stocking perspective. I think when you look at the early early data, as I mentioned, 6,000 patient starts, 3,000 prescribers, about a quarter of the top CSU physicians prescribing the medicine. That's all, I think, in the right direction. We think that the early script data probably has to be interpreted, you know, carefully because we are using sampling and bridge programs. As payer coverage expands, we will start to see the conversion from free to paid, but that's gonna be a stepwise process over the course of the year.

Vasant Narasimhan: Yeah, absolutely. I would say first on stocking, we've seen stocking levels that are, you know, in line with what we've seen historically for brands. I don't think there's a significant, anything that's out of what we would expect from a stocking perspective. I think when you look at the early early data, as I mentioned, 6,000 patient starts, 3,000 prescribers, about a quarter of the top CSU physicians prescribing the medicine. That's all, I think, in the right direction. We think that the early script data probably has to be interpreted, you know, carefully because we are using sampling and bridge programs. As payer coverage expands, we will start to see the conversion from free to paid, but that's gonna be a stepwise process over the course of the year.

Speaker #4: And as payer coverage expands, we will start to see the conversion from free to paid. But that's going to be a stepwise process over the course of the year.

Speaker #4: Thank you.

Speaker #11: Thank you.

Speaker #4: Your next question comes from the line of James Quigley from Goldman Sachs. Please go ahead.

Speaker #4: We have some early access wins. ESI, Signum, Op Signa, Optum, and, you know, we have been able to secure first-line post-antihistamine coverage across those commercial plans.

Speaker #12: Great. Thanks for taking my questions. I got one on Del Dizaran in DM1. So as we're heading into the data, what are you thinking would be a clinically meaningful impact on video hand opening time?

Speaker #12: And to what extent are the secondary endpoints even more important here in interpreting the data into an overall benefit from a functionality perspective? And then also, any comments you have on the recent early data from Sarepta in the same indication?

Speaker #4: So I think overall, that gives us gives us confidence. But I would expect it to be a steady increase in these initial months, not a hockey stick, simply because it does take time to get all of that in place and then ultimately start bridging patients.

Vasant Narasimhan: We have some early access wins, ESI, Cigna, Optum. You know, we have been able to secure first-line post-antihistamine coverage across those commercial plans. I think overall that gives us confidence, but I would expect it to be a steady increase in these initial months, not a hockey stick, simply 'cause it does take time to get all of that in place and then ultimately start bridging patients. We would expect then to see an acceleration in 2027 as we then have the payers, payer coverage in place, and then we're well-suited to have a significant launch. Doesn't change our long-term outlook. As we've guided, we think this can be a very large medicine in CSU alone.

Vasant Narasimhan: We have some early access wins, ESI, Cigna, Optum. You know, we have been able to secure first-line post-antihistamine coverage across those commercial plans. I think overall that gives us confidence, but I would expect it to be a steady increase in these initial months, not a hockey stick, simply 'cause it does take time to get all of that in place and then ultimately start bridging patients. We would expect then to see an acceleration in 2027 as we then have the payers, payer coverage in place, and then we're well-suited to have a significant launch. Doesn't change our long-term outlook. As we've guided, we think this can be a very large medicine in CSU alone.

Speaker #12: So where do you think Del Dizaran will be differentiated relative to the emerging competitors? Thank you.

Speaker #4: We would expect then to see an acceleration in, in 2027 as we then have the payers payer coverage in place. And then we're well suited to have a significant launch.

Speaker #13: Yes. So I think we would be in a position to kind of comment on a specific video hand opening time. But we do believe it's a well-understood endpoint.

Speaker #4: Doesn't change our long-term outlook. As we've guided, we think this can be a very large medicine in CSU alone. And then when you add SINDU on top and then hopefully, MS, hopefully HS, and then down the line additional indications, food allergy, etc., we have a really exciting path ahead of us for the medicine.

Speaker #13: And if we reach statistical significance, we think that would be an important milestone. And all of our physician discussions would suggest that would be sufficient to warrant broad use of the medicine.

Speaker #13: I think importantly, as well, we're going to be looking at additional functional outcomes such as the quantitative muscle testing, and patient reportered outcomes, as well as the 10-meter walk-and-run test.

Speaker #3: Thank you.

Speaker #6: Thank you.

Speaker #3: Your next question comes from the line of James Quigley from Goldman Sachs. Please go ahead.

Vasant Narasimhan: When you add SINDO on top and then hopefully MS, hopefully HS, and then down the line additional indications, food allergy, et cetera, we have a really exciting path ahead of us for the medicine.

Vasant Narasimhan: When you add SINDO on top and then hopefully MS, hopefully HS, and then down the line additional indications, food allergy, et cetera, we have a really exciting path ahead of us for the medicine.

Speaker #13: I think all of that will help us to further characterize the treatment effect. Now, when we look at some of the competitor data, I think it's important to note it's quite early.

Speaker #5: Great. Thanks for taking my questions. I got one on, on Deldizaran in, in DM1. So, as we're heading into the data, what are you thinking would be a clinically meaningful impact on video hand-opening time?

Speaker #13: And as we know, in these medicines, that ultimately you need a relatively broad patient group because of the diversity of manifestations of the disease.

Speaker #5: And, and to what extent are the secondary endpoints even more important here in interpreting the data into the f and, and overall benefit form of functionality perspective?

Vasant Narasimhan: Thank you.

Operator: Thank you.

Thibault Boutherin: Thank you.

Thibault Boutherin: Thank you.

Thibault Boutherin: Your next question comes from the line of James Quigley from Goldman Sachs. Please go ahead.

Operator: Your next question comes from the line of James Quigley from Goldman Sachs. Please go ahead.

Speaker #5: And then also, any comments you have on from, Sarepta in the in the in the same indication. So where do you think, Deldizaran will be will be differentiated relative to the emerging competitors?

Speaker #13: So I wouldn't want to overinterpret what we're seeing. Certainly, it's exciting that there are many medicines coming forward to treat DM1 patients. But we feel like because of the large data set that we have now, over 100 patients treated across multiple disease states, 500 infusions, up to four years of multi-infusion, multi-year exposure, that gives us a longitudinal data set that can really help us interpret the impact we're seeing.

James Quigley: Great. Thank you for taking my questions. I've got one on deldisiran in DM1. As we're heading into the data, what are you thinking would be a clinically meaningful impact on video hand opening time? To what extent are the secondary endpoints even more important here in interpreting the data into the and overall benefit from a functionality perspective? Also any comments you have on the recent early data from Sarepta in the same indication. Where do you think deldisiran will be differentiated relative to the emerging competitors? Thank you.

James Quigley: Great. Thank you for taking my questions. I've got one on deldisiran in DM1. As we're heading into the data, what are you thinking would be a clinically meaningful impact on video hand opening time? To what extent are the secondary endpoints even more important here in interpreting the data into the and overall benefit from a functionality perspective? Also any comments you have on the recent early data from Sarepta in the same indication. Where do you think deldisiran will be differentiated relative to the emerging competitors? Thank you.

Speaker #5: Thank you.

Speaker #4: Yes. So, we're—I think we'll be in a position to kind of comment on a specific MA, the video hand-opening time. But we do believe it's a well-understood endpoint.

Speaker #4: And if we reach statistical significance, we think that would be an important milestone. And all of our physician discussions would suggest that would be sufficient to, warrant, you know, broad use of the of the medicine.

Speaker #13: And I think most important for us is the muscle manifestations. I know there's been a lot of discussion as well about CNS. But I think in this particular disease, what really matters is muscle mobility and managing those muscle-related manifestations.

Speaker #4: I think importantly as well, we're gonna be looking at additional functional outcomes such as the quantitative, muscle testing, and patient reporter reported outcomes as well as the 10 meter, walk-and-run test.

Vasant Narasimhan: Yes. I think we'll be in a position to kind of comment on a specific video hand opening time, but we do believe it's a well-understood endpoint. If we reach statistical significance, we think that would be an important milestone, and all of our physician discussions would suggest that would be sufficient to warrant, you know, broad use of the medicine. I think importantly as well, we're gonna be looking at additional functional outcomes such as the quantitative muscle testing and patient reported outcomes, as well as the 10-meter walk and run test. I think all of that will help us to further characterize the treatment effect. When we look at some of the competitor data, I think it's important to note it's quite early.

Vasant Narasimhan: Yes. I think we'll be in a position to kind of comment on a specific video hand opening time, but we do believe it's a well-understood endpoint. If we reach statistical significance, we think that would be an important milestone, and all of our physician discussions would suggest that would be sufficient to warrant, you know, broad use of the medicine. I think importantly as well, we're gonna be looking at additional functional outcomes such as the quantitative muscle testing and patient reported outcomes, as well as the 10-meter walk and run test. I think all of that will help us to further characterize the treatment effect. When we look at some of the competitor data, I think it's important to note it's quite early.

Speaker #13: And that's very much our focus. So having, I think, 54-week follow-up long-term data on a large cohort of patients gives you a very robust read.

Speaker #4: I think all of that will help us to further characterize the, the treatment effect. Now, when we look at some of the competitor data, I think it's important to note it's, it's quite early.

Speaker #13: And I think we feel confident that based on everything we've seen in the phase two study, that we're set up well as well as we can be towards that phase three readout.

Speaker #4: And as we as we know, in these in these medicines, that ultimately you need a relatively broad patient s group because of the diversity of manifestations of the disease.

Speaker #13: Next question.

Speaker #4: So I, I wouldn't wanna overinterpret what we're seeing. Certainly, it's exciting that there are many medicines coming forward to treat DM1 patients. But we feel like because of the large data set, that we have now, over 100 patients treated across multiple, disease set states, 500 infusions, up to four years of, of multi-infus multi-year exposure, that gives us, a longitudinal data set that can really help us interpret the impact we're, we're s we're seeing.

Speaker #4: Thank you. Your next question comes from the line of Florence Cespedes from OdoBHS. Please go ahead.

Speaker #12: Good afternoon. Thank you very much for taking my questions. Florence Cespedes from OdoBHS. A big-picture question from Vas. On your last slide, you highlighted that there will be multiple readouts in H2 that could raise your mid-term to long-term growth outlook.

Vasant Narasimhan: As we know in these medicines, that ultimately you need a relatively broad patient group because of the diversity of manifestations of the disease. I wouldn't want to overinterpret what we're seeing. Certainly, it's exciting that there are many medicines coming forward to treat DM1 patients. We feel like because of the large dataset that we have now, over 100 patients treated across multiple disease set states, 500 infusions, up to 4 years of multi-year exposure, that gives us a longitudinal dataset that can really help us interpret the impact we're seeing. I think most important for us is the muscle manifestations.

Vasant Narasimhan: As we know in these medicines, that ultimately you need a relatively broad patient group because of the diversity of manifestations of the disease. I wouldn't want to overinterpret what we're seeing. Certainly, it's exciting that there are many medicines coming forward to treat DM1 patients. We feel like because of the large dataset that we have now, over 100 patients treated across multiple disease set states, 500 infusions, up to 4 years of multi-year exposure, that gives us a longitudinal dataset that can really help us interpret the impact we're seeing. I think most important for us is the muscle manifestations.

Speaker #12: Maybe Vas, could you be a little bit more specific and give us a bit more color or from where do you see the potential upside coming from?

Speaker #4: And I think most important for us is to is the, the muscle manifestations. I know there's been a lot of discussion as well about CNS.

Speaker #4: But I think in this particular disease, what really matters is muscle mobility and, and managing those muscle-related, manifestations. And that's very much our, our focus.

Speaker #12: Thank you.

Speaker #2: Yeah. Thanks, Laura. When you look at what we guided to last fall, I mean, our focus was very much on what we had in hand and a probabilized view of our pipeline.

Speaker #4: So having, I think, 54-week follow-up long-term data on a large cohort of patients gives you a very robust read. And I think, you know, we feel confident that, based on everything we've seen in the phase two study, that we're set up well as well as we can be towards that phase three readout.

Speaker #2: And I think when then some of these medicines, if they ultimately come forward and we unprobabilize, that can lead to significant upsides versus where we are today.

Vasant Narasimhan: I know there's been a lot of discussion as well about CNS, but I think in this particular disease, what really matters is muscle mobility and managing those muscle-related manifestations, and that's very much our focus. Having, I think, 54-week follow-up long-term data on a large cohort of patients gives you a very robust read. I think, you know, we feel confident that based on everything we've seen in the phase 2 study, that we're set up well, as well as we can be towards that phase 3 readout. Next question.

Vasant Narasimhan: I know there's been a lot of discussion as well about CNS, but I think in this particular disease, what really matters is muscle mobility and managing those muscle-related manifestations, and that's very much our focus. Having, I think, 54-week follow-up long-term data on a large cohort of patients gives you a very robust read. I think, you know, we feel confident that based on everything we've seen in the phase 2 study, that we're set up well, as well as we can be towards that phase 3 readout. Next question.

Speaker #2: I think obviously the big readout's not surprisingly. I think to all of you, we'll certainly be Remibrutinib for the five-year term. Remibrutinib in MS, Remibrutinib in HS, Del Dizaran, the DM1.

Speaker #4: next question.

Speaker #3: Thank you. Your next question. Comes from the line of Florence Cespedes from OdoBHF. Please go ahead.

Speaker #7: Good afternoon. Thank you very much for taking my questions. Florence Cespedes from OdoBHF. A big-picture question for Vas. On your last slide, you highlighted that there will be multiple readouts in H2 that could raise your mid-term to long-term growth outlook.

Speaker #2: We also believe Yinalimab in first-line ITB can be billion-dollar-plus indication. I think Paul Carson will be significant. I think it will take longer to build over time.

Speaker #2: And I think overall, the combination of Paul Carson plus DII-235 will give us a very significant opportunity. But in that kind of five-year term, I think that medicine will take time to build up.

Vasant Narasimhan: Thank you. Your next question comes from the line of Florence Aspedes from ODHS. Please go ahead.

Operator: Thank you. Your next question comes from the line of Florent Cespedes from ODDO BHF. Please go ahead.

Speaker #7: Maybe Vas, could you be a little bit more specific and give us a bit more color or on, from where do you see the potential upside coming from?

Florence Aspedes: Good afternoon. Thank you very much for taking my questions. Florence Aspedes from ODHS. A big picture question for Vas. On your last slide, you highlighted that there will be multiple readouts in H2 that could raise your midterm to long-term growth outlook. Maybe, Vas, could you be a little bit more specific and give us a bit more color or on, from where do you see the potential upside coming from? Thank you.

Florent Cespedes: Good afternoon. Thank you very much for taking my questions. Florent Cespedes from ODDO BHF. A big picture question for Vas. On your last slide, you highlighted that there will be multiple readouts in H2 that could raise your midterm to long-term growth outlook. Maybe, Vas, could you be a little bit more specific and give us a bit more color or on, from where do you see the potential upside coming from? Thank you.

Speaker #2: But I think those were the medicines where if we see some wins, it could allow us to, once we do the modeling, to reevaluate the 5 to 6 percent growth out to 2030 and hopefully drive additional upsides.

Speaker #7: Thank you.

Speaker #4: Yeah. Thanks, Laura. When you when you look at what we guided to last fall, I mean, our, our focus was very much on what we had in hand and a probabilized view, of, of our pipeline.

Speaker #2: So I think that's a great story. And I would say also in 2027, we have a number of readouts important readouts as well. Avastamab in stroke prevention, we will have as well the ILS no, we'll have as well the Kacimta data as well as some other phase two readouts as well as starting to readout as well our immune reset portfolio.

Speaker #4: And I think, when then some of these medicines, if they ultimately come forward and we unprobabilize, that can lead to, you know, significant, upsides, versus where we are today.

Vasant Narasimhan: Yeah, thanks, Florence. When you look at what we guided to last fall, you know, our focus was very much on what we had in hand and a probabilized view of our pipeline. I think, when then some of these medicines, as they ultimately come forward and we unprobabilize, that can lead to, you know, significant upsides versus where we are today. You know, I think obviously the big readout, not surprisingly, I think all of you will certainly be, you know, remibrutinib for the 5-year term, remibrutinib in MS, remibrutinib in HS, deldisiran, the DM1. We also believe, you know, ianalumab in first-line ICB can be a billion-dollar plus indication. I think palovarogene will be significant.

Vasant Narasimhan: Yeah, thanks, Florent. When you look at what we guided to last fall, you know, our focus was very much on what we had in hand and a probabilized view of our pipeline. I think, when then some of these medicines, as they ultimately come forward and we unprobabilize, that can lead to, you know, significant upsides versus where we are today. You know, I think obviously the big readout, not surprisingly, I think all of you will certainly be, you know, remibrutinib for the 5-year term, remibrutinib in MS, remibrutinib in HS, deldisiran, the DM1. We also believe, you know, ianalumab in first-line ICB can be a billion-dollar plus indication. I think palovarogene will be significant.

Speaker #4: You know, I think obviously the, the big, readout's not surprisingly. I think they'll it's all of you will, will certainly be, you know, Remibrutinib, for the five-year term.

Speaker #4: Remibrutinib, in MS, Remibrutinib in HS, Deldizaran, the DM1. We also believe, you know, Yanalimab in first-line ITB can be, billion-dollar-plus, indication. I think Paul Carson will be significant.

Speaker #2: So I think a number of readouts coming that could further bolster the long-term outlook of the company.

Speaker #12: They were clear. Thank you very much.

Speaker #4: Thank you. Your next question comes from the line of Kerry Holford from Barenberg. Please go ahead.

Speaker #4: I think it will take longer to build over time. And I think overall, the combination of Paul Carson plus, DII-235 will give us a very significant opportunity.

Speaker #14: Oh, thank you. Question for me on Plevicto. Please. So following the recent European filing withdrawal in that pre-taxing setting, just keen to hear whether you plan to run any additional trials to address the EMA requirements.

Speaker #4: But in that kind of five-year term, I think that medicine will take time, to, to build up. But, you know, I think those were the medicines where, you know, if we see some wins, it could allow us to, once we do the modeling, to reevaluate the 5 to 6 percent growth out to 2030 and hopefully drive additional, upsides.

Speaker #14: And if not, does the lack of a pre-taxing approval in that region have any impact on your peak sales forecast for that drug?

Vasant Narasimhan: I think it will take longer to build over time, I think overall, the combination of palovarogene plus DII235 will give us a very significant opportunity. In that kind of 5-year term, I think that medicine will take time to build up. You know, I think those are the medicines where, you know, if we see some wins, it could allow us to, once we do the modeling, to reevaluate the 5% to 6% growth out to 2030 and hopefully drive additional upsides. I think that's a great story. I would say also in 2027 we have a number of readouts as important readouts as well. abelacimab, in stroke prevention. We will have, as well the, IL...

Vasant Narasimhan: I think it will take longer to build over time, I think overall, the combination of palovarogene plus DII235 will give us a very significant opportunity. In that kind of 5-year term, I think that medicine will take time to build up. You know, I think those are the medicines where, you know, if we see some wins, it could allow us to, once we do the modeling, to reevaluate the 5% to 6% growth out to 2030 and hopefully drive additional upsides. I think that's a great story. I would say also in 2027 we have a number of readouts as important readouts as well. abelacimab, in stroke prevention. We will have, as well the, IL...

Speaker #4: So, I think that's a great story. And I would say also, in 2027, we have a number of readouts, important readouts as well.

Speaker #2: Yeah. Thanks, Kerry. So no impact on the peak sales forecast. We continue to expect $5 billion plus. We had assumed all along that navigating the European feedback on the comparator arm would be a challenge.

Speaker #4: Avelastamab, in, in stroke prevention, we will have, as well, the, ILS no, we'll have as well the Casimpta, data as well as some other phase two readouts as well as starting to read out as well our immune reset portfolio.

Speaker #2: We evaluated multiple ways to try to address it. And we tried to make the best arguments that we could. But ultimately, we thought it was prudent at that point to withdraw.

Speaker #4: So I think a number of readouts coming that could, could further bolster the long-term outlook of the company.

Speaker #2: We do see continued strong uptake in the vision population in Europe. It's important to note as well, in Japan, and in China, we are able to both have the PSMA4 and PSMA vision populations which are critical long-term markets.

Speaker #5: very clear. Thank you very much.

Speaker #3: Thank you. Your next question. Comes from the line of Kerry Holford from Barenberg. Please go ahead.

Vasant Narasimhan: No, we'll have as well the Kesimpta data as well as some other phase II readouts, as well as starting to readout as well our immune reset portfolio. I think a number of readouts coming that could further bolster the long-term outlook for the company.

Vasant Narasimhan: No, we'll have as well the KESIMPTA data as well as some other phase II readouts, as well as starting to readout as well our immune reset portfolio. I think a number of readouts coming that could further bolster the long-term outlook for the company.

Speaker #2: And the next step now for Europe will be the hormone-sensitive setting where we because Plevicto is used in combination with an ARPI versus an ARPI, there are the comparator arm is what EMA would want.

Speaker #6: Oh, thank you. A question for me on Plivicto, please. So, following the recent European filing withdrawal in that pre-taxing setting, just keen to hear whether you plan to run any additional trials to address the EMA requirements.

Florence Aspedes: Very clear. Thank you very much.

Florent Cespedes: Very clear. Thank you very much.

Speaker #2: And I think would allow us then if we're to move forward. Now we have the strong as you know, RPFS data. We're waiting on the OS data.

Florence Aspedes: Thank you. Your next question comes from the line of Kerry Holford from Berenberg. Please go ahead.

Operator: Thank you. Your next question comes from the line of Kerry Holford from Berenberg. Please go ahead.

Speaker #6: And if not, does the lack of a a pre-taxing approval in that region have any impact on your peak sales forecast for that drug?

Speaker #2: Once we have that OS data, we should be able to file in Europe and then expand the patient population there. So I think that was the best outcome we decided rather than running additional studies that would take many years, to just withdraw the file and wait for the HSPC readout.

Kerry Holford: Oh, thank you. A question for me on Pluvicto, please. Following the recent European filing withdrawal in that pre-taxane setting, just keen to hear whether you plan to run any additional trials to address the EMA requirements. If not, does the lack of a pre-taxane approval in that region have any impact on your peak sales forecast for that drug?

Kerry Holford: Oh, thank you. A question for me on PLUVICTO, please. Following the recent European filing withdrawal in that pre-taxane setting, just keen to hear whether you plan to run any additional trials to address the EMA requirements. If not, does the lack of a pre-taxane approval in that region have any impact on your peak sales forecast for that drug?

Speaker #4: Yeah. Thanks, Kerry. So no impact on the peak sales forecast. We continue to expect $5 billion plus. We had assumed all along that navigating the European feedback on the comparator arm would be, you know, a challenge.

Speaker #14: Lovely. Thank you.

Speaker #4: Thank you. Your next question, Si, comes from the line of Seascale from TD. Securities, please go ahead.

Speaker #4: We evaluated multiple ways to try to address it. and we tried to make the best arguments that we could. but ultimately, we thought it was prudent at that point to, to withdraw.

Speaker #15: Oh, thank you so much. Some of your competitors are becoming increasingly vocal about extending big LOEs at the end of the decade. Novartis is the notable exception.

Speaker #4: We do see continued, a strong uptake in the VISION population in Europe. It's important to note, as well, in Japan and in China, we are able to both have the PSMA-4 and PSMA VISION populations, which are critical, you know, long-term markets.

Vasant Narasimhan: Yeah, thanks, Kerry. No impact on the peak sales forecast. We continue to expect $5 billion plus. We had assumed all along that navigating the European feedback on the comparator arm would be, you know, a challenge. We evaluated multiple ways to try to address it, and we tried to make the best arguments that we could, but ultimately we thought it was prudent at that point to withdraw. We do see continued strong uptake in the PSMA VISION population in Europe. It's important to note as well in Japan, and in China, we are able to both have the PSMAfore and PSMA VISION populations, which are critical, you know, long-term markets.

Vasant Narasimhan: Yeah, thanks, Kerry. No impact on the peak sales forecast. We continue to expect $5 billion plus. We had assumed all along that navigating the European feedback on the comparator arm would be, you know, a challenge. We evaluated multiple ways to try to address it, and we tried to make the best arguments that we could, but ultimately we thought it was prudent at that point to withdraw. We do see continued strong uptake in the PSMA VISION population in Europe. It's important to note as well in Japan, and in China, we are able to both have the PSMAfore and PSMA VISION populations, which are critical, you know, long-term markets.

Speaker #15: It could be attributed to nothing more than communication practices. But if Novartis feels it has a good shot at delaying Cosentyx LOE, then why not note that?

Speaker #4: And the next step now for Europe will be the hormone-sensitive setting where we, because Plivicto is used in combination with an ARPI versus an ARPI, there are the comparator arm is what, EMA would want.

Speaker #15: And if this is an area of active pursuit, what is it that you're doing? Co-formulation, extended dosing, and related to all this, if Karen Hale is in the room, can she compare and contrast this to her experience at AbbVie?

Speaker #4: and I think would allow us then if we're, to move forward. Now we have the strong as you know, RPFS data. We're waiting on the OS data.

Speaker #15: Thank you.

Speaker #2: Yeah. Thanks, Steve. So Karen Hale is in the room, but I'll spare her from having to compare her thoughts with AbbVie things that would be not the appropriate setting to do that.

Speaker #4: Once we have that OS data, we should be able to file in Europe and then expand the patient population there. So I think that was the, the, the best outcome we, we decided rather than running additional studies that would take many years, to just withdraw the file and wait for the HSPC readout.

Vasant Narasimhan: The next step now for Europe will be the hormone-sensitive setting where because Pluvicto is used in combination with an ARPI versus an ARPI, there the comparator arm is what EMA would want, and I think would allow us then if we're to move forward now, we have the strong, as you know, RFS data. We're waiting on the OS data. Once we have that OS data, we should be able to file in Europe and then expand the patient population there. I think that was the best outcome we decided rather than running additional studies, it would take many years to just withdraw the file and wait for the HSPC readout.

Vasant Narasimhan: The next step now for Europe will be the hormone-sensitive setting where because PLUVICTO is used in combination with an ARPI versus an ARPI, there the comparator arm is what EMA would want, and I think would allow us then if we're to move forward now, we have the strong, as you know, RFS data. We're waiting on the OS data. Once we have that OS data, we should be able to file in Europe and then expand the patient population there. I think that was the best outcome we decided rather than running additional studies, it would take many years to just withdraw the file and wait for the HSPC readout.

Speaker #2: But we appreciate the question. I mean, of course, we have extensive efforts to defend our IP and then look at other ways to formulate our medicines.

Speaker #6: Lovely. Thank you.

Speaker #3: Thank you. Your next question, let's see, comes from the line of C. Scaler from TD Securities. Please go ahead.

Speaker #2: I mean, a good example is the Kacimta two months, which we do have now planned readout. We have additional efforts as well. The life cycle managed Kacimta into longer intervals as well, which are still in the early phases of efforts.

Speaker #8: Oh, thank you so much. Some of your competitors are becoming increasingly vocal about extending big, big LOEs at the end of the decade. Novartis is the notable exception.

Speaker #8: It could be attributed to nothing more than communication practices. But if Novartis feels it has a good shot at delaying Cosentyx LOE, then why not note that?

Kerry Holford: Lovely. Thank you.

Kerry Holford: Lovely. Thank you.

Speaker #2: We'll see how that progresses. All of that would generate new IP I think. And so that one is clear. I think with Cosentyx, we have a number of cell line formulation and other patents that we continue to prosecute.

Kerry Holford: Thank you. Your next question, Steve, comes from the line of Steve Scala from TD Securities. Please go ahead.

Operator: Thank you. Your next question comes from the line of Steve Scala from TD Securities. Please go ahead.

Speaker #8: And, and if this is an area of active pursuit, w-what is it that you're doing co-formulation, extended dosing, and related to all this, if Karen Hale is in the room, can she compare and contrast this to her experience at AbbVie?

Steve Scala: Oh, thank you so much. Some of your competitors are becoming increasingly vocal about extending big LOEs at the end of the decade. Novartis is the notable exception. It could be attributed to nothing more than communication practices. If Novartis feels it has a good shot at delaying Cosentyx LOE, why not note that? If this is an area of active pursuit, what is it that you're doing? Co-formulation, extended dosing? Related to all this, if Karen Hale is in the room, can she compare and contrast this to her experience at AbbVie? Thank you.

Steve Scala: Oh, thank you so much. Some of your competitors are becoming increasingly vocal about extending big LOEs at the end of the decade. Novartis is the notable exception. It could be attributed to nothing more than communication practices. If Novartis feels it has a good shot at delaying Cosentyx LOE, why not note that? If this is an area of active pursuit, what is it that you're doing? Co-formulation, extended dosing? Related to all this, if Karen Hale is in the room, can she compare and contrast this to her experience at AbbVie? Thank you.

Speaker #2: We are as a practice don't add those in as potential scenarios until we've gotten further along. And I think in the litigation phase to really understand where those trials ultimately fit.

Speaker #8: Thank you.

Speaker #4: Yeah. Thanks. Thanks, Steve. So, you know, Karen Hale is in the room, but I will, I'll spare her from having to compare the, the her, her thoughts with AbbVie, I think it would be not the appropriate setting to do that.

Speaker #2: So I think with Cosentyx, with Kacimta, many efforts. I think we've discussed extensively with Kiscali the efforts around CDK2, CDK2.4, the Picovation efforts as well.

Speaker #2: Harder with a small molecule as you know to come up with significant reformulation efforts. But something that we're certainly looking at. I would point out even for medicines like Semblix, we're actively already working on ways to hopefully extend that franchise even further.

Speaker #4: But we appreciate, appreciate the question. I mean, of course, we have extensive efforts to defend our IP and then look at other ways to, you know, formulate our medicines.

Vasant Narasimhan: Yeah. Thanks. Thanks, Steve. You know, Karen Hale is in the room, but I'll spare her from having to compare the her thoughts with AbbVie. I think it would be not the appropriate setting to do that, but we appreciate the question. I mean, of course, we have extensive efforts to defend our IP and then look at other ways to, you know, formulate our medicines. I mean, a good example is the Cosentyx two-month, which we do have now planned readout. We have additional efforts as well to lifecycle manage Cosentyx into longer intervals as well, which are still in the, you know, early phases of efforts. We'll see how that progresses. All of that would generate new IP, I think, that one is clear.

Vasant Narasimhan: Yeah. Thanks. Thanks, Steve. You know, Karen Hale is in the room, but I'll spare her from having to compare the her thoughts with AbbVie. I think it would be not the appropriate setting to do that, but we appreciate the question. I mean, of course, we have extensive efforts to defend our IP and then look at other ways to, you know, formulate our medicines. I mean, a good example is the Cosentyx two-month, which we do have now planned readout. We have additional efforts as well to lifecycle manage Cosentyx into longer intervals as well, which are still in the, you know, early phases of efforts. We'll see how that progresses. All of that would generate new IP, I think, that one is clear.

Speaker #4: I mean, a good example is the Casimpta two-month, which we do have now planned readout. We have additional efforts as well. The lifecycle managed Casimpta into, longer intervals, as well, which are, are, are still in the, you know, early phases of efforts.

Speaker #2: You know with Lekvio, we moved from six-month also to now go to 12-month and also to look at combinations of Lekvio to target other siRNA targets within cardiovascular disease, things like HMG-CoA reductase amongst others.

Speaker #4: We'll see how that progresses. All of that would generate new IP. I think, and so that one is clear. I think with Cosentyx, we have a number of cell line formulation and other patents that we continue to prosecute.

Speaker #2: So I think we have quite a broad effort to always think about this. But we don't want to overpromise at this stage sitting here in 2026 what may or may not happen five years from now.

Speaker #4: We, as a practice, don't add those in as potential scenarios until we've gotten further along, I think, in the litigation phase, to really understand where those trials ultimately fit.

Speaker #2: But rest assured, those efforts are ongoing. And as soon as we have something that we think is credible to put forward, we certainly will let the markets know.

Speaker #4: So I think with Cosentyx, with Casimpta, many efforts. I think we've discussed extensively with Kiscali the efforts around the Picovation efforts as well. Harder with a small molecule as in, as you know, to come up with, you know, significant reformulation efforts.

Speaker #4: Thank you. Your next question today. Comes from the line of Noras Chohan from Inturn Health. Please go ahead.

Vasant Narasimhan: I think with Cosentyx, we have a number of cell line formulation and other patents that we continue to prosecute. We are, as a practice, don't add those in as potential scenarios until we've gotten further along, I think, in the litigation phase to really understand where, you know, where those trials ultimately fit. I think with Cosentyx, many efforts. I think we've discussed extensively with Kisqali, the efforts around CDK2, CDK4/6, the Pikavation efforts as well. Harder with a small molecule, as you know, to come up with, you know, significant reformulation efforts, but something that we're certainly looking at. I would point out even for medicines like Scemblix, we're actively already working on ways to hopefully extend that franchise even further.

Vasant Narasimhan: I think with Cosentyx, we have a number of cell line formulation and other patents that we continue to prosecute. We are, as a practice, don't add those in as potential scenarios until we've gotten further along, I think, in the litigation phase to really understand where, you know, where those trials ultimately fit. I think with Cosentyx, many efforts. I think we've discussed extensively with KISQALI, the efforts around CDK2, CDK4/6, the Pikavation efforts as well. Harder with a small molecule, as you know, to come up with, you know, significant reformulation efforts, but something that we're certainly looking at. I would point out even for medicines like SCEMBLIX, we're actively already working on ways to hopefully extend that franchise even further.

Speaker #16: Hi there. Thanks for taking my question. Just one, please, on Cosentyx. As we think about the margin impacts of the Cosentyx LOE, is it fair to assume that you've already started optimizing the profitability of Cosentyx as would be typical ahead of any other LOE?

Speaker #4: But something that we're certainly looking at. I would point out even for medicines like Semblix, we're actively already working on ways to hopefully extend that franchise even further.

Speaker #4: You know, with Lekvio, we moved from six-month also to now go to 12-month and also to look at combinations of Lekvio to target other siRNA, targets within cardiovascular disease, things like HMG-CoA reductase amongst others.

Speaker #16: Thank you.

Speaker #2: Thanks, Noras. I'll give that to Mukul.

Speaker #17: Yeah. Nice. Thanks for the question. Yeah, absolutely. I would confirm that. I think as we have previously indicated, I think we are we've projected an LOE in the US for Cosentyx in 2029.

Speaker #4: So I think, you know, we have quite a broad effort to always think about this. But we don't wanna over-promise at this stage sitting here in 2026 what may or may not happen five years from now.

Speaker #17: There is also an IRA event in 2028 that we have factored into our numbers. And this is all baked into our back to 40% latest by 2029 guidance on the margin.

Vasant Narasimhan: You know, with Leqvio, we moved from 6 months also to now go to 12 months and also to look at combinations of Leqvio to target other siRNA targets within cardiovascular disease, things like HMG-CoA reductase, amongst others. I think, you know, we have a quite a broad effort to always think about this, but we don't wanna overpromise at this stage, sitting here in 2026, what may or may not happen 5 years from now. Rest assured, those efforts are ongoing, and as soon as we have something that we think is credible to put forward, we certainly will let the markets know.

Vasant Narasimhan: You know, with LEQVIO, we moved from 6 months also to now go to 12 months and also to look at combinations of LEQVIO to target other siRNA targets within cardiovascular disease, things like HMG-CoA reductase, amongst others. I think, you know, we have a quite a broad effort to always think about this, but we don't wanna overpromise at this stage, sitting here in 2026, what may or may not happen 5 years from now. Rest assured, those efforts are ongoing, and as soon as we have something that we think is credible to put forward, we certainly will let the markets know.

Speaker #4: But rest assured, those efforts are ongoing. And as soon as we have something that we think is credible to put forward, we certainly will let the markets know.

Speaker #16: Thank you.

Speaker #2: Perfect. Thanks, Mukul.

Speaker #4: Thank you. Your next question. Comes from the line of Seamus Fernandez from Guggenheim Securities. Please go ahead.

Speaker #3: Thank you. Your next question today. Comes from the line of Naras Chauhan from Intern Health. Please go ahead.

Speaker #18: This is Zach Dunn on behalf of Seamus Fernandez. Thank you for the questions. We are encouraged by the advancement of your IL-15, the GIA632 into Vitiligo.

Speaker #9: Hi there. Thanks for taking my question. Just one, please, on Cosentyx. As we think about the margin impact of the Cosentyx LOE, is it fair to assume that you've already started optimizing the profitability of typical, ahead of, any other LOE?

Speaker #18: Can you share your thoughts on how you think about the market size of biologic eligible Vitiligo patients? And if you don't mind tying that into your thoughts on atopic dermatitis and the market opportunity there.

Vasant Narasimhan: Thank you. Your next question today comes from the line of Naresh Chauhan from Intron Health. Please go ahead.

Operator: Thank you. Your next question today comes from the line of Naresh Chouhan from Intron Health. Please go ahead.

Speaker #9: Thank you.

Speaker #4: Thanks, Naras. I'll give that to Mukul.

Naresh Chauhan: Hi there. Thanks for taking my question. Just one thing on Cosentyx. As we think about the margin impact of the Cosentyx LOE, is it fair to assume that you've already started optimizing the profitability of Cosentyx, as would be typical, ahead of any other LOE? Thank you.

Naresh Chouhan: Hi there. Thanks for taking my question. Just one thing on Cosentyx. As we think about the margin impact of the Cosentyx LOE, is it fair to assume that you've already started optimizing the profitability of Cosentyx, as would be typical, ahead of any other LOE? Thank you.

Speaker #5: Yeah. Nice. Thanks for the question. yeah, absolutely. I would confirm that. I think, as we have previously indicated, I think we are we've projected an LOE in the US for Cosentyx in 2029.

Speaker #18: Thank you.

Speaker #2: Yeah. Thanks. I mean, the IL-15 is something we did mention at the meet the management. And we are quite excited by the profile of the of this medicine.

Speaker #5: There is also an IRA event, in 2028 that we have factored into our numbers. And this is all baked into our, back to 40% latest by 2029 guidance in the margin.

Speaker #2: For those of you who are not aware, this is a medicine that we in-license. It's overexpressed in patients with atopic dermatitis. But we also see the opportunity to address a number of other diseases over time, including Vitiligo.

Vasant Narasimhan: Thanks, Naresh. I'll give that to Mukul.

Vasant Narasimhan: Thanks, Naresh. I'll give that to Mukul.

Mukul Mehta: Yeah. Naresh, thanks for the question. Yeah, absolutely. I would confirm that. I think, as we have previously indicated, we've projected an LOE in the US for Cosentyx in 2029. There is also an IRA event in 2028 that we have factored into our numbers, and this is all baked into our back to 40% latest by 2029 guidance in the margin.

Mukul Mehta: Yeah. Naresh, thanks for the question. Yeah, absolutely. I would confirm that. I think, as we have previously indicated, we've projected an LOE in the US for Cosentyx in 2029. There is also an IRA event in 2028 that we have factored into our numbers, and this is all baked into our back to 40% latest by 2029 guidance in the margin.

Speaker #9: Thank you.

Speaker #4: Perfect. Thanks. Thanks, Mukul.

Speaker #3: Thank you. Your next question comes from the line of Sheamus Fernandez from Guggenheim Securities. Please go ahead.

Speaker #2: And so it's early days. I mean, these phase two studies are ongoing. The phase two A study in atopic dermatitis is now recruiting. The Vitiligo study is set to begin.

Speaker #10: This is Actan on behalf of Sheamus Fernandez. Thank you for the questions. We are encouraged by the advancement of your IL-15, the GIA632, into vitiligo.

Speaker #2: Obviously, if we can show meaningful improvements over the standard of care in atopic dermatitis or can obviously become a standard of care in Vitiligo, these would be very large indications.

Naresh Chauhan: Thank you.

Naresh Chouhan: Thank you.

Vasant Narasimhan: Perfect. Thanks. Thanks, Mukul.

Vasant Narasimhan: Perfect. Thanks. Thanks, Mukul.

Vasant Narasimhan: Thank you. Your next question comes from the line of Seamus Fernandez from Guggenheim Securities. Please go ahead.

Operator: Thank you. Your next question comes from the line of Seamus Fernandez from Guggenheim Securities. Please go ahead.

Speaker #10: Can you share your thoughts on how you think about the market size of biologic, eligible Vitiligo patients? And if you don't mind tying that into your thoughts on atopic dermatitis and the market opportunity there.

Speaker #2: I wouldn't be in a position to give you precise numbers. But obviously, very large market opportunities. And we are actively looking at moving that IL-15 across multiple other immunology indications over time.

Zachary Dunn: This is Zach Dunn on behalf of Seamus Fernandez. Thank you for the questions. We're encouraged by the advancement of your IL-15, the GIA632 into vitiligo. Can you share your thoughts on how you think about the market size of biologic-eligible vitiligo patients? If you don't mind tying that into your thoughts on atopic dermatitis and the market opportunity there. Thank you.

Zach Dunn: This is Zach Dunn on behalf of Seamus Fernandez. Thank you for the questions. We're encouraged by the advancement of your IL-15, the GIA632 into vitiligo. Can you share your thoughts on how you think about the market size of biologic-eligible vitiligo patients? If you don't mind tying that into your thoughts on atopic dermatitis and the market opportunity there. Thank you.

Speaker #10: Thank you.

Speaker #2: So I think as we progress, we'll, of course, keep you posted. And maybe I'll also note in atopic dermatitis, we also have the GHC program, which also IL-13, IL-18, which we're also on track.

Speaker #4: Yeah. Thanks. I mean, the, the IL-15 is something we did mention, at, at the Meet the Management. And we are quite excited by the profile of the, o-over, you know, of this medicine.

Speaker #4: you know, for those of you wh are not aware, this is a, a medicine that we in-license. It's, overexpressed in patients with atopic dermatitis.

Speaker #4: But we also see the opportunity to address a number of other, you know, diseases over time, including, including vitiligo. And so it's early days.

Speaker #4: Thank you. As a reminder, if you would like to ask a question, please press star one. And one on your telephone and wait for your name to be announced.

Vasant Narasimhan: Yeah, thanks. I mean, the IL-15 is something we did mention at the Meet the Management, and we are quite excited by the profile of the over, you know, of this medicine. You know, for those of you who are not aware, this is a medicine that we in-licensed. It's overexpressed in patients with atopic dermatitis, but we also see the opportunity to address a number of other, you know, diseases over time, including vitiligo. It's early days. I mean, these phase two studies are ongoing. The phase two-A study in atopic dermatitis is now recruiting. The vitiligo study is set to begin.

Vasant Narasimhan: Yeah, thanks. I mean, the IL-15 is something we did mention at the Meet the Management, and we are quite excited by the profile of the over, you know, of this medicine. You know, for those of you who are not aware, this is a medicine that we in-licensed. It's overexpressed in patients with atopic dermatitis, but we also see the opportunity to address a number of other, you know, diseases over time, including vitiligo. It's early days. I mean, these phase two studies are ongoing. The phase two-A study in atopic dermatitis is now recruiting. The vitiligo study is set to begin.

Speaker #4: I mean, these phase two studies are ongoing. The phase two A study, in atopic dermatitis is now recruiting. the Vitiligo study is set to, to begin.

Speaker #4: Please limit yourself to one question and return to the queue for any follow-up. You'll now take the next question. And the question comes from the line of Matthew Weston from UBS.

Speaker #4: obviously, if we can show meaningful improvements over the standard of care in, in atopic dermatitis or can, obviously become a standard of care in Vitiligo, these would be very large, indications.

Speaker #4: Please go ahead.

Speaker #2: Thanks, Matt. It's a quick follow-up about my first question about Rapsudo and XUS. And I was intrigued by your comment around you coming in for US approval before MFN.

Speaker #4: I wouldn't be in a position to give you precise numbers. But obviously, very large market opportunities. And we are, actively looking at moving that IL-15 across multiple, other, immunology indications over time.

Speaker #2: Just thinking about the CNS indication, which I think you've said previously is going to have a separate brand name, but obviously the same active ingredient at a different dose.

Vasant Narasimhan: Obviously, if we can show meaningful improvements over the standard of care in atopic dermatitis or can become a standard of care in vitiligo, these would be very large indications. I wouldn't be in a position to give you precise numbers, obviously very large market opportunities. We are actively looking at moving that IL-15 across multiple other immunology indications over time. I think as we progress, we'll of course, you know, keep, you know, keep you posted. Maybe I'll also note in atopic dermatitis, we also have the GHC program, which also IL-13, IL-18, which we're also, you know, on track.

Vasant Narasimhan: Obviously, if we can show meaningful improvements over the standard of care in atopic dermatitis or can become a standard of care in vitiligo, these would be very large indications. I wouldn't be in a position to give you precise numbers, obviously very large market opportunities. We are actively looking at moving that IL-15 across multiple other immunology indications over time. I think as we progress, we'll of course, you know, keep, you know, keep you posted. Maybe I'll also note in atopic dermatitis, we also have the GHC program, which also IL-13, IL-18, which we're also, you know, on track.

Speaker #4: So I think as we, as we progress, we'll, of course, you know, keep, you know, keep you posted. And maybe I'll also note in atopic dermatitis, we also have the GHC program, which, also IL-13, IL-18, which we're also, you know, on track.

Speaker #2: Does that mean it would also be excluded from MFN considerations because of the original approval, or is that something that we'd have to think of in MS?

Speaker #19: Yeah. So our current assumption Matthew, it's a very good question. Our current assumption working assumption is that this is based on the chemical compound in question.

Speaker #3: Thank you. As a reminder, if you would like to ask a question, please press star one, and one on your telephone, and wait for your name to be announced.

Speaker #19: So all because Remibrutinib has an approval that even with different brand names that all of the subsequent Remibrutinib indications would be susceptible to the Medicaid element of the MFN story, but not the overall MFN across all segments of US reimbursement environment.

Speaker #3: Please limit yourself to one question and return to the queue for any follow-up. You'll now take the next question. And the question comes from the line of Matthew Weston from UBS.

Vasant Narasimhan: Thank you. As a reminder, if you would like to ask a question, please press star one and one on your telephone and wait for your name to be announced. Please limit yourself to one question and return to the queue for any follow-up. We'll now take the next question. The question comes from the line of Matthew Weston from UBS. Please go ahead.

Operator: Thank you. As a reminder, if you would like to ask a question, please press star one and one on your telephone and wait for your name to be announced. Please limit yourself to one question and return to the queue for any follow-up. We'll now take the next question. The question comes from the line of Matthew Weston from UBS. Please go ahead.

Speaker #3: Please go ahead.

Speaker #4: Thanks, Matt. This is a quick follow-up about my first question regarding Rapsido and XUS. I was intrigued by your comment about you coming in for US approval before MFN.

Speaker #19: I would say that is our current working assumption. And if that changes, we'll let you know. But our current expectation is that would be how Remibrutinib would be treated as would be the case for other medicines where such as Xeljanzma, where we have Advisma but while the dose is changing, of course, the underlying gene therapy is the same.

Speaker #4: Just thinking about the CNS indication, which I think you've said previously is gonna have a separate brand name. But obviously, the same active ingredients at a different dose.

Matthew Weston: Thanks, Vas. It's a quick follow-up about my first question about Rhapsido and NX-US, and I was intrigued by your comment around you coming in for US approval before MFN. Just thinking about the CNS indication, which I think you've said previously is gonna have a separate brand name, but obviously the same active ingredient at a different dose.

Matthew Weston: Thanks, Vas. It's a quick follow-up about my first question about Rhapsido and NX-US, and I was intrigued by your comment around you coming in for US approval before MFN. Just thinking about the CNS indication, which I think you've said previously is gonna have a separate brand name, but obviously the same active ingredient at a different dose.

Speaker #19: So that is our assumption for all of those medicines.

Speaker #4: Does that mean it would also be excluded from MFN considerations 'cause of the original approval, or that's something that we'd have to think of in MS?

Speaker #2: Cool. Many thanks.

Speaker #4: Thank you. Your next question. Comes from the line of Michael Lyston from Jefferies. Please go ahead.

Speaker #11: Yeah. So our current assumption, Matthew, it's a very good question. Our current assumption working assumption is that this is based on the chemical compound, in question.

Speaker #20: Thank you for taking the follow-up question from Mukul, please. The gross margin is pressured by negative mixed effect, obviously. That is partly driven by the generic erosions.

Speaker #11: So all because Remibudinib has an approval that even with different brand names that all of the subsequent Remibudinib indications would be susceptible to the Medicaid element of the MFN story, but not the overall, MFN across all segments of US reimbursement environment.

Graham Parry: Does that mean it would also be excluded from MFN considerations because of the original approval, or that's something that we'd have to think of in MF?

Matthew Weston: Does that mean it would also be excluded from MFN considerations because of the original approval, or that's something that we'd have to think of in MF?

Speaker #20: And partly by the new products having payaways. Is there a scale factor in here that we should take into consideration as we think about the first half, second half of the year, or is the gross margin just plain and simple mixed driven?

Vasant Narasimhan: Yeah. Our current assumption, Matthew, it's a very good question. Our current assumption, working assumption is that this is based on the chemical compound in question. Because remibrutinib has an approval that even with different brand names, all of the subsequent remibrutinib indications would be susceptible to the Medicaid element of the MFN story, but not the overall MFN across all segments of US reimbursement environment. I would say that is our current working assumption. And if that changes, we'll let you know. Our current expectation is that would be how remibrutinib would be treated, as would be the case for other medicines such as Zolgensma, where we have it ianalumab. While the dose is changing, of course, the underlying gene therapy is the same.

Vasant Narasimhan: Yeah. Our current assumption, Matthew, it's a very good question. Our current assumption, working assumption is that this is based on the chemical compound in question. Because remibrutinib has an approval that even with different brand names, all of the subsequent remibrutinib indications would be susceptible to the Medicaid element of the MFN story, but not the overall MFN across all segments of US reimbursement environment. I would say that is our current working assumption. And if that changes, we'll let you know. Our current expectation is that would be how remibrutinib would be treated, as would be the case for other medicines such as Zolgensma, where we have it ianalumab. While the dose is changing, of course, the underlying gene therapy is the same.

Speaker #17: Yeah. So I think there is, as you rightly said, I think there's two things at play here. If we look at Q1, the overall decrease in the margin is 4.1%.

Speaker #11: I would say that is our current working assumption. and if that changes, we'll let, we'll let you know. But our current expectation is that would be how Remibudinib would be treated, as would be the case for other medicines where, such as Xeljanzma, where we have Ipisma but, while the dose is changing, of course, the underlying gene therapy is the same.

Speaker #17: 3 percentage points of that comes from R&D spend. And a percentage point comes from the GX impact on gross margin. Now, GX impact on gross margin pretty much, I think if we take 2025 as a base, pretty much H2 base is what we should what you guys should model going into this year.

Speaker #11: that so that is our assumption for all of those medicines.

Speaker #4: Cool. Many thanks.

Speaker #17: And that should be the base. And as far as R&D spend, it's concerned, I think we have to take into account not just the avidity deal that we did, but we also did three other pretty significant deals in Turmalin, Anthos, as well as Regulus and I think they were they all came into the P&L from Q2 onwards.

Speaker #3: Thank you. Your next question comes from the line of Michael Lyston from Jefferies. Please go ahead.

Speaker #12: Oh, thank you for taking the follow-up. question from Mukul, please. the, the gross margin is pressured by negative mixed effect, obviously, that is partly driven by the generic erosions, and partly by the new products having payaways.

Vasant Narasimhan: That is our assumption for all of those medicines.

Vasant Narasimhan: That is our assumption for all of those medicines.

Graham Parry: Cool. Many thanks.

Matthew Weston: Cool. Many thanks.

Speaker #17: So in Q1, all of these three deals plus one month of avidity is incremental and going forward, I think part of it is already in the base.

Speaker #12: Is, is there a scale factor in here that we should take into consideration as we think about the first half, second half of the year, or is the gross margin just plain and simple mixed-driven?

Graham Parry: Thank you. Your next question comes from the line of Michael Leuchten from Jefferies. Please go ahead.

Operator: Thank you. Your next question comes from the line of Michael Leuchten from Jefferies. Please go ahead.

Speaker #17: So the run off the P&L.

Michael Leuchten: Thank you for taking the follow-up. A question for Mukul, please. The gross margin is pressured by negative mix effect. Obviously, that is partly driven by the generic erosions, and partly by the new products having payaways. Is there a scale factor in here that we should take into consideration as we think about the H1, H2 of the year? Or is the gross margin just plain and simple mix-driven?

Michael Leuchten: Thank you for taking the follow-up. A question for Mukul, please. The gross margin is pressured by negative mix effect. Obviously, that is partly driven by the generic erosions, and partly by the new products having payaways. Is there a scale factor in here that we should take into consideration as we think about the H1, H2 of the year? Or is the gross margin just plain and simple mix-driven?

Speaker #5: Yeah. So the I think there is, as you rightly said, I think there's two things at play here. If we look at Q1, the overall decrease in the margin is 4.1%.

Speaker #20: Thank you.

Speaker #2: Next question.

Speaker #4: Thank you. Your next question. Comes from the line of Tibo Baldwin from Morgan Stanley. Please go ahead.

Speaker #5: Three percentage points of that comes from R&D spend. And a percentage point comes from the GX impact on gross margin. Now, GX impact on gross margin, pretty much, I think if we take 2025 as a base, pretty much H2 base is what we should—what you guys should—model going into this year.

Speaker #21: Yes. Thank you. Just a question on your comments. On Votoplam and the potential discussion with the phase with FDA on the phase two, we had the phase two data some time ago.

Mukul Mehta: I think there is, as you rightly said, I think there's two things at play here. If we look at Q1, the overall decrease in the margin is 4.1%. 3 percentage points of that comes from R&D spend, and 1 percentage point comes from the GX impact on gross margin. GX impact on gross margin, pretty much, I think if we take 2025 as a base, pretty much H2 base is what you guys should model going into this year, and that should be the base. As far as R&D spend is concerned, I think we have to take into account not just the Avidity deal that we did, but we also did three other, pretty significant deals in Tourmaline, Anthos, as well as Regulus.

Mukul Mehta: I think there is, as you rightly said, I think there's two things at play here. If we look at Q1, the overall decrease in the margin is 4.1%. 3 percentage points of that comes from R&D spend, and 1 percentage point comes from the GX impact on gross margin. GX impact on gross margin, pretty much, I think if we take 2025 as a base, pretty much H2 base is what you guys should model going into this year, and that should be the base. As far as R&D spend is concerned, I think we have to take into account not just the Avidity deal that we did, but we also did three other, pretty significant deals in Tourmaline, Anthos, as well as Regulus.

Speaker #21: Have you seen anything new in the full data open label extension that makes you more confident on the potential for the FDA to accept a path for accepted approval?

Speaker #5: And that should be the base. And as far as R&D spend is concerned, I think we have to take into account not just the Avidity deal that we did, but we also did three other pretty significant deals in Turmalin, Anthos, as well as Regulus, and I think they all came into the P&L from Q2 onwards.

Speaker #2: Yeah. I think as I said, we feel like the results that we've seen confirm our planned design in phase three and also confirm that the 10 milligram dose is the right dose to take forward.

Speaker #2: I think at this point, we're still in discussions with our partner company on the right approach with PTC, on the right approach with any further engagement with FDA.

Speaker #5: so in Q1, all of these three deals plus one month of avidity is incremental and going forward, I think part of it is already in the base.

Speaker #2: And I think as soon as we have clarity on that, we'll, of course, and have those discussions with FDA, we can keep the market updated.

Speaker #5: So, the a the incremental R&D spend would start to run, run, run off the P&L.

Speaker #2: But I think no further comment until those discussions are complete. Next question.

Speaker #12: Thank you.

Speaker #4: Next question.

Mukul Mehta: I think they all came into the PNL from Q2 onwards. In Q1, all of these three deals plus one month of Avidity is incremental. Going forward, I think part of it is already in the base. On the incremental R&D spend would start to run off the PNL.

Mukul Mehta: I think they all came into the PNL from Q2 onwards. In Q1, all of these three deals plus one month of Avidity is incremental. Going forward, I think part of it is already in the base. On the incremental R&D spend would start to run off the PNL.

Speaker #3: Thank you. Your next question comes from the line of Tibo Baldwin from Morgan Stanley. Please go ahead.

Speaker #4: Thank you. Your next question comes from the line of Graham Parry from Citigroup. Please go ahead.

Speaker #13: Yes. Thank you. Just, a question on your comments. On Votoplam and the potential discussion with the phase, with FDA on the phase two, we had the alliance, phase two data some time ago.

Speaker #22: Okay. Thanks for taking my follow-up. And just on case index actually, be useful if you could qualify the grace to net adjustments. Both in the base year and this year at the quarter.

Speaker #13: Have you seen anything new in the full data open-label extension? that makes you, more confident on, on the, the potential for the, the FDA to accept, a path for accelerated approval?

Michael Leuchten: Thank you.

Michael Leuchten: Thank you.

Speaker #22: And previously, you talked about US growing mid-single digit growth over the mid-term to an 8 billion peak on that asset. Just that was absent from the release and slide today.

Vasant Narasimhan: Next question.

Vasant Narasimhan: Next question.

Vasant Narasimhan: Thank you. Your next question comes from the line of Thibault Boutherin from Morgan Stanley. Please go ahead.

Operator: Thank you. Your next question comes from the line of Thibault Boutherin from Morgan Stanley. Please go ahead.

Thibault Boutherin: Yes, thank you. Just a question on your comments on votoplam and the potential discussion with FDA on the phase II. We had the lens, phase II data some time ago. Have you seen anything new in the full data open label extension, that makes you more confident on the potential for the FDA to accept a path for accelerated approval?

Thibault Boutherin: Yes, thank you. Just a question on your comments on votoplam and the potential discussion with FDA on the phase II. We had the lens, phase II data some time ago. Have you seen anything new in the full data open label extension, that makes you more confident on the potential for the FDA to accept a path for accelerated approval?

Speaker #22: Just wonder if that still sounds. Thank you.

Speaker #4: Yeah, I think, as I said, we feel like the results that we've seen confirm our plan design in Phase 3 and also confirm that the 10 milligram dose is the right dose to take forward.

Speaker #19: Yes. So on the gross and net adjustments for Cosentyx from quarter one last year.

Speaker #17: Yeah. So I think if we exclude the gross to net impact on Cosentyx, Cosentyx moves into a positive growth territory for the US. I think to be exact, around 1%, 0 to 1%, closer to 1% for the quarter.

Speaker #4: I think at this point, we're still in discussions with our partner company on the right, approach with, with PTC on the right approach. with any further engagement with FDA.

Speaker #4: And I think as soon as we have clarity on that, we'll, of course, and have those discussions with FDA. We can keep the markets, updated.

Vasant Narasimhan: Yeah, I think as I said, we feel like the results that we've seen confirm our plan design in Phase III and also confirm that the 10-milligram dose is the right dose to take forward. I think at this point we're still in discussions with our partner company on the right approach with DTC on the right approach with any further engagement with FDA. I think as soon as we have clarity on that, we'll of course and have those discussions with FDA, we can keep the market updated. I think no further comment until those discussions are complete. Next question.

Vasant Narasimhan: Yeah, I think as I said, we feel like the results that we've seen confirm our plan design in Phase III and also confirm that the 10-milligram dose is the right dose to take forward. I think at this point we're still in discussions with our partner company on the right approach with DTC on the right approach with any further engagement with FDA. I think as soon as we have clarity on that, we'll of course and have those discussions with FDA, we can keep the market updated. I think no further comment until those discussions are complete. Next question.

Speaker #17: We have to think of and then I think if we think of an overall basis, we have 2 percentage points in our base for gross to net in the US.

Speaker #4: But I think no, no further comment until those discussions are complete. Next question.

Speaker #3: Thank you. Your next question comes from the line of Graham Parry from Citigroup. Please go ahead.

Speaker #17: In Q1 2025, I think we also have a positive impact this year. The net comes to about 1% on an overall P&L.

Speaker #14: great. Thanks for taking my follow-up. just on case NT, it's actually beautiful if you could qualify the grace to net adjustments, both in the base year and this year at the quarter.

Speaker #2: And then I think Graham, when you look going forward, yeah, we continue to expect it to be in this mid-single digit range globally. And I think that will be a mix of US and ex-US.

Speaker #14: And, previously, you talked about, US, growing mid-single-digit growth over the mid-term to an 8 billion peak on that asset just that was absent from the release and slide today.

Vasant Narasimhan: Thank you. Your next question comes from the line of Graham Parry from Citigroup. Please go ahead.

Operator: Thank you. Your next question comes from the line of Graham Parry from Citigroup. Please go ahead.

Speaker #2: And we're going to have to, I think, see how the coming quarters evolve. But that's our current expectation is that we would be in that mid-single digit range.

Speaker #14: Just wonder if that still sounds. Thank you.

Speaker #2: Clearly, the peak sales for Cosentyx would most likely be in 2027 given the IRA event in 2028 would impact the overall pricing in Medicare, but also into the Medicaid best price in 2028.

Graham Parry: Okay. Thanks for taking my follow-up. Just on Cosentyx, actually. Be it all, if you could qualify the gross to net adjustments, both in the base year and this year at the quarter. Previously, you talked about some US, growing mid-single digit growth over the mid-term to an $8 billion peak on that asset. Just that was absent from the release in five stages. Just wonder if that's still sound. Thank you.

Graham Parry: Okay. Thanks for taking my follow-up. Just on Cosentyx, actually. Be it all, if you could qualify the gross to net adjustments, both in the base year and this year at the quarter. Previously, you talked about some US, growing mid-single digit growth over the mid-term to an $8 billion peak on that asset. Just that was absent from the release in five stages. Just wonder if that's still sound. Thank you.

Speaker #4: Yeah. So on the on the gross to net, and adjustments for Cosentyx from, from quarter one last year.

Speaker #5: Yeah. So I think if we if we exclude the gross to net, impact on Cosentyx, Cosentyx moves into a positive growth territory for the US.

Speaker #5: I think to be exact, around 1%, 0 to 1%, closer to 1% for the quarter. We have to think of, and then I think if we if we think of an overall basis, we spoke we have 2 percentage points in our base for gross to net in the US.

Speaker #2: So all of those dynamics are unfolding alongside the PMR launch and the ongoing launch in IV.

Vasant Narasimhan: Yeah. On the gross and net, and adjustments for Cosentyx from Q1 last year.

Vasant Narasimhan: Yeah. On the gross and net, and adjustments for Cosentyx from Q1 last year.

Mukul Mehta: I think if we, if we exclude the gross to net impact on Cosentyx moves into a positive growth territory for the US. I think to be exact, around 1%, 0% to 1%, closer to 1% for the quarter. I think if we, if you think of an overall basis, we spoke, we have 2 percentage points in our base for gross to net in the US in Q1 2025. I think we also have a positive impact this year. The net comes to about 1% on an overall P&L.

Mukul Mehta: I think if we, if we exclude the gross to net impact on Cosentyx moves into a positive growth territory for the US. I think to be exact, around 1%, 0% to 1%, closer to 1% for the quarter. I think if we, if you think of an overall basis, we spoke, we have 2 percentage points in our base for gross to net in the US in Q1 2025. I think we also have a positive impact this year. The net comes to about 1% on an overall P&L.

Speaker #4: Thank you.

Speaker #2: Next question.

Speaker #4: Your next question comes from the line of James Quigley from Goldman Sachs. Please go ahead.

Speaker #5: In Q1 2025, I think we also have a positive impact this year. The net comes to about 1% on an overall P&L.

Speaker #23: Hello. Thank you for taking my second question. So just following up on the removal food allergy data from phase two, that is supporting the phase three trial.

Speaker #4: And then I think, you know, Graham, when you look going forward, yeah, we continue to expect to, to be in this mid-single-digit range globally.

Speaker #23: So what is it in the modeling that you saw that makes the 75 milligram the most appropriate dose given the data we've seen for the 100 milligram and the 25 milligram?

Speaker #4: And I think that will be a mix of US and ex-US. And we're gonna have to, I think, see how the coming quarters evolve.

Speaker #23: Is there a bridge between where the efficacy is between the two, or would the 75 milligram dose have the same target engagement as 100 milligrams?

Speaker #4: But that's our current expectation is that we would be in that mid-single-digit range, clearly the, the peak sales for Cosentyx would most likely be in 2027 given the, IRA event in 2028 would impact the, the overall pricing in Medicare, but also, into, the Medicaid, best price, in 2028.

Vasant Narasimhan: I think, Graham, when you look going forward, we continue to expect it to be in this mid-single digit range globally. I think that will be a mix of US and ex-US. We're gonna have to, I think, see how the coming quarters evolve, but that's our current expectation is that we would be in that mid-single digit range. Clearly, the peak sales for Cosentyx would most likely be in 2027, given the IRA event in 2028 would impact the overall pricing in Medicare, but also into the Medicaid best price in 2028. All of those dynamics are unfolding alongside the PMR launch and the ongoing launch in IV.

Vasant Narasimhan: I think, Graham, when you look going forward, we continue to expect it to be in this mid-single digit range globally. I think that will be a mix of US and ex-US. We're gonna have to, I think, see how the coming quarters evolve, but that's our current expectation is that we would be in that mid-single digit range. Clearly, the peak sales for Cosentyx would most likely be in 2027, given the IRA event in 2028 would impact the overall pricing in Medicare, but also into the Medicaid best price in 2028. All of those dynamics are unfolding alongside the PMR launch and the ongoing launch in IV.

Speaker #2: That's a great question. So we modeled this really carefully based on the full data set that we have. And we do believe that at 75 milligrams, we do have full target engagement.

Speaker #2: And we should be able to achieve efficacy that approaches the 100 milligram dose. But and so we felt like this was a reasonable approach to take, particularly given that we want to move into the adolescent population and FDA would surely ask us to use the minimum required dose to achieve the efficacy required.

Speaker #4: So, all, all of those dynamics are unfolding alongside the PMR launch and the ongoing launch, in, in IV.

Speaker #3: Thank you.

Speaker #2: So based on all our modeling, we believe we can get the necessary target engagement at 75 milligrams and then deliver the efficacy that you saw in the study, which as you could see with was really very compelling.

Speaker #4: Next question.

Speaker #3: Your next question comes from the line of James Quigley from Goldman Sachs. Please go ahead.

Speaker #15: Hello. Thank you for taking my second question. so just following up on the removal nib, food allergy data from the phase two, that are supporting the, the phase three trial.

Speaker #2: Next question.

Speaker #4: Thank you. We will now take our last question for today. And the last question comes from the line of Steve Scala from TD Securities.

Speaker #15: So what is it in the in the modeling that you saw that makes the 75 milligram, the most appropriate dose given the data we've seen for the 100 milligram and the 25 milligram?

Vasant Narasimhan: Thank you.

Operator: Thank you.

Vasant Narasimhan: Next question.

Vasant Narasimhan: Next question.

Speaker #4: Please go ahead.

Vasant Narasimhan: Your next question comes from the line of James Quigley from Goldman Sachs. Please go ahead.

Operator: Your next question comes from the line of James Quigley from Goldman Sachs. Please go ahead.

Speaker #24: Oh, thank you so much for the follow-up. Slide 25 no longer mentions MFN, whereas the same slide in the Q4 deck did. I'm just curious why.

Speaker #15: Is there a, a bridge between where the efficacy is between the two, or, or, or would the 75 milligram dose have the same, target engagement as, as 100 milligrams?

James Quigley: Hello. Thank you for taking my second question. Just following up on the remibrutinib food allergy data from the phase 2 that are supporting the phase 3 trial. What is it in the modeling that you saw that makes the 75 milligram the most appropriate dose given the data we've seen for the 100 milligram and the 25 milligram? Is there a bridge between where the efficacy is between the two or would the 75 milligram dose have the same target engagement as 100 milligrams?

James Quigley: Hello. Thank you for taking my second question. Just following up on the remibrutinib food allergy data from the phase 2 that are supporting the phase 3 trial. What is it in the modeling that you saw that makes the 75 milligram the most appropriate dose given the data we've seen for the 100 milligram and the 25 milligram? Is there a bridge between where the efficacy is between the two or would the 75 milligram dose have the same target engagement as 100 milligrams?

Speaker #24: I heard your earlier responses to Matthew's questions, but slide 25 suggests that Novartis is increasingly confident in its ability to deal with MFN. And I'm just wondering what has changed as we start 2026.

Speaker #4: that's a great question. So we, we modeled this really carefully based on the full data set that we have. And we do believe that at 75 milligrams, we do have full target engagement.

Speaker #4: And we should be able to achieve efficacy that approaches the 100 milligram dose. But, we've and so we felt like this was a, a reasonable approach to take, particularly given that we wanna move into the adolescent population and FDA would surely ask us to use the minimum required, dose to achieve the efficacy required.

Speaker #24: Thank you.

Speaker #25: Hold on. One second, Steve. We're just trying to get slide 25 up. It's just oh, okay. So I think no sorry. No change in our perspective on MFN.

Vasant Narasimhan: That's a great question. We modeled this really carefully based on the full data set that we have. We do believe that at 75 milligrams we do have full target engagement, and we should be able to achieve efficacy that approaches the 100-milligram dose. We felt like this was a reasonable approach to take, particularly given that we wanna move into the adolescent population, and FDA would surely ask us to use the minimum required dose to achieve the efficacy required. Based on all our modeling, we believe we can get the necessary target engagement at 75 milligrams and then deliver the efficacy that you saw in the study, which, as you could see, was, you know, was really, you know, very compelling. Next question.

Vasant Narasimhan: That's a great question. We modeled this really carefully based on the full data set that we have. We do believe that at 75 milligrams we do have full target engagement, and we should be able to achieve efficacy that approaches the 100-milligram dose. We felt like this was a reasonable approach to take, particularly given that we wanna move into the adolescent population, and FDA would surely ask us to use the minimum required dose to achieve the efficacy required. Based on all our modeling, we believe we can get the necessary target engagement at 75 milligrams and then deliver the efficacy that you saw in the study, which, as you could see, was, you know, was really, you know, very compelling. Next question.

Speaker #4: So based on all our modeling, we believe we can get the necessary target engagement at 75 milligrams and then deliver the efficacy that you saw in the study, which, as you could see, was, you know, was really, you know, very compelling.

Speaker #25: I mean, we fully factored in MFN into the guidance that we've given, both for this year and the five-year period. So that's fully factored in.

Speaker #25: If anything, I think we've gotten even better now in modeling the MFN impact. So we've made clear assumptions on the impact on the existing portfolio of medicines for the Medicaid effect as well as on future launches.

Speaker #4: Next question.

Speaker #3: Thank you. We will now take our last question for today. And the last question comes from the line of Steve Scala from TD Securities.

Speaker #25: A set of assumptions on launch phasing for drugs that have a full MFN effect. And then we'll ultimately, of course, see how this all unfolds.

Speaker #3: Please go ahead.

Speaker #16: Oh, thank you so much for the follow-up. Slide 25 no longer mentions MFN, whereas the same slide in the Q4 deck did. I'm just curious why.

Speaker #25: We also have signed the agreements to allow us to not have an impact from tariffs with the commercial agreement that we've signed with the US government as well as scaling up, as you've seen, our manufacturing plants around the United States to allow us to produce fully in the US for the US.

Speaker #16: I heard your earlier responses to Matthew's questions, but slide 25 suggests that Novartis is increasingly confident in its ability to deal with MFN. And I'm just wondering what has changed as we start 2026.

Vasant Narasimhan: Thank you. We will now take our last question for today, the last question comes from the line of Steve Scala from TD Securities. Please go ahead.

Operator: Thank you. We will now take our last question for today, the last question comes from the line of Steve Scala from TD Securities. Please go ahead.

Speaker #25: Such that we wouldn't expect any tariff impact. So all that to say, I guess at this point, we feel confident enough with MFN that we don't need to mention it anymore.

Steve Scala: Oh, thank you so much for the follow-up. Slide 25 no longer mentions MFN, whereas the same slide in the Q4 deck did. I am just curious why. I heard your earlier responses to Matthew's questions, slide 25 suggests that Novartis is increasingly confident in its ability to deal with MFN, and I am just wondering what has changed as we start 2026. Thank you.

Steve Scala: Oh, thank you so much for the follow-up. Slide 25 no longer mentions MFN, whereas the same slide in the Q4 deck did. I am just curious why. I heard your earlier responses to Matthew's questions, slide 25 suggests that Novartis is increasingly confident in its ability to deal with MFN, and I am just wondering what has changed as we start 2026. Thank you.

Speaker #16: Thank you.

Speaker #4: hold on. What a s one second, Steve. We're just trying to get slide 25 up. Is this okay. So I think no, sorry, no, no change, in our perspective on, on MFN.

Speaker #25: Hence, that's why you're not seeing it on the slides.

Speaker #24: Thank you.

Speaker #2: I think that is all the questions. So thank you all very, very much for engaging discussion. I know we have some follow-ups, but we'll get back to you.

Speaker #4: I mean, we, we don't we fully factored in MFN into the guidance that we've given, both for this year and the five-year period. so that's fully factored in.

Speaker #4: If anything, I think we've gotten even better now in modeling the MFN impact. So we've made clear assumptions on the impact on the existing portfolio of medicines for the Medicaid effect, as well as on future launches.

Vasant Narasimhan: Hold on one second, Steve. We're just trying to get slide 25 up. I think no sorry, no change in our perspective on MFN. I mean, we've fully factored in MFN into the guidance that we've given both for this year and the 5-year period. That's fully factored in. If anything, I think we've gotten even better now at modeling the MFN impact. We've made clear assumptions on the impact on the existing portfolio of medicines for the Medicaid effect as well as on future launches, a set of assumptions on launch phasing for drugs that have a full MFN effect. We'll ultimately, of course, see how this all unfolds.

Vasant Narasimhan: Hold on one second, Steve. We're just trying to get slide 25 up. I think no sorry, no change in our perspective on MFN. I mean, we've fully factored in MFN into the guidance that we've given both for this year and the 5-year period. That's fully factored in. If anything, I think we've gotten even better now at modeling the MFN impact. We've made clear assumptions on the impact on the existing portfolio of medicines for the Medicaid effect as well as on future launches, a set of assumptions on launch phasing for drugs that have a full MFN effect. We'll ultimately, of course, see how this all unfolds.

Speaker #4: A set of assumptions on launch phasing, for drugs that have a, a full MFN effect. And then we'll ultimately, of course, see how this all unfolds.

Speaker #4: We have also signed the agreements to allow us to not have an impact from tariffs, with the commercial agreement that we've signed with the US government, as well as scaling up, as you've seen, our manufacturing plants around the United States to allow us to produce fully in the US for the US.

Speaker #4: Such that we wouldn't have, expect any tariff impact. So all that to say, I guess at this point, we feel confident enough with MFN that we don't need to mention it anymore.

Vasant Narasimhan: We also have signed the agreements to allow us to not have an impact from tariffs, with the commercial agreement that we've signed with the US government, as well as scaling up, as you've seen, our manufacturing plants around the United States to allow us to produce fully in the US for the US such that we wouldn't expect any tariff impact. All that to say, I guess at this point we feel confident enough with MFN that we don't need to mention it anymore. Hence, that's why you're not seeing it on the slides.

Vasant Narasimhan: We also have signed the agreements to allow us to not have an impact from tariffs, with the commercial agreement that we've signed with the US government, as well as scaling up, as you've seen, our manufacturing plants around the United States to allow us to produce fully in the US for the US such that we wouldn't expect any tariff impact. All that to say, I guess at this point we feel confident enough with MFN that we don't need to mention it anymore. Hence, that's why you're not seeing it on the slides.

Speaker #4: hence, that's why you're not seeing it on the slides.

Speaker #16: Thank you.

Speaker #4: I think that is all the questions. So thank you all very, very much for, engaging discussion. I know we have some follow-ups, but we'll get back to you.

Speaker #4: we appreciate your time as always. And we'll look forward to keeping you up to date, in the months ahead. Have a great day.

Steve Scala: Thank you.

Steve Scala: Thank you.

Vasant Narasimhan: I think that is all the questions. Thank you all very much for an engaging discussion. I know we have some follow-ups, we'll get back to you. We appreciate your time as always, and we'll look forward to keeping you up to date in the months ahead. Have a great day.

Vasant Narasimhan: I think that is all the questions. Thank you all very much for an engaging discussion. I know we have some follow-ups, we'll get back to you. We appreciate your time as always, and we'll look forward to keeping you up to date in the months ahead. Have a great day.

Vasant Narasimhan: Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.

Operator: Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.

Q1 2026 Novartis AG Earnings Call

Demo
NVS

Novartis

Earnings

Q1 2026 Novartis AG Earnings Call

NVS

Tuesday, April 28th, 2026 at 12:00 PM

Transcript

No Transcript Available

No transcript data is available for this event yet. Transcripts typically become available shortly after an earnings call ends.

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