Roche Full Year 2025 Roche Holding AG Earnings Call | AllMind AI Earnings | AllMind AI
Full Year 2025 Roche Holding AG Earnings Call
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At this time, it's a pleasure to introduce you to Thomas Unica COF group, Mr. Silica the stages here.
Thank you very much and good morning, good afternoon and good evening.
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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 use.
So let me get started on the normal overview slides.
So group sales in two.
<unk> 2025 grew with 7%.
Pharma, 9% diagnostics, 2% again this was due to the China health care pricing reforms without that diagnostics actually grew 7% last year.
Thomas Schinecker: 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 +13% and a core operating margin +1.9 percentage points, and core EPS +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 impacts, we had an impact of about CHF 700 million. Now I come really to the exciting part. We had truly an outstanding Q4 when it comes to pipeline use.
Very strong operating performance with the core operating profit of.
13% and are cooperating margins plus one nine percentage points and 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 impacts that we had the impact of about $700 million.
Not really to the exciting parts.
We had truly an outstanding Q4, when it comes to pipeline news flow.
From a regulatory perspective, EU approval for <unk> in lupus nephritis U S and EU approval for <unk>.
Cut solutions third line plus Follicular lymphoma.
Thomas Schinecker: From a pharma regulatory perspective, the EU approval for Gazyva and lupus nephritis, US and EU approval for Lunsumio subcut solution third line plus follicular lymphoma, and US filing for giredestrant in post-CDK4/6 positive, HER2-negative metastatic breast cancer. Now come the many positive readouts that we had. Phase 3 FENtrepid and FENhance, so two positive studies in fenebrutinib, one in PPMS, the other one in RMS. A positive Phase 3 study just already this year in Enspryng in MOGAD. Positive Phase 3 lidERA giredestrant study in adjuvant positive HER2-negative breast cancer. A positive Phase 3 PSGY in AHUS, and a positive Phase 3 in Gazyva in INS, and another positive Phase 3 Gazyva in SLE. And positive Phase 2 in CT-388 in obesity.
And U S filing for tiered restaurants in post CDK I E. Our positive hertz negative metastatic breast cancer.
Now I'll come the many positive readouts that we have.
Phase III.
Intrepid and finance so two positive studies <unk>, one and <unk> the other one in RMS.
Our positive phase III study just already this year in spring and <unk>.
Positive phase III, Lydia Jessica study in adjuvant ER positive <unk> negative breast cancer.
Now, come the many positive readouts that we had in Phase 3.
Center and F hands. So, two positive studies in Brut: one in PMS, the other one in RMS.
A positive phase III P S guy in the us and a positive phase III in <unk>.
A positive Phase 3 study just already this year in NSPR in MOAT.
And another positive phase III, cassava, Nossa <unk> and.
And positive for phase two in cities 388 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 theyre more exciting things to come also this year.
Positive Phase 3, uh, like the investment study in, uh, event ER-positive, HER2-negative breast cancer.
A positive Phase 3, PSI in AAS, and a positive Phase 3 in Gaza in INS, and another positive Phase 3 CASA in SLE.
On the diagnostics side regulatory approval of the Lexus.
Thomas Schinecker: And I know Teresa will go through a lot of these details with you, but you can see we're 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 Elecsys Dengue test. Matt will talk about that, the cobas 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 fenebrutinib study in RMS. We are awaiting persevERA, so the giredestrant in first-line positive, HER2-negative metastatic breast cancer. We have other studies reading out for Itovebi, but also for our Divarasib KRAS medicine, and further in Lunsumio and Gazyva. So again, I think very exciting.
Dengue tests.
Matt will talk about that the Cobra Speedy CV test and also the mass spectrometry extension of our menu so exciting launches there as well.
And positive Phase 2 in CT-388 in obesity, and I know Teresa will go through a lot of these details with you, but you can see we have a very, very busy news flow and I think there are more exciting things to come. Also, this year,
You slow hits in 2026, we are awaiting the second spin of Britain of study in RMS We are awaiting a person of euro so that youre desperate in first line <unk> positive <unk> negative metastatic breast cancer, we have other studies reading out in the fall I.
On the diagnostic side, regulatory approval of the Alexis and Deni tests—Matt will talk about that. That covers the BBC test and also the mass spectrometry extension of our menu, so exciting launches there as well.
<unk>, but also for Dave Arista K Ras.
Medicine and further inland to me.
So again, I think very exciting and we have a number of phase II readouts coming so it could again be a very busy year in terms of transitions from phase two into phase III and of course.
Everyone.
Thomas Schinecker: And we have a number of phase 2 readouts coming, so it could again be a very busy year in terms of transition from phase 2 into phase 3. 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 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 2 years. And even before that, when we had the washout of COVID-19 tests and the medicine, we had a good underlying growth.
He's talking about it.
Exploration sequencing solution and we promised it for many years now here. It is so I'm super excited or supposedly that we're now coming with this very exciting solution to the market.
There is significant use flow ahead in 2026. We are waiting for the second and a brutal study in RMS. We are evading, uh, persevere so that your test runs. Uh, in first line, your positive for 2 negative, metastatic breast cancer, we have other studies reading out in, uh, for it to be but also for our diversity cos, um, medicine and further in Lumio and Giva. So again, I think very exciting and we have a number of phase 2 results coming. So it could, again, be a very busy year in terms of transitions from phase 2 into phase 3. And, of course,
Everyone.
Yeah, I think it will cause a couple of waste 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 this slide is that we have consistently strong growth in the last two years and even before that when we have to wash out of COVID-19 tests and the medicine, we had a good underlying growth so.
Is talking about it—our next-generation sequencing solution, and, uh, we promised it for many years now. Here it is. So I'm super excited. It's 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.
We always said we will deliver.
And we delivered.
Now on the 2025 pharma kept growing at 9% diagnostics. We did have the health care pricing reforms impact in China without that diagnostics was also have been growing consistently instead of 7% over this time period.
Thomas Schinecker: 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 biosimilars, 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 copay assistance foundations, and Teresa will go into that.
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 SEOs, 19 tests, and the medicine, we had good underlying growth. So,
We always said, we will deliver.
and we delivered,
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 the Roche group has 7% growth.
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.
And this is really driven across our entire portfolio.
Diagnostics I already explained and I know, Matt will go into that further.
But by a small 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 U S market now that we are also supporting more on the copay assistance foundations and Teresa will go into that.
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 the Roche Group has 7% growth.
Across our entire portfolio, I think Diagnostics. I already explained, and I know Matt will go into that further.
Also OXXO there keeps growing significantly because either we have now launching.
Lupus nephritis, but you will see also the other indications really contributing to the growth in this business.
Thomas Schinecker: Also, Xolair keeps growing significantly. Gazyva, 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, 6%. For Phesgo, we're now at a global conversion rate above 50%. Tecentriq returning to low single-digit growth, Alecensa growth driven by the US and Japan. On the hematology side, Polivy strong now. We are reaching a US patient share of 36%. Columvi, Lunsumio, growth 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 Ocrevus franchise, we see now a strong uptake of the subcut solution, as we also discussed, and Evrysdi 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%.
Um, the buy more, we have continued strong global growth. We do expect that, uh, we will see even more uptake in the next year when it comes to the US market. Now that, uh, we are also supporting more on the co-pay assistance foundations, and Teresa will go into that.
I'll call it you're growing well at 6%.
Professional we're now a global conversion rates above 50%.
The century, returning to low single digit growth of sensor growth driven by U S and Japan.
On the hematology side, probably be strong now we are reaching a U S patient share of 76% Callaway's consume your growth is driven by our second line plus launch and third line plus D. C. L strong sort line growth in Follicular lymphoma. So you can see also in the bulk of our franchise we saw.
Um, also, so there keeps growing significantly, Cassa. We have, uh, now, uh, launching, uh, in lupus nephritis, but you will see also the other indications really contributing to the growth in this, uh, business. Oncology growing well, 6%. For Fesco, we're now at the global conversion rates, about, uh, 50%.
The Centric returning to low single-digit growth, a sensor growth driven by the US and Japan.
Now a strong uptake of the sub cuts a solution as we also discussed and Arista as the leading SaaS solution.
And medicine now with more than 21000 patients on treatment.
Okay.
So overall, we have achieved the upgraded guidance.
On mid single digit sales growth, we had 7% and you may remember in the Q R E.
I our call in Q3.
On the uh, hematology side. Poly a strong. Now we are reaching a US, patient share of 36% color wheel on. Sumo growth is driven by uh second line plus launch and third line plus dlbcl, strong third, line growth in the lymphoma so you can see also in the Oculus franchise. We see now a strong, uptake of the sub Cuts solution as we also discussed, and with the, the leading SMA solution, uh, um, and medicine now, with more than 21,000 patients on treatment.
You asked why are we not upgrading the guidance on sales and my answer was because 7% is still mid single digits and we delivered 7%. So we delivered on what we also communicated.
So, overall, we have achieved the upgraded guidance.
Thomas Schinecker: You may remember in the QR, 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 a 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 2024 and in 2025.
On Mid single digit sales growth. We had 7% and you may remember in the QR uh in the IR, call in Q3
On core EPS, we upgraded the guidance from high single digits to high single digit to low double digits.
And why did we do that because we already knew that we would land in the 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 dividend 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 this.
You asked why are we not upgrading the guidance on sales? And my answer was, because 7% is still missing digits, and we delivered 7%. So we delivered on what we also communicated.
Two guidance is every time in 'twenty, four and 'twenty five.
Yeah.
Now what's super exciting is the growth outlook and the growth outlook has fundamentally changed based on some of the phase III readouts that we've seen in Q4.
So your desk strengths.
On Core EPS, we upgraded the guidance from high single digits to high single digit to low double digits. Um, and why did we do that? Because we already knew that we would land in the 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 guides every time in '24 and in '25.
Thomas Schinecker: Now what's super exciting is the growth outlook. The growth outlook has fundamentally changed based on some of the phase III readouts that we have seen in Q4. Giredestrant, our SERD, has had two positive readouts, one with avERA and a second one with lidERA. LidERA reading out early, we expected the readout only next year, but based on the very significant results, it's read out early already this year. We're now waiting for the persevERA 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.
Search has had two positive readouts.
Now, what's super exciting is the growth outlook?
One with the Bureau, and the second one was the idea that you are reading out early we expect it to readout only next year, but based on the very significant results. It read out earlier already this year.
And the growth outlook has fundamentally changed, based on some of the Phase 3 results that we have seen in Q4.
Dearest.
We're now waiting for the person Bureau data, but we clearly see that we have a very active and very good molecule in hand, not only is he going to replace the standard of care and it's going to become the new backbone.
Our third has had two positive readouts, one with Vera and the second one with Lia Ladder. Reading out early. We expected the readout only next year, but based on the very significant results, it's read out early already this year.
Fields.
But it's so safe and.
And tolerable that we do believe that this will become the standard of care.
Bruce Nip in M. S. We had two positive studies here in RMS and then P. P. M. S. N. No Teresa will go into that we're still waiting for the second defend hence one 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.
We're now waiting for the Persevera 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, it's going to become the new backbone in this field.
Thomas Schinecker: Fenebrutinib in MS, we had two positive studies here in RMS and in PPMS, and now Teresa will go into that. We're still waiting for the second, the FENhance one 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. Gazyva, the same. We've had already positive data in lupus nephritis. Now we had two more additional Phase III data, again, something that will give us momentum in the midterm. On the Vamikibart and in Enspryng, 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 a fully positive trial. In the second trial, one dose was positive, the other one was negative.
But it's so safe—so tolerable—that we do believe this will become the standard of care.
Scene.
Because either the same we've had already positive data in lupus nephritis now we had the two more additional phase III data again, something that will give us momentum in the midterm.
On the Mickey part and in spring, we had two trials each and each of the two trials, we always had two arms and two different doses.
For the Bruton’s, SNIP in MS, we had two positive studies here in RMS and in PPMS, and now, uh, Teresa will go into that. We're still waiting for the second, the FINANCE-1 study in RMS. In order to be able to file this, you will see the data, uh, in not the distant future, but again, we're very excited with the data that we have seen.
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.
Giva, the same. We've already had positive data in lupus nephritis. Now, we have two more additional Phase 3 data points. Again, something that will give us momentum in the midterm.
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.
On the Mickey board, and in Spring, we had two trials each. And in each of the two trials, we always had two arms and two different doses.
So this is the midterm and in the long term. What's also exciting is that we had 10 enemies.
Thomas Schinecker: Now, this was always a very close call. Based on the conversations we had with the FDA, we do believe that the FDA will support filing here. This is the midterm. In the long term, what's also exciting is that we had 10 NMEs moving into phase 3. That's a record for us. We've never had 10 NMEs moving into phase 3. 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 minds is our agreement with the US government. The agreement we reached with the US government is not an LOI; it's a contract with the US government. 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 1 trial. In both of those it was fully positive trial in the second trial 1 dose was positive. The other 1 was negative
Moving into phase III.
That's a record for US we've never had 10 nanometers moving into phase III and these are all enemies with substantial revenue and patient impact attached to them.
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.
Now.
Moving into phase 3.
We know what the other part or topic. That's on your mind is our agreement with the U S government.
That's a record for us.
Now the agreement we reached with the U S. Government is not an L. O I, it's a contract with a U S government and based on this contract with the U S government, which has terminated for the next three years, we get an exemption from terrorists.
We've never had 10 NMEs moving into phase 3, and these are all NMEs with substantial revenue and patient impact attached to them.
We know the other part, or topic that's on your mind, is our agreement with the US government.
And we get the exemption of the demo project.
In return, we agreed to the Medicaid rebates in some of our portfolio.
We agreed to the encouragement of other wealthy nations to reward the biopharmaceutical innovation and to pay their share to contribute to innovation.
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 terrorists.
Thomas Schinecker: 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. We also support the direct-to-patient medication access with our influenza portfolio, Xofluza, and Tamiflu, and also future medicines with which we can go direct to patients. We agreed to invest in the United States $50 billion over the next 5 years. This includes R&D and PP&E investments. 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. In Boston, we're investing in our research hub, as well as we're going to invest more in Genentech in San Francisco.
And we get an exemption for the demo projects.
And we also supported the direct to patient medication access with <unk>.
In return, we agree to the Medicaid rebates in some of our portfolio.
Our influenza portfolio, so fluzone and tamiflu 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.
We agree to the encouragement of other wealthy nations to reward biopharmaceutical innovation and to pay their share to contribute to innovation.
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 CVR M portfolio.
And we also support direct-to-patient medication access with our influenza portfolio. So, Xofluza and Tamiflu, and also future medicines with which we can go direct to patients.
In Indianapolis It we're investing in CGM manufacturing and in Boston, We are 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 president in the United States.
Now, it's all about delivering on the next innovation cycle. So I think we have a good growth momentum. We do believe we can sustain the good growth momentum and how do we keep that beyond 2030.
Also, we agreed to invest in the United States, $50 billion over the next 5 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, Holly 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.
Thomas Schinecker: 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 the 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 PAs and also end disease areas.
as well as we're going to invest more in Chantek in San Francisco, but we already have
A wrong manufacturing and R&D network present in the United States.
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.
Now it's all about delivering on the next innovation cycle. So, I think we have a good growth momentum. We do believe we can sustain the good growth momentum. And how do we keep that beyond 2030?
We've introduced a bar so that we focus on those medicines with the highest impact we have an intentional focus in terms of P. A's and also entered and disease areas and we look at the portfolio as our overall investment portfolio with certain risk and reward profile that we want to balance to have.
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 organizations, about delivery, and about execution. And I do believe we've delivered on that.
Our rights portfolio.
We're expanding into new technologies, not only in dire, but also in pharma and we're implementing AI across the value chain.
Thomas Schinecker: 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 diet, but also in pharma, and we're implementing AI across the value chain. 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 2023, if you take it end of 2022, it's even higher. The same for the total portfolio value. Since end of 2023, it's about 45%. If you look at end of 2022 as a comparator, we are more than 60% higher, and this is a risk-adjusted value.
And we've made good progress in R&D now more than 60% of the enemies of post bar, 66% of the late stage projects have pest and disease potential we want to get to 80%.
We have introduced the bar so that we focus on those medicines with the highest impact. We have an intentional focus in terms of PAs and also in 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.
And 60% more average peak sales pipeline project, if you actually take not end of 'twenty. Three if you take it end of 'twenty two it's even higher than the same for the total portfolio value.
We are expanding into new technologies, not only in DIA, but also in Pharma, and we're implementing AI across the value chain.
Since the end of 'twenty three it's about 45%. If you look at the end of 'twenty, two as a comparator where more than 60% higher and this is a risk adjusted value.
And we've made good progress in R&D now—more than 60% of the NMEs post bar, 66% of the late-stage projects have best-in-disease potential. We want to get to 80%.
So we do believe we've made a significant move when it comes to our pipeline in terms of higher rewards and also manage the risk.
And 60% more average peak sales per pipeline project—if you actually take not end of ’23, if you take end of ’22, it’s even higher, and the same for the total portfolio value.
We have a strong on market portfolio.
Thomas Schinecker: 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 midterm, we have great readouts that are going to help us sustain our growth, but we have many, many NMEs 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 3. And this has resulted in a significant shift in our portfolio value. As mentioned, this is year-end 2023 as a baseline. If you take year-end 2022, it's even significantly higher.
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.
Since the end of '23, it's about 45%. If you look at the end of '22 as a comparator, we are 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.
And here you can see the prioritization that we have done over the years in our portfolio.
Taking out high risk low value projects, and adding higher value projects with very strong data as a foundation and that gives us more confidence into phase III.
In the midterm, we have great readouts that are going to help us sustain our growth. But we have many, many NME's 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 this has resulted in a significant shift in our portfolio value as mentioned this is year end 'twenty three as a base.
And here you can see the prioritization that we have done over the years in our portfolio.
Baseline if you take you in 'twenty two it's insignificant.
And on the diagnostic side.
Really taking out high-risk, low-value projects and adding, uh, higher-value projects with very strong data as a foundation—that gives us more confidence in the Phase 3.
As I mentioned, we have the experienced they've been experiencing the headwinds in China from the Heska pricing reforms.
These headwinds would become a lot less in 'twenty to 'twenty six it will be gone in 2027.
Thomas Schinecker: 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 an additional CHF 1 billion when it comes to sales per year. And again, very excited about the sequence 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, 2027, 2028, 2029, we'll have many different NMEs that will have phase III readouts.
And this has resulted in significant shifts 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 a diagnostic side,
We will continue to grow significantly this year, we expect mid single digit growth, but then back to mid to high single digit growth in dis.
As I mentioned, we have been experiencing the headwinds in China from the healthcare pricing reforms.
Products that you see here can each contributes additional 1 billion when it comes to sales for you.
These headwinds will become a lot less in 2026. They will be gone in 2027.
And again very excited about the sequence of that's coming.
Now let me go through the outlook.
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...
For 2020 six we again have an exciting year when it comes in terms of pipeline Readouts.
But then after that 27 28 29, we will have many different enemies that we'll have phase III readouts.
And again, very excited about the sequencer that's coming.
Now, let me go through the outlook.
In 26, I just want to highlight a couple.
The press of your put your restaurant.
For 2026, we again have an exciting year when it comes to pipeline readouts.
If in the Brutes Nip I Tobey Dave ERISA.
A number that.
Thomas Schinecker: In 2026, I just want to highlight a couple: persevERA for giredestrant, fenebrutinib, Itovebi, Divarasib, a number that can also continue to drive our growth in the next years. And of course, we have a number of Phase II 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.
Can also continued to drive our growth in the next years.
But then after that, 2027, 2028, 2029 will have many different enemies that will have Phase 3 results.
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 end it well in terms of Readouts and the year started well in terms of Readouts. So we're very positive in terms of the momentum that we have and that we can continue this momentum.
In 26, I just want to highlight a couple—uh, persevere for your dest. Um, find a brute nip, I told be the reset.
A number that, uh, can also continue to drive our growth in the next years.
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 two patients out there. So I'm very excited about what's ahead for us.
And, of course, we have a number of Phase 2 readouts in obesity—two of them have already been positive this year. So we had a very good start; 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 that we can launch by the end of the decade.
Now, it's clear that not all 19 ultimately will make it.
Now, let me talk about the 'twenty 'twenty fixed guidance.
And group sales again, we expect mid single digit sales growth in core EPS high single digits core EPS growth and we do believe that we can continue to further increase the dividend in Swiss francs.
Thomas Schinecker: 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 it over to Teresa. To Alan.
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.
With that and over to Theresa.
In group sales.
Oh yeah.
I think well.
No no.
Yeah, welcome from my side as well.
As Thomas has a great pipeline progress.
Again, we expect mid-single-digit sales growth and high-single-digit core EPS growth. And we do believe that we can continue to further increase the dividend in the interest ranks.
With that.
And it really then combined with great financial results I think that's really a that's a great setup and thanks to the whole Roche team for delivering that so let's go into the results right away.
Operator: To Alan, yeah.
And over to Teresa.
[Company Representative] (Roche Holding Ltd): Well, good. I think, yeah, well, welcome from my side as well. As Thomas said, great pipeline progress. 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, yeah, for delivering that. So let's go into the results right away. Here's the overview. I will focus on the right-hand side, so really the changes in constant exchange rates. Sales +7%. Matt and Teresa will go into this. 9% on the pharma side, 2% on the diagnostics side. As said, I think on the diagnostics side, with the impact from China, Matt will highlight this. Core operating profit +13%. So you see really good cost containment, but at the same time, we have invested where it really matters. I will lead you through this.
To Allen. Yeah, good, I think. Yeah, well, no, no, like that. Um, yeah, welcome from my side as well.
And here's the overview and I will focus on the right hand side, so really the changes in concentrates.
Sales plus 7% [noise] met entry reached that would go into this 9% of the pharma side, 2% on the die outside as said I think.
[Company Representative] (Roche Holding Ltd): Then Thomas mentioned it, slower momentum on the core net income and the core EPS, yes, driven by a higher tax load, roughly CHF 600 million, CHF 579 million more taxes that we had to pay, which brought the momentum a little bit down. IFRS net income up 58%. You know where it comes from. It comes from a base effect from last year. We had two goodwill impairments accounting for CHF 3.2 billion negatively. If you adjust for that, I think it would be +20%, which in my opinion mirrors very well the operational performance. Well, now I come to the cash flow, yeah, and we could now debate quite a bit about the cash flow. I think you see it, CHF 16.2 billion down from CHF 20.2 billion.
Um as Thomas said, great pipeline progress. Um and that really then combined with great financial results? I think that's really, that's a great setup. And thanks to the whole row team. Yeah, for delivering that. So let's go into uh the results right away. Um, and here's the overview and I will focus on the right hand side. So really the changes in constant rates uh sales plus 7% met and your Visa will go into this. 9% of the Pharma side, 2% on the dire side as said, I think on the dire side with the impact from China. Matt will uh uh 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. Uh and I will lead you through this. And then Thomas mentioned it uh slower momentum on the Cornet income and the core EPS yes driven by a higher tax load roughly 600 million, 579 million more taxes. Um, that we had to pay which brought the momentum a little bit down. I
[Company Representative] (Roche Holding Ltd): 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 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 CHF 600 million. I come to this, but I think that explains the number very well. As 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.
Net income up 58%, um, and, and you know where it comes from comes from a base effect from last year, uh, we had to a Goodwill impairments accounting for 3.2 billion negatively. Um, if you adjust for that, I think it would be a plus 20%, Which in my opinion, mirror is very well, the operational performance. Well now I come to the cash flow. Yeah. And we can now debate quite a bit about the cash flow. I think you see it uh 16.2 billion uh down from 20 to 20.2 billion. Um let me say here we have 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 I expecting quite a strong cashier 2026. Um the other piece here is in the net trade working, capital inventories. Um we had the situation that we had to deal with the tariffs, so we brought inventories up, uh, a little bit that contributed to this. Um, and last but not least, we have invested, uh, more
[Company Representative] (Roche Holding Ltd): 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 +2% because we have the currency impact in, which is quite significant with minus 5 percentage points. Let me focus on the middle. You see pharma and the loss of exclusivity of -CHF 745 million in total, +9% as mentioned. Then you see the situation in diagnostics where we have a 7% growth, yeah, excluding China. And we have then an impact of -CHF 579 million coming really from the healthcare pricing reform in China, which means a -24% of sales in China itself. Good. With that, let's go through the P&L. I talked about the sales growth.
Into intangible assets, roughly $600 million, I come to this. But I think that explains the number very well. I said, I think we will recover quite well, um, 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.
94% of sales in China itself.
Good with that. Uh, let's go through the P&L.
[Company Representative] (Roche Holding Ltd): Other revenue, I think on one hand, we had a lower milestone income compared to last year, CHF -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, yeah, increased their cost of sales by 7%, but with very different dynamics. I think really from a volume point of view in pharma, +13%. So very, very clearly, I think here a driver for the +7% growth on the cost side. I think that growth was also a little bit supported, yeah, by royalty expenses. And the diagnostics division, yeah, +4% on the volume side compared now to a +7% growth on the cost side. So what is that triggered by? Well, very clearly, the healthcare reform plays a role here.
[Company Representative] (Roche Holding Ltd): 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, LumiraDx, etc. And last but not least, we had a tariff impact on the diagnostic side of CHF 64 million half-year impact. So that's also something we potentially have to deal with in 2026. Core operating profit up 13%, a nice margin increase. When you look at the margins itself, I think really in constant rates overall, +1.9 percentage points for the group. You see a nice progression on the pharma division. You see a decrease of -1.1 percentage points in CER on the diagnostics division side, which is explainable given, yeah, that here a significant portion of the sales in China went away.
I talked about the sales growth, um, other Revenue, I think on 1 hand, we had uh, uh, lower Milestone income compared to last year, minus 87 million but we also had higher royalty income that why this is very very stable. Um and uh uh really looks good cost of sales, both divisions. Yeah. Increase their cost of sales by 7%. But with very different Dynamics, I think, very in uh, from a volume point of view and Pharma Plus 13% so very very clearly. I think here a driver for the plus 7% growth on the on the cost side. I think that growth was also a little bit supported. Yeah, bye bye. Royalty expenses. Um and the diet division yeah plus 4% on the volume side compared now to a plus 7% growth on the cost side. So what is that triggered by? Well very clearly the healthcare reform plays a role here so China once again and but also higher costs related to placing of machines which certainly fuels our future growth of Diagnostics. So well invested here and we have
Certainly, investments into the new technologies like CGM Lumiere, etc. And last but not least, we had a tariff impact, you know, on the diagnostic side of $64 million half-year impact. So it's also something we potentially have to deal with in 2026. Cooperating profit up 13%, and a nice margin increase.
[Company Representative] (Roche Holding Ltd): When you look at the core financial results, and really here, interestingly, I think really in CER, we have an increase. You look at Swiss francs, we have a decrease. 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 results. That's one conclusion here. You see the equity securities with CHF -88 million. I think 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 CHF +69 million in CER would be rather flattish. But let me say here, certainly the weak US dollar helped.
When you look at the margins itself, I think really in constant rates overall plus 1.9 percentage points, um, uh, for the Group. Uh, you see a nice progression on the Pharma Division. You see a decrease of minus 1.1 percentage points in Crescent. On the Diagnostics Division side, which is explainable given, yeah, that here a significant portion of the sales in China went away.
[Company Representative] (Roche Holding Ltd): 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 of the slide first. You see really the effective tax rate, full year 2024, excluding the resolution of tax disputes, 18.1%. And then you see really the effective tax rate, full year 2025, excluding the resolution of tax disputes, 19.5%. So you really see the increased momentum here. Both years, yeah, were really mitigated by the resolution of tax disputes. In 2024, that was a positive of CHF 263 million, representing the minus 1.4 percentage points. And in 2025, it was a lower effect, plus CHF 185 million in constant rates, resulting in minus 0.9 percentage points, leading to the effective tax rate, full year 2025, with 18.6%.
Um, when you look at the core financial results, um, uh, and really here, interestingly, I think really in, in Crescent, we have an increase. And you look at Swiss francs, we have a decrease. Yeah. And I think, really what that speaks for is, well, the US dollar being weak hurts us a little bit in the P, but helps us with the financial result. And that's, that's one conclusion here. You see the equity securities with minus 888. I think the market has recovered, but we have some investments in the Ro Venture Fund where we wait for data, so hopefully a better year ahead. Uh, net interest income, we had less cash available, led to less income here. Interest expenses with plus 69 million in concentrated would be rather flattish. Um, but, but let me, 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.
[Company Representative] (Roche Holding Ltd): 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, yeah, coming from that. Financial income and expenses are negative in constant rates. This slide is in constant rates. That's a negative, is roughly CHF 60 million. And then effective tax rate changes, as said, this is the once again mentioned increase on the tax side, yeah, that we have seen here. So operations was the major driver. All other effects on that slide worked against us.
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, the resolution of tax disputes 18.1%. And then you see with the effective tax rate, fully a, 2025 excluded, the resolution of tax dispute is 19.5. So you really see uh, uh, the increased momentum here. But here, yeah, we are 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 concent rates. Uh resulting in minus 0.9 percentage points leading to the effective tax rate full year 2025 with 18.6%.
Well, for 2026, I think we will hover more toward a 20% tax rate.
Corey PPS, um, 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 Corey. PS is driven by operations, and I think there's nothing better to say here. Um, look, I think the, the product disposals. Uh, uh, you've seen the p&l. I think less income. Yeah, coming from that, uh, Financial income and expenses and negative in concentrates. The slides in concentrates. That's a negative
[Company Representative] (Roche Holding Ltd): When you look at non-core and the IFRS income, I've mentioned the IFRS income; you see it on the right-hand side, +58%. Core operating profit, I've mentioned as well, with +13%. Perhaps two points to mention on that slide. One is the global restructuring plans. You see really the restructuring charges have increased by roughly CHF 300 million. I would argue that's a positive because that gives us savings in the future. Then I think you see the impairments of intangible assets, as mentioned, not a lot of impact in 2025. In 2024, with CHF 4.6 billion negatively, an enormous impact, very much driven by the two goodwill impairments for Spark Therapeutics and Flatiron Health amounting both together, -CHF 3.2 billion. With that, let's go to the cash. Here's the story. When you look at the left-hand side, CHF 20.2 billion, I've mentioned that already in 2024.
Negative is roughly $60 million, and then effective tax rate changes. As said, this is, once again, the mentioned increase on the tax 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,
Of impact in 2025, uh, in 2024, with $4.6 billion negatively, an enormous impact very much driven by the two good villains for Spark and Flatiron, uh, accounting posts. Yeah, together, uh, minus $3.2 billion.
With that, let's go to the cache, and here's the story.
[Company Representative] (Roche Holding Ltd): And then you see in constant rates, full year 2025 with CHF 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 net working capital movement. And out of that net working capital movement, minus CHF 2.2 billion comes from net trade working capital. And as said, predominantly driven by accounts receivables. Let me mention here that has nothing to do with extended payment terms for certain products, yeah, and nothing to do with Vabysmo. This is really we have for, especially for Vabysmo, 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 accounts receivables up.
[Company Representative] (Roche Holding Ltd): We have the higher inventories on the pharma side. That explains the -CHF 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 CHF 645 million, very much driven by Zealand and the deal we have done there. Then foreign exchange kicks in with -8 percentage points, quite significantly leads us to an operating free cash flow of CHF 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, yeah, I can just really point back to the fact, yeah, 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.
Um, when you look at the left-hand side, uh, $20.2 billion, I've mentioned that already in 2024, and then you see in concentrates full year, 2025 with $17.7 billion. Well, you see, really, when you go back to the left-hand side, uh, uh, the operating profit net of cash adjustments—I think that's the positive momentum coming from operations, really positive—and then you see the net working capital movement. And out of that net working capital movement, minus $2.2 billion comes from net trade working capital, and that is predominantly, uh, driven by accounts receivables. Let me mention here that has nothing to do with extended payment terms for certain products, yeah, and nothing to do with the BIS. So, this is really, we have, especially for the buyers, more 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 accounts receivables up. We have the IV, a higher inventories on the Pharma side—that explains the minus $2.
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 Sealant and the deal we have done there. Then foreign exchange kicks in with minus 8 percentage points, quite significantly, leads us to, uh, 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. Um, uh, when you look for it? Yeah, I can just really point back to the, to, to the fact that we will recover in 2026.
[Company Representative] (Roche Holding Ltd): And as said, I think interestingly, when you look really at net debt at the end of 2024 with -CHF 17.3 billion, and you compare that on the right-hand side with the net debt position at the end of 2025, we have reduced by CHF 1.1 billion. So you might ask yourself, okay, the cash flow was not so strong, yeah, 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 and in M&A is pretty equal. Yeah, CHF 4.6 billion in 2024 and even more in 2025 with CHF 5.1 billion. One driver here, yeah, is the weaker US dollar.
Now, uh, uh, when I talk about cash, I have to talk about the net debt development and debt in total, um, as well. Um, and as said, I think interestingly, um, when you look really at net debt, at the end of 2024, with minus 17.3 billion. And 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 I might ask yourself. Okay. The cash flow was not so strong. Yeah. How, how is that possible? Did they invest less? Especially on the m&a side know, we didn't. I think that the numbers are be really on the, 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. Yeah, 4.6 billion in 2024 and even more in 2025 with 5.1 billion
[Company Representative] (Roche Holding Ltd): Yeah, and you see it really when you look really on this bar, -CHF 10.7 billion dividends, M&I, and alliance transactions and other; there is the currency translation point with +CHF 1.8 billion. That is a major driver and helps us on the debt side. By the way, we have decreased gross debt by CHF 3.1 billion. And certainly, as 70% of our gross debt is in US dollar, the US dollar helps in that sense to bring the debt down, at least when we report interest rates. 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.
1 driver here. Yeah. Um is the week a US dollar. Yeah. 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 dead side. By the way, we have decreased gross debt by 3.1 billion and certainly as 70% of our gross debt is in US dollar. The US dollar helps in that sense to bring the debt down at least when we report interest rates.
[Company Representative] (Roche Holding Ltd): When you look at other current assets, well, higher trade receivables, as mentioned already, mostly coming from the pharma side. When you look really at the non-current assets, that was driven by higher intangible assets of CHF 4.1 billion, mostly acquisitions accounting for +CHF 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 payables and bank creditors, some loans here. The non-current liabilities decreased slightly due to the decrease in long-term debt. I've mentioned the CHF 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.
Good with that quick comment on the balance sheet. Um, uh, not too much to say. When you look, great, on the, uh, uh, on the left-hand side, uh, where we have the assets. I think cash and marketable securities went a little bit down. Uh, uh, nothing to mention here, paid the dividend, all of that. Uh, when you look at other current assets, well, higher trade receivables, as mentioned already, mostly coming from the Pharma side. Uh, 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 payables and bank creditors, some loans here, and the non-current liabilities decreased slightly due to the decrease in long-term debt, I've mentioned the $3.1 billion already.
Um, leads us to an equity increase quite nicely, and now an equity ratio of 38%.
[Company Representative] (Roche Holding Ltd): You see, really, the result for the full year: -5 percentage points on sales, -8 percentage points on core operating profit, -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 those rates from today until the end of the year 2026. So 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 bottom line. The impact would be -4 percentage points on sales and -6 percentage points on core operating profit and core EPS. This topic remains in 2026. Good core EPS.
So on the diet side with the impact from China met will a real 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.
I will lead you through this and then Thomas mentioned at a slower momentum on the core net income in the core EPS, yes, driven by a higher tax load.
The 600 million 579 million more Texas that.
If you had to buy average broad the momentum a little bit down I address net income up 58% and and you know where it comes from comes from a base effect from last year, and we had to goodwill impairments accounted for 3.2 billion negatively.
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 4 percentage points on sales and minus 6 percentage points on core operating profit and core EPS. This topic remains you know in 2026
If you adjust for that I think it would be a plus 20%, which in my opinion mirrors very well the operational performance.
[Company Representative] (Roche Holding Ltd): I think really we want to set the base right for you, yeah, 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 CHF 19.46 per share as reported. Then I think really we adjust for CHF 0.37 to get to the CHF 19.83 per share, which would be the starting base for your calculations in 2000 or if you like for the core EPS in 2026. So let me explain now the CHF 0.37. What you see here, these are the exchange rate effects. This is a result of deriving the 2025 currency losses of minus CHF 273 million as well as the 2025 losses on net monetary position in hyper-inflationary economies of minus CHF 48 million.
Good. Corey, PS.
Now I come to the cash flow and be cutting out debate quite a bit about the cash flow I think you'll see it a 16.2 billion down from 'twenty to 'twenty 0.2 1 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 expecting quite a strong cassia 2026.
Um, I think really, we want to set the base right for you—yeah, for the core EPS. And what is the starting point? Because we have currency effects, yeah, 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
The other piece here is internet trade working capital inventories, we had the situations that we have to deal with the tariffs. So we brought inventories up.
Uh, and then I think really we adjust for 0.37 Swiss francs, yeah, to get to the 19.837.
A little bit that contributed to this and loss of lease we have invested more into intangible assets roughly 600 million I come to this but I think that explains the number very well as 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.
[Company Representative] (Roche Holding Ltd): This is shown in note 4 of the consolidated financial statements on page 64. So on page 64, you find these two numbers, net of taxes and non-controlling interest by the number of diluted shares, yeah, of 803 million. 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 CHF 1 billion for 2026.
Um, what you see here, these are the exchange rate effects. This is the 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
Good I think when you look at the bridge here for the sales and concentrate 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 Miami on this five percentage points, let me focus on the middle <unk>.
You see pharma and the loss of exclusivity of minus 745 million in total at plus 9% as mentioned and then you see the situation in dire and where we have a 7% growth excluding China and we have then an impact of minus five fund at 979 million coming really from.
<unk> kept pricing reform in China, which a means of minus 24% of sales in China itself.
[Company Representative] (Roche Holding Ltd): So relatively narrow, yeah, to what we had for 2025 and well in line between CHF 1 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 TV. Fantastic. Thanks, Alan. So I'm going to hand it back to Alan. Hand it back to me. TV, it's not very nice. It's hard to bring it to you, yeah. But let me make a last comment here. We have a change in our income statement presentation for 2026. Let me say very clearly, yeah, it has nothing to do with the group in itself. So really, when you look at sales, group core operating 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.
Good with that lets go through the P&L I.
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 by this is very very stable.
This is Sean in Note. 4 of the Consolidated financial statements on page 64. So, on page 64, you find that these 2 numbers. Net of taxes and non-controlling interest by the number of diluted shares here of 803 million. And this number is outlined in note, 29 of the finance report on page 126. Yeah, just to confirm that, uh, 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, uh, that we have estimated, or as that, we expect of roughly a billion, uh, for 2026. So relatively narrow. Yeah, to what we, uh, had for, uh, 2025 and well, in line between the 1 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 Theresa, fantastic, thanks alen. Um, so I, oh,
And really looks good cost of sales both divisions increased their cost of sales by 7%, but with very different dynamics I think really in a from a volume point of view and pharma plus 13%. So very very clearly I think here driver for the plus 7% growth on the on the cost side I think that gross was also live.
I'm going to hand it back to Alan your head back to me at TV so it's it's hard to to to bring it to you. Yeah. But let me make a last comment. Here we have uh we have a change in our income statement uh presentation for 2026. Um let me say very clearly, yeah, has nothing to do with the group in itself. So really, when you look at sales group,
Supported by by royalty expenses.
And the dire division plus 4% on the volume side compare now to a plus 7% 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, and but also higher costs related to placing of machines, which suddenly fuels, our future growth of diagnostics sobell invested here.
[Company Representative] (Roche Holding Ltd): That's what we're doing. That has quite an impact. When you look at pharma, we reduced the SG&A costs in pharma by CHF 250 million, roughly, I think, certainly in constant rates, which represents roughly half a percentage point in core operating profit margin. So you should adjust for that in your calculations. On the diagnostic side, that's roughly CHF 50 million less for the SG&A costs, which represents 0.4 percentage points in the core operating profit margin in core. Corporate equally then would increase by CHF 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. Now, yeah, I have the pleasure to hand over to Teresa.
And we had certainly investments into the new technologies like CGM, Nomura etcetera, and last but not least we had a tariff impact you know on the diagnostics side of 64 million half year impact. So that's also something we potentially have to deal with in 2026 cooperating profit up a 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'll see a nice progression on the pharma division, you'll see a decrease of minus 1.1 percentage points in C. R. On the diagnostics Division side, which is explainable given you had that here a significant portion of the sales in China went away.
Operating 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. Um, and that has quite an impact. When you look at Pharma we reduced the sgna costs in former by 250 million. Yeah. Roughly I think certainly in constant rates which represents roughly half a percentage Point. Yeah, incorporating profit margin so you you should adjust for that in your calculations on the diagnostic side that's roughly 50 million less for the sgna costs which represents 0.4 percentage points. Yeah, in the cooperating profit margin in Crescent corporate equally then would increase by 300 million. Yeah, just to point that out. I said for the group accounts, nothing changed. Yeah. This is between the divisions and corporate. Yeah. Just to remind you when you project your margins forward for 2026, especially
for the divisions.
[Company Representative] (Roche Holding Ltd): 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.
And when you look at the core financial results Ah and really here Interestingly I think really in you can see our we have an increase and you look at Swiss Springs, we have a decrease.
And I think really what that speaks for as well the U S. Dollar this week hurts us a little bit in the P&L, but helps us with the financial result town. That's that's one conclusion here you see the equity Securities. This 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.
And now, yeah, I have the pleasure to hand over to—I'm going to move forward really quickly in case they try and take it away from me again. So, 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 6.
Net interest income we had less cash elevate available led to less income here interest expenses was plus 69 million concentrated would be rather flattish.
But but let me let me say he has suddenly the weak U S. Dollar helped and then we have really here other and these are predominantly less hyper inflation impacts compared to last year, so with that let's go to the tax rate.
[Company Representative] (Roche Holding Ltd): This includes Gazyva in immunology, Giredestrant in breast cancer, Fenebrutinib MS, Vamikibart in UME, and Enspryng 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 post-bar 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.
Thomas mentioned it I mentioned it a already let's focus on the middle of the slide first you'll see really the effective tax rate full year 2024 exclusive the resolution of tax disputes 18, 1% and then you see really the effective tax rate full year 2025, excuse me to the resolution of tax dispute was 19 point.
Breast cancer, Brute Ms., the Mickey Bart, and um, me and spring 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 will be sharing that with you a little bit later this year.
5%, So you really see the.
The increased momentum here Bose, yes, yeah, we're 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 concentrate.
[Company Representative] (Roche Holding Ltd): 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 CHF 47.7 billion.
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. Uh, and through rigorous application of the bar, we have successfully rejuvenated our pipeline with our post-bar NME's. We have the potential to enter new disease areas like Alzheimer's and obesity, and we aim to bring multiple new transformative—uh, transformational—medicines to patients.
<unk> yeah.
Resulting in minus <unk> nine percentage points, leading to the effective tax rate full year 2025 was 18.6% 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 to increase in core EPS is driven by operations, Yeah, and I think that's nothing better to say here and look I think the practice poses a you've seen the P&L I think less income you are coming from that.
As I mentioned at Farmer day, all of our activities are really driven by 2 key, tenants 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.
[Company Representative] (Roche Holding Ltd): All regions are delivering strong performance, led by our international region with 14% growth. 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 Venclexta in the US, which was offset by lower income from our outlicensing 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.
Financial income and expenses are negative and concentrates the slides and concentrates that's a negative is roughly $60 million and then effective tax rate changes asset. This is once again mentioned increase on the tech side, you know that we have seen here so operations, whilst a major driver all other effects on that slide worked against us.
So as you heard from both Thomas and Allen farmer 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%.
When you look at noncore.
And the IRS income I've mentioned, the iron Francine come see it on the right hand side, plus 58% cooperating profit I've mentioned as well as plus 13%, perhaps two points to mention on that slide one is the global restructuring fence. Your series of restructuring charges have increased by roughly 300 million I would argue that's a positive because it gives us savings in the future.
As Alan mentioned, COP increased by 13% versus that 9% sales increase for the COP margin of 49.2%. So, a 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 decline. Um, other Revenue slightly decreased by 1% with higher profit share income from the higher sales of in the US which is offset by lower income from our out, licensing agreements.
As Alan mentioned costs of sales increased 7% against a 13%, volume growth.
And then I think you see the impairments of intangible assets as mentioned not a lot of impact in 2025.
[Company Representative] (Roche Holding Ltd): 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 three 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 Ocrevus and Xolair, 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. We continually evaluate the strategy to ensure that it remains aligned to patient needs. Finally, other operating income and expenses decreased by 43%, and this is primarily due to lower gains on the disposal of products.
In 2024 was $4 6 billion negative if you're an enormous impact very much driven by the two goodwill impairments for spark and flight iron accounting boasts yet to get up a.
R&D costs declined by 3%. This was mainly driven by savings and flat iron as well as some other operational efficiencies the upper 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 cvrm phase 3 trials.
Minus 3.2 billion.
With that let's go to the cash and he is the story.
SG&A costs increased by 8%, and this was primarily for two reasons. It was driven by some investments in our growth drivers, particularly—okay, and, uh, and, um,
When you look at the left hand side, a 20.2 billion I've mentioned that already in 2024, and then you see in concentrates full year 2025 was 17.7 billion well you see really when you go back to the left hand side are the.
GoAir, but also increased donations to multiple independent co-pay assistance foundations.
As part of our broader corporate philanthropy.
Operating profit net of cash adjustments I think that's the positive momentum coming from operations really positive and then you see the net working capital movement and out of that net working capital movements minus 2.2 billion comes from net trade working capital that said predominantly driven by accounts receivables let me.
Zhinantech doubled its donations to those independent co-pay assistance foundations in 2025 versus 2014.
For corporate giving strategy is focused on supporting the patients, most in need across multiple therapy.
Immunology and Ophthalmology, and we continually evaluate the strategy to ensure that it remains aligned to patient needs.
Mentioned here that has nothing do with extended payment terms for certain product and nothing to do with this revised Moe. This is really we have four especially pharma buys more 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 accounts receivables up we have the IV are higher.
[Company Representative] (Roche Holding Ltd): 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, and year-over-year growth rates are presented at constant exchange rates. At full year, our top brands, Phesgo, Xolair, Ocrevus, Hemlibra, Vabysmo, and Polivy generated roughly CHF 3.6 billion in new sales at constant exchange rates. For the fourth quarter in a row, Phesgo is our number one growth driver with 48% growth, closely followed by Xolair, driven by the continued outstanding uptake in food allergy. You'll also notice the strong performance of Xofluza. 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 2025 in China.
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.
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 sealant and the deal. We have done there then foreign exchange kind of it.
At full year, our top brands, Phesgo, Zercepac, Ocrevus, Hemlibra, Evrysdi, and Polivy, generated roughly $3.6 billion in new sales at constant exchange rates for the fourth quarter. In a row, Phesgo is our number 1 growth driver with 48% growth, closely followed by Xolair, driven by the continued outstanding uptake in food allergy. Um, you'll also notice
[Company Representative] (Roche Holding Ltd): This may create a bit of a base effect for Xofluza 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 CHF, primarily driven by our HER2 franchise. As I mentioned, Phesgo 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 Perjeta conversion to Phesgo continues to impact Perjeta sales, which is to be expected. Kadcyla growth continues to be driven by uptake in adjuvant breast cancer.
In was 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 yeah I cant just really point back to the to the fact that we will recover in 2026.
A strong performance of the foosa, 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 zosa 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.
Now.
When I talk about cash I have to talk about the net debt development and that in total.
As well.
<unk> said I think interestingly.
When you look really at net debt at the end of 2024 was minus 17.3 billion. If you compare that on the right hand side, which the net debt position at the end of 2025, we have reduced by 1.1 billion. So I'm I'd ask yourself, okay. The cash flow. It was not so strong how how is that possible invest less especially on the M&A side.
[Company Representative] (Roche Holding Ltd): Looking forward to the HER2 franchise overall, and as I've said previously, we expect the HER2 franchise to peak this year at about CHF 9 billion at 2024 exchange rates, followed by a steady decline through the end of the decade with a solid tail of around CHF 4 billion. That CHF 4 billion is primarily Phesgo, about CHF 1 billion for Kadcyla, and a bit of H&P. We do not foresee a biosimilar in the US for Perjeta until the end of 2027. And let me also confirm again that we do not expect a cliff situation for the HER2 franchise. For Itovebi, we see good launch momentum in our first-line PI3 kinase HR-positive breast cancer population, and we expect two phase 3 readouts this year with INAVO 121 and 122, which could enable further indication expansion.
We didn't I think that the numbers I'll be a BD on the on the lower part of the slide as you can see on the right hand side you see what we've invested in intangible assets and an M&A is pretty equal yeah.
$4 6 billion in 2024, and even more in 2025 was $5 1 billion.
One driver here is.
Is the weaker U S dollar and.
And that $4 billion is primarily fees, about a billion for Kilo and a bit of H&P. We do not foresee a biosimilar in the US for Proetta until the end of 2027. And let me also confirm again that we do not expect a cliff situation for the Heru franchise.
And you see it really when you look really on this bar minus 10.7 billion dividends MNI and alliance transactions and other so as the currency penetration point with plus one 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 suddenly.
[Company Representative] (Roche Holding Ltd): But of course, the highlight of Q4 was the positive phase 3 lidERA result for giredestrant. I am going to cover this in more depth on the next slide, but let me give you a few quick updates on giredestrant 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 US approval later this year. lidERA results will be filed with the US and EU regulators this year. And the first half of this year, we expect the readout of persevERA in first-line, ER-positive, HER2-negative metastatic breast cancer. Moving on to Tecentriq, Tecentriq exited 2025 with 3% growth and actually quite a nice Q4.
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 I'm not too much to say when you look right on the edge on the left hand side, where we have the assets I think cash and marketable securities went a little bit down nothing to mention he had paid the dividend all of that but.
For it to be, we see good lunch momentum and our first-line, pi3 Chinese HR positive, uh breast cancer population. And we expect 2 phase 3, readouts this year with the Neva 121 and 122, which could enable further indication expansion. But of course, the highlight of Q4 was the positive phase 3 Lera result for your dest. Um I am going to cover this in more depth on the next slide, but let me give you a few quick updates on gear adjustment in general. Um, we presented Vdara data at San Antonio breast and we have already filed the AA results with the FDA that happened at the end of last year and EU filing is expected for uh, 2026.
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.
Therefore, we expect a Vera us approval later. This year, leera results will be filed with the US and EU Regulators this year. And the first half of this year, we expect the readout of persevera and first line uh ER, positive of her to negative metastatic breast cancer
[Company Representative] (Roche Holding Ltd): For 2026, we expect low single-digit growth for Tecentriq driven by the positive studies that we shared last year, such as IMforte in small cell and IMvigor in MIBC, anatomic and dMMR colon cancer. Finally, before I move to the next slide, let me just briefly mention that we expect the first phase three readout for our KRAS G12C inhibitor Divarasib later this year. Now let's take a closer look at the lidERA results for giredestrant. Here are the giredestrant lidERA results in adjuvant ER-positive, HER2-negative breast cancer, which we presented last December. As you can see, giredestrant 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 SERD to show superior IDFS versus endocrine therapy in the adjuvant setting.
Current liabilities increased mainly due to the higher accounts payables and bank credit us some loans here and the non current liabilities decreased slightly due the decrease in long term debt I've mentioned, a 3.1 billion already.
Moving on to the Centric to Centric exited with 20 exit, 2025 with 3% growth. And actually, uh, quite a nice Q4, uh, for 2026. We expect low single digit growth for to Centric driven by the positive studies that we shared last year, such as in Forte and small, uh, small cell, and vigor, and mibc, and atomic and DMM are calling cancer.
Leads us to an equity increase quite nicely and now an equity ratio of 38%.
And finally, before I move to the next slide, let me just briefly mention that we expect the first Phase 3 readout for our KRAS G12C inhibitor, giresa, later this year.
So now, let's take a closer look at the Lera results for Gear Dust Room.
Yeah.
Good leads me to the currencies well, yeah, I think really the volatility is certainly disturbing and the weak U S. So that's something we're fighting against them you see really the results for the full year and minus five percentage points on sales and minus eight percentage points on cooperating profit of minus seven percentage points on core EPS.
So here are the gear dust front leader results in addivon and are positive. Her 2 negative breast cancer, which we presented last December. As you can see your desperate present, uh, demonstrated a statistically, significant and clinically meaningful Improvement, and invasive, disease-free survival versus standard of care. Endocrine therapy achieving a hazard ratio of op point 7.
Yes.
[Company Representative] (Roche Holding Ltd): In terms of overall survival, the data was still immature, but clearly a positive trend for giredestrant was observed with a hazard ratio of 0.79. Giredestrant's safety profile remains favorable, as we've seen in previous studies. Importantly, we saw a lower discontinuation rate with giredestrant versus the comparator arm. This is a significant improvement in this setting, and it indicates the improved patient experience on giredestrant compared to standard of care. Taken together, these results further underline giredestrant'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 giredestrant development program. Now, given the positive avERA and lidERA results we just discussed and the upcoming readouts, we're very excited for the future of giredestrant.
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. So I think it would be basically the same impact when you compare it year end 2025, and you keep these currency rates stable.
Let me emphasize here that this is the first oral surg to show. Superior idfs versus endocrine therapy in the aydin setting and in terms of overall survival, the data was still immature but clearly a possible, a positive trend for gear, adjustment was observed with a habit, Hazard ratio of 0.79
Until the end of 2026, you see it really on the Bulks 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 in 2026.
Do safety profile remains favorable. As we see it in previously, uh, previous studies. And importantly, we saw a lower discontinuation rate with your death versus the comparator arm. This is a significant Improvement in this setting and it indicates the improved patient experience on your desktop.
Good core EPS.
Uh compared to standard of care. So taken together, these results further, underlying gear duster's potential as a Next Generation best-in-class, endocrine therapy and er, positive breast cancer.
I think really we wanted to set the base right for you know for the core EPS and what is the starting point because we have currency effects in there in the core EPS. So let me lead you through this you'll see on the left hand side, the 19.46 Swiss francs per share as reported.
To expand on this, let me dive a little bit deeper into the jurisdiction development program.
[Company Representative] (Roche Holding Ltd): Giredestrant has the potential to replace standard of care endocrine therapy in ER-positive breast cancer and become the new backbone of choice in this setting. As you can see in the treatment paradigm on the left, our clinical development program for Giredestrant covers different lines of treatment and risk groups with the readout of persevERA in first line expected mid-first half of this year. Please note that the Giredestrant plus CDK4/6 combination in lidERA 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 US and expect lidERA filing in Q1.
And then I think really be adjust for all points III seven Swiss francs, yet to get to the 19.83.
So now, given the positive data of error in Ladera results we just discussed, and the upcoming readouts, we're very excited for the future of Gerard. Gerard has the potential to replace standard-of-care endocrine therapy in ER-positive breast cancer, and become the new backbone of choice in this setting.
Swiss francs per share, which would be the starting base for your calculations into solves an awful if you like for the core EPS in 2026. So let me explain now the old points III seven Swiss francs.
As you can see in the treatment paradigm on the left, our clinical development program for Deathstrike covers different lines of treatment and risk groups, with the readout for Persevere in first line expected mid–first half of this year.
And what you see here. These are the exchange rate effect. This is a result of dividing the 2000 and twenty-five currency losses of minus 273 million Swiss francs, as well as the 2005 or five Tucson and twenty-five losses on net monetary position in hyper insulin I appreciate economies of minus 48.
[Company Representative] (Roche Holding Ltd): Beyond Giredestrant, 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 CDK4/6 inhibitor, which may overcome some of the limitations of currently available CDK4/6 inhibitors. As I mentioned, we believe Giredestrant has the possibility to become the new backbone of choice in ER-positive breast cancer. 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 Giredestrant. 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 CHF 8.6 billion in sales.
Please note that the gear desktop, plus cdk, 46 combination in Lera relates to a single arm. Subsidy that's still being evaluated that's in combination with Emma. Um we have also started a sub study in combination with ribo as well. Um 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 fired a very we have already filed a Vera in the US and expect Lera filing in q1.
Million. This is shown in note four of the consolidated financial statements on page 64. So on page 64, you'll find that these two numbers net of taxes and noncontrolling interests by the number of diluted shares you off $803 million and this number is outlined in note 20.
Beyond giredestrant testing, we also have a strong pipeline of potentially best-in-class molecules in breast cancer. That gives 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 giredestrant has the possibility to become the new backbone of choice in ER-positive breast cancer.
Nine of the Finance report on page 126, just to confirm that.
Breast cancer. And therefore, we're exploring, uh, many combinations with some of the internal assets. And, as I just mentioned,
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. He asked the guidance again Thomas has alluded to it let me mention two at the loss of exclusivity impact that we have estimated or S. E that we expect of roughly 1 billion.
Additionally, our phone keeps ringing as we are getting calls from potential partners interested in combination studies with Pure Desire.
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.
[Company Representative] (Roche Holding Ltd): 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. Polivy's growth momentum continued in 2025, reaching US patient shares of 36% in first-line DLBCL. But in fact, we reached two significant milestones with Polivy last year. First, it is now the most prescribed regimen for IPI 2 to 5 patients in the US. And second, we have officially hit more than CHF 1 billion in sales in the first-line DLBCL setting alone. Shifting to Columvi and Lunsumio, our CD20 and CD3 bispecifics, launch performance remains on track for Columvi in third-line plus DLBCL, with second-line DLBCL launches gearing up. For Lunsumio, we're happy to report that the subcutaneous formulation has been approved in both the US and the EU.
For 2026, so relatively narrow yet to what we had for 2025 and well in line between the one and one 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 TV.
The Hematology franchise delivered strong growth of 15% in 2025, achieving 8.6 billion Swiss francs in sales. However, it 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.
Thanks Alan.
So I hope.
I'm going to hand, it back to Alan head back to me at Televisa.
Yes, it's hard to try to bring it to you, but let me make a last comment here.
Have a we have a change in our income statement presentation for 2026.
Milestones with poly last year first. It is now the most prescribed regimen for IPI 2 to 5 patients in the US. And second, we have, uh, officially hit more than 1 billion Swiss Francs, in sale, in the first line DLB setting alone,
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.
[Company Representative] (Roche Holding Ltd): 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 Lunsumio later this year. We expect US approval for Lunsumio plus Polivy in second-line DLBCL based on the positive SUNMO results. And we expect the readout for the phase three CELESTIMO in second-line plus follicular lymphoma. So now let's move on to neurology. Our neurology franchise achieved CHF 9.8 billion in sales in 2025, with a strong growth of 11%. Ocrevus continues to have good momentum, delivering 9% growth globally and crossing the CHF 7 billion milestone in annual sales. We're excited to see the increasing growth momentum of our subcutaneous formulation known as Zunovo in the US. In Q4, more than half of global Ocrevus growth was driven by the subcut formulation.
This topic is between corporate and the divisions and basically what we are doing is we are centralizing the legal department, that's what that is.
Shifting to Columbia and Lumia, our cd20 CD3 by specifics launch. Performance remains on track for Columbia and third line plus dlbcl with second line. Dlbcl, launches gearing up for Lund sumia, 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 um
What we're doing.
And that has quite an impact when you look at pharma, we reduced the SG&A costs in form of about $250 million roughly I think suddenly in concentrates which represents roughly half a percentage point in cooperating profit margin. So you should adjust for that in your calculations on the diagnostics side that.
Reduces administration time from hours down to actually under a minute. Additionally, we expect two key events for Lumio later this year. We expect US approval for Lumio plus Poly. And second line DLBCL based on the positive Sun Mill results, and we expect the readout for the Phase 3 Silesto in second line plus follicular lymphoma.
So now let's move on to neurology.
Roughly $50 million less for the SG&A costs, which represents all points and four percentage points in the cooperating profit margin in C. R. Corporate equally then would increase by $300 million, Yeah, just to point that out as said for the group accounts nothing changed now this is between the divisions and corporate.
[Company Representative] (Roche Holding Ltd): Importantly, in the US and many other early launch countries, roughly 50% of Zunovo patients are naive to Ocrevus. This represents that acceleration that we've been talking about. US uptake continues to be driven primarily by community practices, which emphasizes how Zunovo is actually expanding the addressable market and can help overcome healthcare system restraints like IV capacity limitations. Overall, we now have more than 17,500 patients on Ocrevus Zunovo 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 Ocrevus. As a reminder, we upgraded our peak sales expectations for Ocrevus for the Ocrevus franchise to CHF 9 billion by 2029. This includes CHF 2 billion of incremental sales from Ocrevus subcut, but of course, there's also going to be some switching from IV to subcut.
Just to remind you when you project your margins fall, but for 2026, especially for the divisions.
And now yeah, I have the pleasure to hand over to do is I'm going to move forward really quickly in case, they try and take it away from me again.
Our neurology franchise achieved CHF 9.8 billion in sales in 2025 with a strong growth of 11%. Ocrevus continues to have good momentum, delivering 9% growth globally and crossing the CHF 7 billion milestone in annual sales. We're excited to see the increase in growth momentum of our subcutaneous formulation, known as the Ocrevus subcutaneous, in the US. In Q4, more than half of global Ocrevus growth was driven by the subcutaneous formulation, and importantly, in the US and many other early launch countries, roughly 50% of the new Ocrevus patients are naive to Ocrevus.
Now, let's jump right in.
So as Tom assured the group perspective, like you're a little earlier I wanted to provide some additional color on the key priorities for the pharma division starting with their 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 of 16 blockbusters across our five third.
Um, this represents that acceleration that we've been talking about us update continues to be driven primarily by Community practices, which emphasizes housing Novo is actually expanding the addressable market, and can help overcome Health Care System, restraints, like Ivy P, IV capacity, limitations overall. We now have more than, uh, 17,500 patients on. Okay, Nova globally and that's roughly 5,000 more than we had at Q3.
If you take areas. We expect this momentum to continue until 2028 and thereafter, we expect that sales at becomes stable just fully compensate for generic erosion importantly, we do not expect the patent cliffs as Thomas mentioned now in the near term, we are expecting to deliver multiple key launches, which come on top of todays on market portfolio. This inquiry.
[Company Representative] (Roche Holding Ltd): Staying with the MS franchise, you've seen the exciting news regarding the positive Phase 3 results for fenebrutinib. We're going to cover that more on the next slide. But for now, let's take a minute on Evrysdi. The global rollout of the tablet formulation 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 Evrysdi internationally was boosted by a tender-related buying pattern, but we are still expecting double-digit growth for Evrysdi next year. Earlier this week, you saw a positive ENDEAVOR from Elevidys in DMD. We continue to believe in the positive risk-benefit profile in the ambulatory DMD population, and more than 1,050 patients have already been treated globally in this setting.
For 2026, we expect to hit high single-digit to low double-digit growth for Okus. And as a reminder, we upgraded our peak sales expectations for Ochrous for the Okus franchise to CHF 9 billion by 2029. This includes CHF 2 billion of incremental sales from Okus Subcut. But of course, there's also going to be some switching from IV to Subcut.
Cause either in immunology, Jerry best friends in breast cancer and in Britain and M. S. Then Niki bar in Nuomi and in spring 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 posts by any means we have the potential to enter new disease areas like Alzheimer's and obesity and we aim to bring multiple.
Staying with the MS franchise. You've seen the exciting, uh, news regarding the positive 3 results. For pona Brut, we're going to cover that more on the next slide but for now, let's take a minute on nzy, the global roll out of the tablet, formation continues. And we see great pick up from that as well as very positive feedback from the patient Community as Thomas mentioned. This Remains, the leader in SMA, um, quick note that Q4 performance Q4 performance forever is the international was boosted by a tender related buying pattern, but we are still expecting double digit growth for everybody next year.
[Company Representative] (Roche Holding Ltd): Furthermore, the latest three-year data from EMBARK shows the durable efficacy and slowing of disease progression for ambulatory DMD patients treated with Elevidys. We are working with EMA continually to find a viable path forward for EU patient access here. Quickly stopping over PROSI, 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 PROSI trial, which is great news for patients. And let me close quickly by speaking a little bit about Enspryng 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.
New transfer transfer transformational medicines to patients.
Um, earlier this week, you saw a positive data from elevit. 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 3 your data from Embark shows the durable efficacy and slowing of disease progression for ambulatory DMD, patients treated with ledes.
As I mentioned that pharma day, Oliver activities are really driven by two key tenets discipline in the business and break out the science.
Um we are working uh with EMA continually to find a viable path forward for EU patient access here.
To put it in the business, we remain committed to keeping our costs 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 our pipeline are entering it including from partnerships or acquisitions.
I am truly excited and confidence in the future if rmi 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.
[Company Representative] (Roche Holding Ltd): The Phase III study Meteoroid read 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 CHF 500 million for Enspryng. So now, as promised, let's take a little bit of a deeper look at fenebrutinib. We are very excited about the positive Phase III readouts for fenebrutinib. This includes FENtrepid and PPMS and FENhance 2 in RMS with the FENhance 1 readout expected mid-half of this year.
So as you heard from both Thomas and Allen Farmer 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 comp increased by 13% versus that 9% sales increase of the cop margin of 49, 2% a slight increase over last year clearly copco ahead of sales, which we mainly attributed 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.
Uh, quickly stopping over py, a quick update here, where we have achieved uh both FBI for the phase 3 study as well as we have been able to materially accelerate site Activation. So our number of months ahead of schedule uh with the prozzy trial, which is great news for patients. And let me close quickly by speaking um, a little bit about inspiring and M D. So mg add, if you are not aware is rare antibody. Mediated autoimmune condition of the central nervous system, which causes inflammation of the brain optic nerve and spinal cord. The phase 3 study 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 nspr.
[Company Representative] (Roche Holding Ltd): These results make Fenebrutinib the only BTK inhibitor with positive Phase III 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 Fenebrutinib as an opportunity to increase high-efficacy treatment rates among MS patients and expand the footprint of our franchise. Ocrevus and now Ocrevus subcutaneous have brought transformational impact to people living with MS, and we believe Fenebrutinib has the potential to be that next transformational medicine for these patients. Let me also briefly remind you that Fenebrutinib is differentiated by design from other BTK inhibitors.
Other revenue and.
Other revenue slightly decreased by 1% with higher profit sharing income from the higher sales I think flex that in the U S, which was offset by lower income from our out licensing agreements.
Alan mentioned cost of sales increased 7% against a 13% volume growth.
So now, as promised, let's take a little bit of a deeper look at Fener. We are very excited about the positive Phase 3 readouts for FENY. This includes Centerpin in PPMS in SanHands 2, and RMS with the FANS 1 readout expected by half of this year. These results make FETA 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.
R&D costs declined by 3%. This is mainly driven by savings in flat iron as well as some other operational efficiency that upper operational efficiencies, but let me say that this reduction it was very thoughtful and deliberate as it gives us the oxygen that we need for the upcoming C. D. R. M phase III trials SG&A costs increased by eight.
We see fenibut as an opportunity to increase high-efficacy treatment rates amongst MS patients and expand the footprint of our franchise, Ocrevus. And now Ocrevus subcut has brought transformational impact to people living with MS. We believe that AbRute has the potential to be that next transformational medicine for these patients.
[Company Representative] (Roche Holding Ltd): 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 first half. 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 9 February. With that, let's move on to immunology. Our immunology franchise grew at 12% at constant exchange rates and reached CHF 6.7 billion in sales. Xolair's strong growth momentum continues, driven by uptake in food allergy. In 2025, we achieved 32% growth in sales of CHF 3 billion.
And this was primarily for two reasons it was driven by some investments in our growth drivers, particularly <unk> and <unk>.
And.
Sure, but also increased donations to multiple independent co pay assistance foundations as part of our broader corporate philosophy, Philadelphia Philanthropy strategy Genentech are doubled its donations to this independent co pay assistance foundations in 2025 versus 2024.
PK profile that allows it to reach its target, including in the brain. So stay tuned for the finance 1 readout and HAV 1. Until then, we look forward to presenting the Entrepreneur results in 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 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.
[Company Representative] (Roche Holding Ltd): We are also happy to celebrate a key Xolair 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 Xolair, 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 Xolair was selected for the latest rounds of IRA negotiations, so let me provide a little bit of extra information on this. Xolair'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.
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 and year over year growth rates are presented at constant exchange rates.
Our Immunology franchise grew at 12%, at constant exchange rates, and reached 6.7 billion Swiss Francs in sales. Strong growth momentum continues, driven by uptake in food allergy and 2025. We achieved 302% growth in sales of 3 billion Swiss Francs. We are also happy to celebrate a key Zolar 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 Xolair, we expect around 20% growth.
Full year, our top brands FESCO Xolair <unk> can lever up a buy sell and preliminary generated roughly $3 6 billion in new sales at constant exchange rates for the fourth quarter in a row Cisco is our number one growth driver with 48% growth closely followed by Xolair driven by the continued outstanding uptake in food allergy.
And this includes the impact of an expected. First biosimilar entering the market in the second half of the year.
You'll also notice the strong performance and stuff like that 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 Cessna and Twenty-twenty sex, especially considering that we haven't seen a similarly strong flu season in China a share.
[Company Representative] (Roche Holding Ltd): 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 1 November 2026. 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, Gazyva is one of our key highlights for the quarter. Following the FDA approval in Q3, we achieved EU approval on lupus nephritis, and we announced positive phase 3 readouts in both SLE and INS.
You will have seen that xolair was selected for the latest rounds of Ira negotiations. So let me provide a little bit of uh extra information on this, the layers inclusion on this list. As you know does not change patient access or pricing at this time, any potential uh pricing impact if applicable would not take effect until 2028 at the earliest. Um, but CMS is going 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 b
So now let's dive into our Tas starting with oncology.
Biosimilar 4, zero will be launched before that date.
Oncology sales increased by 2% to $15 3 billion Swiss francs, primarily driven by our hurts your franchise as I mentioned FESCO posted an impressive 48% growth in 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 project conversion dofasco continues to impact for China sales, which used to be expect.
September 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. And to, 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.
I can't find the growth continues to be driven by uptake in adjuvant breast cancer I'm looking forward to the her two franchise overall and as I've said previously previously we expect the her two 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 the <unk>.
[Company Representative] (Roche Holding Ltd): In both indications, Gazyva 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. I'm also very happy to share that the FDA has granted breakthrough therapy designation for Gazyva and childhood-onset idiopathic nephrotic syndrome, which is INS, based on the positive INSPYR results. We are not quite done with Gazyva just yet. There's one more phase III trial, which is expected to readout in 2026, and that's MAJESTY in membranous nephropathy. As a reminder, we see up to a CHF 2 billion opportunity for Gazyva in kidney disease.
Solid tail of around 4 billion and that $4 billion is primarily a cisco about a billion for cat silo and a bit of A&P, we do not foresee a biosimilar in the U S. But forget out until the end of 2027 and let me also confirm again that we do not expect a cliff situation for the hurt your franchise.
Just like in Q3 Gaza is 1 of our key highlights for the quarter following the FDA approval in Q3, we achieved EU approval on Loop of nephritis. And we announced positive phase 3 readouts in both SLE and ins and both indications, because Ziva has has first and cost potential. Uh, SLE results have been submitted for presentation, at SLE Euro. In early March in the ins results. Have been submitted to WCN in late. March both indications as uh 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. Um,
It's healthy we see good lunch momentum in a first line P&C a kinase.
HR positive breast cancer population and we expect to phase III Readouts. This year it with another 121 and $1 22, which could enable further indication expansion, but of course, the highlight of Q4 with a positive phase III of the Dara result figure that strength I am going to cover this in more depth on the next slide but let me give you a few quick updates.
Therapy designation for because I have a childhood onset idiopathic nephrotic syndrome, which is INS based on the positive in-shore results. And we are not quite done with Gaza just yet—there's one more Phase 3 trial, which is expected to read out in 2026, and that's Majesty in membranous nephropathy.
[Company Representative] (Roche Holding Ltd): And just finally, I'd like to mention the upcoming phase 3 readout for felzartamab and IgAN, which is expected later in the year. Now let's move on to ophthalmology. Ophthalmology grew by 10%, achieving CHF 4.2 billion in sales. The Vabysmo 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 in the branded IVT market in the US of about 15%. Nevertheless, the Vabysmo continues to gain market share in the branded IVT market in the US and across early launch countries globally. In the US, we now see that more than 60% of the Vabysmo patient starts are from treatment-naive patients, and this further solidifies the Vabysmo's position as the standard of care.
And as a reminder, we see up to a 2 billion, uh, Swiss franc opportunity for Gaza and kidney disease. And just finally, I'd like to mention the upcoming phase 3 readout for Pherson and IGN, uh, which is expected later in the year. Now, let's move on to Opthalmology.
Gary just aren't in general.
We presented to the library data at San Antonio Breast and we have already filed their results with the FDA that happened at the end of last year, an EU filing is expected for 2026. Therefore, we expect a very U S. Approval later this year, but Dara 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 perseverance and first line I E are positive of her two negative metastatic breast cancer.
Moving onto centric to centric exited with exited 2025 with 3% growth in actually quite a nice Q4 for.
[Company Representative] (Roche Holding Ltd): Looking forward, we would expect the US branded market to gradually recover in 2026. Taking this into account, we expect a growth acceleration in 2026, driven by the ex-US continued growth and US 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 Vamikibart in UME, which is expected to be filed in both the US and EU, and Enspryng in thyroid eye disease will be filed in the US, and we are currently considering ex-US 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 newsflow-rich 2026.
For 2020 six we expect low single digit growth for to centric driven by the positive studies that we started last year such as in 14, and small a small cell and bigger and it might be C anatomic and DMR colon cancer and.
And finally before I move to the next slide let me just briefly mention that we expect the first phase III readout for our K Ras G. C inhibitor either asset later this year.
Opthalmology grew by 10% achieving 4.2 billion Swiss Francs and sales, the biso performance. As you know, was impacted by the contraction of the US branded Market. It, landed at 12% uh, growth for the year, which is still quite strong. Um, we had mentioned this contraction, previously and through 2025, we saw a decline of branded IBT Market in the US of about 15%. Um, nevertheless the bizmail continues to gain market, share in the Branded IBT Market in the US and across early launch countries globally in the US. We now see that more than 60% of the biso patient. Starts are from treatment, naive patients, and this further, solidifies the biso position as the standard of care uh, looking forward. We would expect the US branded Market to gradually recover in 2026 and taking this into account. We expect a growth acceleration in 2026 driven by um the xus continued growth and US recovery. Um in fact, as Thomas mentioned, there is a lot to look forward to in Opthalmology. This year, we have 2 potential new medicines entering, our Opthalmology portfolio, that's the Mickey Bart and ume.
So now let's take a closer look at the lit Darrin results for Guestroom.
So here the Jerry that's around like Arizona, and adjuvant <unk> positive her two negative breast cancer, which we presented last December as you can see if you're desperate presented demonstrated a statistically significant and clinically meaningful improvement and they said disease free survival versus standard of care of endocrine therapy, achieving hazard ratio of <unk> seven.
[Company Representative] (Roche Holding Ltd): So earlier this week, we shared positive final Phase II topline results at week 48 for the once-weekly CT-388 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 estimand 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.
Which is expected to be filed in both the US and the EU, and Spring and Thyroid Eye Disease will be filed in the US, and we are currently considering ex-US filings, um, 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 new, slow, rich 2026.
Let me emphasize here that this is the first oral sorry, I just had a superior I D F S versus endocrine therapy in the adjuvant setting and in terms of overall survival data is still immature, but clearly a possible positive try and for Gary desperate was observed with the habit hazard ratio of appoint 79.
So earlier this week, we shared positive, uh, final Phase 2 topline results at week 48 for the once-weekly CT-388 in people with obesity. This is Study 103.
Tiered restaurants safety profile remains favorable as we've seen in previously PV.
Ah studies and importantly, we saw a lower discontinuation rate with your desktop versus the comparator arm. This is a significant improvement in this setting and it indicates the improved patient experience on Gary that's right.
For the efficacy. Estimand, we achieved a placebo adjusted weight loss of 22.5% as a reminder. The efficacy estimate includes patients, who dropped out from further analysis. So, the effects size measured represents the true efficacy of the medicine tested
Pair to standard of care. So taken together. These results further underlying youre desperate potential as a next generation best in class endocrine therapy, and ER positive breast cancer.
To expand on this let me dive a little bit deeper into the Jared I start development program.
[Company Representative] (Roche Holding Ltd): Now, this is 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 estimands 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 estimands.
So now given the positive area and the Dara results. He just discussed and the upcoming Readouts. We're very excited for the future of Teradata strength, that's where it has the potential to replace standard of care of endocrine therapy, and ER positive breast cancer and becomes a new backbone of choice in the setting as you can see in the treatment paradigm on the left our clinical development programs, which are definitely it covers different lines of treatment in <unk>.
Scripps with the readout of personnel and first line expected mid first half of this year. Please.
Please note that they carry desktop plus CDK four six combination in madera relates to a single arm subsidy, that's still being evaluated that's in combination with a demo and we have also started a sub study in combination with <unk> 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 fired in there we have already filed a ore in the U S and expect Madera filing in Q1.
[Company Representative] (Roche Holding Ltd): In that context, I should also point out that in most of the recent Phase III trials in obesity, marked differences between the estimands 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. 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 24mg. Taken together, this clearly indicates that further weight loss can be achieved after 48 weeks, and it gives us confidence in CT-388's potential to deliver best-in-class efficacy for obesity. In terms of safety and tolerability, CT-388 was well tolerated, and the tolerability profile was generally consistent with the incretin class.
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 is a question, we received a number of times over the last week, so I'm just going to take another minute here to 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 3 from a more flow, uh, flexible dosing regimen which allows patients to stay on Lower maintenance doses. In case of tolerability issues, to the incentive of the long-term extension, to retain more Placebo patients, but these kinds of measures, um, should serve to improve the discontinuation rate, and eventually reduce the gap between the 2 estimates.
To contact. I
that in most of the
Here, a desk and we also have a strong pipeline of potentially best in class molecules in breast cancer that give us the opportunity for numerous feature of combinations for instance, our highly potent CDK four two inhibitor, which may overcome some of the limitations of currently available C. D. K four six inhibitors and as I mentioned, we believe there is the possibility to become the new backbone of choice and are positive.
Differences between the estimates greater than 5% have been observed.
Let me also highlight 2 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 the visible efficacy Plateau at 48 weeks for the highest is tested which was 24 milligrams.
Breast cancer and is 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 Jared Astrium.
[Company Representative] (Roche Holding Ltd): 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 CT-388 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 mg dose was similar to the total discontinuation rate observed. We look forward to sharing more detail on the phase 2 results with you in an upcoming medical conference later this year. Similarly to 388, we saw positive results for CT-868 in the phase 2 O04 study in type 1 diabetes. And just like for CT-388, 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.
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.
He came out of the hematology franchise delivered strong growth of 15% and 2025, achieving $8 6 billion Swiss francs himself and lever it closed the year with strong growth of 12% driven by increasing adoption in the non inhibitor patient population for.
For 2020 six we expect low single digit growth and that's partly driven by competitor launches, which are anticipated later in year <unk>.
Taken together this clearly indicates that further weight loss can be achieved after 48 weeks, and it gives us confidence in CT, 388 potential to deliver best-in-class, efficacy for obesity in terms of safety and tolerability. CT 388 was well, tolerated, tolerated. And the tolerability profile was generally consistent with ankerton class. The majority of gastrointestinal related events, were mild to moderate and total treatment discontinuous due to the AES and all arms were low at 5.9% for CT, 388 versus 1.3% for the placebo arm. Let me also highlight here as we receive this question number of times as well. The discontinuation rate due to AES at the highest 24 milligram dose was similar to the total discontinuation rate reserved
<unk> gross momentum continuing into 2025, reaching U S patients, there's a 36% in first line there'll be C. L. But in fact, we reached two significant milestones with pulling me last year first it is now the most prescribed regimen for Ipi two to five patients in the U S and second we have officially hit more than 1 billion Swiss francs in sale in the first line setting.
We look forward to sharing more detail on the phase 2 results with you in an upcoming medical conference later. This year.
Similarly to 388, we saw positive results for CT868 in the Phase 2-04 study in Type 1 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,
[Company Representative] (Roche Holding Ltd): As a reminder, we announced for both CT-388 and CT-868 that we will move them into phase 3 development in 2026. For CT-388, we can now provide a first update. The phase 3 trials for CT-388, named ENNIS-1 and ENNIS-2, are now scheduled to start in Q1. In addition, you can see that we plan to initiate the first phase 2 studies for petrelintide and CT-996, as well as a phase 2 combination study for CT-388 with petrelintide. In addition, we have a number of other CVRM readouts scheduled for 2026. There are multiple phase 2 readouts to look forward to. For CT-388, we have data for patients with obesity and with type 2 diabetes, which will come later this year.
Yeah.
Shifting to Colombian law semi our C D 20th C. D. Three bi specifics launch performance remains on track for Colombia in third line plus the L. B C. L. With second line D. L. P. C. L. Lunch is gearing up for launch Emil We're happy to report that the subcutaneous formulation has been improved in both the U S and the EU and just a reminder that that new formulation.
Study initiations. As a reminder, we announced for both CT-388 and CT-868 that we will move them into Phase 3 development in 2026.
[noise] reduces administration time from hours down to actually under a minute. Additionally, we expect two key events Frameless EMEA later this year, we expect U S approval for Eylea in Sydney, a plus plenty in second line there'll be C. L. Based on the positive fundamental results and we expect the readout for the phase III Celesio in second line plus Follicular lymphoma.
For CT. 388, we can now provide a first update the phase 3 trials. For CT 388 named Enos 1 and enith 2 are now scheduled to start in q1. In addition, you can see that we plan to initiate the first phase 2 studies for patrol laid and CT 996 as well as a phase 2 combination study for CT 388 with petrol and tied.
in addition, um,
So now let's move on to neurology.
Our neurology franchise achieved 9.8 billion Swiss francs and sales in 2025 with a strong growth of 11%, Oklahoma continues to have good momentum delivering 9% growth globally and crossing the 7 billion milestone in annual sales were excited to see the increasing growth momentum of our subcutaneous formulation notice.
[Company Representative] (Roche Holding Ltd): We also expect the first phase II readout for CT-996, our oral GLP-1, and for Petrelintide, the ZUPREME 1 and 2 trials in obese overweight patients with and without type 2. Finally, omega-3 and trisulfamide 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 newsflow. We start the year with four green check marks, certainly a good omen for the year ahead. We have discussed everything else on previous slides, so I won't go into more detail here.
Uh, we have a number of other CVR and readout schedules for 2026. There are multiple Phase 2 readouts to look forward to. Um, the for CT 388. We have data for patients with obesity and with type 2 diabetes which will come later this year. We also expect the first 2 uh Phase 2 readout for CT 9996. Our oral G glp1 and for petrol and tied. Um, the Supreme 1 and 2 trials, in obese, overweight patients with and without type 2. And finally a move of our answers. Appetite combination data in obesity are expected towards the end of the year.
Oh in the U S. In Q4 more than half of global Okra Mis growth was driven by the sub cut formulation and importantly in the U S and many other early launch countries roughly 50% of Novo patients are naive to know Chris.
This represents that acceleration that we've been talking about U S. Uptake continues to be driven primarily by community practices, which emphasizes how does the novo is actually expanding the addressable market and can help overcome health care system restraints like IV passively IV capacity limitations overall, we now have more than 17500 patients on OCA.
[Company Representative] (Roche Holding Ltd): For any of you who are feeling the lack of the 2025 newsflow 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, Teresa. 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 CHF 13.8 billion, regrouped 2% or CHF 292 million, 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%.
As you can see, we can 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 check 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.
Mobily and that's roughly 5000 more than we had at Q3 for.
For 'twenty 'twenty six we expect to hit high single digit to low double digit growth for OCA of us and as a reminder, we upgraded our peak sales expectations for <unk> for the Alkermes franchise to 9 billion CHF by 2029. This includes $10 billion of Swiss francs, and incremental sales from sub cut but of course, there's also going to be some switching from IV to <unk>.
Wild. All right. Wild times. Thank you, Teresa. 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 Allan and from Thomas sales, uh and Diagnostics were 13.8 billion Swiss Francs, regroup 2% or 292 million, Swiss Francs, compared with 2024 constant exchange rates.
Staying with the MS franchise, you've seen the exciting news regarding the positive three results for Penn in Britain, and we're going to cover that more on the next slide but for now let's take a minute on that.
Global rollout of the tablet formation continues and we see great pick up from that as well as very positive feedback from the patient community as Thomas mentioned this remains the leader in SMA.
[Company Representative] (Roche Holding Ltd): So now let me walk you through these results by each of our customer areas. So sales in our largest customer area, Core Lab, were flat, again, driven by this previously mentioned healthcare pricing reform. Excluding this effect, sales were +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.
But as you heard from both Thomas and Alan earlier, excluding the sales in China—which I would reiterate is our second largest market—it was impacted by healthcare pricing reforms. The growth of the Diagnostics business was 7%.
So now let me walk you through these results, uh, by each of our customer areas. So
Quick note that Q4 procurement Q4 performance for ever see in international was boosted by a tender related buying patterns, but we are still expecting double digit growth forever I see next year.
Fact sales were plus 10%.
Earlier. This week you saw positive data from <unk> in D. M. D. We continue to believe in the part of risk benefit profile and the ambulatory DMD population and more than 1050 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 <unk>.
[Company Representative] (Roche Holding Ltd): Sales in our near-patient care customer area decreased at -3%, mainly driven by the decline of our blood glucose monitoring business at -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. 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 +14%, mainly driven by sales of advanced STAINY at +10% and our companion diagnostics business, which grew at +25%. Now I'd like to show the geographic performance that's behind these results.
Sales in the molecular lab increased at 4% due to a growth in our blood screening business. Now this was partially offset by reduced sales growth and the Infectious Disease segment which grew at 1%. This was impacted by the US Aid funding stop and q1. That caused a corresponding decrease in HIV testing which I covered last year.
Yes.
We are working with EMA continually to find viable path forward for EU patient access here.
I'll quickly stopping over probably a quick update here, where we have achieved both F. P. I for the phase III study as well as we have been able to materially accelerate site activation. So are a number of months ahead of schedule.
With the prostate trial, which is great news for patients and let me close quickly by speaking a little bit about and spring and multi day somebody. 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 setting meteoroid readout positively.
Sales in our near patient care. Uh, customer decreased at minus 3, mainly driven by the decline of our blood. Glucose monitoring business, 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, uh, from Thomas, we expect the CGM, uh, product to really be a driver for this customer area in the future, and we continue to invest in expanding and preparing for this.
We're looking forward to presenting that data at an upcoming medical conference. Later this year, we expect to file these results with the U S and EU regulators in 2026, and this additional indication could unlock an upside of approximately 500 million for spring.
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%.
[Company Representative] (Roche Holding Ltd): Taking through the regional view, North America, the business grew at +9%, well ahead of market. You saw good growth in EMEA at +6%, again, ahead of market. Latin America, strong growth at +11%. Now, Asia Pacific, again, as we discussed, -12%, driven by the -24% decline in China. Excluding the effect of China, APAC grew at +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 +2%.
Now as promised let's take a little bit of a deeper look at set up right. Now we are very excited about the positive phase III readouts for Fannie <unk>.
It's been trapped in N P. P. M. S. N sand has two in RMS with the fed has one readout expected Manhattan to share. These results makes ibrutinib the only be TK inhibitor with positive phase II results in both RMS and P. P. M S and it has the potential to be both first and best in class and our M. S. N. P. P. M S, which would also make it the first and only high efficacy.
So, now I'd like to show, uh, the geographic performance that's behind these results. Um, taking you through the regional view: North America, the business grew at plus 9%, well ahead of the 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.
Oral treatment for both relapsing and progressive multiple sclerosis.
Let me see if that in Britain name as an opportunity to increase high efficacy treatment rates amongst MF patients and expand the footprint of our franchised okra missing out of sub cut have brought transformational impact people living with M. S and we believe that in Britain. It has the potential to be that next transformational medicine for these patients.
However, given that we anticipate diminished but continuing headwinds in China for 2026, we would set our ambition this year at mid-single digits.
Uh, for 2026 again, our consistent ambition is to grow this business and mid to high single digits.
Let me also briefly remind you that then in Britain. It is differentiated by design from other PTK inhibitors. It is the only non covalent binding PTK in phase III development for MF and has a highly optimized PK profile that allows it to reach its target including in the brain. So stay tuned for the fan hands one readout in half one and until then we look forward to presenting with intrepid results in P. P.
[Company Representative] (Roche Holding Ltd): Cost of sales, as you heard from Alan, grew at +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. I would highlight that we saw growth of some of our key platforms, like our immunoassay, at strong double-digit increase. For example, our molecular workstation, the 5800, grew at over 40%. Very strong placement of instruments. R&D costs decreased at -2%. Now, this is a result of significant and focused cost containment measures across the organization in response to China impact.
Now, I'd like to walk you through the P&L line by line. As previously mentioned, sales grid plus 2%.
Cost of sales, as you heard from Alan, grew at plus 7%. Now, this was mainly driven by the unfavorable impact of the China healthcare price, which informs half of your impact of tariffs.
EMS at actions, where we are also inviting you to attend our IR event on the ninth of February.
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 and sales Xolair has strong growth momentum continues driven by uptake in food allergy in 2020 five we achieved 32% growth in sales of 3 billion Swiss francs.
And the production ramped 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, uh, growth of some of our key platforms like our immunoassay, it strong double digit increase. And for example, our molecular workstation, the 5800 grew it over 40%, so very strong placement of instruments.
[Company Representative] (Roche Holding Ltd): 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 SBX sequencing solution, and LumiraDx. SG&A decreased by 2%, again, reflecting focused cost containment measures across the organization. This resulted in a core operating profit of approximately CHF 2 billion, 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 cobas i 601, which, as you heard from Thomas, these are CHF billion opportunities that we're very excited about and their potential to really deliver growth to the diagnostics division. So, as I mentioned before, current mass spectrometry primarily relies on lab-developed tests and lack automation, are highly manual, and require highly skilled labor.
We're also happy to celebrate our key Xolair milestone in 2025, which is more than 100000 patients have now been treated for food allergy since launch.
Regarding the 2006.
R&D cost decline 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, or CIO sequencing solution and Lumiere DX,
2026 outlook first of all are we expect around 20% growth.
This includes the impact of an expected first biosimilar entering the market in the second half of the year.
Sgna decreased by 2% again reflecting focused Cost Containment measures across the organization.
You will have seen that so there was selected for the latest rounds of Iran. Negotiations. So let me provide a little bit of extra information on this so there's inclusion on this list as you know does not change patient access our pricing at this time any potential pricing impacts applicable would not take effect until 2028 at the earliest.
This resulted in a core operating profit of approximately CHF 2 billion, declining by 4% at constant exchange rates, which reflects the cost control initiatives.
The famous has got final guidance provides for the selected drug will no longer be subject to negotiation and will cease to be a selected drug if CMS determined that a generic or biosimilar has been marketed by November one 2026, and we do expect that a biosimilar for us although it will be launched before that date.
Our camera sales declined by 2% in 2025 as predicted we are now seeing increased biosimilar impact in the U S, which resulted in a 10% decline in growth and 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.
So now I would like to transition to some of the Innovation that we launched in the in in last year and really specifically focus on our cobos Mass Spec I 601, which as you heard from Thomas, these are billion Swiss franc opportunities that were very excited about and they're uh potential to really deliver growth to the Diagnostics division. So as I mentioned before, current Mass Spec primarily relies on lab developed tests
[Company Representative] (Roche Holding Ltd): With the launch of our Mass Spec solution in 2024, we've introduced the first fully automated IVD platform for clinical Mass Spec. So throughout 2025, we received CE mark for all of our wave one menu, composed of 39 analytes spanning the key parameters used in Mass Spec 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.
and lack automation; they are highly manual and require highly skilled labor.
Just like in Q3, because that is one of our key highlights for the quarter. Following the FDA approval in Q3, we achieved EUR prelim lupus nephritis, and we announced positive phase III readouts in both SLE and I N S. In both indications because either has been has first in class potential S. Early results have been submitted for presentation at SLE Euro in early March and the.
With the launch of our Mass Spec solution in 2024, we've introduced the first fully automated IVD platform for clinical Mass Spec. So throughout 2025, we received CE marked for all of our Wave 1 menu, composed of 39 analytes spanning the key parameters using mass spec 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.
<unk> results have been submitted to WCS in late March both indications as a as I mentioned I think previously will be filed in the U S and EU later this year and I'm also very happy to share that the FDA has granted breakthrough.
I would add that this system which integrates with our existing serum work area platforms. Strengthens our leading position in the core lab.
RP designation for because I havent childhood onset idiopathic nephrotic syndrome, which as I N S. Based on the positive in short results and we are not quite done with cause iva just yet there's one more phase III trial, which is expected to read out in 2026, and that's Majesty and membranous nephropathy.
[Company Representative] (Roche Holding Ltd): 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 Elecsys 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, immunoassay platform, which comprises of approximately 120 different parameters.
And now I'd like to talk about some of the high medical value content that we launched last year, for our, our CRM work area. Specifically, uh, our Deni antigen tests which received CM Mark in October.
And as a reminder, we see up to a 2 billion Swiss franc opportunity for I guess, either in kidney disease, and just finally I'd like to mention the upcoming phase III readout for facts are sending IGN, which is expected later in the year now lets move on to ophthalmology.
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 geography, such as South America, to now in Europe and North America. Diagnosing dengue can be challenging as patients are often misdiagnosed.
Ophthalmology and grew by 10% achieving 4.2 billion Swiss francs in sales the buys low performance as you know was impacted by the contraction of the U S branded market and landed at 12% growth for the year, which is still quite strong.
<unk> mentioned this contraction previously and through 2025, we saw a decline in branded IV T market in the U S of about 15%.
Due to overlapping conditions with other federal illnesses, with our Lexus antigen tests, we will enable health care systems to diagnose more reliably and efficiently by providing all four dengue virus serotypes, differentially diagnosed with a rapid test that takes only 18 minutes.
The less the buys no continues to gain market share in the branded IGT market in the U S. In a crunch early launch countries globally and the U S. We now see that more than 60% of our buys no patient starts are from treatment naive patients and this further solidifies the business position as the standard of care looking forward, we would expect the U S branded market to gradually.
This will add 1 more tests to our leading immune histochemistry platform or excuse me, Amino chemistry platform which uh comprises of approximately 120 uh different uh parameters.
[Company Representative] (Roche Holding Ltd): So now I would like to move on to a customer area very near and dear to my heart, the molecular lab, and switch to discussing our cobas BVCV assay, which we received CE mark in December. Sexual health diagnostics market is valued at CHF 1.1 billion, 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 cobas 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.
Over 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 and.
So now I would like to move on to a customer at a very near and dear to my heart, uh, the molecular lab, and switch to discussing our cobas BVC V assay, which we received CE Mark for in December. Sexual Health Diagnostics Market is valued at 1.1 billion Swiss Francs, with a yearly growth rate of 11%.
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 then Niki bar and you let me, which is expected to be filed in both the U S. You and spring in thyroid eye disease will be filed in the U S. And we are currently considering ex U S file ex U S filings I'm with.
Vaginitis is the primary growth driver within this segment showing a yearly growth rate of 26%.
With the appropriate regulators now, let's jump into our C. D around pipeline, if there's 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 niche slow rich 2026.
[Company Representative] (Roche Holding Ltd): 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 CE mark 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.
So earlier this week, we shared positive a final phase two topline results at week 48 for the once weekly C. T 388 in people with obesity and this study 103.
With our cobots BV CV. Assay, we will provide a multiplex assay designed for the direct detection of bacterial vaginosis in Canada, 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 assets.
For the efficacy estimate we achieved a placebo adjusted weight loss of 22, 5% as a reminder, the efficacy estimate includes patients who dropped out from further analysis of the effect size measured represents the true efficacy of the medicine test it.
Transitioning to our our point of care portfolio. Um I would like to discuss our recent CM Mark and FDA clearance with a Cleo. Waiver for our liabella panel. For ptosis is a highly contagious disease. That causes more than 24 million. Estimated yearly cases, resulting in a 160,000 deaths with the majority of those in children.
For the treatment regimen S demand, we achieved a placebo adjusted weight loss of $18, 3%. The treatment regimen estimate reflects a more real world outcomes acknowledging the fact that not all patients will be able to adhere to treatment. In this case data after treatment just can take continuation either in the treatment or placebo arm are included in the analysis. So for example, it includes data from patients who discontinued.
New treatment early and have regained weight.
This is 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.
[Company Representative] (Roche Holding Ltd): As you can see from this slide, this launch, we further expand our cobas Liat menu of lab-equivalent point-of-care testing, and we will continue to expand this in the future. 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 SBX 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. I would also again highlight that this represents a potential blockbuster opportunity for us with sales potential above the CHF 1 billion range.
Diagnosing ptosis can be particularly challenging as its symptoms of often overlap with those of common colds, leading to underdiagnosis. Our lead Board of telepath panel, offers a reliable point of care uh, solution delivering results in just 15 minutes between 3 board to tell a pathogens. And again, delivers label 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, leat menu of lab equivalent point of care. Testing. Uh and we will continue to expand this in the future.
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 due to the incentive of a long term extension to retain more of placebo patients, but these kinds of measures should serve.
To improve the discontinuation rate and eventually reduce the gap between the two last months and.
With that context, I should also point out that in most of the recent phase II trials in obesity market differences between the estimate is greater than 5% have been observed.
[Company Representative] (Roche Holding Ltd): I would also like to call out the expansion of our neurology menu, including the Elecsys pTau217, which is a blood-based diagnostic for Alzheimer's disease, and Elecsys Neurofilament Light Chain for detection of disease activity in multiple sclerosis, greatly expanding our offering in neuroscience. Additionally, I would like to, 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, and I look forward to keeping you updated over the course of the year. Thank you, and now I'll hand it to Bruno. Thanks, Matt. And with that, we open our Q&A session.
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 the visible efficacy plateau at 48 weeks for the highest dose tested which was 24 milligrams.
And with that, I would like to transition to our key launches in 2026 and call out a few highlights. Um again I would really want to emphasize that 2026 is the year that we will launch our Excel 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, uh, Blockbuster opportunity for us with sales, potential above the 1 billion, Swiss franc range. Um, I would also like to call out the expansion of our neurology menu, including the Alexis ptow 217, which is a blood-based diagnostic for Alzheimer's disease, and Alexis neurofilament, light chain for detection of disease, activity in multiple sclerosis,
Together. This clearly indicates that further weight loss can be achieved after 48 weeks and it gives us confidence in C. T. Three eight eights potential to deliver best in class efficacy for obesity in terms of safety and Tolerability of C. T 388 was well tolerated tolerated in the Tolerability profile is generally consistent with the increase in class the majority of gastrointestinal related.
Greatly expanding our offering and Neuroscience. Additionally, I would like to 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 is significant commercial opportunity. And I'm very convinced that we will offer a very differentiated highly competitive solution here.
Events were mild to moderate and total treatment discontinuation due to as an all arms were low at five 9% for C. T 388 versus one 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.
And overall, this 2026 is going to be a very exciting year of launches, and I look forward to keeping you updated over the course of the year. Thank you. And now, I'll hand it to Bruno.
[Company Representative] (Roche Holding Ltd): The first question goes to Sachin Jain from Bank of America. Sachin, please. Hi there. Thanks for taking my questions. 2, please. So firstly, on the Vabysmo, 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 2025 versus 2024 mean relative to historic levels? Like, where is that funding relative to sort of a 3- or 4-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.
Thanks man. And with that we open our Q&A session. Uh, the first question goes to Sachin, Jain, from Bank of America such please
Observed.
We look forward to sharing more detail on the phase two results with you at an upcoming medical conference. Later this year. Similarly to 388, we saw positive results for C. T 868 in phase two of our fourth study in type one diabetes and just like for C. T 388, we will show 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 two and phase III study initiations as a reminder, we announced for both C. T 388 N C. T 868 that we will move them into phase III development in 2026.
Hi there. Thanks for taking my questions uh to please. Uh so firstly on the buy mode, I don't if guided to growth for this year Beyond acceleration. So any color on what you're seeing within the guide and perhaps Trace, you could just provide a bit more color on your um funding comments and what if that doubling in 25 249 related to sort of a 3 4 year average and any color on how that flows back to patients when we should see an impact of sales,
Uh, the second question is on persevere, if I may.
[Company Representative] (Roche Holding Ltd): 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 Vabysmo, 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 products. 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.
For C. T. Three eight we can now provide the first update the phase III trials for C. T 388 named <unk>, one and <unk>. Two are now scheduled to start in Q1. In addition, you can see that we plan to initiate the first phase two studies for Petro Lin tied and C. T 996, as well as our phase two combination study for C. T 388 with petrol the tide.
If the study hits is any hits clinically meaningful for you? Or would you need to see a certain Hazard ratio? Absolutely. PFS benefits to use that wording in the press release. The reason for question is there's been speculation since your San Antonio call around passing an interim. Um, those are my 2 questions. Thank you.
So, uh, in terms of the BISMO,
In addition.
We have a number of other C. The army that's scheduled for 2026, there are multiple phase II readouts to look forward to them. The four C. T 388, we have data for patients with obesity and with type two diabetes, which will come later this year. We also expect the first two a phase two readout for <unk> 99, six our oral G. G. L. P. One and perpetual then tied to.
Supreme One and two trials in obese and overweight patients with and without type two and finally, a move of our answers appetite combination data in obesity are expected towards the end of the year. So as you can see we continue to progress our feed your own 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 22.
[Company Representative] (Roche Holding Ltd): We do believe that 2025 represented sort of a rebaselining of the branded market in the US. And so what we are hopeful is that 2026 will now allow the underlying growth of Vabysmo 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 clearly the fact that we've now seen positive data from giredestrant in a number of important settings, both 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.
Six farm a key news flow, we start the year with four Green Checkmark, certainly a good omen for the year ahead, and we have discussed everything else on previous slides. So I wont go into more detail here for any of you who are feeling the lack of the 2025 years slow table, we have moved that to the appendix and with that I would say I'll give it back to Alan but it'll be crazy and I'll give it over to Matt.
On the amount of money that we contributed. Because as you, as you have heard me say many, many times before our charitable giving is not in any way related to our commercial, uh, expectations for the products. So, those 2 things are and have to be completely separate. Um, 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 as you, uh, as you sort of alluded to, um, we do believe that 2025 represented sort of a rebate lining of the Branded Market in the US. And so what we are hopeful is that 2026 will now allow the underlying growth of the bismo to actually be more visible. Um, and so we would expect an acceleration, uh, in 2026. And I don't believe, uh, we've been more specific than that, uh, in terms of persevera. So, you know, clearly the fact that we've now seen positive data from gear adjuster and in a number of important settings,
While the wild Alright, Wild times, Thank you Teresa and good morning, and good afternoon, everyone. It's my pleasure to present, the full year 2025 Diagnostics Division financial results.
both Neo addivon addivon and, um,
So with sales as you heard from Alan <unk> from Thomas sales and diagnostics were 13.8 billion Swiss francs, regroup, what 2% or 292 million Swiss francs, compared with 2024 at constant exchange rates, but as you heard from both Thomson all earlier, excluding the sales in China, which I would reiterate is our second law.
[Company Representative] (Roche Holding Ltd): 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 Verdult from BNP Paribas. Peter, please. Thanks, Bruno. Peter Verdult from BNP. Two questions. Teresa, just on obesity, we understand from Zealand that the amylin data is in-house. And the market seems to have set the bar at sort of being low to maintain weight loss. Forget the market for a second. Can we just focus on Roche?
Largest market was impacted by health care pricing reforms the growth of the diagnostics business was 7%.
So now let me walk you through these results by each of our customer area. So.
Sales in our largest customer our core lab were flat again, driven by the previously mentioned health care pricing reform excluding this effect.
In, in a complex, late stage population, um, sort of underscores our belief in this molecule and that clinically it. It is potent. It's active and it's combinable, it's tolerable. Um, it it, it's given us great confidence that we do have the opportunity to be really impactful, uh, for many different patients, and to really become a new standard of care and hormone receptor positive breast cancer. Um, reading through, though, to different settings is complex. And so, you know, 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. Um in terms of what would be clinically meaningful we have designed the study to yield a clinically meaningful result. Um and so you know generally speaking you know, a 20% reduction you know would be considered clinically meaningful.
so, to answer your question,
Thank you so much.
Sales were plus 10%.
Sales in the molecular lab increased 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.
Okay, very good. Then we move on. Next song in the row would be, um, Peter Fiddle.
From BNP party, Bob Peter.
Please.
Sales at or near patient care customer decrease at minus three mainly driven by the decline of our blood glucose monitoring business is 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.
Thanks Bruno. Uh, people help from BNP 2 questions. Um, to just on Obesity we understand from Zen that the amling data is in house
[Company Representative] (Roche Holding Ltd): 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 relapsing-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 ALT that you've seen in the dataset can be attributed to other or non-drug causes? Thank you. Yeah. So I'm going to start with your second question first because I think we've gotten a lot of questions over the last couple of weeks about tolebrutinib and read-throughs to fenebrutinib. And I think we have to be very, very cautious here.
We are from Thomas we expect the CGM product to really be a driver for this customer in the future and we continue to invest in expanding in preparing for this.
And the market seems to have set the bar at sort of, you know, low to mid teens weight loss. Um, forget the market for a second. Can we just focus on Rush? You know, what is the minimum Target profile? You are looking to to demonstrate for amberlynn, uh, in obesity and then. Secondly, on BTK you sound very confident about the approval. Um, despite you know, recent crls, elsewhere in the BTK class, um, you know, the efficacy in the first that's remitting study and ptms.
Finally sales into pathology lab grew strongly at plus 14%, mainly driven by sales of advanced staining at plus 10% and our companion diagnostics business, which flu grew at plus 25%.
So now I'd like to show the geographic performance. That's behind these results are taking through the regional view North America. The business grew at plus 9% well ahead of market.
We don't just want to sense or get tires with you. Is your confidence based on a highly skewed benefit risk profile or is it more? Because you think, the 2 cases of high flow that you've seen in the data set, can be attributed to other or non-drug causes thank you.
first, because I
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%.
[Company Representative] (Roche Holding Ltd): If you actually read that CRL, it is incredibly specific to the risk-benefit that was seen with tolebrutinib. And unfortunately, they had a number of failed trials. They had a number of Hy's Law cases. So I think it is very difficult and inappropriate to actually take the language that was applied to tolebrutinib and actually put that forward onto fenebrutinib. Let me be really clear because I think there has been some confusion about what we've actually seen in terms of Hy's Law cases for fenebrutinib. 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 FENhance 1, 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 Hy's Law case.
Read throughs Defender, 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 tolerate neb. Um, and
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. The diagnostics division is to grow our sales at mid to high single digits.
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 are consistent ambition is to grow this business at mid to high single digits.
You know, unfortunately, they had a number of failed trials. They had a number of, of, uh, of his law cases. So I think it is very difficult and inappropriate to actually take the language that was applied to Toleranib and actually put that forward on Defender. Let me be really clear, because I think there has been some—there's been some confusion about what we've actually seen in terms of His Law cases for Federanib.
Now I'd like to walk you through the P&L line by line as previously mentioned sales grew at plus 2%.
Um, we had two cases of elevated liver enzymes, uh, with bilirubin, which was what put us on clinical hold with the FDA.
Cost of sales as you heard from Alan grew at plus 7%, but this was mainly driven by that and favorable impact of the China health care pricing reforms.
[Company Representative] (Roche Holding Ltd): The other one was confounded due to alcohol use by the patient. And so right now, in fenebrutinib, we have only one case, and it is in FENhance 1, 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 fenebrutinib, particularly when you consider the other half of that coin, which is the benefit. When you look at the phase two trials for fenebrutinib, you saw a significant amount of clinical benefit to patients. And the data that we've seen are sort of very consistent.
Are your 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.
Um, both of those cases were in finance 1, 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 Hy's Law case. Um, the other one was confounded due to, um, alcohol use by the patient, and so right now in Fener we have only one case and it is in finance 1. So we are sort of blinded to any more detail.
um,
Strong double digit increase in for example, our molecular workstation. The 5800 grew at over 40%. So very strong placement of instruments R&D cost o'clock 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 C. G M dark seal their sequencing solution and luminaire Dx.
[Company Representative] (Roche Holding Ltd): And so I think when you look at that very high efficacy with a very, what looks to be a very manageable safety profile, I think we're just in a totally different situation than what you saw with tolebrutinib. So hopefully that kind of provides a little bit more perspective there. So in terms of petrelintide, so as a monotherapy, we believe that petrelintide 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%, with the potential to be a much more improved tolerability profile compared to the GLP classes, as well as a, it's just a better patient experience in terms of titration, quality of weight loss, etc.
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.
Liver monitoring in place in the clinical trials, we have not seen any more uh, any more cases. And so I think we we feel very good about the overall benefit risk profile that we have with fenerin in particularly, when you consider the other half of that coin, which is the benefit. When you look at the phase 2, uh, trials for fener, brute. And if you saw a significant amount of clinical benefit to patients and, you know, the, the, 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 a in an in in a totally different situation than what you saw with tolerant nib so hopefully that kind of provides a little bit more. Um,
So now I would like to transition to some of the innovation that we launched in the last year and really specifically focus on our cobalt mass spec I 601, which as you heard from Thomas These are billion Swiss franc opportunities that we're very excited about and there are potential to really deliver grow.
To the diagnostics division so as I've mentioned before current mass spec primary relies on lab developed tests.
And lack automation are highly manual and require a highly skilled labor.
[Company Representative] (Roche Holding Ltd): 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. Did this answer your questions? Yep. Thanks, Bruno. And we move on then. 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 fenebrutinib, I just wondered if you could give us some idea about how we should be thinking about the relative tolerability profile of fenebrutinib versus Ocrevus ahead of the FENhance's data. And how do you see, in light of that, fenebrutinib being positioned relative to Ocrevus? And then secondly, a question for Matt. It's a little while since you unveiled to us the new sequencing offering.
With the launch of our mass spec solution in 'twenty 'twenty four we've introduced the first fully automated IBD platform preclinical mass spec. So throughout 2025, we received CE Mark for all of our wave one menu composed of 39 analyzed spanning the key parameters using mass spec testing, including therapeutic drug monitoring steroid in hormone.
Uh, a little bit more perspective there. So, in terms of petrol lenti. So as a monotherapy, we believe that Patrol LEDs the potential to be a foundational therapy for a weight management. Um, we are, are, are looking forward to, um, 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%, um, with the potential to be a, a, a much more improved, tolerability profile, compared to the glp, uh, classes as well as a basic, you know, it's the better patient experience in terms of titration and quality of weight loss. Etc. So obviously we don't again happily have long to wait, we'll see that uh we'll see that data soon. Um, you mentioned the data being in house, we are, we remain blinded to that data. Um,
So, we have not seen it, um, but we do expect to see it very soon.
So, your questions?
Yeah. Thanks Bruno.
With this as well as vitamin D testing.
These comprise the majority of parameters used in routine clinical mass spec lab, and we are going to fall that with a second wave of additional parameters.
And we move on. The next one would be Simon Baker from Redburn Simon.
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 tests, 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 our year round risk with locally transmitted cases shifting from historical geographies, such as South America two now in euro.
Thanks so much Bruno. Um, for taking the questions 2 from a please. Um, first you just continuing, um, on Petes question about um, uh, about fener. Um, I just want to let you could, if you could give us some idea about how we should be thinking about the relative tolerability profile, um, of fener versus um, Aqua ahead of the actions data. And and how do you see in light of that Fen have been positioned relative to aquifers?
Uh and then secondly a question for um Matt. Um it's a little while since you unveiled to us.
[Company Representative] (Roche Holding Ltd): I just wondered if you could update us on the market feedback you've had in terms of levels of demand and where that demand's 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. I would be happy to give the floor. Wow. So yeah, I would maybe give a plug for our Diagnostic 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, in more than we had originally anticipated ahead of launch. We are already starting commercial activities with select customers, and the feedback from our early evaluators has been extremely positive.
In North America, diagnosing dengue it can be challenging as patients are often misdiagnosed due to overlapping conditions with other febrile illness with our lexis 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.
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 on where that demand is coming from whether it's smaller scale or larger scale applications or indeed both thanks so much.
Test it takes only 18 minutes.
This will add one more test to our leading immuno histochemistry platform or excuse me immuno chemistry platform, which comprises of approximately 120 a.
You want to go first? I, I would be delighted to go first and I'll be happy to yield the floor. Wow. So, um, yeah, and and I would maybe give a plug for our Dia de in May which will talk quite a bit more about this and Bruno will will mention that at the close, maybe you'll just say that first. But yeah, we've seen uh a high level of demand uh, for the sequencer.
Different parameters.
So now I would like to move on to our customary very near and Dear to my heart.
[Company Representative] (Roche Holding Ltd): 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 focused clinical applications, such as 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, and 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, Simon? Perfect. Yes. Great. So when we think about where fenebrutinib sits, I mean, we believe that it has best-in-class potential.
Molecular lab and switch to discussing our cobalt BV fever assay, which we.
We received CE Mark in December sexual health diagnostics market is valued at $1 1 billion Swiss francs with a yearly growth rate of 11%.
Vaginitis as the primary growth driver within this segment showing a yearly growth rate of 26% with our cobalt B B C. B assay, we will provide a multiplex assay designed for the direct detection of bacterial vaginosis in Canada, vaginitis and expand our molecular STI offering with the addition to our STI portfolio we will.
To enable testing of the most commonly sexually transmitted infections, usually a single tube and 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.
I would say in, uh, more than we had, uh, originally anticipated, um, ahead of launch. Um, we are already starting, um, commercial activities with select customers, um, 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, um, focused 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, and 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. Mhm.
um, so
[Company Representative] (Roche Holding Ltd): And together with Ocrevus, Ocrevus subcut, and potentially further on down the line, Ocrevus high concentration, 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 fenebrutinib starting. But I think ultimately, we believe that this is the combination of these two therapies gives us the opportunity to 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, Zoe. I just slipped back onto mute for some reason, 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.
Transitioning to our point of care portfolio.
I would like to discuss our recent CE, Mark and FDA clearance with a CLIA waiver for our LIBOR to tell a panel pertussis is a highly contagious disease that causes more than 24 million estimated yearly cases, resulting in a 160000 deaths with the majority of those in children diagnosing pertussis can be particularly challenge.
<unk> as its symptoms of it often overlap with those of common colds, leading to under diagnosis are LIBOR to tell a panel offers a reliable point of care.
When we think about where fed, uh, where fed and upsets, I mean, we believe that it has best-in-class potential and together with ocherous, ocherous subcut, um, and potentially, you know, further on down the line, ocherous, 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, um, right now 30% of patients are on a less efficacious oral therapy and so that's
Solution delivering results in just 15 minutes between three four to tell of pathogens and again delivers lab like performance. This will enable health care providers to act quickly and prevent severe complications, especially in vulnerable populations such as children.
Sort of an easy place to imagine Fender Putin of starting. But I think ultimately, you know, we we believe that this is, you know, the combination of these 2 therapies um gives us the opportunity to you know, really sort of revolutionize, the entire patient Journey. Um for Ms. Patients and I I think we we're feeling
very confident about our ability to do that.
As you can see from this slide this launch we further expand our Cobalts Liang menu of lab equivalent point of care testing.
For some reason that but they both answered very clearly. Thank you. Great thanks. Simon.
And we will continue to expand this in the future.
Next question is go to Matthew Weston from UBS.
And with that I would like to transition to our key launches in 2026 and call out a few highlights.
[Company Representative] (Roche Holding Ltd): Thank you for taking the questions. The first one on giredestrant. Teresa, 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 giredestrant. 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 Perjeta. Clearly, there are multiple patents, so you can do deals with biosimilar companies.
Again, I would really want to emphasize that 2026 is the year that we will launch our axial Yo 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. It would also again highlight.
This represents a potential blockbuster opportunity for us with sales potential and above the 1 billion Swiss franc range.
Hopefully you can now hear me. Um, thank you for taking the questions. Uh, the first 1 on, uh, Dior Theresa, there's a lot of debate about how the commercial potential in the adant setting could be impacted by the data from Pera. Can you give us your thoughts? As to whether or not, you see add event as independent of that Frontline metastatic result. And also, there's a lot of debate about the peak sales potential of Gerard. So when are we when should we expect to hear? What rash thinks, the potential of this medicine is
I would also like to call out the expansion of our neurology menu, including the Alexis P. Tau to one seven which is a blood based diagnostic for Alzheimer's disease, and Alexis neuro filament light chain for detection of disease activity in multiple sclerosis.
Lately, expanding our offering and neuroscience. Additionally, I would like to I would really like to particularly mentioned our TV egret test our assay to detect latent tuberculosis infection, which remains a global health care challenge and a significant commercial opportunity and I'm very convinced that we will offer a very differentiated highly competitive <unk>.
[Company Representative] (Roche Holding Ltd): 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 -40% that has been kind of the underlying trend so far when we actually see biosimilars enter the market? Yeah. So thanks, Matthew, for your questions. I'll take your second one first, and 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 biosimilar impact is not a one-size-fits-all. So in some parts of the world, with some therapies, you are going to see an immediate decline.
Lucian here and.
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 I'll hand, it to Bruno.
And then, secondly, if I can just pick up on biosimilar erosion. So, Q2 and Q3 of last year, you made a number of comments about, uh, delays to the entry of Xolair. And now similar comments about potential delays to the entry of biosimilar Petta. 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?
Thanks, Matt and with that we open our Q&A session. The first question goes to Sachin Jain from Bank of America such in place.
Hi, Matt Thanks for taking my questions cheap please.
So firstly on for volumes my guidance.
And it's a growth this year beyond the acceleration so any color on what you're assuming within the guide and perhaps I'm curious if you could just provide a bit more color on your funding comments I wonder if that doubling in 25 vessels 24 main relative to historic levels like where was that funding relative to sort of a three or four year average and any color on how that flows back to patients when we should see.
[Company Representative] (Roche Holding Ltd): With some others, like Xolair, we just do expect that to be a smidge more sticky because you're dealing ultimately with a very allergic patient. 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 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 the adjuvant, so this market is somewhere between a $20 and 30 billion opportunity. Adjuvant is about 2/3 of that between initiation and maintenance therapy.
Impact of silence.
Question is on persevere, if I may.
It's a topic that I think it's come up on prior calls, but just to reiterate as we approach data.
If the study here is any hits clinically meaningful fee would you need to see a sudden hazard ratio absolutely benefits us that wording in the press release. The reasons. The question is there's been speculation since your San Antonio Cool around passing an interim nice my two questions. Thank you.
Um, so I'll, I'll take thanks Matthew for your questions. I'll take your second 1 first and 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 it, this is 1 of those things where, um, you know, biosimilar impact is is not a 1 size, fits all. So, you know, in some parts of the world with some therapies, you are going to see an immediate decline with some others. Like Zur, 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. Um and so I think this is 1 of those areas where we are constantly monitoring the environment. We're constantly talking to treating Physicians to get a sense of how they may, think about the utilization of bio similars and we give to you our our best knowledge of how we believe those erosion curves will happen. Um, but it's, it's very difficult to give you 1 answer because I think it is actually quite variable Again by therapeutic area.
By geographic area.
Great.
So in terms of the buys now.
When it comes to gear duster, um, so this market is somewhere between 20 and 30.
I'm not going to give you specifics on the amount of money that we contributed because as you as you have heard me say many many times before our charitable giving is not in any way related to our commercial our expectations for the product. So those two things are in have to be completely separate.
[Company Representative] (Roche Holding Ltd): We do think that adjuvant and first-line is pretty separate. And we think that giredestrant 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 Perjeta as well, because you had this question. So we don't expect biosimilar for Perjeta until 2028 in the US and 2027 in the EU. Correct. Just to clarify that. Matthew, in the PM, final question. That's perfect. Thank you. And we move on. Next one would be James Gordon from Barclays. Hello, James Gordon from Barclays.
Billion dollar opportunity, um, adant is about 2/3 of of that, uh, between, uh, initiation and maintenance therapy. Um, we do think that Advan and first line is is pretty separate, um, and we think that gear dust has the opportunity as we said, to really be establishing itself as a new standard of care. Um,
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 are as you sort of alluded to them.
We do believe that 2025 represented sort of a rebase lining of the branded market in the U S and so what we are hopeful is that 2026 will now allow the underlying growth of our buys mode to actually be more visible.
Um, when are you going to get a better read through from that? Q1 is a very data-rich, uh, care. So the first half is a very data-rich, uh, time for us. We're in the process of updating, um, updating our, our our own, uh, assumptions. And as soon as we have a clear read through, we will share that with you.
And so we would expect an acceleration.
Maybe just to answer your question on on projecte as well because you had this question. So we don't expect to buy a similar from a Jetta until 28 in the US and 27 in the EU. Correct?
Just to clarify that.
In 2022nd I don't believe we've been more specific than that.
In terms of perseverance. So you know clearly the fact that we've now seen positive data from Gary desperate in a number of important settings, both neo adjuvant and adjuvant and and and in a complex late stage population sort of underscores our belief in this molecule and that clinically it it is.
Question. That's perfect. Thank you.
And we move on, um,
Next 1 would be James Gordon from Berkeley.
[Company Representative] (Roche Holding Ltd): Thanks for taking the questions. Two questions, please. What will be on giredestrant? 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 giredestrant, the lidERA study, the side study of about 100 patients, I think they're 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 then 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 fenebrutinib.
<unk> is 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 since you really become a new standard of care in hormone receptor positive breast cancer reading three though to different settings is complex and so you know thinking about how we would read through.
Hello, James Gordon from Barclays. Thanks for taking the questions. Uh, 2 questions, please, what, what will be on your desktop, um, actually 2 Star Parts, 1 will be the slight delay in persevere, or read out timing, and it's now more likely to be Q2 is that could the event rate a little bit slower? Or, or could you be getting a few more events in and could that actually help the power in which is going to concern, some people have had
To persevere 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 say you know generally speaking you know.
And also enjoy this from the ladder. I studied with at the side study of about 100 patients, I think they're getting it on top of the cdk. How will you communicate? That and it it sounds like you're filing ahead of that because you're filing the data in q1 so is that something that they think it's added to the filing package and you hope to have on the initial label or how does that work?
[Company Representative] (Roche Holding Ltd): So you sound very confident talking about the big 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 that 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 fenebrutinib when we have all of the studies read out and when we look at the pooled safety.
A 20% reduction would be considered clinically meaningful.
So to answer your question.
Thank you so much.
Yeah.
Okay very good then we move them nexon and the ROE would be Peter for Don.
Yeah.
From BNP, probably about Peter.
These.
Thanks Bruno.
And then the other 1 was on on fenibut. So you sound very confident, um, talking about the business and upcoming launch, which is great. And there's been some talk about liver already, but in terms of about the tolerability issues, I saw the comment in the original release about additional safety data is further being evaluated. So it could there be some other of Target BTK side effects for me to think about and just on the side effect Point, like if if you're comparing it to something like oppressed, 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?
Even though from BNP two questions I'm Troy just on obesity, we understand from us even that the eminent dates within the house.
Great. Okay. So
And the market seems to set the bar at sort of being low to mid teens waitlist forget the market for a second could you just focus on rush what is the minimum target profile you are looking for some to demonstrate family.
[Company Representative] (Roche Holding Ltd): 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 fenebrutinib has, I think this is going to be a meaningful medicine in MS. So more to come as we get the FENhance 1 data.
And then secondly on P. T K you sound very confident about the probability.
Despite recent CRM elsewhere in the BT U K class you know the efficacy in the first readout from existing studying PQ man squeeze on just wanted a sense. We'll go kick the tires with you has your confidence based on our highly skewed benefit risk profile or is it more because we think the two cases of hydro that you've seen.
Uh, we'll start with the second question first. So, uh, we intend to assess the, the, uh, safety of feta brute nib when we have the, all of the studies read out and we looked at when we look at the pooled safety. Um, so obviously we only have 2 of the 3 studies. So, we, we need to wait a little bit in order to be able to step back and look at that, um, 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.
And the data set can be attributed to other non drug causes. Thank you yeah.
So I'm going to start with your second question first because I think we've gotten a lot of questions over the last couple of weeks about Tullow Brayton had been and read certain and read read throughs tied up right now and I think we have to be very very cautious here. If you actually read that C. R. L. It is incredibly specific to the risk benefit that was seen with Tullow Britain.
[Company Representative] (Roche Holding Ltd): 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 this year, and that has not changed. So that is remaining consistent. And again, we do plan to file the lidERA data first. We get the avERA data, I believe the sub-study data comes. Is that also in Q1? Guys, someone's going to have to remind me of that. And then the RIBO study, which is a 200-patient sub-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.
And.
Um, in terms of liver monitoring as is typical when you uh 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. Um and again I think when you look at the efficacy and the and uh the the risk benefit profile that fener nib has, I think this still, this is going to this is going to be a meaningful medicine um, in Ms. So um, more to come as we get financed 1 data, uh, for 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 um,
Unfortunately, they had a number of failed trials. They had a number of of a highs law cases. So I think it is very difficult in an inappropriate to actually take that the language that was applied to tell of Britain had been actually put that forward on incentive right now let me be really clear because I think there have been some there's been some confusion about what we have.
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 leera data. First, we get the, uh, the Amma data I believe,
Actually seen in terms of highest law cases, four five right now and we had two cases of elevated liver enzymes with deliver then which was what put us on clinical hold with the FDA.
Both of those cases, we're in fine hands, one which currently is a study that's still remains blinded when we looked at those two cases only one case was deemed by the F. D. A to be a highs law case. The other one was confounded due to alcohol use by the patients.
The the substudy data comes is that also in q1, guys, someone's going to have to remind me of that. Um, and then the ribo study, which is a 200 patient step study is just kicking off, so that will come later. Um, so those, those are data pieces that clearly as soon as they are available, we will be making public. Um, but the add event filing is going, uh, is going in and to q1 as planned, and it looks like end of 2026 for the subsidies.
Thank you.
James all questions on.
[Company Representative] (Roche Holding Ltd): The next one is Sarita Kapila from Morgan Stanley. Yay. Thanks for taking my question. So you addressed the fenebrutinib 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 liver tox launch post-CD20 approval, which have struggled to reach CHF 1 billion. So I guess why is fenebrutinib different? And how are you viewing risk from Novartis's remibrutinib in RMS? Data's in Q2, and they've had no signs of liver tox 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 possible study and the potential read across to persevERA? Thank you. Great. So let's start with fenebrutinib.
That's great. Thanks a lot.
And so right now in Senate Britain. It we have only one case and it is and it isn't fan hence one so we are sort of blinded to any more detail.
Then, uh, next one as a retailer from Long Stanley.
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.
Any more cases, and so I think we feel very good about the overall benefit risk profile that we have with tenet Brittany, particularly when you consider the other half of that coin, which is the benefit when you look at the phase two trials for Senate Britain have you saw a significant amount of clinical benefit to patients and.
Yeah, thanks for taking my questions. So, you addressed if there's any 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 been? So, we've seen orals with liver tox launch post-CD20 approval, which have struggled to reach $1 billion. So, I guess why has this been abrupt and if different, and how are you viewing risks from Novartis's remibrutinib? And I've been looking at their RMS data in Q2, and they've had no signs of liver tox so far.
Is it the data that we've seen are very consistent and so 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 it and in a totally different situation than what you saw with calibrate. It. So hopefully that kind of provides a little bit more.
And then the second one is just on PERSEVERE. 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 possible study and the potential read-across to PERSEVERE? Thank you.
[Company Representative] (Roche Holding Ltd): 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 FENhance 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 2 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 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 2 data, we believe we have a highly efficacious molecule on our hands.
A little bit more perspective, there so in terms of petrol and tied so as a mono therapy. We believes that petrol untied holds the potential to be a foundational therapy for weight management and we are looking forward to being able to deliver a weight loss at the vast majority of people are actually looking for which is something more in that sort of 10.
Twentyish percent with the potential to be a much more improved tolerability profile compared to the G. L. P classes as well as a patient you know it's the.
Great. Um, so let's start with, um, fener, Brutonib. So obviously the data have not yet been presented, so the, um, PPMS data goes to ACTS shortly. And then the RMS data, uh, will be packaged together when we have FINANCE 1 as well. Um, 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. Um, and in particular, people were really impressed with the phase 2 data that we've seen. So what we're talking about is the ability to get Okra.
Better patient experience in terms of penetration quality of weight loss et cetera. So obviously, we don't again happily have long to wait we will see that we will see that data. Soon you mentioned the data being in house. We are we remain blinded to that data so.
[Company Representative] (Roche Holding Ltd): In terms of the Novartis data, I mean, it's important to remember we haven't really seen anything in MS from Novartis yet. This is a dose that I think is what, 4 times higher than the existing dose. They had a sort of second-mover advantage that they started their trial with liver monitoring. So 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 2 data. And yeah, I mean, I think it's very difficult to say anything until we actually see data. It's also, I think, important to remember that fenebrutinib 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, even though you're taking it chronically, if you need to stop for whatever reason, it does leave your system more quickly.
So we have not seen it but we do expect to see it very soon.
Does this answer your questions.
Thanks Breanna.
And we move on and then next one would be Simon Baker from retro and Simon.
Thanks, very much Bruno thank.
Taking the questions two from me. Please firstly just continuing on.
Like efficacy in an oral treatment. And for many patients for many, many different reasons. That's a very attractive option. So, um, you know, again, I think in this market a lot of it comes down to the overall efficacy that we're able to deliver. Um, and based on the phase 2 data, we believe we have a, a highly efficacious molecule, um, on our hands in terms of the nardis data. I mean, it's important to remember we haven't really seen anything in Ms from nardis yet. Um, this is a a dose that I think is what 4 times higher than the, the existing dose. Um, they had the had sort of second mover advantage or they started their trial with liver monitoring. Um, so you know, I I think
On Pete's question about.
About <unk>.
I just wonder if you could if you could give us similar to about how we should be thinking about the relative tolerability profile.
Of.
Bush's awkwardness are ahead of the actions data.
I think it's very difficult to compare um because we just really haven't seen anything. Um we have first mover Advantage here, we've had robust Phase 2 Data. Um and yeah, I mean I think we're uh, it it it's very difficult to say anything until we actually see data it's
And how do you see.
In light of that kind of bridges being positioned relative to octopus.
And then secondly, a question for Matt.
Well since you unveiled to us.
[Company Representative] (Roche Holding Ltd): I think that really, in a chronic care environment, is a benefit. So in terms of read-through for persevERA, it's clear when breast cancer is dependent on the endocrine receptor for viability, giredestrant 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 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, 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 PALBO plus letrozole. So Sarita, all questions answered? Yes. Thank you. Yeah. And the next one in the queue is Richard Vosser from JP Morgan. Richard?
You sequencing offering I'm just wondering 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. When the bus. Thanks so much.
All going to remember that Fen and brute and it was a non-covalent molecule and in a chronic indication, that non-covalent really matters because it just, it it means that even though you're taking it, um, 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's that really in a chronic care environment, is is a benefit.
Gotta go first I would be delighted to go first and I'll be happy Super before Wow, So yeah, and I would maybe give a plug for our diode day in May, which we'll talk quite a bit more about this and Bruno well will mention that at the close maybe I'll just say that first but yeah, we've seen a high level of demand for this.
Winter I would say in a more than we had originally anticipated ahead of launch.
We are already starting.
Commercial activities with select customers and the feedback from our early evaluate or 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 onto more focused.
Receptor for viability gear, adjustment can perform very well, and we've seen that, uh, in in a number of settings. Um, so all of these patients are by definition dependent on the, ER, signaling and it's worked really well here. So clearly in the front line the likelihood that it's successful, um, hasn't hasn't gone down, um, and, uh, we should always be really cautious with cross trial comparisons, and so I think we are, um, you know, again, as I mentioned the benefit is, we don't really have long to wait. So we'll, we'll know really soon.
oh, and and yes, persevera uh is designed to show Improvement uh, over Pavo plus let Russell
So we do all questions answered.
Yes, thank you.
Yeah.
Focused clinical applications, such as whole genome sequencing in germline, so what really seen as the potential of an instrument with that kind of flexibility throughput and accuracy and 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 sequel.
[Company Representative] (Roche Holding Ltd): Thanks, Bruno. Thanks very much. Two questions, please. First question, just to go to diagnostics for a little bit. Margins obviously hit by a ramp-up of 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 two businesses up. So how should we think about 2026 and then the improvement in the margins from there? And then second question, back to pharma, just going back to Vabysmo, 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 injectable products? I think Ocula has one half-yearly. How do you think about that sort of competition? And also closer to today, the biosimilars are really starting to come.
And the next 1 in the queue is uh, Richard fossa from JP Morgan Richard.
Applications and I think we're very confident in the potential for this technology as well as the launch.
Does that answer your question.
Salman perfect, yes, great.
So when.
When we think about where fund had a where Senate Britain obsess I mean, we believe that it has best in class potential and together with the OCA vis OCA met some cut.
Thanks for now. Um, thanks very much, 2 questions, please. Uh, first question just to go to diagnostics for a little bit. Uh, margins obviously hit by, uh, by, uh, ramp up of, um, you know, Mass Spec sequencing and the Machine placement. 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 2 businesses up. Uh, so how should we think about 26 and then and then the Improvement in the margins uh from there? Uh and then second question back to Farmer, just going back to the buys Mo. Um uh, thanks for the comments on the foundations. Could we go a little bit?
And potentially you know further on down the line OCA is high concentration. We believe ultimately we are going to have a range of highly efficacious and very tolerable therapies that meet every patient with M S 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 Center Britain, starting but I think ultimately we.
[Company Representative] (Roche Holding Ltd): 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 earlier on Vabysmo? Thanks very much. So in this case, maybe I'll just keep talking. Yeah. Go ahead. I can take a break. Thank you. So maybe starting with diagnostics, so we talked about a couple of facts. There's the new technologies. There's the tariffs, of which Alan said we had half a year. We'll have a full year this year. But the biggest effect 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 diminish this year. 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.
We believe that this is the combination of these two therapies gives us the opportunity to really sort of revolutionize the entire patient journey for Ms patients and I think we what we're feeling.
Bit further out and think about the future competition potentially from less frequently dosed injectable products. I think ocular has 1 half yearly, uh, how how you think about that sort of competition and also closer to today. Uh, the biosimilars are really starting to come. They're having some impact in, in, in Europe as far as we can see. So just what's, uh, what's the thoughts, uh, globally us, Europe on biosimilars, from Ilya on for bismo. Thanks very much.
So in this case, maybe no go ahead.
I could use a break.
Confident about our ability to do that.
Alright, thanks, so much sorry, I would just sit back them to meet some reason that concept.
Okay. Thanks Ana.
Next questions go to Matthew Weston from UBS.
Yeah.
Hopefully you can hear me.
[Company Representative] (Roche Holding Ltd): 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 out, 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 washout of that. Anything you would add to that, Alan?
Thank you for taking the questions. The first one on <unk>.
Two industrial Teresa is there's a lot of debate about how the commercial potential in the adjuvant setting could be impacted by the data from et cetera.
You give us your thoughts as to whether or not you see adjuvant is independent of that frontline metastatic result.
And also there's a lot of debates about the peak sales potential of jewelry restaurants. So when do we when should we expect to hear what rush thinks the potential of this medicine is.
So uh maybe starting with Diagnostics so we talked about a couple of facts. There's the new technologies there's the the tariffs on which Allan said we had half a year and 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 expected to decline, but it'll be small enough that it won't really be, uh, meaningful. And then we expect to see a recovery. Um, in terms of specific ambition on margin this year. I think I would refer you back to the, to the group, uh, position that Allan writer that Allan mentioned earlier. But I would say our consistent ambition is to grow profit faster than sales. And that is, you know, once we really get ourselves to the headwinds this year, that is our ambition going forward. Um, and it's also our continuous, uh, ambition to improve the margin and Diagnostics. That's something that is, uh,
um,
And then secondly, if I can just pick up on the Biosimilar erosion.
So Q2 Q3 of last year, you made a number of comments about.
No delays to the entry of Zola I'm now similar comments about potential delays to the entry of Biosimilars Jets are clearly there are multiple patents. So you could 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.
[Company Representative] (Roche Holding Ltd): Well, for 2026, I think, well, we expect kind of a stabilization. I think that's a little bit here, but we will 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. I think on a group level, you've 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. Yep. You go ahead. That was beautiful. That was great. I'd like first just to start by talking about Vabysmo.
a goal for the entire organization. What I would call it though, in 2025, is you add our second largest Mar market with the 25% reduction. So obviously there was a an impact but that's something that you can see with our discipline on the cost line. Uh, that we, you can also expect to see continued again in in 2026 but uh we expect the gradual, um, wash out of that. Um, anything you would add to that. Alan
Free or should we still continue to expect to see like a minus 40% has been kind of the underlying trends so far when we actually see biosimilars and to the market.
So I'll I'll take thanks, Matthew for your questions I'll take your second one first and 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 it's this is one of those things where biosimilar impact is is not a one size fits all so you know in some part.
Well, I think for for, for 26, I think, well, we, we, we expect kind of a stabilization. I think that's a, that's a little bit. Yeah, but we would give us additional information. So yeah. So I would, I would maybe just refer to what Alan said, we 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 uh, in uh 2026. And what I've said in the past it still holds which is that also going forwards we will at least keep margins stable. Yeah, also for the coming years.
Perfect. Does that answer your question?
I think so. Yep. You you great.
It's a the world with some therapies you are going to see an immediate decline with some others like xolair or we just do expect that to be a smidge more sticky because youre dealing ultimately it was a very allergic patient.
[Company Representative] (Roche Holding Ltd): So I mean, Vabysmo is a highly efficacious therapy with a very well-defined safety profile where patients and physicians do have a lot of good experience in extending doses. 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 3 with a very small safety database and really no known data on long-term safety. And when you talk about something that's going to be used intraocularly 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.
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 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 gave to you are our best knowledge of how we believe those erosion curves will happen.
Bye. Bye now. So I mean but bye. Asmo 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 um, when you, when you look at you as soon as
specifically about ocular, I mean, this, this drug, uh, is going into phase 3 with a very small
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 carry restaurant. So this this market is somewhere between 20 and 30.
Billion dollar opportunity.
M. Adjuvant is about two thirds of of that between our initiation and maintenance therapy, and we do think that adjuvant. In first line is is pretty separate them and we think that Gary <unk> 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.
[Company Representative] (Roche Holding Ltd): So I think from a future competition perspective, just like in other disease areas, sort of the bar is high here to unseat Vabysmo. And you had one other question. Oh, biosimilars. So far, what we see is that the Eylea biosimilars are taking from Eylea. And so for those patients who are really benefiting from a new and novel treatment, Vabysmo, we're just less impacted. So yeah, I mean, I think we saw Lucentis take from Lucentis. We're seeing Eylea biosimilars take from Eylea. We're seeing high-dose Eylea take from low-dose Eylea. 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 Vabysmo. Yeah. And on ophthalmology, I would like to add that we have an amazing pipeline in ophthalmology.
Q1 is a very data rich care. So in the first half is a very data rich time for us we're in the process of updating them updating on our own assumptions and as soon as we have a clear read through we will share that with you.
To think about, you know, how these you know, how something like that is a threat to something that has such good efficacy, such good safety. Um and and where you do actually have the ability to to extend doses. So, I think from a, um, from a future competition perspective, you know, just just like, uh, in in other disease areas, sort of the bar is high here to to unseat uh, the bismo. Um,
Maybe just to answer your question on project as well because you have this question. So we don't expect the Biosimilar Fujitsu until 28 in the U S and 27 in the correct.
Just to clarify that.
Matthew.
Question, So that's perfect on Q.
Hum.
The next one would be <unk> from Barclays.
And you would 1 other question? Uh, oh, biosimilars so, so far. Um, you know what we see is that the Ia biosimilars are taking from Aaliyah? Um, and so for those patients who are really benefiting from a a new and novel treatment, but bismo, they're they're they're just less impacted. So um, yeah, I mean, I think we, we saw lucentis take from lucentis, we're seeing a Leo biosimilar to take for my Leah. And we're seeing high dose by Leah take from low dose Aaliyah. So there's a lot of trading within that space, But I think for new patients who are going on therapy, uh, Physicians are picking the best available therapy out there available to them and that is the bizmail.
Two students Barclays. Thanks for taking questions.
[Company Representative] (Roche Holding Ltd): 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-specific, tetra-specifics, DudaFABs, etc. So if I look at our ophthalmology pipeline, I think the one that's going to succeed surpassing Vabysmo is then hopefully us. Yeah. Very good. Richard? Yeah. Perfect, everyone. Thank you very much. Very helpful. Thanks, Bruno. Thanks, Richard. And next one in the Q 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 giredestrant and revisiting lidERA, what's the KOL reaction been from your side?
Questions. Please.
Okay.
Okay.
The labor to the original target.
If somebody wants to be Q2.
It's a little bit slower.
Could you be getting a few more than denim and could that actually help the car, which is where they can send some people aren't.
And also it has something to do with study of this size, it's not even about 100%.
And on of theology, I would like to add that we have an amazing pipeline in ofm. 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 tried specific, Tetris specifics, um, uh, do the Fabs, Etc. So, uh, you know, if I look at the optomology pipeline, I think the 1 that's going to
October.
We communicated that.
Succeed, uh you know, surpassing the bias moments and hopefully us. Yeah.
It sounds like Youre funding.
The touch screen.
On page <unk>.
Very good. Um, Richard
It's too late.
Yeah.
And then Neil Boehm, Brazil.
Yeah, perfect, everyone. Thank you very much. Uh, very helpful. Thanks. Thanks.
You sound very consistent.
Great.
And next 1 in the queue is um, James quickly from Golden sax.
And so literally.
So in terms of affordability.
The general release.
Safety data.
Related to that.
To be sure.
Hey side effects, we have to think about.
[Company Representative] (Roche Holding Ltd): So some of the KOLs we spoke to have been a little bit more cautious than the presenter at your SAMSIS event, giving them more limited follow-up versus the CDK4/6 class. So how do you think this could impact the Giredestrant trajectory, of course, assuming approval? Would it be more of a stepwise ramp or more of a stepwise ramp as more data comes, or does your feedback suggest a potential for a faster, more optimistic ramp on Giredestrant? So first one. Second one, more of a financial question. So underlying pharma growth has been pretty strong in recent years, driving operating leverage. So how is Roche balancing R&D investment with profitability? But 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, but how long can this go on to support operating leverage? Thank you. Yeah.
Cleveland.
Turning it to some of the older vis so you've got the advantage of oral but could you also have liver monitoring or something like that could not be a barrier to becoming a pretty big how would you think about it.
Right Okay. So.
Well start with the second question first so we.
Thanks, Bruno. Hope you can hear me. Um, just a couple of quick questions from my side leftover. So firstly, again, on duration and revisiting ladder. Um, what's the care? I'll re reaction been from, from your side. So, some of the carols we spoke to have been a little bit more cautious than, than the presenter at your sobs event. Um, giving them more limited follow-up versus the the cdk 46 class. So, how do you think this could impact the, uh, durest trajectory of, of course, assuming approval. I would be more of a step step-wise ramp or, um,
We intend to assess the safety of Senate Britain. It when we have the all of the studies read out and we looked at 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 on the data that we've seen so far we haven't seen anything that is different than <unk>.
Uh, or or or more of a stepwise ramp, as more data comes or do you, or does your feedback suggests a potential for a faster more more optimistic ramp um on your restaurant? So as first 1, second 1 uh more of a financial question so
What you would see in the background rate of the overall and Thats population in terms of liver monitoring as is typical when you are 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.
[Company Representative] (Roche Holding Ltd): I mean, I think what we're hearing from the KOL community regarding where they would use lidERA is pretty bullish. I mean, I think what we hear from the lidERA population is 55% of the adjuvant breast cancer population. That's 10% more than what we saw in the NATALEE trials. So I think you are really seeing physicians believe that this could have very broad applicability in their practice. And so I think that's what leads us to be fairly bullish about the opportunity. There's a 74% overlap with the population in NATALEE and monarchE. 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. Yeah. Let me answer the second question, but first, something to add on giredestrant.
Underlying farm and growth has been pretty strong in recent years driving operating leverage. So, how is Rush balancing R&D investment with profitability but how long can R&D expenses? Stay Stay flat. Um, this half seemed to show that rash has a strong ability to, to reallocate costs in R&D. But how long, how long can this go on to support operating leverage? Thank you.
The efficacy and the and the risk benefit profile that Fanapt route and it has I think there's still this is going to this is going to be a meaningful medicine.
M S. So more to come as we get the fan hence one data.
Person Dara just to be really clear the timing on that has not changed we have consistently been messaging. The first half maybe first half of.
Of this year and that has not changed so that that is remaining Ah Ah that is remaining consistent.
And again, we do plan to file the lid Dara data first we get the the Burma data I believe.
The sub study data come since that also in Q1 Guy someone's going to have to remind me of that.
[Company Representative] (Roche Holding Ltd): 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. That's final. But what you have on top of that is the tolerability. 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 SERD 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 even 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.
And then the ribose study, which is a 200 patient subset is just kicking off so that will come later on so those databases that clearly are sitting there.
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% of the um, adant breast cancer population, that's 10% more than what we saw in the Natalie trials. So, you know, I 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 what that's what that's what leads us to be fairly um, fairly bullish about the opportunity. Um, you know, there's a 74% overlap with the population in Natalie and monarchy and so I I think we're, we're very um, yeah. I think we're very confident that we we have something on our hands here that is is quite a game changer based on the data that we've seen. Yeah, let me answer the second question. But first something to add on on Jeran. I mean, you look at the hazard ratio of 0.7. Um, you can see that that's I would say highly competitive
In public.
The filing is Ah is going in and doing it looks.
Looks like end of 'twenty.
Upside is.
Okay.
All questions and answers.
Okay.
Then.
Excellent I shall read a couple of them.
Absolutely.
To also, some of the CDK, uh, for six trials that you've seen at finals. But what you have on top of that is the tolerability. Uh, you know, if you look at CDK4/6, you have a quite a high, uh, amount of patients that actually stopped using it, uh, simply because they cannot take the tolerability. So I think these, uh, uh, all the right arguments, uh, for, uh, SEARCH to be used. Uh, so I do believe that, uh, you know, the pickup will be strong. Unfortunately, it wasn't at the Congress in San Antonio, but the
Hi, Thanks for taking my question. So you would have asked us any approval risk and I guess I'll just touched on it but what is underscoring our confidence in the commercial potential what's the initial feedback from the physician community bank can be seen all rules that liver tox launch how you see just plenty of people, which had struggled to reach 1 billion just shy I guess why.
That was in standing ovation, uh, from, uh, from, uh, the clinicians there. Uh, then the second question on R&D. Um,
[Company Representative] (Roche Holding Ltd): 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 before. Yeah, and that I made before, which is, because this is the, it's clear for 2026, expand margin. And as previously always said, at least stable. Discipline. For the long term. James. Thank you very much. Okay. Then we move on to Graham Parry from Citi. Graham. Bless you. Bless you. Thank you. One on lidERA.
I sent a pretty Smith different and how are you viewing breath from Novartis is rarely approve snip in RMR stake. Thank you Candace and they've had no signs of liver Tox I saw.
And then the second one system has a favorite until they've 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 possible study and the potential read across to pass Sarah. Thank you.
Right.
So let's start with Senate Britain. It. So obviously the data have not yet been presented so the P. P. M. S stayed out goes to App trends shortly and then the RMS data will be packaged together and when we have done has one as well.
Doing that, um, regarding R&D expenses, uh, also for 2020, uh 6. Uh I would say it would be broadly, uh flat. Uh again really focusing very hard on, you know, making sure that we uh put the money to work in in the best possible way for the sake of patients, in our company and for our investors,
That having been said, we've obviously shared it with with those physicians who are part of the trial and I think people have been really impressed with the data that we've seen in in particular people were really impressed with the phase II data that we've seen so what we're talking about is the ability to get OCA of us.
And it all goes back to the margin point that you've made. Yeah, that I made before, which is because this is the you know it's clear for 26. Expand margin. And as previously always said at least stable, yeah, discipline for the long term.
James.
Thank you very much.
Okay.
and um,
Like efficacy in an oral treatment and for many patients for many many different reasons, that's a very attractive option. So you know.
we move on uh, to Graeme Perry from City Graeme.
[Company Representative] (Roche Holding Ltd): Thanks for clarifying the filing timeline as being Q1. Just wondered 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 RIBO combo sub-study data, 200 patients? How long does that take to recruit? And could we see something by the end of this year? Is that a next-year event? And then on the fenebrutinib, could you just confirm how important you think confirmed disability progression is versus annualized relapse rate reduction in showing a risk-benefit profile in differentiation versus Ocrevus versus to the regulator, just given it's a very brain-penetrant molecule and has potentially, therefore, the ability to work on disability progression where CD20 doesn't? And then the final question is, you're technically still on clinical hold with FDA.
Again, I think in this market a lot of it comes down to the overall efficacy that.
And that we're able to deliver them 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 and MFS from Novartis. Yet. This is a dose that I think is about four times higher than the existing dose.
They had a had sort of a second mover advantage or 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 had robust phase two data and.
Bless you bless you. Thank you. So, 1 on the Dara, thanks for clarifying. The, the fighting calendar is being q1. Just wonder if you could comment on, whether you expect priority review or to use a priority review voucher or not. Um, and when exactly, do you think you would expect to see the ribo combo study data? Um, 200 patients, uh, 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 blue nib, um, could you just confirm how important you think confirmed disability progression is versus annualized relapse, rate reduction, uh in showing a risk benefit profile and differentiation versus
Yeah, I mean, I think we are at it.
It's very difficult to say anything until we actually see data. It's also I think important to remember that Senate Britain. It as a non covalent molecule and in a chronic indication that non covalent and see really matters because it means that even though you're taking it.
[Company Representative] (Roche Holding Ltd): 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. Yep. Okay. So we expect the Abema sub-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 FENhance filings, but we've obviously been in consistent conversation with the agency over time. So we've been in very close contact. I won't comment on our filing strategy, only to say that we plan to bring lidERA to patients as quickly as possible. And in terms of confirmed disability progression, I think the annualized relapse rate is also a very good endpoint here.
Broker us to the regulator uh just given the the it's a very brain penetrant molecule uh and has potentially therefore, the ability to work on disability progression where a cd20 doesn't. Um, and then the final question is um your 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.
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's that really in a chronic care environment is a benefit.
So in terms of read through for persevere, our you know.
Yeah, okay, so we expect the AMA subsidy by the end of the year. Uh, we would expect, uh, ribo in 2027—that is really only starting now, so we've got, uh, we've got a little time. That's 100 patients, um, in the AA arm.
It's clear when when breast cancer is dependent on the endocrine receptor for viability geared restaurant 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 ear signaling and it's worked really well here. So clearly on the frontline the likelihood that a successful.
Hasn't hasn't gone down.
And we.
We should always be really cautious with cross trial comparisons and so I think we are you know.
And in ribo, it's 200 patients. Um, the FDA hold, uh, will be addressed as part of the planned fenny filings, but we've obviously been inconsistent conversation, um, with the agency over time. So they're uh, we we've been in in very close uh, 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, Lera to patients as quickly as possible.
um, and for in terms of, um,
Again as I mentioned the benefit is we don't really have along the way. So we'll we'll know really soon.
Confirmed disability progression. I think we are, uh,
Oh, and yes, persevere is designed to show improvement over Palo plus I'll, let Russell.
[Company Representative] (Roche Holding Ltd): And we are confident that that is giving us what we need in order to proceed. Graham, any additional questions or—all good? Then we will move on. And I hand over to Rajesh Kumar from HSBC. Rajesh, please. Hi. Two questions, if I may. First, on CT-388, 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 III trials as an option. But could you give us some color on how you're thinking about phase III progression? Would 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 obesity, quick follow-up. You highlighted the overall term this class is targeting to be quite a large number. You are filing with a few.
Sorry for all the questions answered.
The annualized relapse rate is, is also a very good. Uh, is also a very good endpoint here, um, and we are confident that that, that is giving us what we need in order to proceed.
Yes. Thank you.
Yeah.
And then Exxon into Qs, Richard Vasa from J P. Morgan.
Can I have any additional questions or
Yeah.
Thanks, Brian.
All good.
Thanks very much two questions. Please first question just to go to the diagnostics for a little bit.
Margins, obviously hit by a by a ramp up of <unk>.
Then we'll move on, and I hand over to Raj Kumar from HSBC.
Mass spec sequencing on 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 those two businesses up so how should we think about 'twenty six and then and then the improvement in the margins from that and then second question back to pharma just gone.
Right, please. Hi there. Uh,
Back to Verbalize my.
Thanks for the comments on the foundations could we got a little bit further out and think about the future competition potentially from less frequently dosed Ah injectable products. Thank God killer has one half yearly Ah how how you think about that sort of competition and also closer to today the biosimilars in a really stellar.
2 questions before May first uh, on uh CT, uh, 380, thanks for clarifying discontinuation rate in the highest dose was similar to the overall group. Uh, you also mentioned the you could consider flexible dozing, uh, in Phase 3 trials as an option. But could you give us some uh, color on how you're thinking about phase 3?
To come they're having some impact in in in Europe as far as we can see say just watch what's the thoughts are globally U S. Europe on Biosimilars from Eylea.
You know, uh, progression would flexible dozing, uh, or an active comparator will be something you might consider, or is it, uh, at the moment. Uh, too early to comment on that, uh, Second, uh, just on to your destination, uh, quick follow-up. Um, you know
All right thanks very much.
Yeah.
Maybe I'll go ahead and disconnect.
[Company Representative] (Roche Holding Ltd): Some persevERA data is about to read. So just in terms of the market segmentation, how much of the market you think it has been risk, de-risk 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, the third question would be just on clarification on the Vabysmo. Appreciate the 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 the Vabysmo? Thank you. So I would just go back to my earlier comments. For Vabysmo, we expect to see an acceleration of growth in 2026.
Thank you.
So maybe starting with diagnostics that we talked about a couple of effects. There is the new technologies. There is the the tariffs of which Alan said, we had half a year and 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.
2027, again, we expect a decline, but it'll be small enough that it won't really be a 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 to the group a position that Allen a reader that Alan mentioned earlier, but I would say are consistent ambition is to grow profit faster than sales and that as you know once we really get ourselves through the headwinds. This year that is our ambition going forward.
Working capital impact has gone up and that sort of reflects a very strong December. So, um,
should we consider the exit trade of December?
And it's also our continuous ambition to improve the margin in diagnostics, that's something that is a.
Our goal for the entire organization, what I would call. It though in 2025 as you at 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.
Uh, closer indication of how you're thinking about growth in 2026, or should we, uh, you know, take, uh, an overall slower growth rate going forward on the Bismarck?
Thank you.
[Company Representative] (Roche Holding Ltd): More to come on that. In terms of the dosing for CT-388, so what we have disclosed is that CT-388, it will be administered once a week, and we're aiming to develop it at 3 maintenance doses. We are not disclosing at this time the details of that dosing strategy. But just to avoid any misunderstanding, we have not indicated that we will be doing flexible dosing within the trial. But right now, the details of that phase III design, that specifically have not been disclosed. Then in terms of giredestrant and the market segmentation, and how much do we feel like has been de-risked? Well, 2/3 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.
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 for 26, I think well we'd be we expect kind of a stabilization I think that's a little bit of time, but as you look give us additional information. So I would I would maybe just refer to what Alan said, we our goal really this year is going to be that we stabilize the margin.
And I think on a group level, you've seen that our intention is to expand margin.
In 2026, and where that sits in the past still holds which is also going forwards we will at least keep margins stable.
Also for the coming years.
Perfect. So to answer your question.
Um, so I I would just go back to my earlier comments for vismo. We expect to see an acceleration of growth in 2026 so more more to come on that. Um, in terms of the dosing for CT 388. So uh, what we have disclosed is it CT 388. Um, it will be administered uh once a week and we're aiming to develop it at 3 maintenance doses. Uh, we are not disclosing at this time, the details of that dosing strategy, um, but just to avoid, uh, any misunderstanding we have not indicated that we will be doing flexible dosing within the trial. So, um, but right now, the details of that phase 3, um, uh, design that specifically have not been um, have not been disclosed and then in terms of gear duster and the market segmentation. So I, you know, and how much do we feel like has been de-risked, well, 2/3 of the market is adjuvant and we have a positive adjuvant trial
so, I mean, I think a significant portion of the, um,
Thanks.
That's great.
Uh, we have a significant portion of the market has been drift.
First just to start by talking about the buys now so I mean, the buys mall is a highly efficacious therapy with a very well defined safety profile, where patients and physicians do you have a lot of good experience in extending doses.
Thank you very much.
[Company Representative] (Roche Holding Ltd): Then next questions are from Michael Leuchten from Jefferies. Thank you, Bruno. Question from 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 to raise that, just going back to the BISO, 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 after yesterday.
Okay then. Um next question is from Michael osten.
From Jeffrey.
And so and it is designed to do just that when.
When you when you look at you asked specifically about ocular I mean this this drug is going into phase three with a very small.
Safety database and really no known no no known data on long term safety and when you talk about something that's going to be used into ocularly them over a long period of time I think you know long term safety is incredibly important and I think it's very difficult to think about you know how the.
Thank you, Bruno, a question from Matt, please. Um, Abbott said last week that the Chinese may be presuming vbp, for, uh, collab oncology to just wondering whether, um, you've heard that and, and how that may or may not be reflected in, in in your outlook, on the margin commentary you made earlier.
You know how something like that is a threat to something that has such good efficacy such good safety.
And while you do actually have the ability to to extend doses. So I think from a from.
And so to raise that, just going back to to the supply. So just to comment about 2025 in the US being a reset, um, Q4 was still soft. Um, I didn't really approve upon Q3 sequentially. So when you, when you say, you think that's, that's now stabilized and it can grow from here, just wondering how you look at that Q4 versus Q3 Q3 dynamic in in the US. Thank you.
[Company Representative] (Roche Holding Ltd): What I would first start off by saying is, as you may know, there was VBP for core lab oncology reagents last year. That was what you see. Our China effect last year significantly represented a decrease in our core lab oncology reagents, which were down about 50%. Some of that effect is still pulling through this year. 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. We don't anticipate additional core lab oncology VBP this year. In thinking about the BISMO, 2025, we saw a big reset in the branded market 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.
From a future competition perspective, you know just just like and in other disease areas sort of the bar is high here to unseat a bias now.
And you had one other question.
Oh biosimilars, so so far you know.
What we see is that the Eylea biosimilars are taking from Eylea.
Okay, 3. Wow. I know what 3 is, I think that's true. So, um, what I would first start off by saying is as, as you may know, uh, there was vbp for core lab oncology reagents last year. Um, and so that was uh, what you see our China effect last year. Um, significantly represented a decrease, in our core lab oncology reagents which are down about
And so for those patients who are really benefiting from a new and novel treatment by buys now there there were just less impacted so yeah and I think we saw lucentis take from the centers, we're seeing eylea biosimilars take from Eylea, and we're seeing high dose eylea take from low dose eylea. So theres a lot of trading within that space, but I think for new patients.
About 50%. So, some of that effect is still pulling through this year, but, um, I can't speak for what was said on that call. But, uh, we are seeing the effect of, uh, the vbp last year, and the national reimbursement reduction. So, uh, we don't anticipate, uh, additional core lab oncology, uh, vbp this year.
Who are going on therapy physicians are picking the best available therapy out there available to them and that is the bias now okay and on the 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 a different level.
so it it
Viseo.
Um, Q4 so 2025, we saw a big reset in the Branded Market in
It's in house and so if you look at our pipeline, we have tri specifics tetra specifics do the fabs et cetera. So.
[Company Representative] (Roche Holding Ltd): And 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 for a year's worth of therapy. What's happening right now in the oncology world is something called the blizzard. It's where every retinal specialist in the US goes and re-verifies the benefits for every single one of their patients. And it's at that point in time that patients actually determine what will they be continuing on their current medication, will they be switching, etc.
If I look at the ophthalmology pipeline I think the one that's going to succeed.
Succeed.
You know it surpassing the buys moves then hopefully us.
Very good.
Richard.
Perfect everyone. Thank you very much very helpful. Thanks for that.
In uh, in the US right? With with the closure of the co-pay foundations, fewer patients were put on branded drugs. More patients were put on a vastin uh and and bio similars. And you know you saw a big just sort of reset and 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, um, because normally when donations are given or grants are given, they're given for years worth of therapy.
And nexon in the Q S J.
Um, what's happening right now in, um,
James quickly from Goldman Sachs.
Thanks, Bruno hopefully you can hear me.
Just a couple of quick questions from my side leftovers. So firstly again on dirt I shouldn't and revisiting them do their work.
It's the kind of gut reaction been from from your side and so some of the cargos. We spoke so had been a little bit more cautious than the present through it youll subsidies event.
[Company Representative] (Roche Holding Ltd): So over the course of the next couple of months, I think we're going to get a real sense of what the trajectory of the branded market is going to look like in 2026. 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 I think there's a reason why we didn't see Q4 look any different than what the rest of the year looked like. I think we had sort of hoped that 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 copay assistance foundations, they're separate, right?
Given the more limited follow up versus the CDK four six class.
It could impact.
Jerry just a trajectory of course assuming approval.
Respectful stepwise ramp or.
Oh.
Most of that was as more data comes or what.
Or does your feedbacks suggest the potential for Boston more optimistic ramp.
Restaurants so.
The first one second one more financial question so.
Underlying pharma growth has been pretty strong in recent news driving operating leverage so how is rough balancing R&D investment with profitability, but how long can R&D expenses stay flat.
This all seem to show you that Russia is a strong ability to reallocate costs in R&D, but how long how long can this go on to support our pricing leverage. Thank you.
[Company Representative] (Roche Holding Ltd): So nothing that in terms of influence. But what we can say is, in general, that our donation was towards the end of Q4. Yeah. And 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 a—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 TD 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 giredestrant in the adjuvant setting? And secondly, how did the change in Xolair biosimilar entry from end of 2026 to before November 2026 come about?
I mean, I think what we're hearing from the Kols community regarding where they would use the Dara is is pretty bullish I mean, I think what we hear from the Madera population is 55% of the.
Like, I think we had sort of hoped that we, we might see. Um, we might see some early signs of recovery, but I think those signs of recovery really are going to come, uh, become a little bit more evident as we get towards, uh, towards the end of q1. So, Michael, I hope that addresses your question. Yeah. And uh, I mean, we the co-existence, uh, uh, foundations. They are separate. Right? So nothing that uh, uh, in terms of influence, but what we can say is in general that, uh, our our donation was uh, towards the end of Q4. Yeah. And again, uh, we don't we don't
Adjuvant breast cancer population, that's 10% more than what we saw in the Natalie trials. So you know I think you are really seeing physicians believe that this could have very broad applicability in their practice and so I think that what that's what that's what leads us to be fairly fairly bullish about the opportunity there was a 74% overlap with the pop.
In Q4 we did see a 4% growth. So we saw, uh, you know, we, yeah, quarter-over-quarter growth. Uh, we did see a 4% growth; we did see a little bit of an uptick.
Michael, any follow on.
<unk> and Natalie and monarchy in so I think where we are 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.
if not then, um,
I would hand over to uh, Paul Kuhn from K, Paul.
Me answer the second question, but first something to add on jewelry. This trend I mean, you look at the hazard ratio of <unk> seven.
You can see that that's I would say highly competitive to also some of the CDK four six trials that you've seen at vinyl, but what you have on top of that is the tolerability.
[Company Representative] (Roche Holding Ltd): Was this a change in the settlement with generic manufacturers? Thank you. So with regards to Xolair, 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. Oh, that is correct. Sorry. We need to have a biosimilar player in the market before 1 November, so then we cannot get negotiated. That is correct. So my reference to 1 November was purely around CMS guidance that says, if you have a marketed biosimilar by 1 November 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.
If you look at CDK four six you had for quite a high amount of patients that actually stopped using it.
Thanks, Bruno. This is Paul on for Steve Scala. Uh, two questions, please. What feedback have you heard from US oncologists and how they plan to initially use Giredestrant in the adjuvant setting? And secondly, how did the change in Solara biosimilar entry from end of 2026 to before November 2026 come about? Was this a change in the settlement with generic manufacturers? Thank you.
Simply because they cannot take the tolerability. So I think these are all the right arguments for so that's to be used.
so,
So I do believe that a.
Pick up will be strong unfortunately, it wasn't at the Congress in San Antonio, but it hurt there wasn't even a standing ovation from a from a.
The conditions there than.
And then the second question on R&D.
Hum.
So we're working very hard to be a high performing very cost efficient organization and 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 wanted to on the one that speed up using AI, but also reduce costs.
Doing that.
[Company Representative] (Roche Holding Ltd): Then feedback from oncologists on where they intend to use for adjuvant. I mean, again, just to continue to reiterate, 55% of the adjuvant population was covered by the lidERA trial. So I think you see a high degree of confidence in oncologists to use in a very significant portion of their patients. Again, what we saw here was a 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 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, are we on to all your questions? Yeah. Thank you. Then next one would be Justin Smith from Bernstein. Justin. Thanks very much, Bruno. Two, please. Pharma number one, NXT007.
Regarding R&D expenses.
Also for 'twenty 'twenty six.
I would say it would be broadly flat again really focusing very hard on.
Making sure that we put.
with regards to solar, 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. Um, I think, um, mentioning November was just related to Ira. So basically, you know, we need to have a bio similar Place, uh, a higher in the market before the 1st of November. Um, so then we cannot get negotiated that is, that is correct. So my, my reference to the first of November was purely around CMS guidance. That says, if you have a marketed bio similar, um, by November 1st 2026, then you will be removed from the, uh, 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, a bio similar in, in the market. Um, and then feedback from oncologists on on where they intend to use for agiiman. I mean, again just to continue to reiterate, um, you know, 55% of the agent population was covered by the Lera trial. And so I think,
Put the money to work in the best possible way for the sake of patients in our company and for our investors.
And as you all goes back to the margin point that you've made.
I hope I made before which is that this is you know it's cleared up with when you fix expand margin and as previously always say, it's at least stable and disciplined for the long term.
James.
Thank you very much.
Okay.
You see, um, a high degree of confidence in an oncologist to use in a very significant portion of their patients. Um, and again, you know, we what we saw here was a, a, a very, um, a very efficacious, uh, seemingly combinable, and and, and, and well, tolerated therapy that I think has the opportunity, um, to, to really become a new standard of care in the setting. So, you know what we're hearing from oncologists?
And.
We move on to Graham Parry from Citi.
In general, is that they're, they're pretty excited to have this in their hands and we're we're excited to get get it to them.
Jim.
Paul, it's—we answer all your questions.
Okay.
All right. Thank you.
Gotcha.
Mhm.
One of them the Dara thanks for clarifying the filing time lines being Q1, just wondered if you could comment on whether you expect priority review, which use approach.
Then, um, next 1 would be Justine Smith from Bernstein Justine.
Rajeev voucher or not.
And when exactly do you think you would expect to see the Rainbow combos that subsidy data 200 patients.
[Company Representative] (Roche Holding Ltd): Just wondered if you could share some thoughts on when the phase 3 design, head-to-head versus Hemlibra, will hit ClinicalTrials.gov. Second one, diagnostics. Matt, just wondered if you could talk a little bit about CGM and when the fingerprick recalibration will be removed and the impact that might have. Many thanks. Wow. 4 is new territory. So I want to first thank Teresa for generosity. But so specifically to your question on autocalibration, 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. Okay. And with regards to NXT007, we would expect those trials to start in Q1, Q2 with ClinicalTrials.gov entries at around that timeframe.
How long does it take to recruit until we see something by the end of this year is that a next year event.
And then on.
The business.
Can you just confirm how important you think confirmed disability progression is this is annualized relapse rate reduction.
Uh, thanks very much Bruno, uh, 2 please, um, farmer number 1, NXT 007 just wondered, if you could share some thoughts on when, uh, the phase 3 design head-to-head versus hem, Libra will hit ct.com second. 1, diagnostic match, just wondered if you could talk a little bit about CGM and when the fingerprint recalibration will be removed and the impact that might have many, thanks.
In showing a risk benefit profile and differentiation. This is <unk> to the regulator.
Given the it's a very brain penetrant molecule and how soon you see therefore, the ability to work on disability progression, whereas CD 20000.
Oh geez.
You're still on clinical hold with FCA. So does that have to be listed before you can actually file or receive approval and what are the steps to doing that thank you.
Yeah.
Wow, the 4 4, 4 is a new territory. So uh I want to first thank Teresa for generosity but so specifically with your question on auto calibration which is the comparison of the CGM device with a blood glucose Lancet. Um, what we are planning to do is have that, um, launch happen this year. Um, I won't say exactly uh, which quarter but that is, uh, an improvement that we expect to deliver this year.
Yeah. Okay. So we expect to see about a sub study by the end of the year, we would expect a rigor in 2020 seven that that that is really only starting now so we've got a we've got a little time, that's 100 patients.
[Company Representative] (Roche Holding Ltd): And again, these are two studies, one head-to-head versus a factor and one Hemlibra. 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 Ocrevus Zunovo. 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 is that we have CHF 2 billion in incremental sales for Ocrevus, but this is true incremental sales. And 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 2029. We might do that at a later point in time.
And the Obama arm.
And in <unk>, it's 200 patients.
The F D. A hold will be addressed as part of the planned feni filings, but we've obviously been in consistent conversation.
Right. And with regards to next, uh, 007 we would expect, uh, we would expect those trials to start in q1, Q2 with, um, with uh, clinical trials.gov, uh, entries that are around that time frame. Um, and again, these are uh, 2 studies 1 head to head and, and 1 versus a factor in 1 H. Libra
Justin, uh, all questions are answered.
With the agency over time, so there that we've been in very close very close contact I won't comment on our filing strategy only to say that we plan to we plan to bring <unk> to patients as quickly as possible.
Yeah, great. Thank you.
And for in terms of.
Confirmed disability progression I think we are at the.
The annualized relapse rate is is also a very good is also a very good end point here.
Question on Acuras Lenovo. So the split of naive versus switch patients, that we are capturing. And what is the target switch rate, uh, for 2026 and at Peak
um,
And we are confident that that is giving us what we need in order to proceed.
Yeah.
Graeme any additional questions or.
Oh good.
Then we will move on.
[Company Representative] (Roche Holding Ltd): 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 Q4 with 4 molecules added, 5 going out, so 5 added, 4 going out, is this now, is there still cleansing ongoing off 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 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.
What I think we have been communicating that we have 2 billion in incremental sales for across but this is true incremental sales. I'm off top on top basically we would have uh um revenues coming from switching. So we have not yet provided uh a detailed uh outlook on what um the the ratio Ivy to subcutaneous would be at around 29. Um, we might do that at a at a later point in time
And I hand over to Raj Kumar from HSBC.
Right.
Hi, there.
Two questions if I may 1st on.
On.
The C D E P T.
Thanks for clarifying discontinuation rate in the high schools with similar to the overall group.
You also mentioned that you could consider a flexible dosing.
Um, there's then a second question, I found interesting on the pipeline, um, 66 enemies. Uh, now on the pipeline is this right sized? And, um, what we have seen now with the turnover and the fourth quarter, um with um, 4 molecules, um added uh 5 going out. So 5 added 4 going out. Is this now the uh is it still a cleansing ongoing of the pipeline is is now the the the regular run rate and the turnover? Or would we target a more enemies overall?
In phase III, because as an option.
Could you give us some color on how you're thinking about safety.
Uh-huh program.
Flexible tubing.
Or an active comparator Kobe, something you might consider or is it a.
[Company Representative] (Roche Holding Ltd): 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 NMEs 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.
At the moment too early to comment on that.
Second just on two different a quick follow up.
Yeah, I mean I can answer that question. So overall uh, you know, you apply the bar. Not only once you play, apply the borrower, constantly Based on data that you generate but also data that you get from from the outside. So, uh, clearly I think we are at a point where we'll continue to bring in, uh, additional enemies. We have actually when you look at the very early stage of, uh, our research, uh organization,
You know who.
You highlighted the overall Tam this class is targeting to be quite a large number.
You are filing with a few from both Super outdated I was about to read so just in terms of the market segmentation.
Organization. We've actually doubled the amount of uh, molecules moving ahead there. So uh 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.
How much of the market you think has been risk.
D. This to some extent and how much are we still depend on the data in your assessment of the market would be.
And then, um, the final question here, um, would be on a capital allocation giving, uh, your positive pipeline progress, farmer deals with the US Administration and with competitor developments and obesity are there any changes to your m&a objectives? And the R&D investment plans
Very much appreciated and because I'm, an analyst and I cannot count.
[Company Representative] (Roche Holding Ltd): I think what we have really shown over the last couple of years is 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. Our intention is to continue to do the same and just continue to be quite disciplined on that. The good thing is we are not in a situation where we have a huge patent lift, right? So we're not in a situation where we have to do late-stage deals, which are very costly. I think we're in a very good position when it comes to our late-stage pipeline.
The third question would be just on clarification on the buy small.
Appreciate the working capital impact of gone up and up.
Sort of reflects a very strong December so.
You should reconsider the exit rate of December.
Close the indication of how you're thinking about growth in 2020 fixed or should be.
<expletive> and overall slower growth rate going forward on goodbye smoke.
Okay.
So I would just go back to my earlier comments for vote by small we expect to see an acceleration of growth in 2026, so more to come on that in terms of the dosing for C. T 388. So what we have disclosed is C. T 388 it.
[Company Representative] (Roche Holding Ltd): But obviously, I mean, if you look at the amount of innovation that's ongoing outside, you 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 9 February, our neurology call. We will cover up the PPMS data for fenebrutinib presented at ACTRIMS.
No, I can I can say there is uh no no fundamental change. Uh 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, you know, really screening the market for uh, you know, interesting molecules with good data. Uh, if you look at the amount of money that we've spent compared to other companies in the kind of pipeline, we've built, uh, doing that. I think we've been pretty efficient and Our intention is to continue to do the same and just continue to be, uh, quite uh, disciplined, uh, on that. Um, the good thing is we are not in a situation where we have a huge patent lift. Right. So we are not in a situation where we have to do, uh, late stage deals which are very costly. Uh, I think we are in a very good position when it comes to a late stage uh pipeline. But obviously, I mean if you look at the
It will be it minister once a week and we're aiming to develop it at three maintenance doses are we are not disclosing at this time the details of that dosing strategy.
Just to avoid any.
Any misunderstanding, we have not indicated that we will be doing flexible dosing within the trial, so but right now the details of that phase III design.
Design that specifically have not been have not been disclosed and then in terms of gear desperate in the market segmentation. So it you know 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.
Kind of innovation that's ongoing outside. Uh you look at what's happening in China. Um we need to continue to uh screen the market and look at everything that's out there. Uh I mean I looked at the statistic in for about 1,000 companies that we look at we do 1, 1 deal. Um and I think that's also what I expect of our organization that we know exactly what's going on uh outside so that we can make data driven, good decisions.
So I mean, I think a significant portion of the.
Oh, we have a significant portion of the market has been derisked.
[Company Representative] (Roche Holding Ltd): Then on 12 May, 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. I think will be SBX sequencing as we are now in the global launch phase. I think there are the next steps to come with pricing and so on. So I think it will be an exciting event. 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.
Okay.
Thank you very much.
Okay then.
Next question from Michael Washington.
From Jefferies.
Thank you Bruno a question from Matt Please.
Abbott said last week that the Chinese may be presumed EVP for core lab oncology just wondering whether.
Very good. I think with that actually, we are at the end of our uh Q&A uh session. Let me just remind you of the 2 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 uh, ppms data, uh, for final protein app, um, presented at act rooms 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 here. I think we'll be SPX sequencing as we are now in the global launch phase. Um, I think there is the next steps to come uh, with pricing and so on. So, um, I think it will be an exciting event and with that I hand over to Thomas for uh, the final remarks.
You've heard that.
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 the base of just your comment about 2025 in the U S being a reset.
[Company Representative] (Roche Holding Ltd): 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. With people like Alan and myself who like math, also we can talk a lot about financials. I think there's a lot of good things that are going on, and we have a good momentum both on financials and pipeline. Very proud of the team. 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. As always, you can count on us because we will deliver. Goodbye.
Q4 was still soft it didnt really improve upon Q3 sequentially. So when you. When you say you think that's that's now stabilized and it can grow from here just wondering how you look at the Q4 versus Q3 Q3 dynamic in the U S. Thank you.
Okay, three Wow [laughter] [laughter].
So.
What I would first start off by saying is as you may know there was GBP for core lab oncology reagents last year and so.
That was what you see are China effect last year significantly.
Forward. We continue to move, we focus, we continue to move with speed. And as always you can count on us because we will deliver
<unk> represented a decrease in our core lab oncology really reagents, which were down about 50%. So some of that effect is still pulling through this year, but.
I can't speak for what we said on that call but.
Goodbye.
We are seeing the effect of the V BP last year and the national reimbursement reduction So we don't anticipate.
Additional core lab oncology BBB this year.
So it it and thinking about.
The buys now.
Q4, So 2025, we saw a big reset in the branded market in.
In our in the U S right with the closure of the copay foundations fewer patients were put on branded drugs more patients were put on avastin and in Biosimilars and you saw a big just sort of reset and how many new patients 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.
Because normally when donations are given or grants or given their get in 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 specialists 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 will they be continuing on their current medication will they be switching etcetera, 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 'twenty 'twenty six but.
Because that underlying base effect of 'twenty 'twenty four is now washout, you should be able to see the actual branded growth of people going on to new therapies actually come through.
So I think there's a reason why we didn't see Q4 look any different than what the rest of the year looked like I think we had sort of hopes that we might see we might see some early signs of recovery, but I think those signs of recovery really are going to come become a little bit more evident as we get towards towards the end of Q1, So Michael I hope that addresses your question.
I mean, we the Cola assistance Oh the.
Foundations they were separate right so nothing that.
In terms of influence with what we can say is in general.
Our our nation was towards the end of Q4, and then again, we don't we don't we don't link those two things it.
It is interesting to know, though that in Q4, we did see a 4% growth. So we saw a.
We went over call it quarter over quarter growth, we did see a 4% growth we did see a little bit of an uptick.
Michael any follow on.
If not then.
I want to hand over to Pelekunu from Cowen <unk> co.
Uh huh.
Yeah.
Thanks, Bruno this is Paul on for Steve Scala too.
Two questions. Please what feedback have you heard from U S oncologists and how they plan to initially use Gary district in the adjuvant setting.
And secondly, how does the change in Xolair Biosimilar entry from end of 2026, two before November 2026 coming out was this a change in the settlement with generic manufacturers. Thank you.
Yeah.
So.
With regards to solar I think we have long said sort of second half of 2026 is when we expected the first biosimilars to come in for the U S. I don't actually think that that's the change.
Hum.
<unk> November was just related to IRI.
We need to have a bias to have a place.
Payer in the market before the first of November.
We cannot get negotiated that it that is correct. That's my my reference to the first of November was purely around CMS guidance that says if you have a marketed biosimilar by November. One 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 'twenty 'twenty sexual.
We would expect to have a biosimilar in the market.
And then feedback from oncologists on on where they intend to use for adjuvant I mean again just to continue to reiterate them in a 55% of the adjuvant population was covered by the the Dara trial and so I think you see a high degree.
We have confidence in and oncologists to use in a very significant portion of their patience and again you know with what we saw here was a very a very efficacious are seemingly combinable, and and and and well tolerated therapy that I think has the opportunity to.
To really become a new standard of care in this setting so what we're hearing from oncologists in general is that there they're pretty excited to have this in their hands and we're excited to get it to them.
Okay.
Paul Let me answer all of your questions.
Thank you.
Mhm.
Then.
Next one would be Justin Smith from Bernstein Justin.
Thanks.
Two please.
Hum.
<unk> 007, just wondering if you could share some thoughts on win.
So you design the head to head versus the Labor P.
Okay.
Second one prognostics not just wondered if you could talk a little bit about CGM.
The fingerprint recalibration will be removed.
Many of them.
Wow for a new territory.
[laughter] so.
I wanted to first thank Theresa for generosity, but.
So David your question on auto calibration, which is the comparison of the CGM device with a blood glucose Lance it what.
What we are planning to do is have that March happened. This year, I won't say exactly which quarter, but that is a an improvement that we expect to deliver this year.
Okay.
With regards to next double the seven we would expect a we would expect those trials to start in Q1 Q2 with a with a clinical.
Clinical trials dot Gov entries that around that time frame.
And again these are two studies, one head to head and in one versus a factor of one hand labor.
Yeah.
Justin.
All questions answer.
Yeah, great. Thank you.
And I Wouldnt, maybe retailer allowances of three questions, which I got from.
Luisa Hector she had to drop off and I promise I will go freedom that.
There is one question on Oculus Lenovo, so distillate of naive versus switch patients that we are capturing and what does the targets which rate for 2026 and at peak.
Hum.
What I think we have been communicating that we have 2 billion in incremental sales for our crews, but this is true incremental sales on top on top basically rewards.
Revenues coming from switching so we have not yet provided a detailed outlook on watch.
The ratio of IV to subcutaneous would be at around 2009, we might do that at a later point in time.
Then the second question I found interesting on the pipeline 66 enemies now on the pipeline is right sized and what we have seen now with the turnover in the fourth quarter with four molecules added five going out so five edit foregoing Alex is this an hour.
Is it still a cleansing ongoing off the pipeline. This does nowadays the regular run rate in the turnover or would we target a more enemies overall.
Yeah, I mean, I can answer that question.
So overall you know you apply the bar not only once you play apply the board 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 enemies. 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 will continue to expand on the minds of enemies.
That we have enough before you'd be onto the 66, but just kind of I would say privatization 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, giving you positive pipeline progress pharma deals with the U S administration on which competitor developments and obesity are there any changes to your M&A objectives, and the R&D investment plans.
No I can 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 Ah interesting molecules with good data.
If you look at the amount of money that we spend compared to our other companies in the kind of pipeline. We felt are doing that I think we've been pretty efficient and our intention is to continue to the same and just continue to be quite disciplined on.
That's the.
The good thing is we are not in a situation, where we have a huge patent cliff right. So we're not illustration, where we have to do a late stage deals which are very closely.
We are 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.
If you look at what's happening in China, we.
We need to continue to screen the market and look at everything Thats out there.
I mean I looked at the statistic.
For about 1002 companies that we look at with the one 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 decisions.
I think with that actually move out 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 of this on February 9th our neurology call. If we were to cover up the a P. P. M S data for kind of broken up.
Rented at actress and then on May 12, we again will have our diagnostic day as a life event in London, where we will take you through the entire portfolio and highlight the C. I think will be SPX sequencing as we all know in the look global launch face I think there is the next steps to come.
But our pricing and so on and 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 blue and a few things also to the team.
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 was the science, which is about progress for patients and with people.
And then myself, who like mess also we can talk a lot about financials. So I think theres 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 you know we've.
Oh, it's done what we said, we're going to do and you'll 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.
