Q1 2026 Roche Holding AG Earnings Call

April 23, 2026

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Thomas Schinecker: ER-positive HER2-negative breast cancer in the US using a priority review voucher, and we do expect approval across two indications in the adjuvant and in the second-line plus before the end of this year. Susvimo was filed in the US. Gazyva, we've had a series of filings in the US and EU across SLE and LN. There are still a number of important readouts, or there have been a number of important readouts. For example, the positive FENhance 1 result in RMS. This is the last one from three fenebrutinib phase three studies where you also saw the results presented at AAN, and there was an IR call yesterday as well on this topic. Now, together with FENhance 2 and FENtrepid, this is the first and only BTK inhibitor with positive phase three across both RMS and PPMS, and we do expect a filing in the next couple of months.

Thomas Schinecker: I know that Theresa will go into more details here. Gazyva, I think, is very much a success story. We've had four positive readouts in a row. The latest one was in MAJESTY in membranous nephropathy, and it follows positive readouts in LN, so lupus nephritis, SLE, and INS. In obesity, we announced positive phase 2 results for Petrelintide. In the study, we've shown excellent tolerability. In fact, we had more dropouts in the placebo than in the control arm, and this tolerability makes it an ideal candidate to combine with our very strong CT-388, which actually showed at week 48 similar weight loss than a leading other player after week 72. We have a very strong GLP-1, GIP. We have a highly tolerable amylin, and we find this is a good combination. Now, moving to business development, I just want to highlight 2 deals.

Uh, I know that Theresa will go into more details here because IA, I think is very much a success story. We've had 4 positive readouts in a row. Uh, the latest 1 was in Majesty in membranous nephropathy and it follows positive without an Ln. So it was a Fridays SLE and ninis.

In obesity we announced positive Phase 2 results for patrol linid in the study. We shown excellent tolerability in fact, we had more dropouts in the placebo than in the control arm and the stability makes it an ideal candidate to combine with our very strong c388, which the glp1 gap, which actually showed at week 48. Uh,

Similar weight loss to the leading other player after week 72. So, we have a very strong TP1 gap. We have a highly tolerable amlan, and we find this is a good combination.

Thomas Schinecker: On the pharma side, we extended our collaboration with C4 Therapeutics on the degrader-antibody conjugates. This is a promising novel platform which could potentially overcome certain therapeutic windows and resistance issues that other drug modalities have. On the diagnostic side, we acquired Saga, or we're in the process of acquiring Saga Diagnostics, and they provide a minimal residual disease test to really monitor disease progression so that we can pick out those patients and where we need to then change the therapy. On the regulatory side, we've had CE marks for new tests for blood screening, which includes hepatitis E. We have the Elecsys APOE4 and the Elecsys NfL for our neurology portfolio. Looking ahead, we still have a couple of important Phase III readouts this year and also some launches in diagnostics. There are 2 more NME readouts.

Now, moving to Business Development. I just want to hide highlights to 2 deals on the farmer side. We extended our collaboration, uh, with C4 Therapeutics on the greater antibody conjugates. And this is a promising novel platform which could potentially overcome certain therapeutic windows and resistance issues that other drug mortalities, have on the diagnostic side, we acquired Saga or we're in the process of acquiring Saga Diagnostics.

And they provide a a minimal residual disease tests to really monitor um uh disease progression. And so that we can pick out those patients and where we need to, then change the the therapy.

Thomas Schinecker: One is Divarasib in non-small cell lung cancer and cefoxitin in IgAN. We have two readouts for inavolisib coming in breast cancer and also Lunsumio in second-line follicular lymphoma. In Diagnostics, we are very excited that Axelios sequencer is coming this summer, and I hope that we can see you at the Diagnostics IR day because we will certainly highlight this there. We'll also launch the Elecsys pTau217, the Elecsys IGRA tuberculosis test, cobas HDV, so hepatitis D, the eplex gastrointestinal panel, and so on. We have quite a lot of launches and exciting things ahead for this year as well. Now, this slide I've shown over the last couple of years. What you can see is that we have shown consistent, strong growth over the last quarters.

Uh, on the regulatory side, we've had CE marks for a new test for blood screening which includes Hepatitis E. We had the Elecsys AOE for p and the Elecsys NFL for the neurology portfolio. Looking ahead, we still have a couple of, uh, important phase 3 results this year and also some launches in Diagnostics. There are two more enemy results. One is the VIS.

Uh, in small, non small, the lung cancer. And in IGN,

We have 2 readouts for it to be coming in in breast cancer and also lunio in second line follicular lymphoma in Diagnostics. We're very excited that axle sequencer is coming this summer. And uh, I hope that we can see you at the Diagnostics Z day because uh we will certainly highlight this uh there. We'll also launch the Lexus ptow 217 the Alexis era tuberculosis test covers hdv, so hepatitis D the eplex um gastrointestinal intestinal panel and so on. So we have quite a lot of launches and exciting things ahead uh for for this year as well.

Thomas Schinecker: We have post-pandemic average growth of 8%, and even in 2023 and 2024, if you strip out the pandemic sales, we did also have an underlying growth of 8%. We continue to have a good performance on the sales side, and we will continue to drive this as we go in the next quarters as well. Now let's look at the numbers in detail at the Group. I mentioned that we grew at 7%. This was driven by Pharmaceuticals with 7%. Diagnostics grew 3%, and as mentioned, this is due to the healthcare pricing reforms in China. Ex-China Diagnostics was at +5%. Overall, the impact on the flu season is about 1%. It's about the CHF 170 million that I was mentioning before. Now, let's take a closer look behind the drivers as well. First, all segments delivered growth.

Website and uh, we will continue to drive this as we go into the next uh, quarters as well. Now, let's look at the numbers in detail. At the group, I mentioned that we grew at 7%.

This was driven, uh, by Pharma with 7%. Diagnostics grew 3%. And as mentioned, this is, uh, due to the healthcare pricing reforms in China and exiting. China Diagnostics was at plus 5%. Overall, the impact on the flu season is about 1%—it's about the $170 million that was mentioned before.

Thomas Schinecker: Now looking at it one by one, I will start with the oncology. Strong PFS conversion from Perjeta continues. The HER2 franchise grew 2.5% in Q1, and we do expect the total HER2 franchise to peak this year with a strong tail remaining. Tecentriq returned to single-digit growth, and this was really driven by new indications. Alecensa had an exceptionally strong Q1 with double-digit growth. We are expecting overall low single-digit growth for full year 2026. In hematology, Polivy sees continued strong uptake in first-line DLBCL, and Columvi and Lunsumio continue to grow in later lines of DLBCL and follicular lymphoma. Hemlibra saw a very strong Q1 with market share gains and volumes. On the neurology side, Ocrevus keeps growing nicely by the strong uptake of the subcutaneous formulation. I know Theresa will go into more details here as well.

Now, let's take a closer look at the drivers as well. Uh, first all segments delivered growth. And now, looking at this 1 by 1, I will start with the oncology, uh, strong fesco conversion. Uh, from projector continues the herd 2 franchise grew, uh, 2.5% in the first quarter. And we do expect the total of 2 franchise to Peak this year with a strong tail, uh, remaining uh, to Centric returned to single digit growth. And this was really driven by a new indication.

At the sense, I had an exceptionally strong q1 with double digit growth, we are expecting overall low, single digit growth uh, for full year 2026 in hematology poly, sees continued strong uptake in first line, uh, dlbcl and column we and Lumia continue to grow in later lines of dlbcl and follicular lymphoma.

Thomas Schinecker: Evrysdi is expanding its global leadership position in SMA globally. On the immunology side, Xolair continues with a strong uptake in food allergy. We're expecting strong growth for the full year 2026, despite the first biosimilar launch in H2. This will be the first, and there will be no other biosimilar that will come in for the next 2 years after that. Gazyva, we're still very much excited about all the positive trials we have. I mentioned 4 positive Phase III in a row, and we're excited about the launches in lupus nephritis, which is ongoing. On the ophthalmology side, we saw an acceleration and continued market share gains here as well, and I know Theresa will go into details here as well. Diagnostics, strong growth in pathology, but also CoreLab growing despite the China healthcare pricing reforms. I think I mentioned all of this already.

Ham. Libra saw a very strong q1, uh, with market share gains and, and volumes on the neurology side. Aqua keeps growing nicely by the strong, uptake of the subcutaneous formulation. I know Theresa will go into more details here as well and risky is expanding. Its Global Leadership position in SMA globally, on the Eman side. Totally continues with a strong update uptake in food allergy. We're expecting, um, strong growth for the full year 2026. Despite the first biosimilar launch in half year. In the second half year, this will be the first and there will be no other biosimilar that will come in for the next 2 years after that cyber, uh, we are still very much excited about all the positive trials we had. I, I mentioned 4 positive phase 3 in a row and we're excited about the launches in lupus nephritis, which is, uh, ongoing on the Opthalmology side. We saw an acceleration and continued, uh, market share gains here as well.

Thomas Schinecker: Now let me briefly talk about our expanding NVIDIA collaboration with this large-scale AI factory. We've had a very long-standing collaboration with NVIDIA over a number of years, and this collaboration really started in 2016, together with NVIDIA, specifically on the DNA sequencing side, because given the amount of data that we're going to produce, and specifically also with the chemistry from Stratos that we brought in, the amount of data needs to be digested and converted, and you need really high-performing chips in order to be able to do that. There's no sequencer in the world that actually produces as much data as our sequencer, so we really needed to go novel steps, and here the partnership with NVIDIA was really critical.

And I know Teresa will go into details uh here uh as well Diagnostics. Strong growth in pathology but also collab growing despite the China Healthcare pricing reforms. I think I mentioned uh all of this already.

Thomas Schinecker: Since then, we've also made a number of acquisitions in this space, like Prescient, for example, but also entered into strategic collaborations for drug discovery as well. We've significantly built up our internal capabilities when it comes to AI as well. Now with the recent agreements, we are expanding our GPU compute infrastructure, and with that, we have the largest AI factory in the pharma industry. Also, what's important, earlier this month, we joined forces with Anthropic, IBM, Meta, and Microsoft to launch a collaborative licensing zone for the development of AI foundational models called Shared AI License Foundation, or SAIL. Now, Roche Genentech is the only pharma company among the founding members, and you can see we're really pushing forward on the AI side. Why are we doing this?

Now let me briefly talk about expanding Nvidia collaboration with uh this large scale AI Factory. So we've had a very long-standing collaboration with Nvidia um over a number of years and this collaboration really started in 2016 together with Nvidia specifically on the DNA sequencing side because given the amount of data that we're going to produce and specifically also with the chemistry from Stratos that we brought in the amount of data needs to be uh you know, digested and and converted and you need really high performing chips in order to be able to do that. There's no sequencer in the world that actually produces as much data as our sequencer. So we really needed to go. No steps. And here the partnership within media was really critical and since then we've also made a number of Acquisitions in this space like depression for example, um, but also entered into strategic collaborations

For drug, uh, Discovery as well.

Um, and we've uh, significantly built up our internal capabilities when it comes to AI as well. Now with the recent agreements, um, we are expanding our GPU uh computer infrastructure and will that we have the largest AI Factory in the farmer industry. And also what's important uh, earlier in this month, we joined forces with anthropic IBM, meta, and Microsoft to launch a collaborative licensing.

Thomas Schinecker: Because we believe that AI will have a disruptive potential across the entire value chain in our company, from drug discovery through manufacturing, diagnostics, imaging, and we're really pressing forward on this with all the great people we have in this space in our company. Now, this will allow us to accelerate the development of therapeutics and diagnostics. Now let's turn to the outlook. We've made substantial progress across all the therapeutic areas since the start of the year. You see a lot of green ticks. There's a strong momentum from a very strong year of pipeline readouts in 2025, now also going into 2026, with a number of key milestones that have been achieved. On the regulatory side, we've just submitted Giredestrant in adjuvant breast cancer. We used a priority review voucher, and with that, we're expecting a launch later in this year, so still in this year.

On for the development of AI foundational models called shared AI licensed foundations or sale. Now Russian Tech is the only farmer company company among the founding members and you can see we're really pushing forward on the AI side and why are we doing this? Because we believe that AI will have a disruptive potential across the entire value chain. In our company from do drug Discovery through manufacturing Diagnostics Imaging. And uh we're really pressing forwards on this, with all the, the great people we have in the space in in our company.

Now, this will allow us to accelerate the development of Therapeutics and and Diagnostics.

Across all the therapeutic areas and start of the year, you see, a lot of green texts, there's a strong momentum from a very strong uh, year of pipeline readouts in 2025. Now, also going into 2026 with a number of key Milestones that have been achieved on the regulatory side. Um, we've just submitted your test in in a event uh breast cancer.

Thomas Schinecker: We've also filed Gazyva and SLE in the US. On the key readouts in Q1, I would like to highlight, on the one hand, giredestrant in the first-line HR-positive breast cancer, persevERA. The study failed, but we saw a numerical benefit in risk separation. The results will be presented at ASCO. Again, I want to reiterate that more than 70% of the opportunity is in the adjuvant setting. This is really a smaller patient population, and we still have another trial in this setting ongoing that could still allow us to enter in the first-line setting as well. Now, with fenebrutinib, we have the first and only BTK inhibitor with positive Phase III studies across RMS and PPMS, and we will be filing in the coming months. Petrelintide, excited about the clean, placebo-like safety profile with double-digit weight loss to be achieved.

Um we used a um priority review voucher um and with that we're expecting a launch uh later in the year. So still in this year we've also filed cassava and SLE in the US.

On the key readouts uh in q1 I would like to highlight on the 1 hand to a restaurant in the first line, your positive breast cancer persevere, the study field but we saw it in the medical benefits in curves. Separating, the results will be presented uh, at ASCO again, I want to reiterate then more than 70% of the opportunity is in the Edmond setting. This is really a smaller patient population and we still have another trial in the setting ongoing that could still allow us to enter in the first line uh setting as well.

Thomas Schinecker: This makes Petrelintide a good candidate to combine it with our very strong GLP-1, the CT-388. The phase II in this combination will be initiated. Just to say, we're making very rapid progress with the CT-388 molecule. We've just also initiated another two phase III studies here. Looking forward, we still have six pivotal phase III studies reading out, including two NMEs, inavolisib, and divarasib. We have a very exciting pipeline. I do believe that given all the readouts we have in the last couple of years, this will give us a much better view in terms of growth in the next coming years. Between 2027 and 2030, we have up to 19 NMEs that could launch. As you can see, many of these NMEs have quite significant sales potential attached to them. We wouldn't stop there. We will continue to do BD activities.

Now we send a brute, we had have the first and only BTK inhibitor with positive phase 3 studies across RMS, and ppms and we will be filing in the coming months. Um, Petri excited about the clean, Placebo, like safety profile with double-digit weight loss, to be achieved. This makes pedrol at a good candidate to combine it with our, um, very, uh, strong glp1. The c388 The Phase 2 in this combination will be initiated. Um, and just to say we're very making very rapid progress, uh, with the CT 388 molecule. Uh, we've just also initiated another 2 phase 3 studies here. Looking forward. We still have 6 pivotal phase 3, studies, reading out, including 2 Enemies. The rip Anderson

We have a very exciting pipeline so I I I do believe that given all the readouts we had in the last couple of years. This will give us a much better view in terms of growth in the next coming years and then between 27 and 2030. We have up to a 19 enemies that could launch

Uh, and as you can see, many of these enemies have quite significant sales, potential attached to them.

Thomas Schinecker: We'll continue to try to speed up more molecules so that we can even increase this number. I think these will really lay the foundation then also for growth in the next decade, which makes us confident that we can continue to have a good growth momentum. Now let me reiterate a couple. Giredestrant, you will see already on the market at the end of the year. There are two more NMEs that will read out this year. In addition, with Divarasib and cevostamab. In addition, we expect two NMEs to be filed in the coming months. One is fenebrutinib and the other one is the vamikibart. Again, the implication is that we don't only have a good short to midterm outlook, but also a very solid base to deliver long lasting future growth as well. On the diagnostic side, we have outlined several platforms.

Um, and we wouldn't stop there. Uh, we will continue to do BD activities. We'll continue to try to speed up more molecules, so that we can even increase this number. So, I think these will really lay the foundation. Then also for growth in the next decade, which makes us, uh, confident that we can continue to have a good growth momentum.

Now let me reiterate a couple uh judicial and you will see already on the market. At the end of the year there are 2 more enemies that will read out this year in addition um with diversity and stuff sir. In addition we expect uh 2 Enemies to be filed uh in the coming months. 1 is for an improvement and the other 1 is the Mickey boards.

Um, and again, the implication is that we don't only have a good short midterm Outlook, but also, a very solid base to deliver, long-lasting future growth as well.

Thomas Schinecker: On the left-hand side, these are all $1 billion plus opportunities, so in diagnostic terms, blockbuster opportunities. Very excited about sequencer coming, and it's just around the corner. We will show it to you at Diagnostics Day. Here with the sequencer, we have clear differentiation on speed and accuracy, specifically also on cost because you don't have to have a full plate to achieve lower cost if you compare that with some other leading companies in this space. On the test side, this is just a small selection of the tests that we're launching, but you can also see the complementarity to the pharma portfolio with Elecsys NfL in combination with multiple sclerosis, Elecsys pTau217 with Alzheimer's.

On the diagnostic side, we have outlined several platforms. Um, uh, on the left hand side, these are all 1 billion plus opportunities. So in diagnostic terms Blockbuster opportunities and uh very very excited uh about uh sequence of coming. Just uh and it's just around the corner.

Um, and we will show it to you, uh, at, uh, Dia de, uh, here with the sequencer. We have clear differentiation on speed and accuracy, specifically also on cost, uh, because you don't have to have a full plate to achieve lower cost. If you compare that with some other, um, leading, um, uh, companies in the space.

Thomas Schinecker: We really have a good strategy to combine and bring together diagnostics and pharma, and I know Matt will cover more on what's coming your way on these slides as well. Now let me wrap up with the guidance. The guidance is confirmed at mid-single digits sales growth, high single digits core EPS growth, and further increase in dividend in Swiss francs. With that, very happy to hand over to Alan.

On the on the test side, uh, and this is just a small selection of the test that we're launching. But, uh, you can also see the complimentary, uh, t to the farmer portfolio with Alexis NFL in combination with multiple sclerosis, pet out to 17 with Alzheimer's, we really have a, a good strategy to combine and bring together Diagnostics and Pharma and, uh, I know, Matt will cover more on what's coming, uh, your way, uh, on on these slides as well.

Uh, now, let me wrap up with the guidance. The guidance, uh, is confirmed at Miss single digits sales growth in high single digit core BS growth and further increase in dividend in Swiss Francs.

Alan Hippe: Yeah. Thanks, Thomas. Sales call today. Just a brief comment on sales to sales currency, and then once again, confirming the guidance. When we look at sales. Let me start really with the big frame. I start on the left-hand side. You compare to the right-hand side, the sales in Q1 2026, I think -5% when you look at Swiss francs. You see on the right-hand side this big red bar with CHF -1.6 billion, that is really the currency impact from the conversion. Then you shift a little bit to the left, and then you see the +6% in CER, and I will go into currencies on the next slide. Let me talk very quickly about the +6% at CER. You see it split down on Pharma with CHF +842 million, excluding the loss of exclusivity product, and then loss of exclusivity CHF -63 million.

With that, uh, very happy to hand over to Alan.

Alan Hippe: When you put the two bars together, you get to the +7% in CER. The -63, I think is a small number. You've heard we are expecting a loss of exclusivity impact on sales of roughly -CHF 1 billion. We stick to that. Certainly was a good start. Actemra helped us, MabThera helped us, but we think these two products will slow down really for the rest of the year, and that I think makes the CHF 1 billion still doable, if you like, and still realistic. When we go to the right-hand side, Diagnostics, Thomas framed it well, and I'm sure Matt will talk a lot about it. Diagnostics with a +148, excluding China, that is representing the 5% in CER. Then you see the China healthcare pricing reform is -60.

The guidance um when we look at sales. Um yeah, let me start really with the big frame. Yeah, I start on the left hand side, you compared to the right hand side, the sales on q1 2026, I think minus5, uh, percent. When you look at Swiss Francs, you see on the right hand side, this big uh uh Red Bar. Yeah, with minus 1.6 billion. That is really the currency impact from the conversion, then you shift a little bit to the left and then you see the plus 6%. Yeah. In Crescent. And I will go into currencies on the next slide, but let me talk very quickly about the plus 6% at Crescent. You see it split down on on Pharma with a plus 842 excluding. The loss of exclusivity product and then lots of exclusivity minus 63. When you put the 2 bars together, you get to the plus 7% in CER. Um, the minus 63, I think is a small number. Yeah, you've heard we expecting, uh, a lot of exclusivity impact on sales of roughly a billion. Uh, negative. We stick to that.

Alan Hippe: When you put the two together, you get to the +3% in CR, and there has been also an effect from respiratory. Good. Now, as promised, let's talk about currency, and that's the next slide. Here you see it, and it's very clear that the Swiss franc has appreciated basically against all currencies. You see on the left-hand side, the CR cross was +6%, and you see on the right-hand side, the -5%, respectively, the -4.7% in Swiss francs. You see really, I think that the major driver here is the US dollar. You might have noticed that we have used the US dollar now carefully to bring that in.

Certainly was a good start. Yeah a camera helped us map Sarah helped us but we think these 2 products will slow down. Yeah. Ready to for the rest of the year and that I think makes the 1 billion still uh doable. If you like and still realistic, when we go to the right hand side Diagnostics, I Thomas framed it well and I'm sure Matt will talk a lot about it. Um, uh, Diagnostics with a plus 148 excluding China. That is representing the 5%, uh, in Crescent. And then you see the China, Healthcare pricing reform with minus 60.

When you put the 2 together, you get to the plus 3% in Crescent. And there has been also an effect from respiratory.

Alan Hippe: When you look at the +6% in CR and the -5% in Swiss francs, if we were converting to US dollar, we would have grown with +9%, which I think supports the constant currency growth clearly. Good. With that, let's go to the outlook here. That is certainly always challenging because we're always assuming that currency rates remain stable until the end of the year, and that makes this outlook, how should I say, not very probable. Nevertheless, we want to give you an orientation. First of all, as shown on the last slide, significant impact in Q1 with the -11 percentage points on sales.

Good. Now, uh, as promised, let's talk about currency and that's the next slide and here you see it and it's very clear that the Swiss franc has appreciated basically, against all currencies. So you see on the left hand side, the Crescent cross with plus 6% and you see on the right hand side, the minus 5% respectively, the minus 4.7%, uh, in Swiss Francs. Um, you see, really, uh, I think that the major driver here is the US dollar. You might have noticed, you know, that we have used the US dollar now, uh, carefully to bring that in. Uh, you know, when you look at the plus 6% in Crescent and the minus 5% in switch ranks, if we were converting to US dollar, we would have grown uh, with 9% which I think supports. Yeah. The, the constant currency growth, um, clearly

Good with that. Let's go, uh, to, uh, the outlook here.

Alan Hippe: When we assume that the currency rates at the end of March remain stable until the end of the year, then I think really you see what you have seen at H1 with the -7 percentage points on sales and the -10 percentage points on core operating profit and core EPS. When you look really at the full year with a -4 percentage points on sales and -6% on core operating profit and core EPS, respectively. If you were taking today's rates, I would argue that's broadly in line with what you see in the full year projection. Let me remind everybody, I think last year in Q1, we had a positive impact from currency. I think the volatility is enormous. Why do I say this? Because the projections for full year, we will see what we really end up with.

And that is certainly always challenging because we're always assuming that currency rates remain stable until the end of the year, and that makes this outlook—how should I say it—not very probable. Nevertheless, we want to give you an orientation. So, um, first of all, as shown on the last slide, significant impact in Q1, with the minus 11 percentage points on sales, when we assume that the currency rate at the end of March remains stable until the end of the year. Um, um, then I think really, you see what you see at half here with the minus 7 percentage points on sales.

And the minus 10 percentage points on corporate and profit and core EPS—um, when you look really at the full year with the minus 4 percentage points on sales and minus 6% on cooperating profit and core EPS respectively, if you were taking today's rates, I would argue that's broadly in line with what you see in the full year projection.

Alan Hippe: I also respect the point, it's very hard to follow our numbers with this volatility that we're going to see knowing that we have roughly 50% of our sales in US dollar. I don't want to dwell too much about the guidance. I think guidance is confirmed. We're very well on track here to achieve the guidance. Let me reiterate once again, yeah, that a lot of exclusivity impact of roughly CHF 1 billion is still expected for the full year 2026, and that gives me the pleasure to hand over to Theresa.

Teresa Graham: Great. Thank you very much, Alan. Okay, let's get started. As you have now heard a couple times, pharma sales grew by 7% at constant exchange rates, reaching CHF 11.5 billion in Q1. We saw strong performance in the US, International, and Japan, with the latter two achieving double-digit performance growth. The EU was impacted by a number of pricing and one-off effects for specific products, which I'll mention more about in the following slides, but overall, pharma volumes were up by an impressive 17%. My standard comment on this graph, this graph has all absolute values in year-over-year growth rates presented at constant exchange rates. In the first quarter of the year, our top brands, Xolair, Phesgo, Hemlibra, Vabysmo, Ocrevus, and Polivy, generated roughly 800 million in new sales in Swiss francs.

So, um, let me remind everybody, I think last year in Q1, we had a positive impact from currency, so I think the volatility is enormous. Why do I say this? Because projections for the full year—we will see what we really, uh, end up with. Uh, I also respect the point: it's very hard to follow our numbers with this volatility that we're going to see, knowing, uh, that we have roughly 50% of our sales in the US dollar. Um, I don't want to dwell too much on, uh, the guidance. I think guidance is confirmed; we're very well on track here to achieve the guidance. Let me reiterate once again, yeah, that's a lot of exclusivity impact—uh, of roughly $1 billion is still expected for the full year 2026. And that gives me the pleasure to hand over to Teresa. Great, thank you very much, Alan. Okay, let's get started. So, as you have now heard a couple of times from us, sales grew by 7% at constant exchange rates, reaching 11.5 billion Swiss francs in Q1. We saw a strong performance in the US, International, and Japan, with the latter achieving double-digit performance.

Growth. Um, the EU was impacted by a number of pricing and one-off effects for specific products, which I'll mention more about in the following slides. But overall, pharma volumes were up by an impressive 17%.

Teresa Graham: We are going to cover the growth dynamics for all of these brands in following slides, but let me pause here for just a quick moment and talk a little bit about Xofluza. As a reminder, we had a very strong flu season and therefore very strong Xofluza sales in Q1 and Q4 of 2025. As I mentioned at our full year call earlier this year, we did anticipate a decrease in flu-related sales in China for Q1 relative to what we saw in Q1 of last year, and that is exactly what we saw materialize, and you can see that here in the graph with the 86% decline in Xofluza. That was fully attributable to just a weaker flu season. Now let's continue by having a closer look at our key TAs, and as always, we will start with oncology.

But let me pause here for just a quick moment and talk a little bit about zofa. So as a reminder, we had a very strong flu season and there therefore very strong. So fluo sales, uh, in q1 and Q4 of 2025. Um as I mentioned at our full year, call earlier this year, we did anticipate a decrease in flu related sales in China for q1 relative to what we saw in q1 of last year and that is exactly what we saw materialize. And you can see that here in the graph with the 86 uh, percent decline in Z fluo. So that was uh fully attributable to just uh a week or flu season.

so now let's continue by having a closer look at our key toss and

Teresa Graham: Oncology sales increased by 3% to CHF 3.7 billion. Phesgo continues to deliver strong growth, with the global conversion rate climbing to 55%. As previously shared, we are aiming for at least a 60% conversion rate at peak. For Kisqali, we see increasing competitive pressure in both the US and EU, in line with our expectations. Additionally, Q1 performance in the US was negatively impacted by some purchasing patterns. As Columvi launch momentum continues to be strong. Before we move off of breast cancer, let's turn to Giredestrant. A lot happened with Giredestrant in Q1, so we'll take a little time here to review the program in some detail. Unfortunately, the persevERA study in the first-line read out negatively, though, as Thomas mentioned, we did see a numerical improvement in PFS.

So oncology sales increased by 3% to 3.7 billion. Swiss Francs says go continues to deliver strong growth with the global conversion rate climbing to 55%. As previously shared. We are aiming for at least a 60% conversion rate at Peak for Keila. We see increasing competitive pressure in both the US and EU in line with our expectations. Uh, additionally q1 performance in the US was negatively impacted by some purchasing patterns.

As Tovey launch momentum continues to be strong. And before we move off of breast cancer. Let's turn to your destination. So, a lot happened with jerd, in q1. So, we'll take a little time here to review the program in some detail.

Teresa Graham: We will present those results at ASCO in June, including at a separate IR event. At the positive side, we successfully submitted the US filing for lidERA, an adjuvant ER-positive, HER2-negative breast cancer. Again, as you heard Thomas mention, for this filing, we used a priority review voucher, which should speed up the regulatory process significantly, enabling approval by the end of the year. We previously shared that we had filed evERA, our positive Phase III in post-CDKI, ER-positive, HER2-negative metastatic breast cancer in the US, and the PDUFA has now been set for 18 December. Let me also remind you of our perspective on the commercial opportunity for giredestrant, because it seems that post-persevERA, there has been some confusion here. Let's start by taking a big step back and reminding ourselves of the composition of the overall breast cancer market.

Teresa Graham: Hormone receptor positive, HER2 negative breast cancer accounts for about 70% of breast cancer patients. Just to put that in a little bit of context, HER2 accounts for only 15% of patients. We're already talking about a much larger patient population. Let's translate that into the actual commercial opportunity. We believe that the total served opportunity across all lines of therapy is somewhere between $20 and 30 billion. Within that ER positive population, adjuvant ER positive breast cancer is by far the largest piece, with 3 times more drug-treated patients than in first-line metastatic, and a much longer treatment duration, so around 5 years. Again, I think this has been really sort of misrepresented in some of the coverage post-persevERA.

So unfortunately, the persevera study in the first line, read out negatively though, as Thomas mentioned we did see a numerical Improvement in PFS. Um, we will present those results at ASCO in June, including at a separate IR event. Um, at the positive side, we suggest, uh, we successfully submitted the US filing for leera and addivon er positive her 2 negative breast cancer. And again as you heard Thomas mentioned for this filing, we used a priority review voucher which should speed up the regulatory process significantly enabling approval. By the end of the year. We previously shared that we had filed a Vera, our positive phase 3 and posted Aki. Um er positive her 2 negative metastatic breast cancer in the US and the Padua has now been set for the 18th of December. Let me also remind you of our perspective on the commercial opportunity for a Gerard restaurant because it seems that post persevera. There has been some confusion here. So, let's start by taking a big step back and reminding ourselves of the composition of the overall breast cancer market. So hormone receptor positive, her 2, uh, negative breast cancer accounts are about 70% of breast cancer patients.

So just to put that in a little bit of context her 2 accounts for only 15% of patients so we're already talking about a much larger patient population. Um let's translate that into the actual commercial opportunity. We believe that the total scrd opportunity across all lines of therapy is somewhere between 20 and 30 billion US Dollars within that. ER positive population adjuvant uh year positive, breast cancer is by far the largest piece with 3 times more drug

Ated products than, uh, patients than in first-line metastatic and a much longer treatment duration, so around 5 years. And again, I think this has been really, um,

Teresa Graham: Of course, while we had hoped for a positive persevERA trial, it is really important to remember that the first-line metastatic breast cancer setting only represented around 10% of the overall giredestrant opportunity. Adjuvant is by far the larger market, and we believe that our data is both strong and compelling. With the positive lidERA and evERA trials, we believe we have captured around 80% of the overall served opportunity, with lidERA accounting for roughly 70% and evERA for another 10%. Let me also remind you that we have one additional Phase III in first-line endocrine-resistant patients, pionERA, which reads out next year. Now, this represents 40% of the first-line population, so still a significant portion of that first-line population.

Really sort of misrepresented in some of the the the coverage post persevera. And of course, while we had hoped for a positive persevera trial, it is really important to remember that the first line metastatic breast cancer setting only represented around, 10% of the overall gear duster opportunity adant is by far the larger market and we believe there are data is both strong and compelling.

With the Positive Lera and a trials. We believe we have captured around 80% of the overall served opportunity with Lera accounting for roughly 70% and Ava for another 10%. Let me also remind you that we have 1 additional phase 3 and first line at the scent patient uh patient.

Teresa Graham: Giredestrant is combined with the physician's choice of CDK4/6, and in this study, we expect 40% of patients are going to carry an ESR1 resistance mutation compared to just the 5% that we saw in persevERA. Overall, we see ourselves very well positioned to capture a meaningful share of this significant market, giving us confidence in the overall commercial potential on Giredestrant. You saw on Thomas's slide; this means peak sales well north of CHF 3 billion, and I think, in fact, you've heard us say before, this could be our largest selling product, and that certainly does seem to still appear to be very possible. With that, we invite you to join us at ASCO to learn more. Now let's shift gears to Alecensa. Alecensa had a very strong Q1, partly driven by buying patterns in the international region.

Pioneer uh which reads out uh, next year. Now this represents 40% of the first line population, so still a significant portion of that first line population. Um, and gear duster is combined with the physician's choice of cdk4 6. And in this study, we expect 40% of patients are going to carry an esr1 resistance mutation compared to just the 5% that we saw on persevera. So overall we see ourselves very well positioned to capture a meaningful share of this significant Market giving us confidence in the overall commercial potential on gear industrial you saw on Thomas's side. This means Peak sale.

Uh well north of 3 billion. And I think in fact you you've heard here to say before this could uh be our our largest selling product and and that certainly does seem to still appear to be very possible um and with that we invite you to join us at ASCO to learn more

Teresa Graham: We did signal at our last call that due to increasing competitive pressure, especially in the US and EU, we do expect low- to single-digit or low single-digit growth for the full year for Alecensa, and that continues to be the case. Moving on to Tecentriq. Growth is driven by our new indications, in particular IMforte in small cell. Additional new indications like IMvigor011 in muscle-invasive bladder cancer and ATOMIC in dMMR colon cancer are expected to help carry this growth momentum forward. Let me mention here that we saw a one-off buying pattern that negatively affected EU performance in Q1, and we do expect that growth is going to gradually recover over the next quarters. With our performance in this quarter, I also want to confirm our full-year 2026 outlook for low single-digit growth for Tecentriq.

Centric growth is driven by our new indications, in particular, in forte in small cell, additional new indications like, envigor 11, in, uh, muscle invasive, bladder, cancer, and atomic and, uh, dmmr colon cancer are expected to help carry this growth momentum forward. Let me mention here that we saw a 1-off buying pattern that negatively affected EU performance in q1, and we do expect that, that growth is going to gradually recover over the next quarter.

Teresa Graham: Finally, looking forward, as Thomas mentioned, we expect phase 3 readouts for Altuviiio as well as the first phase 3 readout for KRAS G12C inhibitor Divarasib later this year. Now let's move on to hematology. The hematology franchise delivered strong growth of 18% at constant exchange rates, achieving CHF 2.2 billion in sales. Hemlibra continues strong global growth momentum from last year, driven by increasing adoption in non-inhibitor patients. Of note, the US performance benefited from a base effect due to buying patterns, which negatively impacted Q1 sales last year. As we have previously shared, we expect low single-digit growth for 2025, and this is driven by the anticipated headwinds from competitor launches later this year. Let's stay briefly with hemophilia A and take a look at the NXT007 developments.

With our performance in this quarter. I also want to confirm our full year 2026 outlook for low single digit growth for toric. And finally, looking forward as Thomas mentioned, we expect phase 3 readouts for it to be, as well, as the first phase 3 readout for our KRA G's 12C inhibitor, diversity later this year,

Now, let's move on to hematology.

Teresa Graham: We have initiated the phase 3 trials in Zebra 1 and 2, which compared NXT007 to factor VIII and Hemlibra, respectively. For both trials, we are using an auto-injector from day one for enhanced administration convenience for patients. Moving on to malignant heme, Polivy's uptake in first-line DLBCL continues to grow steadily. We're now at 39% of US patient share, with more than 95,000 patients treated globally. Please note that the EU Q1 performance here was negatively impacted by a base effect due to the release of sales accruals in Germany in Q1 of last year. Overall, Gazyva delivered solid growth in Q1, but its performance does bear a little bit of explanation given our launch in immunology and the delay in the data that allows us to tease out performance between the two therapeutic areas. What is it that we see happening?

The hematology franchise delivered, strong growth of 18% at constant exchange rates, uh, achieving 2.2 billion Swiss Francs and sales Hebrew, uh, continues strong Global growth momentum from last year, uh, driven by increasing adoption and non-inhibitor patients of note. The US performance benefited from a base effect due to buying patterns, which negatively impacted q1, uh, sales last year. Um, as we have previously shared, we expect single low digit growth for 2025 and this is driven by the anticipated, headwinds from competitor launches later. This year, let's stay briefly with hemophilia a and take a look at the latest next 007 developments. We have initiated the phase 3 trials, in zebra 1 and 2. Uh which compared a next 007 to factor 8 and he will leave a respectively. And for both trials, we are using an auto injector from day 1, for enhancing

Convenience for patients.

Teresa Graham: In oncology, Gazyva sales in the US and EU were negatively impacted by the launch of Venclexta and Acalabrutinib combination in first-line CLL, which increased competitive pressure on the Venclexta Gazyva regimen. We believe this dynamic is masking the uptake that we see in immunology, which I'll discuss in just a little bit. We are eager to show the Gazyva sales by TEA. We're actively working on getting that data, and we'll be able to have more visibility into the immunology uptake in the future. Again, more to come in a few slides. Finally, rounding out Heme, our CD20-CD3 bispecifics, Columvi and Lunsumio, continue to see good uptake in their respective indications.

Moving on to malignant heating. Pva's, uptake in first line deal, BCL continues to grow steadily. We're now at 39% of us, patients share with more than 95,000 patients, treated globally. Um, please note that the EU q1 performance here was negatively impacted by a base effect due to the release of sales across in Germany, uh, in q1 of last year. Um, overall Gaza delivered solid growth in q1, but its performance does bear a little bit of explanation, given our launch in immunology and the delay in the data that allows us to tease out performance between uh, the 2 thurm areas. So what is it that we see,

Negatively impacted.

And a celebrate of combination and firstline CLL which increased competitive pressure on the vener regimen.

Teresa Graham: Importantly, we completed the US filing of Lunsumio in second-line plus DLBCL based on the positive SEMO results, and we expect the readout for the Phase III CELESTIMO study of Lunsumio in second-line plus follicular later this year. Now let's move on to neurology. Neurology started the year strong with 10% growth at constant exchange rates, reaching CHF 2.4 billion in sales. For Ocrevus, we see continued good growth driven by the subcutaneous formulation, which is known as Zunovo in the US. As anticipated, subcut furthered its acceleration, and you can see in the global patient count, which has increased to roughly 24,000. This represents an increase of 7,000 patients compared to last quarter, and that's almost 2,000 more patients than the increase we saw in Q4. That acceleration is starting to happen.

Uh, we believe this Dynamic is masking. The uptake that we see in. I'm not in which I'll discuss in just a little bit. Um, we are eager to show because I have a sales by ta. We're actively working on on getting that data and we'll be able to have more visibility into the Immunology uptake in the future. Um, so again more to come in a few slides and finally rounding out, he our cd20 CD3 by specifics, uh, Colombian lunio. Continue to see good uptake in their respective indications. Uh, importantly. We completed the US filing of lunio on second line, plus dlbcl based on the positive son, no results. And we expect the readout for the phase 3, Celeste study of lunio, and second line plus Fick later this year. So, now let's move on to

To neurology.

Teresa Graham: As previously shared, the US Zunovo uptake is a very good indicator of how we're expanding the addressable market for MS. Roughly 60% of the Zunovo volume is coming from community practices, and roughly half of patient starts are now new to the Ocrevus brand. One more comment on the US performance. Q1 sales were negatively impacted by some payer dynamics, which we often see in Q1, largely around recertifications and lower sales days relative to Q1 2025. All of that having been said, for 2026, we continue to expect high single digit to low double-digit growth for Ocrevus as a whole. A reminder that we upgraded our peak sales expectations for Ocrevus franchise to $9 billion by 2029, and that includes $2 billion incremental sales from Ocrevus Zunovo. More key updates for the MS franchise.

Neurology started the year, strong with 10% growth at constant exchange rates, reaching 2.4 billion in sales for okus. We see continued good growth driven by the sum containers formulation, which is known as Novo in the US as anticipated subcut. Furthered its acceleration, and you can see in the global patient count, which has increased roughly 24,000, this represents an increase of 7,000 patients compared to last quarter and that's almost 2,000 more patients than the increase. We saw in Q4 so that acceleration is starting to happen as previously shared the US. No uptake is a very good indicator of how we're expanding the addressable market for Ms. Roughly 60% of the zenova volume is coming from Community practices and roughly half of patients, starts are now new to the okay brand? Um, 1 more comment on the US performance, q1 sales, more negatively impacted by some, uh, paradigms which we often see in in q1 largely around. Um, uh, uh, re certifications, and lower sales days relative to q1 2025, all of that. Having been said for 2026, we continue to

Expect high single-digit to low double-digit growth for okra this as a whole.

So, a reminder that we upgraded our peak sales expectations for Okra franchise to $9 billion by 2029, and that includes $2 billion incremental sales from Okra subcut.

Teresa Graham: We are very pleased to report a positive outcome for the Phase III FENhance 1 study of fenebrutinib in RMS. Just a few days ago, the full results for FENhance 1 and 2 were presented at AAN, and I will share those highlights briefly on the next slide. Let's round out quickly with the other products in our neurology portfolio. Starting with Evrysdi, off to a very strong start to the year, partially boosted by tender-related buying in international, and we continue to see Evrysdi expanding its strong global position, thanks to the global rollout of the tablet formulation. Moving on to Elevidys and DMD, we continue to believe strongly in the positive risk-benefit profile in the ambulatory population, and therefore, we have made the decision to initiate a new Phase III trial to enable regulatory resubmission in the EU, and other regions globally.

Teresa Graham: This new trial, ENCORE, includes a placebo control arm and is focused on early ambulatory patients. We're confident that this is the most viable path to achieve EU approval and that it will allow us to bring this new treatment option to patients. Another highlight of the quarter is the positive Phase 3 Enspryng data in MOGAD, which was presented just a few days ago at AAN, and I'll cover that in more detail. Now let's move on to fenebrutinib. With the positive readout of FENhance 1, we now have three positive Phase III trials for fenebrutinib in MS, FENhance 1 and 2 in RMS, as well as FENtrepid in PPMS. I will take you through the details of the RMS results in a moment, but let me make one thing really clear up front.

We have made the decision to initiate a new phase 3, trial to enable regulatory resubmission in the U and other regions globally. Um, this new trial Encore includes a placebo control arm and is focused on early ambulatory patients. Uh, we're confident that this is the most viable path to achieve EU approval and that it will allow us to bring this new treatment option to patients. And another highlight of the quarter is the positive 3 and spring data in mogad which was presented, just a few days ago at a an and I'll cover that in more detail.

So now let's move on to fib.

So with the Positive, read out, if enhance 1, we now have 3 positive phase 3 trials for phenibut nib in Ms, van Health 1 and 2 and RMS as well as entrepid and ppms.

Teresa Graham: We are confident that Fenebrutinib has the potential to become the first and only high-efficacy oral treatment for both RMS and PPMS. We also reaffirm our belief in the potential peak sales of more than CHF 3 billion. Now, let's provide some background on where this conviction comes from, and we'll start with the RMS results. Fenebrutinib met the primary endpoint, showing significant reduction of relapses, 51% in FENhance 1, 59% in FENhance 2, compared to Teriflunomide. Together, these results translate into one relapse approximately every 17 years. Additionally, when looking at key secondary endpoints for disability progression, there is a constant trend favoring Fenebrutinib. This is true for CCDP12 as well as the modified CCDP12, which is focused on EDSS in the nine-hole peg test, and these findings further support Fenebrutinib's positive impact on progressive biology as seen in the FENtrepid trial for PPMS.

I will take you through the details of the RMS results in a moment, but let me make one thing really clear up front. We are confident that Vennep has the potential to become the first and only high-efficacy oral treatment for both RMS and PPMS. And we also reaffirm our belief in the potential peak sales of more than 3 billion Swiss francs. Now, let's provide some background on where this condition comes from, and we'll start with the RMS results. So, fenebutmab met the primary endpoint, showing significant reduction of relapses—51% in FINANCE 1, 59% in FINANCE 2—compared to teriflunomide.

To gather these results, translate into 1 related, approximately every 17 years.

Additionally, when looking at key secondary endpoints for disability progression, there is a constant trend favoring Fener.

Teresa Graham: Let me also cover the safety profile of fenebrutinib. The percentage of patients with liver enzymes in FENhance 1 and 2 is lower than what we saw in FENtrepid trial and is broadly similar to what we saw in teriflunomide. There was one Hy's Law case in each of the fenebrutinib and teriflunomide arm of FENhance 1. Both cases were asymptomatic and resolved after study drug discontinuation. There were no additional Hy's Law cases across all the other fenebrutinib trials in MS or any of the autoimmune indications where it has been studied after implementation of liver monitoring every two weeks during the first 20 weeks of treatment. Lastly, to mention, we did see an imbalance in fatal AEs across the fenebrutinib arms of 1 and 2, as well as in FENtrepid.

Um, this is true for ccdp 12, as well as the modified CCP 12, which is focused on edey's. In the 9-hole peg test, and these, uh, findings further. Support, find a group and its positive impact on Progressive biology. Um, as seen in the frappe trial for ppms,

let me also cover the safety profile of fener them.

The percentage of patients with liver enzymes and finance 1 and 2 is lower than what we saw in fendt trepid trial and is broadly similar to what we saw in teriflunomide. There was 1 his law case in each of the center of inter, of flutamide arm of venance 1. Both cases were asymptomatic and resolved after study drug discontinuation. There were no additional highs law cases, across all the other kind of trials in Ms or any of the autoimmune indications where it has been studied after implementation of liver monitoring every 2 weeks during the first 20 weeks of treatment.

Teresa Graham: Various causes and time points were observed for those fatal AEs as were presented and discussed at AAN in more detail. Again, let me be very clear. Patient safety is our number one priority. Throughout the study, there was a continuous exchange with the FDA and the IDMC, including on AEs, and we are confident in the favorable risk-benefit profile of fenebrutinib in RMS and PPMS, and the totality of data from those Phase II trials will be submitted to regulatory authorities in the coming months. Now let's move on to Enspryng. As previously mentioned, we're quite excited about the positive Phase III results for Enspryng in MOGAD. I'm guessing that not everyone is familiar with MOGAD, or myelin oligodendrocyte glycoprotein antibody associated disease. There will be a test on that later. Let me share some background.

Lastly to mention we did see an imbalance in fatal AES across the fed and of arms of 1 and 2 as well as infant trepid various causes. And time points were observed, for those fatalities as were presented and discussed at aan in more detail.

Teresa Graham: MOGAD is a demyelinating rare autoimmune disease that can cause severe neurological disability in children and adults. This includes loss of vision, cognitive dysfunction, and loss of ambulation. There are currently no approved therapies, and disease management frequently relies on acute treatment with high-dose corticosteroids, primarily aimed at reducing relapses. IL-6 signaling is implicated in the pathophysiology of MOGAD, and so therefore Enspryng, our anti-IL-6 antibody, sort of makes perfect sense in this disease. As I mentioned, at full year, we believe MOGAD represents at least a CHF 500 million peak sales opportunity for Enspryng. Now let's look at the data and what has us so excited. Here it is, what the METEOROID study just presented a few days ago. For the primary endpoint, the portion of patients that are relapse free, Enspryng achieved a strong risk reduction of 68% versus placebo.

Um again let me be very clear. Patient. Safety is our number 1 priority throughout the study. There was a continuous exchange with the FDA and the idmc including on AES. And we are confident in the favorable risk benefit profile of fenerin in RMF and ppms and the totality of data from those phase 3 trials will be submitted to regular authorities in the coming months. So, now let's move on to nspr. As previously mentioned, we're quite excited about the positive phase 3 results, uh, for nspr and mogad, I'm guessing that not everyone is familiar with mogad or milin, aglio dendrite glycoprotein antibody Associated disease. There will be a test on that later. Um, so let me share some background. Mogad is a demyelinated. There are currently no approved therapies and disease management frequently. Relies on acute treatment with high-dose corticosteroids primarily a Dame aimed at reducing relapses.

Dial 6. Signaling is implicated in the path, the pathophysiology of, uh, MOGAD and so, therefore, spraying our anti-ILS antibody, uh, sort of makes perfect sense in this disease.

Teresa Graham: Patients demonstrated a response as early as eight weeks, and Enspryng achieved a significant reduction in annualized relapse rates, active MRI lesions, and rescue therapy. Safety was comparable to placebo, nicely rounding out these results, which have been extremely well-received at AAN. I think you can see why we in the KOL community are so excited for Enspryng in MOGAD and the opportunity that we have to bring a very meaningful benefit to patients. We expect to complete filing in the US and EU for this indication later this year. With that, let's switch over to immunology. Our immunology franchise grew at 8% at constant exchange rates, and it's $1.5 billion in sales. The key growth driver here is Xolair, which continues to show exceptionally strong uptake in food allergy as well as continued growth in CSU.

Um, as I mentioned it at full year, we believe mogad represents at least a 500 million Swiss franc Peak sales opportunity for n spring and now let's look at the data and what has us so excited. So, here it is. What the meteorite study just presented a few days ago. Um, for the primary endpoint, the portion of patients that are relapse-free and spring achieved, a strong risk reduction of 68% versus placebo. Um, patients, demonstrated a response as early as 8 weeks and entering achieved a significant reduction in annualized relapse rates, active MRI, lesions, and rescue therapy. Uh, safety was comparable to Placebo. Nicely rain rounding out these results, which have been extremely well received at a am. I think you can see why we in the kol community are so excited for nspr and mogad and the opportunity that we have to bring a very meaningful benefit to patients.

We expect to complete filing in the US and EU, uh, for this indication later this year. And so with that, let's switch over to Immunology.

Teresa Graham: In terms of 2026 outlook, we continue to expect around 20% growth for Xolair this year, and this includes the expected impact of the first biosimilar entering the market in H2 2026. Actemra sales declined by 4% in Q1, driven by biosimilar impact in the US and EU. Now again, there is a lot of positive news flow around Gazyva, so we're going to take this step by step. I'm going to go into the details of SLE, MN, and INS on the next slide. However, here again, I want to briefly comment on the ongoing launch in lupus nephritis. As I mentioned earlier, we are looking at splitting out the data between immunology and hematology sales. Once that happens, you will see Gazyva begin to appear on this slide. In the meantime, let me share with you some qualitative insights on how the launch is going.

Camera sales declined by 4% in q1 driven by biosimilar, impact in the US and EU.

Teresa Graham: Across early launch countries in the US and EU, we see positive feedback from doctors and patients, including awareness, intent to treat, and treatment satisfaction. What we're hearing in the field also gives us good confidence that Gazyva is off to a strong start in immunology. For example, a doctor in the UK has remarked that there's no reason to just use MMF and steroids anymore. Gazyva is clearly a better option. Safe to say I continue to be excited about the potential for Gazyva in immunology, and we remain confident that this is up to a $2 billion opportunity across all of the immunology indications. Finally, I'd like to mention the upcoming phase 3 readout for Sofoxatrigine in IgAN, which is now expected for later in the year. Let's take a look at Gazyva in a little bit more detail.

Now again there is a lot of positive news flow around Gaza. So we're going to take this step by step. I'm going to go into the details of SLE MN and ins on the next slide. However here again, I want to briefly comment on the ongoing launch in lupus nephritis, as I mentioned earlier we are looking at splitting out the data between immunology and hematology sales. Once that happens, you will see because I have a b into appear on this slide and in the meantime, let me share with you some qualitative insights on how the launch is going across early launch countries in the US and EU. We see positive feedback from doctors and patients including awareness intent to treat and treatment satisfaction. And what we're hearing in the field, also gives us good confidence that because Iva is off to a strong start in Immunology. Uh, for example, a doctor in the UK is remarked that there's no reason to just use MMF in steroids anymore, um, because I was clearly a better option.

Teresa Graham: Gazyva is on a tremendous run, achieving four out of four positive Phase III trials in immunology since we reported the first results back in 2024 in LN. The positive Phase III MAJESTY in membranous nephropathy, but we're going to talk about more of that in a minute. First, I want to highlight the strong Phase III results from ALLEGORY and SLE, which were just recently presented at SLEuro. You can see on the left the primary endpoint and key secondary endpoints all show a clear benefit for Gazyva treatment relative to placebo. On the back of these results, we believe Gazyva has the potential to be the new standard of care in SLE. Again, when you look across these four indications, you can clearly see why we believe in the potential for that CHF 2 billion upside opportunity comes from.

So safe to say, I continue to be excited about the potential for a good and Immunology. And we remain um, confident that this is up to a 2 billion opportunity across all of the Immunology indications. And finally, I'd like to mention the upcoming phase 3. Readouts, the force or factors in and IGN, um, which is now expected for later in the year. So, let's take a look at it in a little bit more detail. Because Viva is on a tremendous run achieving 4 out of 4 positive phase 3 trials in Immunology since we reported the first results back in 2024 in Ln the positive phase 3 magistrate and me membranous nephropathy. Um,

Teresa Graham: You can also see that we are progressing our filing activities at pace. LN is already approved, and the US and EU launches are ongoing. SLE has been filed in the US and the EU, and the US PDUFA has been set for 4 December. MN will be filed in the US and EU later this year, and INS has been filed with the US, and EU filing is expected later this year. A ton of momentum for Gazyva in immunology, and we are excited to update you. Let's move on to ophthalmology. Ophthalmology grew by 10%, achieving $1.1 billion in sales. Vabysmo started this year with strong quarter with 13% growth at constant exchange rates. While we continue to see global market share gains across countries, I did want to highlight the US performance here in particular. Q1 marks a return to growth in the US.

Uh but we're going to talk about more of that in in in a minute. Uh, first thing I want to highlight the strong, phase 3 results from allegory and SLE, which were just recently presented at Flay Euro. You can see on the left, the primary endpoint in key, secondary endpoints all show a clear benefit for because I have a treatment relative to Placebo. And on the back of these results, we believe because I have a, has the potential to be the new standard of care in SLE again. Um, when you look across these 4 indications, you can clearly see, uh, why we believe in the potential, uh, for that 2 billion. Uh, CSF. Uh, upside opportunity comes from. You can also see that we are progressing. Our filing activities at PACE. Ln is already approved and the US and EU launches are ongoing. SLE has been filed in the US and the EU, and the US Padua has been set for the 4th of December, and then we'll be filed in the US and EU later this year. And ins has been filed with the US and EU filing is expected later this year. So, uh, a ton of momentum for Gaza and Immunology and we are excited to update you. So let's move on to Opthalmology, Opthalmology grew by 10%, achieving 1.1 billion, uh in sales, but bye.

Teresa Graham: In fact, we see 4% sales growth with low double-digit volume growth and a steady market share expansion. Vabysmo continues to establish itself as the standard of care across AMD, DME, and RVO, as underscored by the fact that roughly 60% of Vabysmo starts are treatment naive. Regarding the branded market contraction we saw in the US over the last quarters, we are now beginning to see the first signs of a recovery. For now, they are only the first signs. We continue to expect to see a gradual recovery of the branded market, going forward. Last but not least, we are excited to have received an updated FDA label for the RVO indication, and that update adds the flexibility for treatment beyond six months based on long-term data from BALATON and COMETA studies. Let me also say a few quick words on the EU performance in Q1.

Started, uh, in, uh, to, uh, supervisor started this year, uh, with a strong quarter with 13% growth at constant exchange rates. Um, well, we continue to see global market share gains across countries. I did want to highlight the US performance here. In particular, Q1 marks a return to growth in the US. In fact, we see 4% sales growth, low double-digit volume growth, and steady market share expansion. But Vabysmo continues to establish itself as a standard of care across AMD, DME, and RVO, as underscored by the fact that rep.

Teresa Graham: In Q1, we had to digest a negative impact due to price impacts, but we saw quite good volume growth in the EU, so therefore, we do expect a return to growth in Europe in the coming quarters. In 2026, the outlook for Vabysmo is a growth acceleration compared to the 2025 growth rate of 12%, which is what we have messaged earlier. Let me highlight that we expect to file two new potential medicines in our ophthalmology franchise later this year, vamikibart in UME and Enspryng in thyroid eye disease. Up next, let's cover the CVRM portfolio. We continue to progress our CVRM assets at pace, and there are two highlights for Q1 that I want to discuss in more detail. Let's start with Petrelintide.

60% of a bismo starts a treatment naive regarding the Branded Market contraction. We saw in the US over the last quarters, we are now beginning to see the first signs of recovery. But for now, they are only the first signs we continue to expect to see a gradual recovery of the Branded Market, uh, going forward. And last but not least, we are excited to have received an updated FDA label for the rvo indication and that update adds the flexibility for treatment Beyond 6 months, based on long-term data from bellaton and commito studies. Uh, let me also say a few quick words on the EU performance in q1 and q1. We had to digest a negative impact due to price impacts, but we saw, um, quite good volume growth in the EU. So, therefore, we do expect a return to growth in Europe in the coming quarters.

In 2026. Uh, the outlift for viseo is a growth acceleration compared to the 2025 growth rate of uh, 12%, which is what we have messaged earlier.

Uh, let me highlight that we expect to file 2, new potential.

Teresa Graham: In Q1, together with our partner Zealand, we shared the positive results of the Phase 2 ZUPREME-1 study of Petrelintide in obese patients without type 2. These results showed that Petrelintide delivered meaningful double-digit weight loss. Importantly, this weight loss was accompanied by a placebo-like tolerability profile. Therefore, we believe in the potential of Petrelintide to address key unmet needs for people living with overweight or obesity, namely to meet their expectations for weight loss and significantly life-limiting adverse events, thereby improving treatment persistence. Moving on to the newly named insepotide, formerly known as CT-388. At the full-year event, we shared the positive Phase 2 top-line results for week 48 for the once-weekly insepotide in people with obesity. That was Study 103. Let me just remind you of the highlights from that data. Using the efficacy estimand, insepotide achieved a placebo-adjusted weight loss of 22.5%.

Medicines in our Opthalmology franchise later this year, the Mickey bar in me and, and spring and thyroid eye disease. So up next, let's cover the cvrm portfolio, we can continue to progress our cvrm assets at PACE. And there are 2 highlights for q1 that I want to discuss in more detail. Let's start with, uh, Patrol, lenti and q1 together with our partner Zealand. We shared the positive results of the phase 2 Supreme 1, study of petrol and tide in obese. Patients, without type 2. These results showed the penalty delivered meaningful, double-digit weight loss. Importantly, this weight loss was accompanied by a placebo, like, tolerability profile. So therefore, we believe in the potential of petrol lenti to address Keon. But needs for people living with

Teresa Graham: We saw a clear dose response relationship with weight loss, and importantly, we are pleased by the absence of a visible efficacy plateau at 48 weeks for the 24 mg dose, which is the highest dose tested. On the back of this strong Phase 2 data, we have successfully initiated two Phase 3 trials in obesity in week 1 and 2 in Q1. For both PETRA and insepotide, we are looking forward to presenting the results at ADA in June, including at a separate IR event. In regards to what's to come in 2026, you will see we have quite a few milestones. We expect additional Phase 2 readouts for insepotide and obesity with type 2 and CT-996, our oral GLP-1 in obesity, and finally, Phase 2 data, Jimena, for Amubagart, intrapetide in obesity. We also expect multiple trial starts.

Scent. Um, we saw a clear close uh clear dose response relationship with weight loss and importantly, we are pleased by the absence of a physical efficacy. Efficacy Plateau at 48 weeks for the 24.

Teresa Graham: We plan to initiate a Phase 2 combination study for insepotide and PETRA with the FPI expected towards mid-year and the first Phase 3 studies for PETRA plus CT-996, or PETRA and CT-996. As you can see, there continues to be a lot happening in our CVRM portfolio, and we will be sharing additional updates throughout the year. Moving on to the news flow slide. Here we have what is happening this year. I believe I've covered all of the changes shown previously, with one exception. Earlier this quarter, we shared that we made the decision to discontinue development of Amubagart in SMA and FSHD. This follows a rigorous assessment of data from the Phase 2 studies, MANATEE and MANOEUVRE. We plan to present these data at upcoming conferences.

On the back of this strong Phase 2 data, we have uh successfully initiated 2 phase 3 trials in obesity enith 1 and 2 in q1 for both Petra and anticipata are looking forward to presenting the results at Ada in June including at a separate event. In regards to what's to come in 2026. You will see, we have quite a few Milestones. So we expect additional Phase 2 readouts, for and separately, and obesity with type 2 and CT, 9996 are oral glp1 and obesity and finally Phase 2, uh data, uh, jinda, for remover bar, in obesity. We also expect multiple trial starts. We plan to initiate a phase 2 combination study for enstatite and Petri with the FBI expected towards mid year and the first phase 3 studies for Petri Plus CT 9996

Um, or its Petri and CT 986. As you can see, there continues to be a lot happening in our CVR and portfolio, and we will be sharing additional updates throughout the year.

Teresa Graham: Just to be clear, there is no impact from this decision on the ongoing phase 2 obesity trial reading out towards year-end. Let's go to my final slide. To close my section today, I wanted to walk you through an update of our well-known consensus gap analysis slide, as we've recently had a series of positive readouts representing significant commercial opportunity. To briefly orient ourselves, the values shown here are now based on the post full year 2025 consensus numbers from sell-side analyst models, and we've pushed out the time frame by one year to look at 2025 to 2030. According to consensus, Roche has a biosimilar gap of CHF 6.7 billion by 2030. However, if you look at the middle section of the slide, you can see where consensus sees sales growth coming from during the same time period.

So moving on to the news flow slide. So here we, uh, here's we have. What is happening this year? I believe I've covered all of the changes shown previously with 1 exceptionalists,

Obesity trial reading out towards your end.

Teresa Graham: Taking the on-market portfolio and the Phase 3 pipeline together, consensus expects a total of CHF 15.9 billion in additional sales by 2030, which compares quite favorably to that projected biosimilar gap. If you take a closer look, these additional sales come from the on-market portfolio, where future growth is expected to deliver an additional CHF 7.5 billion in sales, with Vabysmo and Ocrevus being at the top of a long list of growth contributors. For the late-stage Phase 3 pipeline, the consensus forecast a total of CHF 8.4 billion in additional sales with Giredestrant, fenebrutinib, and inavolisib, all projected to be top growth drivers, where most of our other Phase 3 assets have rather modest sales projections at this point.

So let's go to my final. Slide to close my section. Today, I wanted to walk you through an update of our well-known consensus consensus Gap analysis slide as we've recently had a series of positive readouts representing significant commercial opportunity to briefly go Oriental to briefly Orient ourselves. The value shown here are now based on the post full year 2025 consensus numbers from cell side analysts models. And we've pushed out the time frame, by 1 year to look at 2025 to 2030. According to consensus row has a bio similar gap of 6.7 billion Swiss Francs by 2030. However, if you look at the middle section of the slide, you can see where consensus sees sales growth coming from during the same time period taking the on-market portfolio in the phase 3 uh pipeline together, consensus expects a total of 5.9 billion. I'm sorry 15.9 billion Swiss Francs, in additional sales by 2030, which Compares quite favorably to that, uh, projected biosimilar Gap. If you take a closer look, these additional sales, uh, come from the on Market portfolio, where future growth is expected to

Teresa Graham: In addition, there are still a number of other assets in our pipeline that are not really covered yet by the consensus presenting potential upside. These are on the right side of the slide, including Enspryng and MOGAD, with the compelling data we just talked about today, Enspryng and TED to be filed later this year, or Gazyva and SLE, again, with very compelling data that has just been released. In summary, if you remember Thomas's slide from earlier, we have the potential to launch 19 NMEs by 2030. There's of course also the possibility that BD might contribute more over time, and I hope this makes you at least as excited as I am for the future of Roche Pharma. We have a lot to look forward to. With that, I will turn it over to Matt.

deliver an additional $7.5 billion, um, in sales, with that being at the top of a long list of growth contributors, and for the late-stage, Phase 3 pipeline, the consensus forecast, uh, total of $8.4 billion in additional sales, with your (desktop?) and abruitide and asepetide, um, all projected to be post-growth drivers, where most of our other Phase 3 assets all have rather modest sales projections. At this point, in addition, there are still a number of other assets in our pipeline that are not really covered yet by the

The consensus, uh, presenting potential upside. These are on the right side of the slide, including, and Spring and Mogad. With the Capelli data, we just talked about today and Spring, and TED to be filed later this year for Gaza in SLE. Again, with very compelling data that has just been released.

Matt Sause: All right. Congratulations, Theresa. With that, good morning, good afternoon, everyone. It's my pleasure to present the Diagnostics financial results for Q1 2026. With sales of CHF 3.3 billion, the Diagnostics division grew sales by 3% or +CHF 88 million compared with 2025 at constant exchange. This growth was achieved despite the ongoing impact of healthcare price reform in China, which continued their impact in 2026. Now, as you heard earlier from Alan, and as well from Thomas, excluding China, the growth of the business was +5% and was additionally impacted by approximately CHF 40 million lower sales due to the weak Northern Hemisphere respiratory season. Now with that, let me walk you through sales by customer area. Sales in our Core Lab increased at 4%. Now, this was impacted by that previously mentioned policy impact from China.

So in summary if you remember Thomas's a slide from earlier, we have the potential to launch 19, enemies by 2030. Um there's of course also the the possibility that BD might contribute more over time and I hope this makes you at least as excited as I am for the future of uh a row. We have a lot to look forward to. And with that I will turn it over to Matt.

Congratulations, Teresa. Um, with that good morning, good afternoon.

Everyone, it's my pleasure to present the Diagnostics financial results for the first quarter of 2026. So, with sales of $3.3 billion—this was Frank—the Diagnostics division grew sales by 3%, or plus $88 million, compared with 2025 at constant exchange. So, this growth was achieved despite the ongoing impact of healthcare price reform in China, which continued their impact in 2026. Now, as you heard earlier from Alan,

And as well from Thomas excluding China, the growth of the business was plus 5% and was additionally impacted by approximately 40 million. Lower sales due to the weak Northern Hemisphere respiratory season.

Now, with that, let me walk you through the sales by customer area.

Matt Sause: Excluding this, Core Lab grew at +8%. Now, sales in Molecular Lab were flat, with strong growth in transplant at +15%, but this was offset by the previously mentioned mild respiratory season, which lowered testing volumes. Now, while blood screening decreased at -9%, this is due to the ongoing conflict in the Middle East, and this impacted some customer deliveries. Sales in Near Patient Care decreased at -5%. This was driven by lower cobas Liat sales, again due to the mild respiratory season, but this was partially offset by growth in our blood glucose monitoring at +8%, following some recent competitive wins. Sales in Pathology Lab grew at +12%, mainly driven by advanced staining growth of +9%, and companion diagnostics growth of +23%. Now I'd like to shift and take you to the regional view.

Sales in our core lab increased at 4%. Now, this was impacted by that previously, mentioned policy impact from China. Excluding this corelab grew at plus 8%.

Now, sales in Molecular Lab were flat, with strong growth in Transplant at plus 15%. But this was offset by the previously mentioned mild respiratory season, which lowered testing volumes. Now, while Blood Screening decreased at minus 9%, this is due to the ongoing conflict in the Middle East, and this impacted some customer deliveries.

Sales again due to the mild respiratory season, but this was partially offset by growth in our blood glucose monitoring at plus 8% following some recent competitive wins.

Sales, and Pathology Lab grew at plus 12%. Mainly driven by Advanced staining growth of plus 9 and companion. Diagnostics growth of Plus 23%.

Matt Sause: I'll take you through the performance by geography. In North America, the business grew at +6%. In EMEA, the business grew at +3%. As previously mentioned, this growth was impacted by the decrease in the blood screening business due to the Middle East conflict. In Latin America, the business grew at +10%. In Asia Pacific, the business declined at -5%. Now, as previously mentioned, sales growth was impacted by the healthcare pricing reform in China. As a result of this, China sales declined at -14%. Now, as stated at the full year, we expect a lessened impact of the China pricing reform in 2026, and our ambition is to grow sales in the Diagnostics division at mid-single digits this year.

So now I'd like to shift uh and take you through the regional view, I'll take you through the performance by geography in North America, the business grew at plus 6%.

In Amia the business grew at plus 3%. As previously mentioned, this growth was impacted by the decrease, in the blood, screening business due to the Middle East conflict.

In LATAM, the business grew at over 10%.

In APAC, the business declined at minus 5. Now, as previously mentioned sales growth was impacted by the health, care pricing reform in China as a result of this, China sales declined at minus 14%. Now, as stated at the full year, we expect a lessened impact of the China pricing reform in 2026. And our ambition is to grow sales in the Diagnostics division at Mid single digits this year.

Matt Sause: I'd like to continue with some updates to our assay pipeline, starting with the CE mark for our cobas MPX-E test, which we announced in March. The blood screening nucleic acid testing market represents approximately CHF 800 million market globally, and screening for hepatitis E, or HEV, is growing in Asia Pacific as well as EMEA due to increasing incidence. With the cobas MPX-E, we will enable labs to officially integrate HEV screening into their existing workflow. This will address a growing demand for comprehensive blood donation safety worldwide. Our tests will improve lab efficiency by simultaneously detecting HIV, HCV, HBV, and HEV from a single sample, and this will eliminate the need for retesting and reduce turnaround times, again, helping patients around the world have access to blood supply.

So, now I'd like to continue with some updates to our assay pipeline, starting with the CE mark for our cobas MPX e test, which we announced in March,

Um the blood screen, nucleic acid testing Market represents approximately 800 million Swiss franc Market globally and screening for Hepatitis E or HEV is growing in APAC as well as a Mia due to increasing incidents.

With the cobas MPX, we will enable labs to officially integrate HV screening into their existing workflow. This will address a growing demand for comprehensive blood donation safety worldwide.

Our tests will improve lab efficiency by simultaneously detecting HIV.

Matt Sause: This test will expand Roche's fully automated blood safety solution portfolio and strengthen our leading position of being the only company with a full nucleic acid and serology testing solution in our portfolio. Now I'd like to move to our leading neurology portfolio, starting with the CE mark of our blood-based neurofilament light chain assay. As you heard quite a bit from Theresa, MS is a progressive disease affecting around 2.8 million people worldwide, and about 45% of patients are currently managed with low-efficacy treatments, and disease monitoring relies heavily on expensive and resource-intensive MRI scans. Our NfL test will enable detection of neuroinflammation in patients with relapsing-remitting MS, which will support more informed treatment decisions. What's specific and differentiated about our test is we have established age-specific NfL percentiles from a comprehensive reference data set.

Hcv hbv and HV from a single sample and this will eliminate the need for retesting and reduce turnaround times. Again uh helping patients around the world have access to blood supply. This test will expand Roshes fully automated blood safety solution portfolio and strengthen our leading position of being the only company with a full nucleic acid and serology testing solution in our portfolio.

So now I'd like to, uh, move to our leading neurology portfolio. Starting with the CE, Mark of our blood-based neurofilament light chain assay. So if you heard quite a bit from from Teresa, Ms is a progressive disease affecting around 2.8 million people worldwide.

And about 45% of patients are currently managed with low efficacy treatments and disease, monitoring relies heavily on expensive and resource intensive MRI scans.

Our NFL task will enable detection of neuroinflammation in patients with relapsing remitting MS.

Which will support more, informed treatment decisions, and with specific and differentiated about our test.

Matt Sause: This is critical for clinical interpretation because NfL values increase with age, and this provides a more robust approach as opposed to other approved tests that rely on a single cutoff. This test will broaden Roche Diagnostics' neurology portfolio with a simple, reliable, and accessible test. Continuing with our neurology portfolio, I'd like to talk a little bit about the data from our p-tau217 blood-based biomarker study readout. This is data that was presented at the AD/PD conference in March, and here we assess our blood-based test across primary, secondary, and tertiary care settings, evaluating its performance throughout the full Alzheimer's disease continuum in two cohorts with a total of 675 participants. Our test demonstrated high diagnostic accuracy consistently across all clinical stages and healthcare settings, and it will be the first p-tau217 test with the potential to be approved across primary and secondary settings.

Is we have established age-specific NFL percentiles from a comprehensive reference data set and this is critical for clinical interpretation because NFL values increase with age and this provides a more robust approach as opposed to other approved tests that rely on a single cut off.

This test will broaden Roche Diagnostics' neurology portfolio with a simple, reliable, and accessible test.

So, continuing with our neurology portfolio, I'd like to talk a little bit about the, the data, um, from our petal. 217 blood-based biomarker study readout.

So this is data that was presented at the adpd conference in March.

And here, we assess our blood-based tests across primary, secondary, and tertiary care settings.

Evaluating its performance throughout the full Alzheimer's disease. Continuum in 2 cohorts, with a total of 675 participants.

Our tests demonstrated High Diagnostics accuracy, consistently across all clinical stages and Healthcare settings,

Matt Sause: Again, differentiating our neurology portfolio through the clinical evidence. This test will enable rapid, minimally invasive diagnosis across care settings, allowing clinicians to identify Alzheimer's disease earlier. Now, you heard a bit about this from Thomas, and I now would like to talk a little bit about our forthcoming Axelios sequencing solution, talk a little bit about some of the data we presented at AGBT, which is the leading genomics conference in February of this year. On the left-hand side of the page, you can see the SBX duplex performance data from a large internal study of over 1,000 human genomes that were processed over 65 runs. Here we demonstrated unprecedented throughput. As you can see from the chart, the system's baseline is very robust, reliably generating an average of 2.3 trillion bases of concordant duplex bases in four hours.

And it will be the first PETAL 217 tests with the potential to be approved across primary and secondary settings. Again, differentiating our neurology portfolio through the clinical evidence,

This test will enable rapid minimally invasive diagnosis across care settings, allowing clinicians to identify Alzheimer's disease earlier.

So now uh you heard a bit about this from Thomas and now would uh like to talk a little bit, our forthcoming xilo sequencing solution.

Uh, talk a little bit about some of the data we presented at agbt, which is the leading genomics conference in February of this year.

Internal study of over 1,000 human genomes that were processed over 65 runs.

Here we demonstrated unprecedented throughput. As you can see from the chart,

Matt Sause: As you heard earlier, one of the key differentiators of our system will be the unprecedented throughput. Now, on the right side, you can see data presented by one of our early evaluators, the Hartwig Medical Foundation. They compared performance of our SBX technology with a leading on-market technology for 118 tumor normal pairs. The results demonstrated high throughput and improved batch flexibility per run, and 99% concordance with the leading technology. These results reinforce the potential of Roche's SBX technology to set a new standard in next-generation sequencing, unprecedented throughput, and accuracy on par with leading technologies. I would also like to highlight a little bit of our recent acquisition, or excuse me, our merger agreement with SAGA Diagnostics. SAGA Diagnostics' Pathlight tumor-informed MRD, or Minimal Residual Disease, testing platform is currently available for early breast cancer and colorectal cancer.

The systems Baseline is very robust reliably generating, an average of 2.3 trillion, bases of concordant, duplex bases in 4 hours. So as you heard earlier 1 of the key, differentiators of our system will be the unprecedented throughput unprecedented. Throughput

Now, on the right side, you can see data presented by one of our early evaluators, the Hartwig Medical Foundation. They compared performance of our SPX technology with a leading on-market technology.

For 1118 tumor normal pairs.

The results, demonstrated high, high high, throughput and improved batch flexibility per run.

And 99% concordance with the leading technology.

These results reinforce the potential of roshes SBX technology, set a new standard in Next Generation sequencing, unprecedented, throughput and accuracy, on par with leading Technologies.

And I would, I would, I would also like to highlight a little bit of our, um, recent acquisition, um, or excuse me, uh, our uh, merger agreement with Saga Diagnostics. So Saga, Diagnostics pathlight, tumor informed mrd or minimal residual disease. Testing platform is currently.

Matt Sause: It relies on DNA sequencing, followed by digital PCR assessment of structural variants for monitoring disease relapse. Pathlight's tumor-informed ultrasensitive MRD platform will be fully integrated into our Foundation Medicine organization. Using our colleagues at Foundation Medicine team, we also plan to leverage the Axelios and our Roche Digital LightCycler PCR platform to develop a decentralized MRD solution, enabling international expansion and improved patient access. This minimal residual disease market is projected to grow at 31% compound annual growth rate, making it one of the fastest-growing segments in diagnostics overall. This acquisition will strengthen our leading oncology portfolio and support our ambition to build an end-to-end offering spanning early detection, diagnosis, therapy selection, and now disease monitoring, powered by our core technologies such as Axelios. To conclude, I'd like to report on progress of our key launch list for the diagnostics division.

Currently available for early breast cancer and colorectal cancer.

It relies on DNA sequencing, followed by digital PCR assessment of structural variants for monitoring disease relapse.

Pathlights tumor informed ultrasensitive mrd platform will be fully integrated into our foundation medicine organization.

Foundation Medicine. We are all using, uh, our colleagues at Foundation Medicine, uh, team. We also plan to leverage the Excel and our RO, digital life cycle PCR platform to develop a decentralized MRD solution, enabling international expansion and improved patient access.

This minimal residual disease market is projected to grow at 31%.

compound annual growth rate, making it 1 of the fastest growing segments in Diagnostics overall,

This acquisition will strengthen our leading oncology portfolio and support our ambition to build an end to end offering spanning early detection. Diagnosis therapy selection and now disease monitoring powered by our core Technologies such as Excel.

so, to conclude,

Matt Sause: For the 11 launches shown here, which you heard a little about earlier, we achieved 3 by Q1, and we're making good progress towards the other launches, which are on track. I look forward to providing future updates at our next meeting. Now I'd like to hand it over to Bruno. Thank you.

Bruno Eschli: Thank you, Matt. Just quickly to point out upcoming IR events. Next events, which are scheduled now, will be the Diagnostics Day on 12 May. This will be, again, a live event in London. We will have Thomas opening the day with a group and the strategy update. Then we, again, will take you through the entire portfolio, and as Matt already mentioned, sequencing will be, I think, in the center. We have then two other events scheduled at the beginning of June. We will have an ASCO event, which will be live out of Chicago. If you want to join us, you can come along. On 2 June, we will primarily focus on Divarasib, the key data again, and also a bit the clinical future development program.

I'd like to report on progress of our key launch list for the Diagnostics division for the 11th is shown here, which you heard a little about earlier. We achieved 3 by q1 and we're making good progress towards the other launches which are on track. I look forward to providing future updates, uh, at our next meeting and now I'd like to hand it over to Bruno. Thank you.

Bruno Eschli: Then on 8 June, we will have an event around ADA, which will focus on the obesity franchise. Key data to be presented will be our CT-388 Phase 2 data and Petrelintide, and we will also hear an update on the next steps in terms of our combination development, where we expect the Phase 2 to start around mid-year. Then I think finally, in H2, Pharma Day is now scheduled for 28 September. Again, a live event in London. We will have a plan for a similar setup like last year, taking you through pharma strategy, then also the primarily late-stage pipeline, and the portfolio. We also have included an update on our AI investments, especially focusing on early drug development here as well. With that, I think we are closed with the presentations and would open the Q&A.

Thank you, Matt. I'm just quickly to point out, um, upcoming IR events, um, next events which are scheduled now. Um, will be the Diagnostics Day on May 12th. This will be, um, again, a live event in London, we will have, um, Thomas opening um, the day with a group and, uh, the strategy update. Um, and then we again will take you through the entire portfolio. And as Matt already mentioned, um, um, sequencing will be, um, I think, um, in the center. Um, we have then 2 other events, um, scheduled beginning of June. We will have um, an an after event which will be live out of Chicago so if you want to join us, um, um, you can, um, come along, um, on the 2nd of June, um, we will hear primarily the focus on dues from the key data again and also um a bit the clinical future development program. Um, and then on June 8th, we will have a event around Ada, which will focus on the Obesity franchise. Um, key data to be presented will be our free, a date, uh, Phase 2.

Data, and petrol and type. And then also here in update on the next steps in terms of our, um, combination development, where we expect the phase 2 to start around mid-year, and then, I think, finally, um, in the second half farmer day, um, is now scheduled for the 28th of September. Um, again, a live event in London. Um, we will have a plan for a similar setup like last year taking you through farmer strategy. Then also the um, primarily late stage, um, Pipeline, and the portfolio.

We also have included an update on our, um, um, AI, um, um, investments, especially focusing on early drug development here, um, as well.

Bruno Eschli: First questions here would go to James Gordon from Barclays. James, please.

With that. Um, I think we are closed with the presentations and would open the Q&A.

Um, first questions here would go to, uh, James Gordon from Berkeley James, please

James Gordon: Hello. James Gordon from Barclays. Thanks for taking the question. First question was about Giredestrant. So, the failure of the persevERA trial, is that at all surprising in light of lidERA? And how do you reconcile the differences in the outcomes? Do you think it could be anything to do with whether it's background CDK4/6 therapies, or do you think it might be more about prior patient experience to hormonal therapies in the persevERA trial, but not the lidERA trial? That would be the first question, please. And then the second one will just be about obesity, because there's lots of different things going on in your pipeline, but we've seen some very low cost GLP-1 generics launched in some places already, such as in India.

James Gordon: How do you think about obesity pricing in the next decade and what that might mean for your next generation therapies, i.e., by the time you launch, there could be some calls for, shortly after, some much lower-priced therapies? Where do you think a drug like petrelintide would be used and could pricing be going to be tougher?

The question, uh, first question was about Joe in essence. So we have failure of the parts of ir trial is that at all, surprising a lot of leura. And and how do you reconcile the differences in the outcomes? Do you think it could be anything to do with whether there's background cdk, 46 therapies? Or do you think we might be more about prior patient experience to hormonal Therapies in in the persevera trial? But not the leera trial. Uh, that would be the first question please, and the second 1 just be about obesity. So, there's lots of different things going on in your pipeline, but we've seen some very low cost copy 1. Generics launched in some places already such as in India.

How do you think about obesity price in the next decade and like what that might mean for your next Generation therapy does? By the time you launch. I think there could be some calls but shortly after some much lower price therapies. So where do you think? Uh, a drug like Petri would be used and could pricing, can that be tougher?

Matt Sause: Yep. Great. Thanks, James. Let's start with persevERA versus lidERA. I think one of the most important things to always remember in oncology trials is that the context and the biology of the line of therapy really does matter a lot.

Teresa Graham: Yep. Great. Thanks, James. Let's start with persevERA versus lidERA. I think one of the most important things to always remember in oncology trials is that the context and the biology of the line of therapy really does matter a lot.

Teresa Graham: Tumor biology differs across lines of treatments, especially in early breast cancer versus later line setting. In EBC, tumor burden is low versus the metastatic setting. The tumor burden increases, the environment becomes more genetically complex. Resistance mechanisms are more prevalent, sort of the later line in therapy that you go. It's really important that we evaluated giredestrant in all of these different lines and settings in multiple different ways because there's differences in the tumor biology. Although the study didn't reach its statistical significance in PFS, a numerical improvement was observed. We do believe that giredestrant is active in the first-line metastatic setting. We are confident in its potential, certainly in early breast cancer, and I think we're very curious what we'll see in pionERA, which is the persevERA covered 60% of the first-line setting.

Yep. Great, thanks James. Um, so let's, let's start with, uh, persevere versus Lera. So, I mean, I think 1 of the most important things to, always remember in oncology trials, is that the context and the biology of the line of therapy really, does matter a lot.

Tumor biology differs across lines of treatments, especially in early breast cancer versus later-line settings. Um, in EBC, tumor burden is low, uh, versus the metastatic setting. The tumor burden increases, the environment becomes more genetically complex, resistance mechanisms, um, are more prevalent, uh, sort of the later line in therapy that you go. Um, and so it, it's really...

Teresa Graham: pionERA covers the 40% remaining, and I think we're very curious what we'll see in the pionERA setting. There isn't anything about persevERA that changes our confidence and our belief in the importance of giredestrant in early breast cancer. Again, where 70% of the opportunity sort of sits. Just to be super clear about that. In terms of obesity pricing, this is very foreseeable. I think when we made the decision to enter this market, we assumed that by the time we got there would be significant price erosion. It's not unexpected that in certain parts of the world you would have very low-priced options.

Really important that we evaluated gear Industrial in all of these different, um, lines and settings and in multiple different ways because that is really, you know, there's differences in in the tumor biology. Um, although the study didn't reach its statistical significance in PFS and numerical Improvement was observed. So we do believe that your dest is active in the first line metastatic setting. Um, and we are confident in its potential, uh, certainly in early breast cancer. And I think we're very curious what we'll see in Pioneer era, which is the, you know, uh, persevera covered 60% of the first line setting. Um, Pioneer covers the the 40% remaining and I think we're very curious, we know what we'll see in in the Pioneer setting. So there there isn't anything about persevera that changes our confidence, in our belief, in the importance of Gerard gestern in in early breast cancer again, where 70% of the opportunity, uh, sort of since so very, uh, yeah, just to be super

Clear about that. Um, in terms of obesity pricing, this was very foreseeable. I mean, I think as we, you know, when we made the decision to enter this market, we assumed that by the time we got there, there would be significant price erosion. It's not—

Teresa Graham: Regardless, I think given the portfolio that we've put together, the clinical benefit that we think our products will provide, the clinical differentiation that we believe that they'll represent, we do believe that there continues to be a very robust opportunity for us in obesity.

Unexpected that in certain parts of the world, you would have very low, uh, low priced options. Um, but regardless, I think given the portfolio that we've put together the clinical benefit that we think our products will provide the clinical differentiation that we believe that they'll represent. Um, we do believe that there continues to be a very robust, uh, opportunity for us in in obesity.

Bruno Eschli: James, did this answer all your questions?

James Gordon: Yes. Thank you.

James. It is so all your questions.

Bruno Eschli: Yep. We move on. Next one is Sachin Jain from Bank of America.

Yes, thank you.

Yep.

And we, uh, move on. Uh, next one is, um, Sachin Jain from Bank of America.

Sachin Jain: Hi there. Thanks for taking my questions. SERD and BTK, Theresa, thanks for the introductory comments on SERD. I just had two around lidERA, and then one on BTK. On lidERA, how should we think about the cadence of launch as you prepare for sort of commercial towards the end of this early next year? Do you think this is a market which will require a lot of community oncologist education versus CDK4/6? Although the data will be easily understood, and we should think about this as a strong launch. Secondly, you and Thomas have commented this could be one of Roche's top drugs, which I guess alludes somewhere in the $5 to 10 billion range. Just interested in your thoughts as to what factors you see that's going to dictate where in that range you end up.

Hi there, thanks for taking my questions. So, certain BTK—so, Teresa, that's the introductory comments on third. I just had two around the idea, and then one on BTK. So, on how should we think about the cadence of launch as you prepare for sort of commercial towards the end of this year or early next year? Do you think this is a market which will require a lot of community oncologists' education versus CDK4/6, or the data will be easily understood and we should think about this as a strong launch?

And then secondly, you and Thomas have commented on that. This could be one of Roche's top drugs, which I guess eludes somewhere in the $5 to $10 billion range.

Sachin Jain: Some of the factors we hear back, would love your perspective on, is adoption in low-risk patients, whether you get any combination use of CDK4/6, and then impact from other adjuvant studies, notably the switch studies that are due next year, CAMRY one and before. That's on lidERA, and then just a very quick one on BTK. You say you've been in continuous exchange with the FDA, IDMC. Any color you can give on the tone of those discussions? Clearly, part of your introductory comment, I guess, is referencing safety where investors just see the death imbalance and I guess lack of color on the suicides, driving concerns on approvability. Thank you.

So just interesting your thoughts as to what factors you see that's going to dictate. Where in that range? You end up. Um some of the factors we hear back would love to your perspective on is adoption and low-risk patients, whether you get any combination uses cdk4 6 and then impact from other agent studies noting me the switch studies uh, that are due. Uh, next year can we want and before, so, that's an idea and then just a very

Teresa Graham: Yep. Great. In terms of cadence of launch, we would expect that giredestrant will have a strong launch. I think there's quite a bit of excitement and interest in this as a therapy for patients living with ER-positive, HER2-negative breast cancer. Where we expect to have the quickest uptake is in that sort of mid-risk population. From there's quite a reasonable belief that we would then move into the high-risk population. Given the tox that you see with the CDK4/6s over time, patients have a difficult time tolerating it. They drop off. We'll have additional data that we will generate in these areas as well, in terms of combination therapy.

A quick one on BTK—you say you've been in continuous exchange with the FDA, IDMC. Any color you can give on the tone of those discussions? Clearly, part of your injury comment, I guess, is referencing safety, where investors just see the death in balance, and I guess lack of color on the suicides, um, driving concerns on a probability. Thank you.

Yep, great. Um, so, in terms of cadence of launch, I mean, we would expect—

Teresa Graham: It is very tough to remain on these regimens over time, and given the safety profile that we saw with giredestrant, we would believe that there will be a number of patients, even in that high-risk population, that will want to make the switch. Low risk, again, we hear KOL intent to use in this low-risk population. As with any kind of oncologic indication, you really want to come out of the gate swinging. What is your strongest weapon that you can use against the cancer? I think the lidERA data very clearly show that we are highly efficacious and very tolerable in this setting. I think we intend to resource and go after this indication, assuming that it is going to be strong right out of the gates. In terms of the switch studies, I think it's an interesting question.

Um and you know, from there, you know, there's quite a reasonable, there's quite a reasonable belief that we would then move into the high risk population, given the talks that you see with the cdk4. Sixes over time, patients, have a difficult time tolerating it, they drop off. Um, we'll have additional data that we will generate in these areas as well. Uh, in terms of combination therapy. But, you know it it is very tough to remain on these regimens over time and given the safety profile that we saw with Gerard. We would believe that there will be a number of patients. Um, even in that high risk population that will want to make the switch uh low risk. I mean again we we hear kol intent uh to use in this low-risk population. I mean, with with uh as with any kind of analytic indication you really want to come out of the gate swinging. Um you know what is your strongest uh weapon that you can use against the cancer and I think you know the the Lera data very clearly show that we are highly efficacious and very tolerable uh in this setting. So you know, I think

We intend to to Resource and go after this indication assuming that it is going to be um you know, strong. You know. Right out of the gates.

Teresa Graham: The switch studies assume that after three to five years of therapy, you're going to make a switch. Why would you save your biggest gun till last? It doesn't kind of totally compute that that's what people would necessarily want to do. I think at the end of the day with lidERA, we asked a very clear scientific question. We got a very clear answer. I think that very clear answer is one that's been quite well-received by the KOL community. Switching over to BTK, in terms of the tone of the discussion, obviously we don't discuss ongoing communications with regulators. I would say, as always, we've been very transparent with our data. They've been very productive discussions. Again, we believe that we've shown a very good benefit-risk profile. There is no medicine out there that doesn't carry some amount of risk.

Um, in terms of the switch studies, I mean, I think this is it's, it's an interesting question. I mean, it that the switch studies assume that after 3, to 5 years of therapy, you're going to make a switch. Um, why would you save your biggest gun till last? I mean, it it doesn't doesn't kind of totally compute that. That's what people would would necessarily want to do. I mean, I think, at the end of the day, with lareau, we asked,

Very clear scientific question. We got a very clear answer um and I think that very clear answer is 1 that's been uh, quite well received by the kol community.

Teresa Graham: We believe that given what we've shown from an efficacy standpoint, we've got a really good treatment for MS on our hands. Let's talk for a minute about suicides and suicidality. First, I think it's just important to put in context that the MS population unfortunately does have a higher risk of suicide and suicidality. It's sort of the backdrop under which you have to sort of consider some of this data, and I think you've heard that from the KOLs who've presented on the podium. There's not a huge number of these events. We clearly are trying very hard to understand them, but it's likely going to require more data and more time. I think what's also important to remember is that we didn't see any suicide or suicidality in our phase 2 trial, including the long-term extension.

I mean, in terms of switching over to BTK, in terms of the tone of the discussion, obviously we don't discuss ongoing, uh, communications with regulators. But I would say, you know, as always, we've been very transparent with our data. They've been very productive discussions, um, and you know, again, we believe that we've shown, uh, we've shown a very, a very good benefit-risk profile. Um, you know, there is no medicine out there that doesn't carry some amount of risk, but we, we believe that given what we've shown from an efficacy standpoint, um, you know, we've, we've, we've got, uh, we've got a really good treatment for MS on our hands. I mean, let's talk for a minute about, about suicides and suicidality. I mean, first, I think it's just important to put in context, um,

That the MS population, unfortunately does have a higher risk of suicide and, and suicides and suicidality. And so it's sort of the backdrop under which, you know, you you have to sort of consider some of this data. And I think you've heard that from the from the kols who've presented um

Teresa Graham: We haven't seen any in the autoimmune indications that we have studied as well. I think there are certainly questions that we have to ask and answer here. Patient safety, as I said previously, is always our number 1 priority. We are looking into this very, very closely, and as we have more information, we will certainly share it.

on the podium. Um, these are there's not a huge number of these events. We clearly are trying very hard to understand them but it's likely going to require more data and more time. Um, and I think with also, you know, important to remember is that we didn't see any suicide or suicidality in our Phase 2 trial, including the long-term extension. Um, and we haven't seen any in

Thomas Schinecker: Yeah. Maybe Sajen, I can add two things here as well, one on giredestrant, and on the switching studies. Well, first of all, just on giredestrant. Giredestrant has demonstrated the highest preclinical potency among the SERDs. Second, if you look at switching studies and people have been pre-treated for three to five years, you are just also in a different setting. I don't think that the data that we have shown necessarily needs to translate to another SERD, which is tested in a very different setting and is a very different molecule. If you then look at when the next study will come in terms of true adjuvant study, this is a number of years away.

Any of the autoimmune indications that we have studied as well. So um I think there are there are certainly uh questions that we have to ask and answer here, patient safety. As I said, previously is always our number 1 priority. We are looking into this, um, you know, very, very, very closely. Um, and, you know, as we have more information, we will certainly share it.

Yeah, maybe sajan I can add uh, 2 things here as well 1 on God. Um, and on the switching studies. Well, uh, first of all, uh, just on your different, your death has demonstrated the highest preclinical potency among the SS

Thomas Schinecker: On the BTK, one thing that I can also give as an indicator is that, on the PPMS side, we have already achieved the approval of getting all of the patients that have been on the trial into the open label extension. Not only that, also the people that were on the placebo arm have switched to Fenebrutinib. I think this is at least a good sign if you ask me, because it shows that the benefit is seen and that these people are allowed to be on this medicine.

Second. If you look at switching studies and people have been pre-treated for 3 to 5, uh, years. You are just also in a different setting. So, um, I don't think the that the, uh, data that we have shown necessarily needs to translate to an other third, uh, which is tested in a very different setting, and it's a very different molecule. Um, and if you then look at, when the next study will come in terms of true, add event study. Uh, this is a number of years away on the BTK, uh, 1 thing that I can also give as an indicator is that, uh, on the ppms side. Um, we have already, uh, achieved the approval of getting all of the um, um, patients that happen on the trial into the open label extension and not only that. Also the people that were on the placebo arm,

Alan Hippe: Did you mention that fenebrutinib was used in other indications as well?

Have switched to a penny button up. So I think this is, at least a good sign if you ask me, um, because it shows that the benefit is seen and and um, yeah, that these people are allowed to be on this medicine.

Teresa Graham: I did.

Thomas Schinecker: Yeah.

Teresa Graham: I did.

Alan Hippe: Okay.

Bruno Eschli: Very good. Let's move on in the queue. The next questions go to Peter Verdult from BNP Paribas. Peter, please.

Peter, please.

Peter Verdult: Yeah, thanks. Peter, BNP. Just to raise a couple of questions on your BC portfolio. If we look through the lens of your R&D bar strategy about prosecuting best or first in class assets. I get it why you're proceeding inipetide forward. Interested to hear more about the phase 3 development plans there. I don't see how the amylin analog petrelintide can be considered first or anywhere near best in class. Interested to hear more your go-forward strategy there on amylin. Just to check, is there any debate internally at Roche whether to make that sort of $2 billion commitment to petrelintide for a full phase 3 development program? Thank you.

Yeah. Thanks BMP. Just to raise a um couple of questions on your BC portfolio. If we look through the lens of your R&D bar strategy about you know, Prosecuting best or first-in-class assets, um I get it. Why you'll proceeding

Teresa Graham: Sure. I think first we should talk about the fact that the amylin class is fundamentally different than the GLP-1 class. It serves a very different role in what we think is going to be a very heterogeneous obesity market. We do see a very different tolerability profile for Petri. When you think about the 50% of the population globally that is going to be obese by 2030, 2035, there are a certain portion of them that are not going to tolerate any kind of adverse event. Petri in combination or in other uses could potentially be a really big benefit for those people who don't need to lose 20% of their body weight, but do need to lose in the low teens, which is exactly where we saw the data come out for Petri, along with that placebo-like efficacy profile.

And it's paid forward interest to hear more about the phase 3 development plan there, but I don't see how the analog PEDY can be considered first or anywhere near best-in-class. So interested to hear more about your go-forward strategy there on Amalyn. And just to check, is there any debate internally at Roche whether to make that sort of $2 billion commitment to PETRI for a full phase 3 development program? Thank you.

Sure. So I mean I think

in the glp glp1 class it, it serves a very different role in um,

Uh in what we think is going to be a very heterogeneous obesity Market. Um,

We do see.

A very different tolerability profile for Petri. And so, when you think about the over, when you think about the 50% of the population globally that is going to be obese, um, by 2030 20335. Um, there are are, are certain portion of them that are not going to tolerate any kind of adverse event and, you know, Petri in combination, um, or you know, or or in other uses could potentially

Teresa Graham: I think for us, as we look across the entire portfolio and the kind of offering that we want to bring to the market in terms of having a differentiated holistic portfolio that addresses all of the different needs that patients will have, we think that there is a role for amylin to play and a role for Petri to play in. More to come on exactly what our phase III trials will look like in the coming months. I think we still continue to believe that there is a place for Petri.

Thomas Schinecker: We have announced that we will do a phase II combination of Petrelintide and CT-388. Especially in the combination, I think it's important to have molecules that are tolerable in the combination. Especially in the combination, we do see the potential between the molecules.

Be a really big benefit for those people who don't need to lose 20% of their body weight, but do need to lose in, in the low teens, which is exactly where we saw the data come out, um, for, for Petri along with that Placebo, like efficacy profile. So, you know, I think for us as we look across the entire portfolio and the the kind of offering that we want to bring to the market in terms of having a differentiated, um, holistic portfolio, that addresses, all of the different needs that patients will have. We think that there is a role for amalin to play, um, and, and a role for Petri to play. And so more to come on exactly what our, our phase 3 trials will look like, uh, in in the coming uh, in the coming months. But I think we still continue to believe that there there is a place uh, for Petri and and we have uh, announced that we will do a phase 2 combination of petrol laid and ct3 A8. Um, and especially in the combination. Um, I think it's important to have molecules that are

Teresa Graham: That's something very differentiated.

Bruno Eschli: Okay. Very good. Let's go on. The next questions come from Sarita Kapila, Morgan Stanley. Savita, please.

Sarita Kapila: Hi, thanks for taking my question. Just one from me. Ahead of the Q4 data in DME, how should we think about competition to Vabysmo from Merck's MK-3000? The early data suggested a similar visual acuity improvement at 12 weeks versus 52 weeks of Vabysmo. How should we be thinking about potential read-through or risk to AMD? Thank you.

Tolerable, uh, in the combination and especially in the condition. We do see the potential between the, the molecules, that's something very differentiated. Okay, then, are you, let's go on. Um, the next question come from, um, Serita, capula gong Stanley. So we don't, please

Hi, thanks for taking my question. Uh, just 1 from me ahead of the queue for data in DME. How should we think about competition to the bismo from Max MK 3000. So the early data suggested, a similar visual Acuity Improvement at 12 weeks versus 52 weeks for the biso. And how should we think about potential read or risk to AMD? Thank you.

Teresa Graham: I think Vabysmo has done an exceptional job over the course of the last couple of years, establishing itself as the standard of care in retinal disease. We see that being consistently reinforced in all of the interviews, information, and exchanges that we have with our retinal specialists. While it's always interesting to see another mechanism of action kind of enter the space, I think Vabysmo has set a high bar. They will have to sort of demonstrate that they can cross over that over the long term with their safety and efficacy data. Again, we also have a win. We're in this race as well. Ophthalmology is a core area for us, but we do believe that at the end of the day, people will need to see something that works better than Vabysmo.

Teresa Graham: As of yet, we don't have anything in a phase III that's proven that.

So, I mean, I think the biso has done an exceptional job over the course of the last couple of years, establishing itself, as the standard of care in these, uh, in in in retinal disease. Um, and we see that being consistently reinforced in all of the interviews and information that in exchanges that we have with our, uh, with our retinal Specialists. So while, uh, you know, it's always interesting to see another mechanism of action, kind of enter the space. I think that the bismo has, um, set a high bar and, uh, and, and they will have to sort of demonstrate that that they can cross over that over the long term with, uh, with their safety and efficacy data. Um, again, we also have have a win. So, um, we're we're in this, uh, in this race as well. Um, Opthalmology is a core area for us, but we do believe that at the end of the day, people will need to see, um, something that works better than the bismo. And as of yet, we don't have anything in a phase 3, that's proven that

Bruno Eschli: Very good. Let's move on. The next questions go to Luisa Hector from Berenberg. Luisa, please.

Very good.

Um then let's move on. Um the next questions, go to um Louisa Hector from bobber Louisa please?

Luisa Hector: Thank you, Bruno. I have a question around the de-risking, really, of the legacy pipeline and your levels of confidence in those drugs. Has that changed your ambitions in terms of business development, R&D investments, and your thoughts around the longer-term sales and margin? Just any color you can give there. Thank you.

Thank you, Bruno. Um, so I have a question around the during really of the Legacy Pipeline and and your levels of confidence in those drugs, has that changed your Ambitions in terms of Business Development R&D Investments, um, and your thoughts around the longer term.

Sales and margin. Just any color, you can give their thank you.

Teresa Graham: When you refer to sort of legacy pipeline, what are you referring to?

Luisa Hector: Oh, Fenebrutinib and Giredestrant. Hearing your levels of excitement around those assets and the positive data that you have, does that lead you to behave differently and think differently towards future business development?

Teresa Graham: Yeah. I mean, both Fenebrutinib and Giredestrant sit in what we call end-to-end disease areas in our pharma strategy. MS and breast cancer are two areas that we have said we have a long-term strategic interest in being leaders in both today and tomorrow. I think it doesn't change our interest. We remain deeply interested in both of these spaces, and are going to be constantly on the hunt for opportunities to really improve patient efficacy in both breast cancer and MS.

So, you know, hearing your levels of excitement around those assets and and the positive data that you have does that lead you to behave differently and think differently towards future Business Development.

Alan Hippe: I mean, from an M&A perspective, I can say that we'll continue to do M&A like you've seen in the last couple of years, but we're not dependent on it.

Yeah, so I mean both Ferb and your dest and what we call end-to-end disease areas and our Pharma strategy. So Ms. And breast cancer are 2 areas that we, um, have said, we have a long-term strategic interest in being leaders in both today and tomorrow so I think it doesn't change our interests. We remain deeply interested in both of these spaces. Um, and are going to be constantly on the hunt for opportunities to really improve. Uh patient efficacy in in both breast cancer and Ms.

Teresa Graham: No.

Alan Hippe: Right. I mean, if you look at the last couple of years, we could actually finance our M&A that we did with the earnings that we had in that year. I think there are other companies that are in a much more different situation where they actually do have to do M&A. Continue to see what we've done over the last couple of years, very disciplined spending. Again, we are in a good position. We will have continued growth even in absence of M&A.

Teresa Graham: Okay.

Bruno Eschli: We don't have a patent cliff, correct?

I mean from an m&a perspective, I can say that we'll continue to do uh m&a like you've seen in the last couple of years but we're not dependent on it, right? I mean, if you look at the last couple of years we could actually Finance our m&a that we did with the uh with the earnings that we had in that year. Um, and uh, you know, I think there are other companies that are in a much more different situation where they actually do have to do m&a. So, uh, continue to see what we've done over the last couple of years, very disciplined spending and uh again we are in a in a good position, we will have continued growth, even in absence of uh m&a

Teresa Graham: We don't have a patent cliff.

Alan Hippe: Yeah.

Bruno Eschli: Very good. Luisa, did we answer all your questions?

And we don't have a patent clip, correct? Yeah. Mhm.

Luisa Hector: Yes. Thank you.

Teresa Graham: Thanks, Luisa.

Bruno Eschli: Next one is Graham Parry from Citi. Graham.

Very good. So you said that, we answer all your questions. Yes. Thank you. Thank you.

Graham Parry: Great. Thanks for taking my question. Just going back to Giredestrant, Theresa, 70% of the market opportunity in adjuvant of a $20 to $30 billion would imply $14 to $20 billion opportunity in adjuvant. Just could you clarify how much of that would assume CDK4/6 combo use or erosion, or how much is just essentially what is currently a monotherapy aromatase inhibitor market, which is aligned with your lidERA study and therefore fairly easy to go after. Then secondly, do you think that you could get a label which would allow aromatase therapy switches on launch or just de novo patients per the lidERA study? Then thirdly, one for Alan, just the thoughts on the margin trajectory of Roche as you go forward and have this multi-billion dollar in-house developed asset that's a small molecule at a high price, driving your revenue growth. Thank you.

And uh, next 1 is grey and Perry from City Graham. Great thanks. Steve my question. So just going back to girardian. The trees are at 70% of the um, Market opportunity in an event of a 20 to 30 billion, would imply 14 to 20 billion opportunity in add event. Um, just to be clarify, how much of that would assume cdk4 6 combo, use or erosion, uh, or how much is Just essentially, what is currently a monotherapy aromatase inhibitor Market, which is is aligned with your leera study and therefore fairly easy to go after. Um, and then, secondly, do you think that you could get a label, which would allow aromatherapy switches on launch or just denovo? Patients per the leera study and then thirdly 1 for, um, Alan, just the thoughts on the margin trajectory of rash as you go forward. And have this multi-billion dollar in-house developed asset. That's a small molecule

Teresa Graham: Yeah. You have asked two sneaky questions. We will not comment on the label negotiations that we're having with the FDA. More to come on that. Right now about 20% to 25% of early breast cancer patients get CDK4/6 combination therapy, but there are very high discontinuation rates due to adverse events. We don't provide peak estimates for our products at this stage, but I will say that we would expect that we will have a significant share of that market. Oh.

At a high price um driving your Revenue growth. Thank you.

Yeah.

Um, so you have asked 2 sneaky questions, so we will not um comment on what we uh and the label negotiations that we're having with the FDA so more to come on that. Um, right now about 20 to 25% of early breast cancer patients, get cdk 46, uh, combination therapy, but there are very high discontinuation uh, rates due to, to Adverse Events. Um, and so we are, uh, we, you know, we we don't provide Peak estimates, uh, uh, for, for our products at this stage. But I will say that, um, we, we would expect that we will have a significant share of that market.

Alan Hippe: Hello?

Teresa Graham: Yeah, I mean, it's in store for you.

Alan Hippe: Yeah. Well, look, I think from the margin point of view, as Thomas always said, I think we defend the margin or increase it. I think these are the points. At least we defend the margin moving forward. I think we've said it also for this year already. I think without increasing the margin, honestly, I think very hard to do and to fulfill the guidance. I think we have a higher burden coming from the tech side. We have a higher burden coming from the financing side that we have to cover. We're going to do that. That's automatic. I think really now distinguishing what's a small molecule or whatever mechanism it is. When you look at the longer term of Roche, I think we've been pretty solid when it comes to the gross margin, especially on the pharma side. Roughly 80%.

Alan Hippe: That's something that we always had somehow here. Was it small molecules or even other mechanisms? I think that looks fine. Certainly, I think that's a great opportunity. We love Giredestrant. I think that's a huge opportunity moving forward. Very clearly, I think that looks promising.

Oh yeah, I mean it's in the stores for you. Yeah well I look I think from the from the margin point of us Tom has always said, I think we defend the margin or increase it. I think these are the point so at least we defend the margin moving forward. I think we've said it also for this year already. I think without increasing the margin, honestly, I think very hard to to do uh, uh, and to fulfill the guidance. I think we have a higher burden coming from the tech side. We have a higher burden coming from the financing side that we have to to cover. So we uh we going to do that. So that's automatic and I think, really now distinguishing, what's a small molecule or whatever mechanism it is when you look at the longer term approach, I think we've been pretty, pretty solid when it comes to the gross margin, especially on the farmers that roughly 80%. That's something that we always had somehow here was it small molecules or even other mechanisms so I think that's, that's

Bruno Eschli: I think what's probably fair to mention that we are well entrenched on the commercial side in these areas.

That looks fine. Certainly I think that's a great opportunity. We we loved yours friend. I think that's a that's a that's a huge opportunity moving forward and very clearly I think uh that looks promising.

Teresa Graham: Oh, absolutely.

Bruno Eschli: We have a big breast cancer sales force, and we have a multiple sclerosis sales force, so there will be benefit on the-

Teresa Graham: Exactly. These, from a S&M perspective, are launching right in our sweet spot.

Bruno Eschli: Yeah. Graham, any additional questions? Follow-on questions? Was the answer to-

But I think what's probably fair to mention that we are, well, entrenched on the commercial side in these areas. So we have a big breast cancer sales force and we have a multis corrosive sales force so there will be benefit on, on the exactly. So, these from a, from a M&D perspective, these are launching right in our sweet spot. Yeah.

Graham Parry: That's great.

Bruno Eschli: Okay.

Graham Parry: Thank you.

Bruno Eschli: Yep. Let's move on. Next questions come from James Quigley at Goldman Sachs.

Um, gra, any additional questions? Follow on questions. What's the answer? Thank you.

Yep.

James Quigley: Great. Thanks, Bruno. Thanks for taking my questions. I got about 2, please. Apologies, I missed the first one on Vabysmo. What is the current bottleneck for the recovery or acceleration of Vabysmo sales in the US? We've sort of seen increased funding towards the back end of last year, but it seems to be taking a while to flow through to patients. What is going on here? Is that normal from what you've seen before? Have you started to see those bottlenecks lifting as we've gone through the quarter? That's the first one. Second one, again revisiting CT-388. You started the phase 3 trials now, so there's 2 of them that I've seen on clinicaltrials.gov. They look like traditional phase 3 designs. Can you confirm to what extent there is any flexible dosing here?

Then let's move on. Uh, next question comes from James. Quickly, got the sax.

James Quigley: Did you also consider adding Semaglutide as a reference arm or even an active comparative to the study? Related to CT-388, what's the progress? What's the next steps in developing combinations with pegloticade? Is that still the plan, and when will we start to see some of that data? Thank you.

Teresa Graham: Yep. Great. So Vabysmo, just to reiterate, a good quarter, 13% for the division back to growth in the US, 4% up. We continue to reiterate that we will see an acceleration from the 12% growth that we saw overall last year. To reiterate, patient assistance foundations are not part of our commercial strategy, and we do not look at them when we think about sales. That having been said, what we have been hearing from the market is that based on what happened last year, physicians have just gotten savvier about where to use patient assistance dollars, and they're using them for patients who truly need them. They're just thinking differently about how they're utilizing those funds as they're made available.

Seen increased funding towards the back in the last year. Um, but it seems to be taking a while to flow through to, to patients. So, um, what is the, uh, what is going on here? Is that normal from what you've seen before? Um, and have you started to see those bottlenecks listing, um, as we've gone through the quarter, that's the first 1, second 1, again, revisiting CT 388. So you started the phase 3 trials now so there's 2 of them are I've seen on clinical trials.gov. Um these look like traditional phase 3 designs. Can you confirm uh to what extent there is any flexible dosing. Uh, here, did you also consider adding some a glue Tail as a reference arm or even an active comparator to the study? And then also related to CD CD 388, um, what, what, what's the progress? What's the next steps in developing combinations with uh with petrol and Tide? Is that is that still the plan? Um and when will we start to see some of that? Uh that data thank you.

Great. Um, so the bismo just to reiterate a good quarter, uh, 13% for the division back to growth in the US. Uh, 4% up, we continue to reiterate that we will see an acceleration from the, from the 12% that, uh, growth that we saw, uh, overall last year, um, to reiterate, uh, patient assistance. Foundations are not part of our commercial strategy and we do not look at them when we think about sales.

Teresa Graham: That is a completely different and separate thing to anything that we do on the commercial side, and I just want to be crystal clear about that. CT-388, you are right, the first two trials are relatively straightforward and standard against placebo, and that is because that is what is currently required for regulatory approval. When you talk about bringing a new molecule in this space to the market, these are the trials that the FDA asks you to run. Therefore that is what we are doing. We will be looking at other things going forward with CT-388 and more to come on our plans in that space. Obviously, we're very excited about launching that fixed dose combination that you've now heard us talk about several times.

Um, that having been said, what we have been hearing from the market, is that based on what happened last year Physicians have just gotten savvier about where to use patient assistance dollars and they're using them for patients who truly need them. Um, and they're just thinking differently about how their uh, how they're utilizing those funds as they're made available, but that is a completely different and separate. Um, thing to anything that we do on the commercial side and I just want to be crystal clear about that.

Um, c388, you are right? The first 2 trials are relatively straightforward in standard, uh, against Placebo. Um, and that is because that is what is currently required for regulatory approval. So when when you talk about bringing a new molecule, in this space to the market, these are the trials that the FDA asks you to run. Um, and so therefore, that is um, that is what we are. That is what we are doing. Um, we will uh,

Be looking at other things going forward with CT 388 and and, and more, more, more more to come, uh, more to come on our plans in that space. And then obviously, um, we are, uh, we're very excited about launching that fixed dose combination that we've now we you've now heard us talk about several times.

James Quigley: Yep.

Bruno Eschli: I think, James, you had a question on the combination development. I think this is to be kicked off mid-year. Mid-year, we would expect the first patient in, and I think we also have the opportunity at the IR event coming up around ADA then to drill a bit more and go into a bit more of the details on the trial design.

James Quigley: Great. Thank you, Bruno.

I think James regarding the, you had a question on the combination development. I think this is to be kicked off of mid year. So, mid year, we would expect the first patient in and I think we also have the opportunity at the IR event coming up around 88 and to drill a bit more and go into a bit more into the details on the trial design.

Bruno Eschli: Yep. Okay. We move on, and the next one is Simon Baker from Redburn. Simon?

Great. Thank you, Bruno.

Yep. Okay.

Simon Baker: Thank you, Bruno, and thanks for taking my questions. Two if I may, please. Firstly for Theresa. I just wonder if you could share some of the feedback from physicians following the AAN presentations of Fenebrutinib. We've had a few drugs recently where there's been a, should we say, a disconnect between a negative market impression and a positive physician impression on drugs. I just wanted to know if that was the case here. A slightly different question going back to the AI factory. I just wonder if you could give us an idea of how and when you will assess the impact, and how and when will we be able to assess the impact of your significant AI investments. Thanks so much.

Then uh we move on. And uh next 1 is Simon Baker from

Thank you, Bruno, and thank you for taking my question, uh, to information, please. Um, firstly for, uh, Teresa. Um, it's something—could you, uh, share some of the feedback, um, from physicians following the, uh, AAN presentations of fenebrutinib? We've had a, a few drugs recently where there's been a, uh, shall we say, a disconnect between a negative market impression, and a positive physician impression on drugs. I just wanted to know if that was the case here.

And then uh, a slightly different question. Going back to the the AI Factory. Um, I just wonder if you could give us an idea of of how and when you will ex uh, assess the impact,

Teresa Graham: Yep. I will say I was at ACTRIMS when we presented the PPMS data, and I have had multiple conversations with the team on the ground at AAN, and the KOL feedback is extraordinarily positive. I think people are very encouraged by the data that they're seeing. They're reassured in some ways by what they're seeing on the safety side with the liver, with the relative understandability of the liver enzymes and the fact that we know we're not really seeing a pattern with some of the other adverse events. There is a huge amount of excitement here. When you think about the MS population, 45% of patients today are either on orals or low-efficacy therapies. This is extremely low-hanging fruit for something like a Fenebrutinib that acts on both the progressive and the relapsing portions of the disease.

And how. And when will we be able to assess the impact of your significant? AI Investments? Thanks so much.

Teresa Graham: I think we see a ton of positive KOL excitement and enthusiasm. I think they're really looking forward to having this tool in their armamentarium. I can pass it on to you, Thomas.

Yeah. So I will say, I was at actrims when we presented the ppms data and I have had multiple conversations with the team on the ground at aan and the kol feedback is extraordinarily positive. I think people are very encouraged by the data that they're seeing. Um, they are, um, you know, they're, they're reassured in some ways by what they're seeing on the safety side with the liver, uh, with, with the, the, the, the relative, uh, understandability of the liver enzymes, and the fact that we know, we're not really seeing a pattern, with, with some of the other, uh, Adverse Events. Um, so there is a huge amount of excitement here. I mean, when you think about the MS population, 45% of patients today are either on orals or low, efficacy therapies. This is extremely low hanging fruit for something like a feda, brute nib that, uh, acts on both the, the progressive and the relapsing portions of the disease. So um, I think we see a ton of uh, positive kol, uh, excitement and enthusiasm um, and

Thomas Schinecker: Yeah. On the AI side, you saw on the slide from Bruno that you will have an update at Pharma Day, and I know Aviv and some of our people will be there. You'll see exactly how many molecules are ready in our pipeline coming through the use of AI tools in research and how we're going to really track that in the future and how we can make it transparent for you so that you can see the benefit that AI has already today. I can say our teams are now really utilizing AI constantly in research, and actually a lot of the molecules

Thomas Schinecker: Have some sort of AI tools used in the development. Bruno, you want to comment on that?

Bruno Eschli: Yeah, I can quickly comment. Really stay tuned for Pharma Day. We will have Ari on stage, and I think we will roll out a bit our strategy here also and how we will track the progress in this field. I think it's fair to say it's early days. We have now generated, I think, a couple of NMEs. Basically all new NMEs have one or another AI component to them. We have established a system where we will track this progress. These molecules, I think, are to enter the clinic within the next couple of quarters. Then, of course, we have to wait one to three years to really collect enough data to get a feel on how this has impacted success rates, for example, or whether we were able to identify new drug targets and many more questions to be asked.

Yeah, on the AI side, uh, you saw on the slide from Bruno, that you will have an update that former day, and I know a Viv, uh, and some of our people will be there. So you'll see exactly how many molecules are ready, uh, in our pipeline, uh, coming through, uh, you know, the use of AI Tools in in research and, and how we're going to really track that in the future and how we can make it transparent for you so that you can see the benefit that AI has already today. But I can say, you know, our our teams are now really utilizing AI constantly in in research and actually a lot of the molecules have some sort of AI tools used in the development. But Bruno you want to comment on that? Yeah, I can, I can quickly comment. So really stay tuned. Um, for Farmer day. Um, we will have an AI on stage and I think we will will roll out a bit, you know. Um, our strategy here also and how we will track the progress in this field. I think it's fair to say it's early days. Uh, we have now generated, I think, you know, a couple

Bruno Eschli: I think September, that's the point in time when we really will kick off, I think, this AI communication and provide you then also some mid- and longer-term perspectives.

Of um, um, um, um, enemies. Basically, all new enemies have 1 or another AI component to them and um, we have established a system where we will track this progress. So these molecules are I think are to enter the clinic within the next couple of quarters. And then, of course, we have to wait 1 to 3 years, to really collect enough data to get a feel on how this has impacted, you know, success rates, for example, or uh, you know, uh whether we were able to um, identify new drug targets and and many more questions to be asked. But I think um,

Simon Baker: Okay. Thanks so much.

September. That's the point in time when we really will kick off. I think this, um, AI, communication and provide you then also some, um, made and longer term perspectives.

Bruno Eschli: Yeah. Okay. We go on. Next questions go to Justin Smith from Bernstein.

Perfect. Thanks so much. Um, yeah. Okay then we go on. Uh next question is go to Justin Smith from posting.

Justin Smith: Thanks very much, Bruno. Just a couple please. Firstly, on Alzheimer's, just wondered if anyone could share any thoughts about how the launch of the p-tau217 test could actually expand the market for biologics. Then just second one on Polivy. Given the potential competition coming up, how would you think about whether the sequential share gains we've seen in the US would be sustainable or not? Thanks.

Thanks Bruno. Um just a couple of these firstly on Alzheimer's. Just wondered if anyone could share any thoughts about how the launch of The Petal. 217 tests could actually expand the market for biologics and then just second 1 on pvi is a potential competition coming up. How we just think about, whether the sequential search share games we've seen in the US would be sustainable or not. Thanks

Matt Sause: Yeah, I'll take the first one on p-tau217. If you think about the dataset, as you heard on the slide, we have data across primary, secondary, and tertiary care. Now, one of the biggest challenges people need to be diagnosed with Alzheimer's disease is the availability of specialists. Oftentimes it takes over two years. By having a primary care claim, potentially with a blood-based biomarker, you have the potential to greatly expand access. For this to get into guidelines, it would need to have a 90% negative predictive value, 90% positive predictive value, with 90% sensitivity, and 90% specificity. If that is achieved, then absolutely, that becomes possible. That's how I characterize 217.

So yeah, I'll take the first 1 in p217. So if you think about the data set as you as you heard on the side we have data across primary secondary and tertiary care.

Now, 1 of the biggest challenges, people need to be diagnosed with Alzheimer's disease, is the availability of specialists.

Often times it takes over 2 years by having a primary care claim.

Teresa Graham: Yeah. I would say from the pharma standpoint, we're extremely excited to have these assays in the market, because we do think this has been one of the limiting factors to uptake. It's that you're just getting proper diagnosis and being able to get those eligible patients in. I think we're super excited to have that partnership. In terms of Polivy, yes, I do think those share gains are sustainable, and I think in addition, we will be releasing even additional data about combinations with Polivy. We set the standard of care 20 years ago plus with Rituxan. We set it again with Polivy and stay tuned.

Potentially, with the blood-based biomarker, you have the potential to greatly expand access. And, you know, for this to get into guidelines, it would need to have, uh, 90% negative predictive value. 90% positive predictive value with a 90% sensitivity and 90% specificity. If that's if that is achieved then absolutely. Uh, that becomes possible. So, that's how I characterize 217. Yeah. And I, I would say, you know, from, uh, from the

Bruno Eschli: Yeah. Also to remind you, we have our own first-line development program ongoing with Skyglo.

From the farmer standpoint. We're extremely excited to have these assays in the market. Um, because we do think this is 1 been 1 of the limiting factors to uptake, um, is that, you know, just getting proper diagnosis and being able to get those eligible patients in. So I think we're, we're super excited to have that partnership. Um, in terms of Olivia, yes, I do think those share gains are sustainable and I think, in addition, we will be, you know, releasing even additional data, um, about combinations with poly. So, um, you know, we set the standard of care, 20 years ago, plus, with for toxin, we sent it again with poly and

stay tuned.

Teresa Graham: Exactly.

Bruno Eschli: This is to come. The other thing is, I think if you look at all the recent study starts, they all have basically been building on Polivy regimen. I think this really tells you that this has been widely perceived as the standard of care in first line.

Teresa Graham: Exactly right.

Bruno Eschli: Which is a roughly CHF 2 billion opportunity, and I think we are really nicely tracking towards.

Teresa Graham: To that.

Bruno Eschli: this goal.

Teresa Graham: Exactly right.

Bruno Eschli: Justin, any other questions?

And also to remind you, we have our own first line development program ongoing with glow. Um, so this is to come. So um, the other thing is, I think if you look at all of the recent study starts, they all have basically been building on uh, uh, on on polyv regimen. So, I think this really tells you that this has been widely perceived as the as the standard of care line. Exactly. Right. Which is a roughly 2 billion opportunity and I think we are really nicely tracking towards um this this skill. Exactly. Right.

Justin Smith: No, that's great, Bruno. Thank you.

Justin, any other questions?

Bruno Eschli: Yep. We move on with Richard Vosser from JP Morgan. Richard.

Uh, know that, that's great for winner. Thank you. Yep. And um, we move on uh, with Richard Foster from JP Morgan with chips.

Richard Vosser: Thanks, Bruno. Couple of questions, please. Maybe on Hemlibra. Theresa, you talked about very strong growth across the world, but also seeing switches back from Altuviiio. Just wanted to think about the sustainability of those switches and how much that's contributing now. Just also, we're going to see a competitor come later this year. Just thoughts on how you defend against that, and what they could do to the growth, which is very good at the moment. Then the second question on Gazyva. You alluded to the impact from competition in CLL. Just could you give us a context of what sort of drag that could be for the rest of the year as we think about the rollout into lupus, just so that we can get an idea of the growth there? Thanks very much.

Thanks, Bernie. Um, a couple of questions, please. Uh, maybe on Hemlibra. Um, so as you talk about, uh, you know, very strong growth across, um, across the world, but also, uh, seeing switches back from Alivio. So I just wanted to think about the sustainability of those switches and how much that's contributing now and just also,

Teresa Graham: Yeah. Absolutely. Sort of exactly what we had thought was likely to happen with Hemlibra is what we're seeing happening, which is patients who were well-controlled on Hemlibra maybe were tempted to try Altuviiio. We see actually a very large percentage of patients switching back. It's around 30% of patients who went to Altuviiio have switched back. We do not see that trend have slowed down dramatically. The growth that Altuviiio is getting is really coming from other Factor VIII at this point. I think what it boils down to is that patients who are on Hemlibra have an incredibly high satisfaction with their therapy, and it's not uncommon that they switch back after time. This is a great therapy.

We think about the the roll out into uh, into lupus just so that we can get an idea of uh uh the growth there. Thanks very much.

Yeah, absolutely. So um

Sort of exactly what we had thought was likely to happen with hem. Libra is what we're seeing happening, which is, you know patients, um,

You know who were who were well controlled on hen Libra. Maybe we're tempted to try l2a. We we see actually a very large percentage of patients switching back. It's around, 30% of patients, who went to l2v have switched back, we do not see, uh, you know, we that that trend has um, have slowed down dramatically the growth. That l2v is getting, is really coming from other Factor AIDS at this point. Um, and so I think what it boils down to is that patients who are on him? Libra have an incredibly High satisfaction with their therapy and it's, you know, it's

Teresa Graham: It has changed the lives of many, many patients living with hemophilia, and I think we expected to see a lot of people come back, and that's exactly what's happened. We also know that Hemlibra has set a very high bar in the treatment of hemophilia, and we don't actually really see any clinical differentiation, to be frank, with Mim8. The efficacy profile doesn't look differentiated, in terms of ABR reduction and patients with zero bleeds. I mean, we do expect increased competition, but we are also doing things to benefit the patient experience of Hemlibra with the new injection kit, with the auto-injector that's in development. We remain confident that Hemlibra will continue to be the standard of care.

It's not uncommon that they switch back after time. So if that's this, this is a great therapy. It has changed the lives of many—many patients living with hemophilia. And I think, you know, we, we, we...

Expected to see a lot of people come back, and that is exactly, um, that's exactly what's happened. Um, we also know that hen Libra has set a very high bar in the treatment of Hemophilia and

Teresa Graham: That having said, we do believe that there will be competitive impacts in H2, and we took that into account when we gave the outlook for this year. As we are looking forward to NXT007, I think it is worth pointing out that we are the only people who have been brave enough to go up against that standard of care, raising the bar on ourselves yet again, by going head-to-head with Hemlibra with NXT007. I think we remain confident that we've got a great product on the market, and that we'll be bringing you the next generation here in the coming years. In terms of Gazyva, I think that the drag on the oncology side, it's probably a little too soon to tell. I'll have a better look for you as we get into H1.

We don't actually really see much clinical. We don't really see any clinical differentiation to be frank with MMA. Um, and so the efficacy profile doesn't look differentiated. Um, in terms of ABR reduction, patients with zero bleeds, I mean we do expect increased competition but we are also doing things to benefit the patient experience of heme Libra with uh, the new injection kit with the auto injector that's in development. And so, you know, we are, we remain confident. That heaven, Libra will continue to be the standard of care that having said, uh, we do believe that there will be competitive impact at the back half of the year and we took that into account when we gave the outlook for, uh, for this year. Um,

Teresa Graham: It's sort of been just enough to kind of tamp down, I think, what we think the initial uptake is in the immunology side of things. Again, it's earlier days, so maybe give us half a year, and then we'll be able to give you a better sense.

but as we are looking forward to next 007, I think it is worth pointing out that we are. The only people who are are, you know, have been kind of brave enough to go up against that standard of care. Raising the bar on ourselves yet again, um, by going head-to-head with, uh, hen Libra with next 007. So I think we're, um, yeah, I think we are, uh, we remain confident that we've got a great product on the market and that we'll be bringing you the Next Generation here in the coming years. Um, in terms of Gaza, I, I think that the, you know, that the drag on the oncology side. Um, it's probably a little too soon to tell I'll I'll have that have a better look for you as we get into half year. Um, you know, it's sort of been just enough to kind of

Thomas Schinecker: Yeah, I think it was launched in Q4 or something.

Tamper down. I think what we think the initial uptake is uh, in in the Immunology side of things. So again, it's it's earlier days, so maybe give us to half year and then we'll be able to give you a better sense.

Teresa Graham: Exactly. It's just a little soon to actually see the data in the market. That is what we're hearing exactly. They're just starting to get uptake.

Thomas Schinecker: One more comment on the Hemlibra to Bayer situation. I think what has also been driving switching back is that, just remember that Hemlibra doesn't cause any inhibitors, and I think this has been an issue constantly.

Teresa Graham: Yes.

Yeah, I think it was launched in the fourth quarter or something exactly. It's just a little soon to actually see the data in the market, but that it is exactly. They're just starting to to get uptake 1, more comment, um, on the H Libra 2v situation, I think what has also been driving switching back. Is that just remember, that doesn't cause any Inhibitors and I think this has been an issue.

Thomas Schinecker: Richard, any other questions?

Richard Vosser: No, that's perfect. Thanks, Bruno. Thanks, Theresa. Cheers.

Um, Richard, any other questions?

Teresa Graham: Yes, thanks Richard.

Bruno Eschli: Next one is Matthew Weston from UBS. Matthew?

No, that's perfect. Thanks, thanks. Thanks. Thanks, then. Uh, next one is Matthew Weston from UBS, have you.

Matthew Weston: Thank you, Bruno. Two questions, please, both on Giredestrant. Theresa, you laid out the market at the very beginning in your introductory comments. I'd be intrigued to know what proportion of ESR1 mutant patients you think already know their status. Because you talked about a strong launch. I can imagine it's even stronger in that late line population, but only if they know whether they're ESR1 mutant.

Thank you, Bruno 2 questions. Please both on durest.

Teresa Graham: Mm-hmm.

Matthew Weston: The second question on Giredestrant is a much more overarching one. I don't know whether it's for you, Theresa, or whether it's for Thomas. Based on the numbers you've laid out, you have one of the most exciting launches coming up in the next couple of years. Historically, breast cancer has been a setting where ex US and US have actually been quite balanced in terms of peak sales potential. Given MFN, how are discussions ongoing with European governments about the idea of accepting higher prices? Do you think we're going to see a rapid rollout of Giredestrant ex US as well as US?

Um, Theresa um, you laid out the market at the very beginning in your introductory comments, I'd be intrigued to know What proportion of esr1 mutant patients. You think already know their status cuz you talked about a strong launch. I can imagine, it's even stronger in that late line population. But only if they know whether they're esr1 mutant and then the second question on durest is a much more over overarching 1? I don't know. It to be you Theresa or whether it's for Thomas, uh, based on the numbers you've laid out, you have 1 of the most exciting launches coming up in the next couple of years and historically,

Ally uh, breast cancer has been a setting where xus and us have actually been quite balanced in terms of peak sales potential.

So given mfn how our discussions ongoing with European governments about the idea of accepting higher prices and do you think we're going to see a rapid roll out of durin xus as well as us?

Teresa Graham: I would say that within breast cancer, testing in breast cancer is actually quite high. In the more mature markets, I would say that it is pretty common that people would know what their statuses are. Therefore, I think that very much enables us with the strong launch. Thomas, do you want to take the grade or you want me to take it?

So I would say that within breast cancer, uh, testing in breast cancer is actually quite High. Um and so in in the more um in the in the more mature markets I would say that it is pretty common that people would know what their statuses are. Um and so therefore I think that that very much enables us uh with with the strong launch

Thomas Schinecker: Sure, I can do that.

Teresa Graham: Okay.

Thomas Schinecker: On the US, we know that we'll be on the market towards the end of the year. This is when we set the price in the US. Of course, we are already in discussions with politicians across Europe, and they do understand that there will be a change in terms of how these medicines will be priced in the future. The good thing is, it's not a one-step change because medicines that are already on the market are not going to be priced higher. It's just for new introductions. It's not a very rapid and steep increase in terms of spending that they have on medicines. I do believe what will happen is you will have more differentiation between those medicines that have extremely strong data and maybe medicines that don't have a strong data.

Or do you want me to take it? Sure, I can do that. So, on, uh, on the US, we know that we'll be on the market towards the end of the year. So this is when we set the price in the US.

Thomas Schinecker: I think with Giredestrant, that being, I think, one of the first molecules we have where we will go through this process, we're actually in a beneficial situation that we have very strong data. Especially the breast cancer space has also a lot of patient groups behind it that are very interested to get this to patients as quickly as possible. We are hopeful that with all of that we will get it to a point where we can get the right kind of pricing also in Europe. Mm-hmm. Very good. Matthew, did this answer your question?

But of course, we already in discussions, uh, with politicians across, uh, Europe, and they do understand that, um, there will be a change in terms of how these measures will be priced, uh, in the future. And, uh, the good thing is it's not a 1 Step change because, uh, medicines that already on the market are not going to be priced higher, it's just for new introductions. So it's not a very rapid and steep increase in terms of spending that they have on medicines. But I do believe what will happen is, you will have a more differentiation between those medicines that have extremely strong data and maybe medicines that don't have a strong data. I, I think what your death Trend, uh, that being I I think 1 of the first molecules we have where we will go through this process. We actually in a beneficial way, uh, beneficial situation that we have very, very strong data.

And, uh, you know, especially the breast cancer space has also a lot of patient groups behind it that are very interested to get this to patients as quickly as possible. So you know, we are helpful that's uh, with all of that that we will get it to a point where we can get the right kind of pricing also in Europe.

Mhm.

Matthew Weston: Thank you. Perfect.

Bruno Eschli: Yeah. Next questions go to Stephen Scala from Cowen. Steven?

Very good Mafia. That just sounds for your question. Thank you, perfect.

Yeah.

Stephen Scala: Thank you so much. I have three brief questions. First, it sounds like Roche still has confidence in the pionERA trial post failure of persevERA, and I'm just wondering what is the basis for that confidence? Second, why isn't Roche doing a cardiovascular risk reduction study of its IL-6 assets following in the footsteps of its competition? And then lastly, Thomas, I don't believe you have opened a diagnostics meeting in the past. I'm curious why the change this year. Thank you.

Then. Um, next question is go to Stephen Scala from

Teresa Graham: Just to reiterate, though persevERA didn't reach statistical significance at PFS, we did see a numerical improvement. We do believe that it's active in the first line setting. The reason that we continue to have confidence in persevERA is it's just being studied in a very different population than persevERA. Again, in that first line setting, context really does matter. We still believe that biologically, there's a very good rationale on why we work in persevERA. 20% to 25% of patients in that setting are ER mutated, and pionERA has enriched the ER mutation patients to 40%. Again, we're sort of designed to really uncover that signal. In terms of the IL-6 assets, don't assume that we haven't looked. I'll just say that, and I don't know who would like to take questions.

Thank you so much. I have 3. Brief questions first. It sounds like Rush. Still has confidence in the pioneer of trial, post failure of Pepa. And I'm just wondering, what is the basis for that confidence? Second? Why isn't rosh doing a cardiovascular risk reductions study of its il6 assets, following in the footsteps of its competition and then lastly Thomas I don't believe you have opened the Diagnostics meeting in the past. I'm curious. Why the change this year? Thank you.

So, just to reiterate, um, they'll persevere didn't reach statistical. Significance at PFS, we did see a numerical Improvement, so we do believe that it's active in the first line setting, um, and the reason that we continue to have confidence and perseverance is just being studied in a very different population than persevera. And so, you know, again, in that first line, uh, setting context, really does matter. And so we, you know, we still believe that biologically. There's a, there's a very good rationale on why we would work with um, with uh, in in persevera, um, 2020 20 to 25% of patients in that setting are er uh ER mutated and Pioneer has enriched CER mutation patients to 40%. So again we're

You know, we're sort of designed uh, to really uncover that signal.

Thomas Schinecker: Yeah, the last one I can do. Yeah, I just want to also reiterate, the reason for our higher confidence in pionERA is simply because it's enriched with ESR1 mutant population. If you look at the hazard ratio in past trials in this population, then you would understand, of course, why we have a higher chance on this one. Regarding the diagnostics, I did open Diagnostics Day before because I was the CEO of Diagnostics. It's the first time that I will actually open it when I'm not the CEO of Diagnostics.

Bruno Eschli: The way Bruno and I discussed it is that I would go once to the Pharma Day, once to the Diagnostics Day, once to Pharma Day, so that I just flip back and forth, and every time I give you more of a group update and would be available for questions in that setting as well.

Thomas Schinecker: The way Bruno and I discussed it is that I would go once to the Pharma Day, once to the Diagnostics Day, once to Pharma Day, so that I just flip back and forth, and every time I give you more of a group update and would be available for questions in that setting as well.

Teresa Graham: Yep.

Um, in terms of the aisle 6 assets, um, don't assume that we haven't looked. So I'll just say that and I don't know who would like to take questions. Yeah, the last 1 I can do. Yeah, I just want to also reiterate, uh, the, the reason for our, um, higher confidence in Pioneer is simply because we've, uh, it's enriched with esr1 mutants, uh, population. And if you look at the hazard ratio in past trials, in this population, um, then then uh, you would understand, of course, why we have a higher uh, yeah. Chance on this 1 and regarding the Diagnostics. I did open Diagnostics, they, uh, before because I was the CEO of that company, uh, but it's the first time that I will actually, um, open it when I'm not the CEO of Diagnostics. Uh, and uh, you know, the way Bruno and I discussed it is that I would uh, uh, go once uh, to the farmer day once the diet day, once the farmer day, so that I just the back and forth. And every time I give you more of a group update and uh, it would be available for questions in that setting as well.

Thomas Schinecker: Very good. Steve, maybe one comment on cardiovascular diseases. You might be reminded that we have other modalities we are focusing on. For example, we highlighted NLRP3 as one of our key targets, and we can imagine that we have also looked into IL-6 in that context. Any other questions?

Very good. Um, Steve, maybe one comment on cardiovascular diseases. You might, uh, be reminded that we, you know, have other, uh, modalities we are focusing on. For example, we highlighted NLRP3 as, uh, one of our, um, uh, key targets. And, uh, we can, um, imagine that we have also looked into IL-6, uh, in that context.

Stephen Scala: May I assume, since you've looked, can we assume that you looked and the trials were not successful?

Um, any other questions?

may I assume since, uh, you've looked

Teresa Graham: All I'll say is just don't assume we haven't looked.

Can we assume that you looked in the trials were not successful is?

Stephen Scala: Okay. Thank you.

I would all I'll say, is just don't assume we haven't looked

Okay, thank you.

Bruno Eschli: Okay, we have next in the row Michael Leuchten from Jefferies. Michael, please.

Michael Leuchten: Thank you, Bruno. Two questions. One question, one clarification. The FDA's increased level of disclosure seems to be triggering some petitions for label changes, and I think Ocrevus is one of them. I just wondered if you could talk to the process here, timelines. Is this something that you think is going to happen more broadly, and how long does it take to get some clarity on that? Clarification question for Theresa, please. Just going back to the comment on Vabysmo US returning to growth. The revenues sequentially aren't. There's 3% growth in Q1. It was 7% in Q4. When you say returning to growth, what's the variable that you're looking at that gives you that lead indicator that we're seeing that?

Okay then um, we have uh next in the row. Michael lawston from Jeff Michaels, please.

Teresa Graham: Yeah. In just speaking to Vabysmo first, I mean, we saw a 4% increase in the US, but we saw a more significant volume increase. Again, this is a highly contracted market, so those things can sometimes look a little bit different. We're also seeing the unbranded use of Avastin start to trickle down. That's another thing that kind of gives us confidence that the branded market may be coming back or is coming back. In terms of the FDA, I assume that you're talking about the letter that was published by the British Medical Journal. Is that what you're referring to?

I think it's going to happen, more broadly. And, and how long does it take to get some clarity on that? Uh, and then clarification questions for Teresa please. Um, just going back to the comment on the US returning to growth. The, the revenue sequentially aren't so. There's 3% growth in q1. It was 7% in Q4. Um, so when when you say returning to growth, what what's the variable that you're looking at, um, that gives you that lead indicator that we're seeing that? Yeah, so in just speaking to, oh, speaking to the biso first, I mean, we saw a, a 4% increase in the US, um, but we saw a more significant volume increase. So again, this is a highly contracted market. So, you know, those, those things, um,

Can sometimes. Look, look a little bit different. We're also seeing the um the uh, unbranded use of of vast and start to trickle down. So that's another thing that kind of gives us confidence.

The Branded Market may be coming back or is coming back. Um in terms of the FDA I I assume that you're talking about the letter that was published by the the British Medical.

Michael Leuchten: Yeah, that's correct.

Teresa Graham: On PPMS? Yes. I just want to be really clear that Ocrevus and PPMS has been used in 450,000 patients since it was approved. We have 1.4 million patient years of exposure. We are approved in 130 countries. This is an approval that KOLs and patients in the FDA are not questioning. We believe strongly in the benefit and the safety of Ocrevus in the PPMS population. That was reinforced with the ORATORIO-HAND study, which was just released in September of last year, which is not at all mentioned in the letter that you're referring to. I think we have an incredible level of confidence in the benefit and the safety of Ocrevus and PPMS. I will leave it there.

Journal. Is that what you're referring to? Uh, yeah. That's correct. Um, PPS. Yes. So I I just want to be really clear that, you know, okra and ppms has been used in, uh, 450,000 patients since it was approved, we have 1.4 million patient years of exposure. Um, we are approved in 130 countries. Um, this is an approval, that Ko's and P

Bruno Eschli: Maybe just, Michael, one add-on, on the Vabysmo side, how are we tracking our performance? I think if we just zoom in on the branded segment and exclude all biosimilars which are in the market, then I think we still keep gaining shares in all the indications, and that's a picture I think you can see globally. The run rate of share gains versus the other branded competitor in the market, I think is very constant quarter over quarter.

Bruno Eschli: It's exactly correct.

Teresa Graham: It's exactly correct.

Bruno Eschli: I think we are reasonably confident.

Teresa Graham: Exactly correct.

Bruno Eschli: Yeah.

Bruno Eschli: That is, by the way, we continue to hear every time we poll KOLs, that hands down, Vabysmo is seen as the most efficacious drug that they have in their armamentarium.

Patience, uh, in the FDA are not questioning, um, we believe strongly in the be the, the benefit and, and the safety of okras in the ppmf population, that was reinforced with the Ohan study, which was just released in September of last year, which was not at all, mentioned in in the letter that you're referring to. Um, so I think we have an incredible level of confidence in the, uh, the benefit and the safety of ocherous and uh ppms. Um, and I will leave it there. Maybe just Michael 1 add-on on the device, no site. Um, how are we tracking our performance? I think, um, if we just zoom in on the brand the segment and exclude all um biosimilars which are in the market, um then I think we still keep gaining shares in all the indications and that's the picture. I think you can see globally and the Run rate of share gains versus the other branded competitors. On the market I think is very constant, a quarter of a quarter. Exactly. So I think therefore, I think we are uh reasonable confidence. Exactly correct.

Bruno Eschli: Yep. Any other questions, Michael?

And that is, by the way, we continue to hear. Every time we we pull Ko's. Um, that hands down the biso is seen as the most efficacious uh, drug that they have in their armor material. Yeah.

Michael Leuchten: No, thank you.

Bruno Eschli: Yep. We come to the final questions, which go to Rajesh Kumar from HSBC. Rajesh, please.

Any other questions Michael? No, thank you.

Yeah, and uh, we come to the final questions. Um, which go to rajeshkumar from HSBC? Rers, please

Rajesh Kumar: Hi. A couple of questions, if I may. First is on the breast cancer opportunity, obviously a very exciting opportunity for you on giredestrant. Your oncology portfolio looks a bit light on the pipeline side. Would you think about or talk us through how you're thinking about capital allocation to augment your oncology portfolio going forward? Definitely interested in understanding if you need to add something more there to utilize your strong position in the market. Second is on the obesity clinical trials. What we have seen more recently is the patient churn increases once patients work out they are not on an active arm. When you're thinking of your phase 3 trials, would you consider running active control trials for registrational purposes to ensure patient churn is not very harsh and you have credible data? Or have you found a workaround that would be very interesting to hear your thoughts?

Hi, uh, couple of questions if I may. Uh, first, if on, uh, breast cancer opportunity—obviously, uh, very exciting opportunity for you on Jestar, your, uh, oncology portfolio. Uh, looks a bit light on the, you know, uh, pipeline side. Uh, would you—

Think about, or talk us through, how you're thinking about capital allocation to augment your oncology portfolio going forward. Definitely interested in understanding if you need to add something more there to, you know, utilize your strong position in the market.

second is, uh, on the Obesity clinical trials, uh,

Uh what we have seen more recently is, you know, the patient Journey increases once patients, work out, they are not on an active arm.

and when you're thinking of your phase 3 trials, you know,

Rajesh Kumar: As always, being an analyst who can't count, the third question is AI. Totally appreciate your excitement around NMEs. If you can help us understand where in the financials will we start seeing the benefit of AI, would it be in R&D intensity, SG&A intensity in the next 3 to 5 years? That would be much appreciated. Thank you very much.

Would you consider running active control, trials, uh, for registration purposes? To ensure patient churn is not very high and you have credible data, or have you found a workaround? That would be very interested in hearing your thoughts.

And as always, being an analyst who can't count, uh, the third question is AI to totally appreciate your, uh, you know, excitement around enemies. Uh, if you can help us,

Uh, understand where in the financials, will we start seeing the benefit of AI? Would it be in R&D intensity FTA intensity in the next 3 to 5 years? That would be much appreciated. Thank you very much.

Thomas Schinecker: Okay. You want me to start?

Teresa Graham: Yeah, sure.

Thomas Schinecker: First, let me start on the capital allocation. We have the five therapeutic areas that we're active in, and we continue to look for opportunities in all of those therapeutic areas that fit in terms of, from a scientific perspective, if we believe that it can be a medicine that could be best in class or first in class. At the same time, we also look at the financials, and the two things have to come together. We want to make sure that we are not in a situation that we overpay for some of these assets. I think the combination is very important. Especially in oncology, what we have seen sometimes is that there has been quite large amounts of money being paid for very early-stage assets. We keep working on that. We brought in CDKs. We brought in a number of different ADCs.

Uh, first, uh, let me start, uh, on the capital allocation.

um,

we have the the bio therapeutic areas that were active in and we continue to look for opportunities in all of those therapeutic areas that fit in terms of, you know, from a from a, from a scientific perspective. If we believe that it can be a medicine that could be best in class or, or first in class.

um, in the same time we also look at the financials

Thomas Schinecker: You see, we keep evolving also our oncology pipeline, but we are also disciplined, right? The reason is, there's just many more opportunities than money. If you don't get an opportunity where you pay a couple of billion, I can tell you will get another opportunity that may be as good or even better for less money. You need to keep looking. What I can say is we look at everything. Everything that goes across the table, I can tell you we've looked at it and we've made our own assessment on it. On AI, we believe that AI will really impact us across actually all of our cost lines. We already utilize AI in manufacturing.

And the 2 things have to come together. Uh, we want to make sure that we are not in a situation that, uh, we overpay, uh, for for some of these assets. And, uh, I think the combination is, is very important. And especially in oncology what we have seen sometimes is that, uh, uh, there has been quite large amounts of money being paid for very, very early stage, uh assets. Um, so we keep, uh, working on that. We, we brought in cdks, we brought in a number of different adc's, so you see, we keep evolving also our oncology, uh, pipeline, but we also disciplines, right? And the reason is, there are just many more opportunities than money. So, um, there, there, you know, if you don't get an opportunity where you pay a couple of billion, uh, I can tell you you will get another opportunity that maybe as good or even better uh, for less money. And so you you need to keep looking. But what I can say is we look at everything.

So everything that goes across the table, I can tell you we've looked at it and we've made our own, uh, assessment on it on AI.

Thomas Schinecker: We use AI to really reshape processes in our organization, where we take processes that in the past would take maybe months. We try to limit that to weeks or even days. We've seen that also across the entire R&D spectrum. This is more, I would say, manual work that people have done in the past, where we can really automate that in a much better way. You can really start to see that happening across the organization. That's why I believe it's going to happen everywhere. It's going to happen or it is happening also on the commercial side. Where the big disruptive opportunity is, I believe in AI, is to really change on how fast we do drug development and also how many molecules we can screen. With these virtual models, you can screen through many more molecules.

So, we believe that AI, um, will really impact us, uh, across actually, all of our cost lines. So we already utilize Ai and Manufacturing, uh, we use AI, um, to really reshape processes in our organization where, uh, we take, you know, processes that in the past will take, maybe months. We try to limit that to, to weeks or even days, and we've seen that also across the entire R&D Spectrum. So this is more. I would say manual work that people have done in the past where we can really automate that in in a in a very in a much better way. So you can really start to see that happening across the organization. And that's why I believe it's going to happen everywhere. It's going to happen or is it is happening. Also on the on the commercial side, where the big disruptive opportunity is, I believe in AI, it's a really change on how fast uh, um, we do drug development and also how many

Thomas Schinecker: You look deep into some of those. You test them in the wet lab. You feed back the data, and this is what we call lab-in-a-loop. You can really continuously build up these models, and these are proprietary models. It's not something that other companies have, and where we believe we're quite far ahead compared to other companies. As we continue to build these models, you will see increasing benefits over time. From a process perspective, we already see some of the benefits in the organization, and we'll continue to see more benefits. In fact, we've trained 100,000 people on AI. It's something we call Everyday AI. We've trained everyone using AI tools, and feedback has been really amazing. People can really see the productivity benefits in their daily work.

Molecules work in screen, um, with, uh, these virtual, uh, models. You can screen through many more molecules, then you look deep into some of those, you, uh, test them in the wet lab, you feedback the data. And this is what we call lab in the loop, and so you can really continuously build up, uh, these models. And these are proprietary models, it's not—

Something that other companies have and where we believe we're quite far ahead compared to other companies. And as we continue to build these models, you will see increasing benefits over time. But from a, from a, from a process perspective, we already see some of the benefits in the organization and we continue to see more benefit. In fact, we've trained 100,000 people on AI

Alan Hippe: Yeah, let me quickly add here. We are also, how should I say, we are investing heavily into our data infrastructure anyway. I think really we have a huge ERP program running. Why do I say this? Because that will facilitate the use of AI moving forward as we will have the whole data in the cloud, that we can really tap into this much more easily than we could in the past.

It's something we call every day. We've trained everyone using AI tools and, you know, feedback has been a really amazing. People can really see the productivity benefits in in, in the daily work.

Teresa Graham: To answer your final question, as I indicated earlier, placebo-controlled trials are still mandated by the FDA. That is why we run them. Obviously, for anybody running large placebo-controlled trials, patient retention is quite key. We have a broad suite of patient retention tools and strategies designed to help keep patients in the CT-388 studies. For obvious competitive reasons, I won't say more.

Yeah, let me quickly add here. We also, how should I say we are we're investing heavily into our data infrastructure anyway, I think really we have a a huge EF program running. And why do I say this because that will facilitate the use of AI moving forward, as we will have the whole data in the cloud. You know that we can really tap into this. You are much more easily than because in the past

Alan Hippe: I think we had a third question, which was, is our next M&A deal an oncology deal? I think I translated this question, decoded this question.

And to answer your final question, um, as I indicated earlier, Placebo control, trials are still mandated by the FDA. So that is why we run them. Um, obviously for anybody running large receiver control, trials. Patient retention is quite key. We have a number of um uh we have a have a broad Suite of patient, retention tools and strategies to design to help keep patients in the. Uh, the CT 388 studies. Um, and for obvious competitive reasons, I won't say more

I think we had a third question, which was is our next. Um, m&a deal, uh, an oncology deal.

Thomas Schinecker: Honestly, I don't know.

Teresa Graham: That's another tricky question.

Alan Hippe: I don't know what our next deal is. We will find out. Yeah. Are we looking for opportunities? Thomas said it. Happy to do that. You know how that is. It takes two to tango, and the question is, who will be our next partner to do a great deal?

Thomas Schinecker: We're looking at all therapeutic areas.

Bruno Eschli: Yeah. With that, I think we have closed the Q&A session. I hand back to Thomas for the final words.

Thomas Schinecker: Yeah. Thank you very much for attending today's call. As you can see, we have continued strong sales momentum as we had over the last couple of years. Based on some recent readouts that we have seen, this gives us much more confidence also in the short to mid-term that we can continue good growth outlook there as well. You've also seen that we have between 27 and 30 opportunities to launch up to 19 NMEs. That's the status today. We continue to work on M&A so that we can increase the number in that time period, but this is really substantial, and many of those have a lot of value attached to them. That also gives us confidence in the longer-term growth outlook of the company. All I can say is you can count on us, and we will deliver.

Yeah, thank you very much for attending today's call. Uh, as you can see we have continued strong sales momentum as we had over the last couple of years and uh, based on some recent readouts that we have seen. Um, this give us a much more confidence. Also in the short to, to Mid midterm that we can continue uh, good growth Outlook there as well. Uh, and you've also seen that we have between 27 and 30, the opportunity to launch up to 19 enemies that status today, we continue to work, uh, on m&a. So that we can increase the number in that time period. But this is really substantial. And many of those have a lot of value attached to them. So that also gives us confidence in the longer term, uh, growth Outlook of the company.

All I can say is, you can count on us, and we will deliver.

Rajesh Kumar: Goodbye

goodbye.

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