Roche Holding AG

Ladies and gentlemen, welcome to Roche's third quarter sales webinar 2024. My name is Henrik and I'm the technical operator for today's call. Kindly note that the webinar is being recorded. I would like to inform you that all participants are in listen-only mode during the call. After the presentation, there will be a question and answer session. You are invited to send in questions for this throughout the entire session using the Q&A functionality of Zoom. In addition to that, you may also raise your virtual hand to address your questions verbally. For participants joining via phone, to raise your hand, use star 9 on your phone's dial pad. When you then get selected to ask your questions, please follow the instructions from the phone and press star 6 to unmute yourself. One last remark, if you would like to follow the presented slides on your end as well, please feel free to go to roche.com slash investors to download the presentation. At this time, it's my pleasure to introduce you to Thomas Schieneker, CEO of Roche Group. Mr. Schieneker, the stage is yours.

Thank you very much and good morning, good afternoon, wherever you are. I'm extremely excited to share with you the very strong Q3 results with you today. Again, very strong growth in this quarter. Now, year-to-date group sales are at plus 6% at constant exchange rates, really driven by a strong base business growth of 8%. The COVID effect is still from Q1. In fact, in Q2 and Q3, we had no COVID effect, and both quarters were growing 9%. So overall, pharma doing well with 9% and diagnostics with 8% growth in the base business. So this is a momentum that will carry us forward into the fourth quarter, but also into next year. The COVID-19 sales decreased by roughly 800 million, and the LOE impact was also about 800 million, and both are in line with guidance, and I'll make more comments about that later in the presentation. Q3 was also a very strong quarter in terms of portfolio progress on the pharma side, with five regulatory approvals of medicines, three positive phase three readouts, and two acquisitions. The five regulatory approvals you see here, one is the U.S. approval of ITOFB, and ITOFB was approved six weeks ahead of schedule, so really also showing how convincing the data was. Beyond that, we had OCRABOS subcut, eccentric subcut approval in the U.S., EU approval for the Weissmoor in retinal vein occlusion, and PSKI in PNH. On the pharma readouts, we had positive, three positive readouts. I would like to highlight Gaciva and lupus nephritis, devastating disease where there are not many very good treatment options. And here with our CD20, we have an opportunity to deliver really a new medicine for these patients. On the diagnostic side, we had two important approvals. One is the respiratory reflex. This is based on a tax technology that we have developed which enables, in this case, 12 different viruses to be detected in a single sample, in a single test, and also the COPUS Pro serology solution, which enters us into the U.S. market for blood banking serology, which is the biggest market in the U.S. And in a lot of parts of the world, in Europe, we've actually gained massive amounts of market share. So I'm really hopeful that we can continue this momentum then also in the U.S., I already mentioned two deals. One is the CDKI portfolio from Riga Therapeutics. The other one is the WINT portfolio, which is a very important pathway in ophthalmology, but also other diseases for antler A. And we closed the Lumira DX deal, which has a very innovative technology in point of care, which we really look forward to bringing to patients around the world. There will be some new flow in this year. I would like to call out the SkyOne data that will come still this year, the TransCinema data, and the PRASI data. We have still some exciting launches ahead on diagnostics with the mass spectrometry, the I601, fully automated, which will come still this year. The next version of COVA6800, 8800, which, as we know, played a significant role in the pandemic. And here we have the next update, which will be launched this year. Again, here just looking at it from a divisional perspective, you can see the sales including and excluding COVID, but really fantastic momentum in both divisions that will continue to drive growth also into the future. Here on the left-hand side, I've shown the slide multiple times now, you can see the group sales development over the last four and a half years. On the right-hand side, you see the development if you exclude COVID. And this is relevant because the COVID effects will not play a significant role going forward. Now, there is one effect in Q4 that I just want to highlight, which is on a diagnostic side. There was a rapid antigen order in Q4 in 2023, last year, and that was roughly around 300 million And so we'll see that impact in Q4, which is approximately 2% of our sales. So not major, so it's something that we can digest. But as we look into 2025, there will be zero impact for us on the COVID side. Here you can see the quarterly development on the pharma and diagnostic side. On the pharma, we see really an acceleration over the last one and a half years into high single-digit range. On the diagnostic side, continuously very good growth between 7, 8%. So we believe we can also continue with a good momentum going forward. Matt will surely talk a little bit more about the last quarter and some impacts in China. But given the new products that we're launching, we're confident also about the outlook in diagnostics. Here you see the key growth drivers of the Roche portfolio in the quarter. And going forward, it has to be clearly the U.S. approval in the U.S. The U.S. approval is very positive for us. We look forward to getting an approval in Europe next year. I already talked about the centric subcuts, that approval. And Libra, we continue to gain market share now climbing to 42%. We also have a phase three enabling readout for the next chain biospecific called NXT-007, which is expected in 2025. On the neuroscience side, we already talked about the U.S. approval for Okvo Subcut, and also Elevitus is really starting to accelerate with more than 100 million in sales just in the last quarter. Then going to the left-hand side, going to Xolair, here, again, we see a very strong pickup of Xolair for food allergy with already more than 30,000 patients on treatment, and we don't expect any biosimilar launches in 2025. On the voivod side, and I know Theresa will comment on that as well, we see a very rapid conversion to the pre-filled syringe in the U.S. And for Susvimo, we're talking several hundred implants in 2024. Diagnostics, we talked about it, very strong base business growth and significant launches that have happened and that will continue to come up. Now, going to the outlook, again, this year, we have launched two new enemies with P.S. Guy and Itofi. And as you can see on the right-hand side, now the new And Young Portfolio, that's very innovative and that's going to carry us into the next years, is now making up 56% of our overall farmer sales. So very good momentum with the new products. Here are the key opportunities for growth beyond 2025. Let me just comment on a couple. First, ITOFBI with the EU approval that we're expecting next year. The Evrisby GYM329, readout that we're also expecting next year, and the recent data from ScholarRock also is quite exciting for us in this regard, and so let's see what will come out of that. Phenobrutinib, we presented at ECTRIMS the phenopt open label extension showing near complete suppression of disease activity and disability progression for up to 48 weeks. Again, I think a good indicator here. We talked about the positive phase three. We're now going to talk to the regulators about these results, and we hope to file next year and get approval as soon as possible. For anti-TL1A, we started phase three trials in UC, and also we will start soon the Crohn's disease phase three trial. There will be additional information on further trials to be shared in the first half of next year. We expect the readout in 25, and I think we've given plenty of updates on our obesity portfolio, which we continue to believe in very strongly. On the diagnostic side, I mentioned the CoBOS Pro serology solutions. This is a product that we've had on the market outside of the U.S. for quite some time. and have gained a lot of market share in this space. Now this is a completely new market opportunity for us in the U.S. because we've not been on the market. Now we've received FDA approval, and so we can gain some momentum there. I talked about the respiratory flex test and the Lumiere DX opportunity as well. So overall, I think we can say 2024 is a very good year for us. We continue to have very strong base business growth. And we believe this will continue in Q4, but also into next year. We do expect the full year COVID-19 sales decline to be 1.1 billion. So the 300 million effect you'll see in the fourth quarter on the diagnostic side, which was a rapid antigen order last year. And we also believe that we'll have to see what really happens in Q4, but we believe there will be some acceleration in terms of LOE impact in Q4 because of Actemra by similar factors. Finally, let me reiterate the guidance which we have raised at half-year on the earnings per share group, sales growing mid-single digits. And I hope you understand also with the COVID effect in Q4, you know, why we believe it will be in the mid-single digit range. We have very good cost discipline. So we are confident in achieving our core EPS growth, and with that, we will further increase dividend in Swiss francs. With that, I hand over to Alan to take you through the financials in a bit more detail.

Yeah, thanks, Thomas. And today is a sales call, so I will be brief. So hi to everybody. It's great to see you. As Thomas said, I can fully agree. I think great performance in Q3. Would like to thank everybody who has contributed to this and certainly foremost the employees. We have really done great things for patients. So let's jump into it. First, a little bit of advertising. I think you get used to this in the meantime. We have really done seven investor events this year. You see that on the lower part of the slide. And we will have two more that are highlighted on the slide. I think really next week we will have a urology event focusing on our Alzheimer disease pipeline, and that's phase one, phase two, Trontinumab data, which we will present at CTAT. And what does that include? I think it includes new data from part one. It includes the cohort four at 28 weeks, and we'll show initial data from the ongoing expansion cohorts in part two. So it will be exciting. Please take a look at it. And then I think we will close the year at November 25th with the digitalization day. And this will be around really using AI and using digital really in R&D development, especially more on the early side. So Aviv Regev will present and you will see especially the use case lab in the loop. Good. With that, let's go into the numbers. I'm not going to talk a lot about the sales because Divisa and Matt will surely cover that masterfully. We have achieved good sales growth, as you've heard from Thomas, in both divisions. And you see that on the left-hand side. When you put it together, you get to the plus 6% at CER, which you see in the middle of the slide. And then you see on the right-hand side the impact coming from currencies, which is minus 4 percentage points, leading us to a growth in Swiss francs of 2%. I think that's a perfect segue to the next slide. So keep the minus four percentage points in mind. So here you see now on the left-hand side, the plus 6%. On the right-hand side, the plus 2% in Swiss francs I've talked about already. And then you see really the major impacts from currencies in the middle. And I think it's pretty evident in our case the U.S. dollar has the highest impact, followed by the Japanese yen, the Chinese yuan in APEC, and certainly the euro. Good. Leads me to the point, okay, what can we expect for full year based on a relatively trivial model that we're following? On the left, let me first say you can see the 2024 average currency rates remain below 2023 for both the U.S. dollar and the euro, which means there is additional impact. And when you then go to the right-hand side and you know what we're doing there, we keep the currency rates end of September 2024 stable until the end of the year, and then look at the impact. And you see really for Q4, we expect a minus 5 percentage points impact. When you then look at year-to-date, full year, if you like, as a full year in total, we expect a minus 4 percentage points, a minus 6 percentage points on cooperating profit, and a minus 7 percentage points on core EPS. I think what is a bit encouraging, I think if you look at 2025 and you do the same thing and take today's currencies and keep them stable, really, over the period of 2025, we would have on sales an impact of minus 2.4 percentage points. Certainly, this is very, very speculative. We will see what's going to happen. But, well, you see really what we guess we will end up with. Certainly, I think as we now progress to year end, this is much more stable compared to the previous quarters. Good. With that, let's go once again to the guidance. And I think Thomas has said a lot. Let me be specific about the core EPS growth because the impact from the resolution of tax disputes in 2023 was a minus $774 million. I think that's important. In the year itself, plus $774 million for 2024. It's a minus $774 million. I think Thomas talked about COVID, the COVID sales, the $1.1 billion. He talked about the loss of exclusivity impact of minus $1.4 billion, which looks conservative at first sight, but includes September. And I'm sure Theresa makes a comment about it. And then I think to be very clear what have been the COVID sales Q4 2023. That was, in diagnostics, 337 million, and in pharma, 5 million. That's why we are going with the rounded numbers of 300 million approximately, but the Q4 2023 numbers are a fact. That's why I mentioned them. I think we also saw it's perhaps also interesting to make a comment about 2025, and certainly we're not giving any guidance here at this stage. We will do that at our full year press conference, but when we look into 2025 and what we know now, We consider the current growth rates for 2025 that we find in the consensus for sales as well as for core EPS reasonable. That's what we can say at this stage. It looks okay. It's something that we can achieve with. There's still a lot of stuff which is going to happen, and we will change that picture potentially. And especially on the core EPS side, because very clearly M&A will play a role and how much debt we will have on the balance sheet plays a major role here. So I think we feel okay with the consensus, looks reasonable at this stage. But still, I think there are lots of things that can move around. Good. And with that, I think I hand over to Theresa.

Great. Thank you so much, Alan. Okay. So year-to-date, pharma delivered 7% growth at constant exchange rates, reaching 34.3 billion Swiss francs in sales. Excluding Rana Preve, we achieved 9% growth at constant exchange rates. All regions, excluding Japan, showed strong growth. I think we can all understand that sales in Japan were impacted by a base effect of about 600 million Swiss francs in Rana Preve sales in Q1 of last year. Excluding Rana Preve, Japan declined at 3% at constant exchange rates, and that's primarily due to mandatory price cuts. Overall, pharma volumes were up by 14%. Our young best-in-disease portfolio continues to deliver strong growth, led by our innovative brands, Bobizmo, Fezgo, Okravis, Hemlibra, Polivi, and Rizzi. Together, they added about $3 billion at constant exchange rates and new sales so far year-to-date. Bobizmo and Fezgo maintain impressive growth trajectories, continuing to exceed market expectations. And as Thomas noted, Elevitis makes its first appearance on this chart. In Q3, it has now launched in six countries outside the U.S. and has already generated sales of 137 million so far this year in our international region. So with that quick overview, let's start taking a deeper dive into our individual therapeutic areas, starting with oncology. Oncology sales increased by 2% to 11.9 billion Swiss francs in the first three quarters of the year. In terms of key news, We're very excited that ITOVB, also known as Invalisib, received U.S. approval in September for first-line PI3 kinase-mutated hormone receptor-positive breast cancer. That is, as Thomas mentioned, more than a month ahead of the PDUFA date and was really based on that strong ANOVA 120 data that showed a doubling of PFS. ITOVB approval was our first step towards expanding our breast cancer franchise into HR-positive breast cancer, and as you heard at Pharmaday, We have a broad and innovative development program in this area that we recently augmented via the Rieger deal that added CDKI portfolio to our pipeline. I'll expand on both ITOBI and the Rieger deal in the subsequent slides. But before we move on, let's take a quick look at our on-market HER2 franchise. Again, the HER2 franchise outperformed market expectations, Capsaicin delivering 6% growth and Fesco 58% growth year-to-date. The FESGO global conversion rate continues to climb, reaching 43% in Q3. That's up from 41% just last quarter, and this positions us extremely well for a conversion rate of more than 50% by 2026. Moving on to Ticentric, there were two Q3 developments that we'd like to highlight. So, as Thomas mentioned, the subcutaneous formulation received U.S. approval, and we are also very happy to report that we had positive Phase III data, the INFORTE trial, in Ticentric. Extensive stage small cell, which further underlines the strong clinical profile of ticentric in small cell lung cancer. And finally, before we move on, regarding the outlook, I just want to confirm that we continue to expect the Skyscraper 1 final OS results for tiragolumab by the end of this year. So moving on to breast cancer, the atopia approval in the U.S. not only came earlier than expected, but we were also granted a very strong U.S. label. All endocrine-resistant patients are included, not only those developing endocrine resistance within 12 months of endocrine therapy. We expect EU approval in the first half of 2025, and we look forward to making this transformative medicine available to more patients. I'm also pleased to share that ITOPI received Chinese breakthrough designation and priority review. As you can see at the treatment paradigm on the right hand of the slide, the additional studies with ITOPI will expand the addressable patient pool within PI3 kinase mutated hormone receptor positive breast cancer. With ANOVA 120, 121, 122, and 123 combined, we are convinced that ITOVI has a peak sales potential of more than 2 billion in HR-positive breast cancer alone. And please remember, beyond these trials, we are also actively looking at other tumor types where PI3 kinase mutation plays a significant role. This slide on the left also highlights our on-market portfolio and in-development breast cancer portfolio. For those of you who joined us at Pharma Day, you will recall that breast cancer is perhaps our furthest along end-to-end disease area, with both a strong on-market presence as well as an ongoing expansion into hormone receptor-positive breast cancer. And while you're very familiar with our oral Sorgiridestrin, which we do expect Phase III data in next year, I did want to talk a little bit more about the CDK test, 4-2 portfolio that we acquired with Regor. So we're extremely excited about this addition into our breast cancer portfolio. The lead asset from Regor is called RGT419B, and it's currently in Phase 1. As you can see on the slide, RGT419B is a highly potent CDK inhibitor that also inhibits CDK. Importantly, currently available CDK inhibitors do not show a significant activity against CDK. and we believe that this MOA may help set RGT419B apart from currently available options by addressing a key mechanism of resistance. While the molecule is currently completing its Phase I trials, we're already moving rapidly to think about ways to expand it into other development options, and this will include Phase II combinations with endocrine therapy, but importantly also combinations with ITOV-B in hormone receptor-positive breast cancer as well as in combination with gear destrinate. We're very excited for the potential that this portfolio recommends, that this portfolio brings, including the Phase I-ready RGT587 molecule. And we're excited to continue to provide you updates and to bring these to patients with urgency. Moving on to hematology, we had a strong growth in hematology of 12% in Q3, and we now stand at 5.8 billion Swiss francs in sales. So let's start with HemLibra. Hem Libre U.S. EU5 patient share has further increased to 42% this quarter, and we've now treated over 27,000 patients globally. We saw a very strong U.S. Q3 performance due to a buying pattern reversal that had negatively affected us in previous quarters. We can now confirm that the MPS trends are back on track and that we are looking at the low to mid-single-digit sales growth for the U.S. for a full year that we had talked about at the beginning of 2024. At the same time, we remain on track to achieving mid-single-digit growth globally in 2024 for Hemlibra. Quite exciting, I think, is also our follow-on next generation bispecific in hemophilia A, NEXT-007. We did share some preclinical data at Pharma Day that gives us confidence in NEXT-007's potential, specifically the potential to achieve zero treated bleeds without the need for Factor VIII treatments. So please stay tuned for the Phase 3 enabling Phase 2 data, which we expect we'll read out next year. So switching over to malignant heme, Polivi's launch keeps on reaching new milestones. We now have 35,000 patients treated globally, and U.S. patient share in first-line DOBCL has climbed to 28%. I'd like to highlight that we will be presenting five-year OS data for Polivi and first-line DOBCL at the upcoming ASH conference and oral presentations. In addition, the launches for both of our biospecifics, Columbia and Luzumio, are on track and progressing as expected with strong uptake in their initial indications. Additionally, there are some important regulatory updates for both that I wanted to share. Columbia's positive Phase III StarGLO results and second-line DLBCL have been filed with global regulators, and we're excited about the potential of moving Columbia into earlier lines of therapy. And for Linsumio, the positive results for the subcutaneous formulation and third-line follicular are expected to be filed later this year in the U.S. and the EU. This new formulation builds on the benefits of the available IV formulation, including the need for no hospitalization and a fixed duration of treatment, but is expected to ease administration and has the potential to require less steroid use. We are excited to bring subcutaneous formulations to patients, and we believe that the combination of moving linsumia to earlier lines of treatment in follicular lymphoma and DLBCL with data that we'll be expecting next year, in addition to the subcut formulation, can really help realize its full potential. So now let's move on to neurology. Our neurology franchise continues to deliver strong growth of 14% at constant exchange rates, achieving $7 billion in sales by Q3. Ocrevus's strong growth momentum continues at 9% driven by all regions. Furthermore, the Ocrevus Zenovo subcutaneous formulation achieved approval in the U.S. after receiving its EU approval last quarter. Zenovo offers all of the benefits that we've come to expect from Ocrevus in terms of a strong clinical profile and every six-month dosing while further easing administration burdens. We're confident that this is going to expand Okravis' footprint in the MS market and that we will see Zenovo as an incremental $2 billion sales opportunity. Already, we're seeing very promising first signals about the uptake of Zenovo in the U.S., with about 80% of our new patients' starts beginning on Zenovo being new to brand and not switches from Okravis IV. We expect this strong momentum to persist into the last quarter, meaning high single-digit growth for Okravis for the full year. MS, as you know, is one of our end-to-end disease areas, and therefore it's also great to see the progression of our oral BTK phenobrutinib is making good progress. We see, as I believe Thomas mentioned, positive data from the Phase II phenoptis study was presented at ECTRIMS showing near-complete suppression of disease activity and disability progression for up to 48 weeks. And as a reminder, the ongoing Phase III trials are expected to read out in 2025. Moving on to SMA, Evrizdi had strong year-to-date growth of 21%. It remains the global market leader for SMA with more than 16,000 patients treated. As expected, Q3 came in a little softer than Q2, and this was due to a one-time tender effect in the international region that we mentioned last quarter. We also showed the two-year rainbow fish data, which was presented at World Muscle, and showed sustained efficacy in safety in newborns with pre-symptomatic SMA. Going back to Elevedes, the first approved gene therapy for DMD has now been used to treat in more than 50 patients, XUS. And let me just say, this is such an amazing milestone. These boys and their families are in so much need, and it's really tremendous to see how quickly we've been able to get Elevedes to patients. We also recently presented muscle MRI outcomes from the Phase III EMBARQ study at WorldMuscle, and the results are consistent with the benefits seen for the EMBARQ functional secondary endpoint. So, continuing to see a good body of evidence building up for elevetes. On the outlook, there are three key items to cover here in neurology. For trontinumab and AD, the updated Phase I-II data will be shared at CTAD. So this data set will contain safety data for an additional 100 patients from the extension cohorts and longer efficacy and safety follow-up for the first 60 patients, which had originally been presented earlier in the year at ADPD. As communicated before, we expect to have sufficient data on trontinumab and AD by the first half to make a decision on taking this molecule into physical phase three trials. And as Thomas, I'm sorry, as Alan mentioned, there's also an IR event at CTAD on the 31st that we would encourage you to join. The phase two pidover readout for PRASI is also expected in Q4. And as a reminder, we consider this high risk but also high reward. And also, the interim readout for the phase 2 of RISD plus GIM 329, which is our anti-myostatin and SMA, was moved into 2025, as was communicated in Pharma Day. But again, with the new data from Scholar Rock, I think we remain excited about what that trial could show. And so with that, let's move on to immunology. Total half-year sales for immunology reached $4.6 billion, which represents a 1% increase in constant exchange rates. As Thomas mentioned, a key highlight is certainly the positive Phase III data here for gaziva and lupus nephritis. The study met the primary endpoint of complete renal response, demonstrating superiority over standard of care. We will be sharing these results with global health authorities in the near term. And beyond lupus, gaziva is also in development for many other diseases of the kidney, and there are three Phase III trials in SLE, MN, and INS. with the SLE data expected in 2025, and that study just recently achieved LPI this quarter. Equally exciting is the ongoing launch of Zoller in food allergy. I think we shared with you how bullish we were on Zoller's opportunity to have a strong impact on families facing food allergies. We now have roughly 30,000 patients on treatment for food allergy, and Zoller achieved an overall Q3 growth rate of 12%. We do expect further growth acceleration in the remainder of 2024. And for 2025, this growth momentum is expected to continue to deliver a year-over-year growth rate for Zoller in the mid-teens. And as Thomas mentioned earlier, we do not expect a U.S. biosimilar launch in 2025. For Actemra, you will notice that we are continuing to grow 5% year-to-date. That's driven by sales and the chronic indications. At the same time, we do know that biosimilars are coming for Actemra and the launches in the U.S. and the E.U., We're frankly just slower than we're expected, and that's not only by us. I believe that's by the market as well. And last but not least, let's quickly talk about our anti-TLNA and immunology. This quarter, we initiated the phase three trials in UC, and we expect to initiate the phase three Crohn's trials in the Q1 of next year. And as Thomas mentioned, we are also working on starting additional trials in the syndication, which will be announced in the beginning of the year. Up next is the Ophthalmology franchise. Performance here continues to be strong, with the franchise reaching 3 billion Swiss francs in sales with an impressive growth rate of 47% at constant exchange rates. The franchise is led by Vibismo, which continues to expand its U.S. market shares. Compared to last quarter, the AMD shares increased by 3 percentage points to 30% in DME, 3% – I'm sorry, the AMD shares increased by 3% to 30%, DME 3% to 22%, and RVO by 5% to 20%. At the same time, we see that our new-to-brand share is about 50% naive patients, which is up from around 40% in earlier quarters. There's still more growth to come. In September, we launched our next-generation pre-filled syringe in the U.S., and already we're seeing about 80% conversion, clearly indicating that HCPs are very eager to to use this simplified one-handed administrative option. We're working to bring the pre-filled syringe to the EU as well. Our filing is currently ongoing. Moving on to SysVimo, our AMD commercial relaunch in the U.S. is underway. And let me give you an idea how we're tracking progress with SysVimo because I think this comes up quite a bit. The way we think about it is that in 2024, we're targeting several hundred implants. In 2025, we're targeting several thousand implants. And in 2026, we target a range of roughly about 10,000 implants. Focusing on driving implants at this point in the launch is really the goal because that sets patients up for actually getting therapy going forward. And already we can see that patients that have one implant are highly interested in getting one for the fellow eye. About 50% of our new implants since relaunch are actually for the fellow eye. In terms of outlook, the phase two readouts for RemicciBart, as we mentioned at Pharma Day, are now in 2025, and this will help inform our future development. And this completes our look at our on-market franchise. But, of course, there is one key in-development franchise that we certainly would like to highlight. And here I wanted to share our continued efforts to strengthen our pipeline in obesity. This is a slide you saw at Pharma Day a couple of weeks ago, and you've also heard a lot of detail about the obesity pipeline at EASD. So I'm only going to briefly touch on a couple of details here. In Q4 of this year, we expect additional Phase I data from CT388 from Cohort 13 and Type 2 diabetes in patients with obesity. This data is expected to be overall confirmatory and as such is planned to be presented at a conference in 2025. Beyond this, no further readouts are planned for 2024. For 2025, the focus is on early Phase II data for CT868 and type 1 diabetes, as well as additional Phase I data for CT996 and type 2 diabetes. So now let's take a step back and take a high-level look at the pipeline overall. So here I just want to highlight our continued efforts to strengthen the pharma pipeline. You saw this slide in my half-year presentation, and in Q3, again, we had some turnover in the NME side. We removed eight NMEs, three in oncology, one in neurology, four in infectious disease, and one in immunology. One of these is what we would call a happy removal. PSKI has been approved to PNH, so it's no longer an NME in our pipeline but moves over to our on-market portfolio. And on the other hand, three NMEs were added, two in oncology and one in neurology, and this includes the Phase 1 CDK for MIGOR as well as an LTB-R antagonist in solid tumors. So as we prepare to wrap up, let's have a quick look at our 2024 key news flow slide. You can see here that we've added quite a few green checks since what we showed at half year, and we've added some additional 2024 news flow below the table. All the new entries in the table and below it I've covered on previous slides, so I'm not going to rehash here, but let me just quickly remind you that the one phase three readout that we are awaiting in 2024 is the final OS readout for tiragolumab and first line non-small cell, and then the additional data for Prazi and Tronti. And one last quick slide before I hand over to Matt. Here we have the expected news flow for 2025, which we also shared at Pharma Day. And there are quite a number of long-anticipated regulatory and clinical events that are anticipated in 2025. I'm just going to highlight a few of them. The Ghirardestrin at Phase III results in first-line HR-positive metastatic breast cancer. Linsumio and Polivi in Phase III readouts in second-line DLBCL. The Okravis high-dose Phase III in MS. the Fetabrutinib Phase III NMS, the Astegolamab Phase III and COPD. These are all significant potential market opportunities and potentially game-changing for their therapeutic areas. And we also have multiple Phase IIs reading out, which will enable Phase III decisions. That includes Tronte, which we've talked about before, Nex007 in hemophilia, and Zeld-Bistron in uncontrolled hypertension. So I'm sure you can understand that we're very much looking forward to next year and sharing with you along the way the results of all of these important trials. But for now, I'm going to hand it over to Matt to take us through the diagnostic section.

Thanks, Teresa. So it's my pleasure to present the Q3 Diagnostics Division sales results. And let me start with the year-to-date top line. So with sales of 10.72 billion Swiss francs, the Diagnostics Division increased at 5% or 0.6 billion Swiss francs at constant exchange rates compared with year-to-date September 2023. Now, this increase is mainly driven by the strong base business growth of 8% and partially offset by the decline of COVID-19 testing sales. So for 2024, as I've said before, we have an ambition for mid to high single-digit base business growth, and I would continue to reinforce our confidence in the base business performance and in achieving this ambition. This is an ambition we will carry forward into 2025 as well. And so as you heard from Alan and Thomas, I would call out that in Q4 2023, we did have a government order of COVID-19 rapid antigen tests that will not repeat in Q4 of 2024. So with that, let me walk you through the sales results by customer area. So sales in our core lab increased at 9% with strong momentum driven by immunodiagnostics at plus 10% and clinical chemistry at plus 8, as well as custom biotech at plus 5. Our molecular lab had an increase of plus 4% due to strong growth in our virology-based business at plus 12, and our molecular blood screening business at plus 15%. This was offset by lower COVID-19 PCR lab-based testing sales. However, excluding all COVID-19 sales, our molecular lab grew strongly at plus 8%. Now, our new customer area, near patient care, had a decline of minus 10%, mainly due to lower COVID-19 rapid antigen testing, as you see on the slide, and the decline of our blood glucose monitoring business by minus 5% due to the market shift to continuous glucose monitoring. Now, we did receive CMARC for our own CGM solution, the AccuCheck Smart Guide, in July, and we're continuing with the staggered launch across selected European countries. However, we do not expect material sales contribution from CGM in 2024, and 2025 as we are currently scaling up our manufacturing. However, we do have strong expectations for this product in the future. Sales in pathology lab grew strongly at plus 15%, mainly driven by advanced staining reagent growth at plus 11%, and by our personalized healthcare business or companion diagnostics business at plus 35%. So now I'd like to take a step back and do the regional view on the commercial performance. Excluding the COVID-19 business, we see good base business growth across all our regions. Now, in North America, the base business excluding COVID-19 grew at plus 10%. In EMEA, the base business excluding COVID-19 grew at plus 6%. In APAC, the base business excluding COVID-19 grew at plus 5%. And here I'd like to call it what you heard from Thomas earlier. We did see the anticipated slowdown in our sales in China due to the macroeconomic situation, which we expect to continue through 2025. I would call out that China is still a critical market for us, and we continue to be the market leader. Now, additionally, as I mentioned earlier, given the strength and resilience in our base business, our ambition to grow mid to high single digits in our base business will carry forward into 2025. So now I'd like to transition to some of the key launches for 2024. First, I'd like to talk about our Cobos Pro serology solution, which will enable us to enter the serology testing segment of the U.S. donor screening market. This segment constitutes more than 40% of the global serology market, which is valued at approximately 900 million Swiss francs. Our Cobos Pro solution is a combination of the Cobos Pro integrated E801, nine Alexis donor screening assays, as well as a new software solution, the Cobos Pro serology controller. Now, altogether, this solution is critical for our success in blood safety in the U.S., as Roche can now offer the full package of nucleic acid testing, serology, and workflow automation, putting us in a very differentiated position in this critical market segment. And now I'd like to move on to another exciting bit of innovation in our R&D pipeline, which is the recent FDA self-collection approval for the COBUS HPV test. So in the United States, over 13,000 new cervical cancer patients are diagnosed and about 4,000 die every year. This disease is entirely preventable through timely screening. However, 30% of eligible women do not get screened regularly. So individual patients, cultural, and health system factors have been identified as primary barriers to the uptake of cervical cancer screening. Now, with HPV self-collection, we can now offer women the option to privately collect their own sample in healthcare settings. So, across countries and multiple clinical studies, self-collection has been shown to nearly double the likelihood of participation in screening programs, and especially in underscreened populations. So this will enable market penetration of this already critical parameter in our molecular diagnostics portfolio. And I would also call out that this takes advantage of our large installed base of X800 fully automated molecular diagnostics platforms, which are widely disseminated across the United States. And so now, sticking with the theme of innovation in molecular diagnostics, I would like to speak about another key innovation in this portfolio, the Respiratory Flex, which brings flexible syndromic panel testing to the existing X800 install base. We received CE Mark for the Cobos Respiratory Flex in August of 2024. So the Respiratory Flex leverages our proprietary TAGS technology. Now, this is an acronym called Temperature Activated Generation of Signals. a technology that enables us to identify up to 15 targets within a single PCR well in a single patient. This assay will enable custom target panels on the X800. This allows healthcare systems to customize the pathogens targeted with the panel and enables customized patient-centric panel testing. So by automating this on our X800 family of instrumentation, we now have the capability to offer automated syndromic panel testing in time, for the 2024 Northern Hemisphere respiratory season. And so lastly, as you also heard Thomas mentioned, we completed the acquisition of Lumira DX in July of this year, and we're looking, working forward for the full integration of Lumira DX within our near patient care portfolio. So Lumira DX is a multimodal technology that can perform clinical chemistry and potentially in the future molecular diagnostics in a multi-flex format on a single consumable on a single instrument. And Lumira DX's attributes have broad applicability across decentralized healthcare and have the potential to enhance access to testing in low and middle income countries. So while we do not expect immediate material contribution to sales from Lumira DX, we expect a significant contribution to the diagnostics divisional sales in the coming years. And so now I'd like to conclude with the key launch list for the Diagnostics Division. I think you've heard at some of our earlier calls this year, this is one of the biggest years, if not the biggest year, for launches that we've had in diagnostics. For the 12 launches you see on this slide, we achieved nine by Q3 of 2024, and we plan to deliver the remaining launches on schedule by the end of 2024. So I look forward to providing future updates on our progress in the future. And with that, I would pass it back to Thomas. Thank you very much.

Okay, thanks. With that, we open the Q&A, and the first questions go to Emily Field from Barclays.

Hi. Thank you for taking my question. I will ask two. The first is on the BISMO. I was just wondering if you are expecting any impact on the at-response of Amgen's biosimilar ILEA to impact dynamics in the United States. Do you expect this to impact your share of switches? And then on Decentric, I believe on the immediate call this morning, there was a headline noting that You said that sales had peaked. Consentus does have this franchise continuing to grow for the next few years. So I was just wondering if you could provide a bit more context for those comments. You know, should we think about Decentric as flat, declining? Any additional call would be helpful.

Thank you. Sure. So starting with your first question on the Amgen Biosimilar launch of ILEA. So, I mean, let's just remember the dynamics of this market to begin with. So the ophthalmology market has been about 50% generic biosimilar with Avastin and Lucentis biosimilars available. We would expect that that dynamic will continue to play out. We are not anticipating to see any material impact to Vobizemo's growth trajectory with ILEA biosimilars entering. We have a highly differentiated product and one that offers, I think, a very compelling benefit to patients. So I think we would expect that 50-50 dynamic to continue to be the case. We're not seeing any payers at this juncture implement biosimilar step-throughs. And so, you know, we remain quite confident in the future growth potential for Vivizemo. Regarding Ticentric, so I think my comments this morning were that we would actually expect Ticentric to continue to grow low single digits for the next year or so. We are starting to reach peak in some of our indications. Right now, I think consensus is something like 4.3 billion for Ticentric. That's pretty close to what our own internal estimates are as well. The place where I think we are beginning to feel the competitive pressure, we've said this before, is adjuvant lung in the U.S. We are actually quite holding our own here right at the moment. So I don't think that we should assume that Cicentric has already peaked. I think there will continue to be growth. And this is pretty consistent with the messages that we've been delivering for the last couple quarters.

Emily, any additional questions?

That's great. Thank you.

Okay. And we will move on. The next one would be Matthew Weston from UBS.

Thank you, Bruno. Can you hear me?

Yes.

So two questions from me, please. Thomas, again, referring to the media call, it was reported this morning that you said you think the FTC should block the Novocatalan transaction despite having no exposure at Roche. I guess it's very unusual for an executive to comment in such a way. So I very much enjoy understanding the color to your thinking and why you made those comments. And then secondly, a number of times on this call, both Thomas and Teresa have highlighted Zola and no bias similar entry assumed in 2025. I think we were expecting a November 25 launch. Are there any specifics around your view? Is there a settlement? Is there a legal barrier that you think is particularly there? or is it simply competitive intelligence on the biosimilar timeline?

Okay, let me answer the first question regarding . I was asked around manufacturing for our, specifically the CT388, because the overall molecule is a small molecule, so we have all of the manufacturing capacity that we need. And here we have agreements with CDMOs. and we will continue to build up our own manufacturing. Now, I think in general, if companies start buying up CMOs, that will limit the amount of competition that there can be, given that there are also a lot of smaller companies that may not have as much access to CMOs as we have. And that's where my comment came from. And I stand behind that. I think it doesn't make sense from a perspective from antitrust authorities who want competition.

And in terms of Zola, we can't be more specific, but I can confirm that there will be no biosimilar entry in 2025.

Matthew, any additional questions, full-on questions?

Yeah, I'm just going to push on Zola. So no comment because something illegal is in the pipeline, we'll never understand, or just a confirmation, full stop.

Oh, you will understand at some point, I assume, but probably not today. Yeah, that day won't be today.

Okay, many thanks indeed. Yeah.

So then the next questions would come from Megan Dobson from Goldman Sachs.

Hi there, this is James Prigley from Goldman Sachs. Thank you for your questions. I've got two, please. So firstly, on LLVDs, there's a pretty strong quarter of the just over 108 million sales there and about. So how does this compare to your expectations? Which countries are you seeing the most traction in so far? And then how are you expecting this to develop in the coming quarters with respect to payer feedback as well? And my second question is on Fender Brutal in MS. In the back of the presentation, it says the primary endpoints are CDP at 12 weeks and annualised relapse rate. Whereas on ct.gov, it's still just analyzed relapse rates. So firstly, have you adjusted the primary endpoint of the trial? And if so, why are you quite out of the confidence in the efficacy? If you see a similar directional result as the other BTP inhibitors with a CDP benefit and an ARR largely neutral versus Obagio, what could be the regulatory implications here? Could you still get approval in RMS if we were to see this type of result in the trial? Thank you.

Great. So for Elevides, we are primarily approved in the Gulf states right now. So that is where we're seeing, you know, a large number of patients being treated. And interestingly, we are seeing what we call sort of, you know, health tourism with families with these boys actually going to countries where there is approval to have their children treated. So we have a We have four of the six countries approved have patients with either treating or in screening. And four of the six countries actually also got the same expanded label as the U.S. Overall, when you include the U.S., we have about 500 patients that have been treated globally. And I would say this is very much in keeping with what we had hoped to see. We do believe that there's a significant amount of unmet need held up for these boys and their families. We see payers being very sympathetic to the situation that these families find themselves in. And so, you know, we're very pleased with the adoption that we're seeing at the moment. For Phenobrutinib, and I'm sorry, I had a little bit of a difficult time understanding the question. So we're very pleased with the results that we have seen so far and with the improvement that we're seeing at ARR at 46 weeks, 48 weeks rather. And at this juncture, we do not have plans to change the primary endpoint.

Got it. Thank you. The question was more referring to the back of the slide. This is the primary endpoint is both the family progressing and ARR. So, again, that's probably where the confusion lies.

Okay. James, did this answer all your questions, or do you have any follow-on questions?

No, that answers it. Thank you, Bruno.

Okay. Yeah, then we go on. Next one in the row is Louisa Hector from Bloomberg. Louisa, please.

Thank you, Bruno. Thanks for the call. A couple, please. On the neuropipeline, I wonder whether you could just talk a little bit about the return of the asset to UCB and then perhaps just to highlight just what specifically we should be looking out for in both the Trontenumab data at CTAD and then Prasnesumab by the end of the year, like what would be a good outcome for each of those. And Alan, you mentioned M&A in the context of 2025 earnings, obviously being an unknown. Could you just update us on capacity for deals and whether you are focused primarily on achieving perhaps more of that end-to-end of the disease areas that you talked about at the farmer day. Thank you.

Great. So for UCB, the decision to return the asset was one based on business reasons and portfolio prioritization. We still remain very committed to the TAO pathway. So there's nothing more behind that decision. In terms of Trontenumab, I think we want to continue to see the strong efficacy that we've seen in terms of plaque removal and the consistent and very clean safety profile that we've seen with Tronti. And I think, you know, should we continue to see that profile, I suspect you'll be hearing us talk about moving into Phase III trials quite soon in the first half. In terms of Prazi, Really, the trial is designed to demonstrate a slowing of motor deterioration in patients with Parkinson's. And so what we would really hope to see is a greater than five-point improvement in the MDS-UPDRS. Sorry, it does not roll off the tongue. But that is the primary endpoint, that very unique time-to-event primary endpoint. And I think if we can see that, we do believe that that will be clinically meaningful.

Luis, did this answer your questions?

The M&A topic is open.

M&A one.

Yeah. Yeah, happy to do this, Luisa. Very fair questions. Not much of a change here to what we have said previously. I think very clearly we have capacity for deals. I think that's clear. When I look back to 2023 and the three deals we have done there, I think nobody would argue that that was not a success with the TR1A, I think really with Kermit, certainly also with Sybiza. So I think really a good characteristic here, while having something like that in 2024, it was certainly great with other certainly with other compounds and other targets here. Will there be a focus on the therapeutic areas? We've talked about it from a day, so I think that's one element here. And certainly, I think we also keep an eye on diagnostics, so as you've seen with the Lomira deal. And overall, I can say, yes, while our radar is running, we remain opportunistic, if you like. But as said, I think 2023 is perhaps a good pattern that we would like to follow.

Thank you. Okay, next one is Peter Welford from Jefferies.

Hi, thanks for taking my questions. So just first of all, I wanted to start on the Myastatin, if I can do GIM329. You made a comment that you're very encouraged by this ScholarRock data earlier. I guess I'm curious if you could just talk a little bit about that study, because I guess firstly, I believe I'm right in saying that you are looking at ambulatory and non-ambulatory patients in your study. And so I guess how that potentially could impact the read-across And also, are we still right in saying that what we get next year will be the Phase 2 part of the trial, so very much a dose finding? And can you give us a timeline, potentially, when could we actually get the efficacy and the read, I guess, from that, given, obviously, now we've seen clear evidence from Scholarock that there does appear to be an effect on the disease. Secondly, then, just on returning back to trantinamab for Alzheimer's, Curiously, you've reiterated several times now that the phase three go decision, if you call it that, will be in the first half of next year. I guess curious, should we take from that that what we're going to see at CTAD concludes that some of the higher doses and the earlier cohorts are encouraging enough that you want to see the follow-up safety data from them? Because, I guess, you already have the follow-up data from a lot of the initial groups. And so, you know, I guess, what is the initial information you need, I guess, to make that phase three go to scene, if that makes sense. And then, finally, sorry, if I could just ask Vanella Vidis, Any way at all you could quantify, do you think there's any warehousing effect here at all? Or when we look at this, I guess the risk is here consensus extrapolates the ramp that we see. Is there anything you would say to us to dissuade us from looking at what we're seeing with elevator sales over the first three quarters? Thank you.

Sure. So maybe I'll start with question three and work my way backwards. So with elevitis, I think that, you know, certainly there are families who have been anxiously awaiting these approvals and are waiting for their opportunity to receive this treatment. We do believe, though, just sort of the way that the labels will ultimately get approval and the way that we will actually be able to bring this treatment to market. is it's not likely to see that huge bolus that you might think of with gene therapy and then a big fall down because sort of everybody has been treated. We do believe that there is going to be sort of more of a longer steady revenue flow just because of the age ranges, the different types of patients that we would treat, the way in which the approvals will happen. And so, you know, I think we are – We're fairly confident that this is going to be a sustainable business for a while. In terms of what we would need to see for Trontanumab, we're going to wait for data from 200 patients and then take the decision. Again, we're very pleased with what we see so far in terms of the rates of plaque removal, area rates remaining low, and we will hit the data that we need to hit by the first half of 2025. And so we're excited to be able to get get all the data in-house and actually make that decision. In terms of the SMA trial, so you are correct, this is a phase two trial of GIM329 in combination with Evrizzi. We do expect data from this trial next year. And the reason that I think we are excited about it is that the Scholar Rock molecule antibody is fairly similar to the GIM329 antibody. And so, I think we're excited by what they've seen and hope that we will actually see a read across to our own molecule. So more to come. We've got a little bit longer to wait, but we're eager to see those results. It is important to note that in general, SMA and FDSH are actually more challenging diseases to see benefit in because they don't have as much myostatin. And so These are just going to be a little bit more challenging patients to actually see a benefit in. But we're hopeful based on what we know about our own molecule and what we've seen in competitive data. I'm sure that there is at least one person on hold who is waiting to ask the question, so then what does this mean for our study in obese patients? So as you know, we currently have a dose-ranging study going on right now with our anti-myostatin in overweight and obese patients. That data will read out by the end of the year. We are not planning to release that data, but it will inform a phase three go decision next year.

Does this answer all your questions?

Yeah, that's great.

Thank you. Peter, follow-on questions? No. Okay. And let's move on. Next one is Steve Scala from Cowan. Steve.

Thank you so much. Two questions. What should be our expectation for the rate of conversion of a grievous IV to sub-Q? For instance, could 50% of current sub-Q patients ultimately be converted, say, within a three- to five-year period? And then secondly, during last month's Pharma Day, the word diagnostics was used 51 times. At the same meeting two years previously, it was used four times. So a difference of more than tenfold at a farm a day. I'm curious why the heightened focus on diagnostics. Both meetings were during or after the pandemic, so it can't be that. Does Roche now have some profoundly increased view of diagnostics, or is there some other reason for this big change? Thank you.

Should I take the last question?

You can take the last one, and then I'll take the next.

So first, we are very excited with – the diagnostics business. I think that's one reason. As you've seen over the last years, diagnostics have done very well. And with the upcoming launches of mass bag, but also CGM, that we just recently launched, and also on the sequencing side, I think we have really good outlook for diagnostics. Also with new group strategy and the focus of, you know, on certain disease areas like cardiovascular and metabolic, where we are the global leader in diagnostics, we have more synergies also that we can leverage across pharma and diagnostics. And so we're very much working very closely together between pharma and diagnostics to make sure that we can leverage those synergies more effectively going forward. And that's why I think it was mentioned 20 times.

And as far as Okramis goes, we actually haven't provided a rate of what we believe the conversion will be And while we do think there will be some conversion from patients who are on IV to subcut, I think what we are actually more excited about is the opportunity to expand the use of Ocrevus in settings where, for whatever reason, IV isn't as available. And so from my perspective, I think if we can offer the convenience of subcut to IV patients, that's wonderful. But I'm actually even more excited about offering the opportunity the efficacy benefits of Ocrevus to patients who may now benefit from a subcut formulation. So I think what we're more likely to see or what will be more impactful is actually just a lot more patients actually coming onto Ocrevus who previously, for whatever reason, weren't able to access IV capacity. So that's, I mean, I think that opening up of new patient populations is why we believe that there's such a large incremental upside for subcuts. And, again, we think that's somewhere around the $2 billion mark, and you don't get that by just converting IV. You have to add new patients on top.

Steve, did this help? Yes, it did. And may I ask why the cough drug was dropped?

I'm sorry? One of the drugs which dropped out of Phase I assets, the cough drug, do we know anything about it, Sabine? We will follow up, Steve, would you? Okay.

Thanks so much.

Yeah, there was no clinically meaningful improvement. That's what I just got as an information. So it's because of data.

Well tolerated, but didn't see the efficacy we need.

Okay, then we move on. The next one in the row is Rarish Kumar from HSBC. Rarish, please.

Hi, good afternoon. Thanks for taking my questions. The first one is, could you talk a little bit more about the anti-TL1A opportunity, which you're expecting, you're flagging as a catalyst next year. What should we expect from, you know, in terms of the market opportunity and the positioning and what is the gap in the market it attempts to fill? The second one is more than once you've highlighted Sky 1 readout. uh as a catalyst uh can you characterize what sort of catalyst is it a positive or negative or you know what should we expect from that catalyst and just uh finally on the covet 19 in your molecular lab and overall diagnostic business can you help us with the run rate contribution from kobe 19 tests and you know, apart from the 300 million you flagged, which will not repeat next quarter, the remainder, what is your view in terms of, you know, whether that's a stable base or should we expect further decline in that?

Do you want me to go first? Yeah, go for it.

Sure. So you heard Alan say last year we had approximately 340 million Swiss francs in the fourth quarter from COVID. We had the 300 million order, and I think it's reasonable to assume we see that kind of molecular lab business in the fourth quarter, although, again, this all depends on the respiratory season, which is highly variable, and we're still waiting to see develop in the northern hemisphere. Going forward, we expect to see COVID on an endemic basis. However, over time, this will reach a very stable plateau, and we think we're Very close to that at the moment, but I think it's going to have to, you know, see how this develops over the coming years. But really a lot of it depends on the severity and the timing of the respiratory season in the northern hemisphere in terms of how this plays out on a year-by-year basis. But I think clearly we're reaching the endemic state, so I think we can probably assume that the rates will be more or less stable. But, again, it will very much depend on the severity of those seasonal outbreaks.

I would just add that for 2025, we will not guide on any COVID number because it's completely irrelevant, right? It's just going to be part of a normal business like all the other tests that we have. So 2025, there will be no impact whatsoever on COVID.

Right. And again, just to be clear, I'm talking about the molecular lab business. This rapid antigen business and government antigen orders, we do not see this recurring in the future. Great.

In terms of SkyOne, that's more just to indicate that the trial will read out. We will have OS by the end of the year. And so that's really all that's meant to convey is just that we will have a final readout this year. In terms of TL1A, so the IBD market overall is probably about a $10 billion opportunity over time. And I think there is a very significant remaining unmet need for these patients. While there are some efficacious therapies on the market today, most patients actually have a recurrence and are unable to be controlled. Fifty percent of patients, in fact, are unable to be controlled over the long term on the drugs that are out there today. And so when you think about the immense physical and, frankly, societal and emotional toll that this disease takes – the need for more efficacious treatments is really quite profound in IBD. The TLNA pathway is a well-validated one in IBD. We believe that we have a molecule that has the potential to be bested disease. We're head-to-head in terms of timing with Merck, and we are very focused on getting these molecules into Phase III and getting those Phase IIIs enrolled as quickly as possible and bringing them to patients. It's also worth noting that the TL1A pathway is a very well-defined one in other autoimmune diseases. And so there are a number of other places that you could potentially take this molecule. We are looking at a number of them already. We will plan to share at least those initial first exploratory steps with you at the beginning of next year. But we do believe that this molecule has the potential to be a very significant contributor over time as additional indications are added on top of IBD.

Okay. Thank you.

Okay. Can we go on? The next one in the row is Eric Berrigaud from Stietel. Eric.

Yes. Thanks, Bruno. Good afternoon. Two questions. First on LVDs, again, Theresa, you said you are not seeing kind of a bullish type of market. So how much Indicative is the current quota of around 100 million and should we take this as a base going forward and see this maybe analyzing already into the 400 million already with four to six countries and with Europe coming that will be additive to this hopefully next year. How much would you see coming from Europe versus rest of the world under your territories of responsibility? And then the second question on BTKs versus CD20s, you're talking about the sub-Q formulation of previous adding about 2 billion, but there's also KOL suggesting, since we've seen the tolerabritinib data in SPMS, that there could be some overlap in population and that by default, some CD20s might be used currently in SPMS, but now with tolerabritinib, there could be some shifts from one into the other. Do you have any idea of how much that represents and how much of a risk that could be? Thank you.

Sure. So with elevaties, I think we've said pretty consistently that we expect this to be, you know, a couple billion dollar market outside the U.S. I think we stand by that assumption at the moment. It will very much depend on how regulatory approvals flow and reimbursement for the procedure flows. So I guess it's a little hard to tell you exactly what to expect next year, but I would say that we should continue to see more and more patients get added. By the time we get to full year results, I think we'll be able to give you a much better picture about what we're expecting into 2025 and 2026 as we have a better sense of what our regulatory approval landscape looks like. but there's definitely pent-up unmet need here. And so we're excited to actually be able to come with this option for families. So in terms of BTK, we actually expect fairly little overlap. We would expect phenobrutinib to take share from the 30%, 40% of the oral market share versus the share that Okravis is in today. How much we might see from new orals kind of cutting into the anti-CD20 share, we're honestly not anticipating that that would be a huge number, to be honest. I think the anti-CD20 high-efficacy market has been fairly stable over time. The entry of new options has really only expanded the market, which is exactly what we had hoped would happen. So I think, you know, we're not particularly worried about this, maybe is another way to answer the question.

Eric, any additional questions?

Yeah, no granularity in terms of Europe versus rest into the 2 billion pixels.

Not at this time.

No, we've not provided it to you. Okay. Thank you.

Yep.

Okay. Then the next one would be Richard Parks. Richard.

Thanks, Bruno. Just got a couple left. So firstly on Inavalisiv, sorry, I haven't learned the brand name properly yet. Could you just update us on physician feedback given the label limits used to power the cyclic as a backbone? I'm just wondering if you're going to be able to to shift prescribing as well and what you're doing to expand the label to include other CDK4-6 inhibitors. And then on Ocrevus subcut, and I know I appreciate it's early, but are you seeing any impact on expansion in the prescriber base or new sites that are prescribing Ocrevus since that launch? Thank you.

So in terms of additional prescribers, absolutely and particularly in the U.S. So I think, you know, in the U.S., OkraVis already has a very well-entrenched customer base in academic settings and hospitals and larger community practices where IV facilities are either in the practice or available, but for smaller community neurologists and or in settings where patients have to travel a long distance or otherwise just don't have access to IV therapies, I think with Ocrevus subcut, we open up a whole new prescribing base in the U.S., and I think that is also true in other parts of the world, again, where just IV capacity is constrained, and now the ability to get your MS treatment in a 10-minute subcut dose is every six months is really just a huge benefit for patient populations and for healthcare systems. Moving on to enamelisib. So, today, PALBO is the global standard of care in frontline hormone receptor-positive breast cancer. And so, in order to provide a triplet therapy to all patients, additional safety data, including combinations with fulvestrant and riborabema are all currently being generated. But I think right now what we are hearing from the KOL community is a lot of excitement around the approval for InnoVelicit. And I don't suspect that the backbone will fully limit utilization, but we are actively working to generate additional data with other CDK4 backbones, CDK4-6 backbones to fill that data gap. But I think we are very excited about what we're hearing from the community about in terms of their level of interest in using this drug with their patients.

Perfect, thank you. Any questions, follow-on questions? No, that's great, thank you. Then next one would be Richard Fosser from J.P. Morgan. Richard.

Thanks, Bruno. A couple of questions, please. Just going back to presonizumab, if you manage to get that five-point benefit that you talked about, Teresa, How are you thinking about the ability to take that to regulators? Or do you think you would need to generate a further maybe one or two phase three trials, depending on the data, of course? And then just Lynn Sumio, maybe give us some thoughts on the trajectory there in the third line and also, you know, how we should think about the second line opportunity, which is clearly bigger and when that can come through as well. Thanks very much. Sure.

So in terms of Lensumio, I mean, I think it's just important to remember that third-line follicular lymphoma is actually a very small patient population. And so the real opportunities for Lensumio are as it moves into second-line DLBCL, second-line follicular, first-line. And so, you know, we will get some of those data sets in 2025 and 2026, and we'll be able to greatly expand the patient population that Lensumio can impact. And I think the combination of the fact that You don't have to go to the hospital. You have a very good dosing schedule. You've got the subcut, potential left steroid use with that subcut. I think there's a lot of opportunity for linsumia, but it just has to get out of third line. Third line is just not a significant patient population. And so when it comes to – so moving on to PRASI – As we would with any Phase II program, if we have positive results, we will speak to the regulators about it. And I think it would be too early to speculate without seeing the results what we believe our chances of success would be. I think, you know, we will definitely need to run confirmatory trials, and that is certainly our expectation. But depending on the strength of the results, as we always would, we will, of course, talk to regulators.

Bridget, any additional questions?

Yeah, and I do want to just continue to underscore that while exciting to finally get this data, because I think we've waited for it for a long time, this is a very high-risk trial. And so high risk, high reward, but we'll know soon.

Okay. Bruno, thank you very much. Thanks, Teresa.

Yeah, thanks. I think actually with that, we are at the end of our Q&A. Then we would close the session. I think for the first time we made it earlier than what we had assumed in terms of time-wise what we would need. I will hand back to Thomas for a final remark.

Thomas, please. Thank you very much, Bruno. And I believe a person said that at Pharma Day we mentioned diagnostics, I think, 51 times. I'm surprised how many times we mentioned obesity today, which was not a lot. So compared to some of the previous calls, we didn't have as many obesity questions, but we would be delighted to answer those questions as well. So overall, I believe we have very positive momentum in our business, and this will carry us into next year and also the years to come. I also want to highlight we are very cost disciplined, and you can count on us that we will continue to do so also in the future. We have, as Teresa mentioned, some exciting readouts next year. And also in diagnostics, we have exciting launches still coming this year and the years to come. So very good overall momentum there on the pipeline. And let me just finish by saying we will deliver. Thank you very much.