Q2 2024 Novartis AG Earnings Call

July 18, 2024

Operator: Good morning and good afternoon, and welcome to the Novartis Q2 2024 Results Release Conference Call and Live Webcast. Please note that during the presentation all participants will be in a listen-only mode and the conference is being recorded. After the presentation, there'll be an opportunity to ask questions by pressing star one and one at any time during the conference. Please limit yourself to one question and return to the queue for any follow-ups. A recording of the conference call, including the Q&A session, will be available on our website shortly after the call ends. With that, I would like to hand over to Ms. Sloan Simpson, Head of Investor Relations. Please go ahead, madam.

Speaker Change: Good morning and good afternoon and welcome to the Novartis Q2 2024 results release conference call and live webcast.

Speaker Change: Please note that during the presentation, all participants will be in a listen-only mode and the conference is being recorded. After the presentation, there will be an opportunity to ask questions by pressing star 1 and 1 at any time during the conference.

Speaker Change: Please limit yourself to one question and return to the queue for any follow-ups. A recording of the conference call, including the Q&A session, will be available on our website shortly after the call ends. With that, I would like to hand over to Miss Sloan Simpson, Head of Investor Relations. Please go ahead, madam.

Sloan Simpson: Thank you, operator. Good morning and good afternoon, everyone.

Sloan Simpson: Thank you, operator. Good morning and good afternoon, everyone. Thank you for joining our Q2 2024 earnings call. The information presented today contains 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. For a description of some of these factors, please refer to the company's Form 20-F and its most recent quarterly results on Form 6-K that recently were filed with and furnished to the US Securities and Exchange Commission. I'd also like to remind everyone to please limit yourself to one question, and we'll cycle through the queue as many times as we can. With that, I will hand across to Vas.

Sloan Simpson: Thank you for joining us for our Q2 2024 Earnings Call. The information presented today contains 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. For a description of some of these factors, please refer to the company's Form 20-F and its most recent quarterly results on Form 6-K, which were recently filed with and furnished to the U.S. Securities and Exchange Commission. I'd also like to remind everyone to please limit yourself to one question, and we'll cycle through the queue as many times as we can.

Speaker Change: Thank you, operator. Good morning and good afternoon, everyone. Thank you for joining our Q2 2024 earnings call.

Speaker Change: The information presented today contains forward-looking statements that involve known and unknown risks, uncertainties, and other factors.

Speaker Change: These may cause actual results to be materially different from any future results, performance, or achievements expressed or implied by such statements.

Speaker: For a description of some of these factors, please refer to the company's Form 20-F and its most recent quarterly results on Form 6-K, which were recently filed with and furnished to the U.S. Securities and Exchange Commission. I'd also like to remind everyone to please limit themselves to one question, and we'll cycle through the queue as many times as we can. And with that, I will hand the floor over to Beth.

For a description of some of these factors, please refer to the company's Form 20-F and its most recent quarterly results on Form 6-K, which were recently filed with and furnished to the U.S. Securities and Exchange Commission. I'd also like to remind everyone to please limit themselves to one question, and we'll cycle through the queue as many times as we can.

Speaker Change: For a description of some of these factors, please refer to the company's Form 20-F and its most recent quarterly results on Form 6-K, which were filed with and furnished to the U.S. Securities and Exchange Commission.

Speaker Change: I'd also like to remind everyone to please limit yourself to one question and we'll cycle through the queue as many times as we can.

Sloan Simpson: And with that, I will hand across to Vas.

Vasant Narasimhan: Thank you, Sloan and thank you, everyone, for joining today's conference call. With me on the call--as always--is our CFO, Harry Kirsch. So, starting with slide four, as you saw in quarter two, we continued the strong growth performance at Novartis, which gives us conviction that we are well on track to deliver our 5% plus sales growth up to 2028 and our 40% margin target. You saw that sales for the quarter were up 11% in constant currency, core operating income up 19%, and our core margin reached 39.6%, reflecting our outstanding productivity programs but also as a consequence of our strong sales growth.

Vasant Narasimhan: Thank you, Sloan and thank you, everyone, for joining today's conference call. With me on the call--as always--is our CFO, Harry Kirsch.

Vasant Narasimhan: Thank you, Sloan, and thank you everyone for joining today's conference call. With me on the call, as always, is our CFO, Harry Kirsch. Starting with slide four. As you saw in Q2, we continued the strong growth performance at Novartis, which gives us conviction that we are well on track to deliver our 5%+ sales growth out to 2028 and our 40% margin target in 2027. You saw that sales on the quarter were up 11% in constant currency. Core operating income up 19%. Our core margin reached 39.6%, reflecting our outstanding productivity programs, but also as a consequence of our strong sales growth.

Voss: And with that, I will hand across to Voss.

Voss: Thank you Sloan and thank you everyone for joining today's conference call. With me on the call as always is our CFO Harry Kirsch.

Vasant Narasimhan: So, starting with slide four, as you saw in quarter two, we continued the strong growth performance at Novartis, which gives us conviction that we are well on track to deliver our 5% plus sales growth up to 2028 and our 40% margin target in 2027. You saw that sales on the quarter were up 11% in constant currency, core operating income up 19%; our core margin reached 39.6%, reflecting our outstanding productivity programs but also as a consequence of our strong sales growth. In addition, we had important innovation highlights in the quarter, which we'll review over the course of the call. But some of the really important ones included the SCEMBLIX first-line CML FDA submission; updated KISQALI NATALEE data, which we think really support the outstanding profile of KISQALI in the adjuvant setting in the early breast cancer setting and we're looking forward to presenting that outstanding data at an upcoming medical congress and continuing to build out our renal portfolio with the ATRASENTAN submission, as well as our broader portfolio of presentations at the recent ERA meetings. Taken together, this allowed us to upgrade our full year 2024 core operating income guidance. Harry will go through that in more detail.

Speaker Change: So starting with slide four, as you saw in quarter two, we continued the strong growth performance at Novartis, which gives us conviction that we are well on track to deliver our 5% plus sales growth up to 2028 and our 40% margin target in 2021.

Speaker Change: 2027.

Speaker Change: You saw that sales on the quarter were up 11% in constant currency, core operating income up 19%, our core margin reached 39.6%, reflecting our outstanding productivity programs, but also as a consequence of our strong sales growth.

Beth: In addition, we had important innovation highlights in the quarter, which we'll review over the course of the call, but some of the really important ones included Assembly's first-line CML FDA submission, and updated Kisgali-Natalie data, which we think really support the outstanding profile of Kisgali in the adjuvant setting, in the early breast cancer setting, and we're looking forward to presenting that outstanding data at an upcoming medical And continuing to build out our renal portfolio with the after-sentence submission as well as our broader portfolio of presentations at the recent ERA meeting. Taken together, this allowed us to upgrade our full year 2024 Core Operating Income guidance. Harry will go through that in more detail.

Vasant Narasimhan: In addition, we had important innovation highlights in the quarter, which we'll review over the course of the call. Some of the really important ones included Scemblix first-line CML FDA submission, updated Kisqali NATALEE data, which we think really support the outstanding profile of Kisqali in the adjuvant setting, in the early breast cancer setting, and we're looking forward to presenting that outstanding data at an upcoming medical congress, and continuing to build out our renal portfolio with the atrasentan submission, as well as our broader portfolio of presentations at the recent ERA meetings. Taken together, this allowed us to upgrade our full-year 2024 core operating income guidance. Harry will go through that in more detail. Now moving to slide 5. Our Q2 growth was broad-based, and we had strong contributions from multiple of our outstanding growth drivers.

Speaker Change: In addition, we had important innovation highlights in the quarter, which we'll review over the course of the call. But some of the really important ones included Assembly's first-line CML FDA submission,

Vasant Narasimhan: But some of the really important ones included the SCEMBLIX first-line CML FDA submission; updated KISQALI NATALEE data, which we think really support the outstanding profile of KISQALI in the adjuvant setting in the early breast cancer setting and we're looking forward to presenting that outstanding data at an upcoming medical congress and continuing to build out our renal portfolio with the ATRASENTAN submission, as well as our broader portfolio of presentations at the recent ERA meetings. Taken together, this allowed us to upgrade our full year 2024 core operating income guidance. Harry will go through that in more detail.

Speaker Change: Updated Kisgali-Natalie data, which we think really support the outstanding profile of Kisgali in the adjuvant setting, in the early breast cancer setting, and we're looking forward to presenting that outstanding data at an upcoming medical congress.

Speaker Change: And continuing to build out our renal portfolio with the after-sentence submission, as well as our broader portfolio of presentations at the recent ERA meetings.

Harry Kirsch: Taken together, this allowed us to upgrade our full year 2024 Core Operating Income Guidance. Harry will go through that in more detail.

Beth: Now moving to slide five. Our Q2 growth was broad-based, and we had strong contributions from multiple of our outstanding growth drivers. Importantly, Cosimta was off to a really outstanding start earlier in the year and continued that momentum. Kisgali also continued its strong momentum. Cosentix, with the recent launches, continues to grow in a robust way. We saw steady growth in Fluvicto, strong growth in Letvio, and Semblix, and, taken together, a 37% constant currency growth, which we expect to continue. Now, taking each one of these brands in turn, step by step, Entresta delivered 28% growth in quarter two, and we continue to have high confidence we will exceed our $7 billion peak sales guidance for this medicine. That growth was driven by all our core geographies.

Vasant Narasimhan: Now, moving to slide five. Our Q2 growth was broad-based and we had strong contributions from multiple of our outstanding growth drivers. Importantly, KESIMPTA was off to a really outstanding start earlier in the year and continued that momentum; KISQALI also continued its strong momentum; COSENTYX, with the recent launches, continues to grow in a robust way; we saw steady growth in PLUVICTO, strong growth in LEQVIO and SCEMBLIX and taken together, they're a 37% constant currency growth, which we expect to continue.

Harry Kirsch: Now moving to slide five.

Harry Kirsch: Our Q2 growth was broad-based, and we had strong contributions from multiple of our outstanding growth drivers.

Vasant Narasimhan: Importantly, Kisqali was also a really outstanding start earlier in the year and continued that momentum. Kisqali also continued its strong momentum. Cosentyx, with the recent launches, continues to grow in a robust way. We saw steady growth in Plerixafor, strong growth in Leqvio and Scemblix, and taken together, 37% constant currency growth, which we expect to continue. Now taking each one of these brands in turn, step by step, Entresto delivered 28% growth in Q2, and we continue to have high confidence we will exceed our $7 billion peak sales guidance for this medicine. That growth was driven by all our core geographies. You can see here in the middle panel, US weekly TRX reached another record high. That 25% growth was fueled by consistent demand across the various segments that we compete in.

Harry Kirsch: Importantly, Cosimta was also a really outstanding start earlier in the year and continued that momentum.

Harry Kirsch: Kisgali also continued its strong momentum. Cosentix, with the recent launches, continues to grow in a robust way. We saw steady growth in Pluvikto, strong growth in Letvio and Semblix, and taken together, a 37% constant currency growth, which we expect to continue.

Beth: Cosentix, with the recent launches, continues to grow in a robust way. We saw steady growth in Fluvicto, strong growth in Letvio, and Semblix, and, taken together, a 37% constant currency growth, which we expect to continue. Now, taking each one of these brands in turn, step by step, Entresta delivered 28% growth in quarter two, and we continue to have high confidence we will exceed our $7 billion peak sales guidance for this medicine. That growth was driven by all our core geographies.

Vasant Narasimhan: Now, taking each one of these brands in turn, step by step, ENTRESTO delivered 28% growth in quarter two and we continue to have high confidence we will exceed our $7 billion peak sales guidance for this medicine. That growth was driven by all our core geographies--you can see here in the middle panel that U.S. weekly TRx reached another record high. That 25% growth was fueled by consistent demand across the various segments that we compete in. Outside of the U.S., growth was 30%--with strong contributions from China and Japan, where we continue to see momentum from ENTRESTO in heart failure but importantly, as well as in hypertension. So, we remain confident in the continued sustained performance of the medicine. For forecasting purposes, we continue to assume an ENTRESTO LOE in mid-2025, however, we continue to enforce our patents and litigate our patents and we'll ensure that we maximize this brand for as long as possible in the United States, alongside EU RDP in November 2026. Then, moving to slide seven, Cosentix grew at 22% in the quarter. This is fueled by our new launches, and I think importantly, if you take a step back, puts us well on our trajectory to reach $7 billion plus peak sales for Cosentix. When you look at demand growth by geography, the U.S. grew 34%, driven by volume.

Vasant Narasimhan: Now, taking each one of these brands in turn, step-by-step, ENTRESTO delivered 28% growth in quarter two and we continue to have high confidence we will exceed our $7 billion peak sales guidance for this medicine. That growth was driven by all our core geographies--you can see here in the middle panel that U.S. weekly TRx reached another record high. That 25% growth was fueled by consistent demand across the various segments that we compete in. Outside of the U.S., growth was 30%--with strong contributions from China and Japan, where we continue to see momentum from ENTRESTO in heart failure but importantly, as well as in hypertension.

Harry Kirsch: So taking each one of these brands in turn, step by step, Entresto delivered 28% growth in quarter two. If we continue to have high confidence, we will exceed our $7 billion peak sales guidance for this medicine.

Beth: You can see here in the middle panel that U.S. weekly TRX reached another record high. That 25% growth was fueled by consistent demand across the various segments that we competed in. Outside of the U.S., growth was 30%, with strong contributions from China and Japan, where we continue to see momentum from Entresta in heart failure, but importantly, as well in hypertension. So we remain confident in the continued sustained performance of the medicine. For forecasting purposes, we continue to assume an Entresto LOE in mid 2025.

Harry Kirsch: That growth was driven by all our core geographies. You can see here in the middle panel, U.S. weekly TRX reached another record high. That 25 percent growth was fueled by consistent demand across the various segments that we That 25 percent growth was fueled by consistent demand across the various segments that we

Vasant Narasimhan: Outside of the US, growth was 30%, with strong contribution from China and Japan, where we continue to see momentum from Entresto in heart failure, but importantly as well in hypertension. We remain confident in the continued sustained performance of the medicine. For forecasting purposes, we continue to assume an Entresto LOE in mid-2025. However, we continue to enforce our patents and litigate our patents, and we'll ensure that we maximize this brand for as long as possible in the United States, alongside EU RDP in November 2026. Moving to slide seven. Cosentyx grew at 22% in the quarter. This is fueled by our new launches. I think importantly, if you take a step back, puts us well on our trajectory to reach $7 billion+ peak sales for Cosentyx.

Harry Kirsch: Outside of the U.S., growth was 30%, with strong contribution from China and Japan, where we continue to see momentum from Entresto in heart failure, but importantly as well in hypertension.

Vasant Narasimhan: So, we remain confident in the continued sustained performance of the medicine. For forecasting purposes, we continue to assume an ENTRESTO LOE in mid-2025, however, we continue to enforce our patents and litigate our patents and we'll ensure that we maximize this brand for as long as possible in the United States, alongside EU RDP in November 2026.

Harry Kirsch: So we remain confident in the continued sustained performance of the medicine.

Harry Kirsch: For forecasting purposes, we continue to assume an Entresto LOE in mid-2025. However, we continue to enforce our patents and litigate our patents, and we'll ensure that we maximize this brand for as long as possible in the United States, alongside EU RDP in November 2026.

Beth: However, we continue to enforce our patents and litigate our patents and will ensure that we maximize this brand for as long as possible in the United States, alongside EU RDP in November of 2026. Then, moving to slide seven, Cosentix grew at 22% in the quarter. This is fueled by our new launches, and I think importantly, if you take a step back, puts us well on our trajectory to reach $7 billion plus peak sales for Cosentix. When you look at demand growth by geography, the U.S. grew 34%, driven by volume.

Vasant Narasimhan: Then, moving to slide seven, COSENTYX grew at 22% in the quarter. This is fueled by our new launches and I think importantly, if you take a step back, puts us well on our trajectory to reach $7 billion+ of our peak sales for COSENTYX. When you look at the demand growth by geography, the U.S. grew 34%, driven by volume; ex-U.S., we were up 10%. And this was partially offset by one-time pricing effects due in Germany, in particular, due to the addition of additional new indication. Normal part of the German process--as you get additional indications, you do see price adjustments. We see COSENTYX doing very well in its core indications--I think one important dynamic is the strong launch in HS is supporting us in our core indications of psoriasis, PsA and AS. We're the number one IL-17 in the U.S. dynamic market, the lead originator biologic in Europe and China. In HS, we're seeing very strong uptake, with market leadership share over 60% in the NBRx; in Germany, we're over 50%.

Speaker Change: We're moving to slide seven.

Speaker Change: Cosentix grew at 22% in the quarter. This is fueled by our new launches, and I think, importantly, if you take a step back, puts us well on our trajectory to reach $7 billion plus peak sales for Cosentix.

Beth: Ex-U.S., we were up 10%. And this was partially offset by one-time pricing effects due in Germany, in particular due to the addition of additional new indications, a normal part of the German process. As you get additional indications, you do see price adjustments. We see Cosensics doing very well in its core indications. I think what an important dynamic is that the strong launch in HS is supporting us in our core indications of psoriasis, PSA, and AS.

Vasant Narasimhan: When you look at the demand growth by geography, the US grew 34% driven by volume. Ex-US, we were up 10%, and this was partially offset by one-time pricing effects, due in Germany in particular, due to the addition of an additional new indication, normal part of the German process. As you get additional indications, you do see price adjustments. We see Cosentyx doing very well in its core indications. I think one important dynamic is the strong launch in HS is supporting us in our core indications of psoriasis, PSA, and AS. We're the number one IL-17 in the US dynamic market, the lead originator biologic in Europe and China. In HS, we're seeing very strong uptake with market leadership, share over 60% in the NBRX. In Germany, we're over 50%.

Speaker Change: When you look at the demand growth by geography, the U.S. grew 34%, driven by volume. Ex-U.S., we were up 10%. And this was partially offset by one-time pricing effects, due in Germany in particular, due to the addition of additional new indications, normal part of the German process, as you get additional indications, you do see.

Vasant Narasimhan: We see COSENTYX doing very well in its core indications--I think one important dynamic is the strong launch in HS is supporting us in our core indications of psoriasis, PsA and AS. We're the number one IL-17 in the U.S. dynamic market, the lead originator biologic in Europe and China. In HS, we're seeing very strong uptake, with market leadership share over 60% in the NBRx; in Germany, we're over 50%. And I think importantly, with the launch of COSENTYX, we're seeing increased diagnosis and desire to treat amongst physicians and patients--which I think will allow the HS market to grow to larger than it's historically been and, of course, allow COSENTYX to help these patients achieve their treatment goals. For COSENTYX IV, we saw solid adoption with over 700 accounts now ordering and we do expect further demand increases in the second half, now that we have a permanent J-code in effect as of July 1.

Speaker Change: Price Adjustments.

Speaker Change: We see Cosensics doing very well in its core indications. I think what important dynamic is the strong launch in HS is supporting us.

Vasant Narasimhan: We're the number one IL-17 in the U.S. dynamic market, the lead originator biologic in Europe and China. In HS, we're seeing very strong uptake, with market leadership share over 60% in the NBRx; in Germany, we're over 50%. And I think importantly, with the launch of COSENTYX, we're seeing increased diagnosis and desire to treat amongst physicians and patients--which I think will allow the HS market to grow to larger than it's historically been and, of course, allow COSENTYX to help these patients achieve their treatment goals. For COSENTYX IV, we saw solid adoption with over 700 accounts now ordering and we do expect further demand increases in the second half, now that we have a permanent J-code in effect as of July 1.

Beth: We're the number one IL-17 in the U.S. dynamic market, and the lead originator biologic in Europe and China. In HS, we're seeing a very strong uptake with market leadership share over 60% in NBRX. In Germany, we're over 50%.

Speaker Change: in our four indications of psoriasis, PSA, and AS. We're the number one IL-17 in the U.S. dynamic market, the lead originator biologic in Europe and China.

Speaker Change: In H.S., we're seeing a very strong uptake with market leadership share over 60% in the NBRX. In Germany, we're over 50%.

Vasant Narasimhan: And I think importantly, with the launch of COSENTYX, we're seeing increased diagnosis and desire to treat amongst physicians and patients--which I think will allow the HS market to grow to larger than it's historically been and, of course, allow COSENTYX to help these patients achieve their treatment goals. For COSENTYX IV, we saw solid adoption with over 700 accounts now ordering and we do expect further demand increases in the second half, now that we have a permanent J-code in effect as of July 1.

Beth: And I think importantly, with the launch of COSENTYX, we're seeing increased diagnosis and desire to treat amongst physicians and patients--which I think will allow the HS market to grow to larger than it's historically been and, of course, allow COSENTYX to help these patients achieve their treatment goals. For COSENTYX IV, we saw solid adoption with over 700 accounts now ordering and we do expect further demand increases in the second half, now that we have a permanent J-code in effect as of July 1. So, moving to slide eight. KESIMPTA also delivered, as I mentioned, a very strong quarter two--65% growth. This was broad-based in terms of its geographic growth profile.

And I think importantly, with the launch of COSENTYX, we're seeing increased diagnosis and desire to treat amongst physicians and patients--which I think will allow the HS market to grow to larger than it's historically been and, of course, allow COSENTYX to help these patients achieve their treatment goals. For COSENTYX IV, we saw solid adoption with over 700 accounts now ordering and we do expect further demand increases in the second half, now that we have a permanent J-code in effect as of July 1.

Vasant Narasimhan: I think importantly with the launch of Cosentyx, we're seeing increased diagnosis and desire to treat amongst physicians and patients, which I think will allow the HS market to grow to larger than it's historically been, and of course, allow Cosentyx to help these patients achieve their treatment goals. For Cosentyx IV, we saw solid adoption with over 700 accounts now ordering. We do expect further demand increases in the H2 now that we have a permanent J-code in effect as of July 1. Moving to slide 8. Kisqali also delivered, as I mentioned, a very strong Q2, 65% growth. This was broad-based in terms of its geographic growth profile. Over 100,000 patients have now been treated worldwide, naive or first switch with Kisqali. In the US, we saw 49% growth.

Speaker Change: And I think importantly with the launch of Cosentix, we're seeing increased diagnosis and desire to treat amongst physicians and patients, which I think will allow the HS market to grow to larger than it's historically been, and of course, allow Cosentix to help these patients achieve their treatment goals.

Vasant Narasimhan: For COSENTYX IV, we saw solid adoption with over 700 accounts now ordering and we do expect further demand increases in the second half, now that we have a permanent J-code in effect as of July 1.

Speaker Change: For Cosentix IV, we saw solid adoption with over 700 accounts now ordering, and we do expect further demand increases in the second half now that we have a permanent J-code in effect as of July 1.

So, moving to slide eight. KESIMPTA also delivered, as I mentioned, a very strong quarter two--65% growth. This was broad-based in terms of its geographic growth profile. Over 100,000 patients have now been treated worldwide, either naive or first switched to Cosimta. In the U.S., we saw 49% growth. This demand growth was driven by TRX volume of 43% versus prior year. We gained 4% market share overall in the segment. Outside of the U.S., we have NBRX leadership in 7 out of 10 major markets. So looking forward, we feel confident we will exceed our Cosimta $4 billion guidance, and peak sales guidance. We see a strong trajectory for this brand. Its profile is unique, self-administered B-cell treatment option, one minute a month dosing, no steroid pretreatment required, and an attractive safety profile with respect to injection site reaction. Persistence and adherence we're seeing in the real-world setting are comparable to infused B-cell therapies. We also continue to generate data that support the strong efficacy profile of this medicine. Now, to move to slide nine.

Vasant Narasimhan: So, moving to slide eight. KESIMPTA also delivered, as I mentioned, a very strong quarter two--65% growth. This was broad-based in terms of its geographic growth profile. Over 100,000 patients have now been treated worldwide, naive or first switch with KESIMPTA. In the U.S., we saw 49% growth. This demand growth was driven by TRx volume of 43% versus prior year. We gained 4% market share overall in the segment. Outside of the U.S., we have NBRx leadership in 7 out of 10 major markets. So, looking forward, we feel confident we will exceed our KESIMPTA $4 billion guidance--peak sales guidance. We see strong trajectory for this brand. Its profile is unique: self-administered B-cell treatment option, one minute a month dosing, no steroid pretreatment required, an attractive safety profile with respect to injection site reaction. Persistence and adherence we're seeing in the real-world setting is comparable to infused B-cell therapies. We also continue to generate data which support a strong efficacy profile of this medicine.

Speaker Change: So moving to slide 8, Cosimta also delivered, as I mentioned, a very strong quarter 2, 65% growth. This was broad-based in terms of its geographic growth profile. Over 100,000 patients have now been treated worldwide, Naive or First Switch with Cosimta.

Beth: Over 100,000 patients have now been treated worldwide, either naive or first switched to Cosimta. In the U.S., we saw 49% growth. This demand growth was driven by TRX volume of 43% versus prior year.

Vasant Narasimhan: This demand growth was driven by TRX volume of 43% versus prior year. We gained 4% market share overall in segment. Outside of the US, we have NBRX leadership in 7 out of 10 major markets. Looking forward, we feel confident we will exceed our Kisqali $4 billion peak sales guidance. We see strong trajectory for this brand. Its profile is unique. Self-administered B-cell treatment option, 1 minute a month dosing, no steroid pretreatment required, an attractive safety profile with respect to injection site reactions. Persistence and adherence we're seeing in the real-world setting is comparable to infused B-cell therapies. We also continue to generate data which support the strong efficacy profile of this medicine. Moving to slide nine.

Speaker Change: In the U.S., we saw 49% growth. This demand growth was driven by TRX volume of 43% versus prior year. We gained 4% market share overall in the segment.

Beth: We gained 4% market share overall in the segment. Outside of the U.S., we have NBRX leadership in 7 out of 10 major markets. So looking forward, we feel confident we will exceed our Cosimta $4 billion guidance, and peak sales guidance. We see a strong trajectory for this brand. Its profile is unique, self-administered B-cell treatment option, one minute a month dosing, no steroid pretreatment required, and an attractive safety profile with respect to injection site reaction.

Speaker Change: Outside of the U.S., we have NBRX leadership in 7 out of 10 major markets.

Vasant Narasimhan: So, looking forward, we feel confident we will exceed our KESIMPTA $4 billion guidance--peak sales guidance. We see strong trajectory for this brand. Its profile is unique: self-administered B-cell treatment option, one minute a month dosing, no steroid pretreatment required, an attractive safety profile with respect to injection site reaction. Persistence and adherence we're seeing in the real-world setting is comparable to infused B-cell therapies. We also continue to generate data which support a strong efficacy profile of this medicine.

Speaker Change: So, looking forward, we feel confident we will exceed our $4 billion guidance, peak sales guidance. We seek strong trajectory for this brand. Its profile is unique. Self-administered B-cell treatment option. One minute a month dosing. No steroid pretreatment required. An attractive safety profile with respect to injection site reactions.

Beth: Persistence and adherence we're seeing in the real-world setting are comparable to infused B-cell therapies. We also continue to generate data that support the strong efficacy profile of this medicine. Now, to move to slide nine.

Speaker Change: Persistence and adherence we're seeing in the real world setting is comparable to infused B cell therapies. We also continue to generate data which support the strong efficacy profile of this medicine.

Vasant Narasimhan: To move to slide nine. KISQALI grew 50% in the metastatic setting, with now leading--or continued leading--NBRx share in the U.S. and ex-U.S. As you know, KISQALI has an outstanding data profile in the metastatic breast cancer setting that's really supporting us consistently now around the world. In the U.S., we saw 67% growth where we gained widespread adoption. We have a leading share now, an NBRx share of 47%; 7,000 HCPs are now prescribing and that provides us with a very strong base of physicians which we can leverage as we move to the early breast cancer launch. Similarly, outside of the U.S., 35% growth at the preferred CDK4/6 inhibitor, we have a leading share of 38%.

Beth: Kisgali grew 50% in the metastatic setting, with now leading or continued leading NB-Rx share in the U.S. and ex-U.S. As you know, Kisgali has an outstanding data profile in the metastatic breast cancer setting that's really supporting us consistently now around the world. In the U.S., we saw 67% growth where we gained widespread adoption. We have a leading share now, an NB-Rx share of 47%, 7,000 HDPs are now prescribing, and that provides us with a very strong base of physicians which we can leverage as we move to the early breast cancer line. Similarly, outside of the U.S., 35% growth at the preferred CDK4-6 inhibitor, while we have a leading share of 38%.

Vasant Narasimhan: Kisqali grew 50% in the metastatic setting and with now leading or continued leading NBRX share in the US and ex-US. You know, as you know, Kisqali has an outstanding data profile in the metastatic breast cancer setting that's really supporting us consistently now around the world. In the US, we saw 67% growth, where we gained widespread adoption. We have a leading share now, NBRX share of 47%, 7,000 HCPs now prescribing, and that provides us a very strong base of physicians which we can leverage as we move to the early breast cancer launch. Similarly, outside of the US, 35% growth as the preferred CDK4/6 inhibitor. We have a leading share of 38%. We're the fastest growing CDK4/6 inhibitor in Europe. When you look at the early breast cancer setting, we're on track now for a launch in H2.

Speaker Change: So moving to slide nine.

Speaker Change: Because Cali grew 50% in the metastatic setting, with now leading or continued leading NBRX share in the US and ex-US,

Speaker Change: As you know, Kiskele has an outstanding data profile in the metastatic breast cancer setting that's really supporting us consistently now around the world.

Speaker Change: In the U.S. we saw 67% growth, where we gained widespread adoption. We have a leading share now, NBRX share, of 47%, 7,000 HCPs now prescribing, and that provides us a very strong base of physicians, which we can leverage as we move to the early breast cancer launch.

Vasant Narasimhan: Similarly, outside of the U.S., 35% growth at the preferred CDK4/6 inhibitor--we have a leading share of 38%. We're the fastest-growing CDK4/6 inhibitor in Europe. And when you look at the early breast cancer setting, we're on track now for a launch in half two. We've completed the manufacturing adjustments in close collaboration with FDA, which we outlined earlier in the year. We're now anticipating a U.S. approval by the end of quarter three. We remain confident in a broad label based on the consistency of results that we've seen across the NATALEE population.

Speaker Change: Similarly, outside of the U.S., 35% growth at the preferred CDK4-6 inhibitor, we have a leading share of 38%. We're the fastest-growing CDK4-6 inhibitor in Europe .

Beth: We're the fastest-growing CDK4-6 inhibitor in Europe, and when you look at the early breast cancer setting, we're on track now for a launch in half two. We've completed the manufacturing adjustments in close collaboration with FDA, which we outlined earlier in the year. We're now anticipating U.S. approval by the end of quarter three. We remain confident in a broad label based on the consistency of results that we've seen across the Nathalie population.

Vasant Narasimhan: When you look at the early breast cancer setting, we're on track now for a launch in H2.

Speaker Change: And when you look at the early breast cancer setting, we're on track now for a launch in half two. We've completed the manufacturing adjustments in close collaboration with FDA, which we outlined earlier in the year. We're now anticipating a U.S. approval by the end of quarter three.

Vasant Narasimhan: We've completed the manufacturing adjustments in close collaboration with FDA, which we outlined earlier in the year. We're now anticipating a US approval by the end of Q3. We remain confident in a broad label based on the consistency of results that we've seen across the NATALEE population. As we announced this morning, we have now updated NATALEE data with a median follow-up of four years. All patients have now completed their three-year course of the medicine, and we see continued clinically meaningful benefit, consistent safety profile. We believe very compelling results that will really support the launch of this medicine. We're really excited to present that data at an upcoming medical meeting and continue to support that Kisqali will hopefully be the preferred medicine for patients with early breast cancer. Now moving to slide 10.

Speaker Change: We remain confident in a broad label based on the consistency of results that we've seen across the Natalie population.

Vasant Narasimhan: And as we announced this morning, we have now updated NATALEE data with a median follow-up of four years--all patients have now completed their three-year course of the medicine. And we see continued clinically meaningful benefits, consistent safety profiles--we believe very compelling results that will really support the launch of this medicine. And so, we're really excited to present that data at an upcoming medical meeting and continue to support that KISQALI will hopefully be the preferred medicine for patients with early breast cancer. They're moving to slide 10.

Speaker Change: And as we announced this morning, we have now updated NATALIE data with a median follow-up of four years. All patients have now completed their three-year course of the medicine, and we see continued clinically meaningful benefits, consistent safety profiles, and we believe very compelling results that will really support the launch of this medicine.

Speaker Change: And so we're really excited to present that data at an upcoming medical meeting and continue to support that Cascale will hopefully be the preferred medicine for patients with early breast cancer.

Vasant Narasimhan: Then, moving to slide 10. So, PLUVICTO demonstrated very steady growth versus prior year. Now, when you take a step back on PLUVICTO, we're now in a transition point where our early rapid uptake is now transitioning to a place where we need to generate demand in the next wave of centers and then, eventually, out in community oncology--both for the success of PLUVICTO but also for the long-term success of RLT. That said, we remain highly confident in the long-term prospects of PLUVICTO to be a multibillion-dollar medicine across the various segments that we'll compete in.

Beth: So Plovicto demonstrated very steady growth versus the prior year. Now, when you take a step back on Plovicto, we're now in a transition point where our early rapid uptake is now transitioning to a place where we need to generate demand in the next wave of centers and then eventually out in community oncology, both for the success of Plovicto but also for the long-term success of RLT. That said, we remain highly confident in the long-term prospects of Plovicto to be a multibillion-dollar medicine across the various segments that it will compete in.

Vasant Narasimhan: Pluvicto demonstrated very steady growth versus prior year. Now, when you take a step back on Pluvicto, we're now in a transition point where our early rapid uptake is now transitioning to a place where we need to generate demand in the next wave of centers and then eventually out in community oncology, both for the success of Pluvicto, but also for the long-term success of RLT. That said, we remain highly confident in the long-term prospects of Pluvicto to be a multi-billion-dollar medicine across the various segments that it will compete in. We do believe that once we're through this period, we will get back to robust growth, particularly driven by the PSMAfore indication, and later, the HSPC and all the metastatic indications. We had growth, as I mentioned, of 44% on the quarter.

Speaker Change: So moving to slide 10.

Speaker Change: So Plovicto demonstrated very steady growth versus prior year. Now when you take a step back on Plovicto, we're now in a transition point where our early rapid uptake is now transitioning to a place where we need to generate demand in a next wave of centers and then eventually out in community oncology, both for the success of Plovicto but also for the long-term success of RLT.

Speaker Change: That said, we remain highly confident in the long-term prospects of Plavicto to be a multi-billion dollar medicine across the various segments that it will compete in.

Vasant Narasimhan: We do believe that once we're through this period, we will get back to robust growth, particularly driven by the PSMAfore indication and later, the HSPC and oligometastatic indications. We had growth, as I mentioned, of 44% on the quarter. Then, when you look specifically at the VISION population, we estimate our market share is in the mid-30 percentile, with 50% share in established RLT treatment sites. We see a dynamic where the sites where we're well-established, we could have market shares above 90%. We have another group of sites where we're working to go from 50% to 90%. And then, we have a third--about a third of sites of the 475 treatment sites that we're operating in, where we need to now get from 10% of share of the VISION population, hopefully, up over time now to 50%, 90%. That will drive the steady growth that we expect over the course of the coming quarters.

Speaker Change: We do believe that once we're through this period, we will get back to robust growth, particularly driven by the PSMA-4 indication and later the HSPC and oligometastatic indications.

Vasant Narasimhan: Now, when you look specifically at the VISION population, we estimate our market share is in the mid-30s percentile, with 50% share in established RLT treatment sites. We see a dynamic where the sites where we're well-established, we could have market shares above 90%. We have another group of sites where we're working to go from 50% to 90%. Then we have a third, about a third of sites of the 475 treatment sites that we're operating in, where we need to now get from 10% share of the VISION population, hopefully up over time to 50%, 90%. That will drive the steady growth that we expect over the course of the coming quarters.

Speaker Change: We had growth, as I mentioned, of 44% on the quarter. Now, when you look specifically at the vision population,

Speaker Change: We estimate our market share is in the mid-30 percentile, with 50 percent share in established RLT treatment sites.

Vasant Narasimhan: We have another group of sites where we're working to go from 50% to 90%. And then, we have a third--about a third of sites of the 475 treatment sites that we're operating in, where we need to now get from 10% of share of the VISION population, hopefully, up over time now to 50%, 90%. That will drive the steady growth that we expect over the course of the coming quarters. Now, when you look specifically at what we're doing to supercharge PLUVICTO and also enable us to build a broad capacity for the system to take on RLT, we're increasing our U.S. promotional efforts--including a field course expansion, which is now completed. We'll be launching a DTC campaign in quarter three. We'll also have the phased launch of the patient-ready dose--which is a very important, I think, step in that it reduces the time from providing PLUVICTO from around an hour to less than 10 minutes. And this will allow sites to hopefully take on more patients, especially sites that have significant capacity to take on more VISION patients. And then lastly, we have German pricing approved, which is why you've seen the uplift in the ex-U.S. market--ex-U.S. sales profile. So, looking ahead, FDA submission for PSMAfore on track in half two, we already have profiled the positive trend in OS and PSMAfore.

Beth: We see a dynamic where the sites where we're well-established could have market shares above 90%. We have another group of sites where we're working to go from 50% to 90%. And then we have a third, about a third of sites of the 475 treatment sites that we're operating in, where we need to now get from 10% of the vision population, hopefully up over time now to 50, 90%. And that will drive the steady growth that we expect over the course of the coming quarters.

Speaker Change: We see a dynamic where the sites where we're well-established, we could have market shares above 90%.

Speaker Change: We have another group of sites where we're working to go from 50% to 90%, and then we have a third, about a third of sites of the 475 treatment sites that we're operating in, where we need to now get from 10% of share of the vision population, hopefully up over time now to 50, 90%. That will drive

Beth: Now, when you look specifically at what we're doing to supercharge PluVicto and also enable us to build a broad capacity for the system to take on RLT, we're increasing our U.S. promotional efforts, including a field course expansion, which is now completed.

Speaker Change: The steady growth that we expect over the course of the coming quarters.

Vasant Narasimhan: Now, when you look specifically at what we're doing to supercharge Pluvicto and also enable us to build a broad capacity for the system to take on RLT, we're increasing our US promotional efforts, including a field force expansion, which is now completed. We'll be launching a DTC campaign in Q3. We'll also have the phased launch of the patient-ready dose, which is a very important, I think, step, in that it reduces the time from providing Pluvicto from around an hour to less than 10 minutes. This will allow sites to hopefully take on more patients, especially sites that have significant capacity to take on more VISION patients. Lastly, we have German pricing approved, which is why you've seen the uplift in the ex-US market, ex-US sales profile.

Speaker Change: Now, when you look specifically at what we're doing to supercharge PluVicto and also enable us to build a broad capacity for the system to take on RLT, we're increasing our U.S. promotional efforts, including a Field Force expansion, which is now completed. We'll be launching a DTC campaign in Quarter 3.

Vasant Narasimhan: We'll be launching a DTC campaign in quarter three. We'll also have the phased launch of the patient-ready dose--which is a very important, I think, step in that it reduces the time from providing PLUVICTO from around an hour to less than 10 minutes. And this will allow sites to hopefully take on more patients, especially sites that have significant capacity to take on more VISION patients. And then lastly, we have German pricing approved, which is why you've seen the uplift in the ex-U.S. market--ex-U.S. sales profile. So, looking ahead, FDA submission for PSMAfore on track in half two, we already have profiled the positive trend in OS and PSMAfore.

Speaker Change: We'll also have the phase launch of the patient-ready dose, which is a very important, I think, step in that it reduces the time from providing Plovicto from around an hour to less than 10 minutes.

Beth: And this will allow sites to hopefully take on more patients, especially sites that have significant capacity to take on more vision. And then lastly, we have German pricing approved, which is why you've seen the uplift in the ex-U.S. market and the ex-U.S. sales profile. So looking ahead, FDA submission for PSMA-4 on track in half two. We already have profiled the positive trend in O.S. and PSMA-4.

Speaker Change: And this will allow sites to hopefully take on more patients, especially sites that have significant capacity to take on more vision patients.

Speaker Change: And then lastly, we had German pricing approved, which is why you've seen the uplift in the ex-U.S. market, ex-U.S. sales profile.

Vasant Narasimhan: Looking ahead, FDA submission for PSMAfore is on track in H2. We already have profiled the positive trend in OS and PSMAfore. China submission is planned in the second half, and we did do a groundbreaking now for a RLT manufacturing site in China, alongside plans now for also a manufacturing site in Japan. Then PSMA addition and PSMA-DC continue to progress as per plan. Moving to slide eleven. Leqvio had strong growth as well, 134% growth. I think we're seeing step by step, more and more acceptance of the option twice a year medicine to achieve 50% to 60% cholesterol lowering, and that's a trend we're seeing broad-based around the world. We have now 4,200 facilities ordering Leqvio in the US.

Vasant Narasimhan: So, looking ahead, FDA submission for PSMAfore on track in half two--we already have profiled the positive trend in OS and PSMAfore. China submission is planned in the second half and we did do a groundbreaking now for a RLT manufacturing site in China, alongside plans now for also manufacturing sites in Japan. And then, PSMAddition and PSMA-DC continue to progress as per plan. Now, moving to slide 11. LEQVIO had strong growth as well, 134% growth. I think we're seeing step-by-step more and more acceptance of the option to take twice a year medicine to achieve 50 to 60% cholesterol lowering. And that's a trend we're seeing broadly around the world.

Speaker Change: So looking ahead, FDA submission for PSMA-4 on track in half two. We already have profiled the positive trend in OS and PSMA-4.

Beth: China submission is planned in the second half, and we did do a groundbreaking now for a RLT manufacturing site in China, alongside planned some for manufacturing sites in Japan, and then PSMA addition and PSMA DC continue to progress. I'm moving to slide 11. Lectio had strong growth as well, 134% growth. I think we're seeing step-by-step more and more acceptance of the option to take twice a year medicine to achieve 50 to 60% cholesterol lowering. And that's a trend we're seeing broadly around the world.

Speaker Change: China submission is planned in the second half, and we did do a groundbreaking now for a RLT manufacturing site in China, alongside plans for also manufacturing sites in Japan. And in PSMA addition, in PSMA, DC continued to progress as proposed.

Vasant Narasimhan: Now, moving to slide 11. LEQVIO had strong growth as well, 134% growth. I think we're seeing, step-by-step, more and more acceptance of the [inaudible] to take twice-a-year medicine to achieve 50% to 60% cholesterol lowering. And that's a trend we're seeing broad-based around the world. We now have 4,200 facilities ordering LEQVIO in the U.S. We continue to steadily expand our breadth and depth, continue to generate additional data to support the profile of LEQVIO as we move also towards our outcomes trials--two outcomes trials for LEQVIO--as well as continue to progress efforts to move LEQVIO into the frontline setting for cholesterol management. Outside of the U.S., our rollout continues with over 35 countries with reimbursement. strong market growth--24% versus prior year. And so, we feel confident that step-by-step, LEQVIO is also progressing towards its multi-billion dollar goal. We're moving to slide 12.

Vasant Narasimhan: LEQVIO had strong growth as well, 134% growth. I think we're seeing step-by-step more and more acceptance of the option to take twice a year medicine to achieve 50 to 60% cholesterol lowering. And that's a trend we're seeing broadly around the world.

Speaker Change: player.

Speaker Change: The movement is slide 11.

Speaker Change: Lethbio has strong growth as well, 134% growth. I think we're seeing step by step more and more acceptance of the option to take twice a year medicine to achieve 50 to 60 percent cholesterol lowering and that's a trend we're seeing broad based around the world. We have now 4,200 facilities ordering Lethbio in the U.S.

Beth: We now have 4,200 facilities ordering Lectio in the U.S. We continue to steadily expand our breadth and depth, continue to generate additional data to support the profile of Lectio as we move also towards our outcomes trials, two outcomes trials for Lectio, as well as continue to progress efforts to move Lectio into the frontline setting for cholesterol management. Outside of the U.S., our rollout continues with over 35 countries with reimbursement strong and market growth 24% versus prior year. And so we feel confident that step-by-step, Lectio is also progressing towards its multi-billion dollar goal. We're moving to slide 12.

Vasant Narasimhan: We continue to steadily expand our breadth and depth, continue to generate additional data to support the profile of Leqvio as we move also towards our outcomes trials, 2 outcomes trials for Leqvio, as well as continue to progress efforts to move Leqvio into the frontline setting for cholesterol management. Outside of the US, our rollout continues with over 35 countries with reimbursement, strong market growth, 24% versus prior year. We feel confident that step by step, Leqvio also is progressing towards its multi-billion dollar goal. Now moving to slide 12. Semglee's momentum continued in Q2, and I think as you're all aware, we have US market leadership in the third line setting.

Vasant Narasimhan: We continue to steadily expand our breadth and depth, continue to generate additional data to support the profile of LEQVIO as we move also towards our outcomes trials--two outcomes trials for LEQVIO--as well as continue to progress efforts to move LEQVIO into the frontline setting for cholesterol management. Outside of the U.S., our rollout continues with over 35 countries with reimbursement. strong market growth--24% versus prior year. And so, we feel confident that step-by-step, LEQVIO is also progressing towards its multi-billion dollar goal.

Speaker Change: We continue to steadily expand our breadth and depth.

Speaker Change: continue to generate additional data to support the profile of LethBio as we move also towards our outcomes trials, two outcomes trials for LethBio, as well as continue to progress efforts to move LethBio into the frontline setting for cholesterol management. Outside of the U.S., our rollout continues with over 35 countries with reimbursement strong, market growth 24% for its prior year, and so we feel confident that step-by-step LethBio also is progressing towards its multi-billion dollar goal.

Vasant Narasimhan: We're moving to slide 12. SCEMBLIX momentum continued in quarter two and I think, as you're all aware, we have U.S. market leadership in the third-line setting. And most importantly, at ASCO, we presented our outstanding first-line data--which I'll go in a little bit further detail about on the next slide. Now, when you look at the third-line setting, we're the market leader in NBRx and TRx share in the U.S. Outstanding performance as well, we're seeing outside of the United States--TRx and monthly prescribers continue to grow across all geography. One important note for modeling purposes is that shortly, we'll be launching a 100 milligram SKU for the T315I patients--a patient group that requires 400 milligrams of SCEMBLIX--which is about 10 pills per day. They will now be able to take four pills per day. But what that will lead to, is about a $15 million sales that will not repeat in quarter two and quarter three.

Beth: Semblance momentum continued in quarter two, and I think, as you're all aware, we have U.S. market leadership in the third-line setting. And most importantly, at ASCO, we presented our outstanding first-line data, which I'll go into a little bit further detail about on the next slide. Now, when you look at the third-line setting, we're the market leader in NBRX and TRX share in the U.S., with outstanding performance as well. We're seeing outside of the United States.

Speaker Change: We're moving to slide 12.

Speaker Change: Semblance momentum continued in quarter two, and I think, as you're all aware, we have U.S. market leadership in the third-line setting, and most importantly, at ASCO, we presented our outstanding first-line data, which I'll go into a little bit further detail about on the next slide.

Vasant Narasimhan: Most importantly, at ASCO, we presented our outstanding first-line data, which I'll go in a little bit further detail about on the next slide. Now, when you look at the third-line setting, we're the market leader in NBRX and TRX share in the US. Outstanding performance as well, we're seeing outside of the United States. TRX and monthly prescribers continue to grow across all geographies. One important note for modeling purposes is that shortly, we'll be launching a 100-milligram SKU for the T315I patients, a patient group that requires 400 milligrams of Scemblix, which is about 10 pills per day. They'll now be able to take 4 pills per day. What that will lead to is about a $15 million sales that will not repeat in Q2 and Q3.

Speaker Change: next slide. Now when you look at the third line setting where the market leader in NBRX and TRX share in the U.S., outstanding performance as well we're seeing outside of the United States,

Beth: TRX and monthly prescribers continue to grow across all geography. One important note for modeling purposes is that shortly we'll be launching a 100 milligram SKU for the T315I patients, a patient group that requires 400 milligrams of Semblance, which is about 10 pills per day. They will now be able to take four pills per day, but what that will lead to is about $15 million in sales that will not repeat in quarter two and quarter three.

Speaker Change: TRX and monthly prescribers continue to grow across all geographies. One important note for modeling purposes is that shortly we'll be launching 100 mg SKU for the T315I patients, a patient group that requires 400 mg of Semblix, which is about 10 pills per day, they will now be able to take 4 pills per day.

Vasant Narasimhan: One important note for modeling purposes is that shortly, we'll be launching a 100 milligram SKU for the T315I patients--a patient group that requires 400 milligrams of SCEMBLIX--which is about 10 pills per day. They will now be able to take four pills per day. But what that will lead to, is about a $15 million sales that will not repeat in quarter two and quarter three. So, for all your modeling, just to take into account that because of that price adjustment, the 100 milligram dose being launched and because we have consistent pricing across SKUs--that adjustment just needs to be factored into your models for SCEMBLIX. But more importantly, we're very confident in the first-line opportunity--we have FDA submission under real-time oncology review, we received breakthrough therapy designation. I think all of you saw the truly outstanding data at ASCO that positioned SCEMBLIX as the medicine of choice for patients in the front-line setting. And we're looking forward to also completing our ex-U.S. submissions in 2024 and 2025, ahem,

Speaker Change: But what that will lead to is about a $15 million sales that will not repeat in quarter two and quarter three. So for all your modeling, just to take into account that because of that price adjust, with the 100 milligram dose being launched, and because we have consistent pricing across SKUs,

Beth: So, for all your modeling, just to take into account that because of that price adjustment, the 100 milligram dose being launched and because we have consistent pricing across SKUs--that adjustment just needs to be factored into your models for SCEMBLIX. But more importantly, we're very confident in the first-line opportunity--we have FDA submission under real-time oncology review, we received breakthrough therapy designation. I think all of you saw the truly outstanding data at ASCO that positioned SCEMBLIX as the medicine of choice for patients in the front-line setting. And we're looking forward to also completing our ex-U.S. submissions in 2024 and 2025, ahem, Now, moving to some of the ASCO data, as a reminder, this was data that demonstrated superior efficacy and a favorable safety and tolerability profile against standard-of-care TKIs in first-line CML.

Vasant Narasimhan: So, for all your modeling, just to take into account that because of that price adjustment, the 100 milligram dose being launched and because we have consistent pricing across SKUs--that adjustment just needs to be factored into your models for SCEMBLIX. But more importantly, we're very confident in the first-line opportunity--we have FDA submission under real-time oncology review, we received breakthrough therapy designation. I think all of you saw the truly outstanding data at ASCO that positioned SCEMBLIX as the medicine of choice for patients in the front-line setting. And we're looking forward to also completing our ex-U.S. submissions in 2024 and 2025, ahem,

Vasant Narasimhan: For all your modeling, just to take into account that because of that price adjustment the 100-milligram dose being launched and because we have consistent pricing across SKUs, that adjustment just needs to be factored into your models for Semglee. More importantly, we're very confident in the first-line opportunity. We have FDA submission under Real-Time Oncology Review. We received Breakthrough Therapy Designation. I think all of you saw the truly outstanding data at ASCO that positions Scemblix as the medicine of choice for patients in the front-line setting. We're looking forward to also completing our ex-US submissions in 2024 and 2025. Now moving to the Scemblix ASCO data. As a reminder, this was data that demonstrated superior efficacy and a favorable safety and tolerability profile against standard of care TKIs in first-line CML.

Speaker Change: That adjustment just needs to be factored into your models for semblance. But more importantly, we're very confident in the first-line opportunity. We have FDA submission under real-time oncology review. We've received breakthrough therapy designation.

Vasant Narasimhan: But more importantly, we're very confident in the first-line opportunity--we have FDA submission under real-time oncology review, we received breakthrough therapy designation. I think all of you saw the truly outstanding data at ASCO that positioned SCEMBLIX as the medicine of choice for patients in the front-line setting. And we're looking forward to also completing our ex-U.S. submissions in 2024 and 2025.

Speaker Change: I think all of you saw the truly outstanding data at ASCO, the physician semblance of the medicine of choice for patients in the frontline setting. And we're looking forward to also completing our ex-UF submissions in 2024 and 2025.

Vasant Narasimhan: Now, moving to some of the ASCO data, as a reminder, this was data that demonstrated superior efficacy and a favorable safety and tolerability profile against standard-of-care TKIs in first-line CML. Efficacy-wise, superior MMR rates and also, deep molecular response, importantly, as well against all TKIs and against IMATINIB with very impressive differences. We had earlier achievement of MMR, greater depth of responses; also, important improvements versus second-gen TKIs in MMR speed and depth. And then, very importantly as well for these patients and, I think, from a physician's standpoint as well, outstanding safety and tolerability. Fewer Grade 3 AEs, fewer dose adjustments or interruptions--really making SCEMBLIX, I think from a safety profile, the medicine of choice for these patients.

Speaker Change: Now moving to some of the ASCO data, as a reminder, this was data that demonstrated superior efficacy and a favorable safety and tolerability profile against standard of care TKIs.

Beth: Efficacy-wise, superior MMR rates and also deep molecular responses, importantly, as well, against all TKIs and against imatinib with very impressive differences. We had earlier achievement of MMR, greater depth of responses, and also important improvements versus second-gen TKIs in MMR speed and depth. And then, very importantly, as well, for these patients, and I think from a physician's standpoint, as well, outstanding safety and tolerability. Fewer grade 3 AEs, fewer dose adjustments or interruptions, really making Semblix, I think, from a safety perspective, the medicine of choice for these patients.

Vasant Narasimhan: Efficacy-wise, superior MMR rates and also deep molecular response, importantly as well, against all TKIs and against imatinib with very impressive differences. We had earlier achievement of MMR, greater depth of responses. Also, important improvements versus second-gen TKIs in MMR speed and depth. Then very importantly as well for these patients, and I think from a physician standpoint as well, outstanding safety and tolerability. Fewer grade three AEs, fewer dose adjustments or interruptions, really making Scemblix, I think from a safety profile, the medicine of choice for these patients. We're very excited about bringing this medicine forward. We guided to $3 billion plus peak sales for Scemblix. As a reminder, Scemblix has protection into the mid-2030s. Also, as a rare disease medicine, will not be expected to be part of the IRA.

Speaker Change: in first-line CML. Efficacy-wise, superior MMR rates and also deep molecular response, importantly, as well against all TKIs and against imatinib with very impressive differences.

Speaker Change: We had earlier achievement of MMR, greater depth of responses, also important improvements versus second-gen TKIs in MMR speed and depth.

Speaker Change: And then very importantly as well for these patients, and I think from a physician's standpoint as well, outstanding safety and tolerability. Fewer grade 3 AEs, fewer dose adjustments or interruptions, really making Stemblix, I think from a safety profile, the medicine of choice for these patients.

Beth: So, we're very excited about bringing this medicine forward--we guided to $3 billion-plus peak sales for SCEMBLIX. As a reminder, SCEMBLIX has protection into the mid-2030s; also is not, as a rare disease medicine, will not be part--expected to be part of the IRA. So, a really great profile, great medicine, very excited about it's future. So, turning to Fabhalta, we had the US PNH launch, which is off to a very encouraging start. We saw really strong growth in quarter two versus quarter one. XUS approvals have also been received in multiple markets.

Vasant Narasimhan: So, we're very excited about bringing this medicine forward--we guided to $3 billion-plus peak sales for SCEMBLIX. As a reminder, SCEMBLIX has protection into the mid-2030s; also is not, as a rare disease medicine, will not be part--expected to be part of the IRA. So, a really great profile, great medicine, very excited about it's future.

Speaker Change: So we're very excited about bringing this medicine forward. We guide it to $3 billion plus peak sales for Sumblix. As a reminder, Sumblix has protection into the mid-2030s, also is not, as a rare disease medicine, will not be part, expected to be part of the IRA. So a really great profile, great medicine, very excited about its future.

Vasant Narasimhan: So, turning to FABHALTA. We had the US PNH launch, which is off to a very encouraging start. We saw really strong growth in quarter two versus quarter one. Ex-U.S. approvals have also been received now in multiple markets. And when you look at the profile of FABHALTA, we're making steady progress--we have REMS-certified HCPs ahead of competitive benchmarks, we see continued uptake across naive and switch patients, patients are getting treated across all hemoglobin levels but also, including those patients at 10 to 12 who are just slightly below normal. I think it's showing the interest there is in a twice-a-day oral option. We also see increasing commercial coverage as part of our--from our bridge program. So, all on track with respect to FABHALTA. We would expect in the second half to now see steady growth but also, take into account that the bolus of patients that we saw in the first half--especially the conversion from bridge--likely won't repeat in the second half. So, our growth rate will be steady and I think it's exciting but also, certainly not at the rates that we saw in the early part of the year.

Vasant Narasimhan: A really great profile, great medicine, very excited about its future. Now turning to Fabhalta, we had the US PNH launch, which is off to a very encouraging start. We saw really strong growth in Q2 versus Q1. Ex-US approvals have also been received now in multiple markets. When you look at the profile of Fabhalta, we're making steady progress. We have REMS-certified HCPs ahead of competitive benchmarks. We see continued uptake across naive and switch patients. Patients are getting treated across all hemoglobin levels, but also including those patients at 10 to 12 who are just slightly below normal, I think, in showing the interest there is in a twice-a-day oral option. We also see increasing commercial coverage as part of our, from our Bridge program. All on track with respect to Fabhalta.

Beth: And when you look at the profile of Fabhalta, we're making steady progress. We have REM-certified ACPs ahead of competitive benchmarks. We see continued uptake across naive and switch patients. Patients are getting treated across all hemoglobin levels, but also including those patients at 10 to 12 who are just slightly below normal.

Speaker Change: So turning to Fabhalta, we had the US P&H launch, which was off to a very encouraging start. We saw really strong growth in quarter 2 versus quarter 1. Ex-US approvals have also been received now in multiple markets.

Speaker Change: And when you look at the profile of FAB-HALTA, we're making steady progress, we have REM-certified ACPs ahead of competitive benchmarks.

Speaker Change: We see continued uptake across naïve and switched patients. Patients are getting treated across all hemoglobin levels, but also including those patients at 10 to 12 who are just slightly below normal, I think, and showing the interest there is in a twice-a-day oral option.

Vasant Narasimhan: I think it's showing the interest there is in a twice-a-day oral option. We also see increasing commercial coverage as part of our--from our bridge program. So, all on track with respect to FABHALTA. We would expect in the second half to now see steady growth but also, take into account that the bolus of patients that we saw in the first half--especially the conversion from bridge--likely won't repeat in the second half. So, our growth rate will be steady and I think it's exciting but also, certainly not at the rates that we saw in the early part of the year.

Beth: I think it's showing the interest there is in a twice-a-day oral option. We also see increasing commercial coverage as part of our--from our bridge program. So, all on track with respect to FabPulsa. We would expect in the second half to now see steady growth, but also take into account that the bolus of patients that we saw in the first half, especially the conversion from bridge, likely won't repeat in the second half.

Speaker Change: We also see increasing commercial coverage as part of our, from our bridge program.

Vasant Narasimhan: We would expect in H2 to now see steady growth, but also to take into account that the bolus of patients that we saw in H1, especially the conversion from Bridge, likely won't repeat in H2. Our growth rate will be steady, and I think it's exciting, but also certainly not at the rates that we saw in the early part of the year. Now, moving to slide 15. Turning to our renal portfolio, as you all know, we've been working to build a attractive portfolio to manage IgAN, C3G, and related renal diseases. As part of that effort, we acquired atrasentan, and in the Phase III ALIGN IgAN study, we announced at ERA in May a 36% proteinuria reduction relative to placebo.

Speaker Change: So, all on track with respect to fat pulse, we would expect in the second half to now see steady growth, but also to take into account that the bolus of patients that we saw in the first half

Beth: So our growth rate will be steady, and I think it's exciting, but also certainly not at the rates that we saw in the early part of the year. Now, moving to slide 15, turning to our renal portfolio. As you all know, we've been working to build an attractive portfolio to manage IgN, C3G, and related renal diseases. And as part of that effort, we acquired Atracentin, and in the Phase III Align IgN study, we announced at ERA in May, a 36% proneurea reduction relative to placebo.

So our growth rate will be steady, and I think it's exciting, but also certainly not at the rates that we saw in the early part of the year.

Speaker Change: especially the conversion from bridge likely won't repeat in the second half so our growth rate will be steady and I think it's exciting but also certainly not at the rates that we saw in the early part of the year

Vasant Narasimhan: Now, moving to slide 15. Turning to our renal portfolio--as you all know, we've been working to build a attractive portfolio to manage IgAN, C3G and related renal diseases. And as part of that effort, we acquired ATRASENTAN and in the Phase III ALIGN-IgAN study, we announced at ERA in May, a 36% proteinuria reduction relative to placebo. We're very excited about this medicine as we think it can be a foundational medicine that provides hemodynamic and nephroprotective potential for patients and physicians. It's a clinically meaningful proteinuria reduction and we see a very favorable safety profile. We think up to 50% of patients with persistent proteinuria progress to kidney failure so, important that these patients get better options.

Speaker Change: Now moving to slide 15.

Speaker Change: Turning to our renal portfolio, as you all know, we've been working to build an attractive portfolio to manage IgN, C3G, and related renal diseases.

Speaker Change: And as part of that effort, we acquired Atracentin, and in the Phase III Align-Eigen study, we announced at ERA in May, a 36% prone urea reduction relative to placebo.

Beth: We're very excited about this medicine, as we think it can be a foundational medicine that provides hemodynamic and nephroprotective potential for patients and physicians. It's a clinically meaningful proneurea reduction. And we see a very favorable safety profile.

Vasant Narasimhan: We're very excited about this medicine as we think it can be a foundational medicine that provides hemodynamic and nephroprotective potential for patients and physicians. It's a clinically meaningful proteinuria reduction. We see a very favorable safety profile. We think up to 50% of patients with persistent proteinuria progress to kidney failure, so important that these patients get better options. We've submitted to FDA, and of course, the study continues in a blinded fashion to 2026 when we would read out the eGFR. Looking forward to launching this medicine in 2025. Alongside that, with iptacopan, we also announced at ERA the full pre-specified Phase III APPEAR-C3G study, which demonstrated 35% proteinuria reduction relative to placebo. You can see the design on the left-hand side of the slide.

Speaker Change: We're very excited about this medicine as we think it can be a foundational medicine that provides hemodynamic and nephroprotective

Speaker Change: potential for patients and physicians.

Speaker Change: It's a clinically meaningful proteinuria reduction. We see a very favorable safety profile. We think up to 50% of patients with persistent proteinuria progress to kidney failure. So important that these patients get better options. We've submitted to FDA. And of course, the study continues in a blinded fashion to 2026 when we would read out the EGFR. So looking forward to launching this medicine in 2025.

Vasant Narasimhan: We think up to 50% of patients with persistent proteinuria progress to kidney failure so, important that these patients get better options. We've submitted to FDA and, of course, the study continues in a blinded fashion to 2026 when we read out the eGFR. So, looking forward to launching this medicine in 2025. Alongside that, with IPTACOPAN, we also announced at ERA the full-result Phase III APPEAR-C3G study, which demonstrated 35% proteinuria reduction relative to placebo. You can see the design on the left-hand side of the slide. On the right-hand side, you see that impressive -30% versus an increase of 7.6% in the placebo arm. We saw numerical improvements in eGFR, favorable safety profile overall. This would be the first treatment--potential treatment targeting the complement pathway in C3G. And again, in these patients, 50% of patients developed kidney failure requiring dialysis. Now, importantly, today we're also announcing that we have end-of-study results for this medicine at the 12-month time point. That data is consistent with the 6-month data, which now allows us to move forward with the filing in the second half of 2024, with an expected launch next year. We'll present that end-of-study data at an upcoming medical meeting but I think this is an important update for this medicine, allowing us to now have FABHALTA hopefully, in next year, in three separate indications. I'd also note we're also working to develop FFABHALTA in atypical hemolytic uremic syndrome; we announced the start of a Phase III program in myasthenia gravis. So, we're very excited. Another medicine that has LOE protection well into the 2030s and then, as well, primarily treating younger patients--not a medicine that's exposed to the Medicare Part D IRA. So, another medicine that we have, we think, that can really drive our growth well into the 2030s across a broad range of rare diseases.

Vasant Narasimhan: We think up to 50% of patients with persistent proteinuria progress to kidney failure so, important that these patients get better options.

Vasant Narasimhan: We've submitted to FDA and, of course, the study continues in a blinded fashion to 2026 when we read out the eGFR. So, looking forward to launching this medicine in 2025. Alongside that, with IPTACOPAN, we also announced at ERA the full-result Phase III APPEAR-C3G study, which demonstrated 35% proteinuria reduction relative to placebo. You can see the design on the left-hand side of the slide. On the right-hand side, you see that impressive -30% versus an increase of 7.6% in the placebo arm. We saw numerical improvements in eGFR, favorable safety profile overall. This would be the first treatment--potential treatment targeting the complement pathway in C3G. And again, in these patients, 50% of patients developed kidney failure requiring dialysis.

Speaker Change: Alongside that, with Octocopan, we also announced that ERA, the Full Result Based Reappearance C3G Study, which demonstrated 35% proteinuria reduction.

Beth: On the right-hand side, you see that impressive minus 30% versus an increase of 7.6% in the placebo arm. We saw numerical improvements in EGFR, and a favorable safety profile overall. This would be the first potential treatment targeting the complement pathway in C3G. And again, in these patients, 50% of patients developed kidney failure requiring dialysis.

Vasant Narasimhan: On the right-hand side, you see that impressive -30% versus an increase of 7.6% in the placebo arm. We saw numerical improvements in eGFR, favorable safety profile overall. This would be the first treatment, potential treatment targeting the complement pathway in C3G. Again, in these patients, 50% of patients develop kidney failure requiring dialysis. Now importantly today, we're also announcing that we have end-of-study results for this medicine at the 12-month time point. That data is consistent with the 6-month data, which now allows us to move forward with the filing in H2 2024 with an expected launch next year. We'll present that end-of-study data at an upcoming medical meeting. I think this is an important update for this medicine, allowing us to now have Fabhalta, hopefully next year, in three separate indications.

Speaker Change: relative to placebo.

Speaker Change: You can see the design on the left-hand side of the slide. On the right-hand side, you see that impressive minus 30% versus an increase of 7.6% in the placebo arm. We saw numerical improvements in EGFR, favorable safety profile overall. This would be the first treatment, potential treatment, targeting the complement pathway in C3G.

Vasant Narasimhan: We saw numerical improvements in eGFR, favorable safety profile overall. This would be the first treatment--potential treatment targeting the complement pathway in C3G. And again, in these patients, 50% of patients developed kidney failure requiring dialysis. Now, importantly, today we're also announcing that we have end-of-study results for this medicine at the 12-month time point. That data is consistent with the 6-month data, which now allows us to move forward with the filing in the second half of 2024, with an expected launch next year. We'll present that end-of-study data at an upcoming medical meeting but I think this is an important update for this medicine, allowing us to now have FABHALTA hopefully, in next year, in three separate indications. I'd also note we're also working to develop FFABHALTA in atypical hemolytic uremic syndrome; we announced the start of a Phase III program in myasthenia gravis. So, we're very excited. Another medicine that has LOE protection well into the 2030s and then, as well, primarily treating younger patients--not a medicine that's exposed to the Medicare Part D IRA. So, another medicine that we have, we think, that can really drive our growth well into the 2030s across a broad range of rare diseases.

Vasant Narasimhan: Now, importantly, today we're also announcing that we have end-of-study results for this medicine at the 12-month time point. That data is consistent with the 6-month data, which now allows us to move forward with the filing in the second half of 2024, with an expected launch next year. We'll present that end-of-study data at an upcoming medical meeting but I think this is an important update for this medicine, allowing us to now have FABHALTA hopefully, in next year, in three separate indications. I'd also note we're also working to develop FFABHALTA in atypical hemolytic uremic syndrome; we announced the start of a Phase III program in myasthenia gravis. So, we're very excited. Another medicine that has LOE protection well into the 2030s and then, as well, primarily treating younger patients--not a medicine that's exposed to the Medicare Part D IRA. So, another medicine that we have, we think, that can really drive our growth well into the 2030s across a broad range of rare diseases.

Speaker Change: And again, in these patients, 50% of patients develop kidney failure requiring dialysis.

Beth: Now, importantly, today, we're also announcing that we have end-of-study results for this medicine at the 12-month time point. That data is consistent with the 6-month data, which now allows us to move forward with the filing in the second half of 2024 with an expected launch next year. We'll present that end-of-study data at an upcoming medical meeting, but I think this is an important update for this medicine, allowing us to now have FAB-ALSA, hopefully next year, in three separate indications. I'd also note we're also working to develop FAB-ALSA in atypical hemolytic uremic syndrome. We announced the start of a Phase III program in myasthenia gravis.

Speaker Change: Now importantly today we're also announcing that we have end of study results for this medicine at the 12-month time point. That data is consistent with the six-month data which now allows us to move forward with the filing in the second half of 2024 with an expected launch next year. We'll present that end of study data at an upcoming medical meeting but I think this is an important update for this medicine allowing us to now have sub-ulcer hopefully in next year in three separate indications.

Vasant Narasimhan: I'd also note we're also working to develop FABHALTA in atypical hemolytic uremic syndrome; we announced the start of a Phase III program in myasthenia gravis. So, we're very excited. Another medicine that has LOE protection well into the 2030s and then, as well, primarily treating younger patients--not a medicine that's exposed to the Medicare Part D IRA. So, another medicine that we have, we think, that can really drive our growth well into the 2030s across a broad range of rare diseases.

Vasant Narasimhan: I'd also note, we're also working to develop Fabhalta in atypical hemolytic uremic syndrome. We announced the start of a phase three program in myasthenia gravis. We're very excited. Another medicine that has LOE protection well into the 2030s, primarily treating younger patients, not a medicine that's exposed to the Medicare Part D IRA. Another medicine that we have, we think that can really drive our growth well into the 2030s across a broad range of rare diseases. Moving to the next slide. In closing, before handing it over to Harry, we expect to continue our innovation momentum in H2. We had 10 positive phase three readouts, as you all know, in 2023.

Speaker Change: And I'd also note...

Speaker Change: We're also working to develop FAB-HALTA, an atypical hemolytic uremic syndrome.

Speaker Change: We announced the start of a Phase III program in Myasthenia Gravis.

Beth: So we're very excited. Another medicine that has LOE protection well into the 2030s, and then as well, primarily treating younger patients, not a medicine that's exposed to the Medicare Part D IRA. So another medicine that we have, we think, that can really drive our growth well into the 2030s across a broad range of rare diseases.

Speaker Change: And so we're very excited, another medicine that has LOE protection well into the 2030s. And then as well, primarily treating younger patients, not a medicine that's exposed to the Medicare Part D IRA. So another medicine that we have, we think that can really drive our growth well into the 2030s across a broad range of rare diseases.

Vasant Narasimhan: Now, moving to the next slide. So, in closing, before handing it over to Harry, we expect to continue our innovation momentum in half two. We had 10 positive Phase III readouts in, as you all know, in 2023. Really, this year is about filing and really making sure that we get these medicines ready to launch. But we are excited as well about the next wave of medicines. One thing we did want to note is, we have shifted our REMIBRUTINIB CSU filing slightly as we do need to make a few [inaudible] adjustments but as a reminder, REMIBRUTINIB showed biologic-like efficacy in the control of CSU, a very good safety profile. So, we're excited to get that medicine submitted in 2025 and then, out to launch. We do, of course, also expect a steady stream of readouts as well in '25-'26, which we'll profile in upcoming meetings.

Speaker Change: So moving to the next slide.

Vasant Narasimhan: Really this year is about filing and really making sure that we get these medicines ready to launch. We are excited as well about a next wave of medicines. One thing we did wanna note is we have shifted our remibrutinib CSU filing slightly, as we do need to make a few CMC adjustments. As a reminder, remibrutinib showed biologic-like efficacy in the control of CSU, a very good safety profile. We're excited to get that medicine submitted in 2025 and then out to launch. We do of course also expect a steady stream of readouts as well in 2025, 2026, which we'll profile in upcoming meetings. With that, let me hand it over to Harry.

Vasant Narasimhan: One thing we did want to note is, we have shifted our REMIBRUTINIB CSU filing slightly as we do need to make a few [inaudible] adjustments but as a reminder, REMIBRUTINIB showed biologic-like efficacy in the control of CSU, a very good safety profile. So, we're excited to get that medicine submitted in 2025 and then, out to launch. We do, of course, also expect a steady stream of readouts as well in '25-'26, which we'll profile in upcoming meetings.

Speaker Change: One thing we did want to note is we have shifted our Remi-Brutonib-CFU filing slightly as we do need to make a few CMC adjustments. But as a reminder, Remi-Brutonib showed biologic-like efficacy in the control of CFU, a very good safety profile.

Harry: So we're excited to get that medicine submitted in 2025 and then out for launch. We do, of course, also expect a steady stream of readouts as well in 2025-26, which we'll profile. So with that, let me hand it over to Harry. Thank you, Voss. Good morning and good afternoon, everybody.

So we're excited to get that medicine submitted in 2025 and then out for launch. We do, of course, also expect a steady stream of readouts as well in 2025-26, which we'll profile. So with that, let me hand it over to Harry.

So we're excited to get that medicine submitted in 2025 and then out for launch. We do, of course, also expect a steady stream of readouts as well in 2025-26, which we'll profile.

Speaker Change: So we're excited to get that medicine submitted in 2025 and then out to launch. We do, of course, also expect a steady stream of readouts as well in 2025-26, which we'll profile in upcoming.

Vasant Narasimhan: So, with that, let me hand it over to Harry.

Harry Kirsch: Thank you, Vas. Good morning and good afternoon, everybody.

Harry: And I'll walk you through, as always, to our financials of the second quarter in the first half. And my comments will always refer to growth rates in constant currencies, unless otherwise stated. I will also be referring to continue operations that will be [inaudible] remainder of this year given the Sandoz Spin in October last year. And as you see and have seen already, we had a very strong first half of the year and continued momentum of our quarter one start into Q2. So, on slide 19.

Harry Kirsch: And I'll walk you through, as always, to our financials of the second quarter in the first half. And my comments will always refer to growth rates in constant currencies, unless otherwise stated. I will also be referring to continue operations that will be [inaudible] remainder of this year given the Sandoz Spin in October last year. And as you see and have seen already, we had a very strong first half of the year and continued momentum of our quarter one start into Q2.

Speaker Change: [inaudible]

Harry Kirsch: Yeah. Thank you, Vas. Good morning and good afternoon, everybody. I'll walk you through, as always, through our financials of the second quarter and the first half. My comments will always refer to growth rates and constant currencies unless otherwise stated. I will also be referring to continued operations that will be still remainder of this year, given the Sandoz spin in October last year. As you see and have seen already, we had a very strong H1 of the year and continued momentum of our Q1 start into Q2. On slide 19, now Q2 sales grew 11%. Core operating income was up 19%. Core EPS was $1.97, growing 21%. Free cash flow was $4.6 billion, very strong, also 40% up in US dollars.

Speaker Change: So with that, let me hand it over to Harry.

Harry Kirsch: Thank you, Voss. Good morning and good afternoon, everybody. I now walk you through, as always, the financials of the second quarter and the first half. And my comments will always refer to growth rates and constant currencies.

Harry Kirsch: unless otherwise stated. I will also be referring to continuing operations that will be still remainder of this year given the sundo spin in October last year.

Harry Kirsch: And as you see and have seen already, we had a very strong first half of the year and continued momentum of our quarter one start into Q2. So on slide 19.

Harry Kirsch: So, on slide 19. Now, Q2 sales grew 11%; core operating income was up 19%; core EPS was $1.97, growing 21%; free cash flow was $4.6 billion, very strong also at 40% up in U.S. dollars. For the first half--which you see on the right side--again, [inaudible] the same 11% growth and core operating income up 21% as Q1 was a bit higher than Q2 but both quarters were super strong. And our core margin on the half year--always better to look on the longer periods, not only one quarter--up to 39% and up 310 basis points, demonstrating clearly our continued progress towards achieving our mid-term margin guidance of +40% by 2027. Core EPS, $3.77, up 22% and free cash flow almost up to $7 billion, up 11%. So clearly, these numbers reflect also the full effect of our pure-play pharma company and our transformation for growth, with a very strong worldwide execution.

Harry: Now Q2 sales grew 11%, co-operating income was up 19%, core EPS was $1.97, growing 21%, and free cash flow was $4.6 billion, very strong, also 40% higher in US dollars. For the first half, which you can see on the right side, again, the same 11% growth and co-operating income up 21% as Q1 was a bit higher than Q2, but both quarters were super strong. And our core margin for the half year, always better to look at a little bit longer periods, not only one quarter, up to 39% and up 310 basis points, demonstrating clearly our continued progress towards achieving our midterm margin guidance

Harry Kirsch: Now Q2 sales.

Harry Kirsch: grew 11%, co-operating income was up 19%.

Harry Kirsch: Core EPS was $1.97, growing 21%. Free cash flow was $4.6 billion, very strong, also 40% up in US dollars.

Harry Kirsch: For the H1, which you see on the right side, again, 11% plus the same 11% growth and core operating income up 21%, as Q1 was a bit higher than Q2, but both quarters super strong. Our core margin on the H1, always better to look on the longer periods, not only one quarter, up to 39% and up 310 basis points, demonstrating clearly our continued progress towards achieving our midterm margin guidance of 40%+ by 2027. Core EPS $3.77, up 22%. Free cash flow almost up to $7 billion, up 11%. Clearly these numbers reflect also the full effect of our pure play pharma company and our transformation for growth, with a very strong worldwide execution.

Harry Kirsch: For the first half, which you see on the right side, again, 11%, the same 11% growth.

Harry Kirsch: And co-operating income up 21 as Q1 was a bit higher than Q2, but both quarters super strong. And our core margin on the half year, always better look a little bit longer periods, not only one quarter, up to 39%.

Harry Kirsch: and up 310 basis points.

Harry Kirsch: demonstrating clearly our continued progress towards achieving our mid-term margin guidance of 40% plus by 2027.

Harry: Core EPS, $3.77, up 22% and free cash flow almost up to $7 billion, up 11%. So clearly, these numbers reflect also the full effect of our pure-play pharma company and our transformation for growth, with a very strong worldwide execution. So, in turning to slide number 20. I think most importantly to understand that we have our continued strong underlying growth dynamics will really continue. We expect that also for the second half.

Core EPS, $3.77, up 22% and free cash flow almost up to $7 billion, up 11%. So clearly, these numbers reflect also the full effect of our pure-play pharma company and our transformation for growth, with a very strong worldwide execution.

Harry Kirsch: Core EPS $3.77 up 22% and free cash flow almost up to $7 billion up 11%.

Harry Kirsch: So clearly these numbers reflect also the full effect of our pure play pharma company and our transformation for growth with a very strong worldwide execution.

Harry Kirsch: So--and turning to slide number 20. I think the most importantly to understand that we have our continued strong, underlying growth dynamics will really continue--we expect that also for the second half. Usually, we do not provide quarterly guidance but this time, it may be helpful as you model the remainder of the year. So, with respect to quarterly phasing, I want to remind you that last year Q3 and those where we had a couple of one-time effects, which are not super significant but likely we see in quarter three because of these two points of one-time effects, more high single-digit growth--so, still very strong. But you may remember, we had a one-time revenue [inaudible] up of KESIMPTA Europe and then, we also had some Sandoz inventory built up ahead of the Spin. I mentioned this quarter three last year but some of you may not remember that as you cover so many companies. And these two items add up to two percentage points of sales growth and so, we would anticipate this high single-digit growth in Q3. And then, of course, there's a bit of an effect on core operating income, usually two to three times of the top line points.

Harry Kirsch: In turning to slide number 20, I think most importantly it's to understand that our continued strong underlying growth dynamics will really continue. We expect that also for H2. Usually, we do not provide quarterly guidance, but this time it may be helpful as you model the remainder of the year. With respect to quarterly phasing, I want to remind you that last year, Q3, we had a couple of one-time effects, which are not super significant, but you likely will see in Q3 because of these two points of one-time effect, more high single-digit growth, so still very strong. But you may remember we had a one-time revenue deduction true-up of Cosentyx in Europe, and then we also had some Sandoz inventory built up ahead of the spin. Right?

Harry Kirsch: So in turning to slide number 20.

Harry Kirsch: I think it's most important to understand that we have our continued strong underlying growth dynamics.

Harry: Usually, we do not provide quarterly guidance, but this time, it may be helpful as you model the remainder of the year. So with respect to quarterly phasing, I want to remind you that last year Q3 and those where we had a couple of one-time effects, which are not super significant, but likely we will see in Q3 because of these two points of one-time effects, more high single-digit growth, so still very strong. And then we also had some Sandoz inventory built up ahead of the spin, right?

Harry Kirsch: will really continue. We expect that also for the second half.

Harry Kirsch: Usually, we do not provide quarterly guidance, but this time, it may be helpful as you model the remainder of the year. So with respect to quarterly phasing.

Harry Kirsch: I want to remind you that last year, Q3, and those were, we had a couple of one-time effects

Harry Kirsch: which are not super significant but likely we see a quarter three because of these two points of one-time effect more high single-digit growth so still very strong but you may remember we had a one-time revenue induction true up of Kacinta in Europe

Harry Kirsch: But you may remember, we had a one-time revenue [inaudible] up of KESIMPTA Europe and then, we also had some Sandoz inventory built up ahead of the Spin. I mentioned this quarter three last year but some of you may not remember that as you cover so many companies. And these two items add up to two percentage points of sales growth and so, we would anticipate this high single-digit growth in Q3. And then, of course, there's a bit of an effect on core operating income, usually two to three times of the top line points. But again, underlying is exactly what we have seen roughly so far.

Harry Kirsch: And then we also had some Sandoz inventory built up ahead of the spin. I mentioned this quarter three last year, but some of you may not remember that as you cover so many companies. And these two items add up to two percentage points of sales growth.

Harry Kirsch: I mentioned Q3 last year, but some of you may not remember that as you cover so many companies. These two items add up to two percentage points of sales growth, and so we would anticipate this high single digit growth in Q3. Then of course, there's a bit of an effect on operating income, right? Usually 2 to 3 times of the top line points. Again, underlying is exactly what we have seen roughly, you know, so far. Then in Q4, it really depends on, you know, how the two potential generics come in, Sandostatin LAR and Tasigna, right? If they don't come in, I would expect us to be at the high end of the guidance, both for that quarter as well as for the year.

Harry: I mentioned this quarter three last year, but some of you may not remember that as you cover so many companies. And these two items add up to two percentage points of sales growth. And so we would anticipate this high single-digit growth in Q3. And then, of course, there's a bit of an effect on cooperating income, right? Usually two to three times the top line.

Harry Kirsch: And so we would anticipate this high single digit quality in Q3.

Harry Kirsch: And then, of course, there's a bit of an effect on cooperating income.

Harry Kirsch: Usually two to three times of the top line points.

Harry: But again, underlying is exactly what we have seen roughly so far. And then, in Q4, it really depends on how the two potential generics come in, Sandoz, Dutton, LAR, and Tersigna. And if they don't come in, I would expect us to be at the high end of the guidance, both for that quarter as well as for the year. So I hope that helps you a bit with the quality phasing. And again, we usually don't do this, but I think this is warranted also as we increase the guidance for the year on the bottom line. At the same time, we had this quarter three base effect last year.

But again, underlying is exactly what we have seen roughly so far.

Harry Kirsch: But, again, underlying is exactly what we have seen roughly.

Harry Kirsch: And then, in Q4, it really depends on how the two potential generics come in--SANDOSTATIN LAR and TASIGNA. And if they don't come in, I would expect us to be at the high end of the guidance, both for that quarter as well as for the year. So, I hope that helps you a bit with the quality phasing and, again, we usually don't do this but I think this is warranted also as we increase the guidance for the year on the bottom line; at the same time, we had this quarter three base effect last year.

Speaker Change: You know, so far...

Speaker Change: and then in Q4

Speaker Change: It really depends on how the two potential generics come in, Sandoz-Dutton-LAR and Tersigna. And if they don't come in, I would expect us to be at the high end of the guidance.

Harry Kirsch: I hope that helps you a bit with the quality phasing. Again, we usually don't do this, but I think this is warranting also as we increase the guidance for the year on the bottom line, at the same time, we had this Q3 year base effect last year. Now moving on to slide 21 for the full year guidance. We continue to expect the sales growth to be in the high single digit to low double digit. However, the strong momentum we are seeing in the business, together with continued productivity savings, gives us the confidence to upgrade our bottom-line guidance. We now expect core operating income to grow in the range of mid to high teens, from prior double digit to mid teens.

Speaker Change: both for that quarter as well as for the year.

Speaker Change: So, I hope that helps you a bit with the quality phasing, and again, we usually don't do this, but I think this is warranting also as we increase the guidance for the year on the bottom line, at the same time, we had this quarter 3 base effect last year.

Harry Kirsch: Now, moving on to slide 21 for the full year guidance. We continue to expect sales growth to be in the high single-digit to low double-digit. However, the strong momentum you're seeing in the business, together with continued productivity results, gives us the confidence to upgrade our bottom line guidance. We now expect core operating income to grow in the range of mid to high-teens from prior double-digit to mid-teens. Now, as I mentioned before, underpinning our guidance are the assumptions that no ENTRESTO, no PROMACTA generics would launch in the U.S. in 2024. To complete the full year guidance, please note that we expect the core net financial expenses to be around several hundred million and our core tax rate to be around 16.2%.

Speaker Change: Now moving on to slide 21 for the full year guidance.

Speaker Change: We continue to expect the sales growth to be in the high single-digit to low double-digit

Speaker Change: However, the strong momentum we are seeing in the business

Speaker Change: Together with continued productivity results gives us the confidence to upgrade our bottom line guidance. We now expect core operating income to grow in the range of mid to high teens from prior double-digit to mid-teens.

Harry Kirsch: Now, as I mentioned before, underpinning our guidance are the assumptions that no ENTRESTO, no PROMACTA generics would launch in the U.S. in 2024. To complete the full year guidance, please note that we expect the core net financial expenses to be around several hundred million and our core tax rate to be around 16.2%. On slide 22, just a little reminder that we remain committed, of course, to our shareholder-friendly capital allocation strategy to invest in the business while also returning attractively our capital to our shareholders in the first half of the year.

Harry Kirsch: Now as I mentioned before, underpinning our guidance are the assumptions that no Entresto or no Promacta generics would launch in the US in 2024. To complete the full year guidance, please note that we expect the corporate financial expenses to be around $700 million and our core tax rate to be around 16.2%. On slide 22, just a little reminder that we remain committed, of course, to our shareholder-friendly capital allocation strategy to invest in the business while also returning attractive yields on our capital to our shareholders in H1. In addition to investing in our internal R&D engine, we also brought in external innovation via bolt-on M&A and BD&L deals, particularly to strengthen our pipeline in oncology as well as our RLT platform.

Speaker Change: Now, as I mentioned before, underpinning our guidance are the assumptions that no interest or no pro maxa generics would launch in the U.S. in 2020.

Speaker Change: 2024.

Speaker Change: To complete the full year guidance, please note that we expect the core net financial expenses to be around $700 million and our core tax rate to be around 16.2%.

Harry Kirsch: On slide 22, just a little reminder that we remain committed, of course, to our shareholder-friendly capital allocation strategy to invest in the business while also returning attractively our capital to our shareholders in the first half of the year. In addition to investing in our internal R&D engine, we also brought in external innovation via bolt-on M&A and BD&L deals, particularly to strengthen our pipeline in oncology as well as our RLT platform. In terms of returning capital to shareholders, we paid out $7.6 billion in dividends in the first half and we also continue our up to $15 billion share buyback, which has approximately $10 billion left to be executed by the end of 2025. Now, on to my final slide around currencies. As always, currencies fluctuate, and we always outline that. And in Q2, FX had a negative 2% point impact on both net sales and co-operating income.

Speaker Change: On slide 22, just a little reminder that we remain committed, of course, to our shareholder-friendly capital allocation strategy to invest in the business while also returning attractively to our capital to our shareholders in the first half of the year.

Harry: In addition to investing in our internal R&D engine, we also brought in external innovation via bolt-on M&A and BDNL deals, particularly to strengthen our pipeline in oncology as well as our RLT platform. In terms of returning capital to shareholders, we paid out $7.6 billion in dividends in the first half.

Speaker Change: In addition to investing in our internal R&D engine, we also brought in external innovation via bolt-on M&A and BDNL deals, particularly to strengthen our pipeline in oncology as well as our RLT platform.

Harry Kirsch: In terms of returning capital to shareholders, we paid out CHF 7.6 billion in dividends in H1, and we also continue our up to CHF 15 billion share buyback, which has approximately $10 billion left to be executed by the end of 2025. Now on to my final slide around currencies. Yeah, as always, currencies fluctuate and, we always outline that. In Q2, FX had a -2 percentage points impact on both net sales and core operating income on our results. If mid-July rates would prevail for the remainder of 2024, we would expect the full year currency impact to be -1 to 2 percentage points on net sales and -3 percentage points on core operating income. As a reminder, the estimated impact of exchange rates on our results are always provided mid-month on our website. Back to Vas.

Speaker Change: In terms of returning capital to shareholders, we paid out $7.6 billion in dividends in the first half.

Harry: And we also continue our up to $15 billion share buyback, which has approximately $10 billion left to be executed by the end of 2025. Now on to my final slide around currencies. As always, currencies fluctuate, and we always outline that. And in Q2, FX had a negative 2% point impact on both net sales and co-operating income.

Speaker Change: And we also continue our up to $15 billion share buyback, which has approximately $10 billion left to be executed by the end of 2025.

Harry Kirsch: Now, on to my final slide around currencies. As always, currencies fluctuate and we always outline that. And in Q2, FX had a -2% point impact on both net sales and core operating income. On our results, the mid-July rates would prevail for the remainder of 2024. We would expect the full-year currency impact to be -1 to 2 percentage points on net sales and -3 percentage points on core operating income. And as a reminder, the estimated impact of exchange rates on our results are always provided mid-month on our website. Back to Vas. Great, thank you, Harry. So before taking your questions, just to briefly summarize, continued momentum in quarter two with sales up 11%, and core operating margin approaching 40%.

Speaker Change: Now on to my final slide around currencies, yeah.

Speaker Change: As always, currencies fluctuate.

Speaker Change: And we always outline that. And in Q2, FX had a negative 2% point impact on both net sales and co-operating income.

Harry: Based on our results, the mid-July rates would prevail for the remainder of 2024. We would expect the full-year currency impact to be negative 1 to 2 percentage points on net sales and negative 3 percentage points on co-operating income. And as a reminder, the estimated impact of exchange rates on our results is always provided mid-month on our website. Back to Voss. Great, thank you, Harry. So before taking your questions, just to briefly summarize, continued momentum in quarter two with sales up 11%, and core operating margin approaching 40%.

Speaker Change: And if mid-July rates would prevail for the remainder of 2024, we would expect the full-year currency impact to be negative 1 to 2 percentage points on net sales.

Speaker Change: and negative three percentage points of co-operating income. And as a reminder, the estimated impact of exchange rates on our results are always provided mid-month on our website.

Harry Kirsch: Back to Vas.

Harry Kirsch: Great, thank you, Harry. So before taking your questions, just to briefly summarize, continued momentum in quarter two with sales up 11%, and core operating margin approaching 40%.

Vasant Narasimhan: Great. Thank you, Harry.

Vasant Narasimhan: So, before taking your questions, just to briefly summarize--continued momentum in quarter two with sales up 11%, core operating margin approaching 40%. We see strong commercial execution, which I think demonstrates our ability to drive our in-brand medicines, drive our growth brands, drive new launches--this supports our bottom line guidance for [inaudible] full year 2024. Our pipeline continues to advance with the FDA submissions of SCEMBLIX in the first-line, ATRASENTAN IgAN, our updated [inaudible] KISQALI in early breast cancer. And we're on track to achieve our mid-term guidance--5% constant currency sales growth through 2028,

Harry: We see strong commercial execution, which I think demonstrates our ability to drive our in-brand medicines, drive our growth brands, and drive new launches. This supports our bottom line guidance for full year 2024. Our pipeline continues to advance with the FDA submissions of Semblix in the first line, Atracentin, and Igan are updated for setting Scaly and early breast cancer, and we're on track to achieve our midterm guidance of 5% constant currency sales growth through 2028.

Vasant Narasimhan: Great. Thank you, Harry. Before taking your questions, just to briefly summarize, continued momentum in Q2 with sales up 11%, core operating margin approaching 40%. We see strong commercial execution, which I think demonstrates our ability to drive our in-market brand medicines, drive our growth brands, drive new launches. This supports our bottom line guidance rates for full year 2024. Our pipeline continues to advance with the FDA submissions of Scemblix in the first line. Atrasentan and IgAN are updated for setting Kisqali in early breast cancer. We're on track to achieve our midterm guidance, 5% constant currency sales growth through 2028, CAGR of 40, a CAGR and a 40% core operating margin by 2027.

Speaker Change: Great, thank you, Harry. So, before taking your questions, just to briefly summarize, continued momentum in quarter two with sales up 11%, core operating margin approaching 40%.

Speaker Change: We see strong commercial execution, which I think demonstrates our ability to drive our in-brand medicines, drive our growth brands, drive new launches, system supports our bottom line guidance race for full year 2024.

Vasant Narasimhan: Our pipeline continues to advance with the FDA submissions of SCEMBLIX in the first-line, ATRASENTAN IgAN, our updated [inaudible] KISQALI in early breast cancer. And we're on track to achieve our mid-term guidance--5% constant currency sales growth through 2028, CAGR at 40% core operating margin by 2027. So, we think it's really a great quarter for the company and we look forward to continuing to drive strong performance through the remainder of this year.

Speaker Change: Our pipeline continues to advance with the FDA submissions of Semblix in the first line, Atracentin, Igand, our updated

Speaker Change: for Setting Scali and Early Breast Cancer. And we're on track to achieve our midterm guidance, 5% constant currency sales growth through 2028, CAGR at 40% core operating margin by 2027.

Vasant Narasimhan: And we're on track to achieve our mid-term guidance--5% constant currency sales growth through 2028, CAGR at 40% core operating margin by 2027. So, we think it's really a great quarter for the company and we look forward to continuing to drive strong performance through the remainder of this year. So, with that, we can open the line for questions. And as Sloan mentioned, please, one question per analyst and then, we'll come back through the list again.

Harry: CAGR at 40% core operating margin by So we think it was a really great quarter for the company, and we look forward to continuing to drive strong performance through the remainder of this year. So with that, we can open the line for questions. And as Sloan mentioned, please, one question per analyst, and then we'll come back through the list again.

Vasant Narasimhan: We think a really great quarter for the company, and we look forward to continuing to drive strong performance through the remainder of this year. With that, we can open the line for questions. As Sloan mentioned, please one question per analyst, and then we'll come back through the list again. Thank you.

Speaker Change: So we think it's really a great quarter for the company, and we look forward to continuing to drive strong performance through the remainder of this year. So with that, we can open the line for questions, and as Sloan mentioned, please, one question per analyst, and then we'll come back through the list again. Thank you.

Vasant Narasimhan: So, with that, we can open the line for questions. And as Sloan mentioned, please, one question per analyst and then, we'll come back through the list again. Thank you.

Operator: 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. To withdraw your question, please press star one and one again. We will now take your first question. The question comes from the line of Emily Field from Barclays. Please go ahead.

Operator: Thank you. Thank you. To ask a question, you will need to press star 1 and 1 on your telephone and wait for your name to be announced.

Thank you.

Operator: Thank you. To ask a question, you will need to press star 1 and 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 and 1 again. We will now take your first question. And the question comes from the line of Emily Field from Barclays. Please go ahead. Hi, thank you so much for taking my question. I just wanted to ask for a bit more context, just on the Natalie delay of the PDUFA in the United States.

Operator: Thank you. To ask a question, you will need to press star 1 and 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 and 1 again.

Speaker Change: Thank you. To ask a question you will need to press star 1 and 1 on your telephone and wait for your name to be announced. To withdraw your question please press star 1 and 1 again.

Operator: To withdraw your question, please press star 1 and 1 again. We will now take your first question. And the question comes from the line of Emily Field from Barclays. Please go ahead. Hi, thank you so much for taking my question. I just wanted to ask for a bit more context, just on the Natalie delay of the PDUFA in the United States.

Operator: We will now take your first question. And the question comes from the line of Emily Field from Barclays. Please go ahead.

Emily Field: Hi, thank you so much for taking my question. I just wanted to ask for a bit more context, just on the NATALEE delay of the PDUFA in the United States. Can you confirm that this was very specific to the manufacturing issue and that the FDA did not ask for any additional information with regards to any of the subgroups or any additional information from the clinical trials? Thank you.

Beth: Can you confirm that this was, you know, very specific to the manufacturing issue and that the FDA did not ask for any additional information with regard to any of the subgroups or any additional information from the clinical trials? Thank you.

Speaker Change: We will now take your first question.

Speaker Change: And the question comes from the line of Emily Field from Barclays, please go ahead.

Emily Field: Hi, thank you so much for taking my question. I just wanted to ask for a bit more context just on the NATALEE delay of the PDUFA in the United States. Can you confirm that this was, you know, very specific to the manufacturing issue and that the FDA did not ask for any additional information with regards to any of the subgroups or, you know, any additional information from the clinical trials? Thank you.

Emily Field: Hi, thank you so much for taking my question. I just wanted to ask for a bit more context, just on the Natalie delay of the PDUFA in the United States.

Speaker Change: Can you confirm that this was, you know, very specific to the manufacturing issue and that the FDA did not ask for any additional information with regards to any of the subgroups or, you know, any additional information from the clinical trials? Thank you.

Beth: Yeah. Thanks, Emily. So, this was only related to the CMC issue. We've already initiated label discussions with the FDA. We submitted some additional data to support our provision of the CMC package. With that, we had the standard three-month extension because we had submitted that additional data so, that extends the PDUFA out by three months. We believe. now. we're well on track having finalized the submission of that data for an approval inside of Q3. Next question, operator. Thank you. Your next question comes from the line of Florent Cespedes from Bernstein. Please go ahead. Good afternoon.

Vasant Narasimhan: Yeah. Thanks, Emily. So, this was only related to the CMC issue. We've already initiated label discussions with the FDA. We submitted some additional data to support our provision of the CMC package. With that, we had the standard three-month extension because we had submitted that additional data so, that extends the PDUFA out by three months. We believe. now. we're well on track having finalized the submission of that data for an approval inside of Q3.

Vasant Narasimhan: Yeah. Thanks, Emily. This was only related to the CMC issue. We've already initiated label discussions with the FDA. We submitted some additional data to support our revision to the CMC package. With that, we had the standard a 3-month extension because we have submitted that additional data, so that extends the PDUFA out by 3 months. We believe now we're well on track, having finalized the submission of that data for an approval inside of Q3. Next question, operator.

Speaker Change: Yeah, thanks, Emily. So this was only related to the CMC issue. We've already initiated label discussions with the FDA. We submitted some additional data to support our provision to the CMC package. With that, we had the standard three-month extension because we had submitted that additional data. So that extends the PDUFA out by three months. We believe now we're well on track.

Beth: So that extends the PDUFA out by three months. We believe now we're well on track. Having finalized the submission of that data for an approval inside of. Next question, operator. Thank you. Your next question comes from the line of Florent Cespedes from Bernstein. Please go ahead. Good afternoon.

Speaker Change: having finalized the submission of that data for an approval inside of Q3.

Next question, operator. Thank you. Your next question comes from the line of Florent Cespedes from Bernstein. Please go ahead. Good afternoon.

Vasant Narasimhan: Next question, operator.

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

Thank you. Your next question comes from the line of Florent Cespedes from Bernstein. Please go ahead. Good afternoon.

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

Speaker Change: Next question, operator.

Speaker Change: Thank you. Your next question comes from the line of Florent Cespedes from Bernstein. Please go ahead.

Florent Cespedes: Good afternoon. Thank you very much for taking my question. A quick question on Cosantix and the new indication in HS. Could you give us some color on how you see the HS opportunity going forward? As it seems that you are getting new patients, you have a new treatment more potent than the existing one, but there will also be new entrants in the coming years? So some color on this HS market opportunity would be great. Thank you. Yeah, thanks, Florent.

Florent Cespedes: Good afternoon. Thank you very much for taking my question. A quick question on COSENTYX and the new indication in HS. Could you give us some color on how you see the HS opportunity going forward? As it seems that you are gaining new patients as you have a new treatment more potent than the existing one but there will also be new entrants in the coming years. So, some color on this HS market opportunity would be great. Thank you.

Beth: Thank you very much for taking my question. A quick question on Cosantix and the new indication in HS. Could you give us some color on how you see the HS opportunity going forward? As it seems that you are getting new patients, you have a new treatment more potent than the existing one, but there will also be new entrants in the coming years? So some color on this HS market opportunity would be great. Thank you. Yeah, thanks, Florent.

Florent Cespedes: Good afternoon. Thank you very much for taking my question. A quick question on Cosentyx, on the new indication in HS. Could you give us some color on how you see the HS opportunity going forward as it seems that you are gaining new patients as you have a new treatment, more potent than the existing one. But there will be also new entrants in the coming years. Some color on this HS market opportunity would be great. Thank you.

Florent Cespedes: Good afternoon. Thank you very much for taking my question. A quick question on cos and tix.

Florent Cespedes: And the new indication in HS, could you give us some color on how you see the HS opportunity going forward? As it seems that you are getting new patients, you have a new treatment, more potent than the existing one, but there will be also new entrants in the coming years. So some color on this HS market opportunity would be great. Thank you.

Vasant Narasimhan: Yeah. Thanks, Florent. As you know, historically, only anti-TNF ADALIMUMAB was the only medicine available--biologic medicine available for these patients. And so, I think the market has not grown to its full potential. I mean, HS is a relatively prevalent dermatological disease--I think the second most prevalent after psoriasis. So, something that--or the second or third most prevalent after psoriasis. So, I think it's something that's really a big unmet need. So, I would expect there to be a significant expansion in the market as more entrants come in. And we continue to believe that COSENTYX in HS alone, will [inaudible] $1 billion medicine. So, we're very optimistic on COSENTYX outlook in HS, even with other entrants coming in, simply because there is so much unmet need. Most patients are not on biologics or many of these patients have dropped out of the system and are not receiving care at all. Now, that physicians know [inaudible] there are safe options available, we believe more and more patients will be brought in. We see that broad-based, globally. As I mentioned as well, we see strong HS uptake for COSENTYX in the U.S. as well as in EU and international markets. So, we think it could be an attractive market in the long run. And we also have a pipeline we're developing as future agents to follow on for COSENTYX in HS. Now in Phase II studies but over--as it matures, we're excited about can we actually address HS with even higher efficacy medicines over time. Thank you very much.

Beth: As you know, historically, only anti-TNF adalimumab was the only medicine available, a biologic medicine available for these patients. And so I think the market has not grown to its full potential. I mean, HS is a relatively prevalent dermatological disease, I think the second most prevalent after psoriasis. So something that, or the second or third most prevalent after psoriasis.

Vasant Narasimhan: Yeah. Thanks, Florent. As you know, historically, only anti-TNF adalimumab was the only medicine available, biologic medicine available for these patients. I think the market had not grown to its full potential. I mean, HS is a relatively prevalent dermatological disease, I think the second most prevalent after psoriasis. Or second or third most prevalent after psoriasis. I think it's something that's really a big unmet need. I would expect there to be a significant expansion in the market as more entrants come in. We continue to believe that Cosentyx in HS alone, which will put a billion-dollar medicine. We're very optimistic on Cosentyx outlook in HS, even with other entrants coming in, simply because there is so much unmet need.

Speaker Change: Yeah, thanks, Florent. As you know, historically, only anti-TNFs, Adalimumab, was the only medicine available, biologic medicine available for these patients. And so I think the market had

Speaker Change: So, not grown to its full potential. I mean, HS is a relatively prevalent dermatological disease, I think it's second most prevalent after psoriasis. So, something that, or second or third most prevalent after psoriasis. So, I think it's...

Beth: So I think it's something that there is a big unmet need for, so I would expect there to be a significant expansion in the market as more entrants come in. And we continue to believe that Cosentix and HS alone will put a billion dollars in medicine. So we're very optimistic about Cosentix, Outlook, and HS, even with other entrants coming in simply because there is so much unmet need. Most patients are not on biologics, or many of these patients have dropped out of the system and are not receiving care at all. Now that physicians know there are safe options available, we believe more and more patients will be brought in. We see that broad-based globally.

Speaker Change: Something that's really a big unmet need.

Vasant Narasimhan: And we continue to believe that COSENTYX in HS alone, will [inaudible] $1 billion medicine. So, we're very optimistic on COSENTYX outlook in HS, even with other entrants coming in, simply because there is so much unmet need. Most patients are not on biologics or many of these patients have dropped out of the system and are not receiving care at all. Now, that physicians know [inaudible] there are safe options available, we believe more and more patients will be brought in. We see that broad-based, globally. As I mentioned as well, we see strong HS uptake for COSENTYX in the U.S. as well as in EU and international markets. So, we think it could be an attractive market in the long run. And we also have a pipeline we're developing as future agents to follow on for COSENTYX in HS. Now in Phase II studies but over--as it matures, we're excited about can we actually address HS with even higher efficacy medicines over time.

Speaker Change: So I would expect there to be a significant expansion in the market as more entrants come in.

Speaker Change: And we continue to believe that Cosentics in NHS alone will equate to a billion dollar medicine. So we're very optimistic on Cosentics' outlook in NHS, even with other entrants coming in, simply because there is so much unmet need. Most patients are not on biologics, or many of these patients have dropped out of the system and are not receiving care at all. Now that physicians know

Vasant Narasimhan: Most patients are not on biologics or many of these patients have dropped out of the system and are not receiving care at all. Now that physicians know there are safe options available, we believe more and more patients would come in. We see that broad-based globally. I mentioned as well, we see strong HS uptake for Cosentyx in the US as well as in EU and international markets. We think it could be an attractive market in the long run. We also have a pipeline we're developing as future agents to follow on for Cosentyx in HS now in phase two studies. As it matures, we're excited about can we actually address HS with even higher efficacy medicines over time.

Speaker Change: There are safe options available. We believe more and more patients will be brought in. We see that broad-based globally. So I mentioned as well, we see strong HS uptake for casentics in the U.S. as well as in...

Vasant Narasimhan: As I mentioned as well, we see strong HS uptake for COSENTYX in the U.S. as well as in EU and international markets. So, we think it could be an attractive market in the long run. And we also have a pipeline we're developing as future agents to follow on for COSENTYX in HS. Now in Phase II studies but over--as it matures, we're excited about can we actually address HS with even higher efficacy medicines over time.

Beth: As I mentioned, we see strong HS uptake for Cosentix in the US as well as in EU and international markets. So we think it could be an attractive market in the long run. And we also have a pipeline we're developing as future agents to follow on for Cosentix in HS. Now in phase two studies, but as it matures, we're excited about can we actually address HS with even higher efficacy medicines. Thank you very much.

Speaker Change: So, we think it could be an attractive market in the long run, and we also have a pipeline we're developing as future agents to follow on for Cosentix.

Speaker Change: Now in Phase II studies, but over as it matures, we're excited about can we actually address HS with even higher efficacy medicines over time.

Florent Cespedes: Thank you very much.

Vasant Narasimhan: Next question. Operator, thank you, Florent.

Florent Cespedes: Thank you very much.

Operator: Thank you. Your next question comes from the line of Emmanuel Papadakis from Deutsche Bank. Please go ahead.

Speaker Change: Thank you very much. Great question. Operator, thank you for.

Beth: Thank you. Your next question comes from the line of Emmanuel Papadakis from Deutsche Bank. Please go ahead. Thank you for taking the question, the pipeline question on I and ALIMAP, which you pulled forward the readout on. Shogun's 2025. So just the drivers for that.

Operator: Thank you. Your next question comes from the line of Emmanuel Papadakis from Deutsche Bank. Please go ahead.

Speaker Change: Thank you. Your next question comes from the line of Emmanuel Papadakis from Deutsche Bank. Please go ahead.

Emmanuel Papadakis: Thank you for taking the question, the pipeline question on I and ALIMAP, which you pulled forward the readout on. Shogun's 2025. So just the drivers for that. David Soergel, Timothy Anderson, Stephen Scala, Simon Baker, Emmanuel Papadakis, Eric Berrigaud, the STI improvement you're hoping to show and indeed whether you still consider that to be the right and definitive endpoint. Thank you. Yeah, thanks, Emmanuel.

Emmanuel Papadakis: Thank you for taking the question. The pipeline question on IANALUMAB, which you pulled forward the readout in Sjögren to 2025. So, just the drivers for that confidence on probability of success and there's been a number of competitor updates in that space recently. So, just perhaps you could refresh us with your thoughts on the magnitude of ESSDAI improvement you're hoping to show and indeed, whether you still consider that to be the right and definitive endpoint. Thank you.

Harry Kirsch: Thank you for taking the question. The pipeline question on iscalimab, which you pulled forward the readout in Sjögren's 2025. Just the drivers for that confidence on probability of success, and there's been a number of competitor updates in that space recently. Just perhaps you could refresh us with your thoughts on the magnitude of ESSDAI improvement you're hoping to show, and indeed, whether you still consider that to be the right and definitive endpoint. Thank you.

Emmanuel Papadakis: Thank you for taking the question. The pipeline question on iscalimab, which you pulled forward the readout in Sjögren's 2025. Just the drivers for that confidence on probability of success, and there's been a number of competitor updates in that space recently. Just perhaps you could refresh us with your thoughts on the magnitude of ESSDAI improvement you're hoping to show, and indeed, whether you still consider that to be the right and definitive endpoint. Thank you.

Emmanuel Papadakis: Thank you for taking the question, the pipeline question on I and ALIMAP, which you pulled for the readout in Shogun's 2025, so just the drivers for that.

Beth: David Soergel, Timothy Anderson, Stephen Scala, Simon Baker, Emmanuel Papadakis, Eric Berrigaud, the STI improvement you're hoping to show and indeed whether you still consider that to be the right and definitive endpoint. Thank you. Yeah, thanks, Emmanuel.

Emmanuel Papadakis: Confidence on probability of success and there's been a number of competitor updates in that space recently so just perhaps you could refresh us with your thoughts on the magnitude of SDI improvement you're hoping to show and indeed whether you still consider that to be the right and definitive endpoint. Thank you.

Vasant Narasimhan: Yeah. Thanks, Emmanuel. So, absolutely, we saw very fast enrollment--higher, faster than expected enrollment for IANALUMAB in Sjögren's. We have pulled forward that readout. As you know, Sjögren--again, a relatively prevalent rheumatological disease without, really, any great--good treatment options. The Phase II data for IANALUMAB in Sjogren's--so, really, the first time that you could have a significant improvement in ESSDAI as well as other patient-reported outcomes. So, obviously, we won't quantitate the magnitude of ESSDAI benefit but if we can repeat what we saw in Phase IIb, we think that would be a really compelling option. Also, a unique mechanism of action, anti-BAFF, allows you to deplete B-cells in multiple compartments--which we think will be important for a disease like Sjögren's, which impacts multiple different tissues.

Beth: So, absolutely, we saw very fast enrollment, higher, faster than expected enrollment for Ionilumab and Sjogren. So we have pulled forward that readout. As you know, Sjogren's, again, a relatively prevalent rheumatological disease without really any great, good treatment options.

Vasant Narasimhan: Yeah. Thanks, Emmanuel. Absolutely. We saw a very fast enrollment, higher, faster than expected enrollment for ianalumab in Sjögren's. We have pulled forward that readout. As you know, Sjögren's, again, a relatively prevalent rheumatological disease without really any good treatment options. The phase 2 data for ianalumab in Sjögren's, really the first time that you could have a significant improvement in ESSDAI as well as other patient-reported outcomes. Obviously, we won't quantitate the magnitudes of ESSDAI benefit, but if we can repeat what we saw in phase 2b, we think that would be really a compelling option. Also a unique mechanism of action, anti-BAFF, allows you to deplete B cells in multiple compartments, which we think will be important for a disease like Sjögren's, which impacts multiple different tissues.

Speaker Change: Yeah, thanks, Emmanuel. So, absolutely, we saw very fast enrollment, higher, faster than expected enrollment for iron alabim in Sjogren's. We have pulled forward that readout. As you know, Sjogren's, again, a relatively prevalent rheumatological disease without really any great good treatment options.

Beth: The phase two data for Ionilumab and Sjogren, so this was really the first time that you could have a significant improvement in S-dye, as well as other patient-reported outcomes. So, obviously, we won't quantify the magnitudes of S-dye benefit, but if we can repeat what we saw in phase 2b, we think that would be a really compelling option. Also, a unique mechanism of action, anti-bath, allows you to deplete B-cells in multiple compartments, which we think will be important for a disease like Sjogren's, which impacts multiple different tissues.

Speaker Change: The Phase II data for inuloma have been shown, so really the first time that you could have a significant improvement in S. di as well as other patient report outcomes.

Speaker Change: So, obviously, we won't quantitate the magnitudes of SI benefit, but if we can repeat what we saw in Phase 2B, we think that would be really a compelling option. Also, a unique mechanism of action, Antibas.

Vasant Narasimhan: Also, a unique mechanism of action, anti-BAFF, allows you to deplete B-cells in multiple compartments--which we think will be important for a disease like Sjögren's, which impacts multiple different tissues. I think what will be important, in addition to ESSDAI, is patient-reported outcomes. I mean, salivary gland function, dry eye--many of these things, these areas are what patients would like to see improved. And if we can demonstrate--in addition to the composite endpoint--PROs that show important benefits for these patients, we think this could be an exciting opportunity. Overall, we think IANALUMAB is a multi-billion dollar opportunity. In combination with Sjögren's, we have multiple other Phase III programs ongoing in three separate--four separate hematological indications where we expect readouts in 2027. We will also take IANALUMAB into other immunology indications, as well. So, this is an opportunity for us to really build a significant medicine. And as a reminder as well, this medicine has protection into the mid to late 2030s. Thank you. Next question, operator.

Speaker Change: allows you to deplete B-cells in multiple compartments, which we think will be important for a disease like Sjogren's.

Beth: I think what will be important, in addition to S-dye, is patient-reported outcomes. I mean, salivary gland function, dry eye, many of these things; these are areas that patients would like to see improved. And if we can demonstrate, in addition to the composite endpoint, PROs that show important benefits for these patients, we think this could be an exciting opportunity. Overall, we think Ionilumab is a multi-billion dollar opportunity. In combination with Sjogren's, we have multiple other phase 3 programs ongoing in three separate, four separate hematological indications where we expect readouts in 2027. We will also take Ionilumab into other immunology indications, as well. So, this is an opportunity for us to really build a significant medicine. And as a reminder, as well, this medicine has protection into the mid to late stage. Thank you. Next question, operator.

Vasant Narasimhan: I think what will be important in addition to ESSDAI is patient-reported outcomes, meaning salivary gland function, dry eye. Many of these things, these areas are what patients would like to see improve. If we can demonstrate, in addition to the composite endpoint, PROs that show important benefits for these patients, we think this could be an exciting opportunity. Overall, we think ianalumab is a multi-billion dollar opportunity in combination with Sjögren's. We have multiple other phase III programs ongoing in four separate hematological indications where we expect readouts in 2027. We also take ianalumab into other immunology indications as well. This is an opportunity for us to really build a significant medicine. As a reminder as well, this medicine has protection into the mid to late 2030s. Thank you.

Speaker Change: which impact multiple different tissues. I think what will be important in addition to STI is patient-reported outcomes. I mean salivary gland function, dry eye. Many of these things, these areas are what patients would like to see improve. And if we can demonstrate, in addition to the composite endpoint,

Speaker Change: PROs that show important benefits for these patients. We think this could be an exciting opportunity. Overall, we think INLMM is a multi-billion dollar opportunity in combination with Sjogren's.

Vasant Narasimhan: Overall, we think IANALUMAB is a multi-billion dollar opportunity. In combination with Sjögren's, we have multiple other Phase III programs ongoing in three separate--four separate hematological indications where we expect readouts in 2027. We will also take IANALUMAB into other immunology indications, as well. So, this is an opportunity for us to really build a significant medicine. And as a reminder as well, this medicine has protection into the mid to late 2030s.

Speaker Change: We have multiple other Phase III programs ongoing in four separate hematological indications where we expect...

Speaker Change: readouts in 2027. We also take Ionilamab into other immunology indications as well. So this is an opportunity for us to really build a significant medicine and as a reminder as well this medicine has protection into the mid to late 2030s.

Beth: So, this is an opportunity for us to really build a significant medicine. And as a reminder, as well, this medicine has protection into the mid to late stage. Thank you. Next question, operator.

Vasant Narasimhan: Thank you. Next question, operator.

Vasant Narasimhan: Next question, operator.

Operator: Thank you. Your next question comes from the line of Richard Parkes from BNP Paribas. Please go ahead.

Speaker Change: Thank you. Next question, operator.

Speaker Change: Thank you. Your next question comes from the line of Richard Parkes from BNP Paribas. Please go ahead.

Richard Parkes: Hi, thank you for taking my question. I was going to stick on pipeline events in 2025. On PELACARSEN, probably your next sort of multi-blockbuster read out, could you just remind us what your powering assumptions are in terms of the benefit that you're looking to see in the Lp(a) HORIZON trial? And then, can you talk about barriers to uptake of Lp(a)-targeting agents? Obviously, PCSK9 uptake has been disappointing for investors, partly due to the need for injections and costs. I'm just wondering if those barriers are going to also limit Lp(a)-targeting agents or is the lack of available alternatives for patients with elevated Lp(a) going to mean those barriers are less significant? So, if you could just talk about that, that would be great. Thank you.

Richard Parkes: Hi. Thank you for taking my question. I was going to stick on pipeline events in 2025. On pelacarsen and probably your next sort of milestone was to read out. Could you just remind us what your powering assumptions are in terms of the benefit that you're looking to see in the Lp(a) HORIZON trial? And then can you talk about barriers to uptake of Lp(a) targeting agents? Obviously, PCSK9 uptake's been disappointing for investors, partly attributed to need for injections and costs. I'm just wondering if those barriers are gonna also limit Lp(a) targeting agents, or is the lack of available alternatives for patients with elevated Lp(a) gonna mean those barriers are less significant. So if you could just talk about that'd be great. Thank you.

Richard Parkes: Hi, thank you for taking my question. I was going to stick on pipeline events in 2025. On Pellicarta, and probably your next sort of multi-bottles to read out, could you just remind us what your...

Speaker Change: Powering assumptions are in terms of the benefit that you're looking to see in the LP little a horizon

Speaker Change: Can you talk about barriers to uptake of Lp-a targeting agents, PCSK9?

Speaker Change: I'm just wondering if those barriers are going to also limit LP, delay targeting agents or is the lack of...

Beth: I'm just wondering if those barriers are going to also limit LP little a targeting agents, or is the lack of available alternatives for patients with elevated LP little a going to mean those barriers are less significant? So if you could just talk about that, that would be great. Yeah, thank you, Richard. So, first, in terms of study design, the way we designed the Pellicarson study was to look at two different levels of Lp a.

I'm just wondering if those barriers are going to also limit LP little a targeting agents, or is the lack of available alternatives for patients with elevated LP little a going to mean those barriers are less significant? So if you could just talk about that, that would be great.

Speaker Change: available alternatives for patients with elevated Lp little a gonna mean those barriers are less significant So if you could just talk about that, that would be great. Thank you

Vasant Narasimhan: Yeah. Thank you, Richard. So first, in terms of study design, the way we designed the PELACARSEN study was to look at two different levels of Lp(a). So first, the top quartile of--at the top quartile of Lp(a) levels and then, a separate analysis--still part of the primary endpoint, which allows us to take a second look at the top decile of patients in terms of their level of Lp(a). That was based on large-scale epidemiologic studies on how risk evolves from different quartiles and deciles of patients with elevated Lp(a). So, our hope is to [inaudible] show both of those analyses and our goal will be to show greater than 20% CVRR but of course, we have aspirations to get even higher. And I think if we can show even higher levels, that would certainly create a lot of motivation in physicians to make sure these patients are tested. One of the things we've learned, I think, through our various cardiovascular launches is, in this day and age, to take more of a specialty cardiology mindset in how we think about launching these medicines. So, rather than trying to do broad-based Lp(a) testing for patients across large populations, is to actually look very systematically looking at large-scale data sets and really targeting the groups, ethnicities that have the highest risk of elevated Lp(a) and try to promote high levels of testing within those patient populations. And alongside that, to target specialty groups which have a higher propensity to want to test and treat. So, those are, of course, cardiovascular specialty groups but also, when you think about interventional cardiology, there's certain specialty groups we're learning that have a higher propensity to look for these biomarkers and then treat in order to avoid the recurrence of events. Also, given the push toward healthcare quality around the world. we're trying to take a very targeted approach in how we think about our LP as a little launch and, in the future, and cardiovascular launches in general, take a more specialty mindset, which allows us to target the right patients in the right positions with better resource allocation and hopefully drive more rapid uptake. Thank you, Richard.

Beth: So first, the top quartile of at the top quartile of Lp a levels, and then a separate analysis, still part of the primary endpoint, which allows us to take a second look at the top decile of patients in terms of their level of Lp a. And that was based on, you know, large-scale epidemiologic studies on how risk evolves from different quartiles and deciles of patients with elevated Lp So our hope is to show both of those analyses, and our goal will be to show greater than 20% CBRR.

Vasant Narasimhan: Yeah, thank you, Richard. First, in terms of the study design, the way we designed the pelacarsen study was to look at two different levels of Lp(a). First, the top quartile of Lp(a) levels, and then a separate analysis, still part of the primary endpoint, which allows us to take a second look at the top decile of patients in terms of their level of Lp(a). That was based on, you know, large scale epidemiologic studies on how risk evolves from different quartiles and deciles of patients with elevated Lp(a). Our hope is to show both of those analysis. I mean, our goal will be to show greater than 20% CVRR. But of course, we have aspirations to get even higher.

Speaker Change: Yeah, thank you, Richard. So first in terms of the study design, the way we designed the Paul Carson study was to look at

Speaker Change: two different levels of Lp a. So first, the top quartile of at the top quartile of Lp a levels

Speaker Change: And then a separate analysis, still part of the primary endpoint, which allows us to take a second look at the top decile of patients in terms of their level of LTa, and that was based on

Speaker Change: you know large-scale epidemiologic studies on how risk evolves from different quartiles and deciles of patients.

Speaker Change: with elevated LP little a so our hope is to show both of those analysis and our goal will be to show greater than 20% CBRR but of course we have aspirations to get even higher and I think if we can show even higher levels that would certainly create a lot of motivation

Vasant Narasimhan: And I think if we can show even higher levels, that would certainly create a lot of motivation in physicians to make sure these patients are tested. One of the things we've learned, I think, through our various cardiovascular launches is, in this day and age, to take more of a specialty cardiology mindset in how we think about launching these medicines. So, rather than trying to do broad-based Lp(a) testing for patients across large populations, is to actually look very systematically looking at large-scale data sets and really targeting the groups, ethnicities that have the highest risk of elevated Lp(a) and try to promote high levels of testing within those patient populations. And alongside that, to target specialty groups which have a higher propensity to want to test and treat. So, those are, of course, cardiovascular specialty groups but also, when you think about interventional cardiology, there's certain specialty groups we're learning that have a higher propensity to look for these biomarkers and then treat in order to avoid the recurrence of events. Also, given the push toward healthcare quality around the world. we're trying to take a very targeted approach in how we think about our LP as a little launch and, in the future, and cardiovascular launches in general, take a more specialty mindset, which allows us to target the right patients in the right positions with better resource allocation and hopefully drive more rapid uptake. Thank you, Richard.

Vasant Narasimhan: I think if we can show even higher levels, that would certainly create a lot of motivation in physicians to make sure these patients are tested. One of the things we've learned, I think, through our various cardiovascular launches is, in this day and age, to take more of a specialty cardiology mindset in how we think about launching these medicines. Rather than trying to do broad-based Lp(a) testing for, patients across a large population, to actually look very systematically, looking at large scale datasets and really targeting the groups, ethnicities, that have the highest risk of elevated Lp(a) and try to promote high levels of testing within those patient populations. Alongside that, to target specialty groups which have a higher propensity to want to test, and treat.

Beth: But of course, we have aspirations to get even higher. And I think if we can show even higher levels, that would certainly create a lot of motivation in physicians to make sure these patients are tested. One of the things we've learned, I think, through our various cardiovascular launches is, in this day and age, to take more of a specialty cardiology mindset in how we think about launching, So rather than trying to do broad-based LP little a testing for patients across large populations to actually look very systematically looking at large scale data sets and really targeting the groups ethnicities that have the highest risk of elevated LP little a and try to promote high levels of testing within those patient populations.

Speaker Change: One of the things we've learned, I think, through our various cardiovascular launches is, in this day and age, to take more of a specialty cardiology mindset in how we think about launching these medicines.

Speaker Change: So rather than trying to do broad-based LP-a testing for patients across large populations, to actually look very systematically, looking at large-scale data sets, and really targeting groups, ethnicities.

Speaker Change: that have the highest risk of elevated LPLA and try to promote high levels of testing within those patient populations.

Vasant Narasimhan: And alongside that, to target specialty groups which have a higher propensity to want to test and treat. So, those are, of course, cardiovascular specialty groups but also, when you think about interventional cardiology, there's certain specialty groups we're learning that have a higher propensity to look for these biomarkers and then treat in order to avoid the recurrence of events. Also, given the push towards healthcare quality around the world. So, we're trying to take a very targeted approach in how we think about our Lp(a) little launch. In the future, as well, in cardiovascular launches in general--take a more specialty mindset, which allows us to target to the right patients and the right positions, with better resource allocation and hopefully, drive more rapid uptake in the future. Thank you, Richard.

Speaker Change: And alongside that, to target specialty groups which have a higher propensity to want to test and treat. So those are, of course, cardiovascular specialty groups, but also when you think about interventional cardiology, I mean, there are certain specialty groups we're learning.

Vasant Narasimhan: Those are, of course, cardiovascular specialty groups, but also when you think about interventional cardiology, I mean, there are certain specialty groups we're learning that have a higher propensity to look for these biomarkers and then treat in order to avoid the recurrence of events, also given the push towards healthcare quality around the world. We're trying to take a very targeted approach in how we think about our Lp(a) launch, and we're in the future as well, and cardiovascular launches in general take a more specialty mindset, which will allow us to target the right patients in the right positions with better resource allocation and hopefully drive more rapid uptake in the future. Thank you, Richard.

Speaker Change: that have a higher propensity to look for these biomarkers and then treat in order to avoid the recurrence of events, also given the push towards health care quality around the world.

Beth: So we're trying to take a very targeted approach in how we think about our LP as a little launch and, in the future, and cardiovascular launches in general, take a more specialty mindset, which allows us to target the right patients in the right positions with better resource allocation and hopefully drive more rapid uptake. Thank you, Richard.

Speaker Change: So we're trying to take a very targeted approach in how we think about our LP little a launch and in the future as well in cardiovascular launches in general take a more specialty mindset which allows us to target to the right patients in the right positions.

Speaker Change: with better resource allocation and hopefully drive more rapid uptake.

Richard Parkes: Thank you.

Speaker Change: in the future.

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

Speaker Change: Thank you, Richard. Thank you.

Beth: Thank you. Thank you. Your next question comes from the line of Graham Parry, Bank of America. Please go ahead. Thanks for taking my questions. I just want to come back to Natalie, actually.

Richard Parkes: Thank you.

Thank you. Your next question comes from the line of Graham Parry, Bank of America. Please go ahead. Thanks for taking my questions. I just want to come back to Natalie, actually.

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

Richard: Thank you.

Thanks for taking my questions. I just want to come back to Natalie, actually. Can you just clarify, you still think there's no manufacturing site inspection needed for the new process? I think you said in Q1 that you didn't expect to see one. I assume you'd actually know by now. And just again, that you remain confident that there is no adcom coming and that you have confidence in the broad label. I know there's some discussion in the market about the node negative patient population and whether that's approvable or not. Thank you. Yeah, thanks, Graham. Again, based on the label discussions that we have, we're confident in the broad label, and there is no manufacturing inspection.

Graham Parry: Thanks for taking my questions. I just want to come back to NATALEE, actually. Can you just clarify, you still think there's no manufacturing site inspection needed for the new process? I think you said on Q1 that you didn't expect to see one--I assume you'd actually know by now. And just, again, do you remain confident that there's no AdCom coming and confidence in the broad label? I know there's some discussion in the market about the node-negative patient population and whether that's approvable or not. Thank you.

Speaker Change: Your next question comes from the line of Graham Parry, Bank of America. Please go ahead.

Beth: Can you just clarify, you still think there's no manufacturing site inspection needed for the new process? I think you said in Q1 that you didn't expect to see one. I assume you'd actually know by now.

Graham Parry: Great. Thanks for taking my questions. Just wanted to come back to NATALEE, actually. Can you just clarify, you still think there's no manufacturing site inspection needed for the new process? I think you said on Q1, you didn't expect to see one. I assume you'd actually know by now. Just again, do you remain confident that there is no AdCom coming and confidence in the broad label? I know there's some discussion in the market about the node negative patient population and whether that's approvable or not. Thank you.

Graham Parry: Alright, thanks for taking my questions. Just wanted to come back to Natalie actually, can you just clarify, you still think there's no manufacturing site inspection needed for the new process? I think you said on Q1.

Speaker Change: You didn't expect to see on, I assume you'd actually know by now, and just again, that you remain confident that there is no adcom coming, and confidence in the broad label. I know there's some discussion in the market about the node negative patient population and whether that's approvable or not. Thank you.

Beth: And just again, that you remain confident that there is no adcom coming and that you have confidence in the broad label. I know there's some discussion in the market about the node negative patient population and whether that's approvable or not. Thank you. Yeah, thanks, Graham. Again, based on the label discussions that we have, we're confident in the broad label, and there is no manufacturing inspection.

Vasant Narasimhan: Yeah, thanks, Graham. Again, based on the label discussions that we have, we're confident in the broad label, and there is no manufacturing inspection. I mean, all of the changes we've made are related to product handling. I think, and some of the suppliers in the system, so there's no inspections. This is just providing stability data, which we're always obligated to do when we make changes. Once we provide that stability data and have adequate stability data, the FDA takes their decision. So it's really a topic of finalizing that review of our stability data from an FDA standpoint. But we have, in the broad label, no other inspections. We're gearing up for launch in late Q3. Next question, operator.

Speaker Change: Yeah, thanks, Graham. Again, based on the label discussions that we have, we're confident in the broad label, and there is no manufacturing inspection. I mean, all of the changes we've made are all related to product handling, and so I think...

Vasant Narasimhan: Yeah. Thanks, Graham. Again, based on the label discussions that we have, we're confident in the broad label and there is no manufacturing inspection. I mean, all of the changes we've made are all related to product handling. And so, I think--and some of the suppliers in the system so, there's no inspections; this is just providing stability data, which we're always obligated to do when we make changes. Once we finish providing that stability data and have adequate stability data, the FDA takes their decision. So, it's really a topic of finalizing that review of our stability data from an FDA standpoint. But we've [inaudible] in the broad label, no other inspections and we're gearing up for a launch in late Q3. Next question, operator.

Speaker Change: and some of the suppliers in the system, so there's no inspections, this is just providing stability data, which we're always obligated to do when we make changes, once we finish, provide that stability data and have adequate stability data, the FDA takes

Beth: I mean, all of the changes we've made are all related to product handling. And so I think, and some of the suppliers in the system, so there are no inspections; this is just providing stability data, which we're always obligated to do when we make changes. Once we finish providing that stability data and have adequate stability data, the FDA takes their decision. So it's really a topic of finalizing that review of our stability data from an FDA standpoint. But we've got equal content in the broad label, no other inspections, and we're gearing up for a launch in late Q3. Next question, operator.

Speaker Change: takes their decision. So it's really a topic of finalizing that review of our stability data from an FDA standpoint. But we've put a little content in the broad label, no other inspections, and we're gearing up for a launch in late Q3.

Vasant Narasimhan: Next question, operator.

Beth: Thank you. Your next question comes from the line of James Quigley from Goldman Sachs. Please go ahead. Great, thank you for taking my questions. I've got one on Plavicto.

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

Speaker Change: Next question, operator.

Speaker Change: Thank you. Your next question comes from the line of James Quigley from Goldman Sachs. Please go ahead.

Great, thank you for taking my questions. I've got one on Plavicto. So could you walk us through some of the competitive dynamics you're seeing in the US? I mean, you mentioned some of the centers had a 30% share. So what are the considerations there in terms of driving the increase in share in those centers? And then, thinking also about the community centers, where are you in terms of the development of the community centers and Plavicto and the offering there? And when you speak to docs, physicians, in those centers, how are they thinking about Plavicto, which is relatively more complicated than the androgen receptor inhibitors, which are all simple and seem to be launching quite strongly as well? Thank you. Yeah, thanks, James.

James Quigley: Great, thank you for taking my questions. I've got one on PLUVICTO. So, could you walk us through some of the competitive dynamics you're seeing in the U.S.? I mean, you mentioned some of the centers had 30% share so, what are the considerations there in terms of driving the increase in share in those centers? And then, thinking also about the community centers, where are you in terms of the development of the community centers and PLUVICTO and the offering there? And when you speak to docs, physicians in those centers, how are they thinking about PLUVICTO--which is relatively more complicated than the androgen receptor inhibitors, which are all simple and seem to be launching quite strongly as well? Thank you.

Beth: So could you walk us through some of the competitive dynamics you're seeing in the US? I mean, you mentioned some of the centers had a 30% share. So what are the considerations there in terms of driving the increase in share in those centers? And then, thinking also about the community centers, where are you in terms of the development of the community centers and Plavicto and the offering there? And when you speak to docs, physicians, in those centers, how are they thinking about Plavicto, which is relatively more complicated than the androgen receptor inhibitors, which are all simple and seem to be launching quite strongly as well? Thank you. Yeah, thanks, James.

James Quigley: Great. Thank you for taking my questions. I've got one on Pluvicto. So could you walk us through some of the competitive dynamics you're seeing in the US? I mean, you mentioned some of the centers had 30% share. So what is the considerations there in terms of driving the increase in share in those centers? And then thinking also about the community centers, where are you in terms of the development of the community centers and Pluvicto and the offering there? And when you speak to docs, physicians in those centers, how are they thinking about Pluvicto, which is relatively more complicated than the androgen receptor inhibitors, which are overall simple and seems to be launching quite strongly as well? Thank you.

James Quigley: Great, thank you for taking my questions. I've got one on Plavicto. Could you walk us through some of the competitive dynamics you're seeing in the US? I mean, you mentioned some of the centres.

Speaker Change: 30% share. So what is the consideration there in terms of...

Speaker Change: driving the increase in share in those centres, and then thinking also about the community centres...

Speaker Change: Where are you in terms of...

Speaker Change: in terms of the development of the community centres and Plovicto and the offering there. And when you speak to docs, physicians in those centres, how are they thinking about Plovicto, which is relatively more complicated than the androgen receptor inhibitors, which are all simple and seem to be launching quite strongly as well. Thank you.

Vasant Narasimhan: Yeah. Thanks, James. When you look at the dynamics on PLUVICTO--so we have, let's say, roughly 425 centers and about a third of those centers, we were really well-established. In the VISION population, we see 90% market share. So, really, high levels of share of the VISION patients. Then we have another group of centers which are still earlier on in their evolution, we see about 50% share. Our goal is to get them to 90%. The last third of centers are much more in the community and here, the dynamics are where we have to just do more work. A lot of it is education so, physicians understand, rather than cycling through--in the case of the VISION population, cycling through chemo and perhaps doing extra rounds of chemo, it's better to refer and have the patients receive PLUVICTO, given the compelling results that we saw in the VISION study. So, in order to motivate that, we're doing a few things, as I mentioned: another field force to get out there to educate on community oncology, community urology and as well, to strengthen that referral base. Second, DTC to make sure patients understand in the community that there is this option, rather than cycling through chemo earlier on--where we know the earlier patients get PLUVICTO, the better the outcomes--to try to motivate that.

Beth: When you look at the dynamics on PluVicto, so we have, let's say, roughly 425 centers, and about a third of those centers, we were really well established in the vision population. We see 90% market share, so really high levels of share of the vision patients. Then we have another group of centers, which are still earlier on in their evolution, we see about 50% share.

Vasant Narasimhan: Yeah, thanks, James. When you look at the dynamics on Pluvicto, we have, let's say, roughly 425 centers. In about a third of those centers, which we're really well established. In the VISION population, we see 90% market share, really high levels of share of the VISION patients. Then we have another group of centers which are still earlier on in their evolution. We see about 50% share. Our goal is to get them to 90%. The last third of centers are much more in the community, and here the dynamics are where we have to just do more work.

Speaker Change: Yeah, thanks, James. When you look at the dynamics on Pluvikto, so we have, let's say, roughly 425 centers, and about a third of those centers

Speaker Change: We were really well established in the vision population, we see 90% market share, so really high levels of share of the vision patients. Then we have another group of centers which are still earlier on in their evolution, we see about 50% share, our goal is to get them to 90%.

Beth: Our goal is to get them. The last third of centers are much more in the community, and here the dynamics are where we have to just do more work. A lot of it is education, so physicians understand rather than cycling through, in the case of the vision population, cycling through chemo and perhaps doing extra rounds of chemo, it is better to refer and have the patients receive Fluvicto, given the compelling results that we saw.

Speaker Change: that.

Speaker Change: The last third of centers are much more in the community, and here the dynamics are where we have to just do more work. A lot of it is education, so physicians understand, rather than cycling through, in the case of the vision population, cycling through chemo, and perhaps doing extra rounds of chemo better to refer and have the patients receive Fluvicto, given the compelling results that we saw.

Vasant Narasimhan: A lot of it is education, so physicians understand rather than cycling through, in the case of the VISION population, cycling through chemo and perhaps doing extra rounds of chemo. Better to refer and have the patients receive Pluvicto, given the compelling results that we saw in the VISION study. In order to motivate that, we're doing a few things, as I mentioned, another field force to get out there to educate community oncology, community urology, and as well to strengthen that referral base. Second, DTC to make sure patients understand in the community that there is this option. Rather than cycling through chemo earlier on, where we know the earlier patients get Pluvicto, the better the outcomes to try to motivate that.

Vasant Narasimhan: A lot of it is education so, physicians understand, rather than cycling through--in the case of the VISION population, cycling through chemo and perhaps doing extra rounds of chemo, it's better to refer and have the patients receive PLUVICTO, given the compelling results that we saw in the VISION study. So, in order to motivate that, we're doing a few things, as I mentioned: another field force to get out there to educate on community oncology, community urology and as well, to strengthen that referral base. Second, DTC to make sure patients understand in the community that there is this option, rather than cycling through chemo earlier on--where we know the earlier patients get PLUVICTO, the better the outcomes--to try to motivate that.

Beth: So in order to motivate that, we're doing a few things, as I mentioned, another field force to get out there to educate on community oncology, community urology, and as well to strengthen that referral base. Second, DTC to make sure patients understand in the community that there is this option, rather than cycling through chemo. Earlier on, where we know the earlier patients get FluVicto, the better the outcomes, to try to motivate that.

Speaker Change: In order to motivate that, we're doing a few things, as I mentioned, another field force to get out there to educate on community oncology, community urology, and as well to strengthen that referral base.

Speaker Change: Second, DTC to make sure patients understand in the community that there is this option rather than cycling through chemo. Earlier on, where we know the earlier patients get FluVicto, the better the outcomes.

Vasant Narasimhan: And I think if we can unlock that segment over the course of the coming months, we can continue to drive PLUVICTO in the VISION population to the multi-billion--or roughly $2 billion potential we think there is. And that includes globally. I would say we're seeing very robust uptake in Germany and over time, we expect robust uptake in other European markets. Now, all of that is important for the current indication but even more important as we move to PSMAfore, where we have three times the patient population. And there, again, it will be really important to, over time, build up confidence in the community to be able--outside of [inaudible] the medical centers [inaudible] to provide radioligand therapy. Not only for PLUVICTO but our portfolio of radioligand therapies that we're currently developing. So, we're confident we're going to get there--step by step but it will take time. I think things like the patient-ready dose will help; I think also, enabling--we have a whole team that enables centers to be able to deploy radioligand therapy in their clinics, which will allow them to, hopefully, not have to refer out but actually provide RLT even within their centers, in their own establishments which will also be, I think really, really attractive. So, it's all on track, in our view, to build this into a major opportunity. And I would also want to take a moment to reflect that in RLT, we have a number of things still continuing to develop.

Vasant Narasimhan: I think if we can unlock that segment over the course of the coming months, we can continue to drive Pluvicto in the VISION population to the multi-billion or roughly $2 billion potential we think there is. That includes globally. I would say we're seeing very robust uptake in Germany, and over time, we expect robust uptake in other European markets. Now, all of that is important for the current indication, but even more important as we move to PSMAfore, where we have three times the patient population. There again, it will be really important to, over time, build up confidence in the community to be able, outside of the main medical centers, to provide radioligand therapy, not only for Pluvicto, but our whole portfolio of radioligand therapies that we're currently developing.

Speaker Change: to try to motivate that. And I think if we can unlock that segment over the course of the coming months, we can continue to drive fluvicto in the vision population.

Speaker Change: to the multi-billion or roughly $2 billion potential we think there is, and that includes globally. I would say we're seeing very robust uptake in Germany, and over time we expect robust uptake in other European markets.

Speaker Change: Now, all of that is important for the current indication, but even more important as we move to PSMA-4, where we have three times the patient population. And there, again, it will be really important to, over time, build up confidence in the

Vasant Narasimhan: And there, again, it will be really important to, over time, build up confidence in the community to be able--outside of [inaudible] the medical centers [inaudible] to provide radioligand therapy. Not only for PLUVICTO but our portfolio of radioligand therapies that we're currently developing. So, we're confident we're going to get there--step by step but it will take time. I think things like the patient-ready dose will help; I think also, enabling--we have a whole team that enables centers to be able to deploy radioligand therapy in their clinics, which will allow them to, hopefully, not have to refer out but actually provide RLT even within their centers, in their own establishments which will also be, I think really, really attractive. So, it's all on track, in our view, to build this into a major opportunity. And I would also want to take a moment to reflect that in RLT, we have a number of things still continuing to develop.

Beth: And I would also want to take a moment to reflect that in RLT, we have a number of things still continuing to develop.

Speaker Change: in the community to be able, outside of being medical centers, to provide radioligand therapy, not only for Plovicto, but our whole portfolio of radioligand therapies that we're currently developing.

Vasant Narasimhan: We're confident we're gonna get there step by step, but it will take time. I think things like the patient-ready dose will help. I think also we have a whole team that enables centers to be able to deploy radioligand therapy in their clinics, which will allow them to hopefully not have to refer out, but actually provide RLT even within their centers, in their own establishments, which also will be, I think, really attractive. It's all on track in our view to build this into a major opportunity. I would also wanna take a moment to reflect that in RLT, we have a number of things still continuing to develop. We are working on Lutathera in small cell lung cancer and glioblastoma.

Speaker Change: So we're confident we're going to get there step by step, but it will take time. I think things like the patient-ready dose will help. I think also enabling, we have a whole team that enables centers to be able to deploy radioligand therapy in their clinics.

Speaker Change: which will allow them to hopefully not have to refer out, but actually provide RLT even within their centers, in their own establishments, which also would be, I think, really, really attractive.

Vasant Narasimhan: So, it's all on track, in our view, to build this into a major opportunity. And I would also want to take a moment to reflect that in RLT, we have a number of things still continuing to develop. We are working on LUTATHERA in small cell lung cancer and glioblastoma. Both of those are in Phase IIb studies. We, in addition, have clinical-stage programs with anti-integrin, anti-bombesin and anti-FAP. We're advancing now into a clinic--a program we're very excited about--a HER2 RLT, where we hope to be able to demonstrate that RLT can provide a compelling safety profile versus current HER2 ADCs. And as well now--with the recent acquisition of Mariana Oncology--moving rapidly to the clinic, additional RLT programs; some of which taking on ADC targets that are established; some of them taking novel targets, which we think could only be used using RLT. So, that's the level of confidence and investment we have in RLT for the long run and we look forward now to getting out into the community and, over time, establishing this as something that's part of routine cancer care in the U.S. and around the world. Next question, operator. Thank you, James.

Speaker Change: So, it's all on track, in our view, to build us into a major opportunity. And I would also want to take a moment to reflect that, in RLT, we have a number of things still continuing to develop. We are working on Lutathera in small cell lung cancer and glioblastoma. Both of those are in disease.

Beth: We are working on glutathera and small cell lung cancer and glioblastoma. Both of those are in phase 2b studies. We, in addition, have clinical stage programs with anti-integrin, anti-bombastic, and NTFAP. We're advancing now into a clinic, a program we're very excited about, a HER2 RLT, where we hope to be able to demonstrate that RLT can provide a compelling safety profile versus current HER2 ADCs. And now, with the recent acquisition of Mariana Oncology, moving rapidly to the clinic, additional RLT programs, some of which taking on ADC targets that are established, some of them taking novel targets, which we think could only be used using RLT.

Vasant Narasimhan: Both of those are in Phase 2b studies. We, in addition, have the clinical-stage programs with anti-integrin, anti-von Willebrand, and anti-SAP. We're advancing now into the clinic a program we're very excited about, a HER2 RLT, where we hope to be able to demonstrate that RLT can provide a compelling safety profile versus current HER2 ADCs. As well now with the recent acquisition of Mariana Oncology, moving rapidly to the clinic, additional RLT programs, some of which taking on ADC targets that are established, some of them taking novel targets, which we think could only be used using RLT.

Speaker Change: to be studied.

Speaker Change: We, in addition, have clinical stage programs with anti-integrin, anti-bombosin.

Speaker Change: We're advancing now into a clinic, a program we're very excited about, a HER2 RLT, where we hope to be able to demonstrate that RLT can provide a compelling safety profile versus current HER2 ADCs.

Vasant Narasimhan: And as well now--with the recent acquisition of Mariana Oncology--moving rapidly to the clinic, additional RLT programs; some of which taking on ADC targets that are established; some of them taking novel targets, which we think could only be used using RLT. So, that's the level of confidence and investment we have in RLT for the long run and we look forward now to getting out into the community and, over time, establishing this as something that's part of routine cancer care in the U.S. and around the world.

Speaker Change: And as well now, with the recent acquisition of Marriott Oncology, moving rapidly to the clinic, additional RLT programs, some of which taking on ADC targets that are established, some of them taking novel targets which we think could only be used using RLT.

Beth: So, you know, that's the level of confidence and investment we have in RLT for the long run, and we look forward now to getting out into the community and, over time, establishing this as something that's part of routine cancer care in the U.S. Next question. Thank you, James.

Vasant Narasimhan: You know, that's the level of confidence and investment we have in RLT for the long run, and we look forward now to getting it out into the community and over time establishing this as something that's part of routine cancer care in the US, and around the world. Next-

Speaker Change: So, you know, that's the level of confidence and investment we have in RLT for the long run. And we look forward now to getting out into the community and over time establishing this as something that's part of routine cancer care in the U.S. and around the world.

James Quigley: Perfect. Thank you.

Vasant Narasimhan: Question, operator. Thank you, James.

Vasant Narasimhan: Next question, operator. Thank you, James.

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

Speaker Change: [inaudible]

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

Speaker Change: Thank you, James. Thank you.

Speaker Change: Your next question comes from the line of Mark Purcell from Morgan Stanley . Please go ahead.

Mark Purcell: Yeah, thank you very much for taking my question. Vas, your revenue aspiration is for mid-single digit growth out to 2030. And now, on a 2024 base, we've got $66 billion. And when we look at consensus, it's about $53 billion at the moment before the results that were very strong today. So, about a $13 billion gap. So, which growth drivers, in your opinion, does consensus underappreciate? And what are the key readouts and progress points that we should look out for which should close the disconnect between expectations and your aspirations?

Mark Purcell: Yeah, thank you very much for taking my question. Vas, your revenue aspiration is for mid-single-digit growth out to 2030, and that on a 2024 base would be at $66 billion. When we look at consensus, it's about $53 billion at the moment before the results that were very strong today, so about a $13 billion gap. Which growth drivers in your opinion does consensus underappreciate? What are the key readouts and progress points that we should look out for which could close the disconnect between expectations and your aspirations?

Mark Purcell: Thank you very much for taking my question. Vas, your revenue aspiration is for mid-single-digit growth out to 2030 and that on a 2024 base would be about $66 billion and when we look at consensus it's about $53 billion at the moment before the results that were very strong today, so about a $13 billion gap. So which growth drivers, in your opinion, does consensus underappreciate and what are the key readouts and progress points that we should look out for which could close the disconnect between expectations and your aspirations?

Beth: So which growth drivers, in your opinion, does consensus underappreciate? And what are the key readouts and progress points that we should look out for? Yeah, thanks, Mark. So obviously, it's often the case that our aspirations are ahead of consensus. The first thing I'd say is, if you look back in 2017, what we said we delivered on a basis, we were a $35 billion innovation, innovative medicines company, and this year, we'll approach a $50 billion innovative medicine company. So I think we generally have delivered against what we said we were going to do.

So which growth drivers, in your opinion, does consensus underappreciate? And what are the key readouts and progress points that we should look out for?

Vasant Narasimhan: Yeah. Thanks, Mark. Obviously, it's often the case that our aspirations are ahead of consensus. The first thing I'd say is, if you look back in 2017 what we said, we delivered, on a historical basis. We were a $35 billion innovative medicines company, and this year we'll approach a $50 billion innovative medicines company. I think we generally have delivered against what we said we were gonna do. When you look at the consensus as you get further out, and as you know, fewer and fewer analysts as you get, you know, farther into the future, there are a few brands that I think are high on our mind. I mean, of course, Kisqali, Pluvicto, Leqvio, iptacopan, all we believe we can drive higher than currently what's out there within the consensus figures.

Speaker Change: Yeah, thanks, Mark. So, obviously, it's...

Vasant Narasimhan: Yeah. Thanks, Mark. So, obviously, it's often the case that our aspirations are ahead of consensus. The first thing I'd say is, if you look back in 2017--what we said, we delivered on an apple-to-apple basis, We were a $35 billion innovation--innovative medicines company and this year, we'll approach a $50 billion innovative medicines company. So, I think, we generally have delivered against what we said we were going to do. So, when you look at the consensus as you get further out--and, as you know, [inaudible] fewer and fewer analysts as you get farther into the future--there are a few brands that I think are high in our mind. I mean, of course, KISQALI, PLUVICTO, LEQVIO, IPTACOPAN--all, we believe we can drive higher than currently what's out there within the consensus figues. And depending on the brand, there's different amounts of variability.

Vas: Well, often the case that our aspirations are ahead of consensus. The first thing I'd say is if you look back in 2017, what we said, we delivered, on a full-time basis. We were a $35 billion innovation, innovative medicines company, and this year we'll approach a $50 billion innovative medicines company.

Beth: So when you look at the consensus as you get further out, and, as you know, a lot fewer and fewer analysts as you get, you know, farther into the future, there are a few brands that I think are high in our mind. I mean, of course, Kisgali, Pluvicto, Lecvio, Tactopan, all we believe we can drive higher than currently what's out there within the market. And depending on the brand, there's different amounts of variability.

Vas: So I think we generally have delivered against what we said we were going to do.

Vas: So when you look at the consensus as you get further out,

Vas: you know, farther into the future. There are a few brands that I think are high in our mind. I mean, of course.

Vasant Narasimhan: I mean, of course, KISQALI, PLUVICTO, LEQVIO, IPTACOPAN--all, we believe we can drive higher than currently what's out there within the consensus figues. And depending on the brand, there's different amounts of variability. Certainly, SCEMBLIX, with $3 billion-plus potential but also with the fact that historically, IMATINIB achieved $4.4 billion globally. We still think there's an opportunity for that medicine's full potential to be appreciated, let's say. And then, when you look at REMIBRUTINIB, you look at VAY--you also have here medicines that are in late-stage development, they'll be launching relatively soon, that we think have the potential to also close a significant portion of the gap.

Vas: Kisgali, Puevito, Lefio, Itakopan, all we believe we can drive higher than currently what's out there within the consensus.

Vasant Narasimhan: Depending on the brand, there's different amounts of variability. Certainly, Scemblix with $3 billion plus potential, but also with the fact that, you know, historically imatinib achieved $4.4 billion globally, we still think there's an opportunity for that medicine's full potential to be appreciated, let's say. When you look at remibrutinib, you look at VAY736, you also have here medicines that are in late stage development, they'll be launching relatively soon, that we think have, you know, the potential to also close a significant portion of the gap. So that alone, that portfolio of medicines, all of which have a pretty long timelines ahead of them, I think can really help us, hopefully over time, close that gap in the early 2030s.

Beth: Certainly Semblix, with $3 billion plus potential, but also with the fact that, you know, historically Imatinib achieved $4.4 billion globally. We still think there's an opportunity for that medicine's full potential to be appreciated, let's say. And then when you look at remibrutinib, you look at VAY, you also have medicines that are in late stage development, they'll be launching relatively soon, that we think have, you know, the potential to also close a significant portion of the gap.

Vas: And depending on the brand, there's different amounts of variability.

Vas: Certainly Semblix with $3 billion plus potential, but also with the fact that historically Imatinib achieved $4.4 billion globally.

Vas: We still think there's an opportunity for that medicine's full potential to be

Vas: Appreciate it, let's say.

Vas: And then when you look at Remy Brutonib, you look at VAY, you also have Hero Medicines, they're in late stage development, they'll be launching relatively soon, that we think have, you know,

Vas: [inaudible]

Vasant Narasimhan: So, that alone, those--that portfolio of medicines, all of which have pretty long timelines ahead of them, I think can really help us hopefully, over time, close that gap in the early 2030s. But I think then, what is really on us now, is to show that the next wave of medicines that we have coming are going to be compelling. So, of course, medicines like PELACARSEN, which we've already discussed on the call; we have novel hypertension and heart failure agent, XXB, that we'll be reading out relatively shortly in hypertension and soon in heart failure.

Vas: So, pretty long timelines ahead of them.

Vas: I think can really help us, hopefully over time, close that gap in the early 2030s. But I think then what is really on us now is to show that the next wave of medicines that we have coming that are going to be compelling. So of course, medicines like telecarcin, which we've already discussed on the call, we have novel hypertension and heart failure agent XXV that we'll be reading out relatively shortly in hypertension and soon in heart failure. As I mentioned, a very broad portfolio of RLTs and cancer. And if any one of those were to hit, they could be very significant.

Vasant Narasimhan: I think then what is really on us now is to show that the next wave of medicines that we have coming that are gonna be compelling. Of course, medicines like pelacarsen, which we've already discussed on the call. We have novel hypertension and heart failure agent XXB that we'll be reading out relatively shortly in hypertension and soon in heart failure. As I mentioned, a very broad portfolio of RLTs in cancer. If any one of those were to hit, they could be very significant medicine. We're very uniquely positioned there, given the scale, the size, and our ability to do both actinium and lutetium. Now building upon that, we also not yet in numbers, which is understandable. We continue to have conviction around immune reset.

Vasant Narasimhan: As I mentioned, a very broad portfolio of RLTs in cancer. And if any one of those were to hit, they could be very significant medicines. And we're very uniquely positioned there, given the scale of size and our ability to do both actinium and lutetium. Now, taking upon that, we're also not yet in numbers--which is understandable. We continue to have conviction around immune reset--we think, between YTB and some of our other programs in immunology, this is a large, multi-billion dollar opportunity. Which is also difficult for competitors to come into given the scale that we, and only a few other competitors, have within cell therapy. And then lastly, we have, obviously, emerging assets within the siRNA space as well that we're hoping to provide updates on in the coming period. So, a combination of existing assets you all have seen, know and will provide more and more data and provide, as you see with our performance today, conviction that they have higher peak sales potential.

Vas: We're very uniquely positioned there given the scale of size and our ability to do both actinium and lutetium.

Vas: And taking upon that, we also not yet in numbers, which is understandable, we continue to have conviction around immune reset, we think.

Vasant Narasimhan: We think between YTB323 and some of our other programs in immunology, this is a large multi-billion dollar opportunity, which is also difficult for competitors to come into given the scale that we and only a few other competitors have within cell therapy. Lastly, we have obviously emerging assets within the siRNA space as well, that we're hoping to provide updates on in the coming period. A combination of existing assets you all have seen, know, and will provide more and more data and provide, as you see with our performance today, conviction that they have higher peak sales potential.

Beth: This is a large, multi-billion dollar opportunity, which is also difficult for competitors to come into given the scale that we and only a few other competitors have within cell therapy. And then lastly, we have obviously emerging assets within the siRNA space as well that we're hoping to provide updates on, period. So a combination of existing assets that you all have seen, know, and will provide more and more data and provide, as you see with our performance today, conviction that they have higher peak sales potential.

Vas: Between YTV and some of our other programs in immunology, this is a large multi-billion dollar opportunity, which is also difficult for competitors to come into, given the scale that we and only a few other competitors have within cell therapy.

Vasant Narasimhan: And then lastly, we have, obviously, emerging assets within the siRNA space as well that we're hoping to provide updates on in the coming period. So, a combination of existing assets you all have seen, know and will provide more and more data and provide, as you see with our performance today, conviction that they have higher peak sales potential.

Vasant Narasimhan: And then lastly, we have, obviously, emerging assets within the siRNA space as well that we're hoping to provide updates on in the coming period.

Vasant Narasimhan: So, a combination of existing assets you all have seen, know and will provide more and more data and provide, as you see with our performance today, conviction that they have higher peak sales potential. Second is assets that we hope will read out and get approved in the next few years with significant multi-billion dollar potential. And then, a very broad early-stage pipeline in our core therapeutic areas, in our core technology areas which I think, again, will prove out over time. We look forward to the challenge but we're very confident that we'll be able to deliver against the goals we set out, as we've done over the last seven years. Thank you.

Vas: And then lastly, we have, obviously, emerging assets within the siRNA space, as well, that we're hoping to provide updates on.

Beth: Second, we have assets that we hope will read out and get approved in the next few years with significant multi-billion dollar potential, and then a very broad early stage pipeline in our core therapeutic areas and in our core technology areas, which I think, again, will prove out over time. We look forward to the challenge, but we're very confident that we'll be able to deliver against the goals we set out, as we've done over the last Thank you.

Vas: in the coming period. So a combination of existing assets you all have seen, know, and will provide more and more data, provide as you see with our performance today, conviction that they have higher peak sales potential.

Vasant Narasimhan: Second is assets that we hope will read out and get approved in the next few years with significant multi-billion dollar potential, and then a very broad early-stage pipeline in our core therapeutic areas, in our core technology areas, which I think again will prove out over time. We look forward to the challenge, but we're very confident that we'll be able to deliver against the goals we set out as we've done over the last seven years.

Vas: Second is assets that we hope will read out and get approved in the next few years with significant multi-billion dollar potential. And then a very broad early stage pipeline in our core therapeutic areas, in our core technology areas, which I think, again, we'll prove out over time.

Vas: We look forward to the challenge, but we're very confident that we'll be able to deliver against the goal to be set out as we've done over the last seven years.

Richard Vosser: Thank you.

Mark Purcell: Thank you.

Vasant Narasimhan: Next question, operator.

Mark Purcell: Thank you.

Beth: Next question, operator. Thank you. Your next question comes from the line of Richard Vosser from JP Morgan. Please go ahead.

Vasant Narasimhan: Next question, operator.

Operator: 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.

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

Vas: Thank you. Next question, please.

Speaker Change: Thank you. Your next question comes from the line of Richard Vosser from J.P. Morgan. Please go ahead.

Richard Vosser: Hi, thanks for taking my question. Maybe a question on PELABRESIB. Could you probably give us an update on your thinking and around the filing? What extra data do you need to file with the product and what sort of conversations are you having with the regulators around that one? Thanks very much.

Richard Vosser: Hi. Thanks for taking my question. Maybe a question on pelabresib. Could you probably give us an update on your thinking and around the filing? What extra data do you need to file with the product and what sort of conversations are you having with the regulators around that one? Thanks very much.

Richard Vosser: Hi, thanks for taking my question. Maybe a question on a collaborative.

Richard Vosser: Could you probably give us an update on your thinking and around the filing? What extra data do you need to file with the product and what sort of conversations are you having with the regulators around that one? Thanks very much.

Vasant Narasimhan: Yeah. Thanks, Richard. So, we're still in the midst of completing the acquisition under German takeover law so, I think there's limited things that I can say at this point. But what I can say is, we are awaiting 48-week follow-up data, which I think will give us a stronger sense of the overall profile of PELABRESIB. We've had good discussions with both the EU and the FDA to get that data. We'll have a better understanding of what will be required in each geography to ultimately bring the medicine forward for patients with myelofibrosis.

Vasant Narasimhan: Yeah, thanks, Richard. You know, we're still in the midst of completing the acquisition under German takeover law. I think there's limited things I can say at this point. What I can say is we are awaiting 48-week follow-up data, which I think will give us a stronger sense of the overall profile of pelabresib. We've had good discussions with both the EU and the FDA. I think as that data, we'll have a better understanding of what will be required in each geography to ultimately bring the medicine forward for patients with myelofibrosis. We remain excited about it, but we think we still need to get the data to finalize the exact filing plans that we have in the different geographies.

Speaker Change: Yeah, thanks, Richard. So, you know, we're still in the midst of completing the acquisition under German takeover law. So I think there's limited things I can say at this point. But what I can say is we are awaiting 48-week follow-up data, which I think will give us a stronger sense of the overall profile of Collaborative. We've had good discussions with both the EU and the FDA to get that data. We'll have a better understanding of what will be required in each geography to ultimately bring the medicine forward for patients with myelofibrosis.

Vasant Narasimhan: So, we remain excited about it but we think we still need to get the data to finalize the exact filing times that we have in the different geographies. Alongside that, the EZH1/2 inhibitor we also acquired in the deal is something we're rapidly assessing, given its profile, potential best-in-class profile to take forward in prostate cancer, potentially in other cancers. That's something we're, as we now go through the process of finalizing the acquisition, also going to take that EZH1/2. That would, of course, help us to round out our overall portfolio in prostate--we have PLUVICTO, we have follow-on actinium agents. We recently did a deal with Arvinas for an AR degrader and then, to add on, another novel agent like the EZH1/2 could help us, I think, really ensure that we have leadership or amongst the leaders in prostate cancer for the long run. Thanks, Richard.

Speaker Change: So, we remain excited about it, but I think we still need to get the data to finalize the exact filing plans that we have in the different geographies.

Vasant Narasimhan: Alongside that, the EZH1/2 inhibitor we also acquired in the deal is something we're rapidly assessing, given its profile potential, best-in-class profile to take forward in prostate cancer, potentially in other cancers. That's something as we now go through the process of finalizing the acquisition, also to take that EZH1/2. That would, of course, help us to round out our overall portfolio in prostate. We have Pluvicto, we have follow on actinium agents. We recently did a deal with Arvinas for an AR degrader, and then to add on a novel agent like an EZH1/2 could help us, I think, really ensure that we have leadership or amongst the leaders in prostate cancer for the long run. Thanks, Richard.

Speaker Change: Alongside that, the EZ-H1-2 inhibitor we also acquired in the deal is something we're rapidly assessing given its potential best-in-class profile to take forward in prostate cancer.

Beth: That's something we're, as we now go through the process of finalizing the acquisition, also going to take that EZH12. That would, of course, help us to round out our overall portfolio in prostate cancer. We have Fluvicto.

Speaker Change: potentially another cancer. So that's something where as we now go through the process of finalizing the acquisition also to take that EZ-H1-2, that would of course help us to round out our overall portfolio in prostate. We have Fluvicto, we have follow-on actinium agents. We recently did a deal with Arbenis for an AR degrader, and then to add on another novel agent like an EZ-H1-2 could help us, I think, really ensure that we have leadership or amongst the leaders in prostate cancer for the long run.

Vasant Narasimhan: That would, of course, help us to round out our overall portfolio in prostate--we have PLUVICTO, we have follow-on actinium agents. We recently did a deal with Arvinas for an AR degrader and then, to add on, another novel agent like the EZH1/2 could help us, I think, really ensure that we have leadership or amongst the leaders in prostate cancer for the long run.

Beth: We have follow-on actinium agents. We recently did a deal with Arbenis for an AR degrader, and then to add on another novel agent like an EZH12 could help us, I think, really ensure that we are leaders or amongst the leaders in prostate cancer. Thanks, Richard.

Vasant Narasimhan: Thanks, Richard. Next question, operator.

Richard Vosser: Thanks.

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

Vasant Narasimhan: Next question. Operator.

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

Speaker Change: Thanks Richard. Thanks. Next question.

Speaker Change: Thank you. Your next question comes from the line of Peter Welford from Jeffreys. Please go ahead.

Peter Welford: Hi, thanks for taking my question. I want to just return to PLUVICTO if I can, please. Just to understand [inaudible], you talked about some of the barriers in terms of gaining share in some of the sites but I'm curious, just in regards to the referral pathway and what you're seeing there. Because I guess if you're starting DTC, it would suggest that you've got a high degree of confidence that some of the patients, particularly in the community, can then get to specialist centres for the VISION indication. So, I guess maybe you can talk a little bit about your confidence in that referral pathway being able to get these patients, let's say, in CDTC, perhaps in the wider community, into centers able to administer. And equally, then, the phased dose you're talking about with the patient-ready dose--is that, at the moment, do you think, a limitation for the VISION population or is that very much geared towards the PSMAfore future use? Just to understand that. And if I can just ask on Germany for PLUVICTO, just quickly, is there a challenge in Europe from still--from the sort of pay hospitals, if you like, so pharmacy-created RLTs? Or are you able to overcome that, do you think, with PLUVICTO?

Richard Vosser: Hi. Thanks for taking my question. I want to just return to the Pluvicto, if I can, please. Just to understand, because you talk about some of the barriers in terms of gaining share in some of the sites. I'm curious just with regards to the referral pathway and what you're seeing there. Because I guess if you're starting DTC, it would suggest that you've, you know, you've got a high degree of confidence that some of the patients, particularly in the community, can then get to specialist centers for the VISION indication.

Peter Welford: Hi. Thanks for taking my question. I want to just return to the Pluvicto, if I can, please. Just to understand, because you talk about some of the barriers in terms of gaining share in some of the sites. I'm curious just with regards to the referral pathway and what you're seeing there. Because I guess if you're starting DTC, it would suggest that you've, you know, you've got a high degree of confidence that some of the patients, particularly in the community, can then get to specialist centers for the VISION indication.

Peter Welford: Hi, thanks for taking my question. I want to just return to Previcta, if I can, please. Just to understand, because you talk about some of the barriers in terms of gaining share in some of the sites, but I'm curious, just with regards to the referral pathway and what you're seeing there, because I guess if you're starting DTC, it would suggest that you've got a high degree of confidence that some of the patients, particularly in the community, can then get to specialist centres for the vision indication.

Beth: So, I guess, clearly, we can talk a little bit about your confidence in that referral pathway of being able to get these patients, let's say, in CDTC, perhaps in the wider community, into centers able to administer them. And equally, then, the phase dose you're talking about with the patient-ready dose, is that, at the moment, do you think, a limitation for the vision population, or is that very much geared towards the PSMA for future use, just to understand that? And if I can just ask Germany, for Previcta, just quickly, is there still a challenge in Europe from pay hospitals, if you like, pharmacy-created RLTs, or are you able to overcome that, do you think, with Previcta?

Richard Vosser: I guess, Peter, you can talk a little bit about your confidence with openness in that referral pathway of being able to get these patients who say they'd see DTC, perhaps in the wider community, into centers able to administer. And equally then the fixed dose you're talking about with the patient-ready dose. Is that at the moment, do you think, a limitation for the VISION population, or is that very much geared towards the PSMA for future use? Just to understand that. If I can just ask on Germany for Pluvicto, is there a challenge in Europe still from the sort of in-hospital, if you like, pharmacy-created RLT, or are you able to overcome that, do you think, with Pluvicto?

Peter Welford: I guess, Peter, you can talk a little bit about your confidence with openness in that referral pathway of being able to get these patients who say they'd see DTC, perhaps in the wider community, into centers able to administer. And equally then the fixed dose you're talking about with the patient-ready dose. Is that at the moment, do you think, a limitation for the VISION population, or is that very much geared towards the PSMA for future use? Just to understand that. If I can just ask on Germany for Pluvicto, is there a challenge in Europe still from the sort of in-hospital, if you like, pharmacy-created RLT, or are you able to overcome that, do you think, with Pluvicto?

Peter Welford: So, I guess maybe you can talk a little bit about your confidence in that referral pathway being able to get these patients, let's say, in DTC, perhaps in the wider community, into centers able to administer. And equally, then, the phased dose you're talking about with the patient-ready dose--is that, at the moment, do you think, a limitation for the VISION population or is that very much geared towards the PSMAfore future use? Just to understand that. And if I can just ask on Germany for PLUVICTO, just quickly, is there a challenge in Europe from still--from the sort of pay hospitals, if you like, so pharmacy-created RLTs? Or are you able to overcome that, do you think, with PLUVICTO?

Speaker Change: So I guess maybe you can talk a little bit about your confidence in that referral pathway of being able to get these patients with CDTC perhaps in the wider community into centres able to administer.

Speaker Change: And equally then, the phase dose you're talking about with the patient-ready dose, is that at the moment, do you think, a limitation for the vision population, or is that very much geared towards the PSMA-IV future use, just to understand that?

Beth: And if I can just ask Germany, for Previcta, just quickly, is there still a challenge in Europe from pay hospitals, if you like, pharmacy-created RLTs, or are you able to overcome that, do you think, with Previcta? All very good questions, Peter.

And if I can just ask Germany, for Previcta, just quickly, is there still a challenge in Europe from pay hospitals, if you like, pharmacy-created RLTs, or are you able to overcome that, do you think, with Previcta?

Victor: And if I can just ask on Germany, so from Victo, just quickly, is there a challenge in Europe from, still, from the sort of pay hospital, if you like, pharmacy-created RLTs, or are you able to overcome that, do you think, with Victo?

Vasant Narasimhan: All very good questions, Peter. So, first on the referral pathways--we do feel like we're making headway into the referral pathways but I think as you get further into the community, there is a first tendency among oncologists to cycle through chemo and then, potentially, even cycle back to ARPI before going to a drug like PLUVICTO. Simply because of lack of familiarity. As we move away from special centers where we see very high shares of PLUVICTO, we now need to educate and get more comfort with making that referrals. We think part of that is physician education, hence, new sales force. But part of it as well is patient activation so that patients and caregivers can ask, as cycles of chemo are completed, the next step hopefully will then be PLUVICTO and then the referrals go out. But I think alongside of that as well is continuing to also expand the capacity of community oncology centers to provide RLTs without having to make a referral--is I think an important--really, also for the long run for radioligand therapy, is something important for us to establish. Those things don't hap[pen quickly but I think i fyou go back in history, looking at things like even when chemo was introduced, but other technologies as well, you can eventually get there step by step. So, that's very much what we see at the moment and that's why we're making these additional investments to get to that next phase of growth for PLUVICTO in the U.S. Now, on the patient-ready dose--

Beth: So, first on the referral pathways: we do feel like we're making headway on the referral pathways, but I think as you get further into the community, there is a first tendency among oncologists to cycle through chemo and then potentially even cycle back to ARPI before going to a drug like Fluvictus simply because of lack of familiarity. So that's very much what we see at the moment, and that's why we're making these additional investments to get to that next phase of growth for Fluvicto in the U.S. Now we're on the patient-ready dose.

Vasant Narasimhan: It's all good, all very good questions, Peter. First on the referral pathways. We do feel like we're making headway into the referral pathways, but I think as you get further into the community, there is a first tendency among oncologists to cycle through chemo and then potentially even cycle back to ARPI before going to a drug like Pluvicto, simply because the lack of familiarity. As we move away from specialist centers where we see very high shares of Pluvicto, we now need to educate and get more comfort with making those referrals.

Speaker Change: All very good questions, Peter. So, first on the referral pathways, we do feel like we're making headway into the referral pathways, but I think as you get further into the community,

Speaker Change: There is a first tendency among oncologists to cycle through chemo and then potentially even cycle back to ARPI before going to a drug like Fluvictus, simply because of lack of familiarity.

Speaker Change: As we move away from specialist centers where we see very high shares of Blue Victo, we now need to educate and get more comfort with making that referral.

Vasant Narasimhan: We think part of that is physician education, hence, new sales force. But part of it as well is patient activation so that patients and caregivers can ask, as cycles of chemo are completed, the next step hopefully will then be PLUVICTO and then the referrals go out. But I think alongside of that as well is continuing to also expand the capacity of community oncology centers to provide RLTs without having to make a referral--is I think an important--really, also for the long run for radioligand therapy, is something important for us to establish. Those things don't hap[pen quickly but I think i fyou go back in history, looking at things like even when chemo was introduced, but other technologies as well, you can eventually get there step by step. So, that's very much what we see at the moment and that's why we're making these additional investments to get to that next phase of growth for PLUVICTO in the U.S.

Vasant Narasimhan: We think part of that is physician education, hence the new sales force, but part of it as well is patient activation, so that patients and caregivers can ask, as cycles of chemo are completed, the next step hopefully will then be Pluvicto, and then the referrals go out. But I think alongside that as well is continuing to also expand the capacity of community oncology centers to provide RLT without having to make a referral, is I think important, really also for the long run for radioligand therapy. It's something important for us to establish. Those things don't happen quickly, but I think if you go back in history looking at things like even when chemo was introduced, but other technologies as well, you can eventually get there step by step.

Speaker Change: We think part of that is physician education, hence the new sales force, but part of it as well is patient activation, so that patients and caregivers can ask, as cycles of chemo are completed, the next step, hopefully, will then be fluvicto, and then the referrals go out. But I think alongside that as well is continuing to also expand the capacity of community oncology centers to provide

Speaker Change: RLT without having to make a referral is I think important really also for the long run for radiologic therapy. It's something important for us to establish.

Vasant Narasimhan: Those things don't happen quickly. But I think if you go back in history, looking at things like even when chemo was introduced--but other technologies as well--you can eventually get there step by step. So, that's very much what we see at the moment and that's why we're making these additional investments to get to that next phase of growth for PLUVICTO in the U.S.

Speaker Change: Those things don't happen quickly.

Speaker Change: But I think if you go back in history, looking at things like even when chemo was introduced, but other technologies as well, you can eventually get there step by step. So that's very much what we see at the moment. And that's why we're making these additional investments to get to that next phase of growth for Plavicto in the U.S.

Vasant Narasimhan: That's very much what we see at the moment, and that's why we're making these additional investments to get to that next phase of growth for Pluvicto in the US. Now, around the patient-ready dose. The patient-ready dose, in my mind, has two opportunities for us. First, within centers that are at very high utilization rates, there is an interest to actually give even more patients Lutathera in first line neuroendocrine tumors for a medium and high risk first line neuroendocrine tumors. Then also to give even more patients Pluvicto. Maybe if they're at 50%, 60% or 90%, maybe they could even do more. By reducing the time, the chair time and the prep time for a given patient, you expand the capacity of those centers.

Vasant Narasimhan: Now, on the patient-ready dose--the patient-ready dose, in my mind, has two opportunities for us. So first, within centers that are at very high utilization rates, there is an interest to actually give even more patients LUTATHERA in first-line neuroendocrine tumors--for medium and high-risk first-line neuroendocrine tumors. And then, also, to give even more patients PLUVICTO--maybe if they're at 50%, 60% or 90%, maybe they could even do more. And so, by reducing the time--the chair time and the prep time--for a given patient, you expand the capacity of those centers. So, it's something we've been working on for some time. And then, that will become even more important as we get to PSMAfore and we triple the number of patients within those centers. We want to be able to have that capacity for them to be able to treat more and more patients.

Beth: The patient-ready dose, in my mind, has two opportunities for us. So first, within centers that are at very high utilization rates, there is an interest in actually giving even more patients Lutathera in first-line neuroendocrine tumors for medium and high-risk first-line neuroendocrine tumors, and then also to give even more patients Fluvicto, maybe if they're at 50-60 or 90%, maybe they could even do more

Speaker Change: Now, we're on the patient-ready dose. The patient-ready dose, in my mind,

Speaker Change: has two opportunities for us. So first...

Speaker Change: Within centers that are at very high utilization rates, there is an interest to actually give even more patients lutefera and first-line neuroendocrine tumors.

Speaker Change: for a medium and high-risk first-line neuroendocrine tumors, and then also to give even more patients Pluvicto. Maybe if they're at 50-60 or at 90%, maybe they could even do more. And so by reducing the time, the chair time and the prep time for a given patient, you expand the capacity of those centers.

Beth: And so by reducing the time, the chair time, and the prep time for a given patient, you expand the capacity of those centers. So it's something we've been working on for some time, and then that will become even more important as we get to PSMA-4 and triple the number of patients within those centers. We want to be able to have that capacity so that they are able to treat more and more patients.

Vasant Narasimhan: So, it's something we've been working on for some time. And then, that will become even more important as we get to PSMAfore and we triple the number of patients within those centers. We want to be able to have that capacity for them to be able to treat more and more patients. And of course, chair time is what eventually could become a constraint so, we want to get ahead of that with the patient-ready dose. Now lastly, with respect to Germany, we've achieved attractive pricing in Germany. We've seen very strong uptake in the initial days and we're seeing shares--to the extent we can get the data. We're slowly but surely 80%, 90% share versus the so-called homebrews or Pharmacy developed RLTs. So we feel confident now with reimbursement in place that will now become, you know, the real only option for patients in the PS desiring PSMA RLT therapy in Germany. So we're excited about the German opportunity. I would say as well, China. I recently visited RLT centers in Shanghai.

Vasant Narasimhan: It's something we've been working on for some time. Then that will become even more important as we get to PSMAfore, and we triple the number of patients within those centers. We wanna be able to have that capacity for them to be able to treat more and more patients. Of course, chair time is what eventually could become a constraint. We wanna get ahead of that with the patient-ready dose. Now lastly, with respect to Germany, we've achieved attractive pricing in Germany. We see very strong uptake in the initial days, and we're seeing, you know, shares to the extent we can get the data, you know, we're slowly but surely 80, 90 percent share versus the so-called home brews or pharmacy-developed RLTs.

Speaker Change: So it's something we've been working on for some time. And then that will become even more important as we get to PSMA-4 and we triple the number of patients within those centers.

Beth: And of course, chair time is what eventually could become a constraint, so we want to get ahead of that with the patient-ready dose. Now, lastly, with respect to Germany, we've achieved attractive pricing in Germany, we've seen very strong uptake in the initial days, and we're seeing shares to the extent we can get the data. We're slowly but surely achieving 80%, 90% share versus the so-called homebrew

Speaker Change: We want to be able to have that capacity for them to be able to treat more and more patients. And of course, chair time is what eventually could become a constraint. So we want to get ahead of that with the patient-ready dose.

Speaker Change: Now, lastly, with respect to Germany, we've achieved attractive pricing in Germany. We see very strong uptake in the initial days, and we're seeing, you know, shares, to the extent we can get the data, you know, we're...

Vasant Narasimhan: Now lastly, with respect to Germany, we've achieved attractive pricing in Germany. We've seen very strong uptake in the initial days and we're seeing shares--to the extent we can get the data. We're slowly but surely 80%, 90% share versus the so-called homebrews or pharmacy-developed RLTs. So, we feel confident now with reimbursement in place that will now become the real only option for patients in the PS--desiring PSMA RLT therapy in Germany. So, we're excited about the German opportunity. I would say as well, China--now, I recently visited RLT centers in Shanghai.

Speaker Change: slowly but surely, 80-90% share versus the so-called homebrews or, you know,

Beth: Pharmacy developed RLTs. So we feel confident now with reimbursement in place that will now become, you know, the real only option for patients in the PS desiring PSMA RLT therapy in Germany. So we're excited about the German opportunity. I would say as well, China. I recently visited RLT centers in Shanghai.

Vasant Narasimhan: We feel confident now with reimbursement in place that we'll now become, you know, the real only option for patients in the PSMA desiring PSMA RLT therapy in Germany. We're excited about the German opportunity. I would say as well, China. Now I've recently visited RLT centers in Shanghai. There is a lot of interest in China, and you've seen us be very successful in launches, whether it's Cosentyx, Entresto, Leqvio in China. The opportunity there is significant. On track to file in China in H2 this year. We've done a groundbreaking for a new manufacturing site in China. And then lastly, in Japan as well, a lot of interest in RLT.

Speaker Change: Physicist Pharmacy developed RLTs. So we feel confident now with reimbursement in place that will now become, you know, the real only option for patients.

Speaker Change: and the desiring PSMA RLC therapy.

Speaker Change: in Germany. So we're excited about the German opportunity. I would say as well China. I've recently visited RLC centers and

Vasant Narasimhan: I would say as well, China--now, I recently visited RLT centers in Shanghai. There is a lot of interest in China and you've seen us be very successful in launches, whether it's COSENTYX, ENTRESTO, LEQVIO in China. And so, the opportunity there is significant. We're on track to file for approval in China in the second half of this year. We've done a groundbreaking for a new manufacturing site in China. And then lastly, in Japan as well. Lot of interest in RLT in Japan as well. So I think the Asian markets as well will give us a boost for RLT and PLUVICTO in the medium. Next question operator. Thank you. Your next question comes from the line of Peter Fedalt from City. Please go ahead.

Speaker Change: in Shanghai. There is a lot of interest in China, and you've seen us be very successful in launches, whether it's Cosentix and Trestle Lectio in China.

Beth: There is a lot of interest in China, and you've seen us be very successful in launches, whether it be Cosentix and Tresolepio in China. And so the opportunity there is significant. We're on track to file for approval in China in the second half of this year.

Speaker Change: And so the opportunity there is significant to come back to file in China in the second half of this year. We've done a groundbreaking for a new manufacturing site in China. And then lastly, in Japan as well, a lot of interest in RLT. So I think the Asian markets as well will give us a boost for RLT and Fluvicto in the medium term.

Vasant Narasimhan: I think the Asian markets as well will give us a boost for RLT and Pluvicto, in the medium term. Next question, operator.

Beth: We've done a groundbreaking for a new manufacturing site in China. And then lastly, there is a lot of interest in RLT in Japan as well. So I think the Asian markets as well will give us a boost for RLT and Fluvicto in the medium. Next question operator. Thank you. Your next question comes from the line of Peter Fedalt from City. Please go ahead.

Richard Vosser: Thank you. Your next question comes from the line of Peter Verdult from Citi. Please go ahead.

Operator: Thank you. Your next question comes from the line of Peter Verdult from Citi. Please go ahead.

Speaker Change: Next question, operator.

Operator: Thank you. Your next question comes from the line of Peter Verdult from Citi. Please go ahead.

Speaker Change: Thank you. Your next question comes from the line of Peter Fedalt from City. Please go ahead.

Peter Verdult: Thank you to Peter, Vidal, and Siddy. Can we go big picture on IRA, just what's the latest you're hearing from your contacts? about how the initial price negotiation process is going for the industry, how manageable you feel IRA is for Novartis going forward, and, with Pellicarton in mind, whether there have been any developments that give you increased confidence that you can get Oligo-Nucleotides to be given the same 13-year exclusivity period as biologics banks. Yeah, thanks, Peter. So first, we'd say it's not a negotiation, it's government price setting. It's not a situation where companies have the opportunity to, in effect, walk away from the prices that are set by the government.

Peter Verdult: Yes, thank you. It's Peter Verdult from Citi. Can we go big picture, please, on IRA. Just what are the latest you're hearing from your contacts about how the initial price--negotiation process is going for the industry? How manageable you feel IRA is for Novartis going forward? And with pelacarsen in mind, whether there have been any developments that give you increased confidence you can get oligonucleotides to be given the same 13-year exclusivity period as biologics? Thanks.

Peter Verdult: Thank you. It's Peter Verdult from Citi. Just can we go big, big picture, please, Vas, on the IRA? Just what's the latest you're hearing from your contacts about how the initial price negotiation process is going for the industry? How manageable you feel IRA is for Novartis going forward? And with pelacarsen in mind, whether there have been any developments that give you increased confidence you can get oligonucleotides to be given the same 13-year exclusivity period as biologics products.

Speaker Change: Thank you to Peter Vidal from Citi. Can we go big picture please on the IRA? Just what's the latest you're hearing from your contacts?

Speaker Change: about how the initial price negotiation process is going for the industry. How manageable do you feel IRA is for Novartis going forward? And with Pellicarton in mind, whether there have been any developments that give you increased confidence you can get?

Vasant Narasimhan: Yes. Thanks, Peter. So first, we'd say it's not a negotiation, it's government price setting. It's not a situation where a company has the opportunity to, in effect, walk away from the prices that are set by government. I'd also say, while in the short-term, this might be manageable on our first set of drugs. In the long run, this policy is really not good for innovation, good for patients in the United States. And the companies are managing, is managing by shifting away from small molecule medicines for--[inaudible]--therapies. And neurological diseases, maybe they can only be treated by small molecules. So, I think it's very important to say the policy is not a good one. It's bad for America patients, it's bad for innovation and sincerely hope that it gets corrected. Now in terms of our midterm guidance, we factored in and our single digit--our mid-single-digit guidance into the 2030s.

Speaker Change: Oligonucleotides to be given the same 13-year exclusivity period as biologics. Thanks.

Beth: I'd also say, you know, while in the short term, this might be manageable with our first set of drugs, in the long run, this policy is really not good for innovation, good for patients in the United States. And if companies are managing, they are managing by shifting away from small molecule medicines for other therapies. And neurological diseases, maybe they can only be treated by small molecules. So I think it's very important to say that this policy is not a good one. It's bad for American patients, bad for innovation, and I sincerely hope that it gets corrected. Now, in terms of our midterm guidance, we factored in IRA, and our single digit, our mid single digit guidance into the 2030s.

Vasant Narasimhan: Yeah. Thanks, Peter. First we'd say it's not a negotiation, it's government price setting. It's not a situation where companies have the opportunity to in effect walk away from the prices that are set by government. I'd also say, you know, while in the short term, this might be manageable on our first set of drugs, in the long run, this policy is really not good for innovation, good for patients in the United States. If companies are managing, it's managing by shifting away from small molecule medicines for cancer or other therapies, and neurological diseases, maybe they can only be treated by small molecules. I think it's very important to say the policy is not a good one. It's bad for American patients, bad for innovation, and sincerely hope that it gets corrected.

Speaker Change: Yeah, thanks, Peter. So first we'd say it's not a negotiation, it's government price setting. It's not a situation where companies have the opportunity to, in effect, walk away from the prices that are set by government.

Speaker Change: I'd also say, you know, while in the short term this might be manageable on our first set of drugs, in the long run this policy is.

Speaker Change: really not good for innovation, good for patients in the United States. And if companies are managing, it's managing by shifting away from small molecule medicines for therapies and neurological diseases, maybe they can only be treated by small molecules. So I think it's very important to say the policy is not a good one. It's bad for American patients, bad for innovation, and

Beth: It's bad for American patients, bad for innovation, and I sincerely hope that it gets corrected. Now, in terms of our midterm guidance, we factored in IRA, and our single digit, our mid single digit guidance into the 2030s. And so we manage it through a combination of the kinds of medicines we develop, the indications we go after, etc. And that's how we're approaching it. I can't comment on the current price setting approach that CMS is taking right now, but those prices will obviously come out in front of Trusto in September. But you know, I think right now our focus is very much still on shifting the policy. There are a few bills in play.

It's bad for American patients, bad for innovation, and I sincerely hope that it gets corrected. Now, in terms of our midterm guidance, we factored in IRA, and our single digit, our mid single digit guidance into the 2030s.

Vasant Narasimhan: Now, in terms of our midterm guidance, we factored in mid-single digit guidance into the 2030s, we factored in IRA. We manage it through a combination of the kinds of medicines we develop, the indications we go after, et cetera. That's how we're approaching it. Can't comment on the current price setting approach that CMS is taking right now. Those prices will obviously come out in September for Entresto. You know, I think right now our focus is very much still to shift the policy. There are a few bills in play. There is a bill that is currently being discussed to, as you rightfully mentioned, correct genetically targeted therapies. Bipartisan support has passed through multiple committees.

Speaker Change: Sincerely hope that it gets corrected. Now in terms of our mid-term guidance we factored in, and our mid-single-digit guidance into the 2030s, we factored in IRA.

Vasant Narasimhan: We factored in IRA. And so, we manage it through a combination of the kinds of medicines we develop, the indication we go after, et cetera, and that's how we're approaching it. Can't comment on the current price setting approach that CMS is taking right now. Although the prices will obviously come out in for Entresto in September. I think right now, our focus is very much still to shift the policy. There are a few bills in play. There is a bill that is currently being discussed to, as you rightfully mentioned, correct genetically targeted therapies, a bipartisan support, has passed through multiple committees. So, we continue to be hopeful that ASOs, sRNAs and related technologies will move from 9% to 13%. Another bill that is being discussed is within the rare disease framework, to move off of a single rare disease to multiple rare disease drugs to have the same benefits if you're in a single rare disease.

Speaker Change: And so we manage it through a combination of the kinds of medicines we develop, the indications we go after.

Speaker Change: etc. And that's how we're approaching it. Can't comment on the current price settings approach that CMS is taking right now.

Speaker Change: Those prices will obviously come out for Entrusto in...

Speaker Change: in September .

Speaker Change: But, you know, I think right now our focus is very much still to shift the policy. There are a few bills in play.

Beth: There is a bill that is currently being discussed to, as you rightfully mentioned, correct genetically targeted therapies. Bipartisan support has passed from multiple committees. So we continue to be hopeful that ASOs, SIRNAs, and related technologies will move from nine to 13. Another bill that is being discussed is within the rare disease framework to move off of a single rare disease to multiple rare disease drugs to have the same benefits if you're in a single rare disease.

Speaker Change: There is a bill that is currently being discussed to, as you rightfully mentioned, correct genetically targeted therapies. Bipartisan support has passed from multiple committees, so we continue to be hopeful that ASOs, SIRNAs, and related technologies will move from 9 to 13.

Vasant Narasimhan: We continue to be hopeful that ASOs, siRNAs, and related technologies will move from 9 to 13. Another bill that is being discussed is within the rare disease framework to move off of a single rare disease to multiple rare disease drugs to have the same benefits as if you're in a single rare disease. If you take a case study like Scemblix, our ability to develop Scemblix beyond CML in another rare cancer is limited because of the IRA's policy. And maybe it would make sense to actually develop it in another cancer type, but difficult to do given the you know the IRA policy. I think that's you know a second bill out there. Then third, there's the full correction of 9 to 13.

Speaker Change: Another bill that is being discussed is within the rare disease framework to move off of a single rare disease to multiple rare disease drugs to have the same benefits if you're on a single rare disease. So if you take a case study like Semblix

Vasant Narasimhan: So if you take a case study like SCEMBLIX, our ability to develop SCEMBLIX beyond CML in another rare cancer is limited because of the IRAs policy. And maybe it would make sense to actually develop it in another cancer type, but difficult to do given the IRA policy. So I think that's a second bill out there. And then third, there's the full correction of 9 to 13. So I think when I'm on the Hill, I have good conversations. I think there's a broad recognition that there needs to be something done, because this was an unintended consequence of a poorly drafted legislation. But how that actually transpires given that we're in a political cycle, I think we'll have to see in 2021 and beyond. Thank you. Next question, operator.

Speaker Change: Our ability to develop semblance beyond CML and another rare cancer is limited because of the IRA's policy.

Speaker Change: And maybe it would make sense to actually develop it in another cancer type, but difficult to do given the, you know, the IRA policy. So I think that's, you know...

Beth: So I think, you know, when I'm on the Hill, I have good conversations; I think there's a broad recognition that there needs to be something done, because this was an unintended consequence of poorly drafted legislation. But how that actually transpires, given that we're in a political cycle, I think we'll have to see in 2025. And Thank you. Next question. Thank you. Your next question comes from the line of Kerry Holford from Barenburg. Please go ahead. I, yes, Kerry Holford.

So I think, you know, when I'm on the Hill, I have good conversations; I think there's a broad recognition that there needs to be something done, because this was an unintended consequence of poorly drafted legislation. But how that actually transpires, given that we're in a political cycle, I think we'll have to see in 2025. And Thank you. Next question.

Speaker Change: You know, a second bill out there, and then third, there's the full correction of 9 to 13.

Vasant Narasimhan: I think, you know, when I'm on the Hill, I have good conversations. I think there's a broad recognition that there needs to be something done because this was an unintended consequence of a poorly drafted legislation. How that actually transpires, given that we're in a political cycle, I think we'll have to see in 2025 and beyond.

Speaker Change: So I think, you know, when I'm on the Hill, I have good conversations. I think there's a broad recognition that there needs to be something done, because this was an unintended consequence of...

Speaker Change: a poorly drafted legislation but how that actually transpires given that we're in a political cycle I think we'll have to see in 2025 and beyond.

Peter Verdult: Thank you.

Vasant Narasimhan: Next question, operator.

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

Speaker Change: Thank you. Next question operator.

Speaker Change: Thank you. Your next question comes from the line of Kerry Holford from Barenburg. Please go ahead.

Speaker 14: Hi. Yes, Kerry Holford from Berenberg. Just one quick question for me on remibrutinib, the delay of the filing in CSU into next year. Vas, you referenced a few CMC adjustments. I wonder if you could provide a little more detail on that. What's required and how long the delay is likely to be. Thank you.

Kerry Holford: Hi. Yes, Kerry Holford from Berenberg. Just one quick question for me on remibrutinib, the delay of the filing in CSU into next year. Vas, you referenced a few CMC adjustments. I wonder if you could provide a little more detail on that. What's required and how long the delay is likely to be. Thank you.

Kerry Holford: Hi, yes, Kerry Holford, Berenberg. Just one quick question for me on remibrutinib. The delay of the filing in CSU into next year, you referenced a few CMC adjustments. So, I wonder if you could provide a little more detail on that, what's required and how long the delay is likely to be? Thank you.

Kerry Holford: Hi, yes, Kerry Holford from Barabang. Just one quick question from me on Rema Brutonet. The delay of the filing in CSU into next year, as you referenced, a few CMC adjustments. I wonder if you could provide a little more detail on that, what's required and how long the delay is likely to be? Thank you.

Vasant Narasimhan: Yes, absolutely, Kerry. So, in the process of finalizing our manufacturing process, we've determined that a single step in the process called nano-milling, for those who are interested, needs some adjustments in terms of time and temperature to make sure that the product profile is optimal. So we're making those adjustments. And once we make those adjustments, as was the case with Kisqali, we made those adjustments. We have to generate stability data. And so, the time to generate the stability data then drives the time line for the filing. We're certainly hopeful that we can get that stability package put together ASAP and then get the file in, because we were ready to go in the filing. And unfortunately, found on this at a relatively late stage. So, our hope is to file in the earlier part of next year and then get an approval quickly thereafter. We certainly have many PRVs in hand. We have not determined at which ones we'll use, we certainly have the capacity to use PRVs. So we hope to be able to close the gap then and make remibrutinib available for patients in the U.S. and then eventually around the world. Next question, operator?

Vasant Narasimhan: Yeah, absolutely, Kerry. You know, in the process of finalizing our manufacturing process, you know, we've determined that a single step in the process called nanomilling, for those who are interested, needs some adjustments in terms of time and temperature to make sure that the product profile is optimal. We're making those adjustments. Once we make those adjustments, as was the case with Kisqali when we made those adjustments, we have to generate stability data. The time to generate the stability data then drives the timeline for the filing. We're certainly hopeful that we can get that stability package put together ASAP and then get the file in, because we were ready to go in the filing and unfortunately found this at a relatively late stage.

Speaker Change: Yeah, absolutely, Kerry. So, you know, in the process of finalizing our manufacturing process, you know, we've determined that a single step in the process called

Speaker Change: Nano milling, for those who are interested, needs some adjustments in terms of time and temperature to make sure that the product profile is optimal.

Kerry Holford: So we're making those adjustments, and once we make those adjustments...

Speaker Change: As was the case with Kisgali, when we made those adjustments, we have to generate stability data, and so the time to generate the stability data then drives the timeline for the filing. We're certainly hopeful that we can get that stability package put together ASAP and then get the file in, because we were ready to go in the filing.

Beth: And so the time to generate the stability data then drives the timeline for the filing. We're certainly hopeful that we can get that stability package put together ASAP and then get the file in because we were ready to go with the filing and, unfortunately, found this at a relatively late stage. So our hope is to file in the early part of next year and then get approval relatively quickly thereafter. We certainly have many PRBs in hand. We have not determined yet which ones we'll use, but we certainly have the capacity to use PRBs.

And so the time to generate the stability data then drives the timeline for the filing. We're certainly hopeful that we can get that stability package put together ASAP and then get the file in because we were ready to go with the filing and, unfortunately, found this at a relatively late stage. So our hope is to file in the early part of next year and then get approval relatively quickly thereafter.

Vasant Narasimhan: Our hope is to file in the earlier part of next year and then get an approval relatively quickly thereafter. We certainly have many PRVs in hand. We have not determined yet which ones we'll use, but we certainly have the capacity to use PRVs. We hope to be able to close the gap then and make remibrutinib available for patients in the US and then eventually around the world. Next question, operator.

Speaker Change: Unfortunately, on this relatively late stage.

Speaker Change: So our hope is to file in the earlier part of next year and then get an approval relatively soon.

Vasant Narasimhan: We certainly have many PRBs in hand. We have not determined yet which ones we'll use, but we certainly have the capacity to use PRBs. So we hope to be able to close the gap then and make Remibrutinib available for patients in the US and then eventually around the world. Next question, operator.

Speaker Change: Quickly thereafter, we certainly have many PRVs in hand. We have not determined yet which ones we'll use, but we certainly have the capacity to use PRVs. So we hope to be able to close the gap then and make Remibrutinib available for patients in the U.S. and then eventually around the world.

Beth: So we hope to be able to close the gap then and make Remibrutinib available for patients in the US and then eventually around the world. Next question, operator. Thank you. Your next question is from the line of Seamus Fernandez from Guggenheim Securities. Please go ahead. Oh, thanks so much for the question. So, Voss, the question is really for you.

So we hope to be able to close the gap then and make Remibrutinib available for patients in the US and then eventually around the world. Next question, operator.

Thank you. Your next question is from the line of Seamus Fernandez from Guggenheim Securities. Please go ahead. Oh, thanks so much for the question. So, Voss, the question is really for you.

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

Speaker Change: Next question operator.

Seamus Fernandez: Thanks so much for the question. So Vas, the question is really for you strategically, as you look at the growth opportunities in the industry and across the industry, oncology, immunology and now cardiovascular metabolic disease, are all core therapeutic areas. One area that Novartis is not currently present in is obesity. You've been in a position to think strategically and act strategically in immuno-oncology, perhaps with disappointment. Just interested to get your thoughts on the opportunity for a late entry into the obesity market, and how Novartis could potentially, or would potentially make sense of that strategically, whether with existing assets, or only as a completely novel approach or novel mechanism moving forward? Thanks so much.

Speaker Change: Thank you.

Speaker Change: Your next question.

Speaker Change: This comes from the line of Seamus Fernandez from Guggenheim Securities. Please go ahead.

Beth: Strategically, as you look at the growth opportunities in the industry and across the industry, oncology, immunology, and now cardiovascular and metabolic diseases with obesity are all, you know, core therapeutic areas. But one area that Novartis is not currently present in is obesity. You've been in a position to think strategically and act strategically in immuno-oncology, perhaps with, you know, disappointment. Just interested to get your thoughts on, you know, the opportunity for a late entry into the obesity market and how Novartis could potentially or would potentially make sense of that strategically, whether with existing assets or only as a completely novel approach or novel mechanism moving forward. Thanks so much.

Speaker 15: Oh, thanks so much for the question. Vas, the question is really for you strategically as you look at the growth opportunities in the industry and across the industry, oncology, immunology, and now cardiovascular metabolic disease with obesity, you know, are all core therapeutic areas. One area that Novartis is not, you know, currently present in is obesity. You've been in a position to think strategically and act strategically in immuno-oncology, perhaps with, you know, disappointment. Just interested to get your thoughts on, you know, the opportunity for a late entry into the obesity market and how Novartis could potentially or would potentially make sense of that strategically, you know, whether with existing assets or only as a completely novel approach or novel mechanism moving forward. Thanks so much.

Seamus Fernandez: Oh, thanks so much for the question. Vas, the question is really for you strategically as you look at the growth opportunities in the industry and across the industry, oncology, immunology, and now cardiovascular metabolic disease with obesity, you know, are all core therapeutic areas. One area that Novartis is not, you know, currently present in is obesity. You've been in a position to think strategically and act strategically in immuno-oncology, perhaps with, you know, disappointment. Just interested to get your thoughts on, you know, the opportunity for a late entry into the obesity market and how Novartis could potentially or would potentially make sense of that strategically, you know, whether with existing assets or only as a completely novel approach or novel mechanism moving forward. Thanks so much.

Speaker Change: Thanks so much for the question. So, Voss, the question is really for you, strategically, as you look at the growth opportunities in the industry and across the industry,

Voss: Oncology, Immunology, and now Cardiovascular and Metabolic Disease with Obesity are all core therapeutic areas.

Speaker Change: One area that Novartis is not, you know, currently present in is obesity. You've been in a position to think strategically and act strategically in immuno-oncology, perhaps with, you know, disappointment.

Speaker Change: I'm just interested to get your thoughts on, you know, the opportunity for a late entry

Speaker Change: into the obesity market and how Novartis could potentially or would potentially make sense of that.

Speaker Change: Strategically, you know, whether with existing assets or only as a completely novel approach or novel mechanism moving forward. Thanks so much.

Vasant Narasimhan: Yeah, thanks, Seamus, for the question. As you can imagine, it's something we've put a lot of thought into and have looked at many of the opportunities that are out there to address obesity, which clearly has the opportunity to have a significant health impact, not only on obesity but many related conditions that we're continuing to see in the data. Our view is that with the current GLP, GIP, and GIPR oral injectable class of medicine, they're going to be very well served by the two leading incumbents who are doing extremely well in the market and are rapidly developing follow-on agents. And so to come in with fast follower or two medicines, even with modestly differentiated profiles, will be difficult because when those medicines come forward at the end of the decade, you will have substantial rebate walls, you will have substantial portfolio blocks in place. And so it will be very difficult to enter with just another of something that's relatively similar to what's already out there.

Vasant Narasimhan: Yes. Thanks, Seamus, for the question. As you can imagine, it's something we put a lot of thought into and have looked at many of the opportunities that are out there. To address obesity, which clearly had the opportunity to have a significant health impact, not only on obesity, but many related conditions that are continuing to see in the data. Our view is with the current GLP, GIP, GIPR oral and injectable class of medicines. They're going to be very well served by the two leading incumbents who are doing extremely well in the market and are rapidly developing follow-on agents. And so to come in with fast follower or two medicines, even with modestly differentiated profiles, will be difficult. Because when those medicines come forward at the end of the decade, you will have substantial rebate walls.

Vasant Narasimhan: Yeah. Thanks, Seamus, for the question. As you can imagine, it's something we've put a lot of thought into and have looked at many of the opportunities that are out there to address obesity, which clearly has the opportunity to have a significant health impact, not only on obesity, but many related conditions that we're continuing to see in the data. Our view is with the current GLP, GIP or oral injectable class of medicines, they're going to be very well served by the two leading incumbents who are doing extremely well in the market and are rapidly developing follow-on agents. To come in with fast follower, too, medicines, even with modestly differentiated profiles, will be difficult because when those medicines come forward at the end of the decade, you will have substantial rebate walls.

Speaker Change: Yeah, thanks, Seamus, for the question. As you can imagine, it's something we put a lot of thought into and have looked at many of the opportunities that are out there to address obesity, which clearly has the opportunity to have a significant health impact, not only on obesity, but many related conditions that we're continuing to see in the data.

Speaker Change: Our view is with the current GLP, GIP, GIPR oral injectable class of medicine, they're going to be very well served by the two leading incumbents who are doing extremely well in the market and are rapidly developing.

Beth: And so to come in with fast follower or two medicines, even with modestly differentiated profiles, will be difficult because when those medicines come forward at the end of the decade, you will have substantial rebate walls, you will have substantial portfolio blocks in place. And so it will be very difficult to enter with just another of something that's relatively similar to what's already out there.

Speaker Change: follow-on agents. And so to come in with fast follower or two medicines, even with

Speaker Change: Modestly differentiated profiles will be difficult because when those medicines come forward at the end of the decade you will have substantial rebate walls

Vasant Narasimhan: You will have a substantial portfolio blocks in place. And so, very difficult to enter with just another of--something that's relatively similar to what's already out there. You can imagine massive amounts of free drug floating around simply, because of the size of the rebates that actually be out there, towards the end of the decade. So, we choose not to participate in that. Insofar as we might need one of those assets as a combination asset for our own portfolio, but rather our core focus is thinking about next-generation medicines to address obesity, or related conditions in cardiovascular health. That includes more long-acting agents, either through biologics or siRNAs, that offers no mechanisms of action, all preclinical, but the ones that we're exploring, either that can provide dosing advantage, tolerability advantages or the ability for muscle sparing.

Vasant Narasimhan: You will have substantial portfolio blocks in place. Very difficult to enter with just another of something that's relatively similar to what's already out there. You can imagine massive amounts of free drug floating around simply because of the size of the rebates that would actually be out there towards the end of the decade. We choose not to participate in that insofar as we might need one of those assets as a combination asset for our own portfolio. Rather our core focus is thinking about next generations.

Speaker Change: You will have substantial portfolio blocks in place.

Speaker Change: And so very difficult to enter with just another of something that's relatively similar to what's already out there.

Beth: You can imagine massive amounts of free drugs floating around simply because of the size of the rebates that will actually be out there towards the end of the decade. So we choose not to participate in that insofar as we might need one of those assets as a combined asset for our own portfolio, but rather, our core focus is thinking about next generations, the next generation of medicines to address obesity or related conditions of cardiovascular health. That includes much more long-acting agents, either through biologics or siRNAs, that are no mechanisms of action, all preclinical, but the ones that we're exploring, either that can provide dosing advantages, tolerability advantages, or the ability for muscle sparing,

Speaker Change: You can imagine massive amounts of free drug floating around simply because of the size of the rebates that will actually be out there towards the end of the decade. So we choose not to participate in that. Insofar, we might need one of those assets as a combination asset for our own portfolio, but rather our core focus is thinking about next generation.

Vasant Narasimhan: Next generation of medicines to address obesity, or related conditions in cardiovascular health. That includes much more long-acting agents, either through biologics or siRNAs that adopt novel mechanisms of action, all preclinical, but the ones that we're exploring either that can provide dosing advantage with tolerability advantages or the ability for muscle sparing. There could be centrally acting mechanisms that are not necessarily targeting, you know, directly the pancreas and orthogonally the central pathways, but actually directly the central pathways. So those are all things we're working on. But, you know, we stick by our conviction to stay disciplined. We had the experience of coming late into PD-1 inhibitors and immuno-oncology with lots of capital spent. In the end, probably not well spent. Rather say, where can we bring something really unique forward?

Speaker Change: Next Generation Medicines to Address Obesity.

Beth: That includes much more long-acting agents, either through biologics or siRNAs, that are no mechanisms of action, all preclinical, but the ones that we're exploring, either that can provide dosing advantages, tolerability advantages, or the ability for muscle sparing, they could be essentially acting mechanisms that are not necessarily targeting, you know, directly the pancreas and orthogonally, the central pathways but actually directly the central pathways.

That includes much more long-acting agents, either through biologics or siRNAs, that are no mechanisms of action, all preclinical, but the ones that we're exploring, either that can provide dosing advantages, tolerability advantages, or the ability for muscle sparing,

Speaker Change: or related conditions in cardiovascular health.

Speaker Change: That includes much more long-acting agents, either through biologics or siRNAs.

Speaker Change: that involves no mechanisms of action, all pre-clinical, but the ones that we're exploring, either that can provide dosing advantages, tolerability advantages, or the ability for muscle sparing.

Vasant Narasimhan: There could be centrally acting mechanisms that are not necessarily targeting directly the pancreas and cognitively the central pathways, but actually directly the central pathways. So, those are all things we're working on. But we stick by our conviction to stay disciplined. We had the experience of coming late into PD-1 inhibitors, immuno-oncology, with lots of capital spend. In the end, probably not well spent. Rather say, where can, we bring something really unique forward, gives us a unique position not only from a physician patient standpoint, but in the U.S., what will matter immensely. And we know this launching many cardiovascular medicines, is you need a compelling proposition for payers. And coming late with another one of the orals or injectable GLPs, GIPs, we think is not a prudent approach for us as a company. Rather look for next breakthroughs--or breakthroughs in other areas and other areas of medicine, where that are underserved. There's enough other areas of medicine that are underserved, and we think there's plenty of opportunity for us to drive dynamic growth in those areas. Next question, operator?

Speaker Change: There could be centrally acting mechanisms that are not necessarily targeting

Beth: So those are all things we're working on. But, you know, we stick by our conviction to stay disciplined; we had the experience of coming late into PD one inhibitors and immuno oncology with lots of capital spent, in the end, probably not well spent. Where can we bring something really unique forward that gives us a unique position, not only from a physician patient standpoint, but in the US, which will matter immensely. And we know that launching many cardiovascular medicines is you need a compelling proposition for payers. And coming in late with another one of the orals or injectable GLP, or GIPs is not a prudent approach for us as a company. Rather, look for next breakthroughs or breakthroughs in other areas and other areas of medicine that are underserved. There are enough other areas of medicine that are underserved that we think there's plenty of opportunity for us to drive dynamic growth. Next question, I'm sorry.

Speaker Change: So those are all things we're working on, but we stick by our conviction to stay disciplined. We had the experience of coming late into PD-1 inhibitors and immuno-oncology with lots of capital spent.

Speaker Change: In the end, probably not well-spent, rather say, where can we bring something really unique forward? Give us a unique position, not only from a physician-patient standpoint, but in the U.S., what will matter immensely, and we know this, watching many cardiovascular medicines.

Vasant Narasimhan: Gives us a unique position, not only from a physician patient standpoint, but in the US, what will matter immensely, and we know this launching many cardiovascular medicines, is you need a compelling proposition for payers. Coming in late with another one of the orals or injectable GLP GIPs, we think is not a prudent approach for us as a company. Rather look for next breakthroughs in other areas of medicine where that are underserved. There's enough other areas of medicine that are underserved, that we think there's plenty of opportunity for us to drive dynamic growth in those areas.

Beth: And we know that launching many cardiovascular medicines is you need a compelling proposition for payers. And coming in late with another one of the orals or injectable GLP, or GIPs is not a prudent approach for us as a company. Rather, look for next breakthroughs or breakthroughs in other areas and other areas of medicine that are underserved. There are enough other areas of medicine that are underserved that we think there's plenty of opportunity for us to drive dynamic growth. Next question, I'm sorry.

Speaker Change: is you need a compelling proposition for payers.

Speaker Change: and coming in late with another one of the orals or injectable GLP-GIPs we think is not a prudent approach for us as a company.

Beth: Rather, look for next breakthroughs or breakthroughs in other areas and other areas of medicine that are underserved. There are enough other areas of medicine that are underserved that we think there's plenty of opportunity for us to drive dynamic growth. Next question, I'm sorry.

Speaker Change: Rather look for next breakthroughs or breakthroughs in other areas and other areas of medicine where That are underserved. There is enough other areas of medicine that are underserved That we think there's plenty of opportunity for us to drive dynamic growth in those areas

Operator: Thanks.

Vasant Narasimhan: Next question, operator.

Operator: Thank you. Your next question comes from the line of Rajesh Kumar from HSBC. Please go ahead.

Beth: Thank you. Your next question? Comes from the line of Rajesh Kumar from HSBC. Please go ahead. Hi, good afternoon. Just on capital allocation. You have maintained a very capital discipline approach in terms of what sort of valuations you're paying for M&A, as well as, you know, what sort of returns you're looking at. When you are in a competitive situation, can you give us some color on whether your competitors are behaving in a similar way, and if they're not, what are the tools you have to, you know, work around that?

Operator: Thank you. Your next question comes from the line of Rajesh Kumar from HSBC. Please go ahead.

Speaker Change: Thank you.

Speaker Change: Your next question.

Speaker Change: It comes from the line of Rajesh Kumar from HSBC. Please go ahead.

Rajesh Kumar: Hi, good afternoon. Just on capital allocation. You have maintained a very capital disciplined approach in terms of what sort of valuations you're paying for M&A as well as what sort of returns you're looking at. When you are in competitive situations, can you give us some color if your competitors are behaving in a similar way? And if they are not, what are the tools you have to work around that?

Speaker 16: Hi, good afternoon. Just on capital allocation. You have maintained a very capital disciplined approach in terms of what sort of valuations you're paying for M&A, as well as, you know, what sort of returns you're looking at. When you are in competitive situations, can you give us some color if your competitors are behaving in a similar way? If they're not, what are the tools you have to, you know, work around that?

Rajesh Kumar: Hi, good afternoon. Just on capital allocation. You have maintained a very capital disciplined approach in terms of what sort of valuations you're paying for M&A, as well as, you know, what sort of returns you're looking at. When you are in competitive situations, can you give us some color if your competitors are behaving in a similar way? If they're not, what are the tools you have to, you know, work around that?

Rajesh Kumar: Hi, good afternoon.

Speaker Change #101: Just on capital allocation, you have maintained a very capital-disciplined approach in terms of what sort of valuations you're paying for M&A, as well as what sort of returns you're looking at.

Rajesh Kumar: When you are in competitive situations, can you give us some color if your competitors are behaving in a similar way? And if they're not, what are the tools you have to work around that?

Vasant Narasimhan: Yes. Thanks, Rajesh. So I think, obviously, I don't want to comment on specific competitors, but I'd say there's variability in terms of capital discipline. And I think now seven years in the role, I've learned the value in playing the long game, staying disciplined, not over structuring. In the end, information asymmetry is a huge disadvantage whenever you do external deals. So, you have to be prudent. You've seen us shift to, again, mostly deals, sub-billion. And if anything, a handful of larger bolt-on deals. We try to stay disciplined against our financial measure. And if we are outbid and it's not within our envelope, we just walk away. And we're okay with that. There will be other opportunities that come. And then rather use our capital to buy back our own shares, as we're doing it in a disciplined way. We are confident in our growth profile. As Harry mentioned, we have still $10 billion in our ongoing buyback program. With buybacks are part of the capital allocation principles of Novartis, return capital to shareholders through dividends and buyback. And then prudent M&A where we see the opportunity to build one of our TAs or one of our technology platforms.

Vasant Narasimhan: Yeah, thanks, Rajesh. I think obviously don't want to comment on specific competitors, but I'd say there's variability in terms of capital discipline and I think now 7 years in the role, I've learned the value in playing the long game, staying disciplined, not overstretching. In the end, information asymmetry is a huge disadvantage whenever you do external deals, so you have to be prudent. You've seen us shift to, again, mostly deals sub-billion, and if anything, a handful of larger bolt-on deals and try to stay disciplined against our financial measures. If we are outbid and it's not within our envelope, we just walk away. We're okay with that. There'll be other opportunities that come.

Speaker Change #102: Thanks, Rajesh. I think, obviously, I don't want to comment on specific competitors, but I'd say there's variability in terms of capital, discipline, and I think for about seven years in the role, I've learned the value in playing the long game, staying disciplined.

Speaker Change #102: Not overstretching. In the end, information asymmetry is a huge, you're a huge disadvantage whenever you do external deals, so you have to be

Beth: You've seen us shift to, again, mostly deals, sub-billion, and, if anything, a handful of larger bolts on deals and try to stay disciplined against our financial measures. And if we are outbid, and it's not within our envelope, we just walk away. And we're okay with that. There'll be other opportunities that come, and then we'll rather use our capital to buy back our own shares, as we're doing in a disciplined way. We are confident in our growth profile. As Terry mentioned, we still have $10 billion in our ongoing buyback program. But buybacks are part of the capital allocation principles of Novartis, returning capital to shareholders through dividends and buybacks, and then prudent M&A, where we see the opportunity to build one of our TAs or one of our technology platforms.

Speaker Change #102: Be prudent. You've seen us shift to, again, mostly deals, sub-billion, and if anything, a handful, a larger bulk on deals.

Speaker Change #102: And try to stay disciplined against our financial measures. And if we...

Speaker Change #102: are outbid and it's not within our envelope.

Beth: There'll be other opportunities that come, and then we'll rather use our capital to buy back our own shares, as we're doing in a disciplined way. We are confident in our growth profile. As Terry mentioned, we still have $10 billion in our ongoing buyback program. But buybacks are part of the capital allocation principles of Novartis, returning capital to shareholders through dividends and buybacks, and then prudent M&A, where we see the opportunity to build one of our TAs or one of our technology platforms.

Vasant Narasimhan: Rather use our capital to buy back our own shares as we're doing in a disciplined way. We are confident in our growth profile. As Harry Kirsch mentioned, we have still $10 billion in our ongoing buyback program. Buybacks are part of the capital allocation principles of Novartis, return capital to shareholders through dividends and buybacks, and then prudent M&A, where we see the opportunity to build one of our TAs or one of our technology platforms. The reality is more and more of that happens earlier. More and more deals that are earlier on the smaller side, because there is an opportunity for where you have a differentiated view versus your competitors. You may have a different view on the science or different expertise, which allows you then to take prudent bets.

Harry Kirsch: We just walk away. And we're okay with that. There'll be other opportunities that come. And then rather use our capital to buy back our own shares, as we're doing in a disciplined way. We are confident in our growth profile. As Harry mentioned, we have still $10 billion in our ongoing buyback program.

Vasant Narasimhan: The reality is more and more that happens earlier, so more and more deals that are earlier on the smaller side, because there is an opportunity for where you have a differentiated view versus your competitors. You may have a different view on the science or different expertise, which allows you then to take prudent bets. We, of course, always look at all opportunities. And if there's something we think we can really generate significant value and we generate the returns that we would expect from a deal, we'll, of course, go after it. But on bidding wars, we're not--I think the company that wins like big bidding wars where companies are going to pay well beyond at least what we would say the valuation of the target asset is. Thanks for the question. Next question, operator?

Harry Kirsch: Technology Platforms.

Harry Kirsch: The reality is more and more that happens earlier.

Harry Kirsch: on the smaller side, because there's an opportunity for where you have a differentiated view versus your competitors. You may have a different view on the science or different expertise, which allows you then to take.

Vasant Narasimhan: We, of course, always look at all opportunities, and if there's something we think we can really, you know, generate significant value and we generate the returns that we would expect from a deal, we'll of course go after it. If it's on bidding wars, you know, we're not, I think the company that wins like big bidding wars where companies are gonna pay well beyond at least what we would say the valuation of the target asset is.

Prudent Betts: Prudent Betts.

Prudent Betts: We of course always look at all opportunities and if there's something we think we can really generate significant value and we generate the returns that we would expect from a deal.

Beth: But in bidding wars, you know, we're not, I think, the company that wins like in big bidding wars, where companies are going to pay well beyond, at least what we would say the valuation of the target asset.

Prudent Betts: will of course go after it. But on bidding wars, you know, we're not I think the company that wins like big bidding wars where companies are going to pay well beyond at least what we would say the valuation of the target asset is.

Beth: Thanks for the question. Next question, operator. Thank you. Your next question comes from the line of Joe Walton from UBS. Please go ahead.

Thanks for the question. Next question, operator.

Speaker 16: Thank you.

Rajesh Kumar: Thank you.

Vasant Narasimhan: Thanks for the question. Next question, operator.

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

Speaker Change #104: Thanks for the question. Next question operator. Thank you. Your next question comes from the line of Joe Walton from UBS. Please go ahead.

Jo Walton: Thank you. My question comes back to PLUVICTO, if I could. And just to look at the number of cycles that a patient is actually taking. I know the maximum is six. If you could tell us what you think the level is today. I think it is quite a bit below six. And how we should be thinking about that going forward into new indications? Do you think you are going to be able to expand the number of cycles? Many thanks.

Speaker 17: Thank you. My question comes back to Pluvicto, if I could. Just to look at the number of cycles that a patient is actually taking. I know the maximum is 6. If you could tell us what you think the level is today. I think it is quite a bit below 6, and how we should be thinking about that going forward into new indications. Do you think you are going to be able to expand the number of cycles? Many thanks.

Jo Walton: Thank you. My question comes back to Pluvicto, if I could. Just to look at the number of cycles that a patient is actually taking. I know the maximum is 6. If you could tell us what you think the level is today. I think it is quite a bit below 6, and how we should be thinking about that going forward into new indications. Do you think you are going to be able to expand the number of cycles? Many thanks.

Joe Walton: Thank you. My question comes back to Pluvikto, if I could, and just to look at the number of cycles that a patient is actually taking. I know the maximum is six.

Beth: If you could tell us what you think the level is today, I think it is quite a bit below six, and how we should be thinking about that going forward into new indications. Do you think you are going to be able to expand the number of cycles? Many thanks.

Joe Walton: If you could tell us what you think the level is today, I think it is quite a bit below 6, and how we should be thinking about that going forward into new indications. Do you think you are going to be able to expand the number of cycles? Many thanks.

Vasant Narasimhan: Yes. I think--Jo, thanks for the question. So right now, we're at three to four cycles per patient, which is really because - especially in more of the community setting, we're seeing referrals that are too late, and we would really like to push the referral rate earlier. I think an earlier indication--and so in effect, and sadly, the patient might demise or ultimately progress, because of the very late nature of the disease. So, I think rather when we get to the earlier line, this will be less of an issue. People will complete their six cycle. More people have the situation where patients have been kept on chemo probably too long, they can only tolerate three cycles before ultimately succumbing to their cancer. And so that's something--another benefit, I think, as we move into the PSMAfore population, in the hormone-sensitive population. In these healthier populations, we would expect the full six cycles, which should also give us a lift. So when you think from a patient volume standpoint on PLUVICTO VISION, we're actually doing pretty well. It's just I think we just need to get those referrals earlier and get the referrals deeper in the community, and that will get us, I think, back on track to that $2 billion goal globally on the VISION population and then well on track as well for the much bigger aspirations we have for the full range of indications. Thank you. Next question, operator.

Vasant Narasimhan: Yeah, I think, Jo, thanks for the question. Right now, we're at 3 to 4 cycles per patient, which is really because, especially in more the community setting, we're seeing referrals that are too late, and we would really like to push that referral rate earlier. I think an earlier indication. In effect, sadly, the patient might demise or, ultimately, progress because of the very late nature of the disease. I think rather when we get to the earlier lines, this will be less of an issue. People will complete their sixth cycle. We won't have this situation where patients have been kept on chemo probably too long. They can only tolerate 3 cycles before ultimately succumbing to their cancer. That's something. Another benefit, I think, as we move into the PSMAfore population and the hormone-sensitive population.

Joe Walton: Yeah, I think, Joe, thanks for the question. So right now we're at three to four cycles per patient, which is really because, especially in

Speaker Change #106: More the community setting, we're seeing referrals that are too late, and we would really like to push the referral rate earlier. I think an earlier indication, so in effect, unsadly, the patient might demise or ultimately progress.

Speaker Change #106: because of the very late nature of the disease. So I think rather when we get to the earlier lines, this will be less of an issue. People will complete their sixth cycle. We won't have this situation where patients have been kept on chemo probably too long. They can only tolerate three cycles before ultimately succumbing to their death.

Beth: So I think when we get to the earlier line, this will be less of an issue; people will complete their six cycles. We won't have the situation where patients have been kept on chemo probably too long, and they can only tolerate three cycles before ultimately succumbing to their cancer. And so that's something, another benefit, I think, as we move into the PSMA-4 population and the hormone-sensitive population. In these healthier populations, we would expect the full six cycles, which should also give us a lift. So when you think from a patient volume standpoint, on Plavicto and Vision, we're actually doing pretty well. It's just, I think, we just need to get those referrals earlier and get those referrals deeper in the community. That will get us, I think, back on track to that $2 billion goal globally for the Vision population and then well on track as well for the much bigger aspirations we have for the full range of indications. Thank you. Next question operator.

Speaker Change #106: Cancer and so that's something another benefit. I think as we move into the PSMA-4 population and the hormone sensitive population

Vasant Narasimhan: In these healthier populations, we would expect the full six cycles, which should also give us a lift. When you think from a patient volume standpoint on Pluvicto and VISION, we're actually doing pretty well. It's just I think we just need to get those referrals earlier and get the referrals deeper in the community. That will get us, I think, back on track to that $2 billion goal globally on the VISION population and then well on track as well for the much bigger aspirations we have for the full range of indications.

Speaker Change #106: In these healthier populations, we would expect the full six cycles, which should also give us a lift.

Beth: So when you think from a patient volume standpoint, on Plavicto and Vision, we're actually doing pretty well. It's just, I think, we just need to get those referrals earlier and get those referrals deeper in the community. That will get us, I think, back on track to that $2 billion goal globally for the Vision population and then well on track as well for the much bigger aspirations we have for the full range of indications. Thank you. Next question operator.

Speaker Change #106: So when you think from a patient volume standpoint on Plavictom and vision, we're actually doing pretty well. It's just, I think we just need to get those referrals earlier and get the referrals deeper in the community. And that will get us, I think, back on track to that $2 billion goal globally on the vision population, and then well on track as well for the much bigger aspirations we have for the full range of indications.

Beth: That will get us, I think, back on track to that $2 billion goal globally for the Vision population and then well on track as well for the much bigger aspirations we have for the full range of indications. Thank you. Next question operator.

Operator: Thank you.

Vasant Narasimhan: Next question, operator.

Operator: Thank you. Your next question comes from the line of Tim Anderson, Wolfe Research. Please go ahead.

Speaker Change #106: Thank you. Next question, operator. Thank you. Your next question comes from the line of Tim Anderson, Wolf Research. Please go ahead.

Vasant Narasimhan: Thank you. Next question, operator.

Jo Walton: Thank you.

Vasant Narasimhan: Next question, operator.

Beth: Thank you. Your next question comes from the line of Tim Anderson, Wolf Research. Please go ahead. Hi, if I could come back to IRA.

Operator: Thank you. Your next question comes from the line of Tim Anderson, Wolfe Research. Please go ahead.

Timothy Anderson: Hi. If I could come back to IRA. There's no formal gag order preventing drug companies from talking about price negotiations that are ongoing. But CMS still seems to be out there telling all the companies that basically to keep quiet about it, and all the companies are obliging. And I'm trying to figure out why. One could read into this that CMS doesn't want companies saying, oh, it's no big deal, we can manage it, because that would take away from a later announcement by them about the big price concessions that they've been able to achieve. So, can you kind of share your thoughts on that one aspect of IRA? Thank you.

Beth: There's no formal gag order preventing drug companies from talking about price negotiations that are ongoing, but CMS still seems to be out there telling all the companies to basically keep quiet about it, and all the companies are obliging. And I'm trying to figure out why, you know, one could read into this that... CMS doesn't want companies saying, oh, it's no big deal. We can manage it, because that would take away from a later announcement by them about the big price concessions that they've been able to achieve. So can you kind of share your thoughts on that one aspect of IRA? Yeah, I, you know...

There's no formal gag order preventing drug companies from talking about price negotiations that are ongoing, but CMS still seems to be out there telling all the companies to basically keep quiet about it, and all the companies are obliging. And I'm trying to figure out why, you know, one could read into this that... CMS doesn't want companies saying, oh, it's no big deal. We can manage it, because that would take away from a later announcement by them about the big price concessions that they've been able to achieve. So can you kind of share your thoughts on that one aspect of IRA?

Speaker 18: Hi. If I could come back to IRA. There's no formal gag order preventing drug companies from talking about price negotiations that are ongoing. But CMS still seems to be out there telling all the companies to basically keep quiet about it, and all the companies are obliging. And I'm trying to figure out why. You know, one could read into this that CMS doesn't want companies saying, "Oh, it's no big deal, we can manage it," because that would take away from a later announcement by them about the big price concessions that they've been able to achieve. Can you kind of share your thoughts on that one aspect of IRA? Thank you.

Tim Anderson: Hi. If I could come back to IRA. There's no formal gag order preventing drug companies from talking about price negotiations that are ongoing. But CMS still seems to be out there telling all the companies to basically keep quiet about it, and all the companies are obliging. And I'm trying to figure out why. You know, one could read into this that CMS doesn't want companies saying, "Oh, it's no big deal, we can manage it," because that would take away from a later announcement by them about the big price concessions that they've been able to achieve. Can you kind of share your thoughts on that one aspect of IRA? Thank you.

Timothy Anderson: Hi. If I could come back to IRA. There's no formal gag order preventing drug companies from talking about price negotiations that are ongoing.

Speaker Change #110: But CMS still seems to be out there telling all the companies to basically keep quiet about it and all the companies are obliging

Speaker Change #108: And I'm trying to figure out why, you know, one could read into this that...

Speaker Change #108: Seamus doesn't want companies saying, oh, it's no big deal. We can manage it, because that would take away from a later announcement by them about the big price concessions that they've been able to achieve. So can you kind of share your thoughts on that one aspect of IRA? Thank you.

Vasant Narasimhan: Yes. I don't know --I don't have much insights on that, Tim, unfortunately. But what I can say is that these are ongoing discussions, the price setting--we continue not to call it a negotiation, the price-setting process is one that have had multiple rounds. And I think often in these situations, there's no benefit for us to particularly go public, as we continue to try to finalize the discussions and take it from there. I think the reality is in this initial round from my two cents, I don't--I can't speak for CMS. But in this initial round, you have a set of medicines that are close to--relatively close to LOE, and because of that, companies that are in generic entries within a certain period of time, and so probably many companies would say this is all manageable, because it's relatively short-term.

Vasant Narasimhan: Yeah, I know I don't have much insights on that, Tim, unfortunately. What I can say is that, you know, these are ongoing discussions. The price setting, we continue not to call it a negotiation. The price setting process is one that has multiple rounds. I think often in these situations, there's no benefit for us to particularly go public as we continue to try to finalize, you know, the discussions and take it from there. You know, I think the reality is in this initial round, for my two cents, I can't speak for CMS, but in this initial round, you have a set of medicines that are relatively close to LOE.

Beth: I don't know if I have, I don't have much insight on that, Tim, unfortunately, but what I can say is that, you know, these are ongoing discussions. The price setting, continue not to call it a negotiation; the price setting process is one that has multiple rounds. And I think often in these situations, there's no benefit for us to go public as we continue to try to finalize the discussions and take it from there. You know, I think, I think the reality is in this initial round, from my two cents, I don't, I can't speak for CMS, but in this initial round, you have a set of medicines that are close to, relatively close to, LOE. And because of that, companies have entered generic entries within a certain period of time. And so, probably, many companies would say this is all manageable in the relatively short term.

Speaker Change #109: Yeah, I, you know...

Speaker Change #109: I don't know if I have... I don't have much insights on that, Tim, unfortunately, but what I can say is that...

Speaker Change #111: You know, these are ongoing discussions, the price setting, continue not to call it a negotiation, the price setting process.

Speaker Change #111: is one that has multiple rounds and I think often in these situations there's no benefit for us to particularly go public as we continue to try to finalize the discussions and take it from there.

Beth: You know, I think, I think the reality is in this initial round, from my two cents, I don't, I can't speak for CMS, but in this initial round, you have a set of medicines that are close to, relatively close to, LOE. And because of that, companies have entered generic entries within a certain period of time. And so, probably, many companies would say this is all manageable in the relatively short term.

Speaker Change #111: You know, I think...

Speaker Change #112: I think the reality is, in this initial round, for my two cents, I can't speak for CMS, but in this initial round, you have a set of medicines that are close to

Vasant Narasimhan: Because of that, companies have priced in generic entries within a certain period of time. Probably many companies would say this is all manageable because it's relatively short term. When you start getting hundreds of drugs on this list and you have drugs that are earlier in their life cycle in areas where you need more time to actually generate the peak sales and the return, I mean, this compounds, it gets uglier and uglier. I think it's just important for all of us to keep pushing government to fix the legislation. 13 years, 15 years is manageable. 9 years for a small molecule, depending on the indication or the ability to go into multiple indications or multiple cancer types is a challenge.

Speaker Change #112: relatively close to LOE

Speaker Change #112: And because of that, companies have filtered in generic entries within a certain period of time.

Beth: And so, probably, many companies would say this is all manageable in the relatively short term. But when you start getting hundreds of drugs on this list, and you have drugs that are earlier in their life cycle in areas where you need more time to actually generate peak sales and return. I think it's just important for all of us to keep pushing the government to fix the legislation. Thirteen years, fifteen years is manageable.

And so, probably, many companies would say this is all manageable in the relatively short term.

Speaker Change #113: And so, probably many companies would say this is all manageable because it's relatively short term. When you start getting hundreds of drugs on this list, and you have drugs that are earlier and earlier in their life cycle in areas where you need more time to actually...

Vasant Narasimhan: When you start getting hundreds of drugs on this list, and you have drugs that are earlier in their life cycle in areas where you need more time to actually generate the peak sales and the return, I mean, this compound gets uglier and uglier. So, I think it's just important for all of us to keep pushing the government to fix the legislation. 13 years, 15 years is manageable. 9 years for a small molecule, depending on the indication or the ability to go into multiple indications, or multiple cancer types, is a challenge. And the way the industry will manage it is we'll just shift away for small molecule drugs for the elderly, which means patients with oncology conditions and neuroscience conditions and certain cardiovascular conditions will suffer. And I think that's the message that policymakers need to hear. Last question--thank you, Tim--the last question, I think, is from Graham. Graham?

Speaker Change #113: generate the peak sales and the return. I mean this compounds and gets uglier and uglier. So I think it's just important for all of us to keep pushing government to fix the legislation.

Beth: Nine years for a small molecule, depending on the indication or the ability to go into multiple indications, is a challenge, and the way the industry will manage it is we'll just shift away from small molecule drugs for the elderly, which means patients with oncology conditions, neuroscience conditions, and certain cardiovascular conditions will suffer, and I think that's the message that policymakers need. Last question. Thank you, Tim. The last question, I think, is from Graham. Graham?

Nine years for a small molecule, depending on the indication or the ability to go into multiple indications, is a challenge, and the way the industry will manage it is we'll just shift away from small molecule drugs for the elderly, which means patients with oncology conditions, neuroscience conditions, and certain cardiovascular conditions will suffer, and I think that's the message that policymakers need.

Speaker Change #113: 13 years, 15 years is manageable. Nine years for a small molecule, depending on the indication or the ability to go into multiple indications.

Vasant Narasimhan: The way the industry will manage it is we'll just shift away for small molecule drugs for the elderly, which means patients with oncology conditions and neuroscience conditions and certain cardiovascular conditions will suffer. I think that's the message that policymakers need to hear.

Speaker Change #113: The way the industry will manage it is we'll just shift away from small molecule drugs for the elderly, which means patients with oncology conditions and neuroscience conditions and certain cardiovascular conditions will suffer. And I think that's the message that policymakers need to hear.

Speaker 18: Thank you.

Tim Anderson: Thank you.

Vasant Narasimhan: Last question. Thank you, Tim. Last question, I think, is from Graham. Graham?

Last question. Thank you, Tim. The last question, I think, is from Graham. Graham?

Speaker Change #113: Last question, thank you Tim, last question I think is from Graham. Graham?

Beth: Your line is now open, Graham. Great, thank you. Just to follow up on Kazim, obviously, you had a very strong quarter there; just wondered if you think you might need to really visit your peak guide there, and if so, and if you could just help us understand how far penetrated you think you are into peak opportunities in the US and the rest of the world, which now seems to be driving almost as much of the growth as the US?

Operator: Your line is now open, Graham.

Graham Parry: Great. Thank you. Just a follow-up on KESIMPTA, obviously had a very strong quarter there. I just wondered if you think you might need to really visit your peak guide there. And if so, if you can just help us understand and how far penetrated do you think you are into peak opportunity in the U.S. and then rest of world, which now seems to be driving almost as much of the growth as the U.S.?

Graham Parry: Great. Thank you. Just to follow up on Kesimpta, which obviously had a very strong quarter there. Just wondered if you think you might need to revisit your peak guide there, and if so, if you can just help us understand how far penetrated do you think you are into peak opportunity in the US and the rest of the world, which now seems to be driving almost as much of the growth as the US.

Speaker Change #113: Your line is now open, Graham.

Graham Parry: Great, thank you. Just to follow up on Kazim, obviously you had a very strong quarter there. I just wondered if you think you might need to really visit your peak guide there, and if so, and if you can just help us understand how far penetrated do you think you are into peak opportunity in the U.S. and the rest of the world, which now seems to be driving almost as much of the growth as the U.S.?

Vasant Narasimhan: Good question, Graham. I think area of internal debate as to how big could KESIMPTA be. Certainly, just to give you some numbers in the U.S., we have--[inaudible]--B-cell share of all patients in RRMS. So there's plenty of room to run most of that at the expense of older medicines, the so-called BRACE, as you know well. So plenty of room to create a larger--basically, the market is for B-cell inhibition and MS could double in the United States as physicians get more and more comfortable with B-cell inhibitors. Similarly, we see similar dynamics in Europe. Obviously, in Asia, MS is less of a topic. So again, an opportunity for further expansion. So, we're certainly looking at the peak sales potential for Kesimpta I think when we're in a place where we can provide more precise guidance, we certainly will. I think one area, of course, we have to watch is the BTK inhibitors. But as you know, the data has not been great so far. Remibrutinib is continuing on track in MS. But if anything, we now view the BTK inhibitors as perhaps supportive, but not being able to replace the B-cell monoclonal antibodies, which also gives a tailwind to KESIMPTA's long-term potential as well.

Vasant Narasimhan: Good question, Graham. I think an area of internal debate as to how big Kesimpta could be. Certainly, you know, just to give you some numbers in the US, we have 55% B-cell share of all patients in RRMS, so there's plenty of room to run, most of that at the expense of older medicines, the so-called BRACE, as you know well. Plenty of room to create a larger market. Basically, the market size for B-cell inhibition in MS could double in the United States, as physicians get more and more comfortable with B-cell inhibitors. Similarly, we see similar dynamics in Europe. Obviously in Asia, MS is less of a topic. Again, an opportunity for further expansion.

Speaker Change #114: Good question, Graham. I think an area of internal debate as to how big could Cosim to be. Certainly, you know, just to give you some numbers in the U.S., we have...

Speaker Change #115: A 50-50% B-cell share of all patients in RRMF, so there's plenty of room to run. Most of that at the expense of older medicines, the so-called brace.

Beth: So plenty of room to create a larger market. Basically, the market size for B-cell inhibition in MS could double in the United States as physicians get more and more comfortable with B-cell inhibitors. Similarly, we see similar dynamics in Europe; obviously, in Asia, MS is less of a topic. So again, an opportunity for further expansion. So we're certainly looking at the B-cell potential for Kesimpta, and I think when we're in a place where we can provide more precise guidance, we certainly will. I think one area we have to watch is the BTK inhibitors, but as you know, the data has not been great so far. Remibrudinib is continuing on track in MS, but if anything, we now view the BTK inhibitors as perhaps supportive, but not able to replace the B-cell monoclonal antibodies, which also gives a tailwind to Kesimpta's long-term potential as well.

Graham Parry: as you know well.

Graham Parry: So plenty of room to create a larger market, basically the market size for B-cell inefficient and MS could double in the United States as

Graham Parry: Physicians get more and more comfortable with B-cell inhibitors.

Graham Parry: Similarly, we see similar dynamics in Europe , obviously in Asia, MS is less of a topic.

Beth: So again, an opportunity for further expansion. So we're certainly looking at the B-cell potential for Kesimpta, and I think when we're in a place where we can provide more precise guidance, we certainly will. I think one area we have to watch is the BTK inhibitors, but as you know, the data has not been great so far. Remibrudinib is continuing on track in MS, but if anything, we now view the BTK inhibitors as perhaps supportive, but not able to replace the B-cell monoclonal antibodies, which also gives a tailwind to Kesimpta's long-term potential as well.

Vasant Narasimhan: We're certainly looking at the peak sales potential for Kesimpta, and I think when we're in a place where we can provide more precise guidance, we certainly will. I think one area, of course, we have to watch is the BTK inhibitors, but as you know, the data's not been great so far. Remibrutinib is continuing on track in MS, but if anything, we now view the BTK inhibitors as perhaps supportive, but not being able to replace the B-cell monoclonal antibodies, which also gives tailwinds to Kesimpta's long-term potential as well. Thank you, Graham. I think that's everything for today. Thank you all very, very much for the call.

Speaker Change #116: So again, an opportunity for further expansion. So we're certainly looking at the peak sales potential for Casimta, and I think when we're in a place where we can provide more precise guidance, we certainly will. I think one area, of course, we have to watch is the BTK inhibitors, but as you know, you know, the data has not been great so far.

Remy Brudin: Remy Brudinow is continuing on track in MS, but if anything, we now view the BTK inhibitors as perhaps supportive, but not being able to replace the B-cell monoclonal antibodies, which also gives a tailwinds to Kesimpta's long-term protection.

Vasant Narasimhan: Thank you, Graham. I think that's everything for today. So thank you all very, very much for the call. We'll look forward to providing you with another update in Q3 and then also looking forward to seeing you all and meeting the management in November. So, thank you again. Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect. Thank you for watching!

Vasant Narasimhan: Thank you, Graham. So, I think that's everything for today. So thank you all very, very much for the call. We look forward to providing you another update in Q3, and then also looking forward to seeing you all at Meet The Management in November. So, thank you again.

Remy Brudin: potential as well.

Speaker Change #118: Thank you, Graham. So I think that's everything for today. So thank you all very, very much for the call. We look forward to providing you another update in Q3, and then also looking forward to seeing you all and meet the management in Q4.

Vasant Narasimhan: We look forward to providing you another update in Q3, and then also looking forward to seeing you all at Meet the Management in November. Thank you again.

Operator: Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.

Speaker Change #118: and

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Operator: Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.

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