Roche Holding AG (ROG) Earnings Call Transcript & Summary

[indiscernible] webinar 2025. My name is Henrik, and I'm the technical operator for today's call. Kindly note that the webinar is being recorded. [Operator Instructions] One last remark, if you would like to follow the presenter's slides on your end as well, please feel free to go to roche.com/investors to download the presentation. At this time, it's my pleasure to introduce you to Thomas Schinecker, CEO Roche Group. Mr. Schinecker, the stage is yours.

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 at 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 health care 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 CHF 800 million impact, down from CHF 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 for Susvimo in nAMD. And we had several positive Phase III readouts. For example, the positive Phase III readout of evERA 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 III without for Tecentriq, a muscle-invasive bladder cancer. We had trial results shown from Phase III in vamikibart in UME and satralizumab. 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 5 additional Phase III decisions on top of the 4 previously announced at half year, so an overall significant progress in our pipeline. There is CT-388 in obesity, CT-868 in type 1 diabetes, zilebesiran in hypertension. Study has already started. Cevostamab in relapsed/refractory multiple myeloma and in HER2 tyrosine kinase inhibitor in HER2 positive breast cancer. Importantly, 4 out of the 5 came actually through partnership agreements in the last 2 years based on positive data, we are moving those forward. On the BD front, we've entered into an agreement to acquire 89bio with the potentially best-in-disease FGF21 analog in MASH. And this deal is highly synergistic with our CRM portfolio, providing further optionalities for combination therapies. We've also entered into an agreement with Hansoh Pharma to license the CDH17 ADC, which is currently in Phase I to be developed in colorectal cancer. On the Diagnostics 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 the primary setting claim, which is, I think, very important to identify patients and to bring them on therapy. Elecsys Troponin-T high sensitive Generation 6, but also the AI algorithm Kidney Klinrisk 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 PiaSky and several diagnostics launches still 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 a 9% growth rate. So very happy with that. Diagnostics growing 1%. I explained the numbers, given the health care 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. So overall, the group is at 7%. If you look at the growth rates over the last 2.5 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 health care 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 Phesgo 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. 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 evERA in Phase III, which represented at the ESMO. Polivy's 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. Hemlibra continues to grow strongly with full year growth now expected in the -- around 10% range. New and -- is also that the NXT007 data will be presented later at ASH. On the neurology side, and I know Teresa will talk about that as well. Ocrevus, Zunovo, we have now 50% of starts in the U.S. are new to brand, and Evrysdi is the #1 SMA treatment and keeps growing with more than 21,000 patients being on treatment. On the immunology side, Xolair continues to work to do well. We have a strong uptake now growing at 34%, and in food allergy, we now have 85 -- more than 85,000 patients on this medicine. The U.S. approval that we've received for Gazyva in lupus nephritis and we got also a positive CHMP opinion in Europe. We expect also the Phase III 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 assistance -- copy of assistance foundations. On the Diagnostics side, as mentioned, good growth in the overall business, the Core Lab being mostly impacted by the general health care 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. 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. If you look at just peak sales per pipeline project, we've increased it now by 57%. So before this prioritization, we had an average value of pipeline project of about CHF 800 million. We're now at CHF 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. What's really exciting is if we look at this slide, it's how many molecules have moved into Phase III this year. This is by far a record for Roche, and we are not even done with this year. So 10 moving into Phase III. And these are all molecules that will launch by the end of this decade. 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, cevostamab, also NXT007 in hemophilia A, received 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 project internally and the value in the business cases behind each of the project. You see where the projects lie for those assets that are pre bar, which are in the gray dots. And in the dark blue dots, you see all the assets that we moved into Phase III. 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 III 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 this. So you see the overvalue 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 2 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 pandemic and there will be a pandemic in the future, but we also see that it's 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 different phases of development, the ones that have moved through the bar and the ones that we are 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 afimkibart that we've initiated at Phase II study in a new indication, which is rheumatoid arthritis. This is a TL1A, where we will see the first readout in 2027, but not in this indication, but in other indications. Afimkibart, we've talked about the Phase III readout, where you can see the efficacy of the molecule giredestrant with a positive readout for evERA, Teresa will talk more about that. Divarasib, there's new Phase III for divarasib in adjuvant setting in non-small cell lung cancer. We've talked about the portfolio transitions of CT-388, CT-868 cevostamab, HER2 tyrosine kinase inhibitor, and giredestrant, 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. Pegozafermin is potentially best-in-disease FGF21 analog. Currently in 2 Phase III 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 clearly 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 the clinical chemistry and immunochemistry setting. Here, we are in the rollout and we will expect a full U.S. launch in 2026. Accu-Chek SmartGuide, 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 under 4 hours. So 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 CHF 1 billion-plus size of opportunity. So really exciting, and I believe this will really cement the future growth of Roche 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 Mass Spec, CGM, SPX, but I also believe very much with something like LumiraDx. 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. Corp 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 with -- which have less biosimilar erosion. 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. And 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, positive Phase III result 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 -- at the end of this decade will continue to contribute to future growth. So we believe we have set up 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 the 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 dividend in Swiss francs. With that, I hand over to Alan.

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 price 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, CHF 3.4 billion. And then you see the loss of exclusivity impact of minus CHF 474 million in total, a 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 CHF 800 million loss due to the loss of exclusivities. When you go to Diagnostics, also 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 CHF 517 million, 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. Yes. Let me get to the currency impact. And yes, we started the year quite well. Well, but now I think you see -- when you look to the left-hand side, the U.S. dollar has further 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 I said, I think certainly dominated by the U.S. 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 30 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, minus 8 percentage points impact on core operating profit and minus 8% -- percentage point impact on core EPS. You might remember, when you looked at this table at half year, we had for core EPS, minus 6 percentage points, and I think that's important. So that has worsened by 2 percentage points to minus 8 percentage points. And that has certainly 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 Teresa.

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 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. At our top brands, Phesgo, 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 contribution from all of our geographies to growth. Phesgo continues to be our #1 growth driver with Xolair our 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 CHF 11.6 billion, primarily driven by our HER2 franchise. Phesgo posted an impressive 54% growth year-to-date. We're very happy to see that, as Thomas mentioned, the global conversion rate climbed 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 Perjeta, the conversion to Phesgo continues and Kadcyla growth is -- 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-05, 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. 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 tale of around CHF 4 billion, and that's primarily Phesgo, around CHF 1 billion for Kadcyla in 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 II/III 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. Itovebi's launch in first-line PI3-kinase mutated hormone receptor positive breast cancer is ongoing and progressing as expected. Moving on to Tecentriq. Our sales gain overall stable for the -- at Q3 and for the full year, we expect the same. There were multiple positive events for Tecentriq in Q3 IMforte and first-line maintenance small cell lung cancer achieved U.S. approval. IMvigor011 in muscle invasive bladder cancer reported positive Phase III results and those data were presented at ESMO. And ATOMIC in 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 III KRASCENDO-2 study of divarasib 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 at the positive evERA results on the next slide. Over the weekend, we presented the evERA data at ESMO in Berlin and here are some of the highlights. As a quick reminder, 100% of patients in evERA 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 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 detected -- also showed favorable trends for PFS and OS with hazard ratios of 0.84 and 0.79, respectively. Taken together, evERA 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 evERA. EvERA 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 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 CHF 500 million plus in sales. Now let's take a look at our hematology franchise. The hematology franchise had strong growth of 15%, delivering CHF 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. 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 NXT007, our next-generation bispecific in Phase III development for hemophilia A. We look forward to sharing additional Phase I data with you in Q4. Next up, let's take a closer look at our malignant hematology portfolio. Polivy 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 2 percentage points versus Q2. We anticipate that Polivy will surpass CHF 1 billion in sales in the first-line DLB setting for the first time this year. Shifting to Columvi and Lunsumio, our CDK CD3 specifics, [ launch ] performance remains on track for Columvi in third-line DLBCL and Lunsumio 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, SKYGLO 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 subcu formulation is expected later this year. As Thomas mentioned, we took the decision to move cevostamab into Phase III 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 CHF 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 Zunovo in the U.S. As a reminder, the permanent J code for Zunovo was granted on April 1, and we do see some acceleration in Zunovo uptake as a consequence of that. It is important to remember that for many practices switching to Zunovo is associated with logistical challenges. We are hoping to manage those, and we expect Zunovo update 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 Zunovo 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 Ocrevus subcut is expanding the addressable market and can help overcome health care system constraints like IV capacity limitations. Overall, we now have more than 12,500 patients on Ocrevus Zunovo globally. We also presented the 2-year data for Ocrevus 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 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 CHF 9 billion by 2029, and this includes CHF 2 billion incremental sales from Ocrevus subcut. Staying with our MS franchise, we are eagerly awaiting the fenebrutinib results in PPMS with the Phase III FENtrepid 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 buy-in expected in Q4. Moving on to Evrysdi and DMD, we continue to believe in the risk-benefit profile for Evrysdi 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 for EU patient access following the negative approval decision. And lastly, Trontinemab, and AD, the final Phase I/II data from the 1.8 and 3.6 milligram cohorts were presented at AAIC. We have already achieved FPI for our Phase III TRONTIER 1/2 study in early AD. And currently, there are roughly 4,000 patients in the pre-screener 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 III 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 rate and reached CHF 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 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 CHF 800 million for full year 2025. A highlight of 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 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 then expect EU approval to follow later this year. We are also expecting to see the readout of the Phase III ALLEGORY trial for Gazyva in SLE in Q4 of this year. 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 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 it 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 CHF 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 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 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 Vabysmo's position as the standard of care. This is also supported by our 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 nAMD, 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 3 Phase III readouts for vamikibart in UME -- I'm sorry, we had 2 Phase III readouts for vamikibart in UME and satralizumab and thyroid eye disease with data presented over the last few days. So let's take a closer look at both. Starting with the vamikibart results in UME, which we presented earlier this week at AAO. The Phase III 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 the proportion of patients with greater than 15-letter BCVA gain. MEERKAT met this endpoint, but SANDCAT did not. However, let me emphasize 2 points. In both studies, a numerically higher portion of patients treated with vamikibart gained vision. The miss for SANDKAT was primarily driven by 1 patient in the 1 milligram vamikibart cohort. It is our belief that the totality of the SANDKAT and MEERKAT data support the use of vamikibart in UME. Vamikibart 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 III SatraGO-1/2 at ASOPRS a few days ago. The Phase III 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 in 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 satralizumab 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 vamikibart, 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 on the next slide, 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, so just very quickly, as you know, we are moving CT-388 and zilebesiran into Phase III trials. Zilebesiran Phase III ZENITH has already achieved FPI. Additionally, CT-996 achieved FPI for a Phase II study and announced today, we will be moving CT-868 into Phase III for type 1 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 II 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 pegozafermin, our new Phase III asset in MASH. For those following the field, it is important to understand that not all FGF21 analogs are the same. Pegozafermin 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 pegozafermin 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 II data, which we also presented at Pharma Day. And in short, pegozafermin 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 pegozafermin. There are 2 Phase III trials currently ongoing, 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 pegozafermin 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 fenebrutinib in PPMS. And with that, I will turn it over to Matt to walk us through Diagnostic slides.

Okay. Thanks, Teresa. 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 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 health care pricing reform in China, which include the implementation of Diagnostic-related groups, which affects volume and volume risk 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 USA 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% and 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 health care 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 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 continued investment in innovation, starting with our AXELIOS 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, team is at the Broad Clinical Labs as well as Boston Children's Hospital conducted an 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 sample, HG002, the team sequence and analyze the whole human genome in less than 4 hours, achieving the world -- the Guinness world record for sequencing. I would like to add that all runs were completed in less than 5 hours from DNA to variant calling. And for the prospective samples, the results were clinically optionable 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 AXELIOS 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 2 specific examples. So as we've said, since we unveiled the AXELIOS 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 SBX for methylation. So this is an internal workflow we developed utilizing taps, which generates direct conversion of 5-methylcytosine to thymine basis paired with our SBX-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 SBX for methylation is directly comparable to the standard SBX-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 collaborators at the Welcome Sanger Institute analyzed a 90 sample cohort melioidosis 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 for Elecsys pTau181 for which we received CE Mark 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, 2/3 of people experience cognitive symptoms remain undiagnosed. Diagnosis takes nearly 3 years on average after symptom onset and relies on subjective cognitive tests as well as expensive imaging analysis. Our pTau181 will offer a minimally invasive blood-based solution to roll 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 blood-based -- second blood-based biomarker for Alzheimer's disease, Elecsys 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 tests that's under development. Now 2 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 going to 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 pTau217 to an internally developed PTL217-AB42 ratio assay. Now this study included patients from 5 cohorts, representing patients across the Alzheimer's disease continuum. And as you can see, the pTau217 isoform by itself demonstrates superior robustness to the ratio test, which is a commonly used approach in other competitive assays. 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 U.S. integrated health care network. This study encompass nearly 2,000 individuals and the interim results, which you see here, showed the area under the curve for the Elecsys pTau217 achieved the highest accuracy amongst the multiple pTau217 methodologies that they evaluated. So when you take these in aggregate, these study results support broad implementation of Elecsys pTau217 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 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. So with that, I'll pass it over to Bruno.

The Q&A session. So the first question goes to Richard Vosser from JPMorgan.

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 Ocrevus, 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 further, but I think I'll stop there because -- we'll stop there.

Great. So I think when you think about the logistical challenges for Zunovo, they're not that dissimilar than from what we saw with Phesgo when we were moving Phesgo 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 -- 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 in to the flow of how to work with Zunovo. 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 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 Zunovo. 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 now. 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 Briumvi or Kesimpta would have been initially a choice. Now they're really migrating towards beginning to migrate towards Zunovo. 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.

Yes, it's up to 1,000 milligrams.

Sorry, up to 1,000 milligrams. Sorry, Thomas. Thank you.

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

No, perfect.

Okay. Then we move on and next questions go to Simon Baker from Redburn.

Two, if I may, and just continue on Rich's question on Ocrevus. If I look at the trends in the U.S. and I look at the CHF 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 U.S. opportunity here. If one looks at the IV subcut conversions you've seen elsewhere, it feels like we may be underestimating the ex U.S. opportunities. So any thoughts on that would be helpful. And then just on news flow more generally, it's obviously not unusual this time of the year to see a few '25 events shift into 2026. You've shifted 6 on the latest slide. I just wondered, 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 was particularly thinking about CT-868 and CT-996. So any thoughts on that would be very helpful.

Sure. So I think with regard to the news flow, 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, where all of those trials will be placed into ADA. And so 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 [indiscernible] shifted for competitive reasons. So 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. 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 U.S. is the expanding into community neurology settings and opening up those -- 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 U.S. market that Zunovo 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 Ocrevus Zunovo to patients is extremely compelling. To be able to deal with your MS twice a year, 10 minutes, that's a pretty compelling -- that's a pretty compelling value proposition. And so we really think as physicians and practices get more comfortable in the U.S. with how to use Zunovo 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 U.S. market as well. Again, for the specific reason that you mentioned is that IV capacity can be more limited in some of those health care systems and for something like Zunovo 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 very encouraged with what we'll see with Ocrevus next year. And a big part of our confidence in that is why we raised the guidance to CHF 9 billion at Pharma Day.

Then we move on. Next one is Michael Leuchten from Jefferies.

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 the U.K. company reach an agreement with Trump. I guess everybody is waiting to see what happens next, just your perspective would be very helpful. And then a question for Teresa. On the HER2 franchise. It looks like in the U.S. this quarter, the combination of the HER2 revenues took a dip. So Phesgo 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 around the tail and the dynamics, but the quarter seemed a little bit soft in the U.S.

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. So 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 HER2 franchise in the U.S., there isn't anything in the underlying dynamics of that business that is particularly -- that stands out in Q3. It's not something that we're worried about at this juncture.

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 strong growth. So I think this is more like order patterns quarter-over-quarter. Nothing and no trend change here. All your questions answered?

Yes.

Yes, then let's move on. And next question go to Luisa Hector from Berenberg.

So just on the oral side for Teresa, just any comment on potential positioning of evERA 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 evERA 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?

Great. Thanks, Luisa. So in terms of where we would be expecting to position giredestrant based on the evERA 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 we have always had confidence that giredestrant was a targeted potent combinable tolerable SERD that actually had the opportunity to potentially redefine a new backbone therapy in this area. And I think what evERA 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 giredestrant is really playing out incredibly well, particularly given that there's -- we didn't see any ocular talks. So I had the privilege to be at ECTRIMS -- I'm sorry, ESMO to spend some time there over the weekend and really talk to physicians. And I would say that sort of everybody that we talked to really felt like the evERA 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 I think we're overall, more encouraged. These are still relatively high-risk trials because of the -- just the nature of the disease. But I think we're very encouraged by what we've seen with evERA. We've always had a lot of confidence in this molecule as a stand-alone molecule. And now we get to wait to see how the trials play out.

Luisa, does this answer your questions?

Yes. Thank you.

Then we go on. James Quigley from Goldman Sachs.

I've got 2, please. So 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 digit 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 3 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 2 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 second reason is the exit rate into 2026. And then second one 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? 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 very much for the question. So I'm not at all concerned about Q4 growth. When I said that 7% is included in 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, yes, 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 CAF's, 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 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 CAF's 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 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 Vabysmo.

James, did this clarify the outlook?

Yes, it does.

Okay. Then next question go to Sachin Jain from Bank of America.

Just a follow-on question to some of the topics already touched on. So firstly, on the Vabysmo lower 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 8, Thomas, that you sort of talked about 7% to 8% sales growth for the last few years, is that sustainable? And I guess the question really homes 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? And then last clarification on the U.S. administration question was already asked. Just I wonder if you were 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?

Thanks for the question. So I'll take your questions in the opposite order. So 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, Xofluza DTP was something that we also discussed with the U.S. government. So 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 it 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 a continued good momentum. And so we feel comfortable that we will also be showing good growth next year.

Okay. And so Sachin, I think your first question was it on granularity of what's going to happen with Ocrevus in 2026? Or would it -- what happened and what did we think was going to happen with Vabysmo in Q3...

Apologies, It was Vabysmo lowered guide. What hasn't happened that you thought was going to happen?