Q3 2025 Roche Holding AG Earnings Call

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Speaker #2: This call .

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Speaker #3: At this time . It's my pleasure to introduce you to Thomas Schinecker CEO workgroup , Mr. Shenkar , the stage is yours .

Operator: It's our pleasure to introduce you to.

Bruno Eschli: Thomas Schinecker, CEO of Roche Holding Ltd. Mr. Schinecker, the stage is yours.

Speaker #4: Thank you very much and good morning . Good afternoon . And I'm happy to share with you our Q3 2025 results . So let's start with our performance .

Thomas Schinecker: Thank you very much and good morning, good afternoon and I'm happy to share with you our Q3 2025 results. Let's start with our performance. We continue to see strong performance for the Roche group year to date. Group sales are still the same as half year at 7% growth, really driven by pharma with 9%. Diagnostics grew year to date with 1%. We see a return to growth. Diagnostics has of course been impacted by the healthcare pricing reforms in China, something that we have communicated multiple times throughout the year. If we exclude China in the numbers, the rest of diagnostics was growing 7%, which is absolutely in line with past performance of diagnostics. We do see that diagnostics continues to perform well on the LOE impact.

Speaker #4: We continue to see strong performance for the Rosh Group . Year to date group sales are still same as half year at 7% growth .

Speaker #4: Really driven by pharma , with 9% . Diagnostics grew year to date with 1% . So we see a return to growth and diagnostics has of course been impacted by the healthcare pricing reforms in China , something that we have communicated multiple times throughout the year .

Speaker #4: If we exclude China in the numbers , then the diagnostics was growing 7% , which has absolutely in line with past performance of diagnostics .

Speaker #4: So we do see that diagnostics continues to perform well on the low impact . We've lowered this now to 800 million impact , down from 1 billion , which we still showed at the half year results in Q3 .

Thomas Schinecker: We've lowered this now to $800 million impact, down from $1 billion, which we still showed at the half year results in Q3. We've had several important milestones that we've achieved on the pharma regulatory side. The U.S. approval for Gazyva in lupus nephritis and the positive CHMP opinion in the EU. The U.S. approval for Tecentriq in first line maintenance small cell lung cancer, U.S. filing process for pembro-namd, and we had several positive Phase 3 readouts. For example, the positive Phase 3 readout of giredestrant results were just presented at ESMO on Saturday. The study met the primary endpoint both in the ESR1 mutant population but also in the ITT population. Definitely Teresa will talk more about that. We had a positive Phase 3 result for Tecentriq in muscle invasive bladder cancer. We had trial results shown from Phase 3 in lamici part in UME in tetralizumab.

Speaker #4: We've had several important milestones that we've achieved on the pharma regulatory side . The US approval for gazyva and lupus nephritis and the positive Chmp opinion in the EU .

Speaker #4: The U.S. approval for Centric in first-line maintenance for small cell lung cancer, U.S. filing for chemo in AMD, and we had several positive Phase III readouts. For example, the positive Phase III readout of Avira District results were just presented at ASCO on Saturday.

Speaker #4: The study met the primary endpoint both in the Esr1 mutant population , but also in the ITT population . Definitely , Theresa will talk more about that .

Speaker #4: We had a positive phase three readouts for tecentriq in muscle invasive bladder cancer . We had trial results shown from phase three in the in in lizumab .

Speaker #4: This we just presented at AAO , for example . And these are some encouraging results . Looking at the efficacy of these medicines .

Thomas Schinecker: This we just presented at AAO for example and these are some encouraging results looking at the efficacy of these medicines and we will discuss those results with global health authorities also here. Teresa will talk more about that. Very importantly, we really refilled our late stage pipeline. Also in the last quarter, we took five additional Phase 3 decisions on top of the four previously announced half year. An overall significant progress in our pipeline. There is CT-388 in obesity, CT-868 in type 1 diabetes. Silvassrin hypertension study has already started. Svostimab in relapsed refractory multiple myeloma and HER2 tyrosine kinase inhibitor in HER2 positive breast cancer. Importantly, four out of the five came actually through partnership agreements in the last two years and based on positive data we are moving those forward.

Speaker #4: And we will discuss those results with global health authorities . Also here , Theresa will talk more about that . Very importantly , we really refilled our late stage pipeline also in the last quarter .

Speaker #4: We took five additional phase three decisions on top of the four previously announced at half year . So an overall significant progress in our pipeline .

Speaker #4: There is a city with a 3.8% obesity rate, CTA 68 in Type 1 diabetes. The Sylvester and Hypertension study has already started Cevostamab in relapsed refractory multiple myeloma and a HER2 tyrosine kinase inhibitor in HER2 positive breast cancer.

Speaker #4: Importantly , four out of the five came actually through partnership agreements . In the last two years and based on positive data , we're moving those forward on the front .

Thomas Schinecker: On the BSD front we've entered into an agreement to acquire 89bio with their potentially best-in-class FGF21 analog in MASH, and this deal is highly synergistic with our CBRM portfolio, providing further optionalities for combination therapies. We've also entered into an agreement with Hunter Pharma to license their CDH17 ADC, which is currently in Phase 1 to be developed in colorectal cancer. On the diagnostic side, with a series of regulatory updates, most importantly the first blood-based rule-out test, Elecsys pTau181, which got the CE mark but also the FDA clearance, on the FDA clearance with a primary setting claim, which is, I think, very important to identify patients and to bring them on therapy.

Speaker #4: We've entered into an agreement to acquire 89 bio with their potentially best in disease , FGF 21 analog in mesh , and this deal is highly synergistic with our CVM portfolio , providing further opportunities for combination therapies .

Speaker #4: We've also entered into an agreement with Hunter Pharma to license their CDH 17 ADC , which is currently in phase one , to be developed in colorectal cancer , and the diagnostic side , we had a series of regulatory updates .

Speaker #4: Most importantly , the first blood based rule out test . Lexus P-tau181 , which got the CE mark , but also the FDA clearance on the FDA clearance with a primary setting claim , which is , I think , very important to identify patients and to bring them on therapy .

Speaker #4: Alexis , troponin T , high sensitive generation six . But also the AI algorithm Kidney clinic risk with the CE mark . There's some news flow left towards the end of the year .

Thomas Schinecker: Elecsys Troponin T high sensitive Generation 6, but also the AI algorithm Kidney Clinic Risk with the CE mark, there's some news flow left towards the end of the year, and Teresa and Matt will cover that. For example, fenebrutinib, Gazyva in SLE, as well as PSK and several diagnostics launches coming this year. Let's look at the overall momentum and the sales numbers. You can see here, Pharmaceuticals still doing extremely well with 9% growth rate. Very happy with that. Diagnostics growing 1%. I explained the numbers given the healthcare pricing reforms in China. This is an effect that severely impacted us this year. There will be some effects next year, but we will see a continuous improvement. Overall, the group is at 7%.

Speaker #4: And Theresa and Matt will cover that. For example, Fenebrutinib and Gazyva in SLE, as well as PSC, and several diagnostics launches coming this year.

Speaker #4: So again , let's look at the overall momentum and the sales numbers . You can see here . Pharmaceuticals still doing extremely well with 9% growth rate .

Speaker #4: So very happy with that . Diagnostics growing 1% I explained the numbers given the healthcare pricing reforms in China . This is an effect that severely impacted us this year .

Speaker #4: There will be some effects next year , but we will see a continuous improvement . So overall , the group is at 7% .

Speaker #4: If you look at the growth rates over the last two and a half years , we've consistently performed , especially if you look at the base business , excluding Covid , with 8% growth on on average again this year , Q1 , Q2 , Q3 were impacted by the healthcare pricing reforms in China in diagnostics , you see that pharma are still growing at 9% .

Thomas Schinecker: If you look at the growth rates over the last two and a half years, we've consistently performed, especially if you look at the base business excluding COVID, with 8% growth on average again this year. Q1, Q2, Q3 were impacted by the healthcare pricing reforms in China. In Diagnostics, you see that Pharma is still growing at 9%, so we continue to have a positive momentum. Now let me talk about some of the key drivers in the Roche portfolio. Starting with the top right and going clockwise, first with oncology and hematology. The Fezgo global conversion rates are now at 51%, plus 5% versus previous quarter. We believe that we can get at least 60% global conversion rate. Alecensa's growth number remains good, driven by the adjuvant ALK-positive non-small cell lung cancer. As mentioned, we have the positive results from inavolisib in Phase 3, which represented the Esmya.

Speaker #4: So we continue to have a positive momentum . Now , let me talk about some of the key drivers in the portfolio , starting with the top right and going clockwise first with oncology and hematology .

Speaker #4: The global conversion rates are now at 51% plus 5% versus previous quarter . We believe that we can get to at least 60% global conversion rate .

Speaker #4: Alecensa's growth numbers remain strong, driven by the adjuvant ALK-positive non-small-cell lung cancer. As mentioned, we have the positive results from the Avira trial in Phase III, which were presented at ESMO Polivy.

Thomas Schinecker: Polivy sees continued strong uptake in first line. DLBCL now reaching 35% patient share in the U.S. and truly has established itself as the new standard of care and Amnever continues to grow strongly with full year growth now expected in the around 10% range. New is also that the NXT CR07 data will be presented later at ASH on the neurology side and I know Teresa will talk about that as well. Ocrevus Xenovo we have now 50% of starts in the U.S. are new to brand and Evrysdi is the number one SMA treatment and keeps growing with more than 21,000 patients being on treatment. On the immunology side Xolair continues to do well. We have a strong uptake now growing at 34% and in food allergy we now have more than 85,000 patients on this medicine. The U.S.

Speaker #4: Is continued strong update uptake in first-line DLBCL now reaching 35% patient share in the U.S., and truly has established itself as the new standard of care? Hemlibra continues to grow strongly, with full-year growth now expected in the around 10% range.

Speaker #4: New is also that the NXT series are seven . Data will be presented later at Ash on the neurology side , and I know Theresa will talk about that as well .

Speaker #4: Ocrevus: we have now 50% of starts in the U.S. that are new to brand, and it is the number one PSMA treatment, which keeps growing, with more than 21,000 patients being standardized on treatment.

Speaker #4: On the immunology side , solar continues to work to do well with a strong uptake now growing at 34% and in food allergy , we now have 85 more than 85,000 patients on this medicine .

Speaker #4: The US approval that we have received for in lupus nephritis , and we called also a positive CMP opinion in Europe . And we expect also the phase three results for Gazyva in SLE to read out later this year on the ophthalmology side , we continue to have overall strong global growth in Vabysmo driven by its differentiated MOA and profile .

Thomas Schinecker: approval that we have received for Gazyva in lupus nephritis and we got also a positive CHMP opinion in Europe and we expect also the Phase 3 results for Gazyva in SLE to read out later this year. On the ophthalmology side we continue to have overall strong global growth in Vabysmo driven by its differentiated MOA and profile but we do see ongoing contraction of the branded market segment in the U.S. because of less funding available for these copay assistance foundations. On the diagnostic side as mentioned good growth in the overall business core lab being mostly impacted by the general healthcare pricing reforms without that diagnostics is growing at 7%. Now let me give you a little bit of a pipeline update. On the left hand side you see how our pipeline prioritization has continued.

Speaker #4: But we do see ongoing contraction of the branded market segment in the US because of less funding available for these coexistence . Copay assistance foundations .

Speaker #4: On the diagnostic side, as mentioned, there was good growth in the overall business, with collaboration mostly impacted by the general healthcare pricing reforms.

Speaker #4: Without that , diagnostics is growing at 7% . Now , let me give you a little bit of a pipeline update on the left hand side , you see how our pipeline prioritization has continued and we constantly apply the bar to all of the molecules that are in our pipeline .

Thomas Schinecker: We constantly apply the bar to all of the molecules that are in our pipeline. We constantly make decisions based on new data available or also external data available and keep prioritizing so we can really allocate the funds to those projects that have the highest impact and the highest potential. With that we can also accelerate a number of these programs. You can see that also how it translates into the overall portfolio value. If you look at just peak sales per pipeline project, we've increased that now by 57%. Before this prioritization we had an average value of pipeline project of about $800 million. We're now at $1.3 billion. Also the total portfolio value in this time period has increased by 27%, which I think is exactly what we wanted to achieve with R&D excellence and the prioritization in our portfolio.

Speaker #4: So we constantly make decisions based on new data available or also external data available , and keep prioritizing so we can really allocate the funds to those projects that have the highest impact .

Speaker #4: And the highest potential . And with that , we can also accelerate a number of these programs . And you can see that also how it translates into the overall portfolio value .

Speaker #4: If you look at just peak sales per pipeline project , we've increased that now to 50 by 57% . So before this prioritization , we had an average value of pipeline project of about 800 million .

Speaker #4: We're now at $1.3 billion. Also, the total portfolio value in this time period has increased by 27%, which I think is exactly what we wanted to achieve with R&D excellence.

Speaker #4: And the prioritization in our portfolio . What's really exciting is if we look at this slide is how many molecules have moved into phase three this year , this is by far a record for Roche , and we are not even done with this year .

Thomas Schinecker: What's really exciting is if we look at this slide is how many molecules have moved into Phase 3 this year. This is by far a record for Roche and we are not even done with this year, so 10 moving into Phase 3. These are all molecules that will launch by the end of this decade. We have a lot, I think, to look forward to. We really see it across all of our therapeutic areas. We see it in oncology with the HER2 tyrosine kinase inhibitor, svostimab, also NXC007 in hemophilia A. We see it in the neurology front in Alzheimer's and Parkinson's. We see it also in the cardiovascular area. We are progressing very well. This really is going to impact our growth momentum at the end of this decade and into the next decade as well.

Speaker #4: So ten moving into phase three . And these are all molecules that will launch by the end of this decade . And so we have a lot , I think , to look forward to .

Speaker #4: And we really see it across all of our therapeutic areas . We see it in oncology with the Her2 tyrosine kinase inhibitor cevostamab .

Speaker #4: Also in NX 007 , in hemophilia A , we see it in the neurology front in Alzheimer's and Parkinson's . We see it also in the cardiovascular area .

Speaker #4: So we are progressing very well . And this really is going to impact our growth momentum at the end of this decade and into the next decade as well .

Speaker #4: The way you can also see how we apply the bar is as we assess points of projects internally, and the value in the business cases behind each of the projects.

Thomas Schinecker: The way you can also see how we apply the bar is as we assess projects internally and the value in the business cases behind each of the projects, you see where the projects lie. For those assets that are pre-bar, which are in the gray, the gray dots, and in the dark blue dots, you see all the assets that we've moved into Phase 3. We haven't added, because this is the slide from Pharma Day, we haven't added all the new ones that we've added into Phase 3 since then. I can say they're all really promising as well. We didn't do that because otherwise you would know exactly which dot is which dot. I just wanted to point that out, that we haven't added all of those. You see the overvalue consistently moving up and the projects consistently moving up.

Speaker #4: You see where the projects lie for those assets that are pre bar , which are in the gray , the gray dots and in the dark blue dots , you see all the assets that we've moved into phase three .

Speaker #4: We haven't added because this is the slide from Pharma day . We haven't added all the new ones that we've added into phase three since then .

Speaker #4: But I can say they're all really promising as well . We didn't do that because otherwise you would know exactly which is which dot .

Speaker #4: But I just wanted to point that out that we haven't added all of those . So you see the overall value consistently moving up and the Pts consistently moving up .

Speaker #4: And and you can see all of the blue dots on the top right corner . Now , this doesn't mean that there will not be any assets that we will have on on the on the left hand side .

Thomas Schinecker: You can see all of the blue dots in the top right corner. This doesn't mean that there will not be any assets that we will have on the left-hand side. Just to point out the reasons for these two dots, one of them, the lower one, is the novel antibiotic. We know that there is currently no market for that. We see it as an opportunity also in case there will be a pandemic and there will be a pandemic in the future. We also see that as an ethical responsibility. The other one is first indication in oncology and we know that this will move into further indications. It will move further to the right as we proceed with additional projects.

Speaker #4: Just to point out the reasons for these two dots , one of them , the lower one , is the the novel antibiotic .

Speaker #4: We know that there is currently no market for that . We see it as a as a opportunity . Also , in case there will be a pandemic and there will be a pandemic in the future , but we also see it as an ethical responsibility .

Speaker #4: And the other one is first indication in oncology . And we know that this will move into further indications . So it will move further to the right as we proceed with additional projects .

Speaker #4: You can also see on the right hand side the portfolio composition through the different phases of development , the ones that have moved through the bar and the ones that we're introduced pre the bar .

Thomas Schinecker: You can also see on the right-hand side the portfolio composition through the different phases of development, the ones that have moved through the bar and the ones that were introduced pre the bar. You can be assured that every portfolio decision that we made in the transitions, they will always have to meet the bar. Now let me talk about also some of the new slope. Here you can see starting with TL1A that we've initiated a Phase 2 study in a new indication, which is rheumatoid arthritis. This is TL1A where we will see the first readout in 2027, but not in this indication, in other indications. The Mickey Bart, we've talked about the Phase 3 readout where you can see the efficacy of the molecule giredestrant with a positive readout for Ivira. Teresa will talk more about that.

Speaker #4: But you can be assured that every portfolio decision that we made in the transitions , they will always have to meet the bar .

Speaker #4: Now let me talk about also some of the the news flow . And here you can see starting with keyboard that we've initiated phase two study in a new indication which is rheumatoid arthritis .

Speaker #4: Arthritis . This is our TL one where we will see the first readout in 2027 . But not in this indication , but in other indications .

Speaker #4: The Milky Bar we've talked about the phase three readout , where you can see the efficacy of of the molecule to and we had a positive readout for Theresa will talk more about that .

Speaker #4: Divarasib . This new phase three for diversity in adjuvant setting in non-small cell lung cancer . We've talked about the portfolio transitions of CC 388868 Her2 tyrosine kinase inhibitor and pedestrian , all based on data .

Thomas Schinecker: Divarasib, there's new Phase 3 for divarasib in the adjuvant setting in non-small cell lung cancer. We've talked about the portfolio transitions of CT-388, CT-868, svostimab, HER2 tyrosine kinase inhibitor, and tilthrin, all based on data. Some of these data you will see as we go into next year in the ADA, especially on the obesity and cardiovascular metabolism medicines. Pegazafermin is potentially best-in-class FGF21 analog, currently in two Phase 3 for MASH in the stages of F2 to F3, but also in MASH for F4. We have announced this deal recently and we look forward to the closing of the deal. Now let's move on to the next slide, to diagnostics, which is also very exciting.

Speaker #4: Some of the data you will see as we go into next year in the ADA, especially on obesity, cardiovascular metabolism, and medicines.

Speaker #4: Pegol is a Furman is a potentially best in disease . FGF 21 analog currently in two phase three for Mash in the stages of F2 to F3 , but also in in Mash for F4 , and we have announced this deal recently and we look forward to the closing of the deal .

Speaker #4: Now let's move on . The next slide to diagnostics , which is also very exciting . If you look at some of the key technologies that will drive future growth , here , you have some of those clearly mass spectrometry , which is one of its kind , something that truly sets us apart from our competitors .

Thomas Schinecker: If you look at some of the key technologies that will drive future growth, here you have some of those, purely mass spectrometry, which is one of its kind, something that truly sets us apart from our competitors and differentiates us even beyond mass spec in a clinical chemistry and immunochemistry setting. Here we are in the rollout and we will expect a full U.S. launch in 2026. Accu-Chek Smart Guide CGM, also here we're making good progress, we're ramping up manufacturing, and very exciting, next year we're going to launch the Roche sequencing solution. You have seen some of the data that was just recently presented at SHG and also the fact that this sequencing solution sets a new world record in terms of speed in sequencing a whole human genome in under four hours.

Speaker #4: And differentiates us even beyond mass spec in the clinical chemistry and immunochemistry setting . Here we are in the rollout and we will expect full US launch in 2026 .

Speaker #4: Accu-Chek Smart Guide CGM . Also here . We're making good progress . We're ramping up manufacturing and very exciting . Next year we're going to launch rush .

Speaker #4: The Rush sequencing solution. You have seen some of the data that was just recently presented at ASHG, and also the fact that this sequencing solution set a new world record in terms of speed in sequencing a whole human genome in under four hours.

Speaker #4: So we really have very competitive product here . And we really look forward to launching this solution next year . All of these areas are , I would say if you look at pharma terms , blockbuster potential .

Thomas Schinecker: We really have a very competitive product here and we really look forward to launching this solution next year. All of these areas are, I would say, if you look at pharma terms, blockbuster potential, so opportunities that are in the $1 billion plus size of opportunity. Really exciting, and I believe this will really cement the future growth of Roche diagnostics. Now let me talk about the outlook, the slide you have seen previously, also shown in different events like the Pharma Day event. On the bottom you see diagnost and diagnostics. We do believe that we can continue the growth momentum that we've seen in the past years, and this will really be cemented by the blockbuster opportunities with mass spectrometry, CGM, SBX. I also believe very much with something like the Mirror DX. We do believe that we can continue to grow mid to high single digit.

Speaker #4: So opportunities that are in the 1 billion plus size of opportunity . So really exciting . And I believe this will really cement the future growth of Roche Diagnostics .

Speaker #4: Now let me talk about the outlook first . This slide this slide you have seen previously also shown in different events like the Pharma Pharma day event .

Speaker #4: On the bottom you see diagnostics and diagnostics . We do believe that we can continue the growth momentum that we have seen in the past years , and this will really be cemented by the blockbuster opportunities with mass spec CGM , ESP .

Speaker #4: But I also believe very much in something like the Mirror DX. So we do believe that we can continue to grow mid to high single digits.

Speaker #4: We will have to wash out the China effect . They will still be some effects next year and that co-op to grow ahead of sales growth .

Thomas Schinecker: We will have to wash out the China effect. There will still be some effects next year on that, co-op to grow ahead of sales growth. You look on the pharma side. On the pharma side, we have very good momentum. In our portfolio, you see the 9% growth, and we do believe that we are one of the companies which have less biosimilar erosion. If you look at the next couple of years, we do believe we can compensate that with the growth momentum that we have with the medicines that we have in hand and that we will continue to grow at least until 2028 and thereafter. The growth of the existing medicines will compensate any additional biosimilar erosion, and anything we have on top in terms of pipeline readouts, positive Phase 3 readout will then add to growth.

Speaker #4: And then you look on the pharma side on the farmer side we have very good momentum in our portfolio . You've seen the 9% growth and we do believe that we are one of the companies which have less biosimilar erosion .

Speaker #4: I mean , if you look at the next couple of years , we do believe we can compensate that with the growth momentum that we have with the medicines that we have in hand and that we will continue to grow at least until 28 .

Speaker #4: In thereafter , the growth of the new of the existing medicines will compensate any additional biosimilar erosion . And anything we have on top in terms of pipeline readouts .

Speaker #4: Positive phase three readouts will then add to growth . So we don't see a case where we will not continue to grow . In fact , any of these readouts that you see , any of these 19 potential medicines that we can launch by the end of the medicine , at the end of this decade , will continue to contribute to future growth .

Thomas Schinecker: We don't see a case where we will not continue to grow. In fact, any of these readouts that you see, any of these 19 potential medicines that we can launch by the end of the decade will continue to contribute to future growth. We believe we are set up for growth, and we also know we're not done with BD. We can continue to invest in BD and bring in more opportunities that will continue to drive growth also into the future. Finally, let me talk about the guidance group sales growth mid single digit, and just to take that upfront, when we grow 7%, we do believe 7% is in the mid single digit range. We look at core EPS at half year. We still talked about high single digit growth. You saw our numbers at half year.

Speaker #4: So we believe we are set up for growth . And we also know we're not done with BD . We can continue to invest in BD and bring in more opportunities that will continue to drive growth also into the future .

Speaker #4: Finally , let me talk about the guidance group sales growth mid-single digit and just to take that upfront , when we grow 7% , we do believe 7% is in the mid single digit range .

Speaker #4: We look at . Core at half year , we still talked about high single digit growth . You saw our numbers at half year .

Speaker #4: That's why we are also increasing here . The guidance from high single digit to high single digit to low double digit core growth .

Thomas Schinecker: That's why we are also increasing here the guidance from high single digit to high single digit to low double digit core EPS growth. We also believe that we can further increase dividends in Swiss francs. With that, I hand over to Alan.

Speaker #4: And we also believe that we can further increase dividends in Swiss francs. With that, I hand over to Ellen.

Speaker #5: Yeah , thanks , Thomas . Sales calls today . So just a few comments from my side on sales currency impacts and a couple of comments on the guidance for 2025 .

Alan Hippe: Yeah, thanks Thomas. Sales calls today. Just a few comments from my side on sales currency impacts and a couple of comments on the guidance for 2025. When you look at the sales bridge, I think that the sales bridge in Swiss francs you see on the left hand side 2024. On the right hand side 2025, 2% growth in total. The bridge splits it up between the growth in constant rates and the currency impact. When I go through the bridge elements for the growth in constant rates 7%. You see pharma quite impressive growth $3.4 billion. You see the loss of exclusivity impacts of $474 million in total, a growth of 9% in constant rates.

Speaker #5: When you look at the sales bridge , I think that's the sales bridge in Swiss francs . You see on the left hand side , 2024 on the right hand side , 2025 2% growth in total .

Speaker #5: And then the bridge splits it up between the growth in constant rates and the currency impact . So when I go through the bridge elements for the growth in constant rates , 7% , then you see pharma quite , quite impressive growth 3.4 billion .

Speaker #5: And then you see the loss of exclusivity impacts of -474 million . In total , the growth of 9% in constant rates , as Thomas alluded to , based on the effect that we have seen so far in the loss of exclusivity section , we think that the new indication for full year should be an 800 million loss due to the loss of exclusivity .

Alan Hippe: As Thomas alluded to, based on the effect that we have seen so far in the loss of exclusivity section, we think that the new indication for full year should be an $800 million loss due to the loss of exclusivities. When you go to diagnostics, although as Thomas has mentioned diagnostics has grown excluding China with plus 7% in constant rates. Matt will lead you through this. You see really the China healthcare pricing reform impact of a -$517 million, -6%, -6 percentage points which in total provides diagnostics with a growth of 1% in constant rates. You see the currency impact which accounts for minus 5 percentage points leads you.

Speaker #5: When you go to diagnostics , although this Thomas has mentioned diagnostics has grown excluding China with plus 7% in constant rates and that will lead you through this .

Speaker #5: And then you see really the China healthcare pricing reform impact of a minus 517, minus 6%, minus six percentage points, which then in total provides diagnostics with the growth of 1% in constant rates.

Speaker #5: You see the currency impact, which accounts for minus five percentage points, leads you to the two percentage points growth in Swiss francs.

Bruno Eschli: To the 2% growth in Swiss francs.

Speaker #5: Well , where does it come from ? I think first , certainly I think the Swiss franc has strengthened again against all major currencies and you see on the left hand side you see the growth in constant rates .

Alan Hippe: Where does it come from? I think first certainly I think the Swiss franc has strengthened again against all major currencies. You see on the left hand side you see the growth in constant rates now 6.7%. That's the 7% rounded that we have mentioned all the time, and on the right hand side you see the growth in Swiss francs was plus 2%. Distance here is minus 4.7 percentage point. That's the minus 5 percentage point that I've mentioned before. You see very clearly the major.

Speaker #5: Now 6.7% . That's the 7% rounded that we have mentioned all the time . And on the right hand side you see the growth in Swiss francs with plus 2% distance .

Speaker #5: Here is -4.7 percentage points. That's the minus five percentage points that I've mentioned before. And you see very clearly the major driver here is the U.S. dollar.

Bruno Eschli: Driver here is the U.S. dollar.

Speaker #5: Yeah . Let me get to the currency impact . And yeah we started the year quite well . Well but now I think you see when you look to the left hand side , the US dollar has frozen weakened against the Swiss franc .

Alan Hippe: Let me get to the currency impact. We started the year quite well, but now I think you see when you look to the left-hand side, the U.S. dollar has weakened against the Swiss franc. When you go to the euro, the euro has shown some stability as you can take from the slide here. As said, I think certainly dominated by the U.S. dollar. When you go to the right-hand side, if you like our modeling and our forecasting for year end, this really is assuming that the September 30 exchange rates remain stable until the end of 2025, which is certainly very unlikely. When you look really at full year, you see really a -5% impact on sales, a -8% impact on operating profit, and a -8% impact on core EPS.

Speaker #5: And when you go to the euro the euro has shown some stability . As you can take from the slide here . But as I said , I think certainly dominated by the US dollar .

Speaker #5: So when you go to the right hand side and our if you like our modeling and our forecasting for , for year end and this really is assuming that the September 30th exchange rates remain stable until the end of 2025 , which is certainly very unlikely .

Speaker #5: But when you look really at full year , you see really a minus five percentage points impact on sales , minus eight percentage points impact on core operating profit and a -8% percentage points impact on core EPs .

Speaker #5: You might remember when you looked at this table at half year . We had for core EPs , a minus six percentage points , and I think that's important .

Alan Hippe: You might remember when you looked at this table at half year, we had for core EPS -6%, and I think that's important. That has worsened by 2% to -8%, and that has certainly an impact on the consensus. I will talk about this in the context of the guidance here. As you've seen in Q3, we have seen an increase in the expected currency impact on core EPS for the full year 2025 by -2% from -6%, which we have forecasted at the end of June, to -8% that we are forecasting now for year end. When looking at the post half year 2025 consensus, the core EPS growth stood at around 5.5%. We believe that this estimate would need to be adjusted for the guided additional currency deterioration of -2% which we have experienced in Q3 for the full year 2025 projection.

Speaker #5: So that has worsened by two percentage points to minus eight percentage points. And that has certainly an impact on the consensus.

Speaker #5: And I will talk about this in the context of the guidance here . So as you've seen in Q3 , we have seen an increase in the expected currency impact on core EPs for the full year 2025 by minus two percentage points from minus six percentage points , which we have forecasted at the end of June to minus eight percentage points that we are forecasting now for .

Speaker #5: For year end . When looking at the post half year 2025 consensus , the core EPs growth stood at around plus 5.5% . We believe that this estimate would need to be adjusted for the guided additional currency deterioration of minus two percentage points , which we have experienced in Q3 .

Speaker #5: For the full year 2025 projections, looking at the latest consensus estimates, this adjustment seems not yet to have happened in most of them.

Alan Hippe: Looking at latest consensus estimates, this adjustment seems not yet to have happened in most of them. With this adjustment, we feel okay with the consensus overall.

Speaker #5: With this adjustment , we feel okay with the consensus overall good , and I think with that I hand over to Theresa .

Matthew Sause: Good.

Alan Hippe: I think with that I hand over to Teresa.

Speaker #6: Great . Thank you very much , Alan . So let's start by taking a look at the overall performance for pharma . So as Thomas mentioned , pharma sales grew by 9% at constant exchange rates , reaching 35.6 billion CHF , all regions are delivering strong growth led by our international region , which grew at 13% overall , pharma volumes were up by 13% .

Teresa Graham: Great, thank you very much Alan. Let's start by taking a look at the overall performance for Pharma. As Thomas mentioned, pharma sales grew by 9% at constant exchange rates, reaching CHF 35.6 billion. All regions are delivering strong growth, led by our International region, which grew at 13%. Overall pharma volumes were up by 13%. As always, let's start with a reminder that on this slide all absolute values and year-over-year growth rates are presented in Swiss francs at constant exchange rates. Our top brands Fezgo, Xolair, Hemlibra, Vabysmo, Ocrevus, and Polivy generated roughly CHF 2.7 billion in new sales. These growth drivers represent a diversified mix of therapeutic areas and contributions from all of our geographies to growth. Fezgo continues to be our number one growth driver, with Xolair a close second as the outstanding launch in food allergy continues. Let's start our TA deep dives with oncology.

Speaker #6: As always , let's start with a reminder that on this slide , all absolute values and year over year growth rates are presented in Swiss francs at constant exchange rates at our top brands .

Speaker #6: Fesco , Zollner , Hemlibra of Ocrevus and Polivy , generated roughly 2.7 billion in new sales . These growth drivers represent a diversified mix of therapeutic areas and contribution from all of our geographies to growth , Fezco continues to be our number one growth driver , with Xolair a close second as the outstanding launch in food allergy continues .

Speaker #6: Now , let's start our to deep dive with oncology oncology sales increased 2% to 11.6 billion CHF , primarily driven by our Her2 franchise .

Teresa Graham: Oncology sales increased 2% to CHF 11.6 billion, primarily driven by our HER2 franchise. Fezgo posted an impressive 54% growth year to date. We're very happy to see that, as Thomas mentioned, the global conversion rate climbed to 51% this quarter. As we have already achieved our goal of 50% conversion, we are now increasing our ambition to hit a global conversion rate of more than 60% before the advent of biosimilars. Looking at Perjeta, the conversion to Fezgo continues and Kadcyla growth continues to be driven by uptake in adjuvant breast cancer. I do want to acknowledge that, in line with expectations, the data that was recently shared from competitors, in particular DESTINY-Breast05, will have a negative impact to Kadcyla of roughly CHF 700 million to CHF 1 billion over time. This is fully in line with the HER2 franchise outlook that we have previously provided.

Speaker #6: Phesgo posted an impressive 54% growth year to date . We're very happy to see that as Thomas mentioned , the global conversion rate climbed to 51% this quarter and as we have already achieved our goal of 50% conversion , we are now increasing our ambition to hit a global conversion rate of more than 60% .

Speaker #6: Before the advent of biosimilars, looking at Perjeta, the conversion to Fezco continues, and Kadcyla growth is continued to be driven by uptake in adjuvant breast cancer.

Speaker #6: I do want to acknowledge that, in line with expectations, the data that was recently shared from competitors, in particular Destiny Five, will have a negative impact on Kadcyla of roughly $700 million to $1 billion over time.

Speaker #6: This is fully in line with the Her2 franchise outlook that we have previously provided . As a reminder , we expect the Her2 franchise to peak at around 9,000,000,000 in 2026 , followed by a steady decline through the end of the decade with a solid tail of around 4 billion .

Teresa Graham: As a reminder, we expect the HER2 franchise to peak at around CHF 9 billion in 2026, followed by a steady decline through the end of the decade with a solid tail of around CHF 4 billion. That's primarily Fezgo, around CHF 1 billion for Kadcyla, and a bit of Herceptin and Perjeta. Let me also confirm again that we do not foresee any cliff situation. Staying with our breast cancer franchise, let's briefly talk about our HER2 TKI. We did make the decision to start a Phase 2/3 study in HER2 breast cancer next year. Our ERBB2 TKI is highly selective with strong blood-brain barrier permeability and CNS retention. These characteristics could be key to overall disease control, prevention, and treatment of brain metastases.

Speaker #6: And that's primarily fezco around a billion for kadcyla and a bit of happy . Let me also confirm again that we do not foresee any cliff situation staying with our breast cancer franchise .

Speaker #6: Let's briefly talk about our her2 , tki . We did make the decision to start a phase two three study in Her2 breast cancer next year .

Speaker #6: Our Her2 tki is highly selective with strong blood brain barrier permeability and CNS retention . These characteristics could be key to overall disease control , prevention , and treatment of brain metastases .

Speaker #6: About 50% of patients with metastatic HER2-positive breast cancer develop brain metastases, and we believe our HER2 has the potential to address a key unmet need in this population.

Teresa Graham: About 50% of patients with metastatic HER2-positive breast cancer develop brain mets, and we believe our HER2 TKI has the potential to address a key unmet need in this population. Last but certainly not least, in our breast cancer franchise, itovi's launch in first-line PI3 kinase-mutated hormone receptor-positive breast cancer is ongoing and progressing as expected. Moving on to Tecentriq, sales remain overall stable at Q3, and for the full year we expect the same. There were multiple positive events for Tecentriq in Q3. MForte and first-line maintenance small cell lung cancer achieved U.S. approval. The Invigor O11 in muscle invasive bladder cancer reported positive Phase 3 results.

Speaker #6: And last , but certainly not least , in our breast cancer franchise , ITV's launch in first line Pi three kinase mutated hormone receptor positive breast cancer is ongoing and progressing as expected , moving on to Tecentriq .

Speaker #6: Sales remain overall stable for the At Q3 and for the full year . We expect the same . There were multiple positive events for Tecentriq in Q3 and Forte , and first line maintenance , small cell lung cancer achieved US approval .

Speaker #6: The level of the vigor O-11 in muscle invasive bladder cancer reported positive phase three results. These data were presented at ASCO and ATOMIC, and adjuvant DMMR.

Operator: Those data were presented at ESMO.

Teresa Graham: Atomic and adjuvant dMMR colon cancer was just included in the latest NCCN guideline update. Taken together, we see several hundred million in incremental sales opportunity from these additional indications. On the back of this, and since Tecentriq has returned to growth in the U.S. in Q3, we now expect to see flat to low single-digit growth for Tecentriq in the coming years. Also in Q3, we initiated the Phase 3 CRESCENDO-2 study of Vivarasib in first-line non-small cell, and that enrollment is actually progressing ahead of plan. Looking ahead, as mentioned at Pharma Day, the Persevera readout of giredestrant is expected in 2026, and speaking of giredestrant, we wanted to take a closer look.

Speaker #6: Colon cancer was just included in the latest NCCN guideline update . Taken together , we see several hundred million in incremental sales opportunity from these additional indications .

Speaker #6: On the back of this , and since Tecentriq has returned to growth in the US in Q3 , we now expect to see flat to low single digit growth for to centric in the coming years .

Speaker #6: Also in Q3 , we initiated the phase three crescendo two study of Divarasib in first line non-small cell , and that enrollment is progressing ahead of plan .

Speaker #6: Looking ahead , as mentioned at Pharma day , the persevere readout of Giredestrant is expected in 2026 . And speaking of Giredestrant , we wanted to take a closer look at the positive results on the next slide .

Operator: At the positive AVERA results on the next slide.

Speaker #6: Over the weekend , we presented the Avera data at SFO in Berlin , and here are some of the highlights . As a quick reminder , 100% of patients in ivory have received a prior endocrine therapy and a prior Cdk4 six inhibitor .

Teresa Graham: Over the weekend we presented the AVERA data at ESMO in Berlin, and here are some of the highlights. As a quick reminder, 100% of patients in AVERA have received a prior endocrine therapy and a prior CDK4/6 inhibitor. The results clearly show that giredestrant significantly improved PFS in patients with ER positive.

Speaker #6: The results clearly show that Giredestrant significantly improved PFS in patients with ER positive metastatic breast cancer , both for patients with Esr1 mutations and for the ITT population displaying strong HR values of 0.38 and 0.56 respectively .

Operator: Metastatic breast cancer, both for patients with.

Teresa Graham: ESR1 mutations and for the ITT population displaying strong HR values of 0.38 and 0.56, respectively. Benefits in PFS, ORR, and DOR were observed across key subgroups irrespective of ESR1 mutation status. Although overall survival remains immature at this time, we saw a positive trend in both the ESR1 mutant and ITT populations. Furthermore, an exploratory analysis in patients without ESR1 mutation detected also showed favorable trends for PFS and OS with hazard ratios of 0.84 and 0.79, respectively. Taken together, the AVERA results reinforce our confidence in the giredestrant clinical development program and show the potential for giredestrant to become the next generation best-in-class endocrine therapy. Let's also take a quick look at the safety results from AVERA. AVERA was well tolerated and the safety.

Speaker #6: Benefits . In PFS , Orr and Dor were observed across key subgroups , irrespective of ESR mutation status , although overall survival remains immature at this time we saw a positive trend in both the ESR mutant and it populations .

Speaker #6: Furthermore , an exploratory analysis in patients without Esr1 mutation detected also showed favorable trends for PFS and OS , with hazard ratios of 0.84 and 0.79 , respectively .

Speaker #6: Taken together , the overall results reinforce our confidence in the Gear clinical development program and show the potential for Giredestrant to become the next generation best in class endocrine therapy .

Speaker #6: Let's also take a quick look at the safety results from Avera . Avera was well tolerated and the safety profile was consistent with previous studies .

Operator: Profile was consistent with previous studies.

Speaker #6: Of note , there were no new safety signals observed , including no cases of autopsia . We find the fact that giredestrant can be combined at the full dose of the Cdk4 six inhibitor without showing any photopsia .

Teresa Graham: Note, there were no new safety signals observed including no cases of photopsia. We find the fact that giredestrant can be combined at the full dose of the CDK4/6 inhibitor without showing any photopsia very encouraging as other CNF inhibitors in development have shown rates of up to 20%. Again, this strengthens our belief in the potential for giredestrant to become a next generation backbone therapy and we would expect in this initial location something around $500 million plus in sales. Now let's take a look at our Hematology franchise. The Hematology franchise had strong growth of 15% delivering $6.4 billion in sales. Hemlibra continues to deliver strong growth of 12% year to date driven by increasing adoption in non-inhibitor patients. While we did see some softness in the U.S.

Speaker #6: Very encouraging , as other CNS inhibitors and development have shown , rates of up to 20% . Again , this strengthens our belief in the potential for gear district to become a next generation backbone therapy , and we would initial location something around 500 million plus in sales .

Speaker #6: Now let's take a look at our hematology franchise. The hematology franchise had strong growth of 15%, delivering $6.4 billion in sales. Hemlibra continues to deliver strong growth of 12% year to date, driven by increasing adoption and non-inhibitor patients.

Speaker #6: While we did see some softness in the US for Q3 , this is primarily due to buying patterns . Given that we had some strong buy ins in Q2 , and based on the strong global performance we are upgrading our full year outlook for Hemlibra to around 10% growth , and that's up from mid-single digit .

Teresa Graham: for Q3, this is primarily due to buying patterns given that we had some strong buy-ins in Q2 and based on the strong global performance we are upgrading our full year outlook for Hemlibra to around 10% growth and that's up from mid single digit. A brief note on next 007, our next generation bispecific in Phase 3 development for hemophilia A. We look forward to sharing additional Phase 1 data with you in Q4. Next up, let's take a closer look at our malignant hematology portfolio. Polivy in first line DLBCL continues to drive strong growth and U.S. first line DLBCL patient share is climbing further and now stands at 35%.

Speaker #6: A brief note on next oh seven . Our next generation bispecific in phase three development for hemophilia A , we look forward to sharing additional phase one data with you in Q4 .

Speaker #6: Next up , let's take a closer look at our malignant hematology portfolio . Polivy . In first line , DLBCL continues to drive strong growth , and US first line DLBCL patient share is climbing further .

Speaker #6: And now stands at 35% . That's up two percentage points versus Q2 . We anticipate that Polivy will surpass 1 billion CHF in sales in the first line .

Operator: That's up 2% versus Q2.

Teresa Graham: We anticipate that Polivy will surpass CHF 1 billion in sales in the first line DLBCL setting for the first time this year. Shifting to Columvi and Lunsumio or CD20 CD3 bispecifics, launch performance remains on track for Columvi in third line DLBCL and Lunsumio in third line plus follicular lymphoma. These initial later line indications are expected to deliver combined peak sales of several hundred million Swiss francs. We also had additional news flow for both of these molecules this quarter. For Columvi, SKYLYTE was accepted as the new confirmatory study for the post marketing requirement, and for Lunsumio we received a positive EU CHMP opinion for the subcutaneous formulation. As a reminder, the U.S. approval for the sub Q formulation is pending.

Speaker #6: DLB setting , DLB setting for the first time this year , shifting to Columbia and Lunsumio our CDK CD3 Bispecifics launched performance remains on track for Columbia in third line DLBCL and Lunsumio , in third line plus follicular lymphoma .

Speaker #6: These initial later line indications are expected to deliver combined peak sales of several hundred million Swiss francs. We also had additional news flow for both of these molecules this quarter.

Speaker #6: For Columvi Skyglow was accepted as the new confirmatory study for the post-marketing requirement and for Lunsumio , we received a positive EU chmp opinion for the subcutaneous formulation .

Speaker #6: And as a reminder , the US approval for the Subcu formulation is expected later this year . As Thomas mentioned , we took the decision to move Cevostamab into phase three development for relapsed refractory multiple myeloma , and that trial is also expected to start next year .

Operator: Expected later this year.

Teresa Graham: As Thomas mentioned, we took the decision to move cevostamab into Phase 3 development for relapsed refractory multiple myeloma and that trial.

Operator: Is also expected to start next year.

Speaker #6: Now let's go to the next slide where we will cover the neurology franchise . Our neurology franchise achieved 7.3 billion in sales in a strong growth of 9% year to date .

Teresa Graham: Now let's go to the next slide.

Operator: Where we will cover the Neurology franchise.

Teresa Graham: Our neurology franchise achieved $7.3 billion in sales and a strong growth of 9% year to date. Ocrevus continues to have good momentum, delivering 7% growth globally. We continue to be encouraged by the ongoing launch of our subcutaneous formulation known as Xenovo in the U.S. As a reminder, the permanent J code for Xenovo was granted on April 1, and we do see some acceleration in Xenovo uptake as a consequence of that. It is important to remember that for many practices, switching to de novo is.

Speaker #6: Ocrevus continues to have good momentum , delivering 7% growth globally . We continue to be encouraged by the ongoing launch of our subcutaneous formulation known as Innovo in the US , as a reminder , the permanent J code for Xenova was granted on April 1st , and we do see some acceleration in uptake as a consequence of that .

Speaker #6: It is important to remember that for many practices , switching to to Novo is associated with logistical challenges . We are hoping to manage those , and we expect novo uptake to accelerate further in coming quarters .

Operator: Associated with logistical challenges.

Teresa Graham: We are hoping to manage those, and we expect Xenovo uptake to accelerate further in coming quarters. Let's take a quick look at some of the underlying data that gives us confidence in the trajectory of the subcut. In the U.S., roughly 50% of de novo patients are naive to Ocrevus, and the same is true for many of our other early large countries such as Germany.

Speaker #6: Let's take a quick look at some of the underlying data that gives us confidence in the trajectory of the Subcut in the US , roughly 50% of novo patients are naive to ocrevus , and the same is true for many of our other early launch countries , such as Germany , for instance .

Operator: For instance, we're encouraged by the fact.

Speaker #6: We're encouraged by the fact that about 60% of US subcut volume is coming from community practices with the prescriber breadth climbing to roughly 800 cps this demonstrates that Ocrevus Subcut is expanding the addressable market and can help overcome healthcare system constraints like IV capacity limitations .

Teresa Graham: That about 60% of U.S. subcut volume is coming from community practices, with the prescriber breadth climbing to roughly 800 HCPs. This demonstrates that Ocrevus subcutaneous is expanding the addressable market and can help overcome healthcare system constraints like IV capacity limitations. Overall, we now have more than 12,500.

Operator: Patients on Ocrevus de novo globally.

Teresa Graham: We also presented the two year data for Ocrevus subcutaneous at ECTRIMS, which shows.

Operator: That the benefit-risk profile is maintained.

Speaker #6: In 2025, we continue to expect high single-digit global sales growth for Ocrevus. It is worth noting here that the U.S. Q3 performance was impacted by a base effect due to a one-off buying pattern that occurred in Q3 of last year.

Teresa Graham: For 2025 we continue to expect high single-digit global sales growth for Ocrevus. It is worth noting here that the U.S. Q3 performance was impacted by a base effect due to a one-off buying pattern that occurred in Q3 of last year. As we previously shared at Pharma Day, we have upgraded our peak sales expectations for the Ocrevus franchise to $9 billion by 2029, and this includes $2 billion.

Speaker #6: As we previously shared at Pharma Day , we have upgraded our peak sales expectations for the Oakridge franchise to 9 billion by 2029 , and this includes 2 billion incremental sales from Ocrevus , Subcut .

Operator: Incremental sales from Ocrevus subcutaneous.

Speaker #6: Same with our Miss franchise. We are eagerly awaiting the results and PPMs, with the Phase Three French rapid readout expected in Q4.

Teresa Graham: Staying with our MS franchise, we are eagerly awaiting the fenebrutinib.

Operator: Results in PPMS with the Phase 3.

Teresa Graham: Frontrepid readout expected in Q4. Moving on to Evrysdi, we now have 21,000 patients on Evrysdi globally, and this includes patients using our new tablet formulation, which has now launched in both the U.S. and EU. A quick note here that Q3 performance in the international region was impacted by tender-related buying patterns with a larger.

Speaker #6: Moving on to everybody , we now have 21,000 patients on Evrysdi globally , and this includes patients using our new tablet formulation , which has now launched in both the US and EU .

Speaker #6: A quick note here that Q3 performance in the international region was impacted by tender related buying patterns , with a larger buy in expected in Q4 .

Operator: Buy-in expected in Q4, moving on.

Speaker #6: Moving on to Arisbe DMD , we continue to believe in the risk benefit profile for adversity and the ambulatory DMD population , and we have approximately 840 patients have been treated globally in the setting .

Teresa Graham: To AVERSD and DMD. We continue to believe in the risk benefit profile for EVERSD in the ambulatory DMD population, and we have approximately 840 patients have been treated globally in the setting. We are continuing to work with the EMA to find a viable path forward.

Speaker #6: We are continuing to work with the EMA to find a viable path forward for EU patient access . Following the negative approval decision .

Operator: For EU patient access following the negative.

Teresa Graham: Approval decision and lastly tauntinumab and AD. The final Phase 1/2 data from the 1.8 and 3.6 milligram cohorts were presented at AAIC. We have already achieved FPI for our Phase 3 Trontier1.2 study in early AD, and currently there are roughly 4,000 patients in the prescreener study Traveler, so we're optimistic that enrollment there will also continue at pace. Also at AAIC, we shared our plan to initiate a Phase 3 and preclinical.

Speaker #6: And lastly , and add the final one to phase one two data from the 1.8 and 3.6mg cohorts were presented at Aaic . We have already achieved FPI for our phase three , tier one two study in early AD , and currently there are roughly 4000 patients in the pre-screening study , traveler .

Speaker #6: So we're optimistic that enrollment there will also continue at pace . Also , at Aaic , we shared our plan to initiate a phase three and preclinical AD in more details on that to come at a later stage .

Operator: AD and more details on that to come at a later stage.

Speaker #6: On the next slide , let's look at the immunology franchise . Our immunology franchise grew at 15% at constant exchange rates and reached 5 billion in sales .

Teresa Graham: On the next slide, let's look at the Immunology franchise. Our Immunology Franchise grew at 15% at constant exchange rates and reached $5 billion in sales. Xolair continues to be the primary growth driver thanks to a very strong launch in Food Allergy. Year to date we see growth of 34% for Xolair, and based on this strong performance we have also updated the full year outlook for Xolair. We now expect growth greater than 30% in 2025, up from the around 20.

Speaker #6: Zoller continues to be the primary growth driver thanks to a very strong launch in food allergy year to date , we see growth of 34% for Xolair , and based on this strong performance , we have also updated the full year outlook for Zöller .

Speaker #6: We now expect growth greater than 30% in 2025 , up from the around 20 estimate that we shared at half year . As a reminder , we expect a first biosimilar launch for Zöller at the end of 2026 .

Operator: Estimate that we shared at half year.

Teresa Graham: As a reminder, we expect a first biosimilar launch for Xolair at the end of 2026. Actemra sales grew 2% year to date with gradually increasing biosimilar erosion impacting performance. In Q3 we saw a decline of 6% in the U.S. due to biosimilar competition. This is aligned with our expectation that biosimilar impact would accelerate in the second half of 2025. We are anticipating that Actemra will see a single digit sales decline in 2025, which has already been included in our LOE outlook of $800 million for.

Speaker #6: Actemra sales grew 2% year to date , with gradually increasing biosimilar erosion impacting performance in Q3 , we saw a decline of 6% in the US due to biosimilar competition .

Speaker #6: This is aligned with our expectation that biosimilar impact would accelerate in the second half of 2025 . We are anticipating that Actemra will see a single digit sales decline in 2025 , which has already been included in our low outlook of 800 million for full year of 2025 .

Operator: Full year of 2025.

Speaker #6: A highlight for this quarter in immunology is certainly gazyva . We achieved FDA approval in lupus nephritis with a strong label and are looking forward to bringing this medicine to patients .

Teresa Graham: A highlight for this quarter in immunology is certainly Gazyva. We achieved FDA approval in lupus nephritis with a strong label and are looking forward to bringing this medicine to patients. The FDA label includes all active lupus nephritis patients receiving standard therapy without limitation to specific background therapies, as well as renal-related events and death data, both of which show a substantial reduction. It also included simultaneous approval of short infusion and inclusion of biomarker and subgroup data that shows consistent Gazyva benefit across subgroups and rapid effect on biomarkers of disease activity. At the same time, we also received a positive EU CHMP opinion and expect EU approval to follow later this year. We are also expecting to see the readout of the Phase 3 ALLEGORY trial for Gazyva and SLE in Q4 of this year.

Speaker #6: The FDA label includes all active lupus nephritis patients receiving standard therapy without limitation , to specific background therapies , as well as renal related events and death data , both of which show a substantial reduction .

Speaker #6: It also included simultaneous approval of short infusion and inclusion of biomarker and subgroup data that shows consistent gazyva benefit across subgroups and rapid effect on biomarkers of disease activity .

Speaker #6: At the same time , we also received a positive chmp opinion and expect EU approval to follow later this year . We are also expecting to see the readout of the phase three trial for Gazyva in SLE in Q4 of this year .

Speaker #6: Turning to Xofluza . Last week , we announced our direct to patient program for Xofluza for patients in the US . This program will provide xofluza at $50 through selected pharmacies , a 70% discount versus list price .

Teresa Graham: Turning to Xofluza, last week we announced our direct-to-patient program for Xofluza for patients in the U.S. This program will provide Xofluza at $50 through selected pharmacy as a 70% discount versus list price. Via this program we aim to improve affordability and access for U.S. patients.

Speaker #6: Via this program , we aim to improve affordability and access for US patients and address the significant health impact that the flu continues to have on society .

Operator: Address the significant health impact that the flu continues to have on society.

Speaker #6: With the flu season in the Northern hemisphere expected to start soon , we believe that now is the right time to direct , to launch our direct to patient program .

Teresa Graham: With the flu season in the Northern Hemisphere expected to start soon, we believe that now is the right time to launch our direct to patient program. Let's move on to ophthalmology. Ophthalmology grew by 11%, achieving $3.2 billion in sales year to date. The Vabysmo performance remains impacted by the contraction of the U.S. branded market, with 13% sales growth year to date. We have all been watching the U.S. market closely, and by now we see a decline of the branded IBT market of roughly 15% so far this year. In the EU, Q3 performance was also impacted by mandatory price cuts. However, we believe that the ongoing rollout of the PFS formulation in the EU.

Speaker #6: So now let's move on to ophthalmology . Ophthalmology grew by 11% , achieving 3.2 billion in sales year to date . The performance remains impacted by the contraction of the US branded market , with 13% sales growth year to date .

Speaker #6: We have all been watching the US market closely and by now we see a decline of the branded IBT market of roughly 15% so far this year in the EU , Q3 performance was also impacted by mandatory price cuts .

Speaker #6: However , we believe that the ongoing rollout of the PFS formulation in the EU will feel will fuel further growth . Considering these dynamics , we have decided to update our full year growth outlook for .

Operator: Will fuel further growth.

Teresa Graham: Considering these dynamics, we have decided to update our full year growth outlook for Vabysmo. We now expect around 15% growth at constant exchange rates, down from the roughly 20% that we had shared earlier this year. Nevertheless, Vabysmo continues to gain market share in the branded IVT market in the U.S. and across early launch countries globally. In the U.S. we now see that more than 60% of Vabysmo starts are naive patients, further solidifying the Vabysmo position as the standard of care. This is also supported by a recent survey amongst ophthalmologists conducted by ASRs. The survey shows that more than half of ophthalmologists see Vabysmo as the IVT treatment option with the best anatomic outcomes and disease control in AMD, DME, and RVO. China also continues to impress with strong uptake following the NRDL listing and rapidly.

Speaker #6: We now expect around 15% growth at constant exchange rates , down from the roughly 20 that we had shared earlier this year . Nevertheless , the business continues to gain market share in the branded IBT market in the US and across early launch countries globally .

Speaker #6: In the US , we now see that more than 60% of Abismo starts are naive patients . Further solidifying the position as the standard of care .

Speaker #6: This is also supported by a recent survey amongst ophthalmologists conducted by ASRS. This survey shows that more than half of ophthalmologists see Vabysmo as the IBD treatment option, with the best anatomic outcomes and disease control for AMD, DME, and RVO.

Speaker #6: China also continues to impress with strong uptake following the Nrdl listing and rapidly expanding market shares . Moving on to the pipeline , as Thomas mentioned , we had three phase three readouts for Vermicular and and I'm sorry , we had two phase three readouts for Vermicular and and satralizumab and thyroid eye disease with data presented over the last few days .

Operator: Expanding market shares, moving on to the pipeline.

Teresa Graham: As Thomas mentioned, we had three Phase 3 readouts for giredestrant, Vabysmo, and UME. We had two Phase 3 readouts for Vabysmo, giredestrant, and UME, and satralizumab in thyroid eye disease with data presented over the.

Operator: Last few days, let's take a.

Speaker #6: So let's take a closer look at both , starting with the results in which we presented earlier this week at AAO . The phase three results from Meerkat and Sandcat show rapid improvement in vision and reduction in macular edema , as well as a well-tolerated safety profile .

Teresa Graham: Closer look at both, starting with the Vabysmo results in UME which we presented earlier this week at AAO. The Phase 3 results from MEERKAT and SANCAT show rapid improvement in vision and reduction in macular edema as well as a well-tolerated safety profile. You can clearly see the vision improvement and reduction in macular edema in the BCVA and CST curves on the right side of the slide. The primary endpoint was the proportion of patients with a greater than 15 letter BCVA gain. MEERKAT met this endpoint but SANCAT did not. However, let me emphasize two points. In both studies a numerically higher proportion of patients treated with Vabysmo gained vision. The miss for SANCAT was primarily driven by one patient in the 1 mg Vabysmo cohort. It is our belief that the totality of the SANCAT and MEERKAT data support the use of Vabysmo in UME.

Speaker #6: You can clearly see the vision improvement and reduction in macular edema in the BCVA and CST curves on the right side of the slide.

Speaker #6: The primary endpoint was the proportion of patients with a greater than 15 letter Bcva gain . Meerkat met this endpoint , but Sandcat did not .

Speaker #6: However , let me emphasize two points in both studies a numerically higher proportion of patients treated with gained vision . The mist for sandcat was primarily driven by one patient in the one milligram .

Speaker #6: The cohort . It is our belief that the totality of the sandcat and Meerkat data support the use of the art in the Mickey Bart may offer novel targeted IV treatment strategy for Uma patients that does not involve steroids and therefore could address a significant unmet need in this underserved patient population .

Teresa Graham: Vabysmo may offer a novel targeted IVT treatment strategy for UME patients that does not involve steroids and therefore could address a significant unmet need in this underserved patient population. As mentioned at our IR event earlier this week, we will discuss this data with health authorities to determine next steps. Moving on to satralizumab in thyroid eye disease, we presented the Phase 3 SATRIGO 1 and 2 results at ASOPRS a few days ago. The Phase 3 results show that satralizumab in TED has a differentiated risk-benefit profile from currently available treatment options. The primary endpoint was proptosis response at week 24 in active thyroid eye disease. For both SATRIGO 1 and 2, a higher proportion of participants treated with satralizumab showed a proptosis response. However, only SATRIGO 2 achieved statistical significance; SATRIGO 1 did not.

Speaker #6: As mentioned at our IR event earlier this week , we will discuss this data with health authorities to determine next steps . Moving on to Satralizumab in Thyroid Eye Disease , we presented the phase three sutra go one and two results at Aso .

Speaker #6: A few days ago . The phase three results show that Sutra and Ted have a differentiated risk benefit profile from currently available treatment options .

Speaker #6: The primary endpoint was Proptosis response at 20 at week 24 and active thyroid eye Disease for both Sutra go one and two . A higher proportion of participants treated with sutra showed a proptosis response .

Speaker #6: However , only sutra go to achieved statistical significance . Significance . Sartre go one did not . Importantly , both studies did show a clinically meaningful improvement across a range of key efficacy endpoints , including diplopia , CAS and proptosis in the active and inactive Ted population .

Teresa Graham: Importantly, both studies did show a clinically meaningful improvement across a range of key efficacy endpoints including diplopia, CAS, and proptosis in the active and inactive TED population. Furthermore, the safety profile for satralizumab was highly favorable. Currently available treatments for TED are associated with sometimes severe adverse effects and none.

Speaker #6: Furthermore , the safety profile for satralizumab was highly favorable . Currently available treatments for Ted are associated with sometimes severe adverse effects , and none of these effects were reported for Sutra .

Operator: No effects were reported for satra.

Speaker #6: As with Bart , we believe that the totality of evidence support its use as a treatment for Ted patients , and we are planning to discuss the results with health authorities .

Teresa Graham: As with the Mickey Bart, we believe that the totality of evidence supports its use as a treatment for TED patients, and we are planning to discuss the results with health authorities. Now moving on to our CVRM portfolio, in terms of developments in our CVRM pipeline, the recently announced 89bio acquisition is certainly a highlight, and I will cover this in more detail in the next slide. Suffice it to say that we are very excited to add a potential best-in-disease, enemy, and MASH into our portfolio. Most of the other updates you've already seen at Pharmaday. Just very quickly, as you know, we are moving CT-388 and Zelbesuron into phase 3 trials. Zelbesuron's phase 3 Zenith has already achieved FPI. Additionally, CT-996 achieved FPI for its phase 2 study, and announced today, we will be moving CT-868 into phase 3s for.

Speaker #6: And now moving on to our CVM portfolio . In terms of developments in our CRM pipeline , the recently announced 89 bio acquisition is currently is certainly a highlight , and I will cover this in more detail in the next slide .

Speaker #6: But suffice it to say that we are very excited to add a potential best in disease enemy and mash into our portfolio . Most of the other updates you've already seen at Pharma day .

Speaker #6: So just very quickly , as you know , we are moving Ct3 88 and on into phase three trials . They'll be on phase three .

Speaker #6: Zenith has already achieved FPI . Additionally , CT 996 , FPI for its phase two study and announced today we will be we will be moving CT 868 into phase three for type one diabetes patients in into into late stage trials .

Operator: Type 1 diabetes patients into late stage.

Teresa Graham: Trials and these data are currently in house and we will be sharing at ADA next year. In fact, most of the Phase 2 trials here will be shared at ADA next year. As you can see, we are progressing our CVRM pipeline at pace. Let's take a deeper look at pegazafermin, our new Phase 3 asset in MASH. For those following the field, it is important to understand that not all FGF21 analogs are the same. Pegazafermin is uniquely engineered for balanced efficacy and extended dosing. It also shows good potential for combination development, including a well-tolerated safety profile. Therefore, we truly believe that pegazafermin has the potential to become a best-in-disease treatment in MASH as well as adding combination optionality to our CVRM portfolio. On the right, you can see the Phase 2 data which we also presented at Pharma Day.

Speaker #6: And these data are currently in house . And we will be sharing at Ada next year . In fact , most of the phase two trials here will be shared at Ada next year .

Speaker #6: So as you can see , we are progressing our pipeline at pace . But let's take a deeper look at Pegasus , our new phase three assay in mash for those following the field , it is important to understand that not all fgf21 analogs are the same things .

Speaker #6: Offerman is uniquely engineered for balanced efficacy and extended dosing . It also shows good potential for combination development , including a well-tolerated safety profile .

Speaker #6: Therefore , we truly believe that Pega Offerman has the potential to become a best in disease treatment in Mash , as well as adding combination optionality to our VRM portfolio .

Speaker #6: On the right , you can see the phase two data , which we also presented at Pharma Day and in short , pigs , Offerman demonstrated clear treatment benefits in F2 to F4 patients , and this potential to bring a treatment benefit to F4 patients .

Teresa Graham: In short, pegazafermin demonstrated clear treatment benefits in F2 to F4 patients, and this potential to bring a treatment benefit to F4 patients, those with the most advanced form of MASH, is a big part of the reason why we are so excited for pegazafermin. There are two Phase 3 trials currently ongoing, one in MASH F2 F3 and one in MASH F4. We expect the top line data for F2 F3 in the first half of 2027, and for F4 we expect top.

Speaker #6: Those with the most advanced form of Mash is a big part of the reason why we are so excited for Pega's , Offerman .

Speaker #6: There are two phase three trials currently ongoing , one in Mash , two three , one in mash , F2 , F3 , and one in mash F4 .

Speaker #6: We expect the top data for F2 and F3 in the first half of 2027, and for F4, we expect topline data in 2028.

Operator: Line data in 2028.

Speaker #6: This deal is subject to customary closing conditions , and we expect the integration of Pegasus . Offerman will further drive the strong development momentum in our CVM pipeline .

Teresa Graham: This deal is subject to customary closing conditions, and we expect the integration of pegazafermin will further drive the strong development momentum in our CBRM pipeline. Now let's move on to my last slide for today. Here is our key news flow with the latest updates. All of these updates we have already covered on previous slides, so I won't repeat them, but I will just reiterate that we do have some key readouts that remain for Q4, including fenebrutinib in PPMS, and with that I will turn it over to Matt to walk us.

Speaker #6: And now let's move on to my last slide for today . Here is our key news flow with the latest updates . All of these updates we have already covered on previous slides .

Speaker #6: So I won't repeat them, but I will just reiterate that we do have some key readouts that remain for Q4, including Fenebrutinib in PMS.

Speaker #6: And with that , I will turn it over to Matt to walk us through the diagnostic slides .

Operator: Through the diagnostic slides.

Speaker #7: Okay . Thanks , Theresa . Good morning . Good afternoon everyone . It is my pleasure to present the year to date September 2025 .

Matthew Sause: Okay, thanks Teresa. Good morning. Good afternoon everyone. It is my pleasure to present the year to date September 2025 Diagnostics Division results. As you heard from Thomas, Diagnostics is back to growth with sales of CHF 10.3 billion. Sales increased by 1% or CHF 0.1 billion compared with year to date September 2024 at a constant exchange rate. This was driven again by the healthcare pricing reform in China, which includes the implementation of diagnostic related groups, which affects volume, and volume based procurement, which affects price. As you heard earlier from Alan, excluding China, the growth of the business was plus 7%. Now let me walk you through the sales driven by each of the customer areas. First, sales in our core lab decreased by 1%, again driven by the aforementioned austerity in China. Excluding this effect, the core lab business grew by plus 10%.

Speaker #7: Diagnostics Division results . So as you heard from Thomas Diagnostics is back to growth with sales of 10.3 billion CHF , sales increased by 1% or 0.1 billion CHF compared with year to date .

Speaker #7: September 2024 . At a constant exchange rate , this was driven again by the health care pricing reform in China , which included the implementation of diagnostic related groups , which affects volume and volume based procurement , which affects price .

Speaker #7: As you heard earlier from Allen , excluding China , the growth of the business was plus 7% . Now , let me walk you through the sales driven by each of the customer areas .

Speaker #7: So first sales in our core lab decreased by 1% . Again driven by the aforementioned austerity in China . Excluding this effect , the core lab business grew by plus 10% sales in the molecular lab increased at plus 4% , and this is due to strong growth in our blood screening business .

Matthew Sause: Sales in the molecular lab increased at plus 4%, and this is due to strong growth in our blood screening business at plus 5%. However, this is partially offset by flat sales in the infectious disease segment due to the USAID pause in Q1. Sales in the near patient care division decreased by minus 4%. Sales in pathology lab grew strongly at plus 13%, mainly driven by advanced staining growth of plus 11% and companion diagnostics growth of plus 21%. Now shifting to our regional view, I'll take you to the regional business performance. North America, great growth of plus 7%. In EMEA, the business grew at plus 6%. LATAM growth of plus 14%. In APAC, the business declined at minus 15%. As we previously mentioned, sales growth was impacted by the healthcare pricing reform in China. As a result of this, China sales have declined by minus 27%.

Speaker #7: At plus 5% . However , this partially offset by flat sales in the infectious disease segment due to the USA pause in Q1 sales in the near patient care division decreased by -4% .

Speaker #7: Sales in Pathology Lab grew strongly at plus 13% , mainly driven by advanced staining growth of plus 11 and companion diagnostics . Growth of plus 21% .

Speaker #7: Now shifting to our regional view, I'll take you to the regional business performance in North America. We saw great growth of plus 7% in EMEA.

Speaker #7: The business grew at plus 6% . Latam growth of plus 14% . Now again in APAC , the business declined at -15% . As we previously mentioned , sales growth was impacted by the health care pricing reform in China .

Speaker #7: And as a result of this , China sales have declined by -27% . This impact is expected to continue over the remainder of 2025 .

Matthew Sause: This impact is expected to continue over the remainder of 2025. For 2025, I'd like to confirm our ambition of low single digit growth. Looking forward, our ambition, and you heard this from Thomas, for the Diagnostics Division is always to grow mid to high single digits. However, given that we anticipate diminished but continuing headwinds in China for 2026, we would set our ambition for 2026 as mid single digits. I'd like to transition to some of the exciting news coming out of our pipeline and really start with some of the exciting updates that reflect our continued investment in innovation, starting with our Xelios sequencing solution, which as you heard is set to launch next year. First I'd like to highlight the results of a recently published correspondence in the New England Journal of Medicine.

Speaker #7: For 2025 , I'd like to confirm our ambition of low single digit growth . Now , looking forward , our ambition . And you heard this from Thomas for the diagnostics division is always to grow mid to high single digits .

Speaker #7: However , given that we anticipate diminished but continuing headwinds in China for 2026 , we would set our ambition for 2026 as mid-single digits .

Speaker #7: So now I'd like to transition to some of the exciting news coming out of our pipeline . And really start with some of the exciting updates that reflect our continued investment in innovation , starting with our sequencing solution , which , as you heard , is set to launch next year .

Speaker #7: So first , I'd like to highlight the results of a recently published correspondence in the New England Journal of Medicine . Here team .

Matthew Sause: Here, teams at the Broad Clinical Labs as well as Boston Children's Hospital conducted analysis using reference and clinical samples from a research cohort to investigate the feasibility of utilizing the sequencing by expansion, or SPX, technology in urgent critical care settings. For one of the reference samples, HG002, the team sequenced and analyzed the whole human genome in less than four hours, achieving the Guinness World Record for sequencing. I would like to add that all runs were completed in less than five hours from DNA to variant calling, and for the prospective samples the results were clinically actionable for all infants. These results demonstrate that fast, reproducible, and robust genomic results can be achieved in a single day and underscore the potential of our SPX technology in critical care settings where rapid genome sequencing is crucial for decision making.

Speaker #7: Is at the Broad Clinical Labs , as well as Boston Children's Hospital , conducted analysis using reference and clinical samples from a research cohort to investigate the feasibility of utilizing the sequencing by expansion , or SBX technology in urgent critical care settings .

Speaker #7: For one of the reference samples, HG 002, the team sequenced and analyzed the whole human genome in less than four hours, achieving the world.

Speaker #7: The Guinness World Record for sequencing . I would like to add that all runs were completed in less than five hours from DNA to variant calling , and for the prospective samples , the results were clinically actionable for all infants .

Speaker #7: These results demonstrate that fast , reproducible and robust genomic results can be achieved in a single day and underscores the potential of our SBX technology in critical care settings , where rapid genome sequencing is crucial for decision making .

Speaker #7: And so now I'd like to continue with updates on our Xilio sequencing solution . I'd like to highlight some some data that was presented last week at the American Society for Human Genetics conference and focus on two specific examples .

Matthew Sause: Now I'd like to continue with updates on our Xelios sequencing solution. I'd like to highlight some data that was presented last week at the American Society for Human Genetics Conference and focus on two specific examples. As we've said since we unveiled the Xelios technology earlier in the year, we plan to demonstrate its applicability for all key applications. Here I'll focus on a couple of them. The first on the left illustrates the suitability of SPX for methylation. This is an internal workflow we developed utilizing TAPS, which generates direct conversion of 5-methylcytosines to thymine bases paired with our SPX duplex sequencing approach. This allows high throughput and simultaneous detection of DNA and methylation variants from the same library.

Speaker #7: So , as we've said , since we unveiled the technology earlier in the year that we plan to demonstrate its applicability for all key applications .

Speaker #7: So here I'll focus on a couple of them . The first on the left illustrates the suitability of SBX for methylation . So this is an internal workflow .

Speaker #7: We developed utilizing Taps, which generates direct conversion of five methylcytosine to thymine bases. Paired with our SBX duplex sequencing approach.

Speaker #7: Now this allows high throughput and simultaneous detection of DNA and methylation variants from the same library . This data presented shows that the performance of SBX for methylation is directly comparable to the standard SBX duplex workflow , with F1 scores for single nucleotide variants at 9.96 , nine , 9.6 or higher , so this really shows that we're able to do methylation , maintaining that high level of accuracy .

Matthew Sause: The data presented shows that the performance of SPX for methylation is directly comparable to the standard SPX duplex workflow, with F1 scores for single nucleotide variants at 99.6% or higher. This really shows that we're able to do methylation while maintaining that high level of accuracy. The second example on the right is RNA sequencing with our longer reads workflow, where our collaborators at the Wellcome Sanger Institute analyzed a 90-sample cohort of melioidosis, a highly heterogeneous infectious disease, and they demonstrated that a higher throughput of 4 billion reads per hour and a 400 base pair read length led to better isoform detection compared to traditional short read workflows. Now, when you take these together, these examples reflect our consistent development progress and the potential of SPX technology for both research as well as clinical applications. We're very much looking forward to the launch of this next year.

Speaker #7: The second example on the right is RNA sequencing . With our longer reads workflow , where our collaborators at the Wellcome Sanger Institute analyzed a 90 sample cohort amyloidosis , a highly heterogeneous infectious disease , and they demonstrated that a higher throughput of 4 billion reads per hour and a 400 base pair read length led to better isoform detection compared to traditional short read workflows .

Speaker #7: Now , when you take these together , these examples reflect our consistent development progress and the potential of SBX technology for both research as well as clinical applications .

Speaker #7: We're very much looking forward to the launch of this next year . And so now I'd like to turn on to turn to another topic , which is quite exciting .

Matthew Sause: I'd like to turn to another topic which is quite exciting and that's our advance of our neurology portfolio, specifically starting with our Elecsys P-Tau181 for which we received CE Mark in July and FDA clearance in October. Alzheimer's disease as well as other dementias remains a key global burden on health, affecting more than 55 million individuals annually and projected to reach over 80 million people by 2030. Despite this, two thirds of people experiencing cognitive symptoms remain undiagnosed. Diagnosis takes nearly three years on average after symptom onset and relies on subjective cognitive tests as well as expensive imaging analysis. Our P-Tau181 will offer a minimally invasive blood-based solution to rule out Alzheimer's disease. As Thomas mentioned earlier, our FDA label has an intended use suitable for primary care settings and we're the only test cleared for this intended use.

Speaker #7: And that's our advancement of our neurology portfolio specifically , starting with our Alexis P Tau181 , for which we received CE mark in July , and FDA clearance in October .

Speaker #7: So Alzheimer's disease , as well as other dimensions remain a key global burden on health , affecting more than 55 million individuals annually and projected to reach over 80 million people by 2030 .

Speaker #7: Now , despite this , two thirds of people experience cognitive symptoms remain undiagnosed . Diagnosis takes nearly three years on average , after symptom onset and relies on subjective cognitive tests as well as expensive imaging analysis .

Speaker #7: Our tau181 will offer a minimally invasive , blood based solution to rule out Alzheimer's disease , and we'll call it , as Thomas mentioned earlier , our FDA label has an intended use suitable for primary care settings , and we're the only test cleared for this intended use .

Speaker #7: So continuing with our neurology portfolio , I'd like to highlight the second example , which is our blood based , a second blood based biomarker for Alzheimer's disease , Alexis p Tau 217 , which is set to launch next year .

Matthew Sause: Continuing with our neurology portfolio, I'd like to highlight the second example which is our second blood-based biomarker for Alzheimer's disease, Elecsys P-Tau217, which is set to launch next year. Here I'd like to provide you with an update on some key data that were presented earlier this year at the Alzheimer's Association International Conference, which is the leading conference on Alzheimer's disease. At this event we showcased both the robustness as well as the accuracy of our test that's under development. Two key studies and the main findings. On the left you see the robustness of our method, which is a key aspect for a test that's going to be used broadly in a routine clinical setting.

Speaker #7: Now here , I'd like to provide you with an update on some key data that were presented earlier early this year at the Alzheimer's Association International Conference , which is the leading conference on Alzheimer's disease .

Speaker #7: At this event , we showcased both the robustness as well as the accuracy of our test that's under development now . Two key studies and the main findings on the on the left , you'll see the robustness of our method , which is a key aspect for a test that's going to be used broadly in a routine clinical setting .

Speaker #7: On the left hand side you can see the results of our own clinical study , where we evaluated the impact of preclinical robustness on immunoassay performance by comparing our two and seven to an internally developed PTL two and seven Ab42 ratio assay .

Matthew Sause: On the left-hand side you can see the results of our own clinical study where we evaluated the impact of preanalytical robustness on immunoassay performance by comparing our P-Tau217 to an internally developed P-Tau217Ab42 ratio assay. This study included patients from five cohorts representing patients across the Alzheimer's disease continuum. As you can see, the P-Tau217 isoform by itself demonstrates superior robustness to the ratio test, which is a commonly used approach in other competitive assays. When you think about implementation in a routine setting, robustness, especially preclinical robustness, is going to be very important. The second example on the right highlights the accuracy of our test against other available methods as compared to the gold standard of amyloid PET. Here you see the results generated. As part of a leading U.S.

Speaker #7: Now , this study included patients from five cohorts representing patients across the Alzheimer's disease continuum . And as you can see , the p tau seven isoform by itself demonstrates superior robustness to the ratio test , which is a commonly used approach in other competitive assays .

Speaker #7: And when you think about implementation in a routine setting , robustness , especially preclinical robustness , is going to be very important . Now , the second example on the right highlights the accuracy of our test against other available methods .

Speaker #7: As compared to the gold standard of amyloid PET, here you see the results generated as part of a leading U.S. integrated healthcare network.

Matthew Sause: integrated healthcare network, this study encompassed nearly 2,000 individuals and the interim results which you see here showed the area under the curve for the Alexis P Tau217 achieved the highest accuracy amongst the multiple P Tau217 methodologies that they evaluated. When you take these in aggregate, these study results support broad implementation of Alexis P Tau217 in routine clinical practice. We look forward to keeping you in the loop as we demonstrate additional data with this exciting biomarker. Last, I'd like to report progress on our key launch list for the Diagnostics Division. Of our 14 launches, that which you see here, we've achieved 7 by Q3 2025. We're making good progress on the other launches and we look forward to updating you at the end of the year. With that, I'll pass it over to Bruno.

Speaker #7: This study encompassed nearly 2000 individuals and the interim results , which you see here , showed the area under the curve for the Alexis p Tau two and seven achieved the highest accuracy amongst the multiple Tau 217 methodologies that they evaluated .

Speaker #7: So when you take these in aggregate , these studies results support broad implementation of Alexis p tau two and seven in routine clinical practice .

Speaker #7: And we look forward to keeping you in the loop as . We demonstrate additional data with this exciting biomarker . So last I'd like to report progress on our key launch list for the diagnostics division of our 14 launches .

Speaker #7: That which you see here , we've achieved seven by Q3 2025 . We're making good progress on the other launches , and we look forward to updating you at the end of the year .

Speaker #7: So with that, I'll pass it over to Bruno.

Speaker #8: Thank .

Speaker #9: The Q&A session . So the first question goes to Richard Foster from JP Morgan . Richard , please .

[Company Representative]: The Q&A session. The first question goes to Richard Fosser from J.P. Morgan. Richard, please.

Speaker #10: Thanks , Bruno . A couple of questions . First of all , on on Ocrevus . Perhaps Theresa could give us a little bit more color in terms of the logistical challenges .

Bruno Eschli: Thanks. Bruno, a couple of questions. First of all, on Ocrevus, perhaps Teresa could give us a little bit more color in terms of the logistical challenges, what they are, how easy they are to resolve, and when we think subcutaneous will start enhancing the growth of the brand. It looks as though we may be plateauing a little bit in the U.S. in October. Just what's going on there, please? Second question just on the HER2 TKI, we've seen quite a few of these in the past, and I think they always had tolerability challenges, maybe diarrhea in the past. Just what's the tolerability profile and what you're thinking about there? I could go first, but I think I'll stop there because we'll stop there. Thanks very much.

Speaker #10: What they are , how easy they are to resolve . And when we think subcutaneous will start enhancing the growth of the brand , it looks as though we maybe plateauing a little bit in the US in in October .

Speaker #10: So just what's going on there , please ? Second question , just on the Her2-tki , we've seen quite a few of these in the past .

Speaker #10: And I think they always had tolerability challenges . Maybe diarrhea in the past . So just what's the tolerability profile and what what you're thinking about there .

Speaker #10: And then I could go for a third , but I think I'll stop there because we'll stop there . Thanks very much .

Speaker #8: Great . Thank you . So I think when you think about the logistical .

Teresa Graham: Thank you. When you think about the logistical challenges for Xenovo, they're not that dissimilar from what we saw with Fezgo when we were moving Fezgo into the oncology setting. It's about making sure that the workflow in the infusion suite is set up to just handle a different kind of different technology. We are well versed in what we need to do because we have done it before and we are steadily working with our community clinics and our academic centers to actually get them into the flow of how to work with it. It is interesting that when you hit that tipping point, and we saw this with Fezgo as well, when you hit that tipping point, clinics go big because they get immediate good feedback from the pharmacist, they get immediately good feedback from the infusion nurses, and they get great feedback from the patient.

Speaker #6: Challenges for Zenodo; they're not that dissimilar from what we saw with Phesgo when we were moving Fezco into the oncology setting.

Speaker #6: It's about making sure that the workflow in the infusion suite is set up to just handle a different kind of a different a different technology .

Speaker #6: And so we are well versed in what we need to do because we have done it before and we are steadily working with our community clinics and our academic centers to actually get them into the flow of , of how to work with Senovo .

Speaker #6: It is interesting that when you hit that tipping point and we saw this with Phesgo as well , when you hit that tipping point , clinics go big because they they get immediate good feedback from the pharmacist .

Speaker #6: They get immediately good feedback from the infusion nurses , and they get great feedback from the patient . But it does take them a minute .

Teresa Graham: It does take them a minute sometimes to think about how it is actually going to work in their particular clinic. Over the course of the last couple of months, we've had now the opportunity to talk to a couple of physicians who started slow and are now up to 100 plus patients on Xenovo. I do think we are going to start to see this ball rolling and really picking up steam. I think we are already seeing that. We are already seeing that we are expanding our prescriber base pretty significantly. We're starting to see some competitive indications that would indicate that subcutaneous is starting to get some traction, particularly in accounts that are in the more rural areas where maybe Bramvir Cosyntha would have been initially a choice. Now they're really migrating towards or beginning to migrate towards de novo.

Speaker #6: Sometimes to think about how it is actually going to work in in their particular clinic over the course of the last couple of months , we've had now the opportunity to talk to a couple of physicians who started slow and are now up to 100 plus patients on Zenodo .

Speaker #6: So I do think we are going to start to see this ball rolling and really picking up steam . I think we are already seeing that we are already seeing that we are expanding our prescriber base pretty significantly .

Speaker #6: We're starting to see some competitive indications that would indicate that Subcut is starting to get some traction , particularly in in accounts that are in the more rural areas where maybe Kesimpta would have been initially a choice .

Speaker #6: Now they're really migrating towards or beginning to migrate towards novo . So I think this is an area that we have a lot of confidence that we're going to start again to see this , this ball really picking up steam in terms of the her2-tki thus far , it has been very well tolerated without any dose limiting toxicities at doses of up to 100 mcg monotherapy .

Teresa Graham: I think this is an area that we have a lot of confidence that we're going to start again to see this ball really picking up steam. In terms of the Hercules PKI, thus far it has been very well tolerated without any dose limiting toxicities at doses of up to 100 mg monotherapy. It has a promising GI safety profile compared with other HER2 TKIs, which I think is one of the reasons why this was so attractive to us. In addition to the fact that it potentially has best in class brain penetrant profile. This is a molecule that we're actually super interested in getting into clinic and seeing how it does.

Speaker #6: And it has a promising GI safety profile compared with other Her2 tkis , which I think is one of the reasons why this was so attractive to us .

Speaker #6: In addition to the fact it potentially has best in class brain penetrant . Profile . So this is a molecule that we're actually super interested in getting into clinic and seeing how it does .

Speaker #4: It's up to 1000mg .

Thomas Schinecker: It's up to 1,000 mg.

Speaker #6: Sorry , up to 1000mg . Sorry , Thomas . Thank you .

Teresa Graham: Sorry?

Operator: Up to 1,000 milligrams. Sorry, Thomas.

Thomas Schinecker: Thank you, Richard.

Speaker #9: Richard . This answer your questions or any additional questions .

[Company Representative]: Does this answer your questions or any additional questions?

Speaker #10: No . Perfect . Thanks . Thanks , Bruno . Cheers , everyone .

Bruno Eschli: No. Perfect. Thanks. Thanks, Bruno. Cheers, everyone.

Speaker #9: Okay . And we move on . And next questions go to Simon Baker from Redburn . Simon .

[Company Representative]: Okay, we move on. Next questions go to Simon Baker from Redburn. Simon, thanks so much, Bruno. Two if I may and just continue on with Richard's question on Ocrevus. If I look at the trends in the U.S. and I look at the $9 billion of peak sales guidance that you've given and where consensus is, there's a little bit of a disconnect here. I was just wondering, Teresa, is the disconnect our perceptions of the ex-U.S. opportunity here? If one looks at the IV subcutaneous conversions you've seen elsewhere, it feels like we may be underestimating the ex-U.S. opportunity. Any thoughts on that would be helpful. Just on news flow more generally, it's obviously not unusual this time of the year to see a few 2025 events shift into 2026. You've shifted six on the latest slide. I just wondered, is there any underlying theme there?

Speaker #11: Thanks so much Bruno . Two , if I may . And just continuing on with this question on on Ocrevus if I , if I look at the the trends in the US and I look at the , the 9 billion of peak sales guidance that you've given and where consensus is that there's a little bit of a disconnect here .

Speaker #11: And I was just wondering , Theresa is the disconnect our perceptions of the ex-US opportunity here . If one looks at the IV Subcut conversions , you've seen elsewhere , it feels like we may be under underestimating the the excuse opportunity .

Speaker #11: It's any thoughts on that would be would be helpful . And then just on newsflow more generally it's obviously not unusual this time of the year to see a few 25 events shift into 2026 .

Speaker #11: You've shifted six on the latest slide . I just wondered , is there any is there any underlying theme there ? Because a lot of these don't seem to be event driven studies .

[Company Representative]: A lot of these don't seem to be event-driven studies. It's not immediately obvious why they might be delayed. I was particularly thinking about CT-868 and CT-996. Any thoughts on that would be very helpful.

Speaker #11: It's not immediately obvious why they might be delayed . And I'm particularly thinking about state and ct9 6996 . So any thoughts on that would be very helpful .

Speaker #11: Thank you .

Thomas Schinecker: Thank you.

Speaker #6: Sure . So I think with regard to the new stuff , some of it is just when data will be presented and you know , the the most appropriate mechanism or vehicle for where that should be presented is 2026 .

Teresa Graham: Sure. I think with regard to the new cell, some of it is just when data will be presented. The most appropriate mechanism or vehicle for where that should be presented is 2026. I think that's the case for 996, 868. All of those trials will be placed into ADA, and that's the reason for the shift. The event-driven studies are really what's determining the shift for giredestrant, which I think, you know, and Amy Gobartrea shifted for competitive reasons. There are multiple sort of series of reasons why things have shifted there within Ocrevus. If I may, I think we're underestimating the opportunity in both places. What we have to remember is that Ocrevus IV was very heavily concentrated in academic and urban centers where IV capacity is very prevalent. One of the biggest opportunities that we have in the U.S.

Speaker #6: I think that's that's the case for 996868 . I mean , where those all of those , all of those trials will be placed into Ada .

Speaker #6: And so that's , that's the reason for the shift . And then the event driven studies are really determined are really what's determining the shift for giredestrant , which I think , you know , and shifted for competitive reasons .

Speaker #6: So there are there are multiple sort of series of reasons why things have shifted their within ocrevus , if I may , I think we're underestimating the opportunity in both places .

Speaker #6: So what we have to remember is that Ocrevus IV was very heavily concentrated in academic and and urban centers , where IV capacity is very prevalent .

Speaker #6: One of the biggest opportunities that we have in the US is the expanding into community neurology settings . And really opening up those more rural , those more rural opportunities , which is where you see a lot of the subcut and oral activity in the in the Ms. market .

Teresa Graham: is expanding into community neurology settings and really opening.

Operator: Up.

Teresa Graham: Those more rural opportunities, which is where you see a lot of the subcutaneous and oral activity in the MS market. That is a huge part of the U.S. market that Xenovo has the opportunity to tap into. I think that is something that maybe is not always quantified in the right way, that there's a big opportunity for us to penetrate in those places. The profile of Ocrevus subcutaneous to patients is extremely compelling. To be able to deal with your MS twice a year, 10 minutes, that's a pretty compelling value proposition. We really think as physicians and practices get more comfortable in the U.S. with how to use Xenovo, we will steadily see additional utilization in those areas. I do also think there is a lot of opportunity in the ex-U.S. market as well.

Speaker #6: And that is a huge part of the US market that has the opportunity to tap into . And I think , you know , that is something that maybe we're not always .

Speaker #6: Quantifying in the right way that there's a big opportunity for us to penetrate in those places . The profile of Ocrevus Novo two patients is extremely compelling to be able to deal with your Ms. twice a year , ten minutes .

Speaker #6: That's a pretty compelling that's a pretty compelling value proposition . And so we really think as as a as physicians and practices get more comfortable in the US with how to use de , that we will steadily see additional additional utilization in those areas .

Speaker #6: And then I do also think there is a lot of opportunity in the US market as well . Again , for the specific reason that you mentioned is that IV capacity can be more limited in some of those healthcare systems , and for something like Novo , where you have the opportunity again , in in a very short period of time to help patients treat Ms. .

Teresa Graham: Again, for the specific reason that you mentioned, IV capacity can be more limited in some of those healthcare systems. For something like Xenovo, where you have the opportunity again in a very short period of time to help patients treat MS, you will open up a large number of centers that might previously have not been as able to accommodate Ocrevus as an IV therapy. There are some early signals within the competitive environment that that is actually beginning to happen. I am very encouraged with what.

Speaker #6: You will open up a large number of centers that might previously have not been as able to accommodate Ocrevus as an IV therapy.

Speaker #6: And again , there are some early signals within the competitive environment that that is actually beginning to happen . And so I'm I'm very encouraged with what we'll see with Ocrevus next year .

Operator: We'll see with Ocrevus next year.

Speaker #6: And a big part of our confidence in that is why we raised the guidance to , to 9 billion at Pharma de . .

Teresa Graham: A big part of our confidence, and that is why we raised the guidance to $9 billion at first.

Speaker #11: That's very helpful . Thanks so much .

[Company Representative]: That's very helpful. Thanks so much. Very good. We move on. Next one is Michael Oysten from Jefferies.

Speaker #9: Very good . Then we move on . Next one is Michael from Jefferies .

Speaker #12: Thank you Bruno , two questions please . One for Thomas . I just wondered if you could give us an update on what's happening in Washington .

Bruno Eschli: Thank you.

Teresa Graham: Bruno, two questions, please. One for Thomas. I just wondered if you could give.

Matthew Sause: us an update on what's happening in Washington? We've seen a U.S. company and a U.K. company reach an agreement with Trump. I guess everybody's waiting to see what happens next.

Speaker #12: We've seen a US company and a UK company reach an agreement with Trump . I guess everybody's waiting to see what happens next .

Speaker #12: Just your perspective would be . Would be very helpful . And then question for for Theresa on the Her2 franchise , it looks like in the US this quarter , the combination of Her2 revenues took a dip .

Bruno Eschli: Just your perspective would be very helpful.

Matthew Sause: A question for Teresa. Two franchises, looks like in the U.S. this quarter the combination of the HER2 revenues took a dip. Fezgo didn't quite pick up the revenue loss seen with Perjeta and Kadcyla. Just wondering if you could go into that a little bit more. I appreciate your comments about the tail and the dynamics, but the quarter seemed a little bit soft in the U.S. thank you.

Speaker #12: So, Fesco didn't quite pick up the revenue loss seen with Perjeta and Kadcyla. Just wondering if you could go into that a little bit more.

Thomas Schinecker: Yeah, thank you very much, Michael, for the question on the U.S. discussions with the government there. I can say that we've been in discussions with the U.S. government for most part of this year, it's not something that has only happened in the last couple of weeks. For example, also the direct to patients access topic we discussed also with the U.S. government. We are in constant exchange with the U.S. government. That's as much as I can say.

Operator: Moment.

Teresa Graham: As far as the Hershey franchise in the U.S., there isn't anything in the underlying dynamics of that business that particularly stands out in Q3.

Operator: It's not something that we're worried about at this juncture.

Bruno Eschli: Thank you.

[Company Representative]: I think, Michael, maybe to add from my side, I think we had a very, if you look at the entire, the two franchise year to date, we had a very strong growth. I think this is more like order patterns, quarter. Nothing. No trend change here.

Matthew Sause: Got it.

Thomas Schinecker: Thank you.

[Company Representative]: All your questions answered.

Matthew Sause: Yes, thank you.

[Company Representative]: Let's move on. Next questions go to Louisa Hector from Birmingham.

Thomas Schinecker: Louisa, please.

Yeah then uh let's move on and uh next question is go to Louisa ha from Benbrook.

Operator: Hi there. Thank you, Bruno. Thanks for the call. Just on the oral third for Teresa, any comment on potential positioning of giredestrant given the changes coming in the first line setting and then maybe to push further on the first line trials and perhaps the adjuvant setting. Could you tell us how your level of confidence has changed ahead of Persevera now that you have giredestrant in house and perhaps remind us a little bit more about the combination of giredestrant with CDK4/6, which kind of plays into both settings, like what data you have that supports that combination being efficacious. Thank you.

Please.

Hi there. Thank you, Bruno. Thanks for the call. Um, so just on the oral side for Theresa, just any comment on potential positioning of a Vera, given the changes coming in the first line setting.

And then maybe to push further on the first line trials and perhaps the adjuvant setting. Um could you tell us how your level of confidence?

Has changed ahead of persevera. Um, now that you have a Vera in-house and perhaps remind us a little bit more about uh, the combination of Judith, Grant with cdk 46, which kind of plays into both settings. Like what data you have that supports

That combination being efficacious.

Teresa Graham: Great.

Operator: Thanks, Lisa.

Teresa Graham: In terms of where we would be expecting to position giredestrant based on the AVERA data, I think we would really be positioning it as standard of care in this patient population. The data certainly support that. I think we have always had confidence that giredestrant was a targeted, potent, combinable, tolerable therapy that actually had the opportunity to potentially redefine a new backbone therapy in this area. I think what AVERA has done is reinforce our confidence in the molecule to say that this is a highly active molecule that really does have the potential to help a really significant number of patients.

Operator: Patients.

Teresa Graham: When you think about combination with Everolimus, I mean, it could really address the resistance to endocrine therapies because it targets different signaling pathways, while it minimizes the impact of treatment for patients because you don't have to have as many injections. It's sort of an all oral combination. I think it's also worth pointing out that the safety profile of giredestrant is really playing out incredibly well, particularly given that we didn't see any ocular tox. I have the privilege to be at ESMO to spend some time there over the weekend and really talk to physicians. I would say that sort of everybody that we talked to really felt like the AVERA data was going to be practice changing for them in that setting. Now, what does that mean for the other trials? I think we do need to be careful about cross trial read throughs.

Thank you. Great. Thanks, Lisa. Um, so in terms of where we would be expecting to position gear duster and based on the Aero data, I mean, I think we would really be positioning it as standard of care in this patient population, um, the, the, the data certainly support that and I think, you know, we have always had confidence that gear industrial was a, a targeted potent. Um, combinable tolerable sword that actually had the opportunity to potentially redefine a new backbone therapy in this area. And I think what Ava has done is sort of reinforce our confidence in the molecule to say that this is a highly active molecule. Um, that really does have the potential to help um, a really significant number of patients. Um,

When you think about combination with um, ever lemus, I mean it could really address the resistance to endocan therapies because it targets different signaling Pathways while it minimizes the impact of of treatment from patients because you don't have to have as many injections it's it's in sort of an all oral combination. Um I think it's also worth pointing out that the safety profile of uh gear duster and is really playing out incredibly well particularly given that there's no we didn't see any ocular talks.

So, you know, I had the privilege to be at ectrims.

Teresa Graham: We know that each one of those trials in the first line and in the adjuvant setting are all designed to answer a slightly different scientific question. I think what we believe to be true is that anywhere where ER signaling remains important to a patient's disease, we have the ability to bring efficacy on top. I think we're overall, you know, more encouraged. These are still relatively high risk trials because of the, you know, just the nature of the disease. I think we're very, we're very encouraged by what we've seen with AVERA. We've always had a lot of confidence in this molecule as a standalone molecule. Now we get to wait to see how the trials play out.

I'm sorry asthma to spend some time there, uh, over the weekend and and really talk to Physicians. And I would say that, you know, sort of everybody that we talked to really felt like the Aveda was going to be practice changing for them in that setting. Now, what does that mean for the other trials? I mean I think we do need to be um careful about cross trial read throughs. Um, we we know that each 1 of those trials in in the first line and and in the adjuvant setting are all designed to answer a slightly different scientific question. But I think what we believe to be true is that anywhere where, um, er, signaling remains important to a patient's disease, we have the ability to bring efficacy on top. And so, you know, I think we're we're, um, overall, you know, more encouraged. These are still relatively high-risk trials because of the, you know, just the nature of the, the disease. Um, but I think we're very, uh, we're we're very encouraged by what we've seen with the Vera. We've always had a lot of confidence in this molecule as a stand.

Handle on molecule. Um, and now we get to wait to see how the trials play out.

[Company Representative]: Louisa, does this answer your questions?

Operator: Thank you. Thank you.

[Company Representative]: Okay, we go on. James, quickly from Goldman Sachs.

We said this this answer your questions and thank you. Yeah, thank you.

Okay.

Thomas Schinecker: James, great.

[Analyst]: Thank you for taking my questions. Bruno, I've got two, please. First of all, on the 2025 revenue guidance, again picking up on a comment you made, Thomas, that 7 is included in mid single digits, and there's a little bit of a concern this morning that mid single digits means 4.5% to 6%, which would suggest that growth in the fourth quarter was 0% to 4%, a good step down from what we've seen for the previous three quarters this year. Can you clarify that in terms of what we should be expecting on revenue growth for the fourth quarter? Asking for two reasons. First of all, with the operating profit growth, sorry, the core EPS guidance upgrade, if revenue falls off in the fourth quarter then maybe it's more cost savings related. Also, second reason is the exit rate into 2026.

And um, we go out and James quickly from Goldman Sachs James.

[Analyst]: Second of all, on Vabysmo, how much visibility do you have in terms of level of funding for the foundations? Is it getting back towards pre-drop levels this year and therefore what is your expectation for the rebound in growth as we see in 2026? Asking because obviously last quarter we had the guidance for 20% growth, we stepped back down to 15% growth this year. Again, it seems like there's a bit of variability in the visibility. Thank you.

Thomas Schinecker: Thank you very much for the question. I'm not at all concerned about Q4 growth. When I said that 7% is included in the mid single digit range, that's exactly what I meant with the 7%. Regarding core EPS, you saw core EPS growth at half year. This is, as you see, that we are doing quite well on the sales growth. At the same time, we've been very good in terms of cost control. We've always committed to keeping R&D flat, and with that, we decided to increase our guidance on core EPS. It's not additional cost savings, it's really particularly what we're seeing at the moment in our P&L that we believe will translate into the end of the year.

0 to 4%, a good step down, from what we've seen for the for the previous uh, 3 quarters of this year. So can you can, you can you clarify that in terms of what we should be expecting on Revenue growth for the fourth quarter asking for 2 Reasons? First of all, if if with the operating profit growth, um sorry the core EPS guidance. Upgrade if Revenue falls off in the in the fourth quarter, then maybe it's more cost savings related. And then also second reason is the exit rate into 2026 and then the second of all on the buyers Mo, um, how much visibility do you have in terms of level of funding for the foundations? Is it getting back towards? Um, pre pre pre drop, um, levels this year uh, and therefore what is your expectation for the for the rebound, uh, in growth as we see in 2026 and asking? Because obviously, last quarter, we had the, the guidance for 20% growth. We stepped back down to 15% growth this year. So again, it seems like there's a bit of variability in the in the visibility. Thank you.

Thank you ma'am. Very much for for the question. So, I'm not at all concerned about, uh, Q4 growth when I said, that 7% is included in the meeting of the range. That's exactly what I meant, uh, with the 7%. Um, regarding Corey PS, you saw a core PS growth at half year. Uh, this is uh, as you see that we are uh, doing quite well on the sales growth, at the same time, we've been very good in terms of cost control. Uh, we've always committed to keeping R&D flat.

Operator: Great.

Teresa Graham: When it comes to the CAFs, I think obviously we don't have clear visibility into what will happen with the co-pay foundation funds because I think as we've always said, that needs to happen at arm's length to the business. That having been said, as we head into 2026, we would expect a gradual normalization of CAF funding in the future and likely what we would expect is that multiple CAFs will step in to fill the gap that's been created here. That may provide some logistical challenges for offices that they just need to get used to working with multiple CAFs and not just one, but I think ultimately we will see funding return into this disease area and that will help normalize and steady the market in this particular place. I think as we think about next year, we do expect recovery in the U.S.

Um, and with that, uh, yeah, we decided to increase our guidance on Corey PS. So it's not additional cost savings, it's really, uh, what we're seeing at the moment in our P&L that we believe will translate into the end of the year.

Great. And when it comes to the calfs, I think obviously we don't have

Um, clear visibility into what will happen with the co-pay Foundation funds. Because, I think, as we've always said that needs to happen at at arms, length to the business that having been said, as we head into 2026, we would expect a gradual normalization of calf funding, um, in, in, in the future and likely. What we would expect is that multiple calfs will step in to fill the Gap. That's been created here. Um, that may provide some logistical, uh, challenges for offices that they just need to get used to sort of working with multiple calfs and not just 1. Um, but I think ultimately we will see funding return into, uh,

Teresa Graham: and a return to strong growth for Vabysmo.

Into this disease area and that, that will help normalize and sort of this steady, uh, steady the market, um, in this particular place, I think, as we think about next year, um, we do expect recovery in the US and a return to to strong growth for viseo.

[Company Representative]: James, did this clarify the outlook?

[Analyst]: Yes, it does. Thank you very much.

[Company Representative]: Okay, the next questions go to Satyan Jain from Bank of America.

James, that is to clarify the outlook. Yes, it is. Thank you very much.

Okay.

Thomas Schinecker: Sachin, hi there.

And, um, next question is to Seth and Jane from Bank of America, please?

Bruno Eschli: Just a follow on question. Some of the topics already touched on. Firstly, on the Vabysmo layered guide, could you just clarify what didn't happen in Q2 that you thought was going to happen? It seems like the dynamics are unchanged. I'm just trying to clarify what's not played through, and to clarify the answer to the last question, is that an acceleration of the growth trends in 2026 relative to 2025 that we should expect? The second question is if you would touch on key pushes and pulls into 2026. Slide 8, Thomas, you sort of talked about 7 to 8% sales growth last two years. Is that sustainable? I guess the question really hones back in on beyond the Vabysmo, Ocrevus, and Hemlibra have seen sequential declines in the U.S., which is what's driving the concern for investors today. Lack of clarifications on the U.S.

Bruno Eschli: Administration question was already asked. I wonder if you're able to comment. What's your ability to do a deal similar to those that have been announced? Is there any prohibition from your business mix that stops you from doing that? Thank you.

Hi there. Um, just to follow on questions, some of the topics really touched on. So, firstly on the Visa and lower guide and you can just clarify what didn't happen in 2 weeks that you thought was going to happen. Uh, because it seems like the Dynamics are unchanged. So just trying to clarify, what's not played through and to clarify the answer to the last question is that an acceleration of the growth Trends in 26 relative to 25 that we should expect the second question. Uh, is just if you would touch on key pushes and pools into into 2026 uh slide 8 to you, sort of um um talked about 7 to 8% sales growth for the last few years. Does that sustainable? And I guess the question really hones back in on beyond the vizma octopus and hebra have seen sequential declines in the US which is what's driving the concern uh from investors today and then at last clarification is on the US Administration question. It was already asked um just I wonder if you're able to comment. What's your ability to do a deal similar to those that have been announced? Uh is there any prohibition from your from your business myths? That stops you from doing that? Thank you.

Thomas Schinecker: Thanks for the question. I'll take your questions in the opposite order. I'll first take your question on the discussions with the U.S. administration. I really cannot comment more except that we've always been in exchange with the U.S. government, and for example, the Supreme Court loser DTP was something that we also discussed with the U.S. government. I really wouldn't want to go into additional details here regarding 2026. I think we gave you a bit of an outlook now into Q4 a bit more concretely than we normally do because there was a concrete question on that. When it comes to 2026, we will update you at full year. What we can say is we will have continued good momentum, and we feel comfortable that we will also be showing good growth next year.

Operator: Okay.

Teresa Graham: Sachin, I think your first question was around granularity of what's going to happen with Ocrevus in 2026 or was it what did we think was going to happen with Vabysmo in Q3.

Matthew Sause: Apologies.

Bruno Eschli: It was the Vabysmo lowered guide. What hasn't happened that you thought was going to happen?

Teresa Graham: Got it. Okay. I'm sorry. You broke up a little bit and I just didn't catch the question. I think, you know, ultimately we had hoped that we would see a return of the branded market and that just didn't happen. I think it was more just the underlying dynamic or the underlying dynamics that we saw in the first half continued into the second half and that just didn't normalize. Hence our revised outlook because of the dramatic change that we saw to the branded market in 2025. I don't think that market shares in 2025 and 2026 are going to be directly comparable, but I think as we start to see a resetting of that baseline growth rate sort of continue to bounce back to more of what we would have expected.

Okay. And so I I Satan, I think your first question was it on granularity of what's going to happen with ochre vist in 2026? Or was it, what happened in? What did we think was going to happen with the biso in Q3? It was it was the vbis lowered guide. What hasn't happened that you thought was going to happen. Got it. Okay, I'm sorry you broke up a little bit and I just didn't catch the question. So I think, you know, ultimately, we had hoped that we would see a, a return of the Branded market and that just didn't happen. So, um, it was I think it was, it was more just the, underlying dynamic or the underlying dynamics that we saw in the first half continued into the second half and that just didn't normalize. Um, so hence, our hence, our revised Outlook, um, because of the dramatic change that we saw saw to the Branded Market in 2025. I don't think that market shares in 2025 and 2026 are going to be directly comparable. But I think, as we start to see a resetting of that Baseline, you will see growth rates sort of, uh,

continue to to, uh,

Teresa Graham: The other thing I think it's important to point out is that in Vabysmo outside of the U.S. we are now fully launching our prefilled syringe and we expect to see a nice uptake ex U.S. of the prefilled syringe. I think there will be two dynamics at play in 2026 for Vabysmo. One is a normalization and a resetting of the baseline in the U.S. market which will allow some of those underlying growth dynamics to play out and be more visible. Also, you'll start to see the benefit of the uptick in the prefilled syringe launch in ex U.S.

Bounce back to sort of more of what we more of what we would have expected. Um, the other thing, I think it's important to point out is that in the buy. Now, outside of the us we are now fully launching our pre-filled syringe. And so we expect to see a, a nice uptake xus of the pre-filled syringe. So I think there will be 2 Dynamics at play in 2026 for viseo 1 is a normalization and sort of a a resetting of the Baseline in

The US market, which will allow some of those underlying growth Dynamics to play out and be more visible. But then also the, um, you'll start to see the benefit of the uptick in the pre-filled syringe launch in xus.

Thomas Schinecker: Thank you.

[Company Representative]: If I understood you right, you also had a bit of a question about the other two growth drivers, Vabysmo and Hemlibra, looking forward into next year.

Bruno Eschli: If you wanted to touch on it, just given the sequential declines in the U.S. seen in the third quarter.

Thank you, if I understood you or I do also had a bit of question about the additive growth drivers across and him Libra looking forward uh into next year.

Teresa Graham: Yeah. I think we just touched on the Vabysmo. I think as far as Ocrevus goes, it is going to be about breaking into new areas for Ocrevus de novo. I think you've always heard us talk about when it comes to Ocrevus, there are sort of two things that we were interested in doing. Obviously converting some of our IV business, but we were never going to reach the goals that we have for Ocrevus if all we were doing is converting. Yes, it's important to convert, but it's also extremely important that we open up new areas for Ocrevus, particularly in the U.S. in those community settings. When you look at the underlying dynamics, the number of healthcare providers that are prescribing Xenovo is increasing.

Yeah, if you wanted to touch on it, just giving the sequential declines in the U.S., seen in the third quarter.

Teresa Graham: We're seeing new prescribers come in and there is that tipping point that once you do it two, three, four, five times, all of a sudden you really get a tipping point into those practices. I think it's both the conversion and then the opening up of new spaces that are going to be important.

Operator: For Ocrevus next year.

Thomas Schinecker: I mean, it's definitely in the plan that we should see a pickup into next year as we also have it in the plan for buyers now.

Yeah, so I mean I think we just touched on the vismo is think of. As far as okra Vis goes, it is going to be about breaking into new areas for for okra sovo. You know, I think you've always heard us. Talk about, you know, when it comes to ocherous, there are sort of 2 things that we were interested in doing obviously converting some of our IB business, but we were never going to reach the goals that we have for ocherous. That's all we were doing is converting. So yes, it's important to convert, but it's also extremely important that we open up new areas for ocherous, particularly in the US in those Community settings. And again, when you look at the underlying Dynamics, the number of uh, healthcare providers that are present, uh, prescribing, zenovic, we're seeing new prescribers come in. Um, and you know, there is that Tipping Point. That once you do it 2 3 4, 5 times, all of the sudden, you know, you really get a Tipping Point into those practices. So I think it's it's both it's it's both, um, it's both the conversion and then the, the opening up of new spaces that are going to be important for okus next year. And I mean

Operator: Yeah, absolutely.

Thomas Schinecker: Okay, very good.

It's definitely in the plan that we should see a pickup, uh, into into next year. As we also have a have it in the plan for a buy as well. Yeah, absolutely.

[Company Representative]: Sachin, did this answer your questions?

Okay.

Matthew Sause: Yeah, perfect.

Thomas Schinecker: Thank you. Yeah.

[Company Representative]: We move on. Next one would be Matthew Weston from UBS.

Any questions? Yeah. Perfect. Thank you.

Yeah, then we move on. Uh, next one would be, um, Matthew Weston from UBS.

Thomas Schinecker: Matthew, we can hear you.

[Company Representative]: Matthew, you're still muted.

Matthew, we can hear you.

Matthew, you're still muted.

Matthew Sause: Can you hear me now?

Can you hear me now?

Bruno Eschli: Apologies, it seems that technology is extremely slow. The unmute box just popped up. Two questions from me, please. The first on Hemlibra, first of all, the sharp slowdown Q3 over Q2, I think that was stocking last quarter. That then looks like it's unwound, but can you please confirm that? Also, it is a product that's meaningfully outperformed consensus expectations over the course of 2025. What's a realistic expectation for this franchise to continue to grow next year? Should we just see a continuation or was there, for some reason, a bolus of demand in 2025? The second question is around the Mickey. Bart, you're obviously excited about the data. You've made that clear. Today you held an investor event that was solely focused on it or 50% focused on it.

Yes, perfect.

I apologize. It's seems that technology is extremely slow. The unmute box just popped up.

Um, 2 questions from me, please. Uh, the First on hem Libra. Um, first of all, the shop, slow down Q3 over Q2 I, I think that was

Stocking last quarter that then looks like it's Unwound but can you please confirm that? And also it is a product that's meaningfully outperformed uh consensus expectations over the course of 25. So what's a realistic expectation for this franchise to continue to grow next year? Should we just see a continuation or was there some for some reason, a bolus of demand in 2025?

And then the second question is around the mikart.

Bruno Eschli: It seems to be in your pack as a $500 million to $1 billion peak sales estimate, which is a very modest product, quite frankly, for Roche total sales. Is there something differentiated about the microbart over time that may mean that it can get bigger than that, or it's just an asset that you want to flag because of the innovation.

Um, you're obviously excited about the data, you've made that clear today uh you held an investor event that was solely focused on it or 50% focused on it, but it seems to be in your pack as a 500 million to a billion dollar Peak sales estimate, which is a very modest product. Quite frankly, for rash total sales.

Teresa Graham: Great, great questions. Thank you. For Hemlibra, you hit the nail right on the head in Q2. We did have a big buy-in that hit in Q2 versus Q3, and that is really the reason that you see that disparity in quarter over quarter. It's purely a buying pattern balancing effect. You're right, we have seen very good growth for Hemlibra in 2025, and that really has been due to increased penetration into the non-inhibitor population globally, something we've always said we wanted to do moving into that more moderate patient base. We are also seeing patients return from Altuvio, which is fantastic to see, but we are sort of tempering our expectations for next year. Given the significant growth that we have seen in 2025 and for 2026, we're really looking at low single digits growth for Hemlibra, which is sort of what our outlook would be there.

So is there something differentiated about the mabat over time? That may mean that it can get bigger than that or it's just uh an asset that you want to flag because of the innovation.

Teresa Graham: In terms of the Mickey Bart, I think the reason that we're excited about this is that UME is, while it is a relatively small patient population, these are younger patients who are getting very high dose steroids, which is just not ideal from a safety perspective over time. The idea of a therapy that can actually meaningfully improve that patient outcome is very compelling from a clinical perspective. It also fits very neatly in with the commercialization of our other products, so it's not like it's a big cost to commercialize this molecule. I think for us, we're very excited about the science and the innovation that it provides and really, frankly, what it can do for patients from a safety perspective.

2 versus Q3. And so, that is really the, the, the reason that you see that disparity in quarter over quarter, it's purely a buying pattern, um, uh, balancing effect. Um, and you're right, we have seen very good growth for a hem Libra in in 2025, and that really has been due to increased penetration into the non-inhibitor, uh, population globally. Um, something we've always said we wanted to do moving into that more moderate patient base. We are also seeing um patients returned from lvo, which is uh fantastic to see. Um but we are uh we are sort of tempering our expectations for next year. Given the significant growth that we have seen in 2025 and for uh 2026 we're really looking at low single digit growth uh, for him. Libra is sort of what what our Outlook would be there. Um, in terms of the Mickey bar,

I think the reason that we're excited about this is that um, me is while it is a relatively small patient population. These are younger patients, who are getting very high dose steroids, which is just, you know, not ideal from a safety perspective over time. And so the idea of a therapy that can actually meaningfully improve. That patient outcome is very compelling from a clinical perspective and it also fits very neatly in with the commercialization of our other products. So it's not like it's a big cost to commercialize, uh, to commercialize this molecule. So, I think for us, we're very excited.

Teresa Graham: We also think that adoption here is going to be a relatively fast thing to drive as it's just a simple injection and it prevents vision loss in, again, a much younger patient population. Very significant unmet need fits very neatly into our commercialization, great science. We're sort of projecting it around $500 million, but oftentimes when you have something like this, you don't totally know what you have until you actually get it into the market and then maybe we'll be pleasantly surprised.

[Company Representative]: Maybe one little add-on here. I think in general we are excited about IL6 in ophthalmology. I think we also shared that there's an opportunity in DME where we have a bispecific which will move ahead. I think it's just the first two cases where we clearly have proven that IL6 is key to a couple of diseases.

Excited about the science and The Innovation that it provides and really frankly what it can do for patients, from a safety perspective. Um, you know, I we also think that adoption here is going to be a relatively, um, fast thing to drive is it's just a simple. Um, you know, it it it's just a simple injection and it prevents vision loss and again, a much younger patient population. So, uh, very significant unmet need fits very neatly into our commercialization great science. Um, and yeah, I mean, we're, we're sort of projecting it around 500 million but, you know, oftentimes when you have something like this, uh, you don't totally know what you have until you actually get it into the market. Um and then, you know, maybe we'll be pleasantly surprised.

Operator: Yep.

Teresa Graham: Great, Bruno, thank you.

Bruno Eschli: Many thanks indeed.

Maybe you want to add on here? I think in general we are excited about aisle 6 in October. I think we also share that there's an opportunity in DME where we have a buy specific which will move ahead. So I think it's just the first 2 cases where we clearly have proven that. Aisle 6 is key to a couple of diseases. Yep, great ad Bruno. Thank you.

Operator: Thanks, Matthew.

[Company Representative]: Okay, then we go on. Next one is Peter Ferdolt from BMP.

Um, any thanks indeed.

Bruno Eschli: Yeah, thanks Bruno. Pete Fdolt, BNP, maybe give Teresa a couple minutes rest. Just a quick one for Matt on China Diagnostics. I think we were aware of the pricing dynamics, but it feels like volumes have also come into the equation in terms of volume decline. I mean, in terms of the visibility you have, Matt, in terms of that stabilizing return to growth, anything you can share with us would be helpful. To raise that arm back to third, the market's been quick to write off the chances for the class in first line adjuvant despite the data you shared. That was not a view shared by the community, ESMO, over the weekend which we attended. If that holds, the only thing to discuss really is the GI tox profile because that's something that's been put to us that puts giredestrant at a disadvantage to other competitors.

Thanks Matthew. Okay then uh we go on. Uh, next 1 is Peter adult from BMP. How about

Yeah, thanks. Brandon people to help BMP, and maybe give trazer a couple minutes rest. Um, just a quick 1 to Matt on. Uh, China Diagnostics. I think we all aware of the pricing Dynamics, but it feels like volumes.

Have also come into the equation in terms of a volume decline. I mean,

In terms of the visibility you have Matt in terms of that stabilizing return to growth and if you can share with us would be helpful and then to raise that arm back to third. Um the Market's been quick to write off the chances.

For the class in, you know, first line add um despite the data you shared, and that was not a view, a view shared by the community, um asmo over the weekend, which we attended. Um, so

If that holds, the only thing to discuss really is.

Bruno Eschli: Anything you can talk to about that as it relates to the Avira data or your comfort with the GI tox profile of giredestrant. Thank you.

[Analyst]: All right, sure.

The GI talks profile because that's something that's been put to us, that puts Durest at a disadvantage to other competitors. So, anything you can talk to about that, as it relates to the Avira data or your comfort with the GI touch profile. Follow the. Thank you.

Matthew Sause: Thank you for the question. This is something that I've addressed since the beginning. We saw a couple of effects going on in China for the last year. One of them was obviously the volume-based procurement and the reimbursement cuts, and the other was the implementation of diagnostic related group audits where they look at appropriate use of testing. The DRG effect is really on volume and the other on price. We've seen both of those pull through the system over the last year, and we expect again the peak is going to be 2024, continue negative impact sales in 2026, but to a lesser extent than this year. As I said, for this year our ambition in Diagnostics is low single digit. For next year we expect to grow. Our ambition is mid single digit, and I want to be clear on that. It's a very dynamic situation.

All right, sure. So, uh, thanks for the question and this is something that I've addressed since the beginning. So we saw a couple of facts going on in China, you know, for the last year, 1 of them was obviously the volume based procurement and the reimbursement cuts. And the other was the implementation of diagnostic Related Group audits where they look at appropriate, use of testing. The drg effect, uh, is really on volume and the other on price and

We've seen both of those pull through the system um, over the last year and we expect again the the peak is going to be 2025, continue negative impact sales in 2026, but to a lesser extent than this year.

And as I said for this year, our ambition and Diagnostics low single digit for next year, we expect to grow mid, our ambition is mid single digit, and I want to be clear on that.

Matthew Sause: I don't think I can be more precise than that.

Teresa Graham: Thank you for the break, Peter.

It's a very dynamic situation. I don't think I can be more precise than that.

Operator: Appreciate it.

Teresa Graham: In terms of giredestrant, I think we are very comfortable with the safety profile that we have seen in multiple studies now, and I think in talking with physicians, they feel like what they've seen is also very manageable and in line with what they might expect. The first-line setting is going to be an interesting one. I think you're right, the investment community has been pretty pessimistic on the earlier line studies. I think that we will need to wait to see what the actual trials read out as. We're very confident in giredestrant as a molecule. We're very confident that anywhere we see the ERα pathway remaining important to people's disease, we can add efficacy on top, and we'll just need to see how the trials read out.

So, Peter, thanks for the break. I appreciate it.

and I think, you know, in talking with Physicians, they they feel like it

Uh, what they've seen is also, you know, very, very manageable and in line with, with what they might expect. Um, you know, the first line setting is going to be an interesting 1. Um, I think, you know, you're right, the investment Community has has been pretty pessimistic on the earlier line studies. Um, I think that we will

Teresa Graham: One thing that I might invite people to consider as you're looking at your models is that right now most people have about $800 million in for giredestrant. With what we think we are likely to get with AVERA, you could argue that we're most of the way there with giredestrant in the model and that anything that comes on top, whether it's first line or adjuvant, is sort of all gravy. I think this is a space to watch. Again, I think we have a lot of confidence in giredestrant as a molecule. The trials, for all the reasons we've mentioned, sort of remain a little bit of a coin toss. If we do hit, this is going to be an incredibly significant drug and one that is going to help many, many patients.

need to wait to see what the actual trials read out as we're very confident in dearest. And as a molecule, um, we're very confident that anywhere we see uh the ear pathway remaining uh significant remaining important to people's disease that we can add efficacy on top and we'll just need to see how the trials read out 1 thing that I might sort of invite people to consider is you're looking at your models, is that right now most people have about ish 800 million in for, uh, in figure gesture. Um, with what we think we are likely to get with a Vera. You could argue that we're most of the way there with, with gear duster, and in the model. And that anything that comes on top whether its first line or add event, um, is is sort of all gravy. And so, you know I I think this is a space to watch again. I I think we have a lot of confidence in gear duster and as a molecule, um, the the the trials, you know, for for all the reasons we've mentioned, sort of remain a little bit of a coin toss, um, but if we do hit this is going to be an incredibly sick.

Teresa Graham: Again, based on the data so far, we're really not seeing any dose-limiting gastrotoxicities, and the profile is seen to be very well tolerated.

Thomas Schinecker: I just want to underline that basically what you have in the models, that's the current results from Ivira. Anything now is going to be on top. I think you have more upside than downsides when you look at your decision. Again, we don't know what the results are going to be. We'll see. Definitely, I would say from the model perspective, it's definitely upside.

Significant drug, and one that is going to help many, many patients. Um, and again, based on the data so far, we're really not seeing any dose-limiting gastro toxicities. And the profile is seen to be, you know, very well tolerated.

Bruno Eschli: Thank you.

Yeah, and I just want to on the on the line that that uh basically what you have in the malls. That's the current, the current, uh, results from a Vera. So, anything now is going to be on top, so I think you have more upsides than others when you look at your decision. But again, we don't know what the results are going to be. We'll see. But definitely, I would say, for the model perspective, it's it's definitely uh, upside

Thank you.

[Company Representative]: Peter, you're done.

Bruno Eschli: Thank you.

You're done.

Alan Hippe: Thanks.

Bruno Eschli: Brunette?

Teresa Graham: Yeah.

[Company Representative]: The next questions come from Sarita Kaplan from Stanley.

Thank you. Thanks brilliant. Yep.

Then, uh, the next question comes from Sarita Capilo from Janley, sorry.

Operator: Hey, thanks for taking my question. Sarita from Morgan Stanley. Just to follow up on Xolair, please. I know we touched on 2026, but how should we think about it in the context of remibrutinib competition in CSU where there's been, you know, quite a positive reception from the KOL community? The second one on Avera and read to Persevera. Given the limited effect size on PFS in wild type patients, are you confident that you've enrolled enough patients into Persevera to hit statistical significance? I believe 990 patients and your competitor has roughly 400 more patients. Does that put them at a greater chance of success? Thank you. Great.

There we go. Nice. Thanks for taking my questions. Syria from Morgan Stanley. Um, just to follow up on solo, please.

I know we touched on 26, but how should we think about it in the context of removing? If competition in CSU, whether there's been quite a positive reception from the KO community, and then the second one on Avera and REACH to Persevere, given the limited effect size on PFS in wild-type patients, are you confident that you've enrolled enough patients into Persevere to hit, stat? I believe you have 9,990 patients in your competitor has roughly 400.

Teresa Graham: Wow. A non food allergy question on Xolair.

For patients. So does that put them at a greater chance of success? Thank you.

Operator: Nice job.

Teresa Graham: I think with CSU we do continue to see relatively good utilization. With CSU, certainly as with asthma, CSU is becoming an increasingly competitive space. The data on Xolair are very good. People are comfortable with it. It's a fairly entrenched option, and I think we're not expecting to see a massive erosion of that quickly, for what it's worth. For Avera and Persevera, I.

Great. Um, so, wow. A non food allergy question on zolar. Nice, nice job. Um, so I think with CSU, we do continue to see relatively good utilization with, with CSU certainly, um, as with asthma CSU is becoming an increasingly competitive space, but the data on zolar are very good, people are comfortable with it. It's a, it's a fairly entrenched option. Um, and so, I think what, you know, we're not expecting to see a massive erosion of that quickly, um, for, for what it's worth.

Operator: Think.

Teresa Graham: We have enriched for the ESR mutations for about 40% in that patient trial. Oh, sorry. That's PIONEER you're talking about. Persevera. You know, Persevera. I'm hopeful that we have the right patient population in there. I think we feel like we've designed that trial well. We've designed it based on what we believe we will need from a patient size in order to see what we powered it appropriately to be able to see what we believe the effect size is. This is an all comers population. In this setting, ESR mutations make up less than 10% of the population. We'll see. These are the trials where honestly it just gets a.

For AA. And persevera, I mean, I think, you know, we are, um,

We have enriched uh for the ESR mutations. Uh for about 40% in that trial. Um, oh sorry, that's Pioneer, you're talking about for spera um, you know, persevera I I

Operator: Little more difficult for everybody.

I'm hopeful that we have the right patient population in there. Um, I think we feel like we've designed that trial. Well, we've designed it, you know, based on what we believe we will need from a patient's size in order to see, um, in order to see what we, uh, we we've powered it appropriately to be able to see what we believe. The effect size is this is an all comers population, um, in this setting if there were mutations make up less than 10% of the population. Um, so you know, we we'll we'll see. This is uh, you know, the these are the trials where, where honestly, it just gets a little more difficult for everybody.

[Company Representative]: Maybe just to add here, Sari, Zedman, you know, we have two studies in first line. One is basically the endocrine therapy sensitive study, which is coming out first. This is the ALISMA study. This of course has less ESR1 mutant patients in and therefore tests the all-comers hypothesis. How broad can we go? We have the 40% of the first line, which is defined as endocrine resistant patients. There, of course, you have like an accumulation of 25-30% of ESR1 mutant patients, and we have further enriched. This is to come in 2027 only. We have split the first line into these two buckets, and we are basically testing ESR1. We know it works, but the big question is will we see the benefit of the ALISMA.

Teresa Graham: Exactly. I think the clinical trial program has actually been designed quite robustly to make sure that we can really answer.

Operator: The very specific patient population questions.

Two buckets, and we are basically testing, uh, and ESL1. We know it works. But the big question is, will we see the benefit of the autonomous exactly? And I think the clinical trial program has actually been designed quite robustly to make sure that we can really answer the very specific patient population questions.

[Company Representative]: Shall we answer your questions or any additional questions?

Operator: Yeah, cool, thank you.

[Company Representative]: Okay, next questions come from Steven Scala from Cowen.

So we could do this, uh, answer questions or any additional questions. Yeah, cool. Thank you.

Mhm. Okay.

Thomas Schinecker: Stephen, thank you so much.

Bruno Eschli: I have one observation and then two clarification questions. Given the passage of time and the lack of clarity, I guess we have to consider a possibility where no pricing deal with Trump is signed. Thomas, is it acceptable that we have that thought in mind? The clarification question, just to be clear, the LOE exposure is expected to be more severe in Q4 versus the cadence through nine months. What products are causing that acceleration? Lastly, to be crystal clear, will Roche file Ivera for all comers.

And um, next questions come from student scholar from K, Steven.

Oh, thank you so much. I have 1 observation and then 2 Clarion questions.

But given the passage of time and the lack of clarity. I guess we have to consider a possibility where no pricing deal with Trump is signed Thomas, is it acceptable that we have that thought in mind?

Um, the

Thomas Schinecker: Thank you.

Teresa Graham: Maybe, Thomas, I'll do a you and answer the last ones first. I won't comment on what our filing strategy is for Avera. I'll leave that for you guys to ponder. You are correct that the pace picks up in Q4, and that is largely due to Actemra. We hadn't seen much biosimilar impact in the beginning of the year. We are starting to see that kick in the U.S. I think you heard me mention that we had about 6% in the U.S. in Q3 alone, and we would expect that to accelerate as we go through.

clarification question, just to be clear, the eloi exposure is expected to be more severe in Q4 versus the Cadence, through 9 months, what products are causing that acceleration. And then, lastly, to be Crystal Clear, will roach file either for all comers. Thank you.

Operator: The end of the year.

Thomas Schinecker: Yeah, on the U.S. topic, I mean I think I said everything that I could. We are in active discussion with the U.S. government and we've done that even prior to the last couple of weeks. One of the things we've discussed with the U.S. government, for example, is the DTP program with Sofuza. Again, we're in discussion with the U.S. government.

So maybe Thomas, I'll I'll I'll do a u and answer the last ones first, so I won't comment on what our filing strategy is for AA. Um, I'll leave that for you guys to ponder and then you are correct that the the pace picks up in Q4 and that is largely due to act camera. Um, you know, we we hadn't seen much biosimilar impact in the beginning of the year, we are starting to see that kick in the US. I think you heard me mention that we had about 6%, um, in the US, uh, in in Q3 alone and we would expect that to accelerate as we go through the end of the year.

Yeah, on the US, uh, topic. I mean, I I think I said everything that I could, we are in active discussion with the US government and we've done that, even prior, uh, to the last couple of weeks. So, um, and 1 of the things we've discussed with the US government, for example, is the DCP program with Sousa.

So again, we're in discussions with the US government.

[Company Representative]: Steve.

Thomas Schinecker: Yes, thank you very much.

Steve.

Yes, thank you very much.

[Company Representative]: We move on. Next question will go to Yihan Lee from Barclays. Yihan, please.

and we move on, um,

Next question, let's go to, uh, Lee from Barclays. You have the floor.

Operator: Hi, can you hear me? Thanks for taking our question from Barclays. I guess like two questions. The first one on Vabysmo. Thank you very much for the clarification and also the commentary. It seems like we are going to see some reversal likely from the beginning of next year. I just want you to further clarify on your expectation for the fourth quarter because it seems like you now upgraded the guidance for 15% year-over-year growth at core EPS, which indicates the U.S. growth will likely be at high single-digit range. Just curious what underpins your confidence for this Vabysmo growth in the U.S. for the fourth quarter. The second question is actually on your NTMAL setting, like GEM 3 to 9. We noticed you have two Phase 2 readouts, SMA and also the FSHD readouts pushed into 2025. Just curious what is the underlying reason.

Hi, can you hear me?

Thanks for taking our question. I guess like 2 questions from my end, the first 1 on that. This. Oh, thank you very much for the clarification and also the commentary. And also it seems like we are going to see some reverse likely from the beginning of next year, but just like want you to further clarify on your expectation for the fourth quarter, because it seems like you now upgraded, the guidance for 15% year-over-year, growth at Crescent, which indicates the US growth,

Will likely be in the high single-digit range, so I'm just curious, what underpins your confidence for this web? Is there more, um, growth in the U.S. for the fourth quarter?

Operator: We know you have already had your Phase 1 dose-finding data in obesity in-house for some time. Just curious, did you observe any similar profile that your competitor showed at ADA? Any commentary there? In the Phase 2 data, are we going to expect it at ADA next year as well? Thank you very much.

Um and then the second question, actually on your um Aunt email setting like Jim 329, so we noticed you have like 2 Face 2, readouts, SMA. And also the fshd readouts pushed it into 2026. So, just like Curious, like what is the underlying reason? And also we know you have already had your face 1,000, um, finding data in obesity in house for some time. So just like Curious, like Did You observe any similar profile that, um, your competitor showed on at Ada? Um, yeah, like any commentary there. And

And also, going to fit two data sets, are we going to expect it at ABA next year as well? Thank you very much.

Teresa Graham: Mover Bard, I think I mentioned, is shifting into 2026 for competitive reasons. That data will be shared next year, including data at ADA in obesity and for Vabysmo in terms of Q4. I mean, I think we are expecting to see it continue to perform in the way that a new standard of care does. The growth rates are still in mid double digits. We're still planning to grow at 15%. We still do hear from retinal specialists around the world that it is the new standard of care. It is their go-to drug for new patients. I think we continue to believe very strongly in the profile of Vabysmo, what Vabysmo can do for patients. As the U.S. market corrects itself, we would expect strong growth next year.

It corrects itself. Um, we you know we would expect strong growth next year.

Operator: Thank you very much.

Thank you very much.

Thomas Schinecker: Okay.

[Company Representative]: I think with that we are at the end of our Q&A session. Thomas, over to you.

okay, I think with that we are uh, at the end, um, of our Q&A session, um,

Thomas Schinecker: Thank you very much, Bruno, and thanks for everyone attending today's call. As you've seen, sales continue to be strong at 7%, pharma continues to perform well at 9%, and diagnostics started to recover. Clearly, I would say we're delivering on the sales front, but not only on the sales front. What we've also said is that we have good cost control so that we are raising our guidance when it comes to earnings expectations. I think everyone is very interested in the readouts that are going to come shortly on fenebrutinib and giredestrant. All I would say is good opportunities were clearly, if you look at the models, there's probably more upsides than downsides at this point in time, but we will have to see what the data ultimately says. Really looking in the pipeline more generally, we have now moved 10 molecules into Phase 3.

Thomas, uh, over to you. Thank you very much. Uh, Bruno. And uh, thanks for everyone attending today's call. Uh, if you've seen our sales continue to be strong at 7%, farmer continues to perform well at 9% and and uh, Diagnostics is started to recover. Um, so clearly I would say we're delivering on on the sales front, but not only in the sales front. What, uh, We've also said is that we have good costs of control, so that we are raising our guidance when it comes to earnings, uh, expectations.

Thomas Schinecker: We really rebuilt and shaped our late-stage pipeline. We have up to 19 medicines that can launch by the end of the decade. I think we've done a really tremendous step forward in terms of our pipeline. I'm quite confident in the long-term outlook for our company. Also, you can see that our on-market portfolio is performing. On the diagnostics side, we have seen the major launches that we've had, each a blockbuster on its own if you take pharma terms in terms of revenue expectations. I do believe that we can continue to take a good momentum into next year and that we will continue to deliver. Thank you very much.

Uh I think uh everyone is very interested in the readouts that are going to come shortly on fener and and your desk Rent, All I would say a good opportunity is we're clearly. If you look at the models there's probably more upsides. Uh and then downsides uh at this point in time, uh but we will have to see what the data ultimately says, but really looking in the pipeline more General, we have now moved to 10 molecules into phase 3. So we really rebuilt and, and shaped our late stage Pipeline with up to 19 medic that can launch by the end of the decade. So, I think we've done,

Really, um, uh, tremendous step forward in terms of of our pipeline. So, I'm quite confident in the long-term Outlook, uh, for our company. But also, you can see that our on Market portfolio, is performing on a diagnostic side. We have seen the major launches that we've had each a Blockbuster on its own. If you take Farah, uh, terms in terms of Revenue expectations. So and, and I do believe that we can continue take take a good momentum into into next year and that we will continue to deliver

Thank you very much.

Operator: Goodbye.