This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

Roche Holding AG
1/29/2026
Ladies and gentlemen, welcome to Roche's full year results webinar 2025. My name is Henrik and I'm the technical operator for today's call. Kindly note that the webinar is being recorded. I'd 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, just star nine on your phone's star pad. When you then get selected to ask your questions, please follow the instructions from the phone and press star six to unmute yourself. One last remark, if you'd 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 our pleasure to introduce you to Thomas Schienecker, CEO of Wash Group. Mr. Schienecker, the stage is yours.
Thank you very much and good morning, good afternoon and good evening. I'm really, really excited to share with you the updates for the full year because we had an amazing fourth quarter, not only in terms of financial results, but also in terms of pipeline news. So let me get started on the normal overview slide. So group sales in 2025 grew with 7%. Pharma at 9%, diagnostics at 2%. Again, this was due to the China healthcare pricing reforms. Without that, diagnostics actually grew with 7% last year, with a very strong operating performance, with a core operating profit of plus 13%. in the cooperating margin plus 1.9 percentage points, in core EPS plus 11%. So you may ask, what's the difference between EPS and OP? Why is there a deceleration there? This is basically mostly driven through higher taxes. On the full year LOE impact, we had an impact of about 700 million. Now I come really to the exciting part. We had truly an outstanding Q4 when it comes to pipeline use. From a pharma regulatory perspective, the EU approval for Casiva and lupus nephritis, US and EU approval for Lunsumio as a subcut solution, third line plus follicular lymphoma, and US filing for gerodestrin in post-CDKI ER positive, HER2 negative metastatic breast cancer. Now come the many positive readouts that we had. Phase III, Phentrapid and PhenHand, so two positive studies in Phenabrutinib, one in PPMS, the other one in RMS. A positive Phase III study just already this year in EndSpring in MOGAD. positive phase three LIDERA study in adjuvant ER-positive HER2-negative breast cancer, a positive phase three PSGI in AHAS, and a positive phase three in GASIVA in INS, and another positive phase three GASIVA in SLE. And positive phase two in CT388 in obesity. And I know Theresa will go through a lot of these details with you, but you can see with very, very busy news flow. And I think there are more exciting things to come also this year. On the diagnostic side, regulatory approval of the Alexis Dengue test. Matt will talk about that. The Covus BVCV test and also the mass spectrometry extension of our menu. So exciting launches there as well. There is significant news flow ahead in 2026. We are awaiting the second phenobrutinib study in RMS. We are evading Persevera, so the gerodestrin in first line, EO-positive, HER2-negative metastatic breast cancer. We have other studies reading out for ITOV-B, but also for our Diverisib KRAS medicine. And further in Lonzumio and Garzalva. So again, I think very exciting. And we have a number of phase two readouts coming. So it could again be a very busy year in terms of transitions from phase two into phase three. And of course, everyone is talking about it our next generation sequencing solution and we promised it for many years now here it is so i'm super excited also personally that we are now coming with this very exciting solution to the market and uh yeah i think it will cause a couple of waves in the market Now, let me go through the growth rates and I don't think I have to cover too much on the left hand side. But what you can see on the slide is that we have consistently strong growth in the last two years. And even before that, when we had the washout of COVID 19 tests and the medicine, we had a good underlying growth. So we always said we will deliver and we delivered. Now, on the 2025, pharma kept growing at 9%. Diagnostics, we did have the healthcare pricing reforms impact in China. Without that, diagnostics would also have been growing consistently at 7% over this time period. Again, here, we just look at the full year, 9% growth, again, by the pharmaceuticals division, 2% by diagnostics, again, without the China effect, it's 7%, and Roche Group has 7% growth. And this is really driven across our entire portfolio. I think diagnostics, I already explained, and I know Matt will go into that further. But Biasmo, we have continued strong global growth. We do expect that we will see even more uptake in the next year when it comes to the US market. Now that we are also supporting more on the co-pay assistance foundations, and Theresa will go into that. Also, Xolair keeps growing significantly. Casiva, we have now launching in lupus nephritis, but you will see also the other indications really contributing to the growth in this business. Oncology growing well at 6%. For Fesco, we're now at global conversion rates above 50%. Ticentric returning to low single-digit growth. Senza growth driven by US and Japan. On the hematology side, Pol-V is strong now. We are reaching a US patient share of 36%. Col-V, Lonsumio, growth is driven by second line plus launch and third line plus DLBCL. Strong third line growth in follicular lymphoma. So you can see also in the Okavos franchise, we see now a strong uptake of the Subcut solution, as we also discussed, and Evristi is the leading SMA solution and medicine now with more than 21,000 patients on treatment. So overall, we've achieved the upgraded guidance. On mid-single-digit sales growth, we had 7%. And you may remember in the IR call in Q3, you asked, why are we not upgrading the guidance on sales? And my answer was, because 7% is still mid-single-digit, and we delivered 7%. So we delivered on what we also communicated. On core EPS, we upgraded the guidance from high single digit to high single digit to low double digit. And why did we do that? Because we already knew that we would land in double digit range. So we wanted to include it in that range. And that's why we upgraded it at the time. And we further increased the dividends in Swiss franc. So I can say we, for the second year, upgraded the guidance during the year and we ended up on the upper end of these two guidances every time in 24 and in 25. Now what's super exciting is the growth outlook. And the growth outlook has fundamentally changed based on some of the phase three readouts that we have seen in Q4. Geodestrin, our third, has had two positive readouts, one with Evira and the second one with Lidera. Lidera reading out early, we expected the readout only next year, but based on the very significant results, it read out early already this year. We're now waiting for the perseverer data, but we clearly see that we have a very active and very good molecule in hand. Not only is it going to replace the standard of care and it's going to become the new backbone in this field, but it's so safe and tolerable that we do believe that this will become the standard of care. Fenabrutinib in MS, we had two positive studies here in RMS and in PPMS. And now Theresa will go into that. We're still waiting for the second, the FENHANCE-1 study in RMS in order to be able to file this. You will see the data in not too distant future. But again, we are very excited with the data that we have seen. GACIVA, the same. We've had already positive data in lupus nephritis. Now we had two more additional phase three data. Again, something that will give us momentum in the midterm. On the MICIBAR and in NSPRING, we had two trials each. And each of the two trials, we always had two arms and two different doses. In one trial, in both of those, it was fully positive trial. In the second trial, one dose was positive, the other one was negative. Now, this was always a very close call. And based on the conversations we had with the FDA, we do believe that the FDA will support filing here. So this is the midterm. And in the long term, what's also exciting is that we had 10 NMEs moving into phase three. That's a record for us. We've never had 10 NMEs moving into phase three. And these are all NMEs with substantial revenue and patient impact attached to them. Now, we know the other part or topic that's on your mind is our agreement with the US government. Now, the agreement we reached with the US government is not an LOI, it's a contract with the US government. And based on this contract with the US government, which is terminated for the next three years, we get an exemption from tariffs and we get an exemption of the demo projects. In return, we agree to the Medicaid rebates in some of our portfolio. We agree to the encouragement of other wealthy nations to reward biopharmaceutical innovation and to pay their share to contribute to innovation. And we also support the direct to patient medication access with our influenza portfolio, sofluza and tummy flu, and also future medicines with which we can go direct to patients. Also, we agreed to invest in the United States $50 billion over the next five years. This includes R&D and PP&E investments. And for example, on the red dots on the right hand side, you can see where these investments are happening. In North Carolina, Holy Springs, we are investing $2 billion in manufacturing for our CVRM portfolio. In Indianapolis, we're investing in CGM manufacturing. And in Boston, we're investing in our research hub as well as we're going to invest more in Genentech in San Francisco. But we already have a very strong manufacturing and R&D network present in the United States. Now it's all about delivering on the next innovation cycle. So I think we have good growth momentum. We do believe we can sustain that good growth momentum. And how do we keep that beyond 2030? Well, one is we've made substantial progress on our initiatives in order to prepare the company for future success. For the last three years, we've been talking about high performing organization, about delivery and about execution. And I do believe we've delivered on that. We've introduced the bar so that we focus on those medicines with the highest impact. We have an intentional focus in terms of TAs and disease areas. And we look at the portfolio as an overall investment portfolio with certain risk and reward profiles that we want to balance to have the right portfolio. We're expanding into new technologies, not only in DIA, but also in pharma. And we're implementing AI across the value chain. And we've made good progress in R&D. Now, more than 60% of the NMEs are post-bar. 66% of the late stage projects have best in disease potential. We want to get to 80%. And 60% more average peak sales per pipeline project. If you actually take not end of 23, if you take it end of 22, it's even higher. And the same for the total portfolio value. Since end of 23, it's about 45%. If you look at end of 22 as a comparator, we're more than 60% higher. And this is a risk adjusted value. So we do believe we've made a significant move when it comes to our pipeline in terms of higher rewards and also manageable risk. We have a strong on-market portfolio. In the mid-term, we have great readouts that are going to help us sustain our growth. But we have many, many enemies that will read out before the end of this decade. And many of them can be significant contributors to the sales of our company. And here you can see the prioritization that we have done over the years in our portfolio. really taking out high risk, low value projects and adding higher value projects with very strong data as a foundation that gives us more confidence into phase three. And this has resulted in a significant shift in our portfolio value. As mentioned, this is year end 23 as a baseline. If you take year end 22, it's even significantly higher. And on the diagnostic side, As I mentioned, we have been experiencing the headwinds in China from the healthcare pricing reforms. These headwinds will become a lot less in 2026. It will be gone in 2027. We will continue to grow significantly this year. We expect mid single digit growth, but then back to mid to high single digit growth. And these products that you see here can each contribute additional billion when it comes to sales per year. And again, very excited about the sequencer that's coming. Now, let me go through the outlook. For 2026, we again have an exciting year when it comes in terms of pipeline readouts. But then after that, 27, 28, 29 will have many different enemies that will have phase three readouts. In 26, I just want to highlight a couple, Persevera for gerodestrin, Fenobrutinib, Itofbi, Diverisib, a number that can also continue to drive our growth in next years. And of course, we have a number of phase two readouts in obesity. Two of them already have been positive this year. So we had a very good start. So the year ended well in terms of readouts and the year started well in terms of readouts. So we are very positive in terms of the momentum that we have and that we can continue this momentum. And these are the 19 medicines that we can launch by the end of the decade. Now, it's clear that not all 19 ultimately will make it. But these are really substantial contributions that they can deliver to the future business of our company and to patients out there. So I'm very excited about what's ahead for us. Now, let me talk about the 2026 guidance. In group sales, again, we expect mid single-digit sales growth. In core EPS, high single-digit core EPS growth. And we do believe that we can continue to further increase the dividend in Swiss francs. With that, I hand over to Theresa. To Alan, yeah.
That's good, I think. Well, no, no, I like that. Yeah, welcome from my side as well. As Thomas said, great pipeline progress. And that really then combined with great financial results. I think that's really, that's a great setup. And thanks to the whole Roche team for delivering that. So let's go into the results right away. And here's the overview. And I will focus on the right-hand side, so really the changes in constant rates. Sales plus 7%. Matt and Theresa will go into this. 9% on the pharma side, 2% on the Daya side. As said, I think on the Daya side, with the impact from China, Matt will highlight this. The cooperating profit plus 13%. So you see really good cost containment, but at the same time, we have invested where it really matters. And I will lead you through this. And then Thomas mentioned it, slower momentum on the coordinate income and the core EPS, yes, driven by a higher tax load, roughly 600 million, 579 million more taxes that we had to pay, which brought the momentum a little bit down. IFRS net income up 58%. And you know where it comes from. It comes from a base effect from last year. We had two goodwill impairments accounting for 3.2 billion negatively. If you adjust for that, I think it would be a plus 20%, which in my opinion mirrors very well the operational performance. Well, now I come to the cash flow. We could now debate quite a bit about the cash flow. I think you see it, 16.2 billion down from 20.2 billion. Let me say here, we had really a very strong December when it comes to sales and quite an increase in accounts receivables. They will convert into cash. So automatically what I'm saying, I'm expecting quite a strong cash year, 2026. The other piece here is in the net trade working capital inventories. We had the situation that we had to deal with the tariffs. So we brought inventories up a little bit that contributed to this. And last but not least, we have invested more into intangible assets, roughly 600 million. I come to this, but I think that explains the number very well. As I said, I think we will recover quite well. on the cash flow side in 2026. Let me say, I will also highlight this, net debt came down at the same time. I will lead you through this. Good. I think when you look really at the bridge here for the sales, in constant rate, 7% up, as you can see. When you go from the left-hand side to the right-hand side, there is a plus 2% because we have the currency impact in, which is quite significant with my minus 5 percentage points. Let me focus on the middle. You see pharma and the loss of exclusivity of minus 745 million in total, plus 9%, as mentioned. And then you see the situation in Daya, where we have a 7% growth, excluding China, and we have then an impact of minus 579 million coming really from the healthcare pricing reform in China, which means a minus 24% of sales in China itself. Good, with that, let's go through the P&L. I talked about the sales growth. Other revenue, I think on one hand, we had a lower milestone income compared to last year, minus 87 million, but we also had higher royalty income. That's why this is very, very stable and really looks good. Cost of sales, both divisions. increased their cost of sales by 7%, but with very different dynamics. I think really from a volume point of view in pharma, plus 13%. So very, very clearly, I think here a driver for the plus 7% growth on the cost side. I think that growth was also a little bit supported by royalty expenses. And the diet division plus four percent on the volume side compared now to a plus seven percent growth on the cost side. So what is that triggered by? Well, very clearly, the health care reform plays a role here. So China once again, but also higher costs related to placing of machines. which certainly fuels a future growth of diagnostics, so well invested here. We had certainly investments into the new technologies like CGM, Lumiera, etc. And last but not least, we had a tariff impact on the diagnostic side of 64 million half-year impact. So that's also something we potentially have to deal with in 2026. Cooperating profit up 13%, a nice margin increase. When you look at the margins itself, I think really in constant rates overall, plus 1.9 percentage points for the group, you see a nice progression on the pharma division. You see a decrease of minus 1.1 percentage points in CER on the diagnostic division side, which is explainable given that here a significant portion of the sales in China went away. When you look at the core financial results, and really here, interestingly, I think really in CER, we have an increase, and you look at Swiss francs, we have a decrease. And I think really what that speaks for is, well, the US dollar is weak, hurts us a little bit in the P&L, but helps us with the financial result. That's one conclusion here. You see the equity securities with minus 88. I see the market has recovered, but we have some investments in the Roche venture fund where we wait for data. So hopefully a better year ahead. Net interest income, we had less cash available, led to less income here. Interest expenses with plus 69 million concentrated would be rather flattish. But let me say here certainly the weak US dollar helped. And then we have really here other, and these are predominantly less hyperinflation impacts compared to last year. So with that, let's go to the tax rate. thomas mentioned it i mentioned it already let's focus on the middle yeah of the slide first you see really the effective tax rate full year 2024 excluding the resolution of tax disputes 18.1 percent and then you see the effective tax rate full year 2025 excluding the resolution of tax disputes 19.5 percent so you really see uh the increased momentum here but both years yeah were really mitigated by the resolution of tax disputes in 2024 that was a positive of 263 million representing the minus 1.4 percentage points and in 2025 it was a lower effect plus 185 million in constant rates resulting in minus 0.9 percentage points leading to the effective tax rate full year 2025 with 18.6 percent Well, for 2026, I think we will hover more to a 20% tax rate. Core EPS. On the core EPS side, this is the bridge here. I think for me, the most important point to say is it's driven by operations. The increase in core EPS is driven by operations. And I think there's nothing better to say here. Look, I think the product disposals, you've seen the P&L, I think less income coming from that. uh financial income and expenses are negative in constant rates the slides in concentrate that's a negative is roughly 60 million and then effective tax rate changes as said this is the once again mentioned increase on the tech side yeah that we have seen here so operations was the major driver all other effects on that slide worked against us when you look at non-core the ifrs income i've mentioned the ifrs income see it on the right hand side plus 58 percent cooperating profit i've mentioned as well this plus 13 perhaps two points to mention on that slide one is the global restructuring plans you see where the restructuring charges have increased by roughly 300 million i would argue that's a positive because that gives us savings in the future and then i think you see the impairments of intangible assets as mentioned not a lot of impact in 2025 In 2024, with 4.6 billion negatively, an enormous impact, very much driven by the two Goodwill impairments for Spark and Flatiron, accounting both together, minus 3.2 billion. With that, let's go to the cash. And here's the story. When you look at the left-hand side, 20.2 billion, I've mentioned that already in 2024. And then you see in constant rates full year 2025 with 17.7 billion. Well, you see really when you go back to the left-hand side, the operating profit, net of cash adjustments, I think that's the positive momentum coming from operations, really positive. And then you see the networking capital movement. And out of that net working capital movements, minus 2.2 billion comes from net trade working capital. And as I said, predominantly driven by accounts receivables. Let me mention here that has nothing to do with extended payment terms for certain products and nothing to do with Webismo. This is really, we have for, especially for Webismo, payment terms for a longer period for the last couple of years, and we have not changed them. So this is really because we had a strong December and that brought the account receivables up. We have the higher inventories on the pharma side that explains the minus 2.2 billion. We have the investments in PP&E, placements in diagnostics for the positive, side investments that we have done. And then we have the investments in intangible assets, the increase of 645 million, very much driven by Sealand. and the deal we have done there. Then foreign exchange kicks in with minus eight percentage points, quite significantly leads us to an operating free cash flow of 16.2 billion. Well, I think when you look at the margins, I think that tells the same story here. When you look for it, I can just really point back to the fact that we will recover in 2026. Now, when I talk about cash, I have to talk about the net debt development and debt in total as well. And said, I think, interestingly, when you look really at net debt at the end of 2024 with minus 17.3 billion, if you compare that on the right hand side with the net debt position at the end of 2025, we have reduced by 1.1 billion. So you might ask yourself, okay, the cash flow was not so strong. How is that possible? Did they invest less, especially on the M&A side? No, we didn't. I think that the numbers are really on the lower part of the slide. As you can see on the right hand side, you see what we've invested in tangible assets in an M&A is pretty equal. 4.6 billion in 2024 and even more in 2025 with 5.1 billion. One driver here is the weaker US dollar. And you see it really when you look really on this bar, minus 10.7 billion dividends, MNI and alliance transactions and other, there is the currency translation point with plus 1.8 billion. That is a major driver and helps us on the debt side. By the way, we have decreased gross debt by 3.1 billion and certainly as 70% of our gross debt is in U.S. dollar, the U.S. dollar helps in that sense to bring the debt down, at least when we report in Swiss francs. Good. With that, quick comment on the balance sheet. Not too much to say when you look really on the left-hand side where we have the assets. I think cash and market securities went a little bit down. Nothing to mention here. Paid the dividend, all of that. When you look at other current assets, well, higher trade receivables, as mentioned already, mostly coming from the pharma side. And when you look really at the non-current assets, that was driven by higher intangible assets of 4.1 billion, mostly acquisitions accounting for plus 2.5 billion. On the right-hand side, you see the liabilities and the equity. The current liabilities increased mainly due to the higher accounts of payables and bank creditors, some loans here. And the non-current liabilities decrease slightly due to the decrease in long-term debt. I've mentioned the 3.1 billion already. Leads us to an equity increase quite nicely and now an equity ratio of 38%. Good. Leads me to the currencies. Well, yeah, I think really the volatility is certainly disturbing and the weak US dollar is something we're fighting against. You see really the result for the full year, a minus 5 percentage points on sales, a minus 8 percentage points on cooperating profit, a minus 7 percentage points on core EPS. To be honest, if you apply today's rates, that would be basically the same picture for 2026 if we keep all that rates from today until the end of the year 2026. I think it would be basically the same impact. when you compare at year end 2025 and you keep these currency rates stable until the end of 2026 you see it really on the box down low the impact would be minus four percentage points on sales and minus six percentage points on core operating profit and core eps this topic remains yeah in 2026. good core eps I think really we want to set the base right for you for the core EPS. And what is the starting point? Because we have currency effects in the core EPS. So let me lead you through this. You see on the left hand side, the 19.46 Swiss francs per share. um as reported and then i think really we adjust for 0.37 swiss francs yeah to get to the 19.83 um swiss francs per share which would be the starting base yeah for your calculations in 2000 or for if you like for the core aps in 2026 so let me explain now the 0.37 swiss francs What you see here, these are the exchange rate effects. This is a result of dividing the 2025 currency losses of minus 273 million Swiss francs, as well as the 2025 losses on net monetary position in hyperinflationary economies of minus 48 million. This is shown in note four of the consolidated financial statements on page 64. So on page 64, you find that these two numbers, net of taxes and non-controlling interest by the number of diluted shares of 803 million. And this number is outlined in note 29 of the finance report on page 126. Just to confirm that, which is, I think, quite a positive because it sets the higher bar for us, so to say. So hopefully a little bit of a positive for the projections for 2025. Here's the guidance again. Thomas has alluded to it. Let me mention to it the loss of exclusivity impact that we have estimated or that we expect of roughly a billion for 2026. So relatively narrow to what we had for 2025 and well in line between the one and 1.5 billion that we've indicated to you that we will have on an ongoing basis. And with that, I have the pleasure to hand over to Teresa.
Fantastic. Thanks, Alan. I'm going to hand it back to Alan.
You hand it back to me, Teresa.
I'm so generous.
It's hard to bring it to you. But let me make a last comment here. We have a change in our income statement presentation for 2026. um let me say very clearly yeah it has nothing to do with the group in itself so really when you look at sales group cooperating profit and the core eps the metrics are unaffected this topic is between corporate and the divisions and basically what we're doing is we're centralizing the legal department that's that's what we're doing and that has quite an impact when you look at pharma We reduced SG&A costs in FOMA by 250 million, roughly, I think certainly in constant rates, which represents roughly half a percentage point in cooperating profit margin. So you should adjust for that in your calculations. On the diagnostic side, that's roughly 50 million less for the SG&A costs, which represents 0.4 percentage points. in the cooperating profit margin in CR. Corporate equally then would increase by 300 million. Just to point that out, as said, for the group accounts, nothing changed. This is between the divisions and corporate. Just to remind you when you project your margins forward for 2026, especially for the divisions. And now, yeah, I have the pleasure to hand over to Teresa.
I'm going to move forward really quickly in case they try and take it away from me again. So let's jump right in. So as Thomas shared the group perspective with you a little earlier, I wanted to provide some additional color on the key priorities for the pharma division, starting with our focus on delivering the on-market portfolio. Q4 2025 marks our eighth consecutive quarter of growth. So today's on-market portfolio continues to deliver strong performance with 16 blockbusters across our five therapeutic areas. We expect this momentum to continue until 2028. And thereafter, we expect that sales become stable to fully compensate for generic erosion. Importantly, we do not expect a patent cliff. As Thomas mentioned, though, in the near term, we are expecting to deliver multiple key launches, which come on top of today's on-market portfolio. This includes Gazaiva in immunology, Geradustrant in breast cancer, Phenobrutinib MS, Femmikibart in UME, and EndSpring with additional indications in both neurology and ophthalmology. We expect that these products are going to continue to extend our growth momentum until well beyond 2028. We are currently in the process of updating our mid- to long-term outlook, and we'll be sharing that with you a little bit later this year. And so while we're very excited for these upcoming launches, we are just as excited about the progress that we've made on our pipeline. As Thomas mentioned, through R&D excellence and rigorous application of the bar, we have successfully rejuvenated our pipeline. With our postpart NMEs, we have the potential to enter new disease areas like Alzheimer's and obesity, and we aim to bring multiple new transformational medicines to patients. As I mentioned at Pharma Day, all of our activities are really driven by two key tenets, discipline in the business and rigor in the science. Discipline in the business, we remain committed to keeping our COP at least stable. And rigor in the science, optimizing how we spend our R&D budget and applying our bar criteria to each and every asset progressing in the pipeline or entering it, including from partnerships or acquisitions. I am truly excited and confident for the future of pharma, delivering transformative medicines and sustaining our growth momentum. So now let's take a closer look at how this momentum played out in 2025. And we'll start with the full year sales. So as you heard from both Thomas and Alan, pharma sales grew at 9% at constant exchange rates, reaching 47.7 billion Swiss francs. All regions are delivering strong performance, led by our international region with 14% growth. And overall, our volumes were up by 13%. As Alan mentioned, COP increased by 13% versus that 9% sales increase with a COP margin of 49.2%, so slight increase over last year. Clearly, COP grew ahead of sales, which we mainly attribute to effective cost management, particularly in R&D. But I am going to drill down on the individual line items in a little more detail. Other revenue slightly decreased by 1% with higher profit share income from the higher sales of NCLEXA in the US, which was offset by lower income from our out licensing agreements. As Alan mentioned, cost of sales increased 7% against a 13% volume growth. R&D costs declined by 3%. This was mainly driven by savings in Flatiron, as well as some other operational efficiencies. But let me say that this reduction was very thoughtful and deliberate, as it gives us the oxygen that we need for the upcoming CBRM Phase 3 trials. SG&A costs increased by 8%, and this was primarily for two reasons. It was driven by some investments in our growth drivers, particularly Okravis and but also increased donations to multiple independent copay assistance foundations. As part of our broader corporate philanthropy strategy, Genentech doubled its donations to those independent copay assistance foundations in 2025 versus 2024. Our corporate giving strategy is focused on supporting the patients most in need across multiple therapeutic areas, including oncology, neurology, immunology, and ophthalmology. And we continually evaluate the strategy to ensure that it remains aligned to patient needs. And finally, other operating income and expenses decreased by 43%, and this is primarily due to lower gains on the disposal of products. And so now let's look at our individual growth drivers. So as always, first I have to comment on the graph. These are all absolute values in year-over-year growth rates are presented at constant exchange rates. At full year, our top brands, Fezgo, Zolaire, Okraves, Hemliver, Avivizmo, and Polivri generated roughly 3.6 billion in new sales at constant exchange rates. For the fourth quarter in a row, Fezgo is our number one growth driver with 48% growth, closely followed by Zolaire, driven by the continued outstanding uptake in food allergy. You'll also notice the strong performance of Zofluza. And I just want to talk for a minute about that here, which is driven by the strong flu season that we saw in Q1 of 2025 in China. This may create a bit of a base effect for Zofluza in 2026, especially considering that we haven't seen a similarly strong flu season in China this year. So now let's dive into our TAs, starting with oncology. Oncology sales increased by 2% to 15.3 billion Swiss francs, primarily driven by our HER2 franchise. As I mentioned, Fezgo posted an impressive 48% growth, and the global conversion rate keeps climbing. We're now at 54%, well on our way to our new goal of 60%. This of course also means that Progetta conversion to Fezgo continues to impact Progetta sales, which is to be expected. Kevsyla growth continues to be driven by uptake in adjuvant breast cancer. Looking forward to the HER2 franchise overall, and as I've said previously, we expect the HER2 franchise to peak this year at about 9 billion at 2024 exchange rates. followed by a steady decline through the end of the decade with a solid tail of around $4 billion. And that $4 billion is primarily Fezgo, about $1 billion for Cadsila, and a bit of H&P. We do not foresee a biosimilar in the US for Progetta until the end of 2027. And let me also confirm again that we do not expect a cliff situation for the HER2 franchise. For ITOVB, we see good launch momentum in our first-line PI3 kinase or HR-positive breast cancer population, and we expect two phase three readouts this year with the NAVA121 and 122, which could enable further indication expansion. But, of course, the highlight of Q4 was the positive Phase III LIDERA result for giridestrin. I am going to cover this in more depth on the next slide, but let me give you a few quick updates on giridestrin in general. We presented the LIDERA data at San Antonio Breast, and we have already filed the AVERA results with the FDA. That happened at the end of last year, and EU filing is expected for 2026. Therefore, we expect Avera U.S. approval later this year. Lidera results will be filed with the U.S. and EU regulators this year. And the first half of this year, we expect the readout of Persevera and Firstline ER-positive or HER2-negative metastatic breast cancer. Moving on to Ticentric, Ticentric exited 2025 with 3% growth and actually quite a nice Q4. For 2026, we expect low single-digit growth for Ticentric driven by the positive studies that we shared last year, such as Mforte in small cell and Vigor in MIBC and Atomic in DMMR colon cancer. And finally, before I move to the next slide, let me just briefly mention that we expect the first Phase III readout for our KRAS G12C inhibitor, D-viracib, later this year. So now let's take a closer look at the LIDERA results for giridestrin. So here are the giridestrin LIDERA results in adjuvant ER-positive HER2-negative breast cancer, which we presented last December. As you can see, giridestrin demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival versus standard of care endocrine therapy, achieving a hazard ratio of 0.7. Let me emphasize here that this is the first oral surge to show superior IDFS versus endocrine therapy in the adjuvant setting. And in terms of overall survival, the data was still immature, but clearly a positive trend for giridestrin was observed with a hazard ratio of 0.79. Gyradustrant safety profile remains favorable, as we've seen in previous studies, and importantly, we saw a lower discontinuation rate with Gyradustrant versus the comparator arm. This is a significant improvement in this setting, and it indicates the improved patient experience on Gyradustrant compared to standard of care. So taken together, these results further underline Gyradustrant's potential as a next-generation, best-in-class endocrine therapy in ER-positive breast cancer. To expand on this, let me dive a little bit deeper into the gerodesserant development program. So now given the positive Avera and Ladera results we just discussed and the upcoming readouts, we're very excited for the future of gerodesserant. Gerodesserant has the potential to replace standard of care endocrine therapy and ER-positive breast cancer and become the new backbone of choice in the setting. As you can see in the treatment paradigm on the left, our clinical development program for gerodesserant covers different lines of treatment and risk groups with the readout of Persevera and Firstline expected mid-first half of this year. Please note that the agiridescent plus CDK4-6 combination in Ladera relates to a single arm sub-study that's still being evaluated. That's in combination with Abema. We have also started a sub-study in combination with Ribo as well. As you would expect, we are working at speed to complete filings and collaborate with regulators to ensure that this transformational medicine gets to patients as fast as possible. And just to reiterate, we have already filed Avera in the U.S. and expect Ladera filing in Q1. Beyond giridestrin, we also have a strong pipeline of potentially best-in-class molecules in breast cancer that give us the opportunity for numerous future combinations. For instance, our highly potent CDK4-2 inhibitor, which may overcome some of the limitations of currently available CDK4-6 inhibitors. And as I mentioned, we believe giridestrin is the possibility to become the new backbone of choice in ER-positive breast cancer. And therefore, we're exploring many combinations with some of the internal assets, as I just mentioned. Additionally, our phone keeps ringing as we are getting calls from potential partners interested in combination studies with gerodestrin. We look forward to sharing future updates on our breast cancer pipeline with you in the near future. But for now, let's move on to hematology. The hematology franchise delivered strong growth of 15% in 2025, achieving 8.6 billion Swiss francs in sales. Hemlibra closed the year with strong growth, 12%, driven by increasing adoption in the non-inhibitor patient population. For 2026, we expect low single-digit growth, and that's partly driven by competitor launches, which are anticipated later in the year. Polivi's growth momentum continued to 2025, reaching U.S. patient sales of 36% in first-line DLB-CL. But in fact, we reached two significant milestones with Polivi last year. First, it is now the most prescribed regimen for IPI 2 to 5 patients in the U.S. And second, we have officially hit more than 1 billion Swiss francs in sale in the first-line DLB setting alone. Shifting to Columbia and Lensumio, our CD20 and CD3 bispecifics. Launch performance remains on track for Columbia and third line plus DLBCL with second line DLBCL launches gearing up. For Lensumio, we're happy to report that the subcutaneous formulation has been approved in both the US and the EU. And just a reminder that that new formulation reduces administration time from hours down to actually under a minute additionally we expect two key events for linsumio later this year we expect us approval for linsumio plus polyv and second line dlbcl based on the positive sunmo results and we expect the readout for the phase three celestimo and second line plus follicular lymphoma so now let's move on to neurology Our neurology franchise achieved 9.8 billion Swiss francs in sales in 2025 with a strong growth of 11%. Okravis continues to have good momentum, delivering 9% growth globally and crossing the 7 billion milestone in annual sales. We're excited to see the increasing growth momentum of our subcutaneous formulation known as Zenovo in the US. In Q4, more than half of global Ocrevus growth was driven by the subcut formulation. And importantly, in the US and many other early launch countries, roughly 50% of Zenovo patients are naive to Ocrevus. This represents that acceleration that we've been talking about. U.S. update continues to be driven primarily by community practices, which emphasizes how Zenovo is actually expanding the addressable market and can help overcome health care system restraints like IV capacity limitations. Overall, we now have more than 17,500 patients on Okra Vista Novo globally, and that's roughly 5,000 more than we had at Q3. for 2026 we expect to hit high single digit to low double digit growth for okravis and as a reminder we upgraded our peak sales expectations for okravis for the okravis franchise to 9 billion chf by 2029. this includes 2 billion of swiss francs of incremental sales from okravis subcut but of course there's also going to be some switching from iv to subcut Staying with the MS franchise, you've seen the exciting news regarding the positive three results for panobrutinib. We're going to cover that more on the next slide, but for now, let's take a minute on Evrizdi. The global rollout of the tablet formation continues, and we see great pickup from that as well as very positive feedback from the patient community. As Thomas mentioned, this remains the leader in SMA. Quick note that Q4 performance for Evrizdi International was boosted by a tender-related buying pattern, but we are still expecting double-digit growth for Evrizdi next year. Earlier this week, you saw a positive data from Elavides in DMD. We continue to believe in the positive risk benefit profile and the ambulatory DMD population, and more than 1,050 patients have already been treated globally in the setting. Furthermore, the latest three-year data from Embark shows the durable efficacy and slowing of disease progression for ambulatory DMD patients treated with Elavides. We are working with EMA continually to find a viable path forward for EU patient access here. Quickly stopping over PRASI, a quick update here where we have achieved both FPI for the Phase III study as well as we have been able to materially accelerate site activation. So we're a number of months ahead of schedule with the PRASI trial, which is great news for patients. And let me close quickly by speaking a little bit about NSPRING and MOGAD. So MOGAD, if you are not aware, is a rare antibody-mediated autoimmune condition of the central nervous system. which causes inflammation of the brain, optic nerve, and spinal cord. The phase III SETI meteoroid rate out positively, and we're looking forward to presenting that data at an upcoming medical conference later this year. We expect to file these results with the US and EU regulators in 2026, and this additional indication could unlock an upside of approximately 500 million for EndSpring. So now, as promised, let's take a little bit of a deeper look at fenabrutinib. We are very excited about the positive phase 3 readouts for FENI. This includes Fentrepid and PPMS and FENHANCE2 and RMS, with the FENHANCE1 readout expected mid-half of this year. These results make fenabrutinib the only BTK inhibitor with positive phase 3 results in both RMS and PPMS, and it has the potential to be both first and best in class in RMS and PPMS, which would also make it the first and only high efficacy oral treatment for both relapsing and progressive multiple sclerosis. We see fenabrutinib as an opportunity to increase high efficacy treatment rates amongst MS patients and expand the footprint of our franchise. Ocrevus and now Ocrevus Subcut have brought transformational impact to people living with MS, and we believe fenabrutinib has the potential to be that next transformational medicine for these patients. Let me also briefly remind you that fenabrutinib is differentiated by design from other BTK inhibitors. It is the only non-covalent binding BTK in phase three development for MS and has a highly optimized PK profile that allows it to reach its target, including in the brain. So stay tuned for the FENHANCE-1 readout in half one. And until then, we look forward to presenting the Fentrepid results and PPMS at Actrims, where we are also inviting you to attend our IR event on the 9th of February. And so with that, let's move on to immunology. Our immunology franchise grew at 12% at constant exchange rates and reached 6.7 billion Swiss francs in sales. Zoller's strong growth momentum continues, driven by uptake in food allergy. In 2025, we achieved 32% growth in sales of 3 billion Swiss francs. We are also happy to celebrate a key Zoller milestone in 2025, which is that more than 100,000 patients have now been treated for food allergy since launch. Regarding the 2026 outlook for Zolaire, we expect around 20% growth, and this includes the impact of an expected first biosimilar entering the market in the second half of the year. You will have seen that Zolaire was selected for the latest rounds of IRA negotiations, so let me provide a little bit of extra information on this. Zoller's inclusion on this list, as you know, does not change patient access or pricing at this time. Any potential pricing impact, if applicable, would not take effect until 2028 at the earliest. But CMS's final guidance provides that a selected drug will no longer be subject to negotiation and will cease to be a selected drug if CMS determines that a generic or biosimilar has been marketed by November 1st of 2026. And we do expect that a biosimilar for Zoller will be launched before that date. Actemra sales declined by 2% in 2025. As predicted, we are now seeing increased biosimilar impact in the US, which resulted in a 10% decline in growth in Q4. This is aligned with all of our previous communications of an accelerating biosimilar impact in the second half of 2025, which will obviously continue into 2026. Just like in Q3, Gazaiva is one of our key highlights for the quarter. Following the FDA approval in Q3, we achieved EU approval in lupus nephritis, and we announced positive phase three readouts in both SLE and INS. In both indications, Gazaiva has first-in-class potential. SLE results have been submitted for presentation at SLE Euro in early March, and the INS results have been submitted to WCN in late March. Both indications, as I mentioned I think previously, will be filed in the US and EU later this year. And I'm also very happy to share that the FDA has granted breakthrough therapy designation for gaziva in childhood onset idiopathic nephrotic syndrome, which is INS, based on the positive inshore results. And we are not quite done with gaziva just yet. There's one more phase three trial, which is expected to read out in 2026, and that's Majesty in membranous nephropathy. And as a reminder, we see up to a 2 billion Swiss franc opportunity for gaziva in kidney disease. And just finally, I'd like to mention the upcoming phase three readout for cefaxircin and IGAN, which is expected later in the year. Now let's move on to ophthalmology. Ophthalmology grew by 10%, achieving 4.2 billion Swiss francs in sales. The Baizmo performance, as you know, was impacted by the contraction of the US branded market. It landed at 12% growth for the year, which is still quite strong. We had mentioned this contraction previously. And through 2025, we saw a decline of the branded IVT market in the US of about 15%. Nevertheless, the Baizmo continues to gain market share in the branded IVT market in the US and across early launch countries globally. In the U.S., we now see that more than 60% of abysmal patient starts are from treatment-naive patients, and this further solidifies the abysmal position as the standard of care. Looking forward, we would expect the U.S.-branded market to gradually recover in 2026, and taking this into account, we expect a growth acceleration in 2026 driven by the ex-U.S. continued growth and U.S. recovery. In fact, as Thomas mentioned, there is a lot to look forward to in ophthalmology this year. We have two potential new medicines entering our ophthalmology portfolio. That's the Mickey Bart and UME, which is expected to be filed in both the U.S. and the U. And spring and thyroid eye disease will be filed in the U.S., and we are currently considering ex-U.S. filings with the appropriate regulators. Now let's jump into our CVRM pipeline. This is one slide with a whole bunch on it, but I am very happy to share with you the key developments in our pipeline as well as provide a perspective on a very news flow rich 2026. So earlier this week, we shared positive final phase two top line results at week 48 for the once weekly CT388 in people with obesity. This is study 103. For the efficacy estimand, we achieved a placebo-adjusted weight loss of 22.5%. As a reminder, the efficacy estimand includes patients who dropped out from further analysis, so the effect size measured represents the true efficacy of the medicine tested. For the treatment regimen estimand, we achieved a placebo-adjusted weight loss of 18.3%. The treatment regimen estimate reflects a more real-world outcome, acknowledging the fact that not all patients will be able to adhere to treatment. In this case, data after treatment discontinuation either in the treatment or placebo arm are included in the analysis. So for example, it includes data from patients who discontinued treatment early and have regained weight. Now, this was a question we received a number of times over the last week, so I'm just going to take another minute here to reiterate. Generally speaking, the difference between the efficacy and treatment regimen estimates is usually driven by treatment discontinuation, either due to patients on the active treatment arm who regained weight after discontinuing treatment or patients on placebo who go on a weight loss therapy after discontinuation. There are many ways to potentially address this phenomenon in our future phase threes from a more flexible dosing regimen, which allows patients to stay on lower maintenance doses in case of tolerability issues, to the incentive of a long-term extension to retain more placebo patients. But these kinds of measures should serve to improve the discontinuation rate and eventually reduce the gap between the two estimons. In that context, I should also point out that in most of the recent phase three trials in obesity, marked differences between the estimons greater than 5% have been observed. Let me also highlight two other key points in terms of the efficacy achieved in the study. First, we saw a clear dose dependent relationship on weight loss. And secondly, and most importantly, we are pleased by the absence of a visible efficacy plateau at 48 weeks for the highest dose tested, which was 24 milligrams. Taken together, this clearly indicates that further weight loss can be achieved after 48 weeks, and it gives us confidence in CT388's potential to deliver best-in-class efficacy for obesity. In terms of safety and tolerability, CT388 was well-tolerated, and the tolerability profile was generally consistent with the Inkerton class. The majority of gastrointestinal related events were mild to moderate, and total treatment discontinuations due to AEs in all arms were low at 5.9% for CT388 versus 1.3% for the placebo arm. Let me also highlight here, as we received this question a number of times as well, the discontinuation rate due to AEs at the highest 24 milligram dose was similar to the total discontinuation rate observed. We look forward to sharing more detail on the phase two results with you in an upcoming medical conference later this year. Similarly to 388, we saw positive results for CT868 in the phase 204 study in type one diabetes. And just like for CT388, we will share the final results at an upcoming medical conference in 2026. So speaking of the outlook for the rest of the year, let's start with our Phase 2 and Phase 3 study initiations. As a reminder, we announced for both CT388 and CT868 that we will move them into Phase 3 development in 2026. For CT388, we can now provide a first update. The Phase 3 trials for CT388 named ENIF1 and ENIF2 are now scheduled to start in Q1. In addition, you can see that we plan to initiate the 1st, phase 2 studies for and as well as a phase 2 combination study for with. In addition. We have a number of other CVRM readouts scheduled for 2026. There are multiple Phase II readouts to look forward to. For CT388, we have data for patients with obesity and with type 2 diabetes, which will come later this year. We also expect the first two Phase II readout for CT996 are oral GLP-1, and for petrolentide, there's the Supreme 1 and 2 trials in obese overweight patients with and without type 2. And finally, Omegle-Gard and triseptide combination data in obesity are expected towards the end of the year. So as you can see, we continue to progress our CVRM pipeline at pace, and we are excited to share updates with you throughout the year. So last but not least, let's go to the next slide to bring us home. Here we have the 2026 pharma key news flow. We start the year with four green chat marks, certainly a good omen for the year ahead, and we have discussed everything else on previous slides so i won't go into more detail here for any of you who are feeling the lack of the 2025 news flow table we have moved that to the appendix and with that i would say i'll give it back to alan but i'll be crazy and i'll give it over to matt that's wild it's wild all right wild times thank you theresa um good morning good afternoon everyone it's my pleasure to present the full year 2025 diagnostics division financial results
So with sales, as you heard from Alan and from Thomas, sales in diagnostics were 13.8 billion Swiss francs, regrouped 2%, or 292 million Swiss francs, compared with 2024 at constant exchange rates. But as you heard from both Thomas and Alan earlier, excluding the sales in China, which I would reiterate is our second largest market, was impacted by healthcare pricing reforms, the growth of the diagnostics business was 7%. So now let me walk you through these results by each of our customer areas. So sales in our largest customer area, CoreLab, were flat, again, driven by this previously mentioned health care price uniform. Excluding this effect, sales were plus 10%. Sales in the molecular lab increased at 4% due to growth in our blood screening business. Now, this was partially offset by reduced sales growth in the infectious disease segment, which grew at 1%. This was impacted by the USAID funding stop in Q1 that caused a corresponding decrease in HIV testing, which I covered last year. Sales in our near patient care customer area decreased at minus three, mainly driven by the decline of our blood glucose monitoring business at minus 2% due to the market shift to continuous glucose monitoring, as well as a decline in respiratory molecular point of care testing due to the late start of the 2025 respiratory season. And again, back to what you heard earlier from Thomas, we expect the CGM product to really be a driver for this customer area in the future, and we continue to invest in expanding and preparing for this. Finally, sales in the pathology lab grew strongly at plus 14%, mainly driven by sales of advanced staining at plus 10%, and our companion diagnostics business, which grew at plus 25%. So now I'd like to show the geographic performance that's behind these results. Taking through the regional view, North America, the business grew at plus 9%, well ahead of market. You saw good growth in EMEA at plus 6%, again, ahead of market. Latin America, strong growth at plus 11%. Now Asia Pacific, again, as we discussed, minus 12%, driven by the minus 24% decline in China. Excluding the effect of China, APAC grew at plus 4%. Now, as you heard earlier, our consistent ambition in the diagnostics division is to grow our sales at mid to high single digits. However, given that we anticipate diminished but continuing headwinds in China for 2026, we would set our ambition this year at mid single digits for 2026. Again, our consistent ambition is to grow this business at mid to high single digits. Now, I'd like to walk you through the P&L line by line. As previously mentioned, sales grew at plus 2%. Cost of sales, as you heard from Alan, grew at plus 7%. Now, this was mainly driven by that unfavorable impact of the China healthcare pricing reforms, half a year impact of tariffs, and the production ramp-up of our new technologies, such as CGM and sequencing, and the placement of a significant number of instruments in 2025. And I would highlight that we saw growth of some of our key platforms, like our immunoassay, a strong double-digit increase. And, for example, our molecular workstation, the 5800, grew at over 40 percent, so very strong placement of instruments. R&D costs decreased at minus 2%. Now, this is a result of significant and focused cost containment measures across the organization in response to China impact. As mentioned previously, we are ensuring delivery on all our key priorities, especially our investment in the key new product areas, such as CGM, our Xelio sequencing solution, and Lumira DX. SG&A decreased by 2%, again, reflecting focused cost containment measures across the organization. This resulted in a core operating profit of approximately 2 billion Swiss francs, declining at 4% at constant exchange rates, which reflects the cost control initiatives. So now I would like to transition to some of the innovation that we launched in last year, and really specifically focus on our Cobos MassSpec i601, which as you heard from Thomas, these are billion Swiss franc opportunities that we're very excited about and their potential to really deliver growth to the diagnostics division. So as I mentioned before, current MassSpec primarily relies on lab developed tests and lack automation are highly manual and require highly skilled labor. With the launch of our MassSpec solution in 2024, we've introduced the first fully automated IVD platform for clinical MassSpec. So throughout 2025, we received C-Mark for all of our wave one menu composed of 39 analytes spanning the key parameters used in MassSpec testing, including therapeutic drug monitoring, steroid and hormone analysis, as well as vitamin D testing. These comprise the majority of parameters used in a routine clinical mass spec lab, and we are going to follow that with a second wave of additional parameters. I would add that this system, which integrates with our existing serum work area platforms, strengthens our leading position in the core lab. And now I'd like to talk about some of the high medical value content that we launched last year for our serum work area, specifically our dengue antigen test, which received CE mark in October. Dengue is the most common mosquito-borne viral disease globally and represents a major global health burden. It accounts for an estimated 390 million infections per year. It has shifted from being a seasonal illness to a year-round risk with locally transmitted cases shifting from historical geographies such as South America to now in Europe and North America. Diagnosing dengue can be challenging as patients are often misdiagnosed, due to overlapping conditions with other febrile illness. With our Alexis antigen test, we will enable healthcare systems to diagnose dengue more reliably and efficiently by providing all four dengue virus serotypes differentially diagnosed with a rapid test that takes only 18 minutes. This will add one more test to our leading immunohistochemistry platform, or excuse me, immunochemistry platform, which comprises of approximately 120 different parameters. So now I would like to move on to a customer very near and dear to my heart, the molecular lab, and switch to discussing our co-boss BVCV assay, which we received C mark in December. Sexual health diagnostics market is valued at 1.1 billion Swiss francs with a yearly growth rate of 11%. Vaginitis is the primary growth driver within this segment showing a yearly growth rate of 26%. With our CoBOS BVCV assay, we will provide a multiplex assay designed for the direct detection of bacterial vaginosis and candida vaginitis and expand our molecular STI offering. With the addition to our STI portfolio, we will continue to enable testing of the most commonly sexually transmitted infections using a single tube and a vaginal swab. In the future, we plan to continue expanding our offering in this area with home collection solutions, as well as novel molecular point of care assays. Transitioning to our point of care portfolio, I would like to discuss our recent CMR and FDA clearance with a CLIA waiver for our Liat Bordetella panel. Pertussis is a highly contagious disease that causes more than 24 million estimated yearly cases, resulting in 160,000 deaths, with the majority of those in children. Diagnosing pertussis can be particularly challenging as its symptoms often overlap with those of common colds, leading to underdiagnosis. Our Liat Bordetella panel offers a reliable point of care solution delivering results in just 15 minutes between three Bordetella pathogens, and again, delivers lab-like performance. This will enable healthcare providers to act quickly and prevent severe complications, especially in vulnerable populations such as children. As you can see from this slide, this launch, we further expand our CoBOS LIAT menu of lab equivalent point of care testing, and we will continue to expand this in the future. And with that, I would like to transition to our key launches in 2026 and call out a few highlights. Again, I would really want to emphasize that 2026 is the year that we will launch our Exelio sequencing solution. This is a groundbreaking high throughput solution that will deliver high accuracy, high throughput and flexible sequencing based on our proprietary sequencing by expansion technology. And would also again highlight that this represents a potential blockbuster opportunity for us with sales potential above the $1 billion Swiss franc range. I would also like to call out the expansion of our neurology menu, including the Alexis P-Tau 217, which is a blood-based diagnostic for Alzheimer's disease, and Alexis Neurofilament Light Chain for detection of disease activity in multiple sclerosis. greatly expanding our offering in neuroscience. Additionally, I would really like to particularly mention our TB IGRA test, our assay to detect latent tuberculosis infection, which remains a global healthcare challenge and a significant commercial opportunity. And I'm very convinced that we will offer a very differentiated, highly competitive solution here. And overall, this 2026 is going to be a very exciting year of launches. I look forward to keeping you updated over the course of the year. Thank you. And now I hand it to Bruno.
Thanks, Matt. And with that, we open our Q&A session. The first questions go to Sachin Jain from Bank of America. Sachin, please.
Hi there. Thanks for taking my questions. Two, please. So firstly on Vibismo, I don't think you've guided to growth for this year beyond acceleration. So any color on what you're assuming within the guide? And perhaps, Teresa, you could just provide a bit more color on your funding comments. What does that doubling in 25 versus 24 mean relative to historic levels? Like where is that funding relative to sort of a three, four-year average? And any color on how that flows back to patients when we should see an impact to sales? The second question is on Persevera, if I may. and it's a topic that I think has come up on prior calls, but just to reiterate as we approach data, if the study hits, is any hit clinically meaningful for you, or would you need to see a certain hazard ratio or absolute PFS benefit to use that wording in the press release? The reason for the question is there's been speculation since your San Antonio call around passing an interim. Those are my two questions. Thank you.
Yep. Great. So in terms of the BISMO, I'm not going to give you specifics on the amount of money that we contributed, because as you have heard me say many, many times before, our charitable giving is not in any way related to our commercial expectations for the product. So those two things are and have to be completely separate. I can tell you that we doubled our donations last year, and that was a significant increase for us over the last couple of years, as you sort of alluded to. We do believe that 2025 represented sort of a re-baselining of the branded market in the US. And so what we are hopeful is that 2026 will now allow the underlying growth of Abismo to actually be more visible. And so we would expect an acceleration in 2026, and I don't believe we've been more specific than that. In terms of Persevera, so, you know, clearly the fact that we've now seen positive data from Gear Adjuster in a number of important settings, neoadjuvant, adjuvant and in a complex late stage population, sort of underscores our belief in this molecule and that clinically it is potent, it's active and it's combinable, it's tolerable. It's given us great confidence that we do have the opportunity to be really impactful for many different patients and to really become a new standard of care in hormone receptor positive breast cancer. Reading through though to different settings is complex. And so thinking about how we would read through to Persevera, happily, we don't have too long to wait to actually get the answer to that question. In terms of what would be clinically meaningful, we have designed the study to yield a clinically meaningful result. And so generally speaking, a 20% reduction would be considered clinically meaningful. Does that answer your question?
Perfect. Thank you so much.
Okay, very good. Then we move on. Next one in the row would be Peter for adult from BNP Paribas. Peter, please.
Thanks, Bruno. People up from BNP two questions. I'm Teresa just on obesity. We understand from Zeedon that the amylin data is in house. And the market seems to have set the bar at sort of low to mid-teens weight loss. Forget the market for a second. Can we just focus on Roche? What is the minimum target profile you are looking to demonstrate for amylin in obesity? And then secondly, on BTK, you sound very confident about the approvability, despite recent CRLs elsewhere in the BTK class. You know the efficacy in the first relapse-remitting study in PPMS. We don't. Just wanted to sense or kick the tires with you. Is your confidence based on a highly skewed benefit risk profile, or is it more because you think the two cases of high law that you've seen in the data set can be attributed to other or non-drug causes? Thank you.
So I'm going to start with your second question first, because I think, you know, we've gotten a lot of questions over the last couple of weeks about tolibrutinib and read-throughs tofetabrutinib. And I think we have to be very, very cautious here. If you actually read that CRL, it is incredibly specific to the risk-benefit that was seen with tolibrutinib. You know, unfortunately, they had a number of failed trials. They had a number of of of high law cases. So I think it is very difficult and inappropriate to actually take the the language that was applied to Tolabrutinib and actually put that forward on defendabrutinib. Let me be really clear, because I think there have been some, there's been some confusion about what we've actually seen in terms of high-law cases for fetabrutinib. We had two cases of elevated liver enzymes with bilirubin, which was what put us on clinical hold with the FDA. Both of those cases were in FENHANCE1, which currently is a study that still remains blinded. When we looked at those two cases, only one case was deemed by the FDA to be a Hyslaw case. The other one was confounded due to alcohol use by the patient. And so right now, in fenabrutinib, we have only one case, and it is in FENHANCE1, so we are sort of blinded to any more detail. It's also really important to note that since we put liver monitoring in place in the clinical trials, we have not seen any more cases. And so I think we feel very good about the overall benefit-risk profile that we have with Phenobrutinib, particularly when you consider the other half of that coin, which is the benefit. When you look at the phase two trials for Phenobrutinib, you saw a significant amount of clinical benefit to patients. And the data that we've seen are sort of very consistent. And so, you know, I think when you look at that very high efficacy with a with a very, you know, what looks to be very manageable safety profile, I think we're just in an in a totally different situation than what you saw with talibrutinib. So hopefully that kind of provides a little bit more perspective there. So in terms of petrolentide, so as a monotherapy, we believe that petrolentide holds the potential to be a foundational therapy for weight management. We are looking forward to being able to deliver a weight loss that the vast majority of people are actually looking for. which is something more in that sort of 10 to 20-ish percent, with the potential to be a much more improved tolerability profile compared to the GLP classes, as well as just a better patient experience in terms of titration, quality of weight loss, et cetera. So obviously we don't, again, happily have long to wait. We'll see that data soon. You mentioned the data being in-house. We remain blinded to that data. So we have not seen it, but we expect to see it very soon.
Peter, did this answer your questions?
Yeah, thanks, Bruno.
Then we move on, and next one would be Simon Baker from Redburn. Simon.
Thanks so much, Bruno, for taking the questions. Two if I may, please. Firstly, just continuing on Pete's question about phenobrutinib, Um, I just wonder if you could, if you could give us some idea about how we should be thinking about the relative tolerability profile, um, of phenobrutinib versus, um, Ocrevus, uh, ahead of the Actrim's data. And, and how do you see in light of that phenobrutinib being positioned relative to Ocrevus? Uh, and then secondly, a question for, um, Matt, um, it's a little while since you unveiled to us. the new sequencing offering. I just wonder if you could update us on the market feedback you've had in terms of levels of demand and where that demand is coming from, whether it's smaller scale or larger scale applications or indeed both. Thanks so much.
Do you want to go first?
I would be delighted to go first.
And I would be happy to yield the floor.
Wow. So, yeah, and I would maybe give a plug for our Dia Day in May, which we'll talk quite a bit more about this, and Bruno will mention that at the close. Maybe he'll just say that first. But, yeah, we've seen a high level of demand for the Sequencer. I would say more than we had originally anticipated ahead of launch. We're already starting commercial activities with select customers, and the feedback from our early evaluators has been extremely positive. So, when you talk about applications, we're really seeing interest in a broad variety of applications, from translational, such as single-cell, but then on to more focus clinical applications such as, you know, whole genome sequencing and germline. So, what we're really seeing is the potential of an instrument with that kind of flexibility, throughput, and accuracy in a dual assay format with the longest reads of simplex as well as the very high accuracy duplex format to have a broad applicability really across the spectrum of sequencing applications. And I think we're very confident in the potential for this technology as well as the launch. Does that answer your question?
Salmon?
Perfect.
Yes. Great. So when we think about where Phenabrutinib sits, I mean, we believe that it has best-in-class potential. And together with Ocrevus, Ocrevus Subcut, and potentially, you know, further on down the line, Ocrevus High Concentration, you know, we believe ultimately we are going to have a range of highly efficacious and very tolerable therapies that meet every patient with MS exactly where they're at. Right now, 30% of patients are on a less efficacious oral therapy. And so that's sort of an easy place to imagine fenabrutinib starting. But I think ultimately, you know, we believe that this is the combination of these two therapies gives us the opportunity to, you know, really sort of revolutionize the entire patient journey for MS patients. And I think we're feeling very confident about our ability to do that.
Great. Thanks so much. Sorry, I just slipped back onto mute for some reason there, but they've both answered very clearly. Thank you.
Great. Thanks Simon.
Next questions go to Matthew Weston from UBS.
Hopefully you can now hear me. Thank you for taking the questions. The first one on Gerodestrin, Theresa, there's a lot of debate about how the commercial potential in the adjuvant setting could be impacted by the data from Persevera. Can you give us your thoughts as to whether or not you see adjuvant as independent of that frontline metastatic result? And also, there's a lot of debate about the peak sales potential of gerodestrin. So when should we expect to hear what Roche thinks the potential of this medicine is? And then secondly, if I can just pick up on biosimilar erosion. So Q2, Q3 of last year, you made a number of comments about delays to the entry of Xolair and now similar comments about potential delays to the entry of biosimilar Pageta. Clearly, there are multiple patents, so you can do deals with biosimilar companies. But do you think investors should get used to a more gradual erosion of some of these biosimilars at the beginning of generic entry? Or should we still continue to expect to see like a minus 40% that has been kind of the underlying trend so far when we actually see biosimilars enter the market?
So I'll take thanks Matthew for your questions. I'll take your second one first that I have a very definitive answer for you Which is that it absolutely depends so it depends on the therapy. It depends on the part of the world I mean, I think this is one of those things where you know biosimilar impact is is not a one-size-fits-all so, you know in some parts of the world with some therapies you are going to see an immediate decline and With some others like Zoller, we just do expect that to be a smidge more sticky because you're dealing ultimately with a very allergic patient. And so physicians might be a little bit more tentative about switching so quickly. And so I think this is one of those areas where we are We're constantly monitoring the environment. We're constantly talking to treating physicians to get a sense of how they may think about the utilization of biosimilars. And we give to you our best knowledge of how we believe those erosion curves will happen. But it's very difficult to give you one answer because I think it is actually quite variable, again, by therapeutic area and by geographic area. When it comes to girodust rent, so this market is somewhere between a 20 and 30, Billion dollar opportunity. Adjuvant is about two thirds of that between initiation and maintenance therapy. We do think that adjuvant and first line is pretty separate. And we think that gear destrant has the opportunity, as we said, to really be establishing itself as a new standard of care. When are you going to get a better read-through from that? Q1 is a very data-rich year, so the first half is a very data-rich time for us. We're in the process of updating our own assumptions, and as soon as we have a clear read-through, we will share that with you.
Maybe just to answer your question on Progetta as well, because you had this question, so we don't expect the biosimilar for Progetta until 28 in the US and 27 in the EU? Correct. Just to clarify that.
Matthew, do you have any questions?
That's perfect. Thank you.
Then we move on. Next one would be James Gordon from Barclays.
Hello, James Gordon from Barclays. Thanks for taking the questions. Two questions, please. One would be on gerodestrin, actually two subparts. One would be the slight delay in Persevera readout timing, and it's now more likely to be Q2. Is that because the event rate's a little bit slower, or could you be getting a few more events in, and could that actually help the powering, which has been a concern some people have had? And also on duodestrin, the LIDERA study, the side study of about 100 patients, I think, are getting it on top of a CDK. How will you communicate that? And it sounds like you're filing ahead of that because you're filing the data in Q1. So is that something that gets added to the filing package and you hope to have on the initial label, or how does that work? And then the other one was on fenabrutinib. So you sound very confident talking about it being an upcoming launch, which is great. And there's been some talk about liver already. But in terms of other tolerability issues, I saw the comment in the original release about additional safety data is further being evaluated. So could there be some other off-target BTK side effects we need to think about? And just on the side effect point, if you're comparing it to something like Ocrevus, so you've got the advantage of oral, but could you have to have liver monitoring or something like that? Could that be a barrier to it becoming a very big drug. How would you think about that?
Great, okay, so we'll start with the second question first. So we intend to assess the safety of Fetabrutinib when we have all of the studies read out and when we look at the pooled safety. So obviously we only have two of the three studies, so we need to wait a little bit in order to be able to step back and look at that. The data that we've seen so far, we haven't seen anything that is different than what you would see in the background rate of the overall MS population. In terms of liver monitoring, as is typical, when you get your label, usually for things like monitoring, you get what you studied in your label. So we would anticipate that we would have the same liver monitoring in our label that we had in our clinical trial. And again, I think when you look at the efficacy and the risk-benefit profile that Phenabrutinib has, I think this is going to be a meaningful medicine in MS. So more to come as we get the PhenHANS1 data. For Persevera, just to be really clear, the timing on that has not changed. We have consistently been messaging the first half, mid-first half of Persevera, of this year and that has not changed so that that is remaining uh uh that is remaining consistent and uh again we we do plan to file the ladera data first we get the uh the abema data i believe the the sub study data comes is that also in q1 guys someone's gonna have to remind me of that And then the RIBO study, which is a 200-patient step study, is just kicking off, so that will come later. So those are data pieces that clearly, as soon as they are available, we will be making public. But the adjuvant filing is going in to Q1 as planned, and it looks like end of 2026 for the sub-studies.
Thank you. James, all questions answered?
That's great. Thanks a lot.
Yeah, then next one is Rita Kapila from Longstanding.
Thanks for taking my question. So you addressed the Feni approval risk, and I guess others have touched on it, but what is underscoring the confidence in the commercial potential? What's the initial feedback from the physician community being? So we've seen orals with Livatox launch post-CD20 approval, which have struggled to reach 1 billion. So I guess why is fenobrutinib different? And how are you viewing risk from Novartis' remibrutinib in RMS? Data's in Q2, and they've had no signs of Livatox so far. And then the second one's just on Persevera. It's also been touched on, but how confident are you that you have enough patients in the trial to hit stat sig? And how should we think about the passable study and the potential read across to Persevera? Thank you.
Great. So let's start with Phenobrutinib. So obviously the data have not yet been presented. So the PPMS data goes to Actrims shortly, and then the RMS data will be packaged together when we have PhenHans 1 as well. That having been said, we've obviously shared it with those physicians who are part of the trial. And I think people have been really impressed with the data that we've seen. And in particular, people were really impressed with the phase two data that we've seen. So what we're talking about is the ability to get Ocrevus like efficacy in an oral treatment. And for many patients, for many, many different reasons, that's a very attractive option. So, you know, again, I think in this market, a lot of it comes down to the overall efficacy that we're able to deliver. And based on the phase two data, we believe we have a highly efficacious molecule on our hands. In terms of the Novartis data, I mean, it's important to remember we haven't really seen anything. NMS from Novartis yet. This is a dose that I think is, what, four times higher than the existing dose. They had a sort of second mover advantage. They started their trial with liver monitoring. So, you know, I think it's very difficult to compare because we just really haven't seen anything. We have first mover advantage here. We've had robust phase two data. And yeah, I mean, I think we're it's very difficult to say anything until we actually see data. It's also, I think, important to remember that phenobrutinib is a non-covalent molecule. And in a chronic indication, that non-covalency really matters because it means that even though you're taking it chronically, if you need to stop for whatever reason, it does leave your system more quickly. And I think that really in a chronic care environment is a benefit. So in terms of read through for Persevera, you know, it's clear when breast cancer is dependent on the endocrine receptor for viability, GERA-adjusterant can perform very well. And we've seen that in a number of settings. So all of these patients are by definition dependent on the ER signaling and it's worked really well here. So clearly on the front line, the likelihood that it's successful hasn't gone down. And we should always be really cautious with cross-trial comparisons. And so I think we are, you know, again, as I mentioned, the benefit is we don't really have long to wait. So we'll know really soon. Oh, and yes, Persevera is designed to show improvement over Palvo plus Ledrosol.
Sarita, all questions answered?
Yes, thank you.
yeah and the next one in the queue is uh richard fosser from jp morgan richard thanks bruno um thanks very much two questions please uh first question just to go to diagnostics for a little bit uh margins obviously hit by uh by a ramp up of um you know mass spec sequencing and the machine placements could you give us a bit of color on how to think about the margins from here those placements seem likely to continue as you ramp those um those two businesses up uh so how should we think about 26 and then and then the improvement in the margins uh from there and then second question back to pharma just going back to verbismo um uh thanks for the comments on the foundations could we go a little bit further out and think about the future competition potentially from less frequently dosed uh injectable products i think ocular has one half yearly how you think about that sort of competition. And also closer to today, the biosimilars are really starting to come. They're having some impact in Europe as far as we can see. So just what's the thoughts globally, US, Europe on biosimilars from ILEA on Vibizmo? Thanks very much.
in this case maybe no go ahead i just can't i could use a break thank you so uh maybe starting with diagnostics so we talked about a couple of facts there's the new technologies there's the the tariffs of which alan said we had half a year we'll have a full year this year but the biggest effect on on what hit us last year on the margin was really the china effect and as you heard from thomas we expect to see this meaningfully diminished this year uh 2027, again, we expect a decline, but it'll be small enough that it won't really be meaningful. And then we expect to see a recovery. In terms of specific ambition on margin this year, I think I would refer you back to the group position that Alan mentioned earlier. But I would say our consistent ambition is to grow profit faster than sales. And that is once we really get ourselves through the headwinds this year, that is our ambition going forward. And it's also our continuous ambition to improve the margin in diagnostics. That's something that is a goal for the entire organization. What I would call it though in 2025 is you had our second largest market with a 25% reduction. So obviously there was an impact, but that's something that you can see with our discipline on the cost line that you can also expect to see continue again in 2026, but we expect the gradual wash out of that. Anything you would add to that, Alan?
Well, I think for 26, I think, well, we expect kind of a stabilization. I think that's a little bit, yeah, but we would give that additional information.
Yeah, so I would maybe just refer to what Alan said. Our goal really this year is going to be that we stabilize the margin.
And I think on a group level, you have seen that our intention is to expand margin in 2026. And what I've said in the past still holds, which is that also going forward, we will at least keep margins stable also for the coming years. Perfect.
Does that answer your question?
I think so.
Great. So I'd like first just to start by talking about Vibizimo. So I mean, Vibizimo is a highly efficacious therapy with a very well-defined safety profile where you know, patients and physicians do have a lot of good experience in extending doses. And so, and it is designed to do just that. When you look at, you asked specifically about Ocular, I mean, this drug is going into phase three with a very small safety database and really no known no known data on long-term safety. And when you talk about something that's going to be used interocularly over a long period of time, I think long-term safety is incredibly important. So I think it's very difficult to think about how something like that is a threat to something that has such good efficacy, such good safety, and where you do actually have the ability to extend doses. So I think from a, from a future competition perspective, you know, just like in other disease areas, sort of the bar is high here to unseat the bismo. And you had one other question. Oh, biosimilars. So, so far, you know, what we see is that the ilea biosimilars are taking from ilea. And so for those patients who are really benefiting from a new and novel treatment, Vibizmo, we're just less impacted. So, yeah, I mean, I think we saw Lucentis take from Lucentis. We're seeing ileobiosimilars take from ilea. We're seeing high-dose ilea take from low-dose ilea. So there's a lot of trading within that space. But I think for new patients who are going on therapy, physicians are picking the best available therapy out there available to them, and that is Vibizmo.
Yeah. And on ophthalmology, I would like to add that we have an amazing pipeline in ophthalmology. So when you look at all the different validated targets, I think we're the only company that actually has all the different validated targets in-house. And so if you look at our pipeline, we have tri-specifics, tetraspecifics, do the fabs, et cetera. So, you know, if I look at the ophthalmology pipeline, I think the one that's going to succeed, you know, surpassing the bias moments, then hopefully us.
Very good.
Richard? Yeah, perfect, everyone. Thank you very much. Very helpful. Thanks.
Thanks, Richard. And next one in the queue is James Quigley from Goldman Sachs.
Thanks, Bruno. Hopefully you can hear me. Just a couple of quick questions from my side, left over. So firstly, again, on geodesic and revisiting the era, what's the KOL reaction been from your side? So some of the KOLs we spoke to have been a little bit more cautious than the presenter at your Sabses event, given the more limited follow-up versus the CDK46 class. So how do you think this could impact the geodesic trajectory? Of course, assuming approval, would it be more of a stepwise ramp or... Or more of a stepwise ramp as more data comes? Or does your feedback suggest a potential for a faster, more optimistic ramp on your restaurant? So that's the first one. Second one, more of a financial question. So underlying farmer growth has been pretty strong in recent years, driving operating leverage. So how is Roche balancing R&D investment with profitability? For how long can R&D expenses stay flat? This half seemed to show that Roche has a strong ability to reallocate costs in R&D.
how long how long can this go on to support operating leverage thank you yeah i mean i i think what we're hearing from the kol community regarding where they would use ladera is is pretty bullish i mean i think what we hear from the the ladera population is 55 percent of the um adjuvant breast cancer population that's 10 percent more than what we saw in the natalie trials So, you know, I think you are really seeing physicians believe that this could have, you know, very broad applicability in their practice. And so I think that's what leads us to be fairly bullish about the opportunity. You know, there's a 74% overlap with the population in Natalie and Monarchy. And so I think we're very, yeah, I think we're very confident that we have something on our hands here that is quite a game changer based on the data that we've seen.
Let me answer the second question, but first something to add on gerodestrin. I mean, you look at the hazard ratio of 0.7. You can see that that's, I would say, highly competitive to also some of the CDK4-6 trials that you've seen. But what you have on top of that is the tolerability. You know, if you look at CDK4-6, you have quite a high amount of patients that actually stop using it. simply because they cannot take the tolerability. So I think these are all the right arguments for SIRT to be used. So I do believe that the pickup will be strong. Unfortunately, I wasn't at the Congress in San Antonio, but I heard there was standing ovation from the clinicians there. Then the second question on R&D. So we're working very hard to be a high performing, very cost efficient organization. There are still opportunities, in my view, to continue to work on that. AI, by the way, plays a big role in that. We're using AI throughout the entire development process, where we want to, on the one hand, speed up using AI, but also reduce costs doing that. Regarding R&D expenses, also for 2026, I would say it will be broadly flat. Again, really focusing very hard on making sure that we put the money to work in the best possible way for the sake of patients in our company. and for our investors.
And it all goes back to the margin point that you've made.
Yeah, that I made before, which is, you know, it's clear for 26, expand margin. And as previously always said, at least stable for the long term.
James.
Thank you very much.
Okay. Then we move on to Graham Perry from Citi. Graham.
Bless you. Bless you.
So one on the data. Thanks for clarifying the filing timeline as being Q1. Just wonder if you could comment on whether you expect priority review or to use a priority review voucher or not. And when exactly do you think you would expect to see the ribocombo sub study data? 200 patients. How long does that take to recruit? And can we see something by the end of this year? Is that the next year event? And then on the buprenorphine, could you just confirm how important you think confirmed disability progression is versus annualised relapse rate reduction in showing a risk benefit profile in differentiation versus Ocrevus to the regulator? Just given the it's a very brain penetrant molecule and has potentially, therefore, the ability to work on disability progression where CB20 doesn't. And then the final question is, you're technically still on clinical hold with FDA. So does that have to be lifted before you can actually file or receive approval? And what are the steps for doing that? Thank you.
Okay, so we expect the Abema step study by the end of the year. We would expect Ribo in 2027. That is really only starting now. So we've got a little time. That's 100 patients in the Abema arm. and in ribo it's 200 patients the fda hold will be addressed as part of the planned fenny filings but we've obviously been in consistent conversation um with the agency over time so there we've been in very close very close contact um i won't comment on our filing strategy only to say that we plan to uh we plan to bring uh ladera to patients as quickly as possible um infer in terms of um CONFIRMED DISABILITY PROGRESSION. I THINK WE ARE THE ANNUALIZED RELAPSE RATE IS ALSO A VERY GOOD END POINT HERE. AND WE ARE CONFIDENT THAT THAT IS GIVING US WHAT WE NEED IN ORDER TO PROCEED.
GRAHAM, ANY ADDITIONAL QUESTIONS? ALL GOOD. Then we will move on. And I hand over to Rarish Kumar from HSBC. Rarish, please.
Hi there. Two questions, if I may. First, on CT388, thanks for clarifying. discontinuation rate in the highest dose was similar to the overall group. You also mentioned that you could consider flexible dosing in phase three trials as an option. So could you give us some color on how you're thinking about phase three progression, what flexible dosing or an active comparator be something you might consider? Or is it at the moment too early to comment on that? Second, just on a quick follow-up, you highlighted the overall TAM. This class is targeting to be quite a large number. You are filing with a few, some Persevera data is about to read. So just in terms of the market segmentation, how much of the market you think have been de-risked to some extent and how much we still depend on the data in your assessment of the market would be very much appreciated. And because I'm an analyst and I cannot count, You know, the third question would be just on clarification or on the buy small. Appreciate the, you know, working capital impact has gone up and that sort of reflects a very strong December. So. Should we consider the exit rate of December a closer indication of how you're thinking about growth in 2026, or should we take an overall slower growth rate going forward on WebISMO? Thank you.
So I would just go back to my earlier comments for Vibismo we expect to see an acceleration of growth in 2026 so more to come on that in terms of the dosing for CT 388 so what we have disclosed is it CT 388 it will be Administered once a week and we're aiming to develop it at three maintenance doses We are not disclosing at this time the details of that dosing strategy but just to avoid any ANY MISUNDERSTANDING, WE HAVE NOT INDICATED THAT WE WILL BE DOING FLEXIBLE DOSING WITHIN THE TRIAL. BUT RIGHT NOW THE DETAILS OF THAT PHASE THREE DESIGN THAT SPECIFICALLY HAVE NOT BEEN DISCLOSED. AND THEN IN TERMS OF GEAR DESTRIN AND THE MARKET SEGMENTATION AND HOW MUCH DO WE FEEL LIKE HAS BEEN DERISKED, WELL, TWO THIRDS OF THE MARKET IS ADJUVANT AND WE HAVE A POSITIVE ADJUVANT TRIAL. So, I mean, I think a significant portion of the... We have a significant portion of the market has been de-risked.
Thank you very much.
Okay, then next questions are from Michael Leuchten from Jefferies.
Thank you, Bruno. A question for Matt, please. Abbott said last week that the Chinese may be pursuing VBP for core lab oncology. Just wondering whether you've heard that and how that may or may not be reflected in your outlook on the margin commentary you made earlier. And then, sorry, Teresa, just going back to Tobias, just your comment about 2025 in the US being a reset. Q4 was still soft. It didn't really improve upon Q3 sequentially. So when you say you think that's now stabilized and it can grow from here, just wondering how you look at that Q4 versus Q3 dynamic in the US. Thank you.
Okay. Three. Wow.
I know what three is.
That's yesterday. So what I would first start off by saying is, as you may know, there was VBP for core lab oncology reagents last year. And so that was what you see. Our China effect last year significantly represented a decrease in our core lab oncology reagents, which are down about 50%. So some of that effect is still pulling through this year. But I can't speak for what was said on that call, but we are seeing the effect of the VBP last year and the national reimbursement reduction. So we don't anticipate additional core lab oncology VBP this year.
So in thinking about the BISMO, um q4 so 2025 we saw a big reset in the branded market in in uh in the us right with the closure of the copay foundations fewer patients were put on branded drugs more patients were put on avastin and biosimilars and you know you saw a big just sort of reset in how many new patients and continuing patients were actually going on a branded therapy, and that constricted the market by about 15%. That constriction went all the way through Q4, because normally when donations are given or grants are given, they're given four years' worth of therapy. What's happening right now in in the oncology world is something called the blizzard it's where every retinal specialist in the u.s goes and re-verifies the benefits for every single one of their patients and it's at that point in time that you know patients actually determine what you know will they be continuing on their current medication will they be switching etc and so you know over the course of the next couple of months i think we're going to get a real sense of what is the trajectory of the branded market going to look like in in 2026 um but because that underlying base effect of 2024 is now washed out you should be able to see the actual branded growth of people going on to new therapies actually come through so you know i think there's a reason why we didn't see q4 look any different than what the rest of the the year looked like i think we had sort of hoped that we we might see We might see some early signs of recovery, but I think those signs of recovery really are going to become a little bit more evident as we get towards the end of Q1. So, Michael, I hope that addresses your question.
Yeah, and I mean, the co-assistance foundations, they are separate, right? So nothing in terms of influence, but what we can say is, in general, that our donation was towards the end of Q4.
Yeah, and then again, we don't link those two things. It is interesting to know, though, that in Q4, we did see a 4% growth. So we saw, you know... Quarter over quarter. Yeah, quarter over quarter growth. We did see a 4% growth. So we did see a little bit of an uptick.
Michael, any follow-on? If not, then... I would hand over to Paul Kuhn from Cowen. Paul.
Thanks, Bruno. This is Paul on for Steve Scala. Two questions, please. What feedback have you heard from US oncologists and how they plan to initially use girudestrin in the adjuvant setting? And secondly, how did the change in Zoller biosimilar entry from end of 2026 to before November 2026 come about? Was this a change in the settlement with generic manufacturers? Thank you.
So with regards to Zoller, I think we have long said sort of second half of 2026 is when we expected the first biosimilars to come in for the US. So I don't actually think that that's a change.
I think mentioning November was just related to IRA. So basically, we need to have a biosimilar place, a player in the market before the 1st of November. So then we cannot get negotiated.
That is correct. So my reference to the 1st of November was purely around CMS guidance. that says if you have a marketed biosimilar by November 1st, 2026, then you will be removed from the negotiated basket. So that's where that date comes from. But we've always said second half of 2026, we would expect to have a biosimilar in the market. And then feedback from oncologists on where they intend to use for adjuvant. I mean, again, just to continue to reiterate, you know, 55% of the adjuvant population was covered by the LIDERA trial. And so I think you see a high degree of confidence in an oncologist to use in a very significant portion of their patients. And again, you know, what we saw here was a a very, very efficacious, seemingly combinable and well-tolerated therapy that I think has the opportunity to really become a new standard of care in this setting. So, you know, what we're hearing from oncologists in general is that they're pretty excited to have this in their hands and we're excited to get it to them.
Paul, let me answer all your questions. Thank you. Then next one would be Justin Smith from Bernstein. Justin.
Thanks very much, Bruno. Two, please. Farmer number one, NXT007, just wondered if you could share some thoughts on when the phase three design head-to-head versus Hemlibra will hit ct.gov. Second one, diagnostics, Matt, just wondered if you could talk a little bit about CGM and when the finger prick recalibration will be removed and the impact that might have. Many thanks.
Wow, there's four, four is new territory. So I want to first thank Theresa for her generosity. So specific to your question on auto calibration, which is the comparison of the CGM device with a blood glucose lancet, what we are planning to do is have that launch happen this year. I won't say exactly which quarter, but that is an improvement that we expect to deliver this year.
All right. And with regards to next 007, we would expect those trials to start in Q1, Q2 with clinicaltrials.gov entries at around that timeframe. And again, these are two studies, one head-to-head versus a factor in one-hand Libra.
Justin, all questions answered?
Yeah, great. Thank you.
Then I would maybe read here aloud three questions which I got from Luisa Hector. She had to drop off and I promised her I will go through them. There is one question on AcroSynovus. So the split of naive versus switch patients that we are capturing and what is the target switch rate for 2026 and at peak? What I think we have been communicating that we have 2 billion in incremental sales for OCROS, but this is true incremental sales. On top, basically, we would have revenues coming from switching. So we have not yet provided a detailed outlook on what the ratio IV to subcutaneous would be at around 29. We might do that at a later point in time. There's then a second question I found interesting on the pipeline. 66 NMEs now on the pipeline, is this right-sized? And what we have seen now with the turnover in the fourth quarter, with four molecules added, five going out, so five added, four going out, is there still cleansing ongoing of the pipeline? Is this now the regular run rate and the turnover, or would we target more NMEs overall?
Yeah, I mean, I can answer that question. So overall, you know, you apply the bar not only once, you apply the bar constantly based on data that you generate, but also data that you get from the outside. So clearly, I think we are at a point where we'll continue to bring in additional NMEs. we have actually when you look at the very early stage of our research organization we've actually doubled the amount of molecules moving ahead there so we do believe that we'll continue to expand on the amount of enemies that we have in our portfolio beyond the 66 but this kind of i would say prioritization is just something that you have to do constantly based on just availability of data
And then the final question here would be on capital allocation. Given your positive pipeline progress, pharma deals with the US administration and with competitor developments in obesity, are there any changes to your M&A objectives and R&D investment plans?
No, I can say there is no fundamental change. I think what we have really shown over the last couple of years that we've been very disciplined, very disciplined in terms of financials, but also in terms of really screening the market for interesting molecules with good data. If you look at the amount of money that we've spent compared to other companies and the kind of pipeline we've built doing that, I think we've been pretty efficient. And our intention is to continue to do the same and just continue to be quite disciplined on that. good thing is we are not in a situation where we have a huge patent cliff right so we're not in a situation where we have to do uh late stage deals which are very costly i think we're in a very good position when it comes to a late stage pipeline but obviously i mean if you look at the amount of innovation that's ongoing outside look at what's happening in china we need to continue to screen the market and look at everything that's out there i mean i looked at the statistic For about 1,000 companies that we look at, we do one deal. And I think that's also what I expect of our organization, that we know exactly what's going on outside so that we can make data-driven good decisions. Very good.
I think with that, actually, we are at the end of our Q&A session. Let me just remind you of the two upcoming IR events we already have flagged. I assume there might even be more. There's on February 9th, our neurology call. We will cover up the PPMS data for Phenobrotinib presented at Actrims. And then on May 12th, we again will have our diagnostic day as a live event in London where we will take you through the entire portfolio and highlight this year will be SBX sequencing. As we are now in the global launch phase, I think there is the next steps to come with pricing and so on. So I think it will be an exciting event. And with that, I hand over to Thomas for the final remarks.
Thank you very much, Bruno, and huge thanks also to the team. I would say quite exciting times. I mean, if I see all the discussions that we've had as a team over the last three years and the progress we made, I think it's significant. And it's not only that, it's also a lot of fun. Because we get to talk about what we like to talk about, which is science, which is about progress for patients. And with people like Ellen and myself who like math, also we can talk a lot about financials. So I think there's a lot of good things that are going on. And we have a good momentum both on financials and pipeline. So very proud of the team. And I do believe we've always done what we said that we're going to do. And you will continue to see that going forward. We continue to move with focus. We continue to move with speed. And as always, you can count on us because we will deliver.