Roche Holding AG

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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. We continue to see strong performance for the Roche Group. Year-to-date group sales still same as half year, it's 7% growth, 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. If we exclude China in the numbers, then the rest of diagnostics was growing 7%, which is absolutely in line with past performance of diagnostics. So we do see that diagnostics continues to perform well. On the LOE 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, we've had several important milestones that we've achieved. On the pharma regulatory side, the US approval for Gaciva and lupus nephritis, and the positive CHMP opinion in the EU. The US approval for Dicentric in first-line maintenance of small cell lung cancer. US filing for SUSFIMO in NAMD. And we had several positive phase three readouts. For example, The positive phase three readout of Avira geodeshirant results were just presented at ESMO. On Saturday, the study met the primary endpoint, both in the ESL1 mutant population, but also in the ITT population. Definitely, Theresa will talk more about that. We had a positive phase 3 redox for T-centric in muscle-invasive bladder cancer. We had trial results shown from phase 3 in the MICI-BOT in UME and tetralizumab. 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 three decisions on top of the four previously announced that have here. So an overall significant progress in our pipeline. There is a CT388 in obesity, CT-868 in type 1 diabetes. Silvestrin in hypertension, study has already started. Sevastamab 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. On the BFD front, we've entered into an agreement to acquire 89Bio with their potentially best indices FGF21 analog in mesh. And this deal is highly synergistic with our CVRM portfolio, providing further optionalities for combination therapies. We've also entered into an agreement with Hanzo Pharma to license their CDH17 ADC, which is currently in phase one to be developed in colorectal cancer. On the diagnostic side, we had a series of regulatory updates. Most importantly, the first blood-based rule-out test, Alexis PTAL-181, 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. Alexis tropitin 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, and Teresa and Matt will cover that. For example, phenobrutinib, Gasaiva in SLE, as well as PSKI, and several diagnostics launches coming this year. 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. So very happy with that. Diagnostics were in 1%. I explained the numbers given the healthcare price 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. So overall, the group is at 7%. 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 Fesco 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. Alicenza's growth number remains good, driven by the adjuvant, ALK-positive non-sensory lung cancer. As mentioned, we have the positive results from Evira in phase three, which represented the asthma. PolyV sees continued strong uptake in first-line DLBCL, now reaching 35% patient share in the US, and truly has established itself as the new standard of care. And Hemliber continues to grow strongly with full year growth now expected in the around 10% range. New is also that the NXT 007 data will be presented later at ASH. On the neurology side, and I know Teresa will talk about that as well, Ocrevus, Sunovo, we have now 50% of starts in the US are new to brand, and Evristi 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 US approval that we have received for gociva in lupus nephritis, and we got also a positive CHMP opinion in Europe, We expect also the phase three results for Gazeiba in SLE to read out later this year. On the off-the-monitor side, we continue to have overall strong global growth in the bias mode driven by its differentiated MOA and profile, but we do see ongoing contraction of the branded market segment in the US because of less funding available for these co-pay assistance foundations. On the diagnostic side, as mentioned, good growth in the overall business, the 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, and we constantly apply the bar to all of the molecules that are in our pipeline. 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 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%. So before this prioritization, we had an average value of pipeline project of about 800 million. We're now at 1.3 billion. And 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. Okay. 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're not even done with this year. So 10 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, and we really see it across All of our therapeutic areas, we see it in oncology with the HER2 tyrosine kinase inhibitor, sebastimab, 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. 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. The way you can also see how we apply the bar is as we assess PTS of 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 area. are the gray dots. And in the dark blue dots, you see all the assets that we've moved into phase three. 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. But 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. But I just wanted to point that out that we haven't added all of those. So you see the oval value consistently moving up and the PTS consistently moving up. 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 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, but we also see it as an ethical responsibility. 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. 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. But 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 news flow. And here you can see, starting with Femke Barth, that we've initiated phase two study in a new indication, which is rheumatoid arthritis. This is RTL1A, where we will see the first readout in 2027. but not in this indication, but in other indications. The MICI-BART, we've talked about the phase three readout, where you can see the efficacy of the molecule. Turidestrin, we had a positive readout for Evira. Theresa will talk more about that. The Verisip, there's new phase three for the Verisip in adjuvant setting in non-small cell lung cancer. We've talked about the portfolio transitions of CT388, CT868, Svostimab, HER2, tyrosine kinase inhibitor, and sylvestrin, 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 cardio metabolism medicines. PEGO-Firmin is a potentially best in disease FGF21 analog, currently in two phase three for MASH in the stages of F2 to F3, but also in MASH for F4. And we have announced this deal recently, and we look forward to the closing of the deal. 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, purely mass spectrometry, which is one of its kinds, something that truly sets us apart from our competitors and differentiates us even beyond mass spec in the clinical chemistry and immunochemistry setting. Here we are in the rollout and we will expect a full US launch in 2026. Acrocheck 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 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. So we really have a very competitive product here, and we really look forward to launching this solution soon. 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. So really exciting. And I believe this will really cement the future growth of brush diagnostics. Now, let me talk about the outlook. First, the slide you have seen previously also shown in different events like the Pharma Day event. On the bottom, you see diagnostics 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 Massback, CGM, SBX, but I also believe very much with something like Lumira DX. So we do believe that we can continue to grow mid to high single digit. We will have to wash out the China effect. There will still be some effects next year on that. to grow ahead of sales growth. And then you look on the pharma side. On the pharma side, we have very good momentum in our portfolio. You've seen a 9% growth. And we do believe that we are one of the companies which have less biosimilar erosion. I mean, if you look at the next couple of years, we do believe we can grow 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. 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 three readout will then add to growth. 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 at the end of this decade will continue to contribute to future growth. So we believe we're 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. 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. And we also believe that we can further increase dividends in Swiss francs. With that, I hand over to Ellen.

Yes, 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. 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. 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 impressive growth, 3.4 billion. And then you see the loss of exclusivity impacts of minus 474 million in total growth of 9%. in constant rates. As Thomas alluded to, based on the effects 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 this Thomas has mentioned, diagnostics has grown excluding China with plus 7% in constant rates and Matt will lead you through this. And then you see really the China health care pricing reform impact of a minus 517, minus 6%, minus 6 percentage points, which then 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 to the 2 percentage points growth in Swiss francs. 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 there 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 points. That's the minus 5 percentage points that I've mentioned before. And you see very clearly the major driver here is the U.S. dollar. 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. And when you go to the euro, the euro has shown some stability as you can take from the slide here. But as said, I think certainly dominated by the US dollar. So when you go to the right hand side and our, if you like, our modeling and our forecasting for year end, and this really is assuming that September 30th exchange rates remain stable until the end of 2025, which is certainly very unlikely. But when you look really at full year, you see really a minus 5 percentage points impact on sales, a minus 8 percentage points impacts on cooperating profit, and a minus 8 percentage points impact on core EPS. You might remember when you looked at this table at half year, we had for core EPS a minus 6 percentage points. And I think that's important. So that has worsened by 2 percentage points to minus 8 percentage points. an impact on the consensus. 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 2 percentage points from minus 6 percentage points, which we have forecasted at the end of June, to minus 8 percentage points that we are forecasting now 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 2 percentage points, which we have experienced in Q3 for the full-year 2025 projection. 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. Good. And I think with that, I hand over to Theresa.

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 Swiss francs. 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, Zoller, Hemlibra, Vibismo, Okravis, and Polively 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. Fezgo continues to be our number one growth driver with Zoller a close second. as the outstanding launch in food allergy continues. Now let's start our TA deep dives with oncology. Oncology sales increased 2% to 11.6 billion Swiss francs, primarily driven by our HER2 franchise. Fesco 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% before the advent of biosimilars. Looking at Progetta, the conversion to Fezgo continues and Kedsilah 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 5, will have a negative impact to Kedsilah of roughly 700 million to 1 billion over time. 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 billion in 2026, followed by a steady decline through the end of the decade with a solid tail of around $4 billion, and that's primarily Fezgo, around $1 billion for Kedsila, and a bit of H&P. 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 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. 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. And last but certainly not least in our breast cancer franchise, ITOVI's launch and first-line PI3 kinase-mutated hormone receptor-positive breast cancer is ongoing and progressing as expected. Moving on to Ticentric. Sales remain overall stable at Q3, and for the full year, we expect the same. There were multiple positive events for Ticentric in Q3. Mforte and Firstline Maintenance small cell lung cancer achieved U.S. approval. The Invigor O11 in muscle invasive bladder cancer reported positive phase three results, and those data were presented at ESMO. And 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 T-Centric has returned to growth in the U.S. in Q3, we now expect to see flat to low single-digit growth for T-Centric in the coming years. Also in Q3, we initiated the Phase 3 Crescendo 2 study of D-Viracib 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 giridestrin is expected in 2026. And speaking of giridestrin, we wanted to take a closer look at the positive Avera results on the next slide. 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 giridusserin 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. 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 ITT populations. Furthermore, an exploratory analysis in patients without ESR1 mutation 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 gear adjustment clinical development program and show the potential for gear adjustment 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 profile was consistent with previous studies. Of note, there were no new safety signals observed, including no cases of phototopsia. We find the fact that giridescent can be combined at the full dose with 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 gear destruct 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-date, driven by increasing adoption in non-inhibitor patients. 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. A brief note on X007, our next generation bispecific in phase three, development for hemophilia A. We look forward to sharing additional phase one data with you in Q4. Next up, let's take a closer look at our malignant hematology portfolio. Polivi and first-line DLBCL continues to drive strong growth. And U.S. first-line DLBCL patient share is climbing further and now stands at 35%. That's up two percentage points versus Q2. We anticipate that Polivi will surpass 1 billion Swiss francs in sales in the first-line DLB setting for the first time this year. Shifting to Columbia and Lunsumio are CDK-CD3 bispecifics. Lantz performance remains on track for Columbia 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 Columbia, 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. And as a reminder, the U.S. approval for the sub-Q formulation is expected later this year. As Thomas mentioned, we took the decision to move Sevastimab into phase three development for relapsed refractory multiple myeloma, and that trial is also expected to start next year. Now let's go to the next slide where we will cover the neurology franchise. Our neurology franchise achieved $7.3 billion in sales and a strong growth of 9% year-to-date. OkraVis continues to have good momentum, delivering 7% growth globally. We continue to be encouraged by the ongoing launch of our subcutaneous formulation, known as Zenovo in the U.S. As a reminder, the permanent J-code for Zenovo was granted on April 1st, and we do see some acceleration there. in Zenovo uptake as a consequence of that. It is important to remember that for many practices, switching to Zenovo is associated with logistical challenges. We are hoping to manage those, and we expect Zenovo 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 US, roughly 50% of Zenovo patients are naive to Ocrevus, and the same is true for many of our other early launch countries, such as Germany, for instance. We're encouraged by the fact 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 OkraVis subcut is expanding the addressable market and can help overcome healthcare system constraints like IV capacity limitations. Overall, we now have more than 12,500 patients on OkraVis-Senovo globally. We also presented the two-year data for OkraVis subcut at ECTRIMS, which shows that the benefit-risk profile is maintained. And for 2025, we continue to expect high single-digit global sales growth for OkraVis. It is worth noting here that the US 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 Okra's franchise to $9 billion by 2029. And this includes $2 billion incremental sales from Okravis Subcut. Staying with our MS franchise, we are eagerly awaiting the Fentabrutinib results in PPMS with the Phase III for Intrepid readout expected in Q4. Moving on to Evrizdi, we now have 21,000 patients on Evrizdi globally, and this includes patients using our new tablet formulation, which has now launched in both the US and EU. 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. Moving on to AVERISD and DMD, we continue to believe in the risk-benefit profile for AVERISD and 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 for EU patient access following the negative approval decision. And lastly, trontinumab in 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 three in preclinical AD and more details on that to come at a later stage. 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 estimate that we shared at half year. As a reminder, we expect a first biosimilar launch for Zoller 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 US 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 full year of 2025. A highlight for this quarter in immunology is certainly Gizaiba. 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 gaziva 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 three allegory trial for gaziva and SLE in Q4 of this year. Turning to Zofluza, last week we announced our direct-to-patient program for Zofluza for patients in the U.S. This program will provide Zofluza at $50 through selected pharmacies, a 70% discount versus list price. Via this program, we aim to improve affordability and access for U.S. patients and address the significant health impact that the flu continues to have on society. 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. So now let's move on to ophthalmology. Ophthalmology grew by 11%, achieving $3.2 billion in sales year-to-date. But by-smell 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 IVT 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 will fuel further growth. Considering these dynamics, we've decided to update our full year growth outlook for Vibesmo. We now expect around 15% growth at constant exchange rates down from the roughly 20 that we had shared earlier this year. Nevertheless, Vibesmo continues to gain market share in the branded IVT market in the US and in across early launch countries globally. In the US, we now see that more than 60% of Vibesmo starts are naive patients, further solidifying the Vibesmo's 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 the BISMO as the IBD treatment option with the best anatomic outcomes and disease control in AMD, DME, and RVO. China also continues to impress with strong update following the NRDL listing and rapidly expanding market shares. Moving on to the pipeline, as Thomas mentioned, we had three phase three readouts for Vimikibar and UME, and I'm sorry, we had two phase three readouts for Vimikibar and UME and Sotrolizumab and thyroid eye disease with data presented over the last few days. So let's take a closer look at both. Starting with the VimikiBART results in UME, 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. 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 a proportion of patients with a greater than 15 letter B CVA gain. Meerkat met this endpoint, but Sandcat did not. However, let me emphasize two points. In both studies, a numerically higher portion of patients treated with the Mickey Bart gained vision. The miss for Sandcat was primarily driven by one patient and the one milligram, the Mickey Bart cohort. It is our belief that the totality of the Sandcat and Meerkat data support the use of the Mickey Bart in UMEA. The MICI-BART may offer novel targeted IVT treatment strategy for UMA 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 three SatraGo one and two results at ASO RPS a few days ago. The phase three results show that Satra and Ted have a differentiated risk benefit profile from currently available treatment options. The primary endpoint was proptosis response at week 24 and active thyroid eye disease. For both SatraGo 1 and 2, a higher portion of participants treated with Satra showed a proptosis response. However, only SatraGo 2 achieved statistical significance. SatraGo 1 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. Furthermore, the safety profile for Satraluzumab was highly favorable. Currently available treatments for TED are associated with sometimes severe adverse effects, and none of these effects were reported for Satra. As with the Mickey 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. And now moving on to our CVRM portfolio. In terms of developments in our CVRM pipeline, the recently announced 89Bio acquisition is currently, is certainly a highlight, and I will cover this in more detail in the next slide, but suffice it to say that we are very excited to add a potential best in disease enemy in MASH into our portfolio. Most of the other updates you've already seen at Pharma Day. So just very quickly, as you know, we are moving CT388 and Zalbiceran into phase three trials. Zalbiceran's phase three Zenith has already achieved FPI. Additionally, CT996 achieved FPI for its phase two study and announced today we will be moving CT868 into phase threes for type one diabetes patients into late stage trials. 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. So as you can see, we are progressing our CVRM pipeline at pace. But let's take a deeper look at Pegasofferman, our new phase three asset in MASH. For those following the field, it is important to understand that not all FGF21 analogs are the same. Pegazoframine 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 Pegazoframine 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 two data, which we also presented at Pharma Day. And in short, Pegasofferman 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 Pegasofferman. There are two phase three 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 line data in 2028. This deal is subject to customary closing conditions and we expect the integration of Pegasofferman will further drive the strong development momentum in our CVRM pipeline. 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, so I won't repeat them, but I will just reiterate that we do have some key readouts that remain for Q4, including Phenobrutinib in PPMS. And with that, I will turn it over to Matt to walk us through the diagnostic slides.

Okay. Thanks, Theresa. Good morning. Good afternoon, everyone. It is my pleasure to present the year-to-date September 2025 Diagnostics Division results. So as you heard from Thomas, diagnostics is back to growth with sales of 10.3 billion Swiss francs, sales increased by 1% or 0.1 billion Swiss francs compared with year-to-date September 2024 at a constant exchange rate. This was driven again by the healthcare pricing reform in China, which include 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. 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 at plus 5%. However, this was 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 through the regional business performance. North America, great growth of plus 7%. In EMEA, the business grew at plus 6%. LATAM, growth of plus 14%. Now again, 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%. 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. Now 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. 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 continuing investment in innovation, starting with our Xcelios sequencing solution, which as you heard is set to launch next year. So first I'd like to highlight the results of a recently published correspondence in the New England Journal of Medicine. 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 SBX 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 underscores the potential of our SBX technology in critical care settings where rapid genome sequencing is crucial for decision-making. And so now I'd like to continue with updates on our Xcelios 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. So as we've said, since we unveiled the Xcelios technology earlier in the year, that we plan to demonstrate its applicability for all key applications. So here I'll focus on a couple of them. The first on the left illustrates the suitability of SPX for methylation. So this is an internal workflow we developed utilizing taps, which generates direct conversion of five methyl cytosines to thymine bases paired with our SPX duplex sequencing approach. 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 SPX for methylation is directly comparable to the standard SPX duplex workflow with F1 scores for single nucleotide variants at 99.6 or higher. So this really shows that we're able to do methylation 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 ameliodosis, 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 SBX technology for both research as well as clinical applications. We're very much looking forward to the launch of this next year. And so now I'd like to turn to another topic, which is quite exciting, and that's our advancement of our neurology portfolio, specifically starting with our Alexis P-Tau 1A1, for which we received CMARC in July and FDA clearance in October. So, Alzheimer's disease, as well as other dimensions, remains a key global burden on health, affecting more than 55 million individuals annually and projected to reach over 80 million people by 2030. Now, 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 PTAL-181 will offer a minimally invasive blood-based solution to rule out Alzheimer's disease, and we'll call out, 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. So continuing with our neurology portfolio, I'd like to highlight the second example, which is our second blood-based biomarker for Alzheimer's disease, Alexis PTAU217, which is set to launch next year. Now 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. Now, two key studies and the main findings. On the left, you'll see the robustness of our method, which is a key aspect for a test that's gonna be used broadly in a routine clinical setting. 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 PTAL217 to an internally developed PTAL217-AB42 ratio assay. Now, this study included patients from five cohorts representing patients across the Alzheimer's disease continuum. And as you can see, the PTAL7 isoform by itself demonstrates superior robustness to the ratio test, which is a commonly used approach in other competitive assays. And 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 as compared to the gold standard of amyloid PET. Here you see the results generated as part of a leading US integrated healthcare network. 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 217 achieved the highest accuracy amongst the multiple P-Tau 217 methodologies that they evaluated. So when you take these in aggregate, these studies results support broad implementation of Alexis P tau 217 in routine clinical practice. 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, 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. So with that, I'll pass it over to Bruno.

Thanks. The Q&A session. So the first question goes to Richard Foster from J.P. Morgan. Richard, please.

Thanks, Bruno. A couple of questions. First of all, on Ocrevus, perhaps Theresa could give us a little bit more colour 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 US in Ocrevus. 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, and I think they always had tolerability challenges, maybe diarrhea in the past. So just what's the tolerability profile and what you're thinking about there? And then I could go for a third, but I think I'll stop there because we'll stop there. Thanks very much.

So I think when you think about the logistical challenges for Zenovo, they're not that dissimilar than 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 disease. a different technology. 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 how to work with Zenovo. 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. But 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 Zenovo. 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. We're starting to see some competitive indications that would indicate. that Subcut is starting to get some traction, particularly in accounts that are in the more rural areas, where maybe Bramvir or Cosimta would have been initially a choice. Now they're really migrating towards or beginning to migrate towards Zenovo. So 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 HER2 TKI, thus far, it has been very well tolerated without any dose-limiting toxicities at doses of up to 100 mg monotherapy. 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, in addition to the fact that 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.

It's up to a thousand milligrams.

Sorry, up to a thousand milligrams. Sorry, Thomas. Thank you.

Richard, does this answer your questions or any additional questions?

No, perfect. Thanks. Thanks, Bruno. Cheers, everyone.

Okay. And we move on and 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 Oculus. If I look at the trends in the US 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. And I was just wondering, Teresa, is the disconnect our perceptions of the ex-US opportunity here? If one looks at the IV subcut chain conversions you've seen elsewhere, it feels like we may be underestimating the ex-US opportunities. Any thoughts on that 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. 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. It's not immediately obvious why they might be delayed. And I'm particularly thinking about CT868 and CT996. So any thoughts on that would be very helpful. Thank you.

Sure. So I think with regard to the new stuff, some of it is just when data will be presented and the most appropriate mechanism or vehicle for where that should be presented is 2026. I think that's the case for 996, 868. I mean, all of those trials will be placed into ADA. And so that That's the reason for the shift. And then the event-driven studies are really determined, are really what's determining the shift for gear destruct, which I think you know. And Amugabart, where you have shifted for competitive reasons. So there are multiple sort of series of reasons why things have shifted there. Within Okravis, if I may, I think we're underestimating the opportunity in both places. So... 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 US is the expanding into community neurology settings and really opening up those more rural opportunities, which is where you see a lot of the subcut and oral activity in the MS market. And that is a huge part of the US market that Zenovo has the opportunity to tap into. And I think that is something that maybe we're not always quantifying in the right way, that there's a big opportunity for us to penetrate in those places. The profile of Okra Vista Novo to patients is extremely compelling to be able to deal with your MS twice a year, 10 minutes. That's a pretty compelling, um, That's a pretty compelling value proposition. And so we really think as physicians and practices get more comfortable in the US with how to use Zenovo, that we will steadily see additional utilization in those areas. And then I do also think there is a lot of opportunity in the ex-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 Zenovo, 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. 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 OkraVis next year. And a big part of our confidence in that is why we raised the guidance to 9 billion at Pharma Day.

That's very helpful. Thanks so much.

Very good. Then we move on. Next one is Michael Oyston from Jefferies.

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. 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. Just your perspective would be very helpful. And a question for Theresa on the HER2 franchise. It looks like in the U.S. this quarter, The combination of the HER2 revenues took a dip, so Fesco didn't quite pick up the revenue loss seen with Pagetta and Katsala. 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 US. Thank you.

Thank you very much, Michael, for the question. On the US discussions with the government there, I can say that we've been in discussions with the US 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 Xofluza direct-to-patient access topic we discussed also with the U.S. government. So we are in constant exchange with the U.S. government. That's as much as I can say at the moment.

And as far as the Hurtu franchise in the U.S., there isn't anything in the underlying dynamics of that business that stands out in Q3. It's not something that we're worried about at this juncture.

Thank you.

I think, Michael, maybe to add from my side, I think we had a very, if you look at the entire HER2 franchise year to date, we had a very strong growth. So I think this is more like order patterns quarter to quarter. Nothing, no trend change here.

Got it. Thank you.

All your questions answered?

Yes. Thank you.

Yeah. Then let's move on. And next questions go to Luisa Hector from Birnbrook. Luisa, please.

Hi there. Thank you, Bruno. Thanks for the call. So just on the oral side for Teresa, just any comment on potential positioning of Avera, 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 Avera in-house? And perhaps remind us a little bit more about the combination of Giro d'Estrane with CDK4-6, which kind of plays into both settings, like what data you have that supports that combination being efficacious. Absolutely.

Thank you. Great. Thanks, Lisa. So in terms of where we would be expecting to position giridestrin based on the Avera data, I mean, I think we would really be positioning it as standard of care in this patient population. The data certainly support that. And I think, you know, we have always had confidence that Ghirardestrin was a targeted, potent, combinable, tolerable SIRD that actually had the opportunity to potentially redefine a new backbone therapy in this area. And I think what Avera has done is sort of 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. 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 from 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 Gary Duster is really playing out incredibly well, particularly given that there's no, we didn't see any ocular tox. So, you know, I had the privilege to be at ECTRIM's, I'm sorry, ESMO, to spend some time there over the weekend. and really talk to physicians. And I would say that, you know, 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 mean, I think we do need to be careful about cross-trial read-throughs. 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. But 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. And so, you know, 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. But I think 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. And now we get to wait to see how the trials play out.

Luisa, does this answer your questions? Thank you.

Okay.

Then we go on. James quickly from Goldman Sachs. James.

Great. Thank you for taking my questions, Bruno. I've got two, please. So first of all, on the 2025 revenue guidance, again, picking up on a comment you made, Thomas, that seven is included in mid-single digits. And there's a little bit of a concern this morning that means 4, 5, 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. So, 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, if 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. And then also the second reason is the exit rate into 2026. And then the second rule on the BISMO, how much visibility do you have in terms of the 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? I'm asking because obviously last quarter we had 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 visibility. Thank you.

Thank you very much for the question. So 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, yeah, we decided to increase our guidance on core EPS. So it's not additional cost savings. It's really what we're seeing at the moment in our P&L that we believe that will translate into the end of the year.

Great. And 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 sort of working with multiple CAFs and not just one. But I think ultimately we will see funding return into CAFs into this disease area and that will help normalize and sort of steady the market in this particular place. I think as we think about next year, we do expect recovery in the U.S. and a return to strong growth for Vibismo.

James, does this clarify the outlook?

Yes, it does. Thank you very much.

Okay. Then next questions go to Sachin Jain from Bank of America. Sachin, please.

Hi there. Just a follow-on question to some of the topics already touched on. So firstly, on the provisional and lowered guide, if you could just clarify what didn't happen in 2H that you thought was going to happen, 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 is just if you would touch on key pushes and pulls into 2026. Slide eight, Thomas, that you sort of talked about 7% to 8% sales growth the last two years. Is that sustainable? And I guess the question really hones back in on beyond the BISMA. Octopus and Hemlibra have seen sequential declines in the U.S., which is what's driving the concern for investors today. And then last clarification is on the U.S. administration question that was already asked. Just 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.

Thanks for the question. I'll take your questions in the opposite order. I'll first take your question on the discussions with the US administration. I really cannot comment more except that we've always been in exchange with the US government. For example, the Suflusa DTP was something that we also discussed with the US 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'd 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 so we feel comfortable that we will also be showing good growth for next year.

And so, Sachin, I think your first question was about granularity of what's going to happen with OkraVis in 2026, or was it what happened in, what did we think was going to happen with Fabizmo in Q3?

Apologies. It was the Fabizmo 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 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 diner or the underlying dynamics that we saw in the first half continued into the second half and that just didn't normalize So 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, you will see growth rates sort of continue to increase. bounce back to sort of more of what we would have expected. The other thing I think it's important to point out is that in Vibismo outside of the US, we are now fully launching our pre-filled syringe. And so we expect to see a nice uptake ex-US of the pre-filled syringe. So I think there will be two dynamics at play in 2026 for Vibismo. One is a normalization and sort of 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, you'll start to see the benefit of the uptick in the pre-filled syringe launch in XUS.

Thank you.

If I understood you right, you also had a bit of a question about the other two growth drivers, Aceros and Hemlibra, looking forward into next year?

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

Yeah. So, I mean, I think we just touched on Vivisimo. I think as far as Okravis goes, it is going to be about breaking into new areas for Okravis and OVO. You know, I think you've always heard us talk about, you know, when it comes to Okravis, there are sort of two 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 Okravis if 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 Okravis. particularly in the U.S., in those community settings. And again, when you look at the underlying dynamics, the number of healthcare providers that are prescribing Zunovo is increasing. 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. So I think it's both the conversion and then the opening up of new spaces that are going to be important for Okrabus next year.

I mean, it's definitely in the plan that we should see a pickup of that into next year, as we also have it in the plan for a BIOS model.

Yeah, absolutely.

OK, very good. Sachin, did this answer your questions?

Yeah, perfect. Thank you.

Yeah, then we move on. Next one would be Matthew Weston from UBS.

Matthew, we can't hear you.

Matthew, you're still muted.

Can you hear me now?

Yes, perfect.

Apologies. It seems that technology is extremely slow. The unmute box just popped up. Two questions from me, please. The first on Hem Libra. 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? And also it is a product that's meaningfully outperformed 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's 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, 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 Roche Total Sales. So is there something differentiated about the Mickey Bart 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 innovations?

Great, great questions. Thank you. So 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 so that is really the reason that you see that disparity in quarter over quarter. It's purely a buying pattern balancing effect. And 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 spectrum. 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 L2VO, 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 digit growth for Hemlibro as sort of what our outlook would be there. 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. And so the idea of a therapy that can actually meaningfully improve that patient outcome is 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 this molecule. So 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. perspective. You know, we also think that adoption here is going to be a relatively fast thing to drive as it's just a simple, you know, it's just a simple injection and it prevents vision loss in, again, a much younger patient population. So, very significant unmet need, fits very neatly into our commercialization, great science. And yeah, I mean, we're sort of projecting at 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.

Maybe one little add-on here. I think in general, we are excited about IL-6 in ophthalmology. I think we also shared that there's an opportunity in DME where we have a bispecific, which will move ahead. So I think it's just the first two cases where we clearly have proven that IL-6 is key to a couple of diseases.

Yep. Great add, Bruno. Thank you.

Many thanks indeed.

Thanks, Matthew. Okay. Then we go on. Next one is Peter Fadult from BNP Paribas.

Yeah, thanks, Bruno. People at LP&P. Maybe give Teresa a couple minutes rest. Just a quick one to Matt on China diagnostics. I think we're all 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. And then, Teresa, back to CERD, the market's been quick to write off the chances of for the class in first line adjuvant um despite the data you shared and that was not a view of you shared by the community um asmo over the weekend which we attended um so if that 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 um girodestrin at a disadvantage to other competitors. So anything you can talk to about that as it relates to the Avera data or your comfort with the GI-TUX profile of girodestrin? Thank you.

All right, sure. So thanks for the question. And this is something that I've addressed since the beginning. So we saw a couple 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. And we've seen both of those pull through the system over the last year. And we expect, again, 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 in 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. It's a very dynamic situation. I don't think I can be more precise than that.

So, Peter, thanks for the break. Appreciate it. So in terms of CERD, I think we're very we are very comfortable with the safety profile that we have seen over multiple studies now with gerodestrin. And I think, you know, in talking with physicians, they feel like it's. 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 Gyrgestrin as a molecule. We're very confident that anywhere we see the ear pathway 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. One thing that I might sort of invite people to consider as you're looking at your models is that right now, most people have about 800 million in for Gyrgestrin. With what we think we are likely to get with Avera, you could argue that we're most of the way there with GearDustRent in the model and that anything that comes on top, whether it's first line or adjuvant, is sort of all gravy. And so, you know, I think this is a space to watch. Again, I think we have a lot of confidence in GearDustRent as a molecule model. And the trials, for all the reasons we've mentioned, sort of remain a little bit of a coin toss. But if we do hit, this is going to be an incredibly significant drug and one that is going to help many, many patients. 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 very well tolerated.

I just want to underline that basically what you have in the models, that's the current results from Ibera. So anything now is going to be on top. So I think you have more upside than downside when you look at your data. But again, we don't know what the results are going to be. We'll see. But definitely, I would say from the model perspective, it's definitely upside. Thank you.

Peter, you're done.

Thank you. Thanks, Bruno.

Yeah. Then next questions come from Sarita Kapila from Monk Stanley. Sorry. Sarita.

Hey, thanks for taking my question, Sarita, from Morgan Stanley. Just to follow up on Zola, please. I know we touched on 26, but how should we think about it in the context of remibrutinib competition in CSU, where there's been quite a positive reception from the KOL community? And then the second one on Avera and Read to Persevera. Given the limited effect size on pfs and wild type patients are you confident that you've enrolled enough patients into persevera to hit stat sig i believe 990 patients and your competitor has roughly 400 more patients so does that put them at a greater chance of success thank you

Great. So wow, a non-food allergy question on Zoller. Nice job. So 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, but the data on Zoller are very good. People are comfortable with it. It's a fairly entrenched option. And so I think we're not expecting to see a massive erosion of that quickly for, for what it's worth. And then for Avera and Persevera, I mean, I think, you know, we are, we have enriched for the ESR mutations for about 40% in that trial. Oh, sorry, that's Pioneer. You're talking about Persevera. You know, Persevera, I, I, 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, we've powered it appropriately to be able to see what we believe the effect size is. This is an all comers population. In this setting, yes, our mutations make up less than 10% of the population. Um, so, you know, we will, 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.

Maybe just to add here, Sarita, you know, we have two studies in first line. One is basically the endocrine therapy sensitive study, which is coming out first. And this is the all-comer study. This, of course, has less ESR1 mutant patients in and therefore tests the all-comers hypothesis. So how broad can we go? And then we have the 40% of the first line, which is defined as endocrine resistant patients. And 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 27 only. But we have split the first line into these two buckets, and we are basically testing an ESL-1. 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.

So, Risa, did this answer your questions or any additional questions?

Yeah, cool. Thank you.

Okay. And next questions come from Stephen Scala from Cowan. Stephen.

Thank you so much. I have one observation and then two clarification 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? 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? And then lastly, to be crystal clear, will Roche file Ivera for all comers? Thank you.

So maybe, Thomas, I'll do a you and answer the last ones first. So I won't comment on what our filing strategy is for Avera. I'll leave that for you guys to ponder. And then 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 the end of the year.

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. And one of the things we've discussed with the U.S. government, for example, is the DTP program with Xofluza. So again, we're in discussion with the U.S. government. Steve?

Yes, thank you very much.

Okay. Then we move on. Next questions go to Yihan Li from Barclays. Yihan, Facebook.

Hi, can you hear me? Thanks for taking our question, Yihan Li from Barclays. I guess like two questions from my end. The first one on Webismo, 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 wanted 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 CER, which indicates the U.S. growth will likely at high single-digit range. So just curious, like, what underpins your confidence for this very small growth in the U.S. for the fourth quarter? And then the second question actually on your anti-melastating like GIMS 329. So we noticed you have like two phase two readouts, SMA and also the FSHD readouts pushed into 2026. So just like curious, like what is the underlying reason? And also, we know you have already had your phase 1 dosing finding data in obesity in-house for some time. So just curious, did you observe any similar profile that your competitor showed at ADA? Yeah, any commentary there? And also, in the phase 2 data, are we going to expect it at ADA next year as well? Thank you very much. Yeah.

Um, so Amu Rabart, I think I mentioned, um, is shifting into 2026 for competitive reasons that data, uh, will be shared next year, um, including, uh, data at ADA in, in obesity and in for the BISMO, um, in terms of Q4, I mean, I think we are, we are expecting to see, um, it continue to perform in the way that a new standard of care does. I mean, 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 is the new standard of care. It is their go-to drug. for new patients. And so, I think we continue to believe very strongly in the profile of Vibismo, what Vibismo can do for patients. And as the US market corrects itself, we would expect strong growth next year.

Thank you very much.

Okay, I think with that, we are at the end of our Q&A session. Thomas, over to you.

Thank you very much, Bruno. And thanks for everyone attending today's call. As you've seen, our sales continue to be strong at 7%. Pharma continues to perform well at 9%. And diagnostics is starting to recover. So clearly, I would say we're delivering on the sales front, but not only in 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 feniprutinib and geradestrin. All, I would say, 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. But really looking in the pipeline more general, we have now moved 10 molecules into phase three. So we really rebuilt and shaped our late stage pipeline. We have up to 19 medicines that can launch by the end of the decade. So I think we've done really tremendous step forward in terms of our pipeline. So I'm quite confident in the long-term outlook for our company, but also you can see that our on-market portfolio is performing. On the diagnostic 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. So, and 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.