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.