Roche Holding (SIX Swiss: RO) Q3 2026 Earnings Call

0:00 Good morning, good afternoon, and I'm excited to share our Q3 2026 results with you today. We had a strong performance yet again, and we made also significant portfolio progress. We had, as mentioned, a strong performance here to date. Group sales are up 6%, driven by pharma with 7%. In Q3, in fact, we had a growth of 7% for the group in CR. And since we now have actually a stabilized currency situation, in Swiss francs, the growth was actually plus 8%. And if you then look at US dollars, we're also at plus 7%. So clearly, the exchange rates have stabilized. As we called out in the presentation in Q3, we had a one-time effect in Q3, which is about 180 million Swiss francs or one percentage point growth.

0:54 This is due to a next generation ERP introduction at Chugai in Japan, and this impacted the timings of the shippings. Now, let me just say that we had a 2% outperformance versus the consensus overall, or about 360 million. and the roughly 180 million means that one percent of the outperformance comes from that, the other percent comes from strong performance in the portfolio. And let me also share that this effect will also then reverse in Q4 2026. Diagnostics growth was four percent and excluding China and you're aware of the healthcare pricing reforms there, the diagnostics grew at plus six percent. and as communicated at half year, we expect full year LOE impact of about 600 million Swiss francs. On the pharma side, we had a very busy quarter in terms of regulatory approvals. We had four approvals, US approval for Ticentric in stage three colon cancer, EndSpring in TED and Gaciva in INS and in the EU, Susfimo received approval for AMD.

2:07 We filed Feniprutinib in RMS and PPMS in the US, which is under priority review there, and Anspring in both the US and the EU in MOGAD, and Vermicubard in UME also in the US and the EU. We also reported several positive phase 3 readouts. One is the Selemestrimo trial with Lonzumio and second line follicular lymphoma. Cefaxircin at interim readout showed significantly reduced protein urea in people with IGAM and the data will be presented tomorrow at ASN and we also look forward to sharing this data with health authorities. In diagnostics, it's worth highlighting a couple of things. One is the rapid response to two recent outbreaks.

2:54 One is Ebola in Congo, and the other one is cyclospora outbreak in the US, where we quickly deployed PCR tests. In urology, we now also received US FDA approval for PTAU217, which is the only marker that can be used in the primary setting for Alzheimer's. On the BAD front, it was an exceptionally busy quarter. We made a series of deals, and I'll come back later to that, but I just wanted to highlight two, both in the obesity space. One is with Hanmi, potentially first in class, Yuri Kortin, two analog, which is in phase one, and also with Rona to target out seven with an RNAi. And both are promising emerging MOAs in the obesity space and have the potential to improve the overall body composition.

3:45 Looking ahead, we have a couple of key milestones still ahead until year end. One is a trial of ITOPI in post-CDKI, HR-positive metastatic breast cancer. And not mentioned on the slide, but of course, we're very much looking forward to our approvals for Giro d'Estreinte this year in the adjuvant and metastatic setting. The VEDUFA dates are November 30th and December 18th. In diagnostics, we also have a launch upcoming. Now let me take you through the next slide again just to reiterate the growth rate at six percent driven by pharma seven percent diagnostics through four percent and as mentioned this is still impacted by the healthcare pricing reforms but as you can see the impact is getting smaller and smaller over time and so it will be back to normal then in the near future.

4:39 Now looking at currencies we've seen a reversal of the headwinds actually in Q3 and you've also seen that when you look to the slides in Q4 and in fact in Q3 we had a positive plus one currency effect but what you see here in terms of currency effects is still really the impact mostly from Q1. Now let's move to the next slide and this shows you yet another quarter of consistent strong growth and as mentioned before in Japan we had a one-time impact in Q3 due to the ERP system implementation and excluding this the growth rate for the quarter would be a strong six percent and as mentioned this effect will reverse in Q4. Now let's look at the key growth drivers. All segments are growing.

5:28 And let me start with oncology slash hematology. We have strong Fesco conversion from Pachetta, which continues. The HER2 franchise is going to peak this year with a strong tail. Decentric growth is driven by new indications. For Alicenza we have raised the full year outlook to low single digit growth from flat before. PolyV continued strong uptake in first line DLBCL and column V and non-sumio continued to grow in later lines in both DLBCL and follicular lymphoma. and Libra keeps growing across the geographies and since we don't expect any competitive pressures anymore this year we are upgrading the outlook to high single digit growth for the full year versus what we said at half year where we still said mid single digit growth. Let me go to neurology. Ocrevus keeps growing strongly and there's a strong uptake of the sub cut formulation. Theresa will provide more details to that.

6:25 Again Evristi also had a very strong quarter and is expanding its market leadership position in the SMA. Xolia continues to strong performance in food allergy and as expected we've now in the third quarter seen the first biosimilar launched. Gaciva we're very encouraged by the initial uptake in lupus nephritis in the US and we also look forward to the approval in SLE later this year. Babaismo in ophthalmology continues to grow well and we also continue to gain market shares and I know Theresa will also go into that. In diagnostics we had pathology with a strong growth and CoLab growing despite the China healthcare pricing reforms and Matt surely will go into that as well.

7:11 Now let's look at the highlights of the portfolio and I like this slide it's showing that we can launch up to 20 new medicines until the end of this decade which is up one versus what we have said at half year and the fact that you see a lot of green boxes means that we've seen a lot of positive news over the last quarter. And let me just say that we've added two molecules to the slides and had one drop off. The two that we added is Tampelli in lung cancer, which had very positive phase three results in second line small cell lung cancer in Chinese patients. And the data was presented at World Lung. And then the VEGF IL-6 DudaFab in DME.

8:01 As I mentioned, this now brings us to 20 NMEs with a potential launch by 2030. And we've had great progress across most of those. And let me highlight a couple of those. First, the positive phase three interim readout for cefaxersen, which I mentioned before. Positive phase two readouts for inazepatide, petrolintide, and CT996. And based on all this data, we have initiated several phase three studies. and as mentioned before, Fenne Brutonib in MS and the Milky Bard in UME have now been filed. For Fenne, look out for the data that we are presenting at MS Toronto this week. Theresa will also cover that. Finally, we've increased the peak sales potential for Diva RACEP to 2 to 3 billion Swiss francs on the back of strong Crescendo 1 data.

8:54 And we will also present this data this weekend at ESMO. So also please take a look Now let's have a broader look at our pipeline. Again, a slide that I really enjoy looking at because it shows how the effect is on the late stage pipeline as we implement the bar. In dark blue, you see all of the projects that we have initiated after the introduction of the bar. On the y-axis, you see the PTS and you see how many projects we have now above 50%. And usually in the past, above 50% meant a very high success rate for us. and on the right to the right on the x-axis you see the value so you see an upward shift in the right hand shift and this is exactly that what we actually want to see now you may ask yourself what is the little blue dot on the left bottom corner this is our novel antibiotic and I'm sure you understand why on the one hand it's important to bring this project forward and the impact it would have in case of a bacterial pandemic.

10:04 But you also know how the business model works today with antibiotics. It's hard to reflect that differently than with a dot in the bottom left corner. On the right hand side, you see the phase three readouts this year, which has been a very strong year for us. Seven out of eight phase three studies were positive. So it means an 88 percentage point success rate. Last year already, we were in line with industry average in terms of phase three success rate. This year, we're actually ahead. Now, 88% is an amazing number. I don't think that this is a long-term rate, but really keeping it at around 80% would be an ideal goal for us.

10:53 Now, moving to the next slide. And this is another way on how we look at our portfolio. We are very rigorous at applying the bar, which means that as we move assets through the development, we constantly assess these molecules. Currently our portfolio stands at 60 enemies and what I can say is we've almost doubled the portfolio value since 23. So not only do we have more meaningful projects, but I think also we have greater value in terms of potential market impact. And we do expect the number of NMEs to increase because we have a lot of things going on in research, as I will show you in a couple of seconds.

11:39 But we will also continue our partnering activity. Talking about partnering, Q3 was a busy year. We closed in total six platform deals. It was a busy quarter, sorry, Q3. We closed in total six platform deals spanning different drug modalities, for example ADCs, bispecifics, degraders and allosteric small molecules. and this also in different therapeutic areas. And these collaborations will also fuel our early pipeline in the next years. Another source of innovation clearly to fuel our early pipeline is also the adoption of AI and my team has also shown you at Pharma Day of how we apply AI in drug discovery and you see that on the right hand side and I do believe that this also shows you that we are front runner when it comes to applying AI in drug discovery. And you can see on the left hand side from LIGO to LOGO to DEFGOs, this is the different phases of our early stage research and development. A significant increase of molecules over this period of time and we believe this will continue.

12:53 And as a reminder also, we have a very comprehensive AI strategy that we have rolled out a couple of years ago. And this AI strategy rests on a couple of pillars. One is we call everyday AI, constantly training all of our employees on using AI tools to become more productive. And we also monitor the usage of these AI tools in our organization. And we see that 75% of our people are very active AI users. So we feel this helps us to get more productive. On the reshape side, this is taking the three main processes of our organization, service, marketing and sales, and R&D, and really reshaping these processes using AI to get faster and more effective and more productive.

13:42 And what we do is we map that out and we create certain use cases which we then invest in in order to get to an acceleration. And we constantly prioritize new use cases so that we are very effective in providing AI tools to accelerate the work that we're doing across these processes. Then the third level is around big ideas. These are the things that can really change the way we do drug discovery or diagnostics. Lab in the loop, as you can see in the right hand side, is one of those, but also in the diagnostic side using AI in our products. and we have platform initiatives. One of them is deploying the AI factory. One of them is built in Europe. The other one is built in the US.

14:27 So you see that we're making extremely good progress when it comes to AI throughout our organization. Now let me talk about diagnostics and we have previously talked about the key platform launches over the last couple of years. CGM, mass spec and sequencing. Today I'll dive deeper on the sequencing solution which delivers unprecedented speed and very high accuracy. It was launched end of June and as you can see on the right hand side has been getting very positive feedback from customers. Now we have a very strong launch momentum here. At Daya Day, Matt talked about the target to sell 100 instruments in the first year. Now in the first 90 days or in the first quarter, we've actually achieved one third of that target.

15:18 So I think the team is doing well here and the feedback I've visited customers myself has been extraordinarily positive. Now let's wrap up with the outlook and here I want to reiterate our guidance that we've also provided both in diagnostics on the diagnostics day and on the pharma day. You see the diagnostics will continue to contribute well to our growth, not only till the end of the decade, but clearly beyond that. But based on all the positive data readouts we've had, we also have very good line of sight for growth to the end of the decade and beyond. And we feel that alone with what we have in hand, we can continue our very positive trajectory that you've seen over the last couple of years.

16:08 but also that we can go into the next decades with the same kind of momentum and this is without additional positive readouts now you've seen yourself on the late stage slide with the 20 enemies with a potential launch till 2030 it's very unlikely that this will not turn into a lot of positive readouts. The amount is very hard for us to predict at this stage, but there are many potential shots on goals. So we do believe that this will add to significant growth on top of what I just said. And on top of that, we'll continue to do more BD. So I do believe that the growth outlook this year, not only, but also next year and the years beyond that is quite positive for Roche and that there is actually no cliff situation that Roche will run into.

17:01 Now with that let me reiterate the guidance mid single digit sales growth and core EPS growth of high single digits and we will increase dividends further. Thank you very much and with that I hand over to Alan.

17:14 Yeah thanks Thomas, great quarter. So hello from my side before I start thanks to everybody who has really contributed here to this great sales development that we have seen and certainly to the benefit for patients. Sales update, so I will be brief. Here's the sales bridge with the growth of 6% in constant currencies. You see a year-to-date September left-hand side, year 2025, year-to-date September 2026 on the right-hand side. When I lead you through the bridge I think you see pharma and then in addition the loss of exclusivity impact of minus 355 million in total a growth of seven percent in constant rates. Let me say the 355 we think is a good number to support the 600 million negative impact that we have prognosed for the full year 2026. We will have a stronger impact from October in Q4. When you look at diagnostics, very steady when it comes to growth excluding China, 6%, I think also at half year we had a growth of 6%, now the year to date with plus 6%.

18:22 What you see shrinking is the impact from China. We are now at a minus 13% sales reduction in China compared to last year's same period. At half year, we were at minus 15%. So when you do the math, you will see in Q3, we were at minus 9%. So you see really that there is a clear reduction of that negative impact moving forward. When you do then look at the currency impact, I think Thomas has alluded to it already, I think we are now at minus five percentage points when it comes to sales. At half year we had minus eight percentage points with the stabilization of currencies in Q3. I think there was also a positive impact on the year-to-date impact. Good, and let's look a little bit more into this. You see here the growth rates on the left-hand side in constant rates, 6.2%. That's the 6% that I've mentioned before.

19:14 On the right-hand side, you see the growth rate in Swiss francs, 1.4%. This is the 1% that we have mentioned before. and in between you see the currency movements and I think it is very clear the major driver here is the US dollar as before but as said I think the impact gets smaller moving forward. Having said this Here is really our overall projection for the full year. When you take a quick look on the left hand side, you see that the 2026 average currency rates remained below 2025 for both the US dollar and the euro. So still a negative impact. You see overall exchange rates movements had a negative impact on minus five percentage points on the group sales growth in the first nine months, as mentioned already.

20:03 and you know our calculation on the right hand side with the estimate for the impact for the full year 2026 if we remain and assume that all the currency rates end of September remain constant until the end of the year 2026 we expect an impact on sales of minus three percentage points cooperating profit of minus five percentage points and core EPS of minus five percentage points that is a slight improvement compared to half year we had a minus four minus six minus six at half year but what you see is really when you really look at the top line you have the sales impact you see in Q3 we had a positive impact in Swiss francs and we even expect a higher impact in Q4 so there's a little bit of light at the end of the tunnel but certainly currency rates in these days are very volatile Good.

20:54 And with that, I think just to confirm the guidance again, it's my pleasure to hand over to Theresa.

20:59 Great. Thank you, Alan. So let's go ahead and get started. So pharma sales grew by 7% at constant exchange rates, reaching 36.2 billion Swiss francs by the end of September. All of our regions continue to deliver growth. Of note, as Thomas mentioned, Q3 sales in Japan were positively impacted by a timing effect related to the implementation of a new ERP system in the context of a business process transformation. The size of this impact is roughly about 180 million Swiss francs at constant exchange rates and excluding this impact, year-to-date pharma sales increased at 6% at CER. And as Thomas mentioned, we do expect this impact to fully reverse in Q4. Overall, pharma volumes were up by 11%.

21:44 As always, all absolute values and year-over-year growth rates on this graph are presented at constant exchange rates. Until the end of September this year, our top brands, Zoller, Hemlibra, Okravis, Fezgo, Vibismo, and Polivi generated roughly 2.1 billion in new sales. I'm going to share the growth dynamics for each of these brands on following slides, so why don't we just go ahead and jump in with oncology. Oncology sales increased by 1% at constant exchange rates to 11.2 billion Swiss francs, driven by Fesco and Ticentric. So let's start our deep dive with breast cancer and Fesco. The global conversion rate for Fesco has climbed to 59%. This is an increase of five percentage points over what we shared at half year. It also brings us very close to achieving the previously stated milestone of at least 60% conversion rate at peak. Moving on to Kedsaila, as we expected, we see increasing competitive pressure in the US and the EU, and that is negatively impacting the growth of Kedsaila. But this is probably a good time to reiterate our HER2 franchise outlook. We continue to expect the HER2 franchise to peak this year at around 9 billion at constant exchange rates 2024, followed by a steady decline through the end of the decade, with a solid tail around 4 billion.

22:55 Half of that's Fezgo, around a billion for Kedsaila, and the rest for Progetta and Herceptin. Due to the increased competitive pressure, we now project Kaid Sila to land a bit lower by a few hundred million. And to reiterate, we do not foresee a biosimilar in the US for Progetta before 2028 and in the EU before 2027, nor do we foresee any sort of cliff situation around the HER2 franchise. The iTOBI launch continues with good momentum, and we expect to see Phase 3 ANAVA-121 results later this year. And last but certainly not least, in breast cancer, gerodestrin, we are eagerly awaiting the U.S. approvals for Ladera in November and Avera in December. For Avera, we're also excited about the recent NEGEM publication highlighting the significantly approved PFS in ER-positive breast cancer.

23:41 And for Ladera, we expect the single-arm substudy in combination with Abema to read out in Q4 and subsequently to be presented in an upcoming medical meeting. As a reminder, at Pharma Day, we announced an expansion of our clinical development program in adjuvant ER-positive breast cancer with two new studies, a Phase III IIS in collaboration with AFT and Natera for MRD-guided CKI usage, and a Phase I-III in collaboration with Pfizer, combining gerodestrin with the CDK4 termocyclib. Now let's shift gears into lung cancer, starting with Ticentric. The new indications continue to drive global growth, then by Inforte in small cell. We just added one more indication with the US approval of Atomic in DMMR colon cancer, and this makes Ticentric the first approved adjuvant immunotherapy regimen in this setting. positioning it to become the new standard of care.

24:30 I also want to confirm our full-year outlook of low single-digit growth for Ticentric. A quick update for Allicenza, based on the continued strong performance, we're increasing the full-year outlook from flat to low single-digit growth. And to close in Lung in just a few days from now, Diva Rassib's positive crescendo one results in second line non-small cell will be presented in the Presidential Symposium at ESMO. So please do tune in for that. And with that, let's move on to hematology. We achieved growth across the entire hematology franchise, resulting in a strong 17% increase at constant exchange rates and 7.1 billion Swiss francs in sales year-to-date. Hemlibra remains the key growth driver, and as you will recall, at half-year, we increased our full-year outlook for Hemlibra to mid-single digit.

25:15 Based on continued strong performance and updates in the competitive environment, I'm happy to share that we once again increased our full-year outlook, and we're now projecting that Hemlibra will go at high single digits for the full year. As a brief reminder, at Pharma Day, we presented the upcoming Hem-Lieber Auto-Injector. This device has the potential to further expand administration options and enhance patient convenience, and we expect the auto-injector to launch by the end of 2027. Next up is Malignant Heme. Polivi has set a new standard of care in first-line DLBCL with continued strong uptake and market share expansion. But you know we're not stopping there. The ongoing Phase 3 SkyGlo study for Polivi plus Columbia plus Archip in first-line DLBCL will read out in 2027 and has the potential to once again redefine the standard of care.

26:00 Importantly, we are not adding our bispecific just onto RCHOP as some of our competitors have done, but we are adding Columbia onto PLUMVY plus RCHIP, the current standard of care and first-line DLBCL. As highlighted at Pharma Day, that phase one data was impressive, showing promising results for the combination with an OR of 100% with 0% grade two CRS events. So in true Roche spirit, we have raised the bar and we are once again seeking to raise the bar on ourself for patients. Let's also highlight the positive phase three readout of Celestimo for Linsumio and Second Line Plus Follicular. Those data reinforced Linsumio's potential to improve clinical outcomes while offering a tolerable safety profile, simple dosing schedule, and outpatient administration. We will submit the data to health authorities and present it at an upcoming medical conference. And to close, let's take a quick look at Gezaiva.

26:51 So as I've mentioned in previous quarters, increasing competitive pressure in CLL and follicular is negatively impacting Gezaiva's performance and the hematological indications. This is happening at the same time as the ongoing launch in immunology, and I will share some updates on that in an upcoming slide. But in short, what we see is that the initial uptake in lupus nephritis is overcompensating for the competitive pressure across the hematological indications. So let me repeat that we will show that sales split by therapeutic area in the future as those data sets mature. So now let's move on to neurology. The neurology franchise achieved 7.6 billion Swiss francs in sales and a 10% growth at constant exchange rates September year to date. Ocrevus is driving the overall growth of our neurology franchise and in turn, Ocrevus global growth is driven by the subcutaneous formulation known as Zenovo in the US.

27:44 We now have roughly 56,000 patients globally on subcut and that's about 12,000 more than we had just at half year. and I'll get more onto the subcutaneous uptake dynamics on the next slide. But before we get there, let me confirm the overall Okravis outlook. For 2026, we continue to expect high single digit growth and our peak sales expectations for the Okravis franchise remain at 6 billion by 2029 and constant exchange rates at 2025. This includes 2 billion in incremental sales from Okravis subcut, but of course there's going to be some switching from IV to subcut on top. and one more good piece of news for Ocrevus. We're excited to have received EU approval for Ocrevus in the pediatric setting for patients 10 years and older based on the positive phase three operetta one two studies.

28:29 And there is more exciting news for our MS franchise. We have successfully achieved US filing for phenobrutinib in both RMS and PPMS. The filing used a priority review voucher or PRV to ensure an expedited review process and enable earlier access for patients. Furthermore, the MS Toronto Medical Conference is currently underway, and we are presenting new data from the Fenebrutinib, RMS, and PPMS studies there, some of which I will highlight on the coming slides. But first, let me share two additional neurology updates. We achieved US and EU filing for NSPRING and MOGAD. The FDA granted priority review, and the PDUFA was set for the 10th of January. And as a reminder, we see the MOGAD opportunity of somewhere north of 500 million. We initiated the phase three Preventron trial for Trontinumab in preclinical AD.

29:17 And as you know, the Preventron study is enrolling cognitively unimpaired individuals at a high risk of progression to symptomatic Alzheimer's and highlights our ambition to maximize the potential impact of Tronti in AD. Just like for the ongoing Tron tier one and two studies in early AD, we see great excitement amongst the medical community and patients for Trontinumab, which is leading to strong recruitment in the Preventron trial. So now, as promised, let's take a bit of a deeper dive into the MS franchise. And let's start with Ocrevus-Synovo. So I already mentioned the strong global patient uptake, and you can see very clearly in the graph on the left here. This is based on volume sales across our 50 launch countries, and the adoption rate is driven both by conversion from Ocrevus IV to subcut, but also and especially by patients naive to Ocrevus, which is frankly exactly what we had intended to do. And for the first time, I also want to share the global Ocrevus IV to subcut conversion. But especially, we can see this on the graph on the right, where you can see that we've now reached greater than 20% conversion to the subcut formulation.

30:21 And we expect to continue this to climb. And in fact, today, Ocrevus subcut is the fastest growing anti-CD20 in the market. and that is really fundamentally the story that these two graphs together tell. Subcut has allowed us to expand our MS footprint to new market segments, particularly in the community setting where IV constraints mean that Ocrevus is simply the better fitting option for patients, doctors and health system needs. And all of this together allows us to continue to grow the Ocrevus market overall. and let's not forget that again, we are not stopping here. We are further innovating for patients with the development of our on-body injector or OB. The OB delivery device has the potential to enable a convenient twice yearly at home self-administration. We showcase the device at Pharma Day and we're expecting our data readouts next year. So now let's take a closer look at some of the data being presented for Phenobrutinib.

31:09 Phenobrutinib, as you know, is the first and only BTKI with positive phase three results in both RMS and PPMS, showing a clear positive effect for both relapsing and progressive biologies. And the additional RMS data currently being presented in MS Toronto are further reinforcing this profile, including acting on markers of progressive disease in the RMS population. Now, I don't want to go into too much detail here, but let me quickly cover the highlights of the data on the slide. On the left, the NIDA-3, which is no evidence of disease activity, results show a 70% reduction of risk for Fetabrutinib compared to teraflutamide in regards to ARR, CDP, and MRI activity. In the middle, we've compared the total brain volume loss between phenobrutinib and teraflutamide patients. Not only is there a clear benefit for phenobrutinib compared to teraflutamide, but patients on phenobrutinib reached a level in line with the brain volume loss rate of healthy adults. On the right side, you see the continued improvement for two key biomarkers of progressive biology for the Phenobrutinib arm, CHIT1 for microglia and Serpina3 for astrocytes.

32:13 Both show continued improvement for Phenobrutinib versus teraflutamide through week 96. And of note, the positive effect of the CHIT1 biomarker underscores Phenobrutinib's ability to cross the blood-brain barrier and act on microglia. There's one more piece of data that I want to highlight in a late-breaking abstract with the oral presentation to follow in the coming days at MS Toronto. Phenobrutinib is showing its therapeutic effect on paramagnetic rim lesion and slowly expanding lesions known as chronic active lesions. In short, Phenobrutinib demonstrated the first prospective therapeutic effect on chronic active lesions in MS for both RMS and PPMS. and RMS Phenobrutinib reduced the volume of slowly expanding lesions by up to 30% and reduced accumulation of paramagnetic lesions by 62%, both versus teraflunomide at 96 weeks. These are exciting and meaningful results that underscore Phenobrutinib's effect on chronic neuroinflammation in the brain, a primary driver of disability progression in MS. So in summary, we are convinced that Phenobrutinib has strong efficacy across lelapsing and progressive biologies. And to further underline this, let's take a look at the next slide. Also at MS Toronto, we presented pooled ARR data from the Phenhans 1 and 2 trials in RMS.

33:24 And this slide really speaks for itself, so I can be brief. Phenabrutinib achieved an impressive 55.4% relative ARR reduction compared to teraflutamide. This makes Phenabrutinib the first and only oral to demonstrate an ARR improvement greater than 50% versus an active comparator in RMS. and that puts Fentabrutinib firmly in the category of a high efficacy treatment as you can see here from the review article taken from Neurology. So yes, we are excited about Fentabrutinib's potential NMS and we are looking forward to bringing this truly transformative medicine to patients. So now let's move on to immunology. Our immunology franchise reached 5 billion Swiss francs, growing 4% at constant exchange rates, with Zoller being our key growth driver. We now have more than 145 patients treated with Zoller for food allergies since launch, and that is an increase to 15,000 patients since half year.

34:16 As you saw in Q3 and as expected, we saw the first U.S. biosimilar in launch for Xolair. Let me briefly comment on the Q3 performance and the outlook for Xolair. Q3 was impacted by some buying pattern and we can continue to expect around 20% growth at full year. Actemra sales declined by 10% year-to-date, driven by biosimilar impact, as was mentioned earlier. And then moving on to gaziva, we see continued strong launch uptake in patient share gains in lupus nephritis across early launch countries. By now, we've treated about 5,000 patients with gaziva for lupus nephritis globally. And as mentioned on the hematology side, the uptake in lupus nephritis is more than compensating for the erosion in hematology. One more good piece of news this quarter for Gaziva, we received U.S.

35:01 approval for INS. And looking forward, we are anticipating U.S. approvals and both SLE and MN for Q4. As Thomas mentioned, one additional highlight of this quarter was certainly the positive phase three interim data for surfactorsin in IGIN. Surfactorsin is the first antisense aglionucleotide evaluated in this disease, and the results show that it has best-in-class potential for selective complement suppression with a clinically meaningful reduction in 24-hour proteinuria. The positive UPCR data will be presented tomorrow at the ASN conference, and we're also planning to share that data globally with health authorities. and of course the study is still ongoing to determine long-term functional eGFR outcomes. And so with that, let's go on to ophthalmology.

35:46 Ophthalmology sales reached 3.3 billion Swiss francs year-to-date, growing 9% at constant exchange rates. Vibismo is the key driver here, and we continue to see global growth in market share gains. By now, Vibismo has established itself as the preferred first-line treatment, including in the US. We have also reached another milestone with an impressive 1.5 million patients treated globally. One more update for Vibismo. Earlier this quarter at uRetina, we updated real-world data from the Voyager study, which now includes more than 5,000 patients. These results reinforce for BiSMO's robust effectiveness and durability across previously untreated and treated eyes in AMD, DME, and RVO. And we are happy to see the strong clinical results for BiSMO once again replicated in real-world clinical practice.

36:34 So let me also reiterate that we expect low double-digit growth for Vivizimo in 2026. And as previously stated, we consider consensus peak sales expectations for Vivizimo of around 6 billion Swiss francs as very reasonable. And we're confident that we are on track to achieve this number. Beyond Vibismo, we had quite a bit of additional news flow in ophthalmology this quarter. NSpring just achieved its U.S. approval in TED just last week. Sesvimo achieved EU approval in AMD, and we filed the Mickey Bart and UME in both the U.S. and the EU with a PDUFA set for the 23rd of July. and we moved our bispecific VEGF IL-6 due to FAB into phase three and DME. And of note, this includes a head-to-head trial against the BISMO, which is frankly something that we are increasingly hearing from ophthalmologists. They want to see trials that use the current standard of care as the comparator, not historical standards of care. So next up, I will cover our CVRM pipeline. So as you heard at Pharma Day, we continue to develop our CVRM assets at pace.

37:33 There are quite a few positive readouts and recently announced phase three trials to cover. So let's start with Enacepatide and Petrolintide, the foundational building blocks of our CVRM pipeline. I'm going to stay a bit more high level here as we have a more detailed slide on both molecules right after this so let's just cover the Q3 highlights here. Both antiseptide and petrolentide delivered positive phase 2 data in obesity with type 2 diabetes and for petrolentide we also presented the full Supreme 1 data EASD and initiated the phase 3 program consisting of Supreme 3, 4, and 5. More on the next slide, but first let's look at the rest of the pipeline, starting with CT996, our Oral GLP-1. So first of all, we have a new name to unroll, Tifaglipron. At Pharma Day, we announced positive phase two data for TIFI and obesity.

38:18 And based on these positive results, we are moving the asset to phase three with trials to be initiated in the first half of 2027. As Thomas mentioned, we also added two new molecules to the CVRM pipeline with partnerships, both in obesity. First, a UCN2 analog in phase one via our partnership with Hanmi Pharmaceuticals. And of note, UCN2 has the potential to simultaneously promote weight loss and preserve lean body mass. And second, an ALK7 targeting RNA via our Arona Therapeutics partnership. This asset is preclinical, and we think it's a very exciting new approach in the obesity field, directly targeting adipose tissue biology. unlike the incretin-based therapies which target the CNS. I'm looking forward to sharing more on these molecules in the future, but now let's take a closer look at anisepatide and petrolentide.

39:05 So you all know that we at Roche have the ambition to become a top three player in obesity. And the two foundational enemies that we believe will get us there are N-acepatide and petrolentide, both as monotherapies and in combination. So let me highlight not only why we believe in the potential of these assets, but also the significant progress we've made in the last few months. So let's start with N-acepatide. Enacepatide is intentionally designed with a biased GLP-1 GIP agonism, which we believe is key to the strong phase two results we've seen so far. In obese overweight patients without type two diabetes, Enacepatide did show robust weight loss of up to 22.7% at 48 weeks with no sign of plateau. And importantly, more than a quarter of treated patients achieved a weight loss of 30% or more at 48 weeks.

39:53 Recently, we shared that in obese and overweight patients with type 2 diabetes, a weight loss of 15.5% at 48 weeks was achieved. And again, there were no signals of weight loss plateau after that 48-week mark. And even more impressive, however, was the HbA1c reduction in this population. At 48 weeks, N-acepatide achieved reductions of up to 2.65%, highlighting its potential for best in disease glycemic control. On the back of these strong phase two results, we have started a comprehensive phase three program, two trials in obesity are already ongoing, and four trials in type two diabetes and glycemic control are to be initiated in the first half of next year. And this includes a head-to-head trial against trisepatide, underscoring our conviction in N-isepatide's best in disease potential.

40:38 And additionally, we're expecting to initiate a CIVOT and HEF-REF trial in the first half of next year. So now let's turn our attention to Petri. Together with our partner Zeeland, we believe that this long-acting amylin has the potential to redefine the weight management experience, in particular by delivering double-digit weight loss and improved tolerability compared to current treatment options. Positive Phase II results from SUPREME I and II studies were announced this year and gave us the confidence to move to Phase III. To pick just one highlight, the recent Zupreme 2 results show that discontinuations due to GIAEs are very similar between Petri and the placebo arm. 1.9% of patients on petrolenti discontinued treatment due to GIAEs and 1.7% did so on placebo. And this while achieving statistically significant and clinically meaningful weight loss and HbA1c reduction.

41:29 and we are moving at pace with Petri as well. We initiated all three phase three studies in obesity this quarter with each of them already having achieved FPI. And one of the great things about having both antiseptide and petrolentide in our portfolio is that we can combine them. And so we are doing just that in our upcoming Zynergy phase two trial. Combining these two molecules with their respective strong clinical profiles has the potential to address unmet needs for patients beyond the scope of monotherapy. in particular for patients needing greater weight loss and or better glycemic control. And that phase two trial is expected to initiate later this year. So taken altogether, you can see why we are excited to have two strong and combinable building blocks in our CVRM pipeline and how they support our ambition to become a top three player in obesity. and with that, let's move to my final three slides, few slides.

42:16 Here we have the 2026 Key Pharma news flow, a lot of green check marks as Thomas noticed earlier, which we love to see and all of the updates I have already covered on previous slides. So to close things out, let's take a quick look at 2027. This is our expected news flow for next year, which we presented to you for the first time at Pharma Day just a few weeks ago. When you look at the table, one thing is immediately obvious and that is that 2027 is a year many key regulatory milestones for us. So our regulatory and launch teams will be exceptionally busy in the months to come to ensure our launch success for our key NMEs and line extensions. However, let's not forget about the upcoming clinical readouts, which include phase three data for two high-profile NMEs, NEXT-007 in hemophilia A and efemcobart and ulcerative colitis.

43:04 I'm very much looking forward to next year and to updating you on all the progress that we will achieve across pharma for patients. And with that, let me hand it over to Matt.

43:13 Thanks, Theresa, and congrats on the strong quarter. So with that, let's get started on diagnostics. So as you heard from Thomas and Alan, with sales of 10.3 billion Swiss francs, the diagnostic division grew by plus 4% at constant exchange or plus 388 million Swiss francs compared to September 2025. Now, as you also heard earlier, this growth was achieved despite the ongoing impact of healthcare pricing reforms in China. Excluding the effect of China, the growth of the business was plus 6%, as Alan mentioned. Sales were additionally impacted by 70 million loss of sales due to the weaker respiratory season in the Northern Hemisphere. Despite that, very steady progress and development from the Diagnostics Division. And looking forward into next year, we expect to return to our constant ambition of mid to high single digit sales growth.

44:01 So now let me walk you through the results by our customer areas. Sales in the core lab increased at plus 5% impacted by the previously mentioned policy impacts in China. Now, excluding this effect, sales in the core lab grew at plus 9%. Sales in the molecular lab grew at plus 3% with strong growth in transplant at plus 17%. However, this was partially offset by the previously mentioned mild respiratory season that lowered testing volumes. the same effect in our near patient care business, which decreased at minus 5%. This was driven by a minus 21% decline in our co-boss Liat sales, but was partially offset by growth in our blood glucose monitoring business at plus 1% following competitive wins.

44:48 Sales in our pathology lab grew strongly at plus 10% driven by advanced staining growth of plus 7% and companion diagnostics growth of plus 21%. So now let's take a geographic view of our performance. In North America, the business grew at plus 9%. In EMEA, the business grew at plus 3%. LATAM grew strongly at plus 12%. Now in APAC, the business declined at minus four. As previously mentioned, sales growth was impacted by the healthcare pricing reform in China. As a result of this, China sales declined at minus 13%. Excluding this effect, APAC grew at plus 6%. Now, you heard a little bit about our groundbreaking Xcelios sequencing launch, and now I'd like to transition to our portfolio updates, starting with the Xcelios sequencing solution, where, as you heard, we've experienced strong launch momentum, achieving approximately a third of our instrument placements that we're targeting for the full year within the first quarter of launch.

45:56 And I would emphasize that in order to continue this momentum, it's critical to demonstrate the capability of Accelios across the most commonly used applications, while at the same time building out the ecosystem of multi-omic tools and partners to support their use. So I'm going to walk you through the slide from left to right. Starting on the left, I'd like to highlight data from UCSF. This was presented this week in Montreal at the American Society of Human Genetics Conference. This data illustrates the capability of Excellios for single-cell RNA sequencing in core labs and some of its key advantages. UCSF demonstrated a high correlation between Excellios and existing sequencing by synthesis workflows across a broad spectrum of cell populations, as you can see on the chart. But what I would call out is that Excellios delivered approximately the same number of reads. However, these reads were approximately three times longer consisting of 300 base pairs as opposed to 90 base pairs with the comparator.

46:57 This enabled deeper isoform resolution. Now finally, UCSF demonstrated the suitability of Excellios for its core lab operations across different applications, including 10X, single cell, and bulk RNA sequencing. Now, if you move to the center of the slide, the second set of data, which was presented by GeneDx, again at ASHG, highlights the complementary capabilities of our SBX duplex high accuracy and SBX simplex single read, longer read modes for whole genome sequencing in rare disease. Today, GeneDx uses frontline short read sequencing combined with additional confirmatory testing for certain variants. Excellios has the potential to consolidate these workflows onto just a single platform by combining our high accuracy shorter reads using our duplex mode together with the longer read capability of our simplex mode.

47:53 And our SBX duplex mode showed concordance with existing frontline testing for all assessed variants. Furthermore, the longer reads generated by SPX Simplex showed the potential for direct read-through of expanded repeats that would normally require additional confirmatory methods. Finally, on the far right, I'd like to highlight our collaboration with Twist Bioscience to develop a target enrichment kit for Exelios. This collaboration will deliver workflows for different sample types, including cell-free DNA and FFPE tissue samples. Together with our previously announced collaborations, such as 10X Genomics and Olink, this will further expand our SPX ecosystem and enable a broader range of applications and workflows. Overall, these examples further demonstrate the capability of Excellios across all relevant sequencing applications together with expanding our ecosystem of partnerships.

48:54 So now I'd like to move to our molecular diagnostics infectious disease portfolio and start with the CE mark for our CoBus HDV assay, which was announced on July 14th. Hepatitis D affects nearly 12 million people globally and severely affects people who are already co-infected with HBV virus. Despite being the most severe form of viral hepatitis, testing still relies largely on manual methods or lab-developed tests, and there is currently no fully automated molecular IVD solution available for hepatitis D. With CoBOS-HDV, we're introducing the first high-throughput automated molecular IVD assay for detection and quantification of hepatitis D virus. Now, this will support the identification of infected patients as well as monitor their response to treatment. This is becoming increasingly important as novel therapies for hepatitis D become available. So with this launch, we further strengthen our leading infectious disease portfolio, specifically in the highly competitive and valuable hepatitis segment and expand our molecular testing offering in an area of growing clinical relevance.

50:05 So now I'd like to continue with molecular diagnostics and pick up on something that Thomas mentioned earlier. I'd like to highlight our rapid outbreak response capability to address public health challenges on a global basis. So within our TIB Mobile organization, we maintain a library of over 15,000 test pre-designs across a wide range of pathogens and more than 3,000 positive control materials. So combined with our strong expertise in oligonucleotide design, we can rapidly develop primer and probe combinations for new pathogens. Now, these tests can be rapidly deployed on our LightCycler and X800 systems to provide prompt response to emerging public health needs.

50:50 Given our global installed base, this is something we can scale very rapidly. A recent example is the Ebola-Bundumbugyo outbreak in the Democratic Republic of Congo, where we developed a PCR test within just six days of the virus genome being published. And I would call out that commonly used PCR tests that were available at the time of the outbreak were not able to detect the Bundumbugyo viral clade, leading to delays in diagnosis. Our test is able to accurately detect this viral clade and we're actively working to support the response to the outbreak in the DRC. A second example is the recent US outbreak of cyclosporiasis. In August, we announced two new PCR RUO tests, one specifically targeting cyclospora and another detecting the parasite as part of a multiplex gastrointestinal parasite panel. This provided a key resource to support outbreak surveillance.

51:46 These examples highlight our leadership in molecular diagnostics and underscore our commitment to support global public health response to emerging infectious diseases. So to conclude, I'd like to report progress on our key launch list for the Diagnostics Division. For the 11 launches here, we've achieved seven by Q3, and we're making good progress towards the other. I would just call out some of the tremendous launches we've had this year, such as our PTAL 217, our Alexis Neurofilament Lye Chain, and our Alexis TB IGRA assay, all of which have tremendous potential for the growth of our division in the future, as well as the ones highlighted by Thomas. So with that, thank you very much for your attention, and I'll hand it over to Bruno for the Q&A.

52:31 Thank you, Matt. And with that, we will start our Q&A session. First questions come from James Gordon from Barclays. James, please.

52:39 Hello, James Gordon from Barclays. Thanks for taking the questions. One question on hemo-oncology which was GenMab and Abby recently announced strong headline data from the DLBCL2 first-line DLBCL study and they had a strong benefit for epikinia and NARCHOC and it looked like a clean side effect profile. So the question was does that raise the bar for what you hope to see for Columbia plus Bolivia and SkyGlo and if SkyGlo delivers on your expectations how do you think first-line patients will be treated in DLBCL? Is it going to be sort of a segmentation by the severity of someone's disease or something like that? Balancing Side Effects and Efficacy. But one question, the second question was on neurology and the slide on AAR benefits and RMS was interesting. And I saw the strong benefits that Feni's got. But then also, how do you think about AAR versus CDP benefits, so disability versus relapse rates? Because different agents have different profiles there, it seems.

53:30 and more broadly in MS, 9 billion peak size for Aquavis. But what is that assuming for the BTKs? And do you still think you can do that even if the BTKs are very good there?

53:42 Great. So let's start with Ipkinley and where we think second line DLBCL would go. And I would say, I think we found that data very encouraging for a variety of different reasons. So first of all, let's remember that we've already seen very strong phase two data for our own combination in this setting. And we do believe that that phase two data will translate into phase three. And although Thank you for joining us. A combination that we believe is going to be very efficacious and much more tolerable and frankly easier to give from a community physician perspective.

54:35 So I think if anything, the data that we saw actually just raises our confidence in what we're likely to see with our own trials. When it comes to Fetabrutinib, so let's start with your last question first, which is we think there is actually still plenty of room for BTKs in MS. We still have 45% of patients today that are on a low efficacy therapy. And those patients are very ripe for moving over to a BTK. So we continue to believe that we have that 9 billion opportunity for Okravis between Subcut. And let's not forget, we also have OB coming as well. There's still a lot of opportunity for us with Okravis in this space. And then we believe Phenobrutinib will ultimately just crack up a whole new market segment very much like Subcut did for us. very much like Subcut did for us with the community physicians for Ocrevus.

55:31 When we look at Phenobrutinib, again, I mean, I think when you look at ARR versus CDP in RMS Phenobrutinib set a new efficacy bar. I mean, we have just never seen medicine with efficacy like what we've seen with Phenobrutinib, 50% reductions in ARR versus teraflutamide, 70% reductions in brain regions, clinically meaningful, nominal and significant, nominally significant improvements and CCD-P12. We are definitely in that high efficacy category. And so we believe that phenobrutinib really does represent that best in class BTK based on the non-covalent binding, the differentiated clinical efficacy that we've seen in phase three. And that dosing really is optimized to reach the concentrations in the blood and CNS that we believe will be clinically meaningful in terms of immune modulation.

56:21 So net-net, I think Feni has set a very high efficacy bar. We see benefits in both progression and disability, and we think it is the one to beat from an efficacy perspective.

56:37 James, did we answer all your questions?

56:39 Yes, you did. I've got lots more questions, but I'll get back in the queue. Thank you.

56:43 Very polite of you. Then let's move on. Next questions go to Matthew Weston from UBS.

56:53 Thanks very much, Bruno. Two from me, please. The first one, quite simple. Teresa, when should we expect to see first overall survival data from LIDERA? Obviously, there are a number of clinicians who are looking at the strength of clinical efficacy data when they look at guidelines and how to integrate duradestrin into the treatment algorithm. And OS is clearly going to make a huge difference to some of the more skeptical docs. And then the second question, just reflecting on the pharma day. It felt like you were more enthusiastic on TL1A combos than perhaps monotherapy. Now, maybe I misinterpreted, but if not, when should we think about the real commercial contribution of a FimCubArt actually having an impact on Roche?

57:36 Yeah, so great questions, Matt. Thank you. So with Ladera, the next OS cutoff is next year, and we anxiously await that just like everyone else, so more to come. In terms of the TL1A combos, I think we, you know, we are still very encouraged by or very, very excited by what we plan to see with monotherapy data with TL1A. I mean, obviously, that's the data that we had with the phase twos, which were very impressive. So, you know, I would expect to FIMC to make a meaningful contribution kind of off the bat as we as we would expect with any new launch in a disease area of this size. I think our excitement around the combos comes from the fact that, as with any immunological disease, these diseases are very heterogeneous and complex. And so the reality is, in order to get the maximal amount of efficacy benefit, a combination, rational combination, likely make sense. And so I think those are things that we will continue to pursue.

58:33 But I wouldn't say I am unexcited about the mono opportunity. I think the data that we saw in phase two was quite compelling and would represent a significant step forward for these patients.

58:46 Could I just push, Bruno, if I'm allowed? Yes, please. The OS data, can you give us any indication during the year? First half, second half? I mean, I'd love a month or a week, but...

58:57 It's more towards the first half.

58:59 Yeah, it's more towards the first half.

59:01 Perfect. Many thanks indeed.

59:02 Yeah, we haven't been more specific than that.

59:04 No, no, that's great. First half's perfect. Thank you.

59:06 Yep. Then let's go on. Our next question goes to Richard Fosser. Check it more. Richard?

59:15 Hi, yeah, thanks Bruno. A couple of questions, please. Firstly, just going back to Ocrevus, we've seen competitive pressures from Bionvi. Just when you think those might abate a little bit? And also on Zenovo, it does seem at the moment that's more switching, which is obviously good for the LOE, but really not adding incremental potential. So when can we see that change? Thanks very much.

1:00:06 Absolutely. So, gosh, these are all very good questions. Where to start? So let's just take them in order. So with Briamvi, I mean, I think the reality is Briamvi is getting inroads because it's using very, very aggressive contracting strategies. We've talked about this now for the last couple of quarters. This is something that we believe ultimately is going to be manageable or is ultimately manageable. And it's probably ultimately not super sustainable. If you look at their share of market versus their share of sort of value, you know, these are, These are aggressive strategies. And so I think we do believe that ultimately we will be able to handle the BMV impact. From a Zenovo standpoint, actually 50% of starts of Zenovo are naive to Ocrevus. And so we are seeing a significant uptake in the naive population.

1:00:59 This is, you know, this is exactly, as I mentioned before, what we really had hoped to see with Zenovo. Ocrevus was very heavily penetrated into our academic centers, into urban centers where IV capacity is very, is very readily available. But when you look into more rural settings, more community-based treatment where IV capacity is more limited, this is a perfect place for Okra Vista Novo. And that is where we saw a lot of our initial uptake, and that's where a lot of those new naive patients come from. Though I will say, as you do see switching in some of the bigger institutions, patients love the convenience of the 10-minute Injection. And so I think you can really, you really see a nice pickup on both sides.

1:01:46 And that's really what you want both for Ocrevus. So yeah, and it's, as I mentioned, it's the fastest growing anti-CD therapy out there right at the moment. So we're quite pleased. I'm quite pleased with what we're seeing with Ocrevus synovus. Now, it might surprise you to learn that I'm not going to reveal all of my launch plans to you on this call, but what I can tell you is that we are very well prepared for ensuring that patients have the ability to access gerodestrin out of the gate. And that does in fact mean that we will do things that are maybe that you've seen more similarly or more familiarly in the immunology settings. We do anticipate creating an access hub program where patients will enroll and where we'll be able to give them assistance as we do in all of our therapeutic areas with maintaining reimbursement.

1:02:39 We will have a bridge program. I won't go into specifics on that. But what I can tell you is that when Girodestrant launches, what you can expect from us in terms of how we will report. So of course you will see sales. What we will also be able to give you are the total number of patients who are enrolled in the HUB program and we will provide that to you on a quarterly basis. All patients in the HUB program will have received a prescription. And so it will start to give you a sense of how many patients are actually sort of actively either getting or in the process of getting gerodestrin. So hopefully that gives you a little bit of a sense of what you can expect in terms of the metrics that we'll be using more publicly to measure the launch.

1:03:33 and just to reiterate, we are expecting that kind of hockey stick like uptake. We all know that this is a chronic therapy. These patients stay on therapy for a very long time, five years plus. And so, you know, we would expect to see more of a hockey stick like uptake. And then again, just to reiterate what I said at half year as well, consensus is about 500 to 600 million for gerontodesk right next year. And we think that that's sort of right in line.

1:04:04 Perfect, thank you very much guys.

1:04:07 Answered all your questions?

1:04:08 Yeah, thank you.

1:04:10 Then next questions go to Graham Perry from Citi. Graham, please.

1:04:20 Great, thanks for taking the questions. So follow-ups there on Giri Deshmet as well. So on the coverage programs and just a couple of points or questions there. So one, do you expect that to cover Medicare patients as well as commercial? and what sort of percentage of patients do you think will be covered by insurance at launch and how do you expect that to progress through 2027 or is that going to be more of a step up in 2028? Do you need the overall survival data for EMA filing? and then on the pharma day you suggested about the and just now you just suggested the consensus five to six hundred million is in line with your internal expectations but does that include just naive patients or are you including switch patients who are already on aromatase inhibitors or have stopped aromatase inhibitor CDK4-6 due to tolerability issues? Thank you.

1:05:16 So maybe just to mix it up, we'll take them in the reverse order this time around. So in terms of who are the patients that we expect to come on initially, so I think it will be a mix. I mean, obviously the biggest sort of bolus of patients you might expect are patients who have dropped off or are looking to drop off their CDK4-6s due to tolerability. It's clearly a fairly large group of patients, and we would expect that they're anxiously awaiting the gerodistrant launch. And then you have naive patients as well, who would clearly be very appropriate to start from a monotherapy perspective as they begin their journey. And then over time, and as our data sets mature, I think obviously you're also going to get those patients who are in need of adjunctive therapy to their CDK4-6s.

1:06:05 So net-net, I think out of the gate, there's actually a significant opportunity within these patients. And as Bruno reminded me before we started today, we have put a ton of epi data in the appendix of this slide deck. So anything and everything you would ever want to know about the epidemiology of hormone receptor positive breast cancer is all in the appendix. So please take a look at that. Oh, so for Pharmaday, the Pharmaday appendix is where it is. There's a ton of great data. So please do take a look. in terms of overall survival. So we do intend to start our conversations with EMA next year. And in keeping with our longstanding commitment to make sure that we go to markets with the filing packages that we believe have the most, the highest likelihood of success to achieve sustainable reimbursement, we would hope to have OS in that package when we begin to talk to our European regulators, which we would expect to do next year.

1:07:05 In terms of gerodestrin, so I'm not going to get into a ton of details for competitive reasons on exactly what the bridge program will look like. But clearly with any new medication, there's always payer challenges and you can rest assured that we have been thinking very, very strategically about how to ensure that we're able to help as many patients as possible get on therapy as quickly as possible. out of the gate. So again, I won't say more on that, but know that we have put a lot of care and thought into our patient assistance programs for gerodistrin at launch.

1:07:42 I think maybe, Perry, what we can add for the bridging programs, I think they are set up for the first six to nine months in this phase when there is still some blocks in place until we have resolved these issues. Any additional questions? All your questions answered?

1:07:57 No, it's great. Thanks, Rene.

1:07:59 Yeah, then let's move on. And we move to Steve Scala from Cowen. Steve.

1:08:06 Thank you so much. Two questions. First for Alan. There are several different 340 reform proposals in the US. Should one of them be passed? What is the range of possible outcomes for Roche? For instance, could it be a material upside for Roche? Secondly, Regarding the PD-1 VEGF target, since Roche's Pharma Day, one of your peers that had been firmly on the sidelines has completed a big investment. Roche is now one of a dwindling group of major oncology companies not involved in this target. Is this Roche's final word on the topic or is Roche's view in transition? Thank you.

1:08:50 You can take, why don't you take the first one?

1:08:53 I can take the 340B topic. So obviously none of the 340B proposed rules are yet final. We are looking at them closely and considering what any of them might mean for our business. What I can tell you right now based on what we know is we would not expect any of them to be material and they seem very mitigatable from our perspective.

1:09:13 And to your second question, we're definitely not on the sideline. We have actually internal programs which look at bispecifics and trispecifics in this space that also includes PD-1 MEGF.

1:09:30 Steve, does this answer all your questions?

1:09:32 It does, Bruno. Thank you.

1:09:36 Then we move on. The next one is Luisa Hector from Bloomberg. Luisa.

1:09:45 Thank you, Bruno. I have a couple. I'll go for Jura Destran again. So maybe just whether you could comment. We're estimating that around half of the eligible patients might be Medicare. I don't know if you can give any colour around that. And then the second question really connects to the outlook for R&D spend, but also business development, because we can see the high level of success that you've had this year. So I wonder if that changes Your appetite for deals or the focus of the deals may be now shifting more early stage since you have such a full late stage pipeline and therefore what does that mean as we think about R&D spend into 2027? Thank you.

1:10:31 Yeah, I can take the second question and you take the first, so I can go with the second. Let me just quickly give an outlook on R&D spend also for next year and also in terms of, you know, what you can expect. So first of all, we do expect that the growth that we have, we can continue a good growth trajectory into next year. And I think what we have already committed is that we will at least keep margins stable. I can say that we'll definitely increase margins also next year. But of course, this means that also we will have more money flowing into R&D because we have so many trials ongoing. But I just want to reassure you, we will increase margins next year.

1:11:23 That's the first thing that I can say. On the BD side, I completely agree with you. We have a very full late stage pipeline. So the pressure that maybe other companies feel, we don't feel that pressure. That doesn't mean that we're not open to late stage opportunities, but they have to make sense. They have to make sense financially. They have to make sense from a scientific perspective. and clearly what you have seen we've done more early stage deals also to make sure that we have a full pipeline once we get beyond all those different medicines that we'll read out. So I think we are in a good position here and as mentioned before we have sufficient M&A firepower if we need it or if we want to spend it but we're not in the same pressure situation and certainly we will not overspend and we'll stay disciplined.

1:12:13 Absolutely. And in terms of the insurance breakdown, we have not disclosed that to date. But what I can tell you is that we are actively looking at all types of insurance and again, how we can help ensure that patients get on therapy as quickly as possible.

1:12:31 Luisa, did these answers help?

1:12:33 That's great. Thank you.

1:12:35 Yeah. Then we go on. The next one on the queue is Truong Huynh from RBC Capital. Strong, you're unmuted.

1:12:56 Apologies. Thanks for taking my questions. I have two, if that's okay. So just the first one, can you just share us your expectations for the Giri label ahead of that November 30 of PDUFA? Do you have any color from the FDA on safety concerns? It does look like the data safety is quite clean, but we're just curious if there's any expectations for any warnings particularly around bradycardia signals we saw in Ladera. Could that translate to any monitoring requirements? And then on Xolair, you reiterated the 20% full-year growth target. We understand the buying patterns in 3Q, but on our calculations, you need close to 40% growth for 4Q to achieve that target.

1:13:41 just what gives you confidence in that trajectory and in one queue you indicated you shouldn't expect any additional Zola biosimilars beyond the first launch for at least two years. Does that guidance still hold? Thank you.

1:13:58 So in terms of the gerodestrin label, we're obviously in active discussions with the FDA right now. So I'm not going to comment on what we believe will be in the label other than to say, you should anticipate it would be broadly in line with what we saw in Ladera. And again, many of the safety events that like QT prolongation, et cetera, that you've seen with other surge, you just simply don't see with gerodestrin. And so, again, I think you've seen the data, you've seen the trial design, and we should extrapolate a label. In terms of Zolaire, We do believe that the buying pattern had an impact in Q3. We obviously do now have the first biosimilar that is in market for Zoller and that will have an impact as well, but we're still quite confident in the around 20% growth that we have been messaging for a full year.

1:14:54 In terms of additional biosimilars, we expect that there could be one or two additional biosimilars coming in US, that's possible, but that is contingent on US approval. So right now we are staying with the outlook that we had provided earlier, which is, again, around 20% in 2026 and flat in 2027.

1:15:17 Maybe trying quickly to add, I think we had two very strong quarters beginning of the year. I plus 26 and plus 28 percent. So now the third quarter is a plus eight. So I think it's doable. And the other thing is, I think the two additional potential biosimilars to come next year, they were always, you know, back on our mind. So we'll have to see how this plays out. But currently it stands as Teresa indicated.

1:15:40 And I think we can say, Bruno, we had plus 20 percent year to date. So I think we need another Q4 with 20% to get to where we want to be.

1:15:51 Any other questions?

1:15:54 That's great, thanks very much.

1:15:56 Okay, then we go on. So next one would be Michael Leuchten from Jefferies.

1:16:03 Michael, please. Thanks Bruno. Could I please ask about the Novera study and the CDK for six combo study that Teresa flagged. There seem to be single arm studies, just wondering why and how you'd be able to, Get those on label if and when they read out. And then clarification, please, on the Weizmann period. Helpful to confirm the growth outlook for the end of this year, low double digit. Dynamics into next year. I think previously you said there's no structural change to the growth profile for Weizmann. Does this still stand for 2027 if the US growth momentum doesn't come back and we see a little bit of a sequential flatlining in Europe?

1:16:47 Yeah, so just to confirm with Novera, so those trials are not meant to be label enabling. They're meant to generate safety in some experience data, but they're not anticipated or expected to be label enabling. When it comes to Vabizmo, I think we've been pretty consistent in where we believe the market for Vabizmo is heading into the future. I think the US has re-baselined. We are expecting to remain in that sort of low single-digit growth for Vabizmo in terms of sales. It's probably important to note though that the volume growth in the US is much higher. There's a contracting effect that kind of takes takes effect there. And then when you look ex-US, there is actually significant growth for Vibismo and sort of more opportunity for growth and penetration to come outside of the US. So I think we remain very confident in that 6 billion consensus peak sales number and believe we're well on track to achieve that.

1:17:51 Michael, did this answer all your questions?

1:17:55 Yes, thank you.

1:17:58 Then next questions go to James Quigley from Goldman Sachs. James.

1:18:04 Great, thanks Bruno, thanks for taking my questions, James Quigley from Goldman Sachs. I've got two please, so one for Lopenzoller. Can you give us a rough idea of the split between the immunology and the food allergy indications in terms of sales or proportional or whatever you can give us? Just trying to think about biosimilars as well in terms of at what point could the biosimilar start to hit the food allergy indication or are there any and other exclusivities or protection that you have for that indication. And the second one is on Tanpelli. So what are your plans here for indication expansion? Some of the competitors in China are looking at significantly expanding into a broad set of cancers. Given the speed of movement out to China, how quickly can you move to establish an early advantage across B7H3 tumours? And what are the gating factors that you need to overcome here as well? Thank you.

1:18:53 Great. So let's start with Tampelli. So I think we shared at Pharma Day that we have great excitement around Tampelli. So obviously the global phase three trial in second line is being initiated by the end of the year. The details of that study design, including the comparator that we'll use, will be announced in due course. And then we are actively looking at accelerating clinical development with global trials across multiple indications, non-small cell, small cell. and additional tumor types that have that B7H3 expression, pancreatic, breast, HCC. So we do believe that the data we've seen with Tampelli, both in terms of efficacy, tolerability is very compelling. And so we have plans for a broad development program for that molecule.

1:19:39 So stay tuned and you will definitely hear more. In terms of the breakdown for allergy and food allergy, We have not previously shared that. So I think we're seeing great growth actually also in our chronic urticaria indication as well. So Xolair overall, it continues to grow both in allergy and in food allergy.

1:20:06 I think maybe as a hint I think since we launched food allergy all the growth we have seen since then basically was was food allergy I think whereas the other indications were more flattish but I think that's how you can calculate it back maybe one add-on I think James if you go to the Pharma Day presentation I think there you have a full list of what we announced with respect to Tampelli so I think we have a phase three global study in non-small cell lung cancer to be initiated later this year in Q4 Small cell lung cancer, sorry. We have, I think, done a global study in non-small cell lung cancer to initiate first half 27. We are looking into prostate cancer. We are looking into breast cancer. I think this is already what we have communicated.

1:20:53 Any other questions?

1:20:55 Just in Zolaire, whether the biosimilars can attack the food allergy straight away or are there any other protections?

1:21:00 Yeah, it fully depends on what label they receive. I mean, I think with allergy in particular, we would expect some stickiness for continuing patients. So I think this is an area that will be interesting to watch as the biosimilars come into play. Because again, you're dealing with allergic patients, and conservatism in that population may be higher. And frankly, you're also getting, particularly in food allergy, a lot of young patients So then you also have to convince parents to be comfortable with that as well.

1:21:32 And biosimilars don't have data in that setting? Correct.

1:21:35 They do not. Very good. Then next questions go to Justin Smith from Bernstein, Societe Generale. Justin, please.

1:21:49 Thank you, Bruno. Just a couple on Zilbesserin, if I can. KOLs we've spoken to have expressed a bit of concern about whether or not there'd be an antidote and then second one, could you talk a little bit about the challenges of managing the placebo arm given these patients are receiving treatment so infrequently?

1:22:07 And I'm sorry, for what molecule?

1:22:10 Zilbesaran.

1:22:11 Oh, they'll be strong. Okay, sorry, that makes more sense now. So this is something that we actually looked at when we began to design the trials, but ultimately when you looked at the effect that we were having, we didn't believe that it was necessary or was going to make sense. So I think we're very comfortable in the efficacy and safety profile that we've seen from Zalbiceran through very large phase two trial populations. And so I think we're very encouraged by what we've seen so far. And frankly, the rapidity with which these trials have enrolled, I think speak overarchingly to the excitement for something that has this profile, particularly given the difficulty in controlling these patients over time.

1:23:01 Thank you. Okay, then next questions go to Peter Fadult from BNP Paribas. Peter.

1:23:13 Yeah, thanks, Bruno. Peter Fadult here, BNP Paribas. Two, please. One on Outlook and one on obesity strategy. Just Thomas, totally hear you on Roche not having a patent cliff to deal with per se, but would like to kick the tires and gauge your early thoughts into next year and whether you would push back on the idea that top line growth decelerates from the sort of mid-to-high single digits enjoyed in the last three years to something closer to low single digits. And I'm saying that not to try and be difficult, but, you know, I get that Giardestra and Feni will be good launches, but you do have growth pressures or slowdowns on a number of products. I won't list them out. You know what they are. We've discussed many of them on the call. So that just seems to be pointing to 2027 perhaps being a lower growth year. So I realized today is not An official guidance platform for next year, but would like appreciate some early thoughts given what you said in your opening remarks. And then secondly, for Thomas or Teresa on obesity strategy, given we now see self-pay, 50% of US injectable obesity market, 90% of the oral market, would Roche have any interest in sort of developing a consumer RX model longer term where you build a sort of portfolio around your obesity pipeline?

1:24:28 to include aesthetics and or men's wellness products. So the question on outlook and obesity strategy. Thank you.

1:24:38 Yeah, so I can take the first question. And I can only say that we're confident that we can maintain a similar momentum that we have. And what I also have said previously is that in terms of margins, we always said that margins will be at least stable. but what I can also commit to even though that we will invest more in R&D and this investment in R&D that we need on top of all of the efficiency gains that we are putting in place on top of that we need those investments for all of the clinical trials and all the exciting new molecules that we have but despite that we will expand margins next year.

1:25:23 And in terms of the obesity strategies, so I think we see the evolution of the market just as you do. Cash pay is certainly going to be a growing part of how monotherapy obesity molecules or medicines are paid for. And we would intend to compete appropriately.

1:25:43 Peter, did this help?

1:25:47 As always, yes. Thank you, Bruno.

1:25:49 OK. Then next questions with Urban Fritsche from ZKIB. Urban, you are unmuted. Urban, you are unmuted. You're muted.

1:26:15 You're still muted. Sorry, it was my fault. Okay.

1:26:20 You're now unmuted. Orban? Okay, let's maybe quickly go on and then we give it a second try later on. Next questions would go to Morgan Stanley, Thibault Buterin. Thibault?

1:26:43 Yes, thank you. Just to follow up on Tampere, based on the data we've seen at WV, CLC, the efficacy looks competitive against other B7H3 and potentially more favorable on the safety profile regarding the ILDs. Is this the key point of differentiation in your view based on the data we've seen so far? And then the second question just on XOLER for next year. Have you already made price concessions in the US given the entrance of Biosimilar? Do you expect to have a very meaningful price impact next year? And so in that context, can you give us an indication on the direction of revenue for XOLER next year if you have any chance of maintaining this franchise or growing this franchise next year? Thank you.

1:27:31 Okay, so for Tampelli, we believe that it's both safety and efficacy that are going to be differentiating for this molecule. I think we've seen it have what we believe to be best in class data on both. So I think we're excited about it from both ends. And I'm sorry, I didn't quite hear I think I mentioned previously that we would expect Zolaire to be flattish next year.

1:28:25 So I think, Thibaut, the first buy similar has launched with a 15% price cut, as you would expect. Nothing exceptional there. And I think we are always, as we have been before, not driving the prices downwards.

1:28:38 Yeah, we're not driving the race to the bottom.

1:28:39 Yeah. Did this answer your questions?

1:28:44 Yes, thank you.

1:28:45 Yeah. Then we have a final analyst in the queue, which is Rajesh Kumar from HSBC. Rajesh, please.

1:28:56 Thank you very much for taking my question. I appreciate you expect to sustain current level of growth with operational gearing. Clearly the street seems to be getting you down to four to five percent top line growth and a bit of margin pressure. I can see that you have An expectation of flat Zolaire versus street modeling a 9 to 10% decline in 27. What are the other assumptions, maybe efficiency on the cost side on AI or R&D phasing or trial phasing costs that we might be missing when we are modeling 27, that we are getting a lower top line growth and a weaker operational gearing?

1:29:49 Let me just comment on that. And so again, I can just reiterate that we do believe we have good momentum. And this momentum will carry us not only through the end of the decade, but into the next decade. And second, please also keep in mind the other revenue line. So we have a number of income that we get from molecules that have been licensed out. that will give us a certain boost. That's why I made the comment that I made. So even though that we stay disciplined in our investment in R&D and M&D, but we know that we also have to invest in the launches, we have to invest in all the trials. We know that we have a certain boost that will help us on the margin.

1:30:44 We have even told the markets that we will grow the other revenue line from 3% of sales to 5% of sales until the end of this decade, until 2030.

1:30:54 So just so that we are clear, are you making a specific assumption about Orphoglipron royalties that the market might be getting wrong? Or, you know, that's a bit more bullish than what the street is modeling?

1:31:12 There are multiple molecules that have been licensed out that will add to growth in that line. And if you just look at the P&L and you assume whatever growth on the sales line, the reality is that any additional growth that will come in that will add to the margin. so I think it's independent what I said is more or less independent of how exactly successful that will be but there is just a certain tailwind that we get through that thank you very much okay did this help right yeah perfect thank you okay and then I think we have one final question Steve came back Steve the final question goes to you

1:32:08 Thank you so much. So there will be some important competitor BTK data at MS Toronto tomorrow. What specifics in that data would represent a clear win for phenobrutinib?

1:32:24 That's a good question. Did you want to answer that? Go ahead. I can answer that. I think that Fenner Brutzenup put in quite a high bar in terms of efficacy. And so we have not seen any data on the efficacy side of that other company. So we're going to be very curious to see how their efficacy data looks.

1:32:47 Okay, I think with that, we will close the call. Thomas, over to you.

1:32:52 Thank you very much, Bruno, and a huge thanks to the team. As we mentioned, I think we have good sales growth this year and good sales momentum. The team and the organization is very disciplined. Also, we have a good line of sight for the next couple of years. We have a number of NME launches. I think that Theresa also showed on her slide how many approvals we will get in the next months. And this will already carry us to the end of the decade. And on top, we have up to 20 NMEs that we could launch, and there are many more readouts that are going to happen. So overall, I think we've made significant progress on our pipeline. and also when you look at face-free success rate, if you look at pipeline value, etc., it also shows that as an organization we've been quite disciplined on cost and we have rearranged and shifted money within our organization to make sure that we can fund a lot of these activities.

1:33:50 And of course, you know, we are very disciplined also on BD and also in the implementation of AI. So overall, you know, very determined, focused and we'll continue to execute and we will deliver.