Q2 2025 Roche Holding AG Earnings Call

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Thomas Schinecker: So let me kick it off on this slide. So overall, our group sales increased by 7%, so very strong growth by pharma with 10%. In fact, if you look at the momentum in Q2, pharma even grew by 11%.

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Thomas Schinecker: Diagnostics was flat, so very similar to what we saw in the first quarter. And this is purely due to the China healthcare pricing reforms. Without those pricing reforms, diagnostics grew 6% in the first half of the year, so in line with past expectations.

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Thomas Schinecker: But what's even more exciting is the strong bottom line performance, with co-operating profit growing 11% and thereby our co-operating margin increasing by 1.1 percentage points in core EPS, even going faster at 12.5%.

Thank you very much and, uh, good morning, good afternoon or good evening uh whoever you are. I'm really happy to talk to you about our half year results which have been extremely strong.

Thomas Schinecker: Also, we want to update our full year LOE impact guidance, which we are now lowering to $1 billion instead of the $1.2 billion. In the second quarter, we had a number of key milestones. Among others, the EU approval of EITOF-B, and also the US approval of SOSIMO. We had mixed results with AstraZeneca.

Thomas Schinecker: One positive study, one negative study, and Teresa will talk to you more about that.

Speaker Change: So let me kick it off on this slide. So overall our group sales increased by 7% so very strong growth by farmer with 10%. In fact, if you look at the momentum in Q2 farmer even grew by 11% Diagnostics was flat. So very similar to what we saw in the first quarter and this is purely due to the China Healthcare pricing reforms without those pricing reforms uh diagnostic screw 6% in the first half of the year so in line with past expectations

Thomas Schinecker: And there have been a number of Phase 3 decisions that have been taken. One is Prazi in Parkinson's disease.

Thomas Schinecker: Also here, Teresa will talk to you about that. And she will actually be able to share the Opal label extension data with you on which basis we made the decision to take that into the Phase 3. But also SOSO as a potentially new antibiotic for gram-negative bacteria. This would be the first in 50 years. So for this year, we've taken four medicines into Phase 3, the number to come. So you can see that we are really refilling the pipeline of new medicines. And it's going to be an exciting year for that with between 8 to 11 medicines moving from Phase 2 to Phase 3, all post-bar and all with the data that supports this move.

Speaker Change: but what's even more exciting is the strong bottom line performance with cooperating profit growing 11% and thereby, our cooperating margin increasing by 1.1 percentage points in core, EPS even growing faster at 12%.

Speaker Change: Also we want to update our full year uh LOE impact guidance uh which we are now lowering to 1 billion instead of the 1 uh 2 billion.

Speaker Change: in the second quarter, we had a number of key Milestones uh among others, the EU approval of it to be uh and also the US approval of CMO

Thomas Schinecker: On the diagnostics regulatory side, we also had two approvals, and Matt will talk to you about that. There's also more significant news flow ahead this year, which we'll keep you updated on.

Thomas Schinecker: Now, let's look at the overall numbers. Again, 7% is very strong growth for the group, but really driven by pharmaceuticals, I already mentioned diagnostics. And this is in line with the performance that we've shown over the last two and a half years. In fact, if you look at the last two and a half years, starting in 23, when we had to phase out epidemic sales, which at one point in time was 12% of our sales, we managed to do that by having very strong growth of 8% during that time period. And even since then, if you look at basically the last two years, we've been growing at the average rate of 8%, as you can see here on the right hand side.

Speaker Change: Uh we had a mixed results with us the GMA 1 positive study 1 uh negative study and Theresa will talk to you more about that and there have been a number of face 3 decisions that have been taken. Um, 1 is prazi in Parkinson's this uh, disease. Also here at Teresa, will talk to you about that and she will actually be able to share the Opel label. They uh, exemption data with you on which basis. We made the decision to take that into into the phase 3 but also so. So as uh potentially new antibiotic for gram negative bacteria, this would be the first in in 50 years. So for this year we've taken 4 medicines into phase 3, the number to come. So you can see that we are really refilling, the pipeline of uh new medicines and it's going to be exciting year for that with between 8 to 11 medicines. Moving from place to place 3, all post bar and all with

Speaker Change: With the data that supports this move.

Speaker Change: On the Diagnostics regulatory side. We also had 2 approvals and Matt will talk to you about that. There's also more significant news flow ahead this year, uh, which will keep you updated on

Thomas Schinecker: Now, the last quarter, there has been an impact in diagnostics, as we mentioned, and this impact should get lighter for us towards the end of the year, because some of this impact already happened in Q4 last year.

Thomas Schinecker: For more information visit www.FEMA.gov Now, let me talk you through a couple of growth drivers. Let me start with Babaismo, which continues its very strong momentum. Babaismo is growing at 18%, so 17% of the overall ophthalmology growth, and we continue to gain market share in the branded market of about 3 percentage points.

Thomas Schinecker: At the same time, we see a contraction of the overall market because of less funding in the United States. Xolair continues to do extremely well with an amazing momentum, and now more than 60,000 patients on this medicine in the United States. Also, in oncology, we continue to do well with 7% growth.

Thomas Schinecker: We have the EU label update for administration outside the hospital for Physco. The center keeps expanding as well. And also on the hematology side, we have now for Poly-V and in first-line DLV-CL, patient share is now reaching 33%. And we continue also to drive expansion of Columbi and Lansumio, and I'll get back to Columbi a little bit later. Also, Hemlibra continues to do well, and we have the next generation Hemlibra in-house, and I know also Teresa will share some data on that. The neurology portfolio, where we are the global leader, continues to do well as well with 10% growth.

Speaker Change: Now, let's look at the overall numbers again 7% is very strong growth for for the group but really driven by Pharmaceuticals. I already mentioned Diagnostics and this is in line with the performance that we showed over the last 2 and a half years. In fact, if you look at the last 2 and a half years, starting in 23, when we uh, had to phase out the epidemic sales, which, at 1 point in time, were 12% of our sales we managed to do that, by having very strong growth of 8% during that time period. And even since then, if you look at, uh, basically the last 2 years we've been growing at uh the average rate of 8%. Um as you can see here on the right hand side, now the last quarter it has been an impact in Diagnostics as we mentioned and this impact to get lighter uh for us towards the end of the year because some of this impact already happened in Q4 uh last year.

Thomas Schinecker: Okavos with a good momentum, we received J codes for the subcut version 1st of April, of course, with only every six months dosing of Okavos patients. It's going to take a little bit until we see that in the numbers, but we are confident in our outlook on Okavos and the additional revenue that we can achieve by adding the subcut version on top.

Thomas Schinecker: Also, as I mentioned, we received the EU approval for the tablet formulation. We're very confident in our growth over the next couple of years because we have a very strong momentum in our on-market portfolio. And we also know that we have a number of key readouts coming in the 27 to 29 timeframe, all of which are driven by a strong phase 2 data and post-bar. And so we're very confident that we can continue our strong momentum even beyond this decade.

Speaker Change: Lbl patient shares now, reaching 33%, and we continue also to drive expansion of column B and, uh, lumio and I'll get back to column v a little bit later.

tosa: Also him, Libra continues to do well, and we have the Next Generation and Libra in-house. And I know also tosa will share some data on that.

Thomas Schinecker: And there are a number of pivotal enemy readouts that are still going to happen this year.

Thomas Schinecker: Now, let's look at some of the product highlights.

tosa: The uh neurology portfolio, where we are the global leader, uh, continues to do well as well with 10% growth occurs with a good momentum. We received J code for the subcut version. First of April, of course with only every 6 months, dosing of octopus, patience. It's going to take a little bit until we see that in the numbers, but we are confident in our outlook on okko's and the additional Revenue that we can achieve by adding the sub Cuts version on top.

Thomas Schinecker: And let me start with diagnostic. As we mentioned before, last year was really an historic year in terms of launches for diagnostic, but we have more to come. The sequencing solution will be launching next year, and here we have a solution that can really be disruptive in terms of throughput, in terms of cost precision, in terms of speed and accuracy. And I know Matt will talk to you more about some recent data that will support that view. And so we are very excited to get ready for this launch. When we already have first customers which are using this instrument in early access on the Acrotech smart guides The CGM solution we launched that last year and we're continuing to ramp up here in Manufacturing and also mass spectrometry we launched end of last year.

tosa: Also, as I mentioned, uh, very briefly we received the EU approval for the tablet formulation.

tosa: Uh, we're very confident in our growth over the next couple of years because we have a very strong momentum in our on Market portfolio. And uh, we also know that we have a number of key readouts coming in the 27th to 29th time frame, all of which are driven by a strong Phase 2, uh, data and post bar. And so, we're very confident that we can continue our strong momentum. Even Beyond, uh, this decade and then number of pivotal enemy results that are still going to happen this year.

Thomas Schinecker: So again, very good momentum and we're bringing new Reagents to the mass spec so we'll see this momentum increase even more Now, all of those three are really for us new segments and segments that will enter us into markets that are multi-billion. So you could say in terms of pharma kind of language, this is all of these would be kind of blockbusters on the pharma side. And also on the essay side, we continue to make good progress.

tosa: Now, let's look at some of the product highlights and let me start with Diagnostics. Um, as we mentioned before last year, was really an historic year, in terms of launches for Diagnostic, but we have more to come. The sequencing solution will be launching uh, next year. And here we have a solution that can really be disruptive in terms of throughputs, in terms of cost position in terms of speed and accuracy. And I know, Matt uh, will talk to you more about some recent data that will support that you and so we are very excited to get ready for this launch.

Thomas Schinecker: And I know also Matt will cover this specific essay, which we have in our pathology.

Thomas Schinecker: On the pharma news flow, just again to highlight Itofi with the EU approval, Prazi and Sozo with the transition into phase three.

Thomas Schinecker: A couple of updates on the other programs, Tiro Golema, we already stopped all we could in the middle of last year because we knew that these programs are likely not going to be successful. We just let the rest run out. And it's confirmed our decision really to do that last year because we can really see that there is no impact of this antibody.

tosa: Um, when we already have first customers, which are using uh this instrument in Early Access on the aitech smart guides, uh the CGM solution, we launched that uh last year and we're continuing to ramp up here in in manufacturing and also Mass spectrometry, we launched uh, end of last year. So again, very good momentum. And we're bringing new uh, reagents to the mass back. So we'll see this momentum increase even

Thomas Schinecker: On the Columbia side, let me just say, we now have 35 countries in the world that have approved this therapy. The data is very strong in terms of the hazard ratio and the benefits to patients compared to standard of care. And it's also in the U.S. NTCN guidelines. So even though we received a CRL based on the ODOC decision that happened a couple of weeks earlier, we are confident in this medicine, and we are confident also that this will get used also in the United States based on these guidelines.

tosa: Now, all of those 3 are really, uh, first new segments and segments that will enter us into, uh, markets that are multi-billion. So you could say, in terms of farmer, uh, kind of language, this is, uh, all of these would be kind of Blockbusters, uh, on the, on the farmer side and also on the S side, we continue to make good progress. And I know also,

tosa: Will cover the specific, uh essay, uh, which we have in our pathology business.

Thomas Schinecker: As Gholabab already mentioned, and in Levitas I know also Teresa will go into that. Also here, we are very convinced of the risk-benefit profile of that gene therapy in ambulatory patients. There are 760 patients in the world in this patient group, and this is the only therapy that is available for these patients. These young boys otherwise had no treatment option. And if you talk to KOLs, if you talk to patients who have received this, they are very much convinced of this gene therapy. So we hope that between Sarepta and the FDA, they will find solutions that patients can continue to receive this kind of treatment.

tosa: On the farmer news flow, uh, just again to highlight it, Toby with the EU approval py and this also with the transition into into phase 3, um, a couple of updates, uh, on on the other programs, Tira golma, we already stopped all we could uh, in the middle of last year, because we knew that these programs are likely not going to be successful. We just let the rest run out and it's confirmed our decision really to do that last year because we can really see that there is no impact uh uh of this of this antibody.

tosa: Um, on the column we side, let me just say, um, we now have 35 countries in the world that have approved this therapy. Um, the data is very strong in terms of the hazard ratio and the, uh, benefits the patients cam compared to standard of care. Um, and it's also in the US entity and guidelines. So even though we received, uh, a, uh, crl based on the Odo decision that happened, uh, uh, a couple of weeks earlier. Um, we are confident in this medicine and we are confident also that this will get used to also in the United States based on these guidelines.

Thomas Schinecker: Let me just quickly talk about Phase 3 GO decisions. And we always said in the beginning of this year, this is going to be a very important year in terms of refilling our late-stage pipeline. We already have four. There will be probably four coming towards the rest of the year, maybe even more. And this will be a record for us in terms of how many new medicines go into the late stage. NXT-007, this is an antibody that's using the recycling technology of Chugai and has a higher level of efficacy. Trantinamab, I think we talked about that many times, about the unique possibility to use brain shuttle technology to get the antibody into the brain with a very low level of side effects.

Speaker Change: Uh, I already mentioned an elevator. I know also Teresa will go into that. Also, here we are very convinced of the risk benefits profile of that, uh, gene therapy in ambulatory patients. There are 760 patients in the world. In this, uh, Patient Group and this is the only therapy that is available for these patients.

Speaker Change: Convinced of this gene therapy. So we hope that between sapta and the FDA, they will find Solutions uh, that uh, patients can continue to receive the sign of treatment.

Thomas Schinecker: Prozi, I know Teresa will talk about that, and I already mentioned SOSU, which is also very important because we know that there will be a next pandemic, and one of the next pandemics could be a bacterial pandemic.

Thomas Schinecker: Let me also talk about R&D excellence.

Thomas Schinecker: And I know that you will get a much deeper and extensive update at Pharma Day. But over the last two and a half years, we have consistently applied the bar across our portfolio. That means we've attrited some of the molecules that were higher risk and lower value. And we've substituted that with more higher value assets. And we generated more data and complemented that also with external innovation. One of the goals that we've had is to increase the share of best indices potential to 80%. And we are in good progress to achieve that. We moved from 58% to 67%.

Thomas Schinecker: And also by doing this pipeline prioritization, what also happened is that we increased the average peak sales per pipeline project. So this is not per NME. This is per pipeline project. So per NME, it can be much more substantial than that, which is an increase of 55 percent. And if we look at the total value of our portfolio in this time period, it's increased by 26 percent. And it's our commitment that we will continue to do that and continue to only move forward projects where we believe these potentials are there. But we, of course, know that in pharma, some of the development times are, you know, for example, late stage, three to four years.

Let me just quickly talk about uh, phase 3, gold stations. And we always said, in the beginning of this year, this is going to be a very important year in terms of refilling. Our late stage pipeline, we already have 4. There will be probably 4 coming, uh, towards uh, the rest of the year, maybe even more, and this would be a record for us, in terms of how many new medicines going into the late stage, NXT series 07. Um, this is a antibody that's, uh, yeah. Using the recycling technology of 2 guy and has a higher level of efficacy, uh, trans Cinema. But I think we talked about that many times about the unique uh, possibility to use brain cell technology to get the antibody into the brain. With a very low level of side effects proy. I know Theresa will talk about that and I already mentioned. So, so which is also, uh, very important because we know that there will be an next pandemic and 1 of the next pandemics could be a bacterial pandemic.

Speaker Change: Let me also talk about R&D excellence and I know that you'll get a much deeper and expensive update at the farmer day. But over the last 2 and a half years, we have consistently applied the bar across our portfolio. That means we have a treated. Some of the molecules that were higher risk and lower value, and we've substituted that with more higher value assets. And we generated more data and complimented that also with external innovation.

Speaker Change: 1 of the goals that we've had is to increase the share of best disease potential to 80% and we are in good progress to achieve that we move, completely 58% to 67%,

Thomas Schinecker: So some of the molecules, like, for example, astigalumab, were pre-BAR era.

Thomas Schinecker: Now, let me also talk about one other aspect that's really important, and it's about resource reallocation. You saw probably in the slide deck that we kept our R&D spending flat, but that doesn't mean that we don't have massive reallocation going on inside. You can see that as a swan kind of on the lake, and we're doing a lot of work, but it may look very calm, but I can tell you there's a lot of reorganization and reshuffling going on. In total, we've been able to save about $1 billion. The goal by 2030 is around $3 billion in savings that we can reallocate into our business.

Speaker Change: And also, by doing this pipeline prioritization, but also happens is that we increase the average Peak sales pipeline project. So this is not for enemy, this is per pipeline project. So per enemy, it can be much more substantial than that, which is an increase of 55%. And if we look at the total value of our portfolio, in this time, period, it's increased by 26% and it's our commitment. Then we will continue to do that and continue to only move forward projects where we believe uh, these potentials are there but we, of course, know that the farmer some of the development times are, you know, for example, in the late stage, 3 to 4 years. So some of the molecules like, for example, as the goab were pre-b bar error,

Thomas Schinecker: We do that, for example, by we reduced the number of CROs we're working with. We used to work with 12. We're now working with three. We renegotiated those contracts. We renegotiated contracts in research. We take out manual work in different parts of the organization by implementing AI. We reduce the system landscape and simplify the organization. So we do a lot of things to really cut out costs so that we can fund the external innovation, which you see here, so that we can fast track certain programs, but also that we can implement new systems, which make the work that our people do much more effective and cost efficient.

Now, uh, let me also talk about uh, 1, other aspect, that's really important and it's about resource 3. Allocation, you saw probably in, in, in the slide deck that we kept our R&D spending flat, but that doesn't mean that we don't have massive reallocation going on. Uh, inside. You can see that as, you know, a small kind of on the lake and we're doing a lot of work, but it may look, uh, very calm. But I can tell you there's a lot of reorganization and and reshuffling going on.

Thomas Schinecker: And this reinvestment, with that, we managed to fast track a number of key assets, like a FIM keyboard, which we accelerated significantly, CT388, which we also accelerated from TINEMAP. When we look at the cycle times that we now have, we've managed to get now a cycle time acceleration of a total of about 11 months. So we are in the excellence. The goal is, of course, much higher by 2030. But this is in a time period where, if you look at the average industry cycle times, they have actually increased. It's very important to also reinvest some of the money into key productivity initiatives, creating new systems, automation and AI, so we can take out costs out of the system.

Thomas Schinecker: Now, let me talk about the guidance. I already mentioned the LOE impact, which we assume is going to be less. The group sales growth, mid-single digit, core EPS, high single digit. Of course, the first question is, well, if you're growing seven percent already in sales, your core EPS is growing by 12 percent. Aren't you being conservative? I would say our reputation is to be conservative. And we also know that we have a lot of geopolitical turbulences these times. And so what we said is we're going to observe the situation. Obviously, we're tracking very well if you compare it to the guidance.

We take out manual work in different parts of the organization by implementing AI, we reduce the system landscape and simplify the organization. Uh, so we do a lot of things to really cut out cost so that we can fund the external Innovation which you see here so that we can Fast Track certain programs but also that we can Implement new systems which make the work that our people do, much more effective and cost efficient and this reinvestment with that, we managed to Fast Track. A number of key assets like a SIM card which we accelerated significantly. CT 388 which we also accelerated from Up.

Um, when we look at uh, the cycle times that we now have, we managed to get uh, now a cycle time acceleration of a total of about 11 months to are in the Excellence. The goal is of course, Much Higher by 2030 but this is in a time period where if you look the average industry cycle times, they have actually increase

Thomas Schinecker: And we have the opportunity to revisit that decision in the next couple of months. Let me say also that, Roche, in our history, we've never missed the guidance. And if you look at the last three years, we've exceeded our guidance every year, including we also raised the guidance last year. So, of course, we want to continue to deliver and I can promise you we will continue to deliver. And so whatever happens in terms of the U.S., we will continue to deliver.

and it's very important to also reinvest some of the money into key productivity initiatives, including new systems.

Automation and AI so we can take out costs out of the system.

Thomas Schinecker: With that, thank you very much. And I hand over to Alan.

Alan Hippe: Yeah, thanks, Thomas.

Alan Hippe: Yeah, hi to everybody. Thanks for coming in. Hope everybody's fine.

Alan Hippe: Very pleased with with the results that I have the pleasure and the honor to provide you and especially with the operational performance that we that we can show.

Alan Hippe: Well, I want to talk about the results. So the P&L, I think a couple of points and on the on on the cash and on the balance sheet. And certainly I think well, these days important to talk about currency.

Alan Hippe: This is the overview. When you really look at the seven percent, I'm sure that Teresa and Matt will give a lot of details about the sales development. When you look really at the cooperating profit with more momentum than the sales growth, I think that underlines good cost management, quantity income even with a higher momentum, plus 13 percent, here the financial result helped with a couple of currency impacts. I will come to that in a positive way. And then you see really core net income and core EPS pretty much in line. IFRS net income up plus 23 percent.

Now let me talk about the guidance. I already mentioned the LOE impact which we assume is going to be less the group sales, growth missing a digit core EPS High single digits. Of course, the first question is well if you're growing 7% already in sales, your core, PS is growing by 12%. Aren't you being conservative? I would say, our reputation is to be conservative, and we also know that, uh, we have a lot of geopolitical turbulence is these times. And so what we said is we're going to observe the situation of tracking very well. So, uh, if you compare it to the guidance and we have the opportunity to revisit that decision, uh, in the next, uh, couple of months. Let me say also that, uh, rash in our history, we've never missed a guide. And if you last look at the last 3 years, we've exceeded our guidance every year. Including we also raised the guidance last year. So of course, we want to continue to deliver and I can promise you, we will continue to deliver

Speaker Change: And so whatever happens in terms of the us, we will continue to deliver with that. Thank you very much and I hand over to Alan.

Speaker Change: Yeah, thanks Thomas. Yeah, hi to everybody. Um, thanks for, um, Coming In hope everybody's fine. Very pleased with uh with the results that I have the pleasure and the honor to provide you and especially with the operational performance. Yeah, that we that we can show. Um, well I want to talk about the results. So the pnl, I think a couple

Alan Hippe: Explanation is simple, lower impairments compared to last year, around about 800 million. And then when you look really operating free cash flow, it looks a bit poor at first sight. But well, first Sealand, 1.2 billion, which has been in licensing deals or goes to the intangible assets and therefore is part of the operating free cash flow where M&A is not, come to this. So I think that's a difference to last year. And then we have a higher level of networking capital, especially on the pharma side, on the accounts receivable, which is not a worry that will balance out until the end.

Speaker Change: Couple of points and on the on, on the cache and on the balance sheet. Uh, and certainly, I think well these days important to talk about currencies,

Alan Hippe: On the free cash flow side, what fuels, if you like, the distance even a little bit more is higher tax payments, but also this will balance out until the end.

Alan Hippe: Good, when we look really at the at the group sales growth and the bridge here, you see left hand side half year 2024, right hand side half year 2025. You see the 7% increase in CEI, you see the currency impact.

Speaker Change: Um, this is the overview. Um, uh, when you really look at the 7%. Um, I'm I'm sure, uh, that Teresa and Matt, uh, will give a lot of details about the sales development. Um, when you look really the cooperating profit with more momentum than the sales growth, I think that underlines yeah, good cost management, uh, quantity income even with a higher momentum plus 13% here, the financial results helped with a couple of currency impacts. I will come to that. Um, in a positive way and then you see, really coordinate income and core EPS, pretty much in line. If reset income up. Plus, 23% explanation is simple, lower impairments compared to last year around about 800 million

Alan Hippe: Yeah, let me start with diagnostics. And so you see the minus 326 in constant rates. This is the China healthcare pricing reform impact on the diagnostic side. If you move one bar further, you see the plus 348. And this is really the plus six percent on the diagnostic side if you exclude the China.

Alan Hippe: Pharma, I think with strong momentum, as said already, Teresa will shed more light on this. And here you see then on the next bar, the impact, the negative impact from loss of exclusivity products was a minus 347. You know, we have that 1.2 billion out as additional information to the guidance. Thomas made a remark on this already. We bring that down to a billion due to the half year impact that you're seeing here. And then you see the currency impact, which I would argue, speaks for itself.

Speaker Change: And then when you look really operating free cash flow, looks a bit poor at First Sight. Um but well first Sealand 1.2 billion uh which has been an in licensing deals or goes to the intangible assets, and therefore, is part of the operating free cash flow where m&a is not. Yeah. Come to this. So I think that's a different to last year and then we have a higher level of networking Capital, especially on the farmer side with on the accounts receivable, which is not a worry that will balance out until your end on the Free Cash Flow side. What what, what fuels if you if you like the distance, even a little bit more is higher tax payments but also this will balance out until your end.

Alan Hippe: Like I said, let's go to the co-operating profit and the P&L, at least the first part of the P&L. Sales is clear. Other revenue pretty stable here. When you look at the cost of sales, plus 8%, pretty much in line, I would argue, with the sales growth. But what is important, the volume has risen by 12%. And this is 15% on the pharma side and 1% on the diagnostic side. I think having that in mind, I think that's a pretty reasonable increase that we're seeing here. And you ask yourself, okay, when you look really into the divisions, you will see that we had a plus 8% in diagnostics as well.

Speaker Change: Good. When we look really at the, at the group sales growth, and the bridge here. Um, you see left hand side, have your 2024 right hand side, have your 2025, uh, you see the 7% increase in Crescent? You see the currency impact? Um yeah, let me start with Diagnostics. And so you see the minus 326 in constant rates. This is the China Healthcare uh uh pricing reform impact on the diagnostic side. If you move 1 bar further, you see the plus 348. And this is really the plus 6%. On the diagnostic side, if you exclude the China affect,

Alan Hippe: This is the China health care pricing reform, manufacturing rank up, especially for CGM, and certainly the increased installed instrument space. R&D pretty flattish. Thomas explained that. I think we have great savings on the R&D side, coming from R&D excellence. I think that is contributing to that stable development.

Speaker Change: Products with a minus 347. You know, we have that 1.2 billion out as additional information to the guidance Thomas made a remark on this already. We bring that down to a billion due to the half year impact that you're seeing here. And then you see the currency impact, which I would argue, uh, speaks for itself.

tosa: They said let's go to uh the cooperating profit and and the pnl, at least, the first part of the pnl, uh uh sales is clear uh other Revenue pretty stable here.

Alan Hippe: Then you have SG&A, and SG&A, well, two major drivers. One driver is on the pharma side, where we have put more money behind marketing and distribution, really just to fuel the momentum of our products, especially with Biosim or Enxolair. And then we have on the diagnostics side, really, really good cost management.

Alan Hippe: So the last point to mention here is really informatics, where we have invested more in AI and more into cloud. Good.

Alan Hippe: Other operating income and expenses. Well, we have done less divestments and we have less gains from divestment of products compared to last year. That explains the minus 168. Good with that. I think you see cooperating profit at roughly 12 billion. Nice margin increase, plus 11% overall. Good. When you look at the margins, you see the margins went up quite well overall, plus 1.1% points for the group in constant currencies. The pharma division is plus 1.7 percentage points as constant currencies. You see the drop in diagnostics, which is not surprising given the impact from China. Therefore, I would argue overall pretty good development.

Speaker Change: Um, when you look at the cost of sales, um, plus 8% pretty much in line, I would argue with the sales growth, but what is important? The volume. Yeah, has risen by 12% and this is 15% on the Pharma side and 1% on the diagnostic side. I think, I think that in mind, I think that's a pretty reasonable um, increase that we're seeing here and you ask yourself, okay? When you look really into the divisions, you will see that we had a plus 8% in uh Diagnostics as well. This is the China Healthcare pricing reform. Manufacturing rank up especially for CGM and certainly The increased installed in uh instruments space R&D pretty flattish. Uh, Thomas explained that I think we have great savings on. On the R&D side coming from R&D Excellence, I think that is contributing to that stable development. Um, then you have sgna and sgna. Well, 2 major drivers, uh, 1 driver is on the Pharma side. Yeah. Where we have put more money behind marketing and distribution really just to fuel. Yeah, the momentum of our products.

Alan Hippe: CoreNet financial results. And as I've said at the beginning, it's interesting, because the net financial result has improved with plus 84 million in constant currencies. And when you look at the at the large green bar on the right hand side, on the other, then it's very clear we had here, the net foreign exchange results was played a role and the net monetary positions and hyper inflationary economies, that was a plus 89 here, which played a role. And that gave us quite a boost here. When you look really at the interest expenses, it's also a positive, that's pretty clear, because most of our debt is in US dollar.

tosa: Especially the buyers and buying solar. And then we have uh uh uh uh, on the on the diagnostic side really, really good cost management. So the last point to mention here is really informatics where we have invested more in Ai and more into Cloud. Good other operating income and expenses. Well we have done less, uh divestments. Yeah, on we have less gains from that product from from DST of products. Compared to last year, that explains the 1, the minus 10068. Good with that. I think you see a cooperating profit at roughly 12 billion. Nice margin. Increase plus 11% overall

Alan Hippe: And as the US dollar has weakened, we receive a positive impact here. And then you look really at the investments that we have in the Roche Venture Fund. And when you look at the portfolio was negatively impacted here by the US dollar as well. Good.

Good. When you look at the margins uh you see the margins uh went up quite well overall plus 1.1% points for the group in constant currencies, uh, the former division. Yep, is plus 1.7. Percentage points as constant currencies, you see the drop in Diagnostics which is not surprising. Yeah. Given the impact from China. Um therefore I I would argue overall pretty pretty good development.

Alan Hippe: With that, let's go to the core tax rate. And that's an easy one this time, because the tax rate is basically stable. We had a couple of positive, couple of negative effects here. For the full year, certainly, you know, that I've said for the full year that we expect a group tax rate of 19.5%. I think given really the relatively good result at half year, I would go now to 19% for the full Good core EPS. And I would argue that's one of the slides which demonstrates the best, how well we have performed on the operational side.

tosa: Cornet Financial results. And as I've said at the beginning, uh, it's interesting because the net Financial result has improved with plus 84 million in constant currencies. And when you look at the, at the large green bound on the right hand side, yeah, under other. Um then it's very clear, we had here uh uh the net, foreign exchange results was played a role and the net monetary positions in hyperinflationary economies that was a plus 89.

Alan Hippe: You see really a comparison half year to half year. We're up in constant rates by 12%, as mentioned by Thomas already. But you see really major trigger here is operations. So what went against us is less product disposals. That's one element here, all the rest really washes out. But as I said, I think the thing we're really proud of is the operational impact. Good.

tosa: In here, which played a role and that gave us, uh, quite a boost here when you look really at the interest expenses. As also a positive, that's pretty clear because most of our debt is is in US dollar. And as the US dollar has weakened, we receive a, a positive impact here. Um, and then you look really at the Investments here that we have in the row Venture fund. Um and uh when you look with the, the portfolio was negatively impacted here by the US dollar as well.

Alan Hippe: Non-core and IFRS income. You see the co-operating profit growing by 11%, as mentioned already. You see, really, when you go down on the right-hand side, the IFRS net income is up by 23%, as mentioned at the beginning. And then you look at the impairment of intangible assets, which has improved significantly. You know that we have revisited the former portfolio. I think we cleaned the portfolio. And therefore, we also cleaned quite some stuff in the balance sheet. So that's a result of it. And therefore, I think, really, the IFRS net income has a nice momentum. Good.

tosa: Good with that, let's go to the cortex trade and that's an easy 1 this time because the tax rate is basically stable. We had a couple of positive, couple of negative effects here uh for the full year. Certainly you know, that I've said for the full year that we expect um, a group tax rate of 19.5% I think giving giving really the the, the relatively good results. Yeah, at half year, I, I would go now to 19% for the full year.

tosa: Good core EPs and and and I would that's 1 of the slides which demonstrates the best here. How well we have performed on the operational side. Uh you see really uh a comparison half year to half year. Um, we're up in constant rates by 12% as mentioned by Thomas already, but you see really major trigger here is operations. So what went against us is less less product disposals? That's 1 element here, all the, the rest really washes out. But as said, I think what the thing we're really proud of is the operational impact here.

Speaker Change: Some stuff in the balance sheet. So as a result of it um and therefore I think really the IRS, net income has a nice momentum.

Alan Hippe: When you look at operating free cash flow and the free cash flow margin, so to say, well, certainly it's not a surprise that this went down, given that we had the sealant deal. I think that's really reflected in the Roche Group, it's also reflected in the pharma division. The diagnostics division, very clearly impacted by China. When you look really at the cash generation of the business, then it decreased by 13%, which is in line with the 14% decrease in the co-operating profit. So I think Valix Group net debt development, you see net debt went up from $17.3 billion end of the year 2024 to $21 billion at the end of June 2025.

Alan Hippe: You see the ingredients, I think we are operating free cash flow, I think ceiling is part of it. And then the non operating free cash flow is taxes and treasury. And then you see an interesting point in dividends, M&A and alliance transactions. And that is a positive impact from, from current currency translations, that's the US dollar once again, roughly 70% of our debt is in US dollar, nominally in US dollar. So it's a positive effect here, which certainly helped a little bit on the net debt development. I think what went a little bit against us, you will see in the balance sheet is that our cash position is reduced, but still at a very comfortable level.

Speaker Change: Good cash. Um, uh, here, you see really um how the cash has developed half year 2024 concentrates to half year 2025 in constant rates. And then you see the currency impact, which gives us an, uh, uh, the reported number. Um, when you look at it, I think really the green bar operational, uh, performance, really great, networking capital. I I've mentioned that, I think really here on the farmer side, increased accounts receivables, due to the sales of a crevice and the buy more, um, I think something which will, uh, balance out until the area end. So I think that that should be fine. And then you see in the investment, in intangible assets, the impact of sealant, the sealant Forma deal of 1.2 billion, which I would argue explains uh uh uh the majority of the difference here. And then you see really when you move over the relatively small, there are currently impact that we had on care side.

Speaker Change: Good. When you look at operating free cash flow and the free cash flow margins. So to say, well certainly it's not a surprise yet that this went down given that we had the sealant deal. I think that's really uh reflected in the Rose groups. Also reflected in the format division. The Diagnostics division uh uh very clearly impacted here by China. Uh, when you look really at the cash generation of the business. Yeah, then it decreased by 13% which is in line. Yeah. With the 14%.

Speaker Change: Decreasing the cooperating profit. So I think well explained to me.

Alan Hippe: And here we are. When you look at the balance sheet, I think first you can see that the decrease in assets at half year has been driven by the reduction of cash and market securities, but still $12 billion on hand. And the decrease was partially offset by higher trade receivables, especially in pharma. When you, by the way, look at the liabilities, the reduction of the non current liabilities is really a reduction of long term debt and quite significant, roughly $4 billion reduction here. um um when you look really at the equity ratio i i think that looks fine um you see really we're at 35 percent now so a little bit down compared to your end compared to your end but you know that the dividend we pay the eight billion is equity deductible so the equity gets reduced by the eight billion dividend and we're basically close to where we have been at year end so i think that speaks for uh the profits we're making and that we're building up the equity and we should have a quite nice equity ratio at the end of the year Good.

Speaker Change: Group, net debt development. You see, net debt, uh, went up from 17.3 billion end of the year 2024 to 21 billion, uh, uh, at the uh, at uh, junior end of June 2025. Um, you see the ingredients? I think we operating free cash flow. I think sealant is part of it and then the non-operating free. Cash flow is taxes and Treasury. And then you see an interesting point in dividends m&a and Alliance transactions. And that is a positive impact from from currency translations. That's the US dollar once again, roughly 70% of our debt is in the US dollar, nominal it in the US dollar. So I had a positive effect here which certainly helped a little bit on the net debt development. I think what went a little bit against us you will see in the balance sheet is that our cash position is reduced but still at a very comfortable level and here we are. Um when you look at the balance sheet, I think first you can see that the decrease in assets. Yeah, at half year has been driven by the reduction of cash and marketable.

Alan Hippe: Let's look at currency. Well, that's the picture for quite a while, to be honest. And you see that the Swiss franc has strengthened basically against all the major currencies. And you see really that the US dollar is the driver here. But certainly also the Chinese renminbi and APEC plays a role here, but also other currencies here. So that is how should I say that it doesn't give us a great platform for the end of the year. When you look really at the currencies itself, you see on the left side that the 2025 average currency rates remain below 2024 for both the US dollar as well as the euro.

Speaker Change: Securities but still, uh, 12 billion on hand. Um, and the decrease was partially offset by higher trade receivables. Especially in Pharma. And when you, by the way, look at the liabilities, the reduction in the non-current liabilities is really a reduction of long-term debts and quite significant, roughly 4 billion reduction. Yeah. Um, um, when you look really at the equity ratio, I I think that looks fine. Um, you see really

Speaker Change: About 35% now. So a little bit down, compared to your end, compared to your end, but, you know, that the dividend we pay the 8 billion is equity deductible, so the equity gets reduced. Thereby the 8 billion dividend and we're basically close to where we have been at year end. So I think that speaks for, uh, uh, the profits were making, uh, that we're building up the equity and we should have a quite nice equity ratio, at the end of the year.

Alan Hippe: So let's move to the right hand side. You see at half year, the minus 3 percentage points, the minus 5 percentage points on cooperating profit and the minus 4 percentage point on core EPS. And yeah, I think for the full year, you see the minus 5 percentage points, minus 6 percentage points and minus 6 percentage points on core EPS, which would result from the assumption that we keep all the currencies at the end of June constant until year end, which is pretty unlikely that this will happen. I think just for the sake of information, I think we run the whole model yesterday with the currency rates of yesterday.

Alan Hippe: And I can argue that the result is not very different to what you see here. It's slightly different, but not very different. So it looks like that this is a little bit the direction we're going. Good.

Alan Hippe: Thomas said everything about the guidance. Well, tariffs is the major point here, which holds us back to make a step here. And it looks a bit inconsistent. I agree. Nevertheless, the risk is there. The uncertainty is there. You've seen the adjustment on the loss of exclusivity impact to a billion. So I think a pretty reasonable picture and we will assess the situation further in the next couple of months.

Speaker Change: Good. Um, let's look at currency. Um, well, that's the picture. Yeah, for quite a while, to be honest. Um, and you see that the Swiss franc has strengths and basically against all the, all the major currencies. Um, and you see really that the US dollar is the driver here. Um, but certainly also the Chinese remember and APAC plays a role here, but also other currencies. Yeah. So, um, that is how should I say that? That it doesn't give us a great platform for the end of the year? Um, when you look really at the currencies itself, you see on the left side, uh, that the 2025 average currency rates, remain below 2024 for both the US dollar, as well as the Euro. So, let's move to the right hand side. You see at half here, the minus 3 percentage points or minus 5% is points on cooperating profit and the minus 4 percentage point on on, on core EPs. And, and yeah, I think for the full year, you see the minus 5 percentage points. Minus

Alan Hippe: Now I come to a pretty formal point that I want to raise here, and the Roche Board of Directors proposing the exchange of GNUS China to Participation Certificates, Partizipation China. A pretty formal move, as shared in our press release, I think yesterday, the Board of Directors proposes this, which the exchange of GNUS China, really an outdated equity instrument, really outdated old instrument.

Speaker Change: The direction we're going.

Alan Hippe: It's not even a good translation for GNUS China, to be honest. So, I think really good to go for the Participation Certificate. And this follows the Roche articles on incorporation is an adjustment driven by the revised Swiss corporate law. It's really now a more modern instrument that we now bring in. Let me emphasize that the Participation Certificates are economically equivalent to the GNUS China. So economically, there is no change. Following this change, the Participation Certificates replacing GNUS China will be listed on the SIG Swiss exchange and have the same dividend entitlement as well as the same entitlement to any liquidation proceeds as the bearer shares.

Speaker Change: Good Thomas, said everything about, uh, the guidance, um, while tariffs is the major Point. Yeah, we chose us back to, to make a step here. And it looks a bit inconsistent. I agree. Nevertheless, the risk is there. The uncertainty is there? You've seen the adjustments? Yeah, on the loss of exclusivity impact to a billion.

So, um, I think, uh, uh, pretty reasonable picture, and we will assess the situation for the next couple of months.

Alan Hippe: So, I think very clearly, no change, just a formal change.

Alan Hippe: Welcome to the digital world. Because so far, we still work with paper here at Roche, and we have to get rid of this. And I think now it's the time because really, the time is running out until we can use this physical coupon of the GNUS China as well as the Inhaba. So, we are really forced to do that move.

Alan Hippe: There will be detailed explanations of the proposals of the Board of Directors, and they will be made available before the shareholder assembly in 2026, where the final approval will be made. It's very important. So, there is a timeline until March 2026, where you can revise it, look at it and get comfortable with the move. And as said, this is more of a formal change than really a change in substance. And then certainly subject to the shareholder approval in the 2026 AGM, the exchange is expected to be implemented shortly after the 2026 AGM.

Now I come to a pretty formal point, you know, that that I want to raise here and the row board of directors, proposed an exchange of gnu China. Uh to participation certificates, participants in China. Um a pretty formal move. Yeah. Um as shared in our press release. Yeah. Um, I think yesterday, the board of directors proposes, this switch the exchange of gnu China, really an outdated Equity instrument. They are really outdated old instrument, there's not even a good translation for gnos China, to be honest, you know? Um, so I think really good to go for the participation certificate and this follows the row Articles of Incorporation, is an adjustment driven by the revised Swiss corporate law. It's really now, a more modern instrument that we in that we now uh uh bring in. Let me in to emphasize that the partition participation certificates are economically equivalent to the condos China. So economically, there is no change uh, following these changes. The participation the

Alan Hippe: Good. Thanks for your attention here.

Teresa Graham: And I'm happy to hand over to Teresa. And all that comes to mind, Teresa, is double digits. First time. Absolutely. This decade. Exactly. First time in a decade.

Speaker Change: Certificates replacing, you know, share will be listed on the 6th with exchange and have the same dividend entitlement as well as the same entitlement to any liquidation proceeds as the bear share. So I think very clearly. Yeah, no change. Just the formal change, welcome to the digital world. Yeah because so far yeah we still work with paper here at row and we have to get rid of this. Um and uh I think now it's the time because really the time is running out here until we can use this physical coupons. Yea of the good news China as well of the inhaler. So we we are really forced to do to do that move.

Teresa Graham: So, thank you, Alan. Let's start by taking a look, as Alan mentioned, on the overall performance of pharma. So, pharma sales grew 10% at constant exchange rates, reaching 24 billion Swiss francs. All regions delivered strong growth, including the US, which grew at 10%. And as Alan mentioned, overall pharma volumes were up by 15%. Co-operating profit increased by 13% with a margin of 52.2%, driven ahead of sales by effective cost management, particularly in R&D. Going through the P&L lines in a little bit more detail, as Alan mentioned, that other revenue line was stable with higher profit share income from higher sales of Zoller XUS and BenClexta in the U.S., offset by lower income from outlicensing agreements.

Teresa Graham: The cost of sales increased by 8%, that's slightly below sales growth against a 15% volume growth. R&D costs declined by 1% and SG&A costs increased by 4%, as Alan mentioned, primarily in support of the ongoing launches. Other operating income and expenses did decrease by 52% due to lower gains on disposal of other products.

Speaker Change: There will be detailed explanations of the proposals of the board of directors and they will be made available before the shareholder assembly, uh, in 2026 where the final approval will be made, it's very important. So there is a timeline until March 2026, which where you can revise it, look at it and get comfortable with the move. And as said, uh, this is more of a formal change and really a change in substance. And then certainly subjects here to the shareholder approval in the 2026 AGM, The Exchange expected to be implemented shortly after the 2026 AGM. Good. Thanks for your attention here. And I'm happy to hand over to Teresa and all that comes to my mind here, Visa is double digits. Double, digits the first time digit. Absolutely. This is decade exactly first time in a second. Um, so thank you, Alan. Let's start by taking a look as Alan mentioned on the overall performance of Pharma

Teresa Graham: So now let's take a look at what was actually driving that growth. So just as my normal quarterly reminder, all absolute values and year-over-year growth rates in this graph are presented in Swiss francs at constant exchange rates. At half year, our top brands, Fezco, Zoller, Hemlibra, Vabaisno, Okervis, and Polivi added roughly $2 billion in new sales at constant exchange rates. Fezco continues to be our number one growth driver, but with Zoller at a really close second with just an outstanding launch in food allergy. You can also see the strong performance across regions here with all geographies contributing to the growth.

Teresa: So Pharma sales grew 10% at constant exchange rates, reaching 24 billion, Swiss Francs. All regions delivered. Strong growth, including the US, which grew at 10% and as, uh, Alan mentioned overall Pharma volumes were up by 15%. Cooperating profit increased by 13%, with a margin of 52.2, uh, driven ahead of sales, uh, by effective cost management, particularly in R&D. Um, going through the p&l lines in a little bit more detail. As Alan mentioned, that other Revenue line was stable with higher profit, share income from higher sales of xolair, xus, and then CLA, uh, in the US offset by lower income from out licensing agreements. Uh, the cost of sales increased by 8%. That's slightly below sales growth against a 15%, volume growth uh R&D costs declined by 1% and sg&a costs, increase by 4% as Alan mentioned primarily in support of the ongoing launches

Teresa Graham: Now let's continue by having a closer look at our key TAs starting with oncology. Oncology sales increased by 2% to 7.8 billion Swiss francs, primarily driven by our HER2 franchise. PheSGO posted an impressive 55% growth at half year. In Q2, we received a positive CHMP opinion in the EU for administration outside of the hospital. Importantly, this does include administration at home. We will talk a little bit more about PheSGO on the next slide. For Progetta, conversion to PheSGO continues, and at Esmo Breast, we shared the final positive OS analysis of our Progetta plus receptive affinity trial in early breast cancer.

Teresa: Um, other operating income and expenses did decrease by 52% due to lower gains on disposal of other products. So now let's take a look at what was actually driving that growth.

Teresa: So just as my normal quarterly, reminder, all absolute values and year-over-year growth rates in, this graph are presented in. Swiss Francs at constant exchange rates at half year, our top brands fees, go, zero hem, Libra. The bismo ocherous. And polity added uh roughly 2 billion in new sales. At constant exchange rates says go continues to be our number 1 growth driver but with xolair at a really close second with just an outstanding

Teresa Graham: This long-term follow-up included data of more than 11 years and showed an overall survival hazard ratio of 0.83. And rounding out the HER2 franchise, KEDSILA continues to deliver good growth, driven by the uptake in the adjuvant breast cancer setting.

Teresa: Standing launch in food allergy. You can also see the strong performance across regions here with all geographies contributing to the growth.

Teresa: Um, now let's continue by having a closer. Look at our TPA starting with oncology.

Teresa Graham: Moving on to hormone receptor positive breast cancer, let's talk about ITOPI. The U.S. launch is ongoing with more than 500 patients on treatment, and we just received EU approval earlier this week. At ASCO, we presented the positive final OS results from Inova 120 with a hazard ratio of 0.67. Let me also mention that for full year, we expect to land above 100 million in global sales, as we are still very much in the early launch phase with ITOPI. Moving on to Tocentric, we previously guided for Tocentric overall sales remaining stable, and that is what we expect going forward.

Teresa Graham: For Tocentric, we had two positive phase three readouts, both of which were shared at ASCO, Inforte and Firstline small cell and Atomic and Adjuvant DNA mismatch repair colon cancer. Both indications represent smaller opportunities in the range of about 700 million Swiss francs. And finally, Alicenza. We continue to see strong growth across all regions, driven by adjuvant, ELK-positive, non-small cell, and increasing market shares in first line. Just really continued strong performance for Alicenza.

Teresa: Outside of the hospital importantly, this does include administration at home, we will talk a little bit more about fees, go on the next slide. Uh for proetta conversion to fesco continues and at esmo breast we shared the final positive OS analysis of our projeta plus receptive, Affinity trial and early breast cancer. This long-term follow-up included data of more than 11 years and showed an overall survival Hazard ratio of 0.83

Teresa: And rounding out the her to franchise Keila continues to deliver good growth driven by the uptake in the admin breast, cancer setting.

Teresa Graham: Looking ahead to the rest of the year, there are two highly anticipated phase three readouts for GERD, with Avera and Persevera expected in the second half. And additionally, we're looking forward to initiating our phase three with Diveracib, our K-RAS inhibitor, on top of standard of care in first line, non-small cell.

Teresa: Moving on to hormone receptor, positive breast, cancer. Let's talk about a tophi. The US launch is ongoing with more than 500 patients on treatment and we just received EU approval earlier this week at ASCO. We presented the positive final OS results from the Neva 120 with a hazard ratio of 0.67. Let me also mention that for full year we expect to land above 100 million in global sales as we as we are still very much in the early launch phase with ITI.

Teresa Graham: Now let's take a little bit of a closer look at the future of our HER2 franchise. And first, let's talk about PheSCO. So as you know, PheSCO is the first monoclonal antibody-based treatment in breast cancer with the flexibility to be administered outside of the hospital, including at home. This convenience, combined with PheSCO's strong clinical profile, are driving global conversion rates, which are now approaching 50 percent. When you look at this chart, you may see a small dip in Q2 in the graph here, but that's really due to us adding more launch countries to the calculation on the global conversion rates as the global expansion progresses.

Teresa: Moving on to to Centric we previously uh guided for to Centric overall sales remaining stable. And that is what we expect going forward for to Centric. We had 2 positive phase 3 readouts, both of which were shared at ASCO in Forte and first line, small, cell and atomic in a vent. DNA mismatch repair colon cancer

Teresa Graham: And you can see the same thing happened at two earlier time points, each time just before an inflection occurred. Overall, with SESGO, we expect to reach a global conversion rate north of 50%. On the right side of the slide, we see that an evolution of the HER2 treatment paradigm is currently ongoing. And as we've previously said, we are confident that our portfolio will remain an integral part of most future combinations. The orange boxes highlight where, due to new clinical data from competitors, a further evolution of the treatment paradigm is to be expected, which will lead to more fragmentation in how patients are treated.

Teresa: Both indications represent smaller opportunities in the range about 700 million uh Swiss ranks at Peak. And finally allisona we continue to see strong growth across all regions surveyed by admin elk positive non small cell and increasingly market, share and increasing market. Share is the first line just really, uh, continued, strong performance trial Senza. Looking ahead to the rest of the year. There are 2, highly anticipated, uh, phase 3 readouts for gear dust with a Vera and persevera expected in the second half. And initially, additionally, we're looking forward to initiating our phase 3 uh with de Raza, our K Ras inhibitor on top of standard of care in first line, non small cell

Teresa: Now, let's take a look a little bit.

Teresa: Closer look at the future of our heru franchise.

Teresa: First, let's talk.

Teresa: Fees go. So as you know, fesco is the first monicon antibody based treatment in breast cancer with the flexibility to be administered outside of the hospital including at home. This convenience combined with ses goes, strong clinical profile are driving Global conversion rates which are now approaching 50%,

Teresa Graham: But, as you can also see immediately, there are also settings, including the adjuvant settings with patients with PCR in the adjuvant-only setting, where PHSGO will remain the standard of care. Based on the anticipated changes, I want to confirm the outlook for our HER2 franchise, which we've previously provided. We expect continued growth of the franchise through 2026, with peak sales of around $9 billion, driven by the continued global penetration of CAD silent into the adjuvant setting and FESCO conversion driving additional market expansion. The first project of Biosimilar is expected towards the end of 2026. However, we expect only a limited initial launch, similar to Actemra, if you need a way to think about it.

Teresa: When you look at this chart, you may see a small dip in Q2 in the graph here. But that's really due to us at us. Adding more launch countries to the calculation on the global conversion rates as the global expansion progresses. And you can see the same thing happened at 2 earlier time Points. Each time, just before an inflection occurred.

Teresa: overall, with fezco, uh, we expect to reach a global conversion rate, north of 50%,

Teresa: on the right side of the slide, we see that an evolution of the her2 treatment Paradigm is currently ongoing. And as we've previously said, we are confident that our portfolio will remain an integral part of most future combinations.

Teresa Graham: After 2026, we forecast a constant, rather steady decline through the end of the decade. We do not foresee a cliff situation for the franchise, but forecast a solid tail of four billion Swiss francs, primarily Fesco and Cabfila, and a bit of aid.

Teresa: So, Orange Box is highlight where due to new clinical data from competitors. A further evolution of the treatment Paradigm is to be expected, which will lead to more fragmentation, in how patients are treated.

Teresa: But as you can also see immediately, there are also settings including the agent setting.

Teresa Graham: So why do we feel so confident about our place in the future HER2 treatment paradigm? So let's take a look at what physicians said at ASCO. As mentioned already on the previous slide, we see that first-line metastatic breast cancer is moving away from a one-size-fits-all approach. This is supported by three key observations made based on recent study readouts in this space, all of which were presented at this past ASCO. Overall, the results underscored benefit to patients with more personalized treatment strategies based on individual disease biology. But there are also open safety questions, especially for the long-term treatment with certain novel assets.

Teresa: This patients with PCR and the agent only setting where fees go will remain the standard of care based on the anticipated changes. I want to confirm the outlook for her to franchise which we've previously provided. We expect to. We expect continued growth of the franchise through 2026 with Peak sales of around 9 billion driven by the continued Global penetration of kept silent into the agent setting and says go conversion driving additional Market expansion.

Teresa: The first project of Bio similar is expected towards the end of 2026. How however we expect only a limited initial launch similar to actra if you need a way to think about it.

Teresa Graham: So questions remain on how to integrate recent data into clinical practice, particularly regarding treatment sequencing and the development of induction and maintenance protocols.

Teresa: After 2026, we forecast a constant rather steady decline through the end of the decade. We do not foresee a cliff situation for the franchise, but forecast, a solid tale of 4 billion. With Frank's primarily says, go and cadila and a bit of h&p.

Teresa Graham: We believe that the Roche HER2 portfolio remains well positioned for the evolving needs of patients and caregivers, and a recent survey amongst oncologists at ASCO actually confirms this view. 91% would use in HER2 for induction only, followed by maintenance with a different regimen. And of those 91%, 80% would consider a P plus H or PheSCO-based regimen for maintenance treatment.

Teresa: So why do we feel so confident about our place in the future her 2 treatment Paradigm? So let's take a look at what physician said at Asco.

Teresa: as mentioned already on the previous slide, we see that first line metastatic

Teresa: Spencer is moving away from a 1 size fits all approach. This is supported by 3 key. Observations made based on recent study readouts, in this space, all of which were presented at this past Asco

Teresa Graham: So for all of these reasons, we continue to feel confident in our assumptions moving forward in the Now let's move on to our hematology. The hematology franchise had strong growth of 19%, delivering 4.3 billion suspranx in sales. Hemlibra had strong performance across all patient segments and regions, with increasing adoption in non-inhibitor patients remaining the largest growth driver. For the US, we're happy to see a return to growth, particularly driven by better patient adherence and higher new patient starts. For full year, we confirm the outlook is mid-single-digit growth for him.

Teresa: Overall, the results underscores benefit to patients with more personalized treatment strategies based on individual disease, biology.

Teresa: But there are also open safety questions, especially for the long-term treatment with certain novel assets.

Teresa: Questions remain on how to integrate recent data into clinical practice, particularly guarding treatment sequencing and the development of induction and maintenance protocols.

Teresa: We believe that the Roshe 2 portfolio remains well, positioned for the evolving needs of patients and caregivers and a recent survey amongst oncologists at ASCO actually confirms this View.

Teresa: With a different regimen.

Teresa Graham: I'll quickly note that we shared positive Phase I-II data for NxS007 at ISTH, but as Thomas mentioned, we'll cover that in more detail on the next slide. For now, let's move on to our malignant hematology portfolio. Polivian first-line DLBCL continues to drive strong growth, and we reached another milestone with more than 60,000 patients now treated globally. And in the U.S., first-line DLBCL patient share continues to climb and is now at 33%, which is up two percentage points from Q1. Shifting to Columbia and Lunsumio, our CD20, CD3 bi-specifics, launch performance is on track for Columbia and Third Line Plus DLVCL and Lunsumio and Third Line Plus Follicular.

Teresa: And of those 91% 80% would consider a p plus H or fezco based regimen for maintenance treatments.

Teresa: So, for all of these reasons, we continue to feel confident in our assumptions. Moving forward in the her2 space

Teresa: Now, let's move on to our hematology franchise.

Teresa: The hematology franchise had strong growth of 19% delivering 4.3 billion, Swiss Francs and sales.

Teresa: Hem, Libra had strong performance across, all patient, segments, and regions with, increasing adoption. In non-inhibitor, patients, remaining in the largest growth driver.

Teresa Graham: These initial later line indications are expected to drive a combined peak sales of several hundred million.

Teresa: For the us, we're happy to see a return to growth, particularly driven by better, patient, adherence and higher new patient starts for full year. We confirm the Outlook of mid single digit growth for him. We grow

Teresa Graham: We have had additional news, though, for both molecules, however, this quarter, so let's dive into them in a little bit more detail. Starting with Columbi, StarGlo two-year follow-up data and second line DLBCL was presented at ASCO and ICML and the EU launch is ongoing. However, you will have seen that we did receive a CRL from the FDA last The CRL stated that STARGLOW data do not provide sufficient evidence to support the proposed second-line DLBCL indication in the U.S. population. However, the third-line plus indication remains on the market, and we are in ongoing discussions to determine whether the Phase 3 SKYGLOW study and first-line DLBCL could serve as the new post-marketing requirements.

Speaker Change: I'll quickly note that we shared positive Phase 1 2 data for next 007 at isph, but as Thomas mentioned, we'll cover that in more detail on the next slide.

Speaker Change: For now, let's move on to our malignant hematology portfolio, Bolivian first line, dlbcl continues to drive, strong growth. And we reached another Milestone with more than 60,000 patients. Now treated globally and in the US first line, dlbcl patient, share continues to climb and is now at 33%, which is up 2 percentage points from q1.

Teresa Graham: While we are, of course, disappointed by this outcome, we want to reinforce our confidence in the benefit we are providing to second line DLBCL patients with the Stargo regimen. Remember that this trial had a 41% reduction in death and a 63% reduction in risk of disease worsening and emphasized that the U.S. rollout is the ex-U.S. rollout is progressing as planned with five approvals ex-U.S. happening in just the last few days. Lansuvio's positive phase 3 data for Lansumio plus Polivy and second line DLBCL from the SUNMO study was also shared by CML. The data shows that PFS was tripled versus the control arm and support the potential for Lansumio to become the first chemo-free combination of a bispecific antibody and an ADC in DLBCL.

Speaker Change: Shifting uh, to Columbia and lunio, our cd20, CD3 by specifics launched performance is on track for Columbia and third line plus dlbcl and then Sumo and third line, plus Flickr. These initial later line indications are expected to drive a combined Peak sales of several hundred million.

Speaker Change: We have had additional news flow for both molecules however this quarter. So let's dive into them in a little bit more detail.

Speaker Change: Starting with Columbia starlow, 2-year, follow-up data, and second line, dlbcl was presented at ASCO and icml and the EU launches ongoing

Speaker Change: However, you will have seen that we did receive a crl from the FDA last week.

Speaker Change: The crl stated that starlow data do not provide sufficient evidence to support the proposed, second line, dlbcl indication in the US population. However, the third line plus indication remains on the market and we are an ongoing discussions to determine whether the fee, the phase 3, skylo study, and first line dlbcl could serve as the new post marketing requirement.

Teresa Graham: Furthermore, we are expecting U.S. approval of the subcutaneous formation of Lusitumio in December of this year. In terms of outlook, we had previously communicated second-line DLBCL opportunity for our bi-specifics could reach about 1 billion combined. This, of course, now has come down several hundred million Swiss francs with the Starglo news in the U.S.

Speaker Change: While we are, of course disappointed by this outcome. We want to reinforce our confidence in the benefit, we are providing to Second Line dlbcl patients with the stargo. Uh, regimen remember that? This trial had a 41% reduction in death in a 63% reduction in risk of disease worsening and emphasized that the US rollout is pro the xus roll out. This progressing as planned with 5 approvals xus happening in just the last few days

Teresa Graham: Now let's go to the next slide where, as promised, we will take a little bit of a deeper dive into the next 007 data. So here we have the mean annual bleed rate by next 707 days in cohort before enrollment and after starting treatment. There was a clear ABR decrease during NEXT 007 treatment compared to baseline. We are especially encouraged to see that there were no treated bleeds in cohorts B3 and B4 during the observation period. Also, no safety concerns were observed up to the highest dose cohort. We believe NEXT 007 has the potential for best in disease efficacy and for hemophilia A patients to achieve zero treated bleeds as well as normalized hemostasis.

Speaker Change: When suvio's positive face rayada data for Lindo plus poly and second line dlbcl from the Sun. Most study was also shared with icml. The data shows that PFS was tripled versus control arm and support the potential for loss to become the first chemo, free combination of a by specific antibody and an ADC and blbl.

Speaker Change: Furthermore, we are expecting us approval of the subcutaneous formation of Lou in December of this year.

Speaker Change: In terms of Outlook, we are expecting us. Uh, I'm sorry, in terms of Outlook, we had previously communicated the second line dlbcl

Teresa Graham: Additional phase 2 data will be shared in an upcoming medical conference in the second half, and as mentioned at Q1, we are moving next 007 into three phase 2 trials next year, including one head-to-head against Hemlibra. And as always, this is the best kind of bar, because this is the bar we're raising on our side.

Speaker Change: Opportunity for our by specifics could reach uh about 1 billion combined. This of course now has come down uh several hundred million Swiss Francs with the uh starlow news in the US.

Speaker Change: Now let's go to the next slide, where as promised, we will take a little bit of a deeper dive into the next Double 007 data.

Teresa Graham: So now let's look at our neurology. Our neurology franchise achieved $4.9 billion in sales, with a strong growth of 10% at half-year. Ocrevus continues to have good momentum, delivering 8% growth globally, and we are also encouraged by the ongoing launch of Zenovo, our subcutaneous formulation in the U.S. As a reminder, the permanent J-code was granted April 1st, as Thomas mentioned, and as expected, we do see acceleration of Zenovo uptake following the availability of the J-code. In the U.S., 50% of Zenovo patients are naive to Ocrevus, and that same is true for some of our other early launch countries, like Germany for instance.

Speaker Change: So here we have the mean annual bleed rate by next 007 days in cohort before enrollment. And after starting treatment, there is a clear ABR, decrease, during next 007 treatment, compared to Baseline.

Speaker Change: We are especially encouraged to see that there were no treated bleeds in cohorts B3 and B4 during the observation period.

Speaker Change: Also no safety concerns were observed up to the highest dose cohort.

Teresa Graham: Overall, we now have nearly 7,000 patients on Ocrevus Novo globally. For 2025, we continue to expect high single-digit global sales growth for Ocrevus.

Speaker Change: We Believe next 007 has the potential for best disease efficacy and for hemophilia a patients to achieve zero treated bleeds as well as normalized hemostasis additional Phase 2 Data will be shared in an upcoming medical conference in the second half and as mentioned at q1, we are moving next. Several 07 into 3 phase 3 trials. Next year including 1 head to head against hem Libra. And as always this is the best kind of bar because this is the bar we're raising on ourselves.

Teresa Graham: Let me quickly jump to fenobrutinib to finish all of the Q2 newsflow in our MS franchise at this time. So fenobrutinib and RMS, we presented positive 96-week data from the Phase 2 Phenoptis Study at CMS. The data showed that patients on fenobrutinib had low relapse rates and no active brain lesions or disability progression after nearly two years of treatment. Having seen these best-in-class Phase II data, we are of course now even more excited for the Phase III studies, which we'll be reading out soon.

Speaker Change: So now let's look at our neurology franchise.

Speaker Change: Our neurology franchise achieved 4.9 billion in sales with a strong growth of 10%. At half year, okras continues to have good momentum, delivering 8% growth globally. And we are also encouraged by the ongoing launch of zenova or subcutaneous formulation in the US.

Teresa Graham: Moving on to a RISD following the US approval last quarter. In Q2, we received the EU approval for the tablet formulation. The tablet formulation offers patients simplified storage, eliminates the need for cold chain and eases administration, great convenience and offers a really great convenience for patients.

Speaker Change: As a reminder, the permanent jode was granted April 1st as Thomas mentioned. And as expected we do see acceleration of zovo uptake following the availability of the J code in the US. 50% of zenova patients are naive to ocrevus and that same is true for some of our other early launch countries like Germany for instance.

Speaker Change: overall, we now have

Speaker Change: Nearly 7,000 patients on Oak risk of globally.

Speaker Change: For 2025, we continue to expect High single digits, Global sales growth for oakus.

Teresa Graham: Now moving on to elevides and DMD. As you know, in June, we made the decision to stop dosing in non-ambulatory patients following two cases of acute liver failure. Earlier this week, we put in place a voluntary and temporary pause of new orders for the treatment of ambulatory patients to countries that reference the FDA approval. Today, Chugai announced that in consultation with the Japanese Ministry of Health, Chugai has decided that they will also not shift LLVDs until the Ministry of Health has pleaded for their safety evaluation. And we are currently in conversation with other global regulators across our territories to determine immediate next steps.

Speaker Change: To finish all of the Q2 news flow in our MS, franchise, uh, at this time, so, finna brute nib and RMS. We presented positive 96 week data, um, from The Phase 2, sunopta study at CMS. The data showed that patients on fener, relapse rates and no, uh, active brain, lesions, or disability progression after nearly 2 years of treatment

Speaker Change: Having seen these best-in-class Phase 2 data. We are of course not even more excited for the phase 3 studies which will be reading out soon.

Teresa Graham: As Thomas mentioned, I just want to be clear that we do still believe in the risk benefit for LVDs in the ambulatory DMD population. We have treated 760 ambulatory patients to date, and we look forward to discussions with regulators and other stakeholders to find a path forward for the treatment of ambulatory patients who have no other therapies available to them and who are suffering from this devastating disease.

Speaker Change: Moving on to have RIS following the US approval of quarter in Q2, we received the EU approval, for the tablet, formulation the tablet. Tablet formulation offers, patients, simplified storage eliminates, the need for cultural chain and uses Administration, great convenience and offers a really great convenience for patients.

Speaker Change: For now, moving on to elevated and DMD.

Speaker Change: As you know, in June, we made the decision to stop dosing in non-ambulatory patients, following 2 cases of acute, liver failure.

Speaker Change: Well earlier this week we put in place a voluntary and temporary pause of new orders for the treatment of ambulatory patients. The countries that reference the FDA approval

Teresa Graham: Moving on to PRASI NPD, you've seen our decision to move into phase three trials in Parkinson's, more on this on the next few slides. And finally, on the outlook for TRANTI NAD, we'll see the final phase one two data from the 1.8 and 3.6 milligram dosing cohorts . at AAIC, which starts just three days from now. And additionally, we will share the phase three trial designs for mild to moderate AD with you at that conference. And for fenobrutinib and MS, we expect the phase three fentrepid results in PPMS at the very end of the year.

Speaker Change: Today, chili announced that in consultation with the Japanese Ministry of Health to guy has decided that they will also not ship LEDs until the Ministry of Health has pleaded for their safety evaluation. And we are currently in conversation with other Global Regulators across our territories to determine immediate. Next steps.

Speaker Change: As Thomas mentioned, I just want to be clear that we do still believe in the risk. Benefit for lvds in the ambulatory DMD population. We have treated, uh, 760 ambulatory patients today.

Teresa Graham: However, the phase three fenhance readout for RMS has just slipped into 2020.

Teresa Graham: Now let's take a closer look at process. As just mentioned, we are moving PRASI into phase three studies for PD. And on this slide and the next, I want to share with you some data and some of the considerations that led to this decision. You see here the results from our Phase IIb PDOVA trial. And for the first time, we are also sharing insights from the open label extension portion of the study. This is the L-DOPA population, so it's approximately 75% of the overall trial population. And you can see that there is a visible positive trend towards reduced motor progression.

Speaker Change: And we look forward to discussions with regulators and other stakeholders to find a path forward for the treatment of ambulatory patients, who have no other therapies available to them and who are suffering from this, uh, devastating disease.

Speaker Change: Moving on to prosy NPD. You've seen our decision to move into phase 3, trials and Parkinson's more on this on the next few slides. And finally on the Outlook uh for tronte NAD. We'll see the Final Phase 1, 2 Data from the 1.8 and 3.6 milligram dosing cohorts

Speaker Change: at AIC which starts just 3 days from now.

Speaker Change: and additionally, we will share the phase 3 trial, designs for mild to moderate add with you at that conference

Teresa Graham: And this trend is sustained at 2.5 years, which includes the six month open label extension data. And of course, all caveats around open label data apply. We are also encouraged by the fact that we see very high retention and rollover of patients into the open label phase. And we saw this not only with Padova, but we saw it in Pasadena as well. Roughly 750 patients from both our phase two studies are now in the open label extension. It was based on this data that we decided to move into phase three trials.

uh, and for fener, nib, and Ms, we expect

Speaker Change: Of the year. However, the phase 3 Finance read out for RMS has just slipped into 2026.

Speaker Change: Now, let's take a closer look at

Speaker Change: As just mentioned.

Speaker Change: Face. We studies for PD and on this slide.

Speaker Change: And the next I want to share with you some data and some of the considerations that led to this decision.

Teresa Graham: But let's take a look at the considerations that led to that. So as you know, the bar is our way of determining whether or not a medicine has transformative potential, and we apply it across the portfolio to each asset entering or progressing. This is true across all stages of R&D, and we apply it also to molecules that we are seeking to acquire through partnering or M&A activities. But the bar, however, does not imply that all studies have to have a 90% success rate. We have to make room for taking smart risks on individual programs. Otherwise, we would not be able to fulfill our mission.

Speaker Change: You see here the results from our phase, 2B Padova trial. And for the first time we are also sharing insights from the open label extension portion of this study. This is the l-dopa population. So it's approximately 75% of the overall trial population. And you can see that there is a visible positive trend towards reduced motor progression. And this trend is sustained at 2.5 years which includes the 6-month open label extension data. And of course, all caveats around open label uh, data apply.

Teresa Graham: Overall risk is managed as a portfolio.

Teresa Graham: So let's talk a little bit about the PROS-E decision specific. I'm sure that we can all agree that there is significant unmet medical need in Parkinson's disease. This is a large and growing patient population that has not seen major innovation in 50 years. It is also one of the few white spots in pharma where there is very limited competition and where we have the opportunity to be many years ahead. One of the most important criteria in the bar assessment is that the programs are either first-in-class or best-in-class. PASI has the chance to be both. It is years ahead of any competition, and significant IP remains.

Speaker Change: We are also encouraged by the fact that we see very high retention and rollover of patients into the open label phase and we saw this not only with Padova but we saw it in Pasadena as well. Roughly, 750 patients from both our face. To studies are now in the open label extension.

Speaker Change: It was based on this data that we decided to move into phase 3 trials. But let's take a look at the considerations that led to that decision.

Speaker Change: So, as you know, the bar is our way of determining whether or not a medicine has transformative potential, and we apply it uh, across the portfolio to each asset entering or progressing.

Speaker Change: This is true across all stages of R&D and we apply it. Also to molecules that we are seeking to acquire through partnering or m&a activities.

Teresa Graham: We also have a growing body of evidence, including in the clinical setting, that hitting alpha-synuclein makes a difference to patients. And in Padova, PROZE was well-tolerated and no new safety signals were observed. This is also reflected in our OLEs, where I mentioned on the previous slide, we have unusually high retention rates. And finally, PRASI is not our only shot on BOLIN PD. We have several early-stage pipeline programs, including the Brain Shuttle and LRP3 program.

Speaker Change: But the bar however does not imply that all Studies have to have a 90% success rate. We have to make room for taking smart risks on individual programs. Otherwise we would not be able to fulfill our mission.

Speaker Change: Overall risk is managed to the portfolio level.

Speaker Change: So let's talk a little bit about the prozzy decision, specifically.

Teresa Graham: For all of these reasons, we made the decision to take PROZI forward into Phase 3. And while we acknowledge that this remains a high-risk, high-reward program, I do firmly believe that these are the kind of risks that patients actually need us to be taking. As Thomas and Levi have both mentioned many times, we take the application of the BAR very seriously, and we believe that its rigorous use across our portfolio will ultimately lead to better trial outcomes and, importantly, more transformative medicines for patients.

Speaker Change: I'm sure that we can all agree that there is significant unmet medical need in Parkinson's disease. This is a large and growing patient population that has not seen major innovation in 50 years. It is also 1 of the few white spots in Pharma where there is very limited competition and where we have the opportunity to be many years ahead.

Speaker Change: 1 of the most important criteria in the bar assessment is that the programs are either first in the class or Best in Class. Puzzy has the chance to be both. It is years ahead of any competition and significant IP remains.

Speaker Change: We also have a growing body of evidence, including in the clinical setting that hitting alphas and nuclei and makes a difference to patients.

Speaker Change: And in Padova proy was well, tolerated and no safety signals. Uh, no new. Safety signals were observed.

Teresa Graham: So now let's move on to our immunology franchise. Our immunology franchise grew 14% at college exchange rates and reached $3.3 billion in sales. Growth was primarily driven by Zolaire and its very strong trajectory in food allergy. The food allergy launch keeps on delivering impressive results with 34% growth at half year. Based on this strong performance, we have also updated the full year outlook for Zolaire, and we now expect growth around 20% up from the mid-teens estimate that we shared at Q1. Let me also add here that we expect a first biosimilar launch for Zolaire at the end of 2020.

Speaker Change: And finally, prozzy is not our only shot on goal. In PD, we have several early stage pipeline programs, including the brain shuttle and lp3 programs

Speaker Change: For all of these reasons we made the decision to take proy forward into phase 3 and while we acknowledge that this remains a high-risk High reward program. I do firmly believe that these are the kind of risks that patients actually need us to be taking

Teresa Graham: Our camera sales grew 4% due to slower-than-expected biosimilar penetration. U.S. biosimilar launch continues to be slower than expected, while EU biosimilar usage is increasing as anticipated. We expect that the overall biosimilar impact will accelerate into the second half of 2025.

Speaker Change: as Thomas. And Levi have both mentioned many times, we take the application of the bar very seriously and we believe that it's rigorous use across. Our portfolio will ultimately lead to better trial outcomes, and importantly, more transformative medicines for patients.

So now let's move on to our Immunology franchise.

Teresa Graham: Turning to astrobolomab and COPD, we are of course disappointed about the mixed results we shared earlier. The Pivotal Phase IIb Allianto study met the primary endpoint of a statistically significant reduction in annualized exacerbation rate at 52 weeks, when Astagolumab was given every two weeks. However, the Phase III Arnosa study didn't. The safety profile of ASCII was consistent with previously reported data, and no new safety signals were identified. Analysis of the Aliento and RNASA datasets will be ongoing, will be discussed with regulatory authorities, and results shared in an upcoming medical meeting.

Speaker Change: Our Immunology franchise grew 14% at college and exchange rates and reached 3.3 billion in sales growth was primarily driven by xolair and it's very strong trajectory uh in food allergy the food, allergy launch keeps on delivering impressive results with 34% growth at half year.

Based on the strong performance. We have also updated the full year outlook for xolair. And we now expect growth around, 20% up from the mid teens estimate, that we shared at q1.

Speaker Change: Let me also add here that we expect a first bio similar launch for zolar at the end of 2026.

Teresa Graham: Two more news flow items for this quarter. We moved our anti-P40-TL1A bispecific into phase two for IBD. And we took the decision to move zosirabalpin in bacterial infection into phase three trials, which are expected to start in 2020.

Speaker Change: A camera sales grew 4%, due to slower than expected biosimilar. Penetration us biosimilar launch continues to be slower than expected while EU biosimilar usage, is increasing as anticipated. We expect that the overall biosimilar impact will accelerate into the second half of 2025.

Teresa Graham: Considering the outlook, this is all about gaziva. US and EU approvals on lupus nephritis are expected later this year, as is the readout for the phase three allegory study in SLE.

Speaker Change: Turning to establish aab and COPD. We are, of course, disappointed about the mixed results. We shared earlier this week, the pivotal phase 2B, aliento, study met the primary endpoint of a specifically significant reduction in annualized exacerbation rate at 52 weeks.

Teresa Graham: So now let's move on to ophthalmology. Ophthalmology grew by 17% achieving $2.1 billion in sales. Vomizemo is leading the franchise and continues to have strong growth momentum. Vomizemo achieved 18% growth at half year despite the ongoing contraction of the branded market in the US. Within the branded IVT market, excluding Avastin and all biosimilars, we continue to see market share expansion for Vomizemo in all indications. Similarly, uptake in early launch countries and the ongoing global expansion are fueling overall growth. China is a really great example here where we see very strong uptake following the NRDL listing earlier this year.

Speaker Change: Um, when asked to go me was given every 2 weeks, however the phase 3 are not the study did not.

Speaker Change: The safety profile of asie was consistent with previously reported data and no new safety signals were identified.

Speaker Change: Analysis of the aliento and rnasa data sets will be uh ongoing will be discussed with regulatory authorities and results shared in an upcoming medical meeting.

Speaker Change: 2, more news, flow items. For this quarter, we moved our anti-p

Speaker Change: 1. A by specific into phase 2 for IBD. And we took the decision to move this or a Balin in bacterial infection into phase 3 trials, which are expected to start in 2026.

Teresa Graham: Taken together, we still expect roughly 20% sales growth globally this year, but have to caveat for difficult to predict U.S. market dynamics.

Speaker Change: Considering the Outlook this is all about Gaza us and EU approvals in lupus to fight us are expected later. This year, as is the readout for the phase 3 allegory study in SLE

Teresa Graham: Some good news for Sysfemo, we achieved U.S. approval in diabetic retinopathy following the DME approval in Q1, and regarding the 2025 outlook, Let me highlight two additional items or several additional items, phase three data for for Mickey Bart and UME and phase three data for Satra and TED.

Speaker Change: So now let's move on to Opthalmology.

Teresa Graham: And now on to our last TA, cardiovascular renal metabolism. Here we want to introduce you to a new regular quarterly slide which will be covering our CBRM pipeline new flow. We want to use this to keep you abreast of the latest development updates and give you a line of sight as to what's coming. For Q2, the key highlight is certainly the Phase 2 start of GMINDA. In this trial, we will investigate the combination of our antilatent myostatin, GIM329, with trizepatide and obesity. Let me also update you that we have decided to discontinue CT173, our PYY analog, and that decision was made based on a comprehensive assessment of its developability, competitive positioning and commercial viability.

Speaker Change: Opthalmology Group by 17% uh achieving 2.1 billion in sales of a miso is leading the franchise and continues to have strong growth momentum. But by asmo achieved 18% growth at half year, despite the ongoing contraction of the Branded Market in the US within the Branded IBT Market. Excluding avastin and all biosimilars we continue to see market share expansion for the bismo in all indications. Similarly uptake in early launch countries in the ongoing, Global expansion or fueling overall growth. China is a really great example here where we see very strong uptake, following the nrd listing earlier this year.

Speaker Change: Taken together. We still expect roughly 20% sales growth globally this year, but have to caveat for difficult to predict us back to Dynamics. Some good news for us as FEMA, we achieved us approval and diabetic. Retinopathy following the DME approval in q1 and regarding the 2025 Outlook.

Teresa Graham: For the remaining new flow in 2025, we will present Phase 2 Cardio 3 data for zalbicerone and hypertension at ESC, and we expect three Phase 3 GO decisions to be taken in the second half, zalbicerone and hypertension, CT868 in type 1 diabetes with overweight or obesity, and CT388 in obesity. Additionally, the first patient in is imminent for our Phase 2 trial of our CT996 oral implant.

Speaker Change: Let me highlight 2 additional items or several additional items phase 3 data, for the Mickey Bart, and ume and phase 3 data for satra and Ted. And now on to our last uh ta uh, cardiovascular Regal and metabolism.

Teresa Graham: Now let's finish up with what you can expect through the end of the day. Here's our key news flow with the latest updates. Most of this has already been covered on previous slides, so I won't repeat what we've already discussed, but I will mention that we had a negative readout for Venclexta and Firstline MDS, and we have added the two positive concentric readouts at the bottom of the slide for Enforte and Atomic for completeness.

Here we want to introduce you to a new regular quarterly slide which will be covering our cvrm pipeline news flow. We want to use this to keep you a breast of the latest development updates and give you line of sight as to what's to come for. Q2 the key highlight is certainly The Phase 2 start of the minda. And this trial, we will investigate the combination of our anti-atoms

Speaker Change: Let me also update you that we have decided to discontinue CT, 173 RP, YY analog. And that decision was made based on a comprehensive assessment of its developability competitive positioning and Commercial viability.

Teresa Graham: And just one more slide to go before I hand over to Matt.

Teresa Graham: I am very pleased to invite you to our Pharma Day on September 22nd. This will be a hybrid event held in London and online.

Teresa Graham: We have a very exciting agenda that we shall cover pharma strategy, business topics, or business updates, and an update on R&D excellence, and a look at pipeline highlights across our five therapeutic areas.

Matt Sause: And with that, Matt, over to you. Thanks, Teresa, and congratulations again. So with that, it's my pleasure to present the results for the first half of the year for the Diagnostics Division. So as you heard from Alan, with sales of 6.96 billion Swiss francs, the Diagnostics Division sales were stable versus half-year 2024. Now, this was driven by the Healthcare Pricing Reforms and Volume-Based Procurement Initiative in China. That's the 326 million Swiss francs at constant exchange rate. As you heard from Alan, excluding China, the growth of our business was six percentage. So now let me walk you through the sales by customer area.

Speaker Change: For the remaining new slow in 2025, we will present Phase 2, cardio, free data for results and hypertension or at ESC. And we expect 3 phase 3, go decisions to be taken in the second half zeron and hypertension. CT 868 in type 1, diabetes with overweight or obesity in CT 3888, in obesity. Additionally, the first patient in is imminent for Phase 2 trial of our CT 9996 oral and obesity.

Speaker Change: Now, let's finish up with what you can expect through the end of the year.

Speaker Change: Here's our key news flow with the latest updates. Most of this has already been covered on previous slides so I won't repeat what we've already discussed, but I will mention that we had a negative readout for venclexta and first line MDS. And we have added, the 2 positive to Centric readouts, at the bottom of the slide for in Forte and atomic for completeness.

Matt Sause: So sales in CoreLab, our largest customer area, decreased by 2% driven by the previously mentioned healthcare pricing reform and VBP in China. Excluding China, CoreLab grew at plus nine. Now sales in the molecular lab increased a plus three percent. This is due to our strong growth in our blood screening business at plus eight percentage points. This was offset by a minus one percent decline in the infectious disease segment, driven by a decrease in our HIV business in Africa, affected by the USAID pause in Q1. Sales in near patient care decreased by 3%. This is mainly driven by the decline of our blood glucose monitoring business by minus four.

Speaker Change: Go before I hand over to Matt, I am very pleased to invite you to our farm a day on September 22nd. This will be a hybrid event held in London and online. Um, we have a very exciting agenda that we shall cover from a strategy business topics, or business updates. And an update on R&D excellence. And a look at pipeline highlights across our 5 therapy areas and with that Matt over to you, thanks Teresa and congratulations again.

Matt: So with that, it's my pleasure to present the results for the first half of the year for the Diagnostics to vision.

Matt: So as you heard from Allen uh with sales of 6.96 billion Swiss Francs, the Diagnostics division sales were stable versus half-year 2024. Now, this was driven by the healthcare pricing reforms and volume-based procurement initiative in China. That's the 326 million Swiss Francs at Constance exchange rate. As you heard from Allan excluding China, the growth of our business was 6 percentage points.

Matt Sause: Due to the market shift to continuous glucose monitoring, and this was partially offset by 1% growth of our molecular point-of-care COBAS-LEAD business, I would note that we are confident that our CGM solution and acquisition of LumiraDX will drive growth in near-patient care in the future. Sales in the pathology lab grew strongly by plus 12%, mainly driven by the advanced staining business growth plus nine and companion diagnostics growth of plus 19%. So now let's take a look at the regional perspective for the sales performance. So we saw strong growth in North America at plus six percentage points.

So now let me walk you through this sales by customer area. So sales and core lab are largest customer area, decreased by 2% driven by the previously mentioned.

Matt: Healthcare pricing reform and vbp in China. Excluding China corelab grew at plus 9%. Now sales in the molecular lab increased at plus 3%. This is due to our strong growth in our blood, screening business. At Plus 8 percentage points. This was offset by a minus 1% decline in the Infectious Disease segment driven by a decrease in our HIV business.

Matt: In Africa affected by the US a pause in q1.

Matt Sause: In EMEA, the volume grew at plus five percentage points. In LATAM, the business grew very strongly at plus 14 percentage points. Now turning to APAC, the business declined at minus 15%. As previously mentioned, the sales growth was impacted by the healthcare pricing reform in VVP in China. And as a result of this, China's sales declined by 26%. This impact is expected to continue over the course of 2025, but because the VVP had a heavy pricing impact, there is a corresponding effect on the profit contribution, which you will see reflected on the P&L slide following this one.

Matt: Sales in near patient care decreased by 3%. This is mainly driven by the decline of our blood glucose monitoring business by minus 4,

Matt: Due to the market shift to continuous glucose monitoring. And this was partially offset by 1% growth of our molecular point of care. Cobos, leat business, I would note that we are confident that our CGM solution and acquisition of Lumiere DX will drive growth in near patient care in the future.

Matt: Sales in the Pathology Lab group strongly by plus 12%. Mainly driven by the advanced staining business growth plus 9 and companion, Diagnostics growth of plus 19%.

Matt Sause: I would like to call out that China is still a very important market for us, and we continue to be the market leader. Now, while it's our consistent ambition... to grow our diagnostics business at mid to high single digits, given the current headwinds in China. Our 2025 ambition is to grow diagnostics by low single digit.

Matt: So now let's take a look at the regional perspective for the sales performance. So we saw strong growth in North America at plus 6 percentage points in Amia the volume Guru at plus 5 percentage points.

Matt Sause: So now let me take you to the P&L for diagnostics. I would note that you can see from the P&L that we have taken significant measures to manage our cost structure in light of these headwinds and stabilize our operating market. With these measures fully in place, by the end of the year, we expect our margin to be roughly at the full year 2024 level. Now let me take you through the cost. Cost of sales increased at plus eight percent. Driven by the unfavorable impact of those same pricing reforms. R&D cost declined by minus 2% as a result of the focus cost efficiency measures I previously mentioned.

Matt: In latam the business grew very strongly at plus 14, percentage points. Now turning to APAC. The business declined at minus 15%. As previously mentioned, the sales growth was impacted by the healthcare pricing reform in vvp in China. And as a result of this China sales declined by 26%. This impact is expected to continue over the course of 2025 but because the VV prea vvp had a heavy pricing impact. There is a corresponding effect on the profit contribution, which you will see, reflected, on the p&l slide following this 1.

Matt: I would like to call out that China is still a very important market for us and we continue to be the market leader.

Matt: Now, while it's our consistent ambition,

Matt: To grow our Diagnostics business, admit to high single digits given the current headwinds in China.

Matt: Our 2025 ambition is to grow Diagnostics, Buy Low single digits.

Matt: So now let me take you through the p&l for Diagnostics.

Matt: Core operating profit.

Matt Sause: I would like to point out that we are continuing to invest in key new products like the MiraDx, CGM, and our Axelios Roche sequencing solution, which I'll describe on some of the following slides. SG&A was stable, again, reflecting our focus cost efficiency measures across the organization. and this reflected or this resulted in a core operating profit of 1.25 billion Swiss francs with a margin of 18 percent at reported current.

Matt: On sales of 6.9 billion with Frank's decreased by 14% at const exchange rates again, due to the previously mentioned, China Healthcare pricing reform. I would note that you can see from the p&l that we have taken significant measures to manage our cost structure in light of these headwinds and stabilize, our operating margin with these measures fully in place. By the end of the year, we expect our margin to be roughly at the full year. 2024 level,

Matt: Now, let me take you through the cost lines.

Matt Sause: So now turning to some of that innovation that I mentioned earlier, and you saw as well in Thomas's slides, I'd like to talk about some of the key updates to our portfolio and research data that we've released, starting with our Axelio sequencing solution set to launch in 2026. I would like to provide an update on some data presented at the European Society of Human Genetics, which is one of the leading international genomics conferences. At this event, we showcased our high speed and accuracy across multiple key applications for next generation sequencing. So I'd like to highlight three of those moving from left to right on the slide.

Matt: Cost of sales increased at plus 8%.

Matt: Driven by the unfavorable impact of those same pricing reforms R&D costs declined by minus 2%. As a result of the Focus cost efficiency measures. I previously mentioned, I would like to point out that we are continuing to invest in key, new products, like the Meridia X CGM, and our axeli roast sequencing solution, which I'll describe on some of the following slides.

Matt: Sgna was stable again, reflecting our Focus cost efficiency measures across the organization.

Matt Sause: So for those of you who remember, the Human Genome Project took 13 years. Rapid sequencing with the SBX FAST protocol, we were able to sequence the human genome in four hours and 23 minutes. And this is important, especially in applications such as the NICU, where trio testing of baby and parents is critical to rapidly identify pathogenic genomic variants. We achieved sequencing of a single genome in under five, but all three genomes in about approximately seven hours. This marks a significant improvement over the data we previously presented at AGVT and highlights the relevance of our SBX technology in clinical settings, where rapid genome sequencing is key for clinical decision making, and I would call out that no other technology is capable of this achievement.

Matt: And this reflected or this resulted in a core operating profit of 1.25 billion. Swiss Francs, with a margin of 18% at reported currency

Matt: Launched in 2026.

I would like to provide an update on some data presented at the European Society of human genetics, which is 1 of the leading international genomics conferences.

Matt: At this event, we showcased our high-speed and accuracy across multiple key applications for Next Generation sequencing. So I would like to highlight 3 of those moving from left to right on the slide. So for those of you who remember the Human Genome Project took 13 years,

Matt Sause: The second application is FFP in oncology. Formalin-fixed paraffin-embedded tissue is the most common sample type used in clinical practice to preserve biological samples for oncology diagnostics, and for any NGS technology, it's absolutely critical to be able to perform well in these sample types. which you can see on the axis on the left is the accuracy and on the bottom, the length of homopolymer which is a sequence of bases. with the same letter. And what you'll see there, when you compare the SBX technology to a very commonly used sequencing technology that ours performs in a superior manner, showing good confidence that we will have excellent performance in this sample type.

Matt: Rapid sequencing with the SBX fast protocol. We were able to sequence the human genome in 4 hours, and 23 minutes.

Matt: And this is important, especially in applications, such as the NICU, where Trio testing of baby and parents is critical to rapidly identify pathogenic genomic variants. We achieved sequencing of a single genome in under 5, but all 3 genomes in under in about approximately 7 hours, this marks a significant improvement over the data. We previously presented at agbt and highlights the relevance of our sdx technology and clinical, settings were rapid genome sequencing is key for clinical decision-making, and I would call out that. No. Other technology is capable of this achievement.

Matt: The second application is ffp in oncology.

Matt Sause: Now moving to the far right, the third example is Minimal Residual Disease Monitoring, or MRD, in oncology. Minimal residual disease, especially with more cancer treatments moving into earlier disease settings, is absolutely critical to understanding patient's response to treatment, predicting disease recurrence, and guiding clinical decision making. What you can see here is we detected MRD in 15 cancer types, demonstrating high accuracy in challenging samples with tumor fractions as low as 1 times 10 to the minus 6 and starting material in the range of nanograms of cell-free DNA, again highlighting the applicability of the SBX technology in this critical application.

Matt: Formal and fixed paraffin embedded. Tissue is the most common sample type used in clinical practice to preserve biological samples for oncology Diagnostics and for any NGS. Technology is absolutely critical to be able to perform well in these sample types.

Matt: Which you can see on the axis on the left, is the accuracy. And on the, on the bottom, the length of homopolymer which is a sequence of bases.

Matt: With the same letter.

Matt: and what you'll see there when you compare the SBX technology to a very commonly used sequencing technology that RS performs in the superior manner, showing uh good confidence that we will have excellent performance in this sample, type

Matt Sause: Taking together, this gives us really high level of confidence in the future of this technology and our ability to both impact the market as well as clinical practice with this, with the SBX, and we're very much looking forward to the launch in 2020.

Matt Sause: So now I'd like to move to the theme of our expanding menu in the Serum Work Area, specifically to highlight our approval of the Alexis Pro-C 3, which received CE mark in April of this year. So MASLD, which is caused primarily by diabetes, obesity, and other cardiometabolic risk factors, affects 30% of the population and generally remains asymptomatic in most patients until advanced age. Standard diagnostics methods, such as biopsy, are expensive, they are invasive, and not always widely accessible. So with the launch of PCA3, we'll be able to provide an accurate and non-invasive test for early detection with results in just 18 minutes.

Matt: Now moving to the far right? The third example is minimal residual disease monitoring or mrd in oncology minimal, residual disease, especially with more Cancer Treatments. Moving into earlier, disease. Settings is absolutely critical to understanding patients response to treatment predicting disease recurrence and guiding clinical decision making.

Matt: What you can see here is we detected mrd in 15 cancer types, demonstrating high accuracy in challenging samples with tumor, fractions as low as 1 is as low as 1. Times 10 to the minus 6, and starting material in the range of nanograms of cell-free DNA. Again, highlighting, the applicability of the SBX technology in this critical application taking together. This gives us really high level of confidence in the future of this technology and our ability to both impact the market, as well as clinical practice with this with the SPX and we're very much looking forward to the launch in 2026.

Matt Sause: Now what's really important to also call out here as part of our Roche Diagnostics strategy, the combination of high medical value diagnostics along with digital tools for clinical decision making. And this takes me to our ADAPT algorithm, which incorporates age, diabetes status, platelet count, as well as Pro-C3, and is set to launch in Q4 of this year. Here, we will provide a simple fibrosis severity assessment to enable timely treatment and patient management, especially as new liver fibrosis drugs emerge. This is a key example of a Roche diagnostic strategy implemented into the market.

Matt: So now I'd like to move to the theme of our expanding menu in the serum work area. Specifically the Highlight, our approval of the Alexis proceed 3, which receives CM Mark in April of this year,

Matt: So Mas which is caused primarily by diabetes obesity and other cardio. Metabolic risk factors affects 30% of the population and generally remains asymptomatic in most patients until Advanced stages.

Matt: Standard Diagnostics methods such as biopsy are expensive. They are invasive, and not always widely accessible.

Matt Sause: So continuing with one of our key strategies, I'd like to talk about menu expansion again in our serum work area, specifically in China, and the approval of pepsinogen one and two, which we see regulatory approval in China in May of this year. So gastric cancer is a major healthcare burden and a highly prevalent condition in China, where China accounts for 40% of new global gastric cases every year. Now atrophic gastritis is a major risk factor for gastric cancer, so timely screening and triage of high-risk patients for endoscopic follow-up is crucial. With the launch of Pepsinogen 1 and 2, we will enable screening and triage for patients at high risk of atrophic gastritis and provide more accessible testing options for patients.

So with the launch of pca3, we will be able to provide an accurate and non-invasive test for early detection with results in just 18 minutes.

Matt: Now, what's really important to also call out here is part of our Roche diagnostic strategy, the combination of high medical value Diagnostics along with digital tools for clinical decision-making.

Matt: And this takes me to our adapt algorithm which incorporates age diabetes, status Plato account, as well as proc 3 and is set to launch in Q4 of this year.

Matt: Here we will provide a simple fibrosis, severity assessment to enable timely treatment and patient management especially as new liver fibrosis, drugs emerge. This is a key example of a roach diagnostic strategy implemented into the market.

Matt Sause: And why this is important for our strategy is this demonstrates our commitment to invest in a menu of China for China assays across high burden disease areas to ensure optimal care for Chinese patients, but also continue to create a menu of highly relevant tests that enables to maintain our leading market position in China.

Matt: So continuing with 1 of our key strategies, I'd like to talk about menu expansion again in our CRM, more area, specifically in China and the approval of pepsinogen 1 and 2 which we see regulatory approval in China in May of this year.

Matt Sause: So now I'd like to move on to another example of us combining high medical value diagnostics as well as digital tools with the breakthrough device designation we received in April for our Ventana TROP2-RXDX, the first AI-driven companion diagnostic for non-small cell lung cancer, which we developed in collaboration with AstraZeneca. Lung cancer affects 2.5 million new patients per year, 80% of which are non-small cell lung cancer. This solution will aid in identifying patients with previously treated advanced or metastatic non-squamous non-small cell lung cancer without actionable genomic alteration, but they are, if detected via this algorithm, eligible for targeted treatment with a greater level of diagnostic accuracy that could not be identified by a pathologist alone.

Matt: So gastric cancer is a major Healthcare burden and a highly prevalent condition in China. Where China accounts for 40% of new, Global gastric cases every year.

Matt: For endoscopic. Follow-up is crucial.

Matt: With the launch of pepsinogen 1 and 2. We will enable screening and triage for patients at high risk of atrophic gastritis and provide more accessible testing options for patients.

Matt: And why this is important for our strategy. Is this demonstrates our commitment to invest in a menu of China for China, has stays across hybern disease, areas to ensure Optimal Care for Chinese patients, but also continue to create a menu of Highly relevant tests, that enables to maintain our leading Market position in China.

Matt Sause: Again, a key example of our commitment to deliver innovations that enable more precise diagnosis in oncology, and again, an example of us putting together high medical value diagnostics and digital solutions to improve patient care.

Matt: So now I'd like to move on to another example of us, combining High medical value, Diagnostics, as well as digital tools.

Matt: With the Breakthrough device. Designation, we received in April, for our Ventana, trop to rxdx the first Aiden companion, diagnostic for non small cell, lung cancer, which we developed in collaboration with astroica.

Matt Sause: So with that, I would like to talk about our key launch list for 2025. We have received four of those by the half year, but I would also be remiss not to call out the very recent C-mark approval of our PTAL 181 blood-based rule-out test for Alzheimer's. This is a test that is the first of its kind in that it has a 93.8% negative predictive value for amyloid pathology and was done in a real world cohort with 22.5% of patients having detected amyloid pathology via PET We're very excited about the potential of this test to change patient care.

Matt: Lung cancer, affects 2.5 million, new patients per year, 80% of which are non small cell lung cancer.

Matt: This solution will Aid in identifying patients with previously, treated, Advanced or metastatic non-squamous non small cell lung cancer with without actionable genomic alteration. But they are, if detected via this algorithm eligible for targeted treatment with a greater level of diagnostic diagnostic, accuracy that could not be identified by pathologist alone again. Uh, key example of our commitment to deliver innovations that enable more precise diagnosis in oncology and again, and

Bruno Eschli: And with that, hand it over to you, Bruno. Thanks a lot, Matt. And let me just quickly add something on the next slide.

Matt: Example of us putting together. Hi, medical value, Diagnostics and digital solutions to improve patient care.

Bruno Eschli: Summarize here the upcoming events. Teresa already mentioned Pharma Day on the 22nd of September. And then we have one additional event scheduled, which will be an ophthalmology update in the second half of October. This will be linked to data, key data to be presented at AAO. And as you have seen on the Key News Flow slide, we have a couple of new flow items here coming up, like Varmiki Barth, the pivotal study in UME. We also have earlier data in DME and then still the Saturday Sum-Up data in TED as well.

Matt: So with that, I would like to talk about our key launch list for 2025. We have received 4 of those by the half year.

Matt: But I would also uh be remiss not to call out the very recent CM Mark approval of our petal. 181 blood-based rule out test for Alzheimer's.

Matt: This is a test that is the first of its kind in that it has a 93.8% negative predictive value for omalo. Pathology

Bruno Eschli: And with that, I think we're done with the presentations and let's jump into the Q&A.

Matt: and was done in a real world cohort with, 22.5% of patients, having detected omalo, pathology via PET scan

Unknown Executive: The first question goes to Richard Fossler from J.P. Morgan. Richard, please. Thanks, Bruno. Hopefully you can hear me. A couple of questions, please.

Bruno: We're very excited about the potential of this test to change, patient care. And with that hand, it over to you, Bruno.

Unknown Executive: First question, just on the Vizemo. Could you give a little bit more colour on your expectations for the second half? I think we could see increased funding of the foundations and the matching programme. So how are you thinking about a potential of a re-acceleration of the product and the market for branded products in the second half?

Unknown Executive: And then the second question, just on Columbia. Obviously, the FDA panel at the end, the FDA talked about proportion of patients in trials in the US. So just wondering if you could reassure us around the enrolment into the first line trials that they have sufficient US patients. Obviously, it's against standard of care for the US with Polivy in the base. So that's not a problem, but just the US proportion of patients. Thanks very much.

Bruno: Thanks a lot, Matt. And um, let me just quickly add something on the next slide. Um, summarized here, the upcoming events to resell maybe mentioned farmer day on the 22nd of September. And then we have 1 additional event scheduled which will be in Opthalmology update. Uh in the second half of October. This will be linked to data key data to be presented at aao and as you have seen on the key news close night, we have a couple of um uh newsflow items here, coming up. Like by Mickey bar, the pivotal study in ume we also have earlier data and DME and then still the sum up data and Tech as well. Um, and with that um, I think we're done with the presentations and let's jump into the Q&A. The first question goes to Richard Foster from JP Morgan Richard please?

Unknown Executive: So let's start with second half expectations. So as I mentioned, we are expecting roughly 20% growth for Vabaismo in the second half. This is, of course, subject to the caveats that the U.S. environment can be a little bit hard to predict. While we saw a 7% contraction of the overall market in ophthalmology in the U.S. in the first half, what we did see is that Vabaismo continued to grow 3% within that branded space. We're still at 60% in growing naive patients, and so the momentum for Vabaismo continues. So as new patients do come to seek treatment, I think we would continue to see Vabaismo take patient share.

Richard Foster: Thanks, Bruno. Hopefully, you can hear me, uh, couple of questions, please. First question, just, uh, on vice versa, could you give a little bit more color on your expectations, uh, for the second half? Uh, I think we could see increased funding of the foundations, under matching programs. So, how are you thinking about a potential of a re acceleration of the product and the market, uh, for Branded, uh, um, uh, products, uh, in the second half. Um, and then the, the second question just, uh, on Columbia and, uh, trials. Uh, the, the first line trials in dlbcl, uh, obviously the FDA panel, uh, at the end, the FDA talked about, uh, proportion of patients, uh, in trials, in the US. Um, so just wondering if you could reassure us around, uh, the enrollment into the first line trials that they have sufficient us, uh, patients obviously. Uh, it's against standard of care for the US with poly in the, in the base. So, that's not a problem.

Bruno: But just uh the US proportion of patients. Thanks very much.

Unknown Executive: In terms of the number of patients for our first-line DLB-CL trials, so clearly U.S. participation in trials is a key issue that everybody is looking at. We are as well for all of our key clinical trials. Each clinical trial that we run is run in these are large global, you know, multi-center studies, and we're working very closely with global regulators, including the FDA, to ensure that we're enrolling patient populations that are representative. And so we are, you know, we are very much. We are very much working to make sure that our trials have sufficient U.S.

Bruno: Great. Um, so let's start with second half expectations. So as I mentioned, we are expecting roughly, um, 20%, uh, growth for viseo in the second half. This is, of course subject to, uh, the caveats of the US environment can be a little bit hard to predict. Um, while we sized 7% contraction of the overall Market in Opthalmology, in the US, in the first half, what we

Unknown Executive: representation, and I believe that we are on a good path.

Bruno: We did see is to put bismo continued to grow 3% within that branded. Um, within that branded space, we are still at 60% and growing naive patients. And so the momentum for the bismo continues. So as new patients, do come to seek treatment. I think we would continue to see the bismo. Um, take patient share.

Unknown Executive: Okay, Richard, any additional questions? No, I'll leave it there. Leave it to someone else. Thank you very much. Okay.

Unknown Executive: Then next questions go to Michael Leuchten at Jeffries. Welcome back, Michael. Thank you, Bruno.

Unknown Executive: Question for Thomas, please, and one for Teresa. Thomas, I think we've seen in the past that instilling financial discipline onto R&D organizations can have adverse effects in terms of R&D productivity as well. Just wondering how you make sure that that does not happen whilst you drive the discipline into the different areas of R&D, as you outlined. Thank you.

Bruno: First line dlbcl trials. So clearly us, uh, participation in Trials is a key issue that everybody is looking at. We are as well for all of our key clinical trials, each clinical trial that we run is run in the. These are large Global, um, you know, multi-center studies and we're working very closely with global Regulators including the FDA to ensure that we're enrolling. Patient. Populations that are representative. Um, and so we are uh, you know, we are very much. Um

Bruno: We we are we are very much uh working to make sure that our our trials are have sufficient us representation. And and I believe that we are on on a good path.

Bruno: Okay.

Unknown Executive: And then Teresa, thank you for the outlook for the HER2 franchise. There's one data point we're still waiting for, which is the third arm in the DB09 trial. Can you just frame how you think about the outcome there and could that have an impact on how you think about the Progetta trajectory or not?

Richard Foster: Um, Richard, any additional questions?

Richard Foster: Thank you very much.

Speaker Change: Okay, the next question is go to miss that Jeffrey's um welcome back Michael.

Unknown Executive: Thank you. Yeah, thank you very much, Michael, for the question. I'm fully convinced that we have enough money to do what we need to do in research and development. As you may remember, between 2019 and 2022, we moved quite a lot of money into research and development. And one of the things that we've done now over the last few years is really to make sure that that money is allocated to the right locations in a very disciplined way. And, you know, I believe that, you know, there is nothing that is being cut that would impact the R&D in any negative way.

Speaker Change: Thank you Bruno uh question for Thomas please. And 1 for Teresa Thomas, I think we've seen in the past that instilling Financial discipline onto R&D. Organizations can have Adverse Events, uh, sorry, adverse effects in terms of R&D productivity as well, just wondering how you make sure that, um, that does not happen whilst you drive to discipline into the different um, uh, areas of R&D as you outlined.

Unknown Executive: In fact, just to give you one example, it's about our collaboration or partnerships with clinical research organizations. We used to work with 12, 13 different clinical research organizations. And what we've done is we've reduced that to a much smaller number, renegotiated that contract. And now we are working with those in the same, you know, in phase two and in phase three, it reduces the white space time between the cycles, and it reduces the cost significantly. So it increased both the quality , and also the cost effectiveness of the work that we're doing. So this is the kind of work that I think makes a lot of sense.

Speaker Change: And then Theresa, um, thank you for the outlook for the her 2 franchise. There's 1 data point. We're still waiting for, which is the um, third arm in the dbo9 trial, can you just frame how you think about the outcome there that and could that have an impact on how you think about the projecte trajectory or or not? Thank you.

Speaker Change: Yeah, thank you very much. Michael for the question. Uh, I'm fully convinced that we have enough money uh to do what we need to do in research and development. As you may remember between 2019 and 2022, we moved quite a lot of money into research and development.

Unknown Executive: The other things that we've done is, for example, use AI in different parts of the process of R&D, for example, when we put together documents, et cetera, things that used to take a couple of months to put together. We can now do it in days. So these kind of activities really cut out costs in the system and free up the resources to spend it in a more valuable way. And that's why we just reallocate money to things that will actually have an impact at the end for patients. and DB09. I mean, certainly, you know, it's possible that the monotherapy arm could potentially have an impact, but we do actually believe it's going to be manageable.

Speaker Change: And, uh, 1 of the things that we've done now, over the last 2 years, is it really to make sure that that money is allocated to the right locations in a very disciplined, uh, way. And, uh, you know, I I believe that, uh, you know, there is nothing that is being cut, that would, uh, impact uh, the R&D in in any negative way. In fact, just to give you 1 example, um, it's about our collaboration or Partnerships with uh clinical research organizations. We used to work with 12 13 different, clinical research organizations and what we've done is uh We've reduced that to a much smaller number. We negotiated that contract. And now we have working with, uh, those in the same, um, you know, in Phase 2 and in Phase 3, it reduces the white space time between cycles and it reduces.

Speaker Change: The cost significantly. So it increased both the quality.

Unknown Executive: The treatment paradigm in HER2 positive breast cancer is just changing. And there are a lot of moving parts. But ultimately, it's going to come down, I think, to an induction and a maintenance phase. And I think it's in that maintenance phase where we are incredibly well positioned. I mean, when you look at DB09 so far, I mean, we've got 20 percent discontinuation of patients, two deaths due to pneumonitis. So I mean, and in that front line setting, that's that's very concerning to physicians. So I think ultimately, what we're going to see is that in this first line setting, we have an incredibly segmented treatment paradigm during in which our portfolio will very naturally find a significant role to play.

Speaker Change: Speeds and also the cost Effectiveness, uh, of of the work that we're doing. So, this is the kind of work that I think makes a lot of sense. Uh, the other things that we've done, is, for example, use AI in different parts of the, uh, process of R&D. For example, when we put together documents Etc, uh, things that used to take a couple of months to put together, we can now do it in days. Um, so these kind of activities really cut out costs in the system and 3 up the resources to spend it in a more valuable way. And that's why, you know, we we just reallocate money into things that uh, will actually have an impact at the end for patients.

Speaker Change: And uh, dbo9, I mean, so certainly, you know, it's possible that the monotherapy arm could potentially have an impact, but we do actually believe it's going to be manageable. Um,

Unknown Executive: Michael, do you have any additional questions? That's great.

Unknown Executive: Thank you. Okay, then we move on.

Unknown Executive: The next one in the row would be Matthew Weston from UBS. There we go. Thank you. Sorry about the short delay.

Unknown Executive: Two pipeline questions for me, please. The first on phenibrutinib. I see from the slides that you've moved the readout in relapsing remitting MS from 2025 and the second half to 26. Teresa, can you tell us, is there anything meaningful behind that? Or is that just normal clinical trial slippage? And can we interpret that as early 2026 if it was late 2025?

Speaker Change: The treatment Paradigm in uh, her 2 positive, breast cancer is, is just changing. And there are a lot of moving Parts. But ultimately it's going to come down, I think to an induction and a maintenance phase. And I think in in that maintenance phase where we are incredibly, well, positioned. I mean, when you look at dbo9 so far, I mean we've got 20% discontinuation of patients, um, 2 deaths due to pneumonitis. So, I mean and, and, and then that that Frontline setting, that's that's very concerning to Physicians. So I I think all

Speaker Change: ultimately what we're going to see is that in this first line setting, we have an incredibly segmented, um, treatment Paradigm uh during in which our portfolio will very naturally find a a significant multiply

Unknown Executive: And then the second question, you've also said that you'll start the phase two for CT388 plus petrelentide at the beginning of 2026. Can you confirm that you've succeeded in the co-formulation work of those two molecules, and that'll be in a single device, or will that be a phase two using two separate injections at the beginning? Thank you. Great. So to answer your first question about fenobrutinib, no, there are no material changes to the trial, no changes to endpoints. You know, it's it's it's all very consistent. This is really just down to a different recruitment speed for fenhans 1 and 2.

Speaker Change: Michael. Do you have any additional questions? Oh, that's great. Thank you.

Speaker Change: Okay.

Speaker Change: Then, uh, we move on. Uh, the next 1 in the row would be Matthew Weston from UBS Matthew.

Unknown Executive: And so the timing readouts have shifted slightly. We will wait for both readouts so we can communicate both together. And that's likely to be now in early 2026. So certainly within Q1, both pentroliptide and CT88 are currently in phase two studies, and we will need to review the results of those two monotherapy studies before we can share very specific timelines and details for the phase two combination. However, our expectation is that we will be moving into a combo initiation in 2026. We also knew that pentroliptide has a tolerability profile, which makes it really suited to a fixed dose combination.

We go. Thank you. Sorry about the short delay. Um, 2 pipeline questions for me, please. Uh, the First on fenibut nib. Uh I see from the slides that you've moved the readout in relapsing remitting Ms from 2025. In this half to 26. Theresa can you tell us, is there anything meaningful behind that or is that just normal clinical trial slippage? Uh and can we interpret that as early 2026 if it was late 2025

Speaker Change: And then the second question, you've also said that you'll start the phase 2 for CT, 388 plus Patrol and tied uh, at the beginning of 2026, uh, can you confirm that you've succeeded in the co-formulation work of those 2 molecules and that'll be in a single device? Or will that be a phase 2 using 2 separate injections? At the beginning.

Unknown Executive: But that fixed dose is still in development.

Unknown Executive: Matthew, just answer your questions. Yeah, just a very quick one. I totally understand waiting for the two FENHANCE studies. Can you confirm that FENTREPID will be the results, headline results would be press released when we had the PPMS studies and then we'd have to wait subsequently for RRMS? Yeah, no, we will press release that one when the results are in. Perfect. Thank you.

Speaker Change: Thank you, great. So to answer your first question about Center brute know, there are no material changes to the trial. Uh, no changes to end points. You know, it's, it's, it's all very consistent. This is really just down to, um, different recruitment speed for uh, San's, uh, 1 and 2. And so, the time you readouts have shifted slightly, um, we will wait for both readouts so we can communicate both together and that's likely to be now an early, uh, 2026. So certainly within q1, um, both

Unknown Executive: Okay, very good.

Unknown Executive: Next questions go to James Quigley from Dalton Sachs. James. Great, thanks for your technical questions.

Unknown Executive: So two questions for me, one on US policy, one on Hemlibra. So with US policy, the administration was supposed to deliver MFM prices last month, I think it was. So what are the next steps? And how does Roche respond? I mean, Thomas, you're in the press talking about going direct to patients. So how are those discussions going? And what could that look like for Roche?

Speaker Change: Combination. However um our expectation is that we will be moving into uh combo initiation in 2026. Um we also know that Pro lipide um has a a tolerability uh profile which makes it really suited to a fixed dose combination. Um, but that fixed dose is still in development.

Unknown Executive: Also on policy, you haven't updated your guidance on tariffs, whereas a lot of your peers have said that at least for 2025, tariff risk is quite low. So we're intrigued to hear what you say there.

Speaker Change: If you just answer your questions. Yeah, just a very quick 1. I totally understand. Waiting for the 2 F hand studies. Can you confirm that Center? Will be the results. Headline results would be press release, uh, when we had the ppms studies, and then we'd have to wait subsequently for our RMS. Yeah, no. We, we will, uh, we will press release that 1 when the results are in perfect. Thank you.

Unknown Executive: For Hemlibra, there was a big beat in strong performance in the US. You flag penetration in the non-inhibitor group as a potential driver, but when I look at prescription trends and IQVIA data, that seems to suggest around 6-7% constant exchange rate growth versus the 21% you achieved. Are there any other factors that support the strong Hemlibra performance for the quarter, particularly given that you've talked about fluctuation in biome patterns in the past? Thank you.

Speaker Change: Okay, very good. Next question is go to James quickly from Belton sex. James

James: Great. Thanks, B. Thanks for your question. So um 2 questions for me, 1 on US policy, 1 on home Libra. So um with us policy um the the administration was supposed to deliver MFM prices. Uh, last month, I think it was. So what are the next steps and and how does Ross respond? I mean, um,

Unknown Executive: Yeah, so let me answer the first question. And let me start on the tariff question. So what we've also done is obviously move around inventories to make sure that we are protected in case tariffs will come. Also, we've ramped up production of all the different medicines that we already produced in the US where we didn't produce enough. And we started the tech transfer of the one medicine that would be the most impacted. We started tech transfer into the US and hopefully we'll have that done in the not too distant future, maybe end of the year, beginning of next year.

Speaker Change: Some of you, you're in the Press talking about going, direct to patients. So uh, how how how are those discussions going and and how? What could that look like for Rush? Um, also on on policy, you haven't updated your guidance on tariffs, whereas a lot of your peers said that at least for 2025 tariff risk is is, is quite low. So, we intrigued to hear what you say there.

James: And for him, Libra.

Unknown Executive: But then the question is, how long does it take for the FDA to also approve the site? And I think that's where we're also in discussion with the US government at the same time. And I gather that's why you asked the question. So if we are in a pretty good situation in tariffs because we have a lot of production sites in the United States, why didn't we not change anything with the guidance? One of the things that we've definitely learned these days is expect the unexpected. So, you know, you always have to be prepared. And obviously, we prepared for all kinds of scenarios.

Speaker Change: There was a, a big beat and strong performance in the US. Um, you flag penetration in the non-inhibitor group um, as as as a potential driver. But when I look at the prescription Trends and iqvia data, that seems to suggest around 6 7%, constant exchange rate growth versus the 21% you achieved. So are there any other factors that support the strong hem lever uh for the performance for the quarter particularly in the um given that you've talked about fluctuation in buying patterns in the past. Thank you.

Speaker Change: Yeah, so let me answer the first question and let me start on the Tariff question.

Unknown Executive: But I think it's always good to just make sure that you're also thinking about things outside of the usual.

Unknown Executive: In terms of most favorite nation pricing, obviously us and other companies have had interactions with the government on that and with HHS. And one of the things we definitely discussed is this direct to patient model is one of the models because we know that PBMs in the United States take more than 50 percent of the profitability. And that would be one of the easiest ways to impact pricing for the patient without destroying innovation. I mean, at the end of the day, pharmaceuticals is very important for the United States also in terms of national security. And if they want to compete with other countries around the world like China, I think it will be very important that the US continues to invest.

So what we've also done is obviously move around uh inventories uh to make sure that we are protected in case. Uh tariffs will come. Uh, also we've ramped up production of uh all the different medicines that we already produced in the us where we didn't produce enough and we started a tech transfer of the 1, uh, medicine. That would be, uh, the most impacted, uh, we started Tech transfer into the US. And uh, hopefully we'll have that done in a not too distant future, maybe end of the year, beginning of next year. But then the question is, how long does it take for the FDA to uh, also approve the site? And I think that's where we're also in discussion with the US government.

Speaker Change: Of things, uh, outside of the usual.

Unknown Executive: So there are models that could could work. And it's clear that, you know, kind of demonstration projects are the things that the US government is looking at. And so these are the kind of discussions that we have. But clearly, for a bigger change, you know, it would have to go beyond the demonstration project and would have to go through legislative procedures to get to that point. So, yeah, no updates yet on that point, but I think we're in good discussions here.

Unknown Executive: And in terms of HEM Libra, so obviously we saw very significant growth for HEM Libra in the first half. As I mentioned in my presentation, we do expect that to normalize to mid-single-digit growth throughout the full year. The strong half-year performance was certainly influenced by buying pattern both in the U.S. and international. It was no one thing, it was sort of a series of things across different geographies. But we still continue to expect HEM Libra to be growing and to be growing quite strongly globally in 2020.

Speaker Change: Um, on terms, in terms of uh, most favorite Nation, uh pricing. Uh, obviously Us and other companies have had interactions, uh, with, uh, uh, government on that and with the HHS and, uh, and 1 of the things we definitely discussed is this direct. Uh, to patients, uh, model is 1 of the models because we know that pbms in the United States, take more than 50% of the profitability and that would be 1 of the easiest ways to um, um yeah, impact pricing for the, the patients without destroying Innovation. I mean at the end of the day, uh, Pharmaceuticals is very important for United States also in terms of National Security and if they want to compete with other countries around the world like China, I think it will be very important that the US continues to invest, so there are models that could could work. And, um, it's clear that, uh, you know, kind of demonstration projects, uh, are the things that the US government.

Unknown Executive: James, did this answer your questions? It does indeed. Thank you very much, Bruno.

Unknown Executive: And let's move on.

Unknown Executive: And the next one would be Peter Verdult from BNP Paribas. Peter, please. Thanks Bruno, Peter Verdult, BNP.

Speaker Change: Is looking at. And so these are the kind of discussions that we have, but clearly for a bigger change, uh, um, you know, it would have to go beyond the demonstration project and would have to go through uh, legislators, uh, procedures to get to that uh, point. So uh, yeah, no updates yet on on that point but I think we're in good discussions. Uh, here.

Unknown Executive: Just two ones, Teresa, on Giro d'Estren, KOLs we've spoken to have set the bar for CERD in first line menostatic at six months PFS over standard care, is that consistent with Roche's view and can I gauge your current level of confidence on the chances of showing such a benefit in the wild type population?

Unknown Executive: And then Thomas, this is a bit of a long shot, but have you had or got any insights on the proposed Europe or Swiss tariff deal with the US, where the farmer will remain exempt or at least the risk of 200% tariffs or exorbitant tariffs being off the table? Thank you. So in terms of Ghirardestan, I mean, I think, depending who you talk to, you hear a lot of things, but that's sort of roughly in the ballpark of what we would expect, or what we've heard. And in terms of confidence, I think, you know, we've always said that we believe that Ghirardestan is an active, potent, selective CERD, and we're very close to having the answer.

Speaker Change: Right. Um, and in terms of him Libra, so obviously we saw a very significant growth for him Libra in the first half. Um, as I mentioned, in my presentation, we do expect that to normalize to Mid single-digit growth throughout the full year. The strong half-year performance was certainly influenced um, by by buying pattern both in the US International. It was no 1 thing. It was sort of a series of things across across different geographies, but we still continue to expect. Um, hem Libre to be growing and to be growing quite strongly globally. Uh, in 2025

Okay. James, this is your question.

James: Does indeed. Thank you very much, Renee.

Speaker Change: And let's move on. Then the next 1 would be Peter F from BNP par pizza place.

Unknown Executive: So, fingers crossed.

Unknown Executive: Yes, so with regards to the trade negotiations between Switzerland and the U.S. I can say that we are in very close contact with the Swiss government. Some, or at least one third of the pledge that Switzerland has done to the United States actually is from Roche, so the 50 billion out of the 150 billion. And, you know, I guess it's just a question of days, if not hours, before there will be some agreements. So I think it's just a question, a question of time. It's been on the table, I guess. And so there should be an answer, a question to that.

Yeah, thanks Brena. I think it'll be, um, just 211 Tressa on on your desktop. Um, okay. Well as we've spoken to, you have set the bar for third in the first line, man of static. Um, I at 6 months PFS, uh, I was of care is that consistent with what Rogers View and can I gauge your current level of confidence on the chances of showing such a benefit in the, in the world type population. And then Thomas. This is a bit of a long shot but have you go ahead or got anything insights?

Speaker Change: On the proposed year of a Swiss that have deal with the us where the farmer will remain exempt, or at least the risk of, you know, 200% tariffs or exorbitant tariffs on being off the table. Thank you.

Speaker Change: So, in terms of your duster, and I think, uh, depending who you talk to, you hear a lot of things, um, but that's sort of roughly in the ballpark of, of what we would expect, or or what, what we've heard. Um, and in terms of confidence, I think, you know, we've always said that we believe that your dust is a, a, is an active potent selective, third, and we're very close to having the answer. So fingers crossed

Unknown Executive: Now, with regards to Switzerland, I think one of the topics that will most likely be in such an agreement is that Switzerland, when it comes to pharma, will not be in the worst position in any other country in the world. So for sure, the kind of best possible outcome.

Speaker Change: Yeah, so with regards to the uh, trade negotiations between Switzerland and the US.

Unknown Executive: And then, of course, there will be the 232 investigation. And here, we've had a number of discussions with the US government. And, you know, there is clearly this idea that was mentioned before, that there is a transition time for pharma companies to bring molecules into the United States. Again, we are in a very good position, because we already have a lot of manufacturing sites. And we have the capacity, about 50% free capacity because of our cell line efficiencies. And so the one which would be the biggest impact, we have processed that movement. Now, if it's a two year timeframe, that was initially discussed, I think, for us, that would be fine.

Speaker Change: Uh, I can say is that we are in very close contact with, uh, the Swiss government some or at least 1, third, of the Pledge that Switzerland has done to the United States actually is from Rush. So the 50 billion out of the 150 billion and, uh, you know, I guess it's just a question of days if not ours, uh, before, uh, there will be some agreements. Uh, um, so I I think it's just a question question of time. It's it's been on the table, I guess. Uh, uh, and so there should be an answer a question to that now uh with regards to um um Switzerland, I think 1 1 of the topics that will most likely be in such an agreement. Is that

Unknown Executive: But clearly, for companies that would have to start building and own sites, manufacturing sites, that would be difficult, right? But I think, as long as it goes into that direction, and we have not heard anything different, you know, we should be fine. But that's why I always say expect the unexpected, right? That's why we also haven't touched the guidance so far. Because if we have learned anything, the last five years is that you always need to be prepared for anything that could happen.

Unknown Executive: Very good. Very good, thank you.

Unknown Executive: Next on the row would be then Shirley Chen from Barclays. Shirley, please. Shall I? The line is open.

Unknown Executive: Okay, let's maybe quickly first move on then with Emmanuel Papadakis from Deutsche Bank. Emmanuel, please. Thanks. I'll take a couple, please. Question on NXT after the decision to progress to Phase 3 and the data presented at ISTH. I guess the Hemlibra head said will give us clear answers along with the rest of the phase three studies, but I'd be interested to hear your perspective on the anti-drug antibodies. issue we saw in that data set and how that might need to be monitored in clinical practice to manage bleed risk and then maybe a broader Financial Outlook question in terms of margins.

Um, and so the 1, which would be the biggest impact. We have a process that movement. Um, now if it's a to your time frame that was initially discussed, I think, for us, that would be fine. But clearly for companies, that would have to start building an own site manufacturing site. That would be difficult, right? But I, I think, uh, as long as it goes into that direction and we have not heard anything different, uh, you know, we should be fine. But that's why I always say expect the unexpected, right? That's why we also haven't touched, uh, the the guidance so far because, uh, if we have learned anything, The Last 5 Years is, uh, that you always need to be prepared for anything that could happen.

Very good. Okay. Thank you.

Speaker Change: Next 1 on the road would be then. Um, share like Chen from bar, please share it, please.

Unknown Executive: You've just achieved double digit farmer revenue growth in H1. You've emphasized your confidence in revenue growth over the coming years. You talked about keeping R&D flattish. So can you talk a little bit about the margin outlook for the group over the next few years? Is it feasible for us to think about Roche reaching a 40% margin, for example, by the end of the decade? Talk to us about the direction of travel.

Speaker Change: Share like the line is open.

Okay, let's maybe quickly, um, first move on then, uh, with the amount of Papa Duck is from Deutsche Bank and tomorrow, please.

Speaker Change: Thank you. So yeah, I'll take a couple please. Maybe. Uh,

Unknown Executive: Thank you. Yeah, I can I can take the first question. And as you seen this year, we've committed to grow our margins and grow profit faster than sales. The commitment that you have, from my side is that we will at least keep margins stable for the next years. And, of course, we will always try to do better at the end of the day. But the commitment that I can give now in the long term is to keep margins at least stable. and we will update every year of course the guidance in terms of the following year but I think this is the long-term guidance that I can give.

Speaker Change: question on NXT or for the decision to progress to phase 3 and the data presented at ist

Speaker Change: I guess. They have Labor, headed, will give us clear answers, along with the rest of the phase 3 studies. But I'll be interested to hear your respective on the anti-drug antibodies.

Speaker Change: Issue we saw in that data set and how that might need to be monitored and clinical practice to manage, bleed risk.

Speaker Change: And then maybe a broader.

Speaker Change: Financial Outlook question in terms of margins um just achieve double digit form of Revenue growth in H1, you've emphasized, your confidence and revenue growth over the coming years. You've talked about keeping R&D flat-ish so can you talk a little bit about the margin outlook for the group over the next few years? Is it feasible for us to think about rash reaching a 40% margin? For example, by the end of the decade, talk to us about the direction of travel. Thank you.

Unknown Executive: So I'm sure you're familiar with with the specific data of the ADAs. I mean, yes, we did see ADAs in this population, but it's far too soon to know what the actual impact of those are. I think it is something that we'll be watching in in the bigger trials. But but for now, it's not something that we believe necessarily gives us pause. I don't think we would expect monitoring in the real world setting. But again, it's it's we'll need to run the trials to see. Yeah. General, I think ADAs are not uncommon. Exactly. Yeah. I think we have to get more data to really understand the impact.

Speaker Change: Yeah, I can, I can take the the first question and, uh, uh, if you seen this year, we've committed to grow our margins, uh, and grow profits faster than sales. Uh, the equipment that you have, uh, from my side is that we will, at least,

Speaker Change: Keep margins stable for for the next years. And um of course we will always try to do better at the end of the day but um the commitment that I can give now in the long term is to keep margins at least stable.

Unknown Executive: So far, there's no evidence that this is clinically meaningful or, you know, has an impact on the efficacy of the molecule.

Speaker Change: and we will update every year, of course, the guidance in terms of the following year, but I think this is the long-term guidance that I can give

Unknown Executive: Thank you very much.

Unknown Executive: Then let's try again.

Unknown Executive: We'll hand over to Shirley Chen from Barclays. Shirley, please, second try. It seems like we have a technician here. Hi, can you guys hear me now? There we go. Sorry. There we go. Oh, sorry. Thank you so much.

Speaker Change: So I I I'm sure you're familiar with uh with the specific date of the Ada's me. Yes, we did see Ada's in this population. Um, but it's it's far too soon to know what the actual impact of those are. Um, I think it is something that we'll be watching in in the bigger trials, but but for now, it's not something that we believe necessarily gives us pause.

Unknown Executive: Okay, just a very quick one on Actemra. So, you know, grow double digit in the US versus declining high single digit in Europe. So do you have any insights on why biosimilar erosion in the US has been so slow? And do you have any estimation of when this could accelerate? So was Actemra of the lowering of the LRE impact from, you know, 1.2 billion to 1 billion?

Speaker Change: Uh I I don't think we would expect monitoring in the real world setting, um but again it's it's we will need to run the trials to see. Yep.

Speaker Change: General. I think Ada are not uncommon and um, yeah I think we have to get more data to really understand the impact. So far there's no evidence that this is a clinically meaningful or, you know, have some impact on the efficacy of the model.

Speaker Change: Thank you very much.

Speaker Change: Um then let's try again. Um we'll um hand over to Shirley Chan from Park Place. Shirley please. Second try.

Unknown Executive: And then just very quick follow up on the DTC effort in the US market. So last week, I think we saw BMS and Pfizer announced the DTC program for Antiqua. So could you please provide more color on what type of products from, you know, from growth could be appropriate for this type of for this kind of program. Thank you so much. Sure, absolutely. So I think, as I mentioned, you know, we are seeing sort of as we would expect biosimilar erosion for Actemra in Europe, but it has definitely been slower. In the US, this is largely due to supply challenges, we believe.

Speaker Change: It seems like we have a technician. Hi, can you guys hear me now? Sorry. There we go. Yeah. Oh sorry. So thank you so much. Um okay just uh a very quick 1 on on camera so um you know grow double digit in the US versus declining High single digit in Europe. So do you have any insights on why B similar erosion in the US has been so slow. And do you have any estimation of when this took accelerate? So it was um, a camera

Unknown Executive: And just quite frankly, we see Actemra being a little stickier in the US than we might have anticipated. But we would expect that that biosimilar erosion will start to accelerate in the second half of the year. In terms of the BMS Pfizer type direct to patient, I think this is absolutely something that we would consider for the right product in our portfolio. And one might imagine that this could be a really good type of program that you would use with your obesity asset. But not only I mean the other other areas as well where we can do that.

Unknown Executive: But these are these are discussions that we're having with the US government. So I hope it's okay that we don't go into those details right here. Thank you so much.

Unknown Executive: Then next questions come from Sachin Jain from Bank of America. Hi there, thanks for taking my questions. Just a few.

Speaker Change: For this kind of program. Thank you so much. Sure. Absolutely. So I think, as I mentioned, you know, we are seeing, um, sort of as we would expect biosimilar erosion for a camera in Europe, but it is definitely been slower. Um, in the US, this is a largely due to supply challenges we believe. And just quite frankly, we see a camera being a little stickier, um, in, in the US than we might have anticipated, but we would expect that that biosimilar erosion will start to accelerate in the second half of the year.

Unknown Executive: Maybe I can go back on policy, Thomas. You mentioned Demonstration Projects answered to a prior question. So how do you frame the possibility of MFN demo in Part B being announced any time soon? And given your large Part B exposure, is that something you see as a potential risk for 25 within your broad geopolitics comment?

Speaker Change: Um, in terms of the BMS fiser uh type direct to patient. I think this is absolutely something that we would consider for the right product in our portfolio. Um, and 1 might imagine that this could be a really good type of program that you would use with your obesity assets.

Unknown Executive: Secondly, just to follow up on third, potentially, Teresa, I'm going to frame it as Astra's potentially being perceived as being more bullish, Kami Zestrand versus your sort of more balanced comments on Persevera. And some investors have interpreted that as molecule different commentary. So one of you just reappraise this of your views of Kami versus your adjacent molecule differences, and if that drives a different commentary. And then finally, just clarification on your HER2, you pointed to 4 billion peak, and I think your commentary was the majority's first go cap silo. Just wanted to check what your cap silo LOE assumption is within that.

Speaker Change: Yeah, but not only, I mean the other other areas as well where we can do that. But these are these are discussions that we are having uh with the US government. So uh I hope it's okay that we don't go into those details right here.

Speaker Change: Thank you so much.

Speaker Change: Okay.

Speaker Change: And um, next question, has come from such and Jane, from Bank of America, that's it.

Unknown Executive: Thank you.

Unknown Executive: Yeah, let me answer the first question on the policy side. I mean, yeah, what I can say is that, in the first discussions we've had with HHS, I think we had good discussions. There is, yeah, you know, I guess, currently, with all the geopolitical uncertainties that we have, it's very hard to exactly say what's, what's going to happen. But there's no indication that we have, that there would be something substantial that would impact this year for us. And, and, yeah, it doesn't seem like there's something going to be immediate. However, again, and that's why I guess we're always on the cautionary side.

Jane: Hi there, thanks for taking my questions. Uh, just a few. Maybe I can go back on um policy Thomas. You mentioned demonstration project and answer to a prior question. So how do you frame the possibility of the mfn demo in Part B being announced anytime soon and giving you a large part of the exposure? Is that something you see as a potential risk for 25 within your broad geopolitics, uh, comment

Jane: Um secondly just to follow up on Sir potentially through Visa. Um, I I'm going to frame this Astros potentially being perceived as being more bullish, chemistry versus your sort of more balanced comments on persevera. Um, some investors have interpreted that as molecule different commentary, so when if you could just reappraise us of your views of Kami versus your adjacent molecule, uh, differences. And if that drives a different commentary, and the finally just clarification on your her 2, you pointed to 4 billion Peak and I think your commentary was the majority is first to go and Camp. Siler just wanted to check what your cats are at LOE. Assumption is within that. Thank you.

Yeah, let me answer. Uh, the the first question on the policy side. I mean

Unknown Executive: We just have to also be ready to, you know, discuss everything with the government. Maybe anything you want to add to that? No, I mean, I think, you know, as you pointed out, Thomas, anything is possible. But I think, you know, demonstration projects, we would most likely focus on Part D, though it is entirely possible you could see some Part B proposals. I think right now what they're looking for is companies to bring proposals, and there's nothing coming directly, you know, top-down, I would say, from the government. So these are discussions that we're having, but again, yeah, we'll have to see, but, you know, we do believe if something major would come, it would have to go through legislators.

Jane: That's a good discussions. Um, there is

Jane: Uh, yeah, you know I guess currently with um all the geopolitical uncertainties that we have. It's very hard to exactly. Say what's uh, what's going to happen. But there's no indication that we have.

Jane: That there would be something substantial that would impact this year uh for us and uh and yeah it doesn't seem like there's something going to be immediate. However again and that's why I guess we're always on the cautionary uh side. Um we just have to also be ready to, you know, discuss everything with the government.

Unknown Executive: So talking about ghirardustrin differentiation, I mean, I think we've been pretty clear on consistent on this for a number of years. So we believe that ghirardustrin has the highest preclinical potency versus the other oral sorts that are out there. It's well tolerated at all doses with no dose limitations in terms of adverse events. It's got broad development program with head to head trials versus standard of care. It seems very combinable with all the CDKIs. It's shown robust data in sort of early studies and metastatic studies with the copiara breast cancer and acera in breast cancer as monotherapy and a combination with with with palbo.

Speaker Change: Maybe anything you want to add on to that? Um no I mean I I think you know, as you pointed out Thomas, anything is possible. Um, but I, I think, you know, demonstration projects we

Speaker Change: Would would would most likely uh, focus on Part D, though? It is entirely possible. You could see some Part B proposals.

Unknown Executive: So I think, you know, we are it seems to be an active molecule and seems to be one that is combinable. And at this juncture, we're at a place where now we are just. Waiting to see how the data read out.

Speaker Change: As possible. Yeah but I think right now what they're looking for is companies to bring proposals agreed, uh, and there's nothing coming directly, uh, you know, top down I would say from the government. I think it's probably true. So so these are discussions that we're having. But again, um, yeah, we'll, we'll have to see. But, you know, we do believe if something major would come. It would have to go through legislators. Yeah. Agreed. Agreed.

Unknown Executive: In terms of CAD-SILA, we actually don't see any biosimilars in the works for CAD-SILA right now. So, so far, there's been no evidence that someone has a CAD-SILA biosimilar in development. Sachin, did these answers help? Thank you. OK.

Unknown Executive: Next one in the row is then Justin Smith from Bernstein. Thank you, Bruno. Could I just ask one on TL1A, please? Could you just talk about the lessons learned from Etrelizumab and also how confident the company is that it can recruit enough patients from the US for the phase three to satisfy FDA? So I think we have definitely taken a hard look at the Etro-Luzumab lessons learned and have applied all of that learning into the TLNAs or into our TLNA program. It is just fundamentally a different molecule. It's a different pathway. I think we're really enthusiastic about this.

Speaker Change: Um so talking about your industrial differentiation, I mean I think we've we've been pretty clear on consistent on this for a number of years. So we believe that gear dust run has the highest pre-clinical potency versus the other oral surg that are out there. It's well tolerated at all doses with no, uh, dose limitations, uh, in in terms of Adverse Events, it's got broad development program with head-to-head trials versus standard of care. Um, it seems very combinable with all the cdk eyes, um, it's shown, uh, robust data in in sort of early, uh, early studies and metastatic studies with The copier, uh, breast cancer and, um, aera in breast cancer as monotherapy and accommodation with with, uh, with Paolo. So, I think, you know, we are, uh,

Speaker Change: It it seems to be an active molecule and seems to be 1, that is combinable. And at this juncture, we're at a place where now we are just

Speaker Change: Waiting to see how the data read out. Um, in terms of CAD Silo, we actually don't see any bad uh we don't see any biosimilars in the works for CAD Silo right now. Um, so so so far, there there's been no evidence that someone has a kilo uh, bio similar in development.

Speaker Change: Such entities. Thank you. Okay.

Unknown Executive: It's a very well-defined biological rationale in IBD. And so I think it's just a little bit of a different bet than Etra was. And in terms of US populations, yes, or US patients, yes. Enrollment in this trial has actually happened at quite a good clip. And we're seeing good interest and pickup from the US patients. Recruitment is going very, very well. It may be also important, I think, to add that our U.S. recruitment was also impacted significantly by the COVID pandemic. So I think this was an exceptional situation, I think, which is no longer a problem today.

Justine Smith: Next 1 in a row is then Justine Smith from Bernstein, Justin.

Justine Smith: Thank you, Bruno. Um, can I just ask 1 on tl1a please? Um could you just talk about the lessons learned from ralis and then also how confident the company is that it can recruit enough patients from the US for the phase 3 to satisfy FDA.

Speaker Change: So I think we have definitely taken a hard look.

Unknown Executive: Justin, any additional questions? All good. Thank you, Bruno.

Unknown Executive: Then next one is Simon Baker from Redburn. Simon, please. Thank you, Bruno. Two quick ones, if I may. Firstly, going back to Ocrevus and Zenova, Teresa, you said 50% of US patients on Zenova are Ocrevus naive. Could you give us a little bit more colour on where they're coming from? Are these patients from existing sites that were using IV or is this opening up territory that wasn't previously being addressed by Ocrevus? And then a second question for Alan on the participation certificate announcement. In doing that, that will bring you in line with other Swiss companies which have a bearer participation dual structure and they are doing buybacks.

Speaker Change: Essence, learned and have applied, all of that learning in into the tnas, OR into our tiene program. Um, it is just fundamentally a different molecule. It's a different pathway. I think we're, we're really enthusiastic about this. Very well-defined biological, uh, rationale in in, uh, IBB and so it, I, I think it it is, it's just a little bit of a different bet than than Etro was, and in terms of us. Populations. Yes. Or us patience. Yes. Um, and enrollment in this trial has actually happened at quite a good slip and we are, uh, you know, we're seeing good interest in pick up from the US patients. Recruitment is going. Uh, very, very well.

Speaker Change: Maybe also important, I think to add that our low us recruitment was also impacted significantly by the co pandemic. So I think this will receptional situation, I think which is no longer

Speaker Change: Just in any additional questions.

B: Okay, thank you, B.

Speaker Change: Then uh next 1 is Simon Baker from Redbarn Sim, please?

Unknown Executive: So is that the right way to read it, that a buyback is now theoretically possible? And if it is, are you able to seek permission to repurchase shares at the 2026 AGM at the same time that you're seeking permission to change the share class? Excellent.

Unknown Executive: So, happily, with regards to your Okervus question, the answer is yes and yes. So we are definitely seeing our existing large academic centers adopt Zenovo as a more convenient option for their patients, but we are also seeing it open up patient population or patient access in more in community neurologists who have more limited IV capacity. So we're seeing pickup in both places and adoption in both places. And there are just some really neat stories out there. If you've ever been to an infusion room, patients talk. And so, you know, you'll see a patient come in to get their Zenovo shot and you'll see another patient turn around and say, hey, what are they getting?

Speaker Change: Participation dual structure and they are doing BuyBacks.

So, is, is that the right way to read it? That a buyback is now theoretically possible. And if it is, are you able to seek permission to repurchase shares at the 2026 AGM? At the same time that you're seeking permission to change the share? Plus thanks a lot.

Unknown Executive: You know, why did they get to get out in 10 minutes? And so, you know, as you start to see it really pick up in these centers, I think we would expect to see an acceleration of both switches and new patients coming on.

Speaker Change: Uh, so happily with regards to your ochre of us question, the answer is yes and yes.

Speaker Change: So, we are definitely.

Unknown Executive: Yeah, share buybacks, good question. I think share buybacks were possible in the past. I think we know that. I think on one hand, we did the big transaction with Novartis, as you know, I think that that was one move, which proves that and the other move is, you know, that we fuel our equity compensation programs by buying back Indus China in the market. So I think basically, that that has been possible. That's not changing with participation certification. But that's not the way to go. Because you know, we lost the dividends, we pay 8 billion in dividends every year, which is quite significant, even a significant impact on our cash side.

Speaker Change: Seeing large academic centers adopt and Novo as a more convenient option for their patients. But we are also seeing it. Open up, patient, populations or or patient access in more uh in in community neurologists who have more limited IV capacity. So we are we're seeing pick up in both places and adoption and both places and there are just some really neat stories out there. Um if you've ever been to an infusion room patients talk and so you know you'll see a patient come in to get their zenova patient turned around and say hey what are they getting? You know, why did they get to get out in 10 minutes?

Speaker Change: um, and so, you know, as you start to see it really, uh,

Unknown Executive: So I don't expect for the time being no change to that past. Simon, your question is answered. Yes, thanks so much for that. OK, and we move on. Steve Scala from Count. Steve. Thank you. Two questions. First on elevides, has Roche's safety experience in Envision and Enville trials mirrored what has been seen in the U.S. trials? And are any safety events not being disclosed? So that's the first question. Second question is on Trontinumab. What are Roche's plans for a prevention trial? Lily seems quite encouraged by the opportunity. And if they are successful, Roche would seem to be at a competitive disadvantage.

Speaker Change: Pick up in these centers. I think we would expect to see an acceleration of both switches and and new new patients coming on

Speaker Change: Yeah, she had 5x put to a good question. I think she had 5x were possible in the past. I think we know that. I think on 1 hand, we did did as a big transaction with no as you know, I think that that was 1 move which proves that and the other move is, you know, that we fuel our Equity compensation programs uh, by buying back into China in the market. So I think basically that that has been possible that's not changing with the participation certification but that's not the way to go, um, because you know, we love the dividends. Yeah. We pay 8 billion in dividends every year which is quite significant even in significant impact on our cash side. So I don't expect for the time being no change to that party.

Unknown Executive: Or do you not believe that prevention holds promise? Thank you. So I would say in terms of prevention, stay tuned. More to come on that at a later date. And in terms of elevities, patient safety is the number one most important thing to us as a pharmaceutical company. And whenever we have relevant safety information, we are the first to report it. So I would say, you know, we don't know anything different from what is available in the public domain today. Please, let us answer your questions. Yes, thank you. Then we hand over to Luisa Hector Birnbach.

Kevin, let's sit down your questions answered. Yes, thanks so much. Bye. Okay. And uh, you move on. Um, Steve Scala from count. Steve.

Speaker Change: um,

Unknown Executive: Luisa, please. Thanks, Bruno. Hi, everyone. Just a couple of questions left.

Steve Scala: Thank you. Uh, 2 questions. First on LEDs has Roshes safety experience in Envision and, and both trials, mirrored. What has been seen in the US trials and are any safety events, not being disclosed. So, that's the first question. Second, question is on Tron tinmen trial? Lily, seems quite encouraged by the opportunity and if they are successful rosh, would seem to be at a competitive disadvantage or do you not believe that. Prevention holds promise. Thank you.

Unknown Executive: So could you please comment on the situation with IRA and how subcutaneous formulations may be treated? Some discussion about them not being considered unique, which obviously has a read into a number of products for you. And then on Astagolumab in COPD, were you surprised at the mixed success of the two trials? And do you think you have an understanding of the reason for the mixed results? Thank you. Sure. So I'll start with ASCII. So I mean, obviously, it's always disappointing when you have a trial that sort of doesn't that that isn't positive. I mean, obviously, we would have needed both of these trials to be positive.

Speaker Change: So I would say in terms of prevention, stay tuned, um, more more to come on that, at a later date and in terms of elevators. Um, patient, safety is the number 1, most important thing to us as a pharmaceutical company and whenever we have relevant safety information, we are the first to report it. Um, so I would say, you know, we we don't know anything different from what is available in the public domain today.

Speaker Change: This sounds just a question. Yes, thank you.

Speaker Change: And uh, we hand over to Lisa. Ha burbach Lisa, please.

Unknown Executive: And in order to have an in order to have a path forward. Was I surprised? I mean, I would say that COPD is a notoriously difficult disease. And we chose to do an all comers trial. We, we, we looked at all of the endophilic blood status, we looked at smokers, nonsmokers, because that, frankly, is the unmet need in in the, you know, in the world. These are the patients that walk through the doors of physicians who need an option and don't have one. So we always knew that this was a big swing, particularly given that we, you know, we had only limited phase two data to move forward on.

Lisa Hurbach: Thanks Bruno. Um, hi everyone. Um just a couple of questions left. So could you please comment on the situation with IRA and how subcutaneous formulations uh may be treated? Um some discussion about them not being considered unique which obviously has a read into a number of products for you and then on asked to go a map in COPD? Were you surprised at the the mixed success of the 2 trials and do you think you have an understanding of of the reasons for the Mixed results? Thank you.

Lisa Hurbach: Sure. So I'll start with asking so I mean obviously um it's always disappointing when you have a trial that sort of doesn't

Unknown Executive: So, you know, this was a pre-bar trial. It was something that certainly was a reasonable, a reasonable bet to make given kind of what we knew about the mechanism of action of Astagolimab, the unmet need in the market and the competitive need to move very quickly. But I think, you know, we've always communicated that this was a high risk, high reward trial. And I think, unfortunately, it kind of read out on on the it read out on the negative side in terms of IRA. And yeah, and Sanofi had a similar surprise. In terms of IRA and subcutaneous formulation, this is actually an open question and so we keep monitoring and so far we believe that subcute isn't going to be impacted, but that could honestly, that could honestly change.

Unknown Executive: I think this is an evolving situation. Thank you, thank you. Then the next questions come from Sarita Kapila, my understanding. Sarita, please. Hello, sorry, can you hear me? Yes, we can hear you. Yeah, perfect. Just a quick one on obesity, please. Could you help frame the competitive profile of petrolintide given the positive developments we saw from Lily's amylin and ADA, so the 11% weight loss at week 12? Do you still believe that the DACRA is a meaningful differentiator? And then it looks as though GLP-1 pricing may be coming down more sharply and quickly than previously anticipated.

Lisa Hurbach: Um it it was something that certainly was a reasonable uh a reasonable bet to make given kind of what we knew about the mechanism of action of as tool and that the unmet need in the market and the competitive need to move very quickly. Um but I think you know we've always communicated that this was a high-risk High reward trial and I think unfortunately it it kind of read out on on the it read out on the negative side in terms of Ira and yeah and and and to know if you had a similar surprise

Lisa Hurbach: Um, in terms of iron simultaneous uh formulation this is actually an open question. And so we we keep monitoring and so far we believe that subq isn't going to be impacted. But that could honestly uh that could honestly change. I think this is a an evolving situation.

Lisa Hurbach: Visa.

Unknown Executive: So are you confident that you have the manufacturing scale, the Revit wall expertise to compete versus a Lily Novo? And then very quickly, we've seen a lot of encouraging data for PD-L1 VEGFs in lung cancer and a flurry of acquisitions in the space. Given your kind of leadership in biospecifics, is this a mechanism that Roche could potentially pursue? And I'm sorry, I missed the first part of your last question. It was about PD-L1 VEGF and the acquisitions we've seen in the space and whether Roche would be interested. Yeah, sure. So as Thomas often says, we look at thousands and thousands of deals a year.

Speaker Change: Thank you. Thank you.

Speaker Change: Then, um, the next question's come from Sita capolow.

Deadly: My name is deadly.

Unknown Executive: And, you know, certainly oncology is a focus area. But you know, we look at many, we look at many different, many different oncology mechanisms and mechanisms and other diseases. So I won't comment on any specific one at this juncture. In terms of scale to compete in obesity, absolutely. In fact, we intend to break ground at the end of August on our manufacturing site in Holly Springs, which is a high volume, high throughput facility, which is, you know, very specifically designed to support our obesity portfolio. We were very aware of the likely pricing dynamics in the space and our sort of our plans are fully geared in order to compete in that arena.

Sita: Sita please. Hello sorry. Can you hear me? Yes, we can hear you perfect and just a quick 1 on Obesity. Please could you help frame the competitive profile of Petrol in tide? Given the positive developments we saw from Lily's amalin and Aza. So the 11% weight loss at week 12. Do you still believe that the darker is the meaningful differentiator? And then it looks as though glp1 pricing may be coming down more sharply and quickly than previously anticipated,

Sita: So are you confident that you have the manufacturing scale, the rebate will expertise to compete versus a lily Nova and then very quickly, we've seen a lot of encouraging data for pdl1 veg in lung cancer and a flurry of Acquisitions in the space, given your kind of leadership in by specifics. Is this a mechanism that row could potentially pursue

Speaker Change: Um, and and I'm sorry I I missed the first part of your last question.

Unknown Executive: In terms of petrolentide, we absolutely believe it remains highly competitive and has the potential for differentiation on tolerability, quality of weight loss, or as a second line option for patients who have discontinued or can't tolerate incretin therapy. I think we, we believe that there is potentially the, you know, a real opportunity for petrolentide to be a best in class asset and that's why we move forward with it. Sarita, any additional questions? No, that was it. Thank you very much. Then next one will be Rajesh Kumar from HSBC. Hi there. Thank you for taking my question.

Speaker Change: Uh, it was about pdl1 Vega and the Acquisitions we've seen in the space and where the rush would be interested. Yeah, sure. Um, so as Thomas, uh, often says, we look at thousands and thousands of deals a year, um, and you know, certainly oncology is a focus area, but, you know, we we look at many, we look at many different, many different oncology, mechanisms and mechanisms, and other diseases. So, um, I won't comment on any specific 1, uh, at this juncture.

Unknown Executive: So Very helpful run-through of how you apply your GoNoGo framework to PRASI. You know, helped us understand how you're prioritizing high-risk assets in the context of your portfolio. I can see that being applied to NXT007, potentially lower risk than PRASI. Can you just, in a similar vein, explain how you applied that framework to another higher-risk asset, Torontonian Maps? Sure. So I mean, I think if you look at the, you know, the qualifications, I mean, there's clearly a high level of unmet need with Alzheimer's disease. There's clearly the opportunity for best in disease performance based on what we've seen with our phase two data in terms of the ability to drop plaque, and to do it very quickly and very safely.

Speaker Change: In terms of scale to compete in obesity. Absolutely. In fact, we intend to break ground at the end of August, on our manufacturing site in Holly Springs, which is a high volume High throughput facility, which is, you know, very specifically designed, um, to support our obesity uh portfolio. Um, we were very aware of the likely pricing Dynamics in this space and our our sort of our plans are fully geared in order to compete in that Arena. Um in terms of petrol and tied,

Speaker Change: We absolutely believe it remains highly competitive, and has the potential for differentiation and tolerability quality of weight loss. Um, or as a second line option for patients who have discontinued or can't tolerate important therapy? Um, I think we we believe that there is, uh, potentially the, you know, a real opportunity for petrol to be a best-in-class, uh, asset. And that's why we move forward with it.

Speaker Change: Any additional questions. Know that was it. Thank you very much.

Speaker Change: Yeah.

then um,

1 uh, will be

Speaker Change: Grayish Kumar from HSBC, right?

Speaker Change: That's uh, thank you for taking my question. So uh,

Unknown Executive: We've seen in our phase twos that it is a highly developable molecule with a very, very acceptable safety profile. And there's certainly a very large patient population and so therefore a very large commercial opportunity. So I think when when you look at Tranti, we didn't, you know, while Alzheimer's is a very, very difficult disease, there seems to be there seems to be a very clear, very clear rationale mechanistically, we see a highly developable molecule, we see an area with significant unmet need, we see potential for best in disease, and we see a large market opportunity.

Speaker Change: Very helpful to run through of how you uh, apply your go noo framework to prai um you know, helped us understand how your prioritizing high risk Assets in the context of your portfolio. Uh, I can see that being applying applied to NXT 00007 potentially lower risk than proxy. Can you just uh, in a similar way and explain how you applied uh, that framework to not a higher risk, asset Tron map?

Unknown Executive: So this one, this one gets screen checks across the board. And it's the prudent foundation targets. Yeah. Sure. Well, I think when you look at our obesity assets, those are, again, those are very proven, as Thomas mentioned, those are very proven foundational targets. We think we have a lot of external data that would suggest that these drugs are going to work. And we have our own internal data that suggests they're going to work and potentially be best in disease. Again, very large, very large potential markets. So you know, those are certainly we would consider relatively more de-risked assets.

Speaker Change: Large, uh patient population. And so therefore a very large commercial opportunity. So I think when, when you look at tanty, um we didn't, you know, while Alzheimer's is a very, very difficult disease. Um, there seems to be there seems to be a very clear, uh, a very clear rationale mechanistically, we see a highly developed molecule. We see an area with significant unmet need, we see potential for best of disease and, and we see a large Market opportunity. So this 1, this 1 gets screen checks across the board and it's the proven foundation on targets. Yeah.

Unknown Executive: TLNA, very, very well understood foundational target in multiple immunological diseases. Again, diseases with significant high unmet need, large patient populations. It's a very well characterized molecule coming out of phase two studies. So its developability characteristics are very well understood. So again, I think we think of that as being a lower risk, a lower risk molecule, next 007, and a significant market opportunity as well. So I mean, I think there are a number of things in the portfolio that very clearly balance out, you know, the bigger swing on something like a prosthenes map. Dr. Hildreth Yeah.

Oh, okay. No, that that's very helpful. Just in terms of the risk profile, just the therapy area. Generally has a higher level of risk. And then you said that the risk was better managed at a portfolio level. So if I look at the Next Generation portfolio, Gotti NXT 00007, so 1, low risk and then you got 2, high risks. So what are the other lower risk which makes the portfolio level risk a lot more manageable?

Unknown Executive: And I would add petrolentide. I think that's also a quite de-risked foundational target now, based on all the totality of the data, including the data from Zealand. Again, if you look at Alzheimer's, I think, you know, and you look at the data, the incredible removal that you see with transinemab and the very low ARIA rate. I mean, this can be really transformational. One of the reasons why you don't see this pickup of the current Alzheimer's medicines is because of the high level of side effects. Very clear. And any synergy between the Alzheimer's strategy and the obesity strategy, especially, you know, given, you know, Novo is already running an Alzheimer's trial, any thoughts there?

Sure. Well, I think when you look at our obesity assets, um those are again, those are very proven, uh, as Thomas mentioned, those are very proven, foundational targets. Um, we think we have a lot of external data that would suggest that these drugs are are going to work. And we have our own internal data that suggests, they're going to work and potentially be best in disease. Again, very large uh very large, uh potential markets. So you know those are certainly we would consider relatively more de-risked assets to

Speaker Change: L1a very very well. Understood foundational Target in multiple immunological diseases. Um again diseases with significant High unmet need large patient populations. Um, it's a it's a very well-characterized molecule coming out of phase 2 studies. So it's developable developability characteristics are very well understood. So again, I think we think of that as being a lower risk, a lower risk molecule, um, next 007 second opportunity, but in a significant Market opportunity as well. So, I mean, I think there are a number of things in the portfolio that very clearly balanced out. Um, you know, the bigger swing on on something like a pro news map.

Unknown Executive: Yeah, maybe I can answer that. I mean, that was exactly the strategic rationale when we said we are going to acquire the common assets and why we're going into this area as well. On the one hand, we do believe that the common assets are differentiated because of the way they bind to the receptor and there's no receptor internalization, so you have a longer durability. So there is an opportunity to differentiate here. Then there is the opportunity to differentiate with amylin, but we also know that there are about 200 comorbidities. And if you look at areas like Alzheimer's or Parkinson's, there is potentially an opportunity for combining some of the assets.

Speaker Change: Yeah and uh I would add control linta. I think that's also a quite uh de-risked National Target now based on all the totality of the data including in the data from uh from Zealand. Yep. Again uh if you look at Alzheimer's, I think uh you know and you look at the data, the incredible Club removal that you see with printed them up and the very low area rates. I mean, this can be really transformational 1 of the reasons why you don't see this pickup of the current. Also my medicines is because of the high level of side effects.

Speaker Change: Yep. Okay. Clear. And any synergies between the Alzheimer's uh, strategy and the Obesity strategy, especially, you know, given uh, you know, so Novo is already running an Alzheimer's trial, any thoughts there?

Unknown Executive: And here again, we can differentiate versus some of the other areas because we just have more assets in our portfolio. So we do believe that if we segment the markets in the future, there will be segments like that that we can also go after. And if we didn't have these in our portfolio, that would be more difficult.

Unknown Executive: Very clear, thank you. I think with that we move on to our final participant here in the queue, which is William Wood from Riley Securities. William, please. So all of our details will be shared on July 27th. So either buy a ticket to AAIC or make sure you show up at Pharma Day and we'll give you all the details. Yes, unfortunately you have to wait a bit longer. Okay, very good.

Speaker Change: Yeah, maybe I can, I can answer that. I mean that was exactly the Strategic rationale when we said we are going to acquire the common assets and why we're going to into this area as well, on the 1 hand, we do believe that the common assets are differentiated because of the way, uh, they bind to the receptor and there's no reception internalization. So you have a longer, uh, um, durability. Um, so there there is an opportunity to differentiate here. Um, then there is the opportunity to differentiate with Amazon, but we also know that, you know, there are about 200 comorbidities, and if you look at areas like Alzheimer's or Parkinson's, uh, there is uh, potentially an opportunity for for combining, some of the assets and here again we can differentiate versus some of the other areas because we just had more Assets in our portfolio. So we do believe that, you know, as we segment the markets in the future, there will be segments like that that we can also go.

Speaker Change: After and if we didn't have these incredibly, you know, portfolio that would be more difficult.

Speaker Change: Very clear. Thank you. I think with that we um move on to our final um participant here in the queue which is a William wood from Riley, Securities William plays.

Unknown Executive: I think with that, we are through all the questions. And I would like to hand back to Thomas for a closing remark. Thomas, please. Yeah, thank you very much to the team for the excellent work this year. And thanks to all of you for attending today's meeting. Again, I think we're making a lot of progress when it comes to our pipeline, on the one hand, by moving a number of molecules from phase two to phase three, but also by filling up our pipeline with more de-risked assets, and also higher value assets. And you can see that also when I showed the numbers on the value of our pipeline, which is clearly increased.

William Wood: Thank you, Bruno. I appreciate you taking our questions. Uh 2 from us on table was hoping you could actually just set our expectations for the tri data updates coming at AIC and and how that may uh have informed your team to go straight to phase 3 any color you could provide on your phase 3 Tron, Tier 1 and 2 design duration and or dose levels. Uh, and how you think about induction versus maintenance would also be greatly appreciated?

Thomas Schinecker: And also when we look at our internal PTS calculations, we already see that kind of trend as we go into the next years of readouts. You've seen in diagnostics, we have had amazing launches last year, but Keep watching out on the secret technology that we're going to launch next year. It's going to be great. Lastly, I just want to say we are delivering on sales and profits as we promised. And I would say even we're over delivering and you can be sure that we will continue to deliver. We'll stay disciplined. We'll stay focused and we'll stay fast so that we continue to deliver what we say we're going to do.

William Wood: Longer.

Thomas Schinecker: Thank you very much.

Okay, very good. I think with that we are um, through all the questions. Um, and I would like to um hand back to Thomas for a closing, remark Thomas, please. Yeah, thank you very much, uh, to the team for the excellent work this year and thanks to all of you for attending today's meeting again. I think we're making a lot of progress when it comes to, uh, pipeline, uh, on the 1 hand, um, by moving a number of molecules from Pace 2 to phase 3, but also by filling up our Pipeline with more de risk assets and also, higher value assets. And you can see that also, when I showed the numbers on the value of our pipeline, which is clearly increased. And also, when we look at our internal pts calculations, we already see that kind of trend as as we go into the next years of of readouts. Um, you've seen in Diagnostics, we have had amazing launches last year, but keep watching out on the secret technology that we're going to launch next year. It's going to be great.

William Wood: Um, lastly, I just want to say, we are delivering on sales and profits as we promised, and I would say, even we're over delivering and you can be sure that we will continue to deliver. We'll stay disciplined. We'll stay focused. And we'll stay fast. So that we continue to deliver what we say we're going to do. Thank you very much.