Roche Holding AG

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Thank you very much and hello to everyone. Good morning, good afternoon, wherever you are. I'm really looking forward to sharing our happy results with you today. Now, let me take you through this slide first. We've had a very strong growth in the first half year. Group sales increased by 8%, excluding COVID by 5%, excluding COVID by 8%. And specifically in the second quarter, as you will see in a second, we had significant growth of 9% overall. Pharma is growing very well in the base business with 8%, diagnosis growing 9%. Both the COVID-19 sales decrease and also the LOE impact are both in line with guidance. The sales decrease in COVID-19 is 0.8 billion and also the LOE impact is 0.6 billion. There was not much COVID impact in the second quarter. Co-operating profit increased by 11%, so significant growth here due to good cost management and shifting resources within the organization. With that, our group core operating margin increased almost two percentage points. Our core EPS grew 9% and also our operating free cash flow grew 9%. We've achieved a number of key milestones in the second quarter. On the regulatory side for pharma, the EU approval for Ocrevus subcut in RMS and PPMS, Alicenza in adjuvant out-positive non-muscle lung cancer, US approval for the bismuth pre-filled syringe and PSGi in PNH, and also an FDA label update to Sosfimo in AMD. And also here we filed for DME and diabetic retinopathy. We have EU filing for Olivius in DMD, and we also have filing for Innovalisip, and we hope to get approval for Innovalisip in November this year. We also had a couple of positive pharma readouts, specifically in obesity space. On the diagnostic side, we had a number of launches here as well that will be covered by Matt, C703 in ISE for the core lab, a segment that's growing very strongly for us. The Colbert-Leard respiratory panel, which received FDA EUA approval. Cobus Pro serology solution, a market that we've not been in, the biggest market in the world for blood screening in serology. We're now entering that space in the US. The continuous glucose monitoring for diabetic patients, then also a number of tests that we've actually launched or received breakthrough designation that time period, and also the HP self-collection solution for the FDA. We have a number of trials and launches still ahead. On the phase three side, for example, gocyba and lupus nephritis. Phase two enabling readouts in Alzheimer's with tritonamab, PRASI, and others. For example, also the phase two data for our obesity medicine in diabetes, the CT868. On the diagnostic side, again, a number of launches still to come. I would like to highlight the mass spectrometry system, which is going to really revolutionize how mass spectrometry is done in hospitals. Here you see the sales growth. Again, great growth in both divisions, 5% overall growth. And if you exit COVID, really a significant high single digit growth. Here on the left-hand side, you can see the sales development over the last four and a half years in the total sales. Between 2020 and 2022, we had total COVID sales of 19 billion. We were the first company to develop diagnostic tests, and we also developed or brought to market two medicines that helped fight this pandemic. So we were a significant contributor. In 2023 and Q1 2024, we still had an impact then as the COVID was washing out. But if you look at the underlying growth, the underlying growth that you see on the right-hand side was really picking up, picking up in the last 1 and 1 half years. We went from somewhere low to mid single-digit growth to high single-digit growth over these 1 and 1 half years. See in 2023, we had 8%, Q1 7%. And now in Q2, we have even 9% growth. And as we mentioned before, there is no COVID impact in Q2 and you can see how these two curves now merge and we have 9% growth overall for the group in the second quarter. Again, looking at the same on a divisional level, you can see that on the pharma side, the base business growth has really accelerated over this time period. On the diagnostic side, we've always been growing seven to eight and now 9%. So we've delivered very solid growth in this division over a pretty long period of time. And we've now pretty much washed out most of our COVID impact there. Let me talk about some key drivers in Roche portfolio and specifically also the pharma portfolio. Diagnostics will be covered by Matt, but clearly some significant launches in Q2 and upcoming launches that are going to support the growth of this division going forward. On the pharma side, let me start with oncology in orange. Here, I received approval for adjuvant R-positive non-small cell lung cancer in the EU and the US. And it's now also included in the NCCN guidelines as category one. We already talked about the breakthrough therapy designation for in the illicit. And the BDUFA date is 27th of November. On the hematology sides with HemLibra and Columv, HemLibra, we have the autoinjector in development. We've previously updated you on that. And we had a positive readout, phase three readout in second line DLBCL here with our bispecific. Our neurology franchise, where we're number one, is doing very well. We've received EU approval for subcut in Ocrevus, and we are waiting for the approval in the US for subcut. The BDUFA date is September 13th. We've also published positive five-year data in type 1 SMA. Xolea, we've had the positive readouts for food allergy, and we see really strong pickup. We already treated more than 15,000 patients, and we do expect that this is going to contribute to growth this year and also next year. Babaismo, what can I say? Doing fantastically well. There is really a strong momentum here, and this momentum will be further supported by, on the one hand, the US approval of the pre-filled syringe, also by the four-year follow-up data in DME, but also as we get more and more approvals or indications around the world, this will continuously support our growth rate. Let me also say we don't see any impact from the J-code in 1st of April in the US for the Regeneron molecule. And also SOSFIMO gives us another option, first now in AMD, but we want to take that also into other indications. And I already covered diagnostics. Let me just highlight four key launches in diagnostics. One is the ISE NEO and the COBRA C703, which gives us up to 100% higher throughput, really important for the large labs around the world. And with that, we are really solidifying our big advantage that we have over other companies when it comes to our portfolio. We've completely, over the last years, rejuvenated our core lab portfolio And we bring new systems to the market, mass spectrometry being one of them, which can be integrated into the Cobus Pro solution. And there's a synergy effect and a pull through because this is also going to support a growth rate in clinical chemistry and immunochemistry. And we already see that, and there's really a high desire for customers to have that. If they could take it with them after they see it, they would have. Unfortunately, it's too heavy for them to put it into their suitcase, but I can tell you we're definitely open to take orders. Continuous glucose monitoring space for diabetes, one of the biggest growth markets. We now bring in a solution that is differentiated in terms of the algorithms. So really excited to see that. And that should give us new momentum in diabetes care. Lastly, next generation sequencing, we're making very good progress. And we believe we have a really differentiated solution compared to what's on the market today when it comes to throughput and cost position. Now, let me just briefly highlight some progress on our key strategic initiatives. We've revised our 10-year goals, which we wrote out in the beginning of the year. We've revised our group strategy, which we've discussed with the board this week, and which we have also worked with others. with people in our company. So this is being rolled out. The same goes for the pharma strategy, where we clarified the 10-year direction in our five therapeutic areas, which are the ones we always show to you as well. In the diagnostic side, we actually refined our strategy in 2020. And at that time, we shifted about 500 million Swiss francs in R&D to development of certain assays, really high medical value assays, and also technologies. really accelerating some of these activities like mass spec, CGM, next generation sequencing point of care. And you can see that paying off with all the launches that are coming through in diagnostics. On the digital side, we really focused our digital health efforts setting peer priorities on really making our core business stronger with digital solutions on how we can differentiate. Also focusing very much in generative AI, where we have some key people in our organization that are driving that forward and with some partnerships, for example, with NVIDIA. On R&D Excellence, and I have an additional slide on that, we set a clear roadmap on how to achieve our productivity targets. You see a lot of the activity that we've done over the last months. We're really focusing our portfolio on best indices and first in class assets. We're augmenting our pipeline by bringing in great assets from the outside. And with that, we can accelerate the key assets where we believe this has the biggest opportunity and we can gain a lot of speed. Additionally, we are constantly working on operational excellence. So I believe that there are plenty of opportunities to still become a more efficient organization without losing any innovation and just making sure that the money that we have available, which is enough, is really focused on projects that will deliver impact. Just very briefly, and you will get much more of an update on R&D excellence and all the fantastic progress that has been made in the autumn. But just along these six areas, we set very clear and ambitious R&D objectives. And these are triggered into the bonus system and MBOs for our people. And we've defined clear roadmaps on how to achieve these productivity levers. We've already last year defined the bar. So the bar is five criteria that each molecule needs to have in order to be worth being in our pipeline. And we constantly assess our pipeline to this bar. This has meant also that we have stopped a number of assets. But we've also brought in assets. We're also accelerating other assets. So you can really see that we are managing our portfolio really holistically, and you can expect us that this is now kind of routine. We established end-to-end governance, really making sure that our organization works seamlessly between the different R&D engines, also that we have high gates so that as we move things into the different phases, we have de-risked assets much earlier. We've accessed some of the best external innovation. We're really optimizing our R&D engines and looking at investing into technologies like generative AI. But there's definitely opportunities to become even better in this, and it's a big focus. The other focus was around talent and culture and mindset, really bringing some of the best people into the organization to make sure that we have key people for the five different disease areas. And we rolled out a high-performance organization concept in the beginning of the organization, really differentiating also performance and pay. Now, let me give you a brief outlook. Over the last nine years, we've launched 20 new medicines. PSKI is the last one, the C5 inhibitor. This has been launched in China, Japan, and the US. We will continue to roll it out in other countries. We will also continue to expand into other indications. In a Melissa, I believe I've covered already, fantastic new medicine, fantastic data. And it has received prior review by the FDA and breakthrough therapy designation, really showing that this is a really great molecule. We'll take it into earlier lines, but also into other cancers. So there is a big opportunity here with Invalicit. On the right-hand side, you can see our pharma sales and how much of the new product, what's the percentage of the contribution from the new portfolio? And you see that keeps increasing. With Ronapref going out, the increases would have been even higher if that wouldn't have gone out. Now, we have a number of key growth drivers on the pharma side and on the diagnostic side. On the pharma side, we all know pharma, there are certain risks in development. Only one out of 10 medicines at the end makes it. Even in phase three, only about 70% to 75%, if you look at the industry average, actually makes it through phase three. So not all of them will make it, but we're confident that with what we have in the pipeline and what we'll continue to add to the pipeline, that we can continue our growth momentum. On the diagnostic side, let me just say here projects are de-risked much earlier. And in fact, the last year before the launch is really mostly a handover from manufacturing, from R&D to manufacturing. So there is not a lot of risk in terms of the pipeline here. Let me just highlight some of them. We mentioned also in the recent release pterogolimab, where we had disappointing data in Sky6. Here, this is about Sky1, but we have reviewed our pterogolimab program. We've had two more programs that we've stopped, and you can be ensured that we will be diligent around this as well. In Olisip, I mentioned Diverisip. We highlighted at ASCO that we have a phase three start here against some competitive molecules. We believe this is potential best in disease. I mentioned the filing in the EU. So we've received the conversations were very positive with the regulatory bodies. was disclosed also that, unfortunately, that phase two didn't work. But it's good that we did risk in the phase two. So that's exactly what we want to do. And we know that geographic atrophy is very hard to treat disease. I don't think I have to cover a lot about obesity. And I'm sure you have a number of questions about that. I already mentioned the launches on the diagnostic side. Really excited how this is developing. We have a very positive outlook for 2024 with a continued strong growth in our base business. There's not so much COVID effects anymore and also the LOE impact is less. So we can confirm our guidance on the group sales. And we do believe that with the momentum we have, this will carry us into 2025 as well. Overall, I mentioned the sales, but we increase our core EPS outlook to now high single digit growth in core EPS because of the strong momentum that we have in terms of operating profit growth as well in the strong cost control. And you can imagine that we're shifting a lot of funds to really make sure that the money is put to good use and in places where we have the biggest impact. I still see opportunities to continue to do that. so that we will continue to, in this year, increase our margin and for future years, at least maintain, if not extend our margins. With that, I hand over to Alan, that will give you a bit more of a deep dive into the finances.

Thanks, Thomas. Yeah, I think you've seen the great sales dynamic. And when you bring that together with reasonable resource allocation, I think you end up with great results. And I think that's what we've shown the first half. And before I dig into this, let me do a little bit of advertising. about the upcoming IR events. There's a lot going on. I think really September, big months for us and a great month to look forward to. We will share full data of the positive phase one for CT3 at eight, so the injectable on the obesity side and also phase one CT996, so the oral in obesity at the European Association for the Study of Diabetes. See that on the slide. And that's followed by the traditional pharma day with updates on the group strategy and the pharma strategy. So surely also an update on R&D excellence. And then in October, we will share the Trontinumab phase one to be expansion core data in Alzheimer's disease at the clinical trials on Alzheimer's disease conference. Good, let's get into the results. And I think it's really a great set of numbers. So let me start on the sales side. And Matt and Teresa will do a great deal to dig deeper into the sales. So let me mention again, the 5% growth in constant rates, 8% when you exclude the COVID impacts. You see the cooperating profit up 11%, even 4% when it comes to Swiss francs. I think great momentum here from good cost, cost control, resource allocation, prioritization. And then you see really the core net income with 8% increase. So where is the mitigation of dynamic coming from? And that comes on one hand from the financial result, higher debt on a balance sheet, therefore higher interest charges. And second is taxes. There's the minimum tax in Switzerland, the pillar two top up tax, which certainly led to higher tax charges. And then you see the cornered income to core EPS, 9%. So we have a higher dynamic in the core EPS. Theresa will talk about sugar, I'm sure, in Japan. And there certainly we see a reduction in sales coming from COVID. On top of that, really, I think the contribution from sugar was a bit lower compared to Japan. The first half 2023, and that leads to a higher dynamic in core EPS. IFRS net income impacted by impairments with the minus 4%. And then the operating free cash flow looks so boring with 8 billion in both half years. But in fact, we overcompensated an impact coming from EPS. last year, we had an inflow from Rona brief of about a billion. And I think we compensated this first half. So really, really strong cash generation. Free cash flow with the plus 1%. Why do we lose dynamic compared to the operating free cash flow? That's clear because we have shifted last year a tax payment from the first half to the second half. Good. Very quickly on the sales bridge for the group. What you see is from left to right, you see half-year 2023 with 29.8 billion. You see half-year 2024 with the 20.8 billion, certainly in constant rates, plus 5%. And then you see really the dire base business with the increase. You see the dire COVID sales impact of a minus 242 million. Then you see the significant impact from the former portfolio vary positively here. Then you see what we lost on the Rona brief sales, 518 million, and then the loss of explosivity at 600 million. If you added that together, you come to a minus 1.4 billion, which worked against us half year to half year. When you look really at the P&L, I think really 5% sales growth, 11% corporate profit growth, which I mentioned a couple of times, already in constant rates. When you look at the absolute number, it's 1.5 billion and the corporate profit of 1.1 billion. And when you go through the lines, let me go through that first. I think in the other revenue, that's Van Clexta and that's also Xolia with the great data on food allergies, which certainly helps us here. You see the cost of sales was a minus 168 million. Both divisions had significant volume increase. So the group plus 10%, DIA plus 4%, Pharma plus 13% even. And we have a very reasonable cost of sales increase with 2%. Nevertheless, we had an effect from last year. Last year, we released a provision at half year, COVID-related provision of 276 million. If you were adjusting for this, cost of sales would have even gone down. So I think very, very good cost control in that line. Same applies to R&D. We know we have a relatively high R&D level. Nevertheless, you see really both divisions were very focused on applying here a very, very reasonable allocation of resources. And we move on as we have really higher impacts now coming from other from other compounds. And therefore, I think in the portfolio makes a lot of sense. SG&A driven by M&D. M&D increased by 111 million and explains the growth that you see here. That means automatically corporate and administration were flat, even a slight decrease here. So also here, well-applied cost control. And then really other operating income and expenses was a minus 212 million, minus 30%. You know, we sell our tail end products where we have lost exclusivity really after a certain period. We do that on a very regular basis. In the first half of 2024, we had lower gains on divestment proposals of 225 million. So that explains that number very well. What is remarkable is when you take the release of the provision, the cost of sales line of 276 million, which was a base effect from last year, And you take the reduction of gains of product divestments of 225 million. That's a 501 million, which basically worked against us. So when you take that into account, you see how strong these results really are. Okay, with that, I think the margins, I think I have to mention that I think margin really went up with plus 1.9 percentage points in constant rates. Pharma division went up with roughly one percentage point and the diagnostics division was a strong plus 3.3 percentage points. As Thomas has said, ambition is very clear, really maintaining with that level somehow and then really defending the margin moving on. So I think a great step forward here. Coronet financial results deteriorated by 276 million in Swiss francs. When you get concentrates, a minus 306 million. Major drivers, obvious, high interest expenses. We have done M&A last year of about 10 billion. You will see that mirrors certainly on the debt side. That's the major driver here. I think all the rest are more minor impacts. When you look at the core tax rate, quite a story. We went from the effective tax rate 16.9% half year 2023 to 17.3% half year 2024. And we have two components. One is the impact of the Pillar 2 top-up tax, so the minimum tax, which was applied in Switzerland. relatively proactively, I have to say. You see now a 1.8 percentage points impact here. So slightly higher than the 1.5 percentage points. Why is that? Well, we have paid a little bit more in the first half than we will pay in the second half. So I think that's one element here. What is certainly nice to see is a reduction on our, let's say, normal corporate tax rate of 15.5% compared to a 16.9% at half year 2023. And here the major impact is really profit distribution in the group. So that's a little bit of an unusual setup that we're having here. Let me say, you know, I mentioned that the group tax rate should go to 19.5% on the full year. I think that's perhaps more on the higher side. Perhaps 19% is a better figure at this stage, but very clear there will be a little bit of a rebalancing of the effective tax rate. Okay, core EPS development. Well, you see the plus 8.9% on top, which is the 9%, which we all have mentioned multiple times. And I think this 9% is certainly a great indicator why we thought really bringing up the guidance for core EPS makes sense, especially for the second half. You see that comes from operations doing very well. Then the product disposal that I've mentioned was the minus 225 million. Financial income and expense in totality was a minus 306. And then the tax rate change was a minus 176. Yeah, really working then against us. Okay, non-core, on the non-core side, well, starting with the cooperating profit plus 11, then the global restructuring plans, I would argue basically in what we have done also last year, 100 million more. You see really the impairments of intangible assets with the minus 803 million. I would argue that's very well related to what we do in R&D excellence. So cleaning up the portfolio, looking really what should be there, what shouldn't be there, making also room to put other stuff into our R&D budget. M&A and the alliance transactions was a minus 32 million, some carbon costs playing into this. And then legal and environmental, I think we had a major release of a provision last year related to a legal case that didn't come back in 2024. And then I think when you put everything together, you see the IFRS net income with a decline of minus 4% in constant rates, minus 11% interest rates. OK, let me get to the cash flow. Very important for us as we want to do more M&A and we want to control the debt level, want to control the interest charges. So I think really, really good when we generate more cash. And we do, as you can see, you see really on the left hand side, 7.7 billion half year 2023 in constant rates. And then you get on the right hand side to the 8.4 billion half year 2024 in constant rates. And you see the bridge here. I think the operative performance is just great with plus 1.2 billion. You see then the net trade working capital movement with a minus 487 million. That is the effect from the Rona brief inflow that we have seen in the first half 2023. Certainly, we had positive effects against this. And I think all the other effects are not very significant. Given a good cash flow development, you see the foreign exchange impact even is relatively reasonable. On the cash flow side. OK, so how about that? And when we look at the debt level on end of and that's now an end year and look at the end of 2023 with minus 18.7 and we look at half year 2024, that's an increase of 6.9 billion. And very clearly, you see in between what it was driven by. On one hand, well, good operating free cash flow generation. I've talked about that. We paid taxes of about 2 billion. We paid the dividend of 7.9 billion. And then we had M&A of 2.5 billion. And that M&A of 2.5 billion, that's Karmat. We paid Karmat the 3.1 billion US dollars, 2.7 billion Swiss francs in the first half of 2024. So let me also mention the gross debt on the balance sheet is 34.4 billion. Okay, balance sheet, I think I can cut that short. The increase in assets is coming from Karmat, goodwill of roughly a billion, intangible assets of roughly 1.8 billion. And then you see really the liabilities going up, the current liabilities and the non-current liabilities. That's the debt increase I've talked about. OK, with that, currencies on everybody's mind. I think really we see a little bit light at the end of the tunnel. But well, very clearly, I think currency rates are volatile. We can't control them. But what you see is when you look really at the impact on sales in Q2, it was a minus two percentage point. So while we see the impacts get smaller for half year, a minus five percentage points, a minus seven percentage points on cooperating profit, a minus eight percentage points on core EPS. If you remain all the currency rate stable until year end, you see really smaller impact. So for full year, a minus three percentage points, a minus five percentage points for cooperating profit and a minus six percentage points for core EPS. And you see on sales, based on that modeling, we expect even zero impacts. So I think it all goes in the right direction. We had a strengthening of the yen yesterday. So I think that all helps us a little bit. Let's see how it comes out at year end. I think Thomas talked about the guidance very clearly, the group sales growth with min-cycle-digit sales growth. I think a couple of topics in the second half, which I think really we have to take into account, and then the core EPS, I think just a derivative of the performance that we have had in the first half. I think we have excluded here the impact from the resolution of the tax disputes in 2023, which was – A story of the second half of 2023, the impact was 774 million in constant rates, so quite significant. So please take that into account. But this is very well in line, the structure of the guidance as we have started the year with. Good. And I think with that, I'm happy to hand over to Teresa.

Great. Thanks, Alan. So let's start by taking a closer look at the sales for pharma in the first half of the year. So year to date, pharma sales reached 22.6 billion, growing at 5% at constant exchange rates, at 8% without Ronaprev. All regions, excluding Japan, delivered very strong growth. As has been alluded to, sales in Japan were impacted by a base effect of about 600 million Swiss francs in Ronaprev sales in Q1 of last year. Excluding Ron and Preve, Japan declined at 5%, and that's primarily due to mandatory price cuts. And as Alan just alluded to, overall farmer volumes were up by 13%. Core operating profit increased by 7%. At constant exchange rates versus 5% sales increase with an impressive margin of 50.5% here. Let me quickly take you through a little bit more detail in the different P&L lines. So other revenue increased by 14%. That was primarily driven by, as Alan mentioned, profit share income from higher sales of Zoller outside the U.S. and Van Clexta in the U.S., Cost of sales increased by 5%, but that was all driven by last year's release of the COVID-19 provisions. Without that, cost of sales would have actually declined, which is pretty impressive on a 13% volume increase. R&D costs remain stable. You can see that 1% increase in SG&A, as Alan mentioned, that is entirely driven by M&D, and that is all in support of our new launches. And in terms of other operating income, this decreased by 35%, and that was really entirely due to lower gains on disposals of products. So now what is driving that strong growth? So as Thomas alluded to, our young best in disease portfolio continues to deliver for us. Our key brands, Vibismo, Fezgo, Okravis, Polivi, RISD, Hemlibra, they delivered an additional almost $2 billion in the first half of the year. Vibismo maintains strong growth trajectory, consistently exceeding market expectations. Fezgo continues to grow very impressively. And Fezgo is on track. I'm sorry, Polyvia is on track to become a blockbuster by the end of 2024. I want to touch quickly on to centric here, if you sort of scoot down to the to the bottom part of the chart. So you can see here that the decline into centric is actually being more than made up for by the growth in international and in Europe. Going forward, we expect to centric to grow in a low single digit range. As we see sort of more increased competition is going to begin to reach peak and some of our key indications like HCC and small cell. While we're on the topic of Dicentric, I'll also mention our sub-Q formulation. We are seeing good uptake following the EU approval, especially in the UK, where the conversion rate has already reached 32%, and we are expecting EU approval, I'm sorry, US approval later this year. So now let's jump into Solid Tumors. This franchise has total sales increased by 2% to 8 billion Swiss francs in the first six months of the year. In terms of key news, as Thomas mentioned, I'm happy to highlight that Innovalisib received FDA breakthrough designation and was granted priority review. with the PDUFA of the 27th of December. And in parallel, we have also completed the EU filing. Let me just take a minute to remind you that end of elicits phase three data and first line PI3 kinase mutated hormone receptor positive breast cancer demonstrated a very strong PFS benefit. with a hazard ratio of 0.43, and that we are going to keep investing here to realize the full potential of this best-in-class medicine in hormone receptor-positive breast cancer, where we do see about a $2 billion peak sales opportunity. Moving on to the HER2 franchise, which again clearly outperformed consensus expectation with Kedsila growing year to date by 6% and Fezgo growing year to date by 60%. That strong growth momentum for Fezgo just continues. The global conversion rate currently stands at 41%. You may be looking at that and saying, well, that looks the same as we saw in Q1, and that is correct. In Q2, we added another five launch countries to the calculation of the global conversion rate. So that's why the rate remains stable. However, if you actually look at the rates in earlier launch countries, we do continue to see that conversion increase. A great example is the U.S., where we are up from 24% in Q1 to 26% in Q2. We also continue to see an overall further penetration in HER2-positive breast cancer in general. So if you take Fesco and Progetta together, and this bodes well for a scenario in which you see more than 50% of Progetta sales being converted to Fesco by 2026. Alicenza remains the global market leader in first-line ELK-positive non-small cell in all major markets and has grown 7% year-to-date. In Q2, we received EU approval for the adjuvant setting, and in addition, a recent NCCN guideline update included Alicenza as a category recommendation for this indication. Going forward, we expect to see low single-digit growth for Alicenza, with the adjuvant setting overcompensating for competitive impact that's expected in first-line. Thomas already mentioned that unfortunately the phase two, three skyscraper six study of tiragolumab and first line non-squame did miss its co-primary endpoint and that study was discontinued. Thomas also mentioned that based on these results, we took a close reevaluation of any of the ongoing trials with tiragolumab and decided to close two additional studies. That's the phase three skyscraper 15 and adjuvant non-small cell. And the SKY-5, which is a phase two and neoadjuvant and neoadjuvant-adjuvant non-small cell. All other trials and other indications have either already completed or are already fully enrolled or close to full enrollment. And so those trials will continue as planned. On the outlook, you'll see several things coming up for the remainder of the year. I'm quickly going to touch on here on diviracib, our potentially best-in-class KRAS G12C inhibitor, which will enter pivotal head-to-head phase three versus the first generation of KRAS inhibitors and second-line non-small cell. And so with that, let's switch to hematology, where growth continues to be strong, and we now stand at 3.8 billion in sales with 10% growth. Hemlibra in the US and EU5 patient shares have climbed to 41%, and we've now treated over 26,000 patients globally. It was great to see the US returning to a positive growth of 3% in Q2. As you might remember, it was impacted by a... by sort of buying pattern in Q1 as well as some competition impact. For the remainder of the year, we expect low to mid single digit growth in the US and mid single digit growth overall for Hemlibra. From a demand perspective, we've seen the first signs of patients switching back from long acting factor eight to Hemlibra. And in Q2, we also provided an update at ISTH announcing the development of a new auto injector for Hemlibra, which will bring additional administration options for our patients. Polivi and first-line DLBCL is further expanding its patient shares. The U.S. is now up to 26%. That's 3% increase from Q1 and has already been used for more than 30,000 patients globally. Let me point out here that the Q2 growth rate for Polivi was impacted by a one-time pricing effect in Germany. And overall, we expect those peak sales to remain at about 2 billion for Polivi. I'm going to talk more about Starglow on the next slide, so I will just quickly touch here on Lunsumio and the fact that we are excited about the positive phase, the positive data for subcutaneous formulation and third-line follicular lymphoma. This sub-Q formulation has all the benefits of the already available IV formulation, including no need for hospitalization, fixed treatment duration, but on top of the convenience of administration, it also seems to require less steroid use. We plan to file and subcut the second half of 2024 with global regulators. Thomas already touched on the PSKI US approval in PNH, EU approval expected in second half. And let me just mention that we see the real upside for PSKI in novel indications and particularly things like the ongoing development in small cell. I'm sorry, in sickle cell. So now let's have a closer look at the Starglow results. So Columbia plus Gemox almost doubled the median overall survival versus the comparator arm or the hazard ratio of up 0.62, reducing the risk of death by 41% for second-line DLBCL patients. Median PFS increased almost fourfold, and there were also almost twice as many complete responses with Columbia Gemox. The safety profile was consistent with the individual study drugs, and this novel combination could offer a very important option for patients who aren't eligible for CAR T-therapy, which is more than 50% of patients in that second line. And we are looking forward to filing these results with global health authorities later this year. Moving on to neurology, our neurology franchise achieved $4.6 billion in sales for the first half, representing an impressive 13% growth. Okravis' strong growth momentum continues at 8%, driven by all regions. Not only is Okravis the market leader in the U.S. and the EU, but it has also reached a milestone of 1 million patient years of cumulative exposure. Furthermore, our six-month subcutaneous formulation has received EU approval, and U.S. PDUFA is set for the 12th of September. Again, this is two times per year, 10 minutes to treat your MS. We expect that Okravis subcut represents an incremental $2 billion in sales opportunity, and we expect this to be increasingly visible in the coming quarters as we are already starting to see some strong pickup in our very early launch countries in the EU. Evrizdi growth increased by 25% in Q2. That's largely due to a significant tender in the international region. The outlook for Evrizdi remains positive. After we became the market leader in terms of patient share and total patients treated in Q1, we expect the full-year growth to be in the high teens. With regards to new follow-up data, as Thomas mentioned, in Q2, we presented the five-year data for children with type 1 SMA, and these results just again validate Evrizio's strong efficacy and safety profile and really underscore why it has become the market leader. Excitingly, for our DMD gene therapy, Elavides, we have completed the EU filing. We have already achieved registration or achieved approval in six countries ex-US. We have booked the first sales for Elavides of 29 million. We remain very excited about this treatment, and we're looking forward to bringing this important medicines to patients as soon as possible. Looking forward, there is a lot coming up in neurology, including Fetabrutinib for MS. We are planning to share the 48-week data, more 48-week data from the Phase II Phenopt trial at ECTRIMS. This will be the first look at relapse data as well as updated MRI data. including T1 and T2 lesions, so definitely something to look forward to there. For trontinumab and AD, we have the updated phase 1-2 data that will be shared at CTAD. This data set will contain more than 100 patients with longer follow-up from the original dosing cohorts and the first data from the extension cohorts. As communicated, we do expect that we will have sufficient data from trontinumab and AD by Q1 to make decisions on whether or not to take this molecule into phase 3 studies. Let me also quickly mention, as Thomas did, the phase two Padova readout for Prazi in Parkinson's, which is now scheduled for Q4 and should definitely be considered high risk, but would also be extremely high reward as there really has been no advances for these patients in many, many years. Moving on to immunology, total half-year sales reached 3 billion, which represents a 1% increase at constant exchange rates. The highlight here is clearly Zolaire and its recent launch in food allergy. With only four months on the market, we already have more than 15,000 patients on treatment. We expect growth in the second half to further accelerate to reach around 20%. We expect this strong growth momentum to be carried forward into 2025 with year-over-year growth rate in the teens. Actemra sales grew slightly in the first half at 3% as biosimilars in the EU experienced a slower than expected rollout. However, we do expect that to accelerate now in both the EU and the US in the second half. And in terms of the outlook, I think most of you know, I'm personally very excited to see the phase three results, the Regency study of gaziva and lupus nephritis, which we expect for Q3. And I'm very pleased to announce that our trials in TL1A and IBD are to be initiated UC in Q4 and Crohn's disease in Q1. Additional indications where we've taken a development decision and where we will be initiating phase two studies will be announced at the upcoming Pharma Day at the end of September. Moving on to Ophthalmology, our Ophthalmology franchise has reached 1.9 billion in half-year sales with an impressive growth of 54%. The Vibismo market share just continues to grow despite the J-code for the ILEA high dose being received in April. We've now reached 27% in AMD, that's up from 24%, 19% in DME, up from 18%, and RVO is now at 15%, up from 8%. This holds true for the dynamic update seen in other early launch markets. In the UK, we see shares of AMD at 29%, France at 19%, Germany at 15%. So the momentum for Vivizimo just keeps building. Importantly, as Thomas mentioned, in Q2, we achieved FDA approval for the pre-filled syringe, which has the potential to ease the administration procedure. And we expect to receive that approval in the EU as well. And just a few days ago, we presented four-year Ronex follow-up for Bovismo in DME at ASRS, which confirms Bovismo's strong safety and efficacy profile. So as Thomas mentioned, the SUSFIMO commercial relaunch in the U.S. is already commencing. I'll talk a little bit more about that in the next slide. But in terms of outlook, We've got the Vibizimo EU approval and RVO and the filing approval of the pre-filled syringe in the EU, and then the readout of two phase two monotherapy studies, two phase two studies, one in monotherapy and one in combination for IL-6, the Mickey Bart and DME, which will help inform future development programs in that area. So now let's take a closer look at SUSFIMO. So as I was saying, we are in the midst of launching SysVimo and AMD in the U.S. with plans to relaunch XCUS in 2025 and beyond. SysVimo, as you know, uses our port delivery platform to enable continuous VEGF delivery versus an intraocular implant, which is clearly preferred by patients over IVT. This approach has demonstrated strong efficacy and safety across AMD, DME, and diabetic retinopathy. And for AMD, long-term follow-up data shows that benefits are sustained even after 144 weeks. On the right side of the slide, you'll see that we've completed filing for two pivotal phase three studies in the U.S., Pagoda in DME and Pavilion in diabetic retinopathy, and additional clinical trials have either been restarted or initiated. We have the phase three B velodrome study assessing every nine-month dosing for sesfimo in AMD, and then the initiation of the phase one to burgundy study with our new bispecific inhibitor of VEGF and ANG2 in AMD. So now switching gears to our emerging assets in obesity, we have reported some early positive phase one top line data for both the weekly injectable CT388 and our oral CT996, with both assets showing a potential best in class profile. CT388 showed a strong placebo adjusted weight loss effect of 18.8%. at week 24 with safety and tolerability consistent with the class. Phase two development, which will now test optimized titration schemes in obese patients, will be initiated in Q3. CT996, our once daily oral, showed a strong placebo Adjusted weight loss effect of 6.1% at week four. Again, safety and tolerability are consistent with the class, and we would expect to start that phase two in obesity in 2025. Additional data for both assets, as Alan mentioned, are planned to be shared at the EASD, and we have the accompanying IR event there as well. So before I close out with the usual news flow side, I wanted to highlight our efforts to strengthen the pharma pipeline. You will have seen this slide from previous quarterly updates. And in Q2, we have again had some turnover on the NME side. We have removed four NMEs, three in oncology and one in CVRM due either to new data or NMEs that just simply don't meet our internal bar. And on the other side, three NMEs were added, two in oncology and one in immunology. In oncology, we added the anti-CMET ADC after entering into a collaboration and licensed agreement with MediLink Therapeutics. And in addition, we moved our second allogeneic CAR-T molecule targeting CD19, CD20 into the clinic, and that is in partnership with Poseida. Overall, we've now terminated 25% of our total NMEs since Q2 of 2023 when we announced our R&D Excellence Program in order to focus on more high-impact programs like many of the ones that we have just covered. So to close off this section, let's have a quick look at our 2024 key news flow. There have been a lot of green check marks added since we last presented this slide in Q1, both for regulatory milestones and clinical results. I have covered quite a number of these things on previous slides, but let me mention a few that I haven't. The phase three Verona readout for Venclexta and first-line MDS has moved to 2025. And unfortunately, as Thomas mentioned, I also have to share that the phase two study of ASO factor B and geographic atrophy missed its primary endpoint. In alignment with our partners in Ionis, we have decided to stop this particular trial, but ASO factor B does remain in development in IgA nephropathy with the phase three imagination study, which initiated recruitment in Q3 of last year. We do look forward to some very exciting additional clinical milestones in second half, particularly, as I mentioned, gaziva and lupus nephritis, PRASI and PD, TRONTI and AD, all of which could be significant therapeutic advances for patients, as well as hitting our remaining regulatory milestones. We are looking forward to sharing all of these results with you in due course. And now I will let Matt guide you through our diagnostics.

Thanks, Teresa. So good morning, good afternoon, everyone. It's my pleasure to present the results for diagnostics for the first half of 2024. As you already heard from Alan and Thomas, with sales of 7.21 billion Swiss francs, the diagnostics division sales increased by 5% or 0.3 billion Swiss francs at constant exchange rate. Now, this increase is mainly driven by the strong business growth of 9% in our base business and partially offset by the decline of COVID-19 testing sales, which, as you heard, are washing out of our numbers going forward. For full year 2024, we have guided for mid to high single-digit base business growth, and I would continue to reinforce our confidence in this performance of our base business and confirm we'll be on the higher end of this range. So if we dig into the different product areas, I'd like to give you a little bit more color on these results. Sales in our core lab business increased by 10% with very strong momentum driven by immunodiagnostics at plus 11%, as well as clinical chemistry at plus 8%. Our molecular lab business increased at 3% due to strong growth in our blood screening business, plus 13%. Our virology-based business, also at plus 13%. And this was offset by the lower COVID-19 PCR lab-based testing sales. So excluding all COVID-19 cells, molecular lab is growing strongly at plus 9%. Our new customer area, near patient care, had a decline of negative 14%, and this is mainly due to lower sales of COVID-19 rapid antigen testing, as well as the decline of our blood glucose monitoring business due to the market shift to continuous glucose monitoring, but would note that we're very much looking forward to the launch of our first continuous glucose monitoring system in the next couple months. Sales in our pathology lab grew strongly at plus 17%. And this is mainly driven by advanced staining reagent growth, as well as our companion diagnostics business, which grew at 46%. So let's take a step back and look at the growth across the different regions. And excluding the COVID-19 business, we see strong base business growth across all of our regions. So North America, which grew at 5%, including COVID, grew at 11% in the base business. And you heard Thomas mention where we just recently got approval for our serology blood screening business there. We've already started to win the first contracts, and we look forward to seeing momentum there in the very short term. In EMEA, the base business, excluding COVID-19, grew at plus 5%. So you see a very small difference between the overall growth of plus 4% and plus 5% in the base. Asia Pacific, as you can see, grew at plus 3%, excluding COVID-19, grew at plus 6%. And Latin America, with growth of plus 16%, grew at plus 18% in the base business. So now I'd like to walk you through the diagnostics P&L line by line. So core operating profit on sales of 7.21 billion Swiss francs increased by 22% at constant exchange rate. Our cost of sales declined at minus 1%, and this is mainly driven due to product mix, particularly lower sales of COVID-19 rapid antigen tests. R&D costs increased at 1%, with a focus on investment in upcoming late-stage launches, such as mass spec, continuous glucose monitoring, and our nanopore sequencing program. SG&A increased at plus 5%, and this is driven by higher distribution costs due to increased sales volume, as well as commercial costs. And this resulted in a core operating profit of 1.58 billion Swiss francs, with a margin of 22% at reported currency. Now, you heard a little bit from Thomas earlier about some of the exciting launches we had in the second quarter. And one of the ones that I'm particularly excited about is in our core lab, where you saw that strong growth, our C703 clinical chemistry, as well as our ISE NEO. Now, we know that laboratories around the world are under pressure in terms of staffing constraints. What I would call out is both of these next generation instruments require 56% less calibration, and once per month regularly scheduled maintenance. But at the same time, they have the same laboratory footprint and deliver twice the throughput of the previous generation. That's 2,000 clinical chemistry results per hour. That's 1,800 ISE results per hour. That is really important as we start to really consolidate the market in the very high throughput end of the laboratory. And this is where the opportunity really lies for this instrument. It rounds out the full launch of our Cobos Pro high throughput configuration. And in summary, this is a system designed with the needs of the modern lab in mind. High throughput, less hands-on time, lower regular maintenance. And so now I'd like to talk about another exciting launch in our near patient care portfolio. And that is a launch of the EUA authorized LIAT respiratory mini panel. This includes the four respiratory viruses most commonly presenting in primary care, as well as the physician office. That's respiratory syncytial virus, flu A, flu B, and COVID-19. And what I would call out is this, our Liat system is going to deliver a gold standard PCR result in 20 minutes. That's more than twice as fast as the leading competitor. And I would note that we have an install base of 13,000 Cobos Liat systems, 8,000 of which are in the U.S. And we look forward to introducing this test well in time for the respiratory illness season in the northern hemisphere. And I would also note that we are continually going to expand the menu on Liat because we see this as an important driver of our business going forward. OK, staying with near patient care, now I'd like to talk a little about our launch of our AccuCheck SmartGuide CGM. On July 10th, we received TUF authorization for our first continuous glucose monitoring solution. And just to remind everyone how we are differentiated from other solutions, we are offering the real power of knowledge to people living with diabetes. And we do that by having predictive algorithms embedded in our solution. That's a two-hour glucose prediction algorithm as well as an overnight glucose prediction algorithm. This is important because it allows people living with diabetes to make important decisions about their health to live better and healthier lives. And so now I would like to talk a little bit about some of the key launches we have in diagnostics. You heard a little bit from Thomas about how this is a historic year for us for diagnostic launches. And what I would call out is of the launches you see on this sheet, we achieved six. in the first half of the year. And as of today, we have received seven. And we look forward to updating you in the coming quarters on the progress here. We're really excited about how these launches are going to drive the business for diagnostics forward into the future. And look forward to sharing that with all of you. Thanks. Back to you, Thomas.

Thank you very much to the team. And thanks for all the good work. And now we take the questions.

So the first question comes from Harry Gillis from Bloomberg. Seems, I don't know, he dropped out. Then we move on. Next question would come from James Quigley, Goldman Sachs.

Great, Bruno, can you hear me? Yes, we can hear you. Perfect, thanks, guys. So first of all, on obesity market development, you mentioned in the press release for excuse me, for CT996 that you could consider using the drug as a maintenance post injectables. So how do you expect the market to play out? And how does this inform your thinking of the potential designs of phase three trials for both CT388 and CT996? And the second question on gross margins, particularly in the pharma division. So you mentioned that without the provisions, provision release, the gross margin would have gone down year on year, or the gross cost of sales would have gone down year on year. So how are you achieving these decreases? Previously, you noted that Vacaville was the last step in the manufacturing optimization program. Are you starting to see some benefits already here? Or could there be more benefits when the deal closes in the second half of the year? Thank you.

So who wants to take the first question on the margin, Teresa?

Yeah, sure. So, I mean, I think what you're seeing with the reduction in cost of goods is actually the result of work that's been going on for the last several years and sort of culminated with the divestment of Vacaville. We've been really looking at creating what we call the network of the future now for quite some time, which has led to sort of dramatic increases in efficiency in our manufacturing footprint. So I think this is... I think this is one of the things that I think we're really proud of is the amount, the way that we've been able to continually update our manufacturing facilities and increase the yield and lower the cost.

Yeah, I can. Should I take the question? Yeah, sure. Okay. So just to only add on the Vacaville, Vacaville has not closed. So we do expect closing somewhere around Q3, end of Q3. That's the current timing. Regarding the question on obesity, first of all, it's going to be a huge market. By 2035, about 50% of the world's population will be obese. And we have the privilege to actually have both an injectable and an oral. Now, depending on which report you look at, you have different assumptions which is going to be bigger. Some say the injectables because you just inject once a week. The needles are very fine. You don't really feel a needle, but there are people that are concerned about needles. And so we have an oral opportunity here as well. Now, as you mentioned, maintenance could be one option. So after you use an injectable that you go into using oral treatments for maintenance, that could be an option. But some people may go onto an oral immediately. Now, the CT996 is not a peptide. It's actually a synthetic small molecule. So what we can actually do is we can use our manufacturing network. We can scale much faster. And with that, one opportunity of the orals is actually to get much broader patient reach. And that's where we also see an opportunity for the orals.

James, did we answer your questions or do you have a follow-on question?

I do have a follow-on if that's okay. I mean, just thinking about your strategy here in obesity, obviously the weight loss you've shown has been pretty fast. Teresa mentioned that the safety profile is in line with the class. So What is the approach here? Because you could be the fourth or fifth injectable or auto market. So is this a combination play? Do you have all the other mechanisms in your portfolio that you want to combine with? Or how is Roche going to differentiate in the obesity space?

Yeah. So you also saw on one of the slides that CT868, which is in the phase two, will read out later in the year. So with Cormat, we didn't only acquire two different assets. We actually acquired a whole array of assets. So with that, we have more opportunities on that side. Now, as part of the R&D prioritization, what we can also do is we can have certain molecules that we go on a fast track. So we have this fast track nomination of certain molecules like also tritonamide. So we go much faster. And I think the expectations on the outside, when we would be on the market, we would believe we can be much faster to the market than what's currently being assumed. On top of that, if you look at the data, we do believe that we have potential best-in-disease molecules. There is a certain differentiation that we have. Just to give the example of CT388, which was designed to have activity on GLP-1 and GIP receptors, but with minimum to no beta-aristin recruitment on either receptor. Now, this bias signaling significantly minimizes receptor internalization and consequently insulin desensitization. So we have a couple of differences to current molecules, and that's why we believe we have such good data that we have seen. The oral one, as I mentioned, is not a peptide. It's a small molecule. So we also have here a certain level of differentiation. So these molecules are different, right? And these are next-generation molecules. That's one element. The second element is we – went into this also with the intent to combine with a number of other medicines that we have in our own pipeline in, uh, in, uh, kidney disease, in ophthalmology, in neurology. Um, So we have a number of opportunities to combine. Also with our GYM329, which is an anti-latent myostatin, as you know, one of the issues is if you lose weight, you also lose muscle mass. If you encounter that, you really then have more sustainable weight loss because if you don't have enough muscles, basically your calorie burn rate goes down significantly and you have to counter that. So there are many opportunities that we believe on how we can firmly differentiate. And so we believe we can be very fast on this and be a very competitive player in the space.

James, did we answer your questions?

That's perfect. Thank you very much.

Then let's move on. The next in the row would be Sachin Jain from Bank of America. Sachin.

Hi there, thanks for taking my questions. I had a couple on obesity and then a clarification for Teresa Ronzola. So on the wires this morning, Thomas, you were pretty vocal on potential further obesity deals. Or if you could just provide a little bit of colour on size of deals you're looking for, what you're looking to complement, and should we be thinking about that as imminent now that you've got the first headline data in-house for your assets? Secondly, on 996, In your introduction and then just to answer the prior question, you talked about mechanistic differences for 388. I wonder if you could do similar for 996 and just call out mechanistic differences versus all food, Danu and other orals. I think there's less visibility there. So those are my two questions. Just one clarification for Teresa on Zola. You quoted teens growth in your introductory commentary. Was that for the brand or in total or just a food allergy segment? And how do you think that plays relative to biosimilars next year? Thank you.

Yeah, great. So maybe I'll start there and then pass it over to Thomas for the obesity questions. So that's for the molecule. So we are well, we sort of have reached peak in asthma. We continue to see growth in Zoller in CIU, which is another indication that continues to do quite well for us. And then you add food allergy on top of that. I think what you see is that the molecule should grow through 20 through 2025 in the teens. We do expect biosimilar competition for Zoller in 2025. That having been said, it's not clear if any biosimilars would include a food allergy label just given when the label came. So there might be some residual food allergy business that sticks with us. Maybe just a little bit of context for why we think that growth will be so significant and so continued. It's actually not so easy for patients to get in to see allergists. Allergists often have quite some wait time. And for food allergy patients, because there hasn't really been anything for them to take, there's also some activation that needs to happen. So that process of getting patients activated, getting them to call their allergist, waiting for the appointment, and then getting on therapy just takes some time. So we're very pleased with the pickup that we've seen so far. And we would expect to see that not only continue to accelerate through the end of the year, but to maintain into 2025.

So to take your other two questions first on deals, we really screen the markets on a constant basis per year. We probably look at thousands of companies and we have to be very diligent in the kind of deals that we do. Now, I hope you understand that I can't comment on anything that we are looking at currently, but I can assure you that we constantly look at it and we want to make sure that the science is there and also that the financial benefits is there. And in terms of the kind of deals, I think what we did last year was Could be something that you could imagine also for this year. But again, it always depends on the availability of deals and the price tag. And I can assure you that we will be extremely disciplined in those deals. Now, when it comes to some of the differentiation on CT996, I believe looking at the data, we have a very good molecule in hand. We have not disclosed the structure externally, but small modifications and differences in these molecules can make a big, big difference for how they work. And so, you know, I don't want to disclose exactly, you know, that structure, but I can tell you that there is differentiation to other molecules.

Perfect. Thank you very much.

Any follow-on questions, Sachin?

No, I'm all good. Thank you.

Yeah. Okay. The next one would be Richard Fosser from J.P. Morgan.

Thanks very much, Bruno. A couple of questions for me as well, please. First one, actually, on diagnostics. I think margins, you know, obviously very strong growth and margins in the first half. So how do we think about the margins in the second half? I know Covid's gone away, but can we already be above 20 for the year for diagnostics? Then a couple of pharma questions. Just wanted to dive a little deeper onto the Evrizdino. Teresa, you called out strong demand, but are you taking share from Spinraza? Are you broadening the patient pool? How should we think about this going forward? I think Zolgensma was very strong as well in that space. So just thoughts there. And then one more, just to go back onto Ticentric. I know you said low single digit growth, but are you seeing on the back of the Sky6 trial any reticence from doctors to use the product on the back of that data? Thanks very much.

Great. So I'll start with diagnostics. So like we talked about with cost of sales, that results from the decrease in the rapid antigen sales. So that is going to be a durable increase in the cost of sales. But I don't think we break out the margin for the end of the year. But I think what you can expect is to see that improvement as rapid antigen is no longer a part of our commercial mix going forward. We don't see a meaningful contribution from rapid antigen. And therefore, that cost of sales improvement is going to remain.

So let me just add to this. And Alan mentioned it. So we had some headwinds on the pharma side because we had a provisional release last year of, I think, $260 million.

276.

276 million. And we probably had some wind in our back on the cost of sales on diagnostics. So I think on the group level, that pretty much evens out. And so I think the momentum that we see overall for the group, I think, should remain for sure for the end of the year. Great.

So starting with Evrizdi, so Evrizdi had very, very strong growth in Q2 that was driven by a sort of one-time tender purchase in Pharma International. And so you're right, we expect to see that growth slow down just because that one purchase won't reoccur. But where is that growth coming from? It's coming from multiple places. So first of all, yes, it is coming from an expansion of the patient population. I think we've kind of always noted that the bigger pool of SMA patients are actually adults who currently are not treated. And so getting these patients activated and getting them to come in and to actually pursue treatment is something that the US in particular has been quite focused on, but something that we are looking at broadly across all of our geographies. And we are starting to see an activation in that older patient pool. And it is also true that we do see switches. And we see a small number of patients who actually take Evrizzi on top of their gene therapies. So I think there's a number of different places that are driving the growth of Evrizzi, but it's pretty exciting to see when you actually understand what you can be doing for these patients and slowing the progression of their disease. I think it's really critically quite important. In terms of Ticentric, I mean, no, even if we were expecting to see impact because of Sky6, it would be far too early to see that impact. I think it's really important for us to understand the implication of Sky6. What we learned from Sky6 was about a very particular way of looking at the use of Ticentric in combination with something else. And so we should be a little careful in how we cross-read. But no, we're not seeing any immediate impact on Decentric or any indication that there's hesitancy to use in the places where it's indicated.

Any additional questions?

No, Bruno. Thank you very much, Teresa. Thank you very much, Thomas. Thanks, Jeremy.

And next questions would go to Emmanuel Papadakis from Deutsche Bank.

Yeah, thank you for taking the questions. Maybe a couple of follow-ups on obesity, if you'll forgive me, and then Question on the outlet for the breast franchise. So obesity, based on relatively limited disclosure so far, does certainly look like the Carmel platform appears to represent a potentially significant strategic opportunity for the company to rebuild in Metabolic. So can you talk a little bit about your device and API preparedness? To what extent are you already investing to develop those capabilities based on the data you've seen so far? And then you made some interesting comments, Thomas, just then about timelines. Apparently you're going to get there fast, and we all believe. Could you potentially put some numbers on that, help us think through the scenarios there? And then a question on a totally separate topic, breast franchise. We had some data at ASCO which suggested that hertizumab might be redundant in combination with n-hertu in potentially both the metastatic and high-risk adjuvant settings. And we have some trials reading out there within the next 12 months or so. So could you just talk a bit about the potential scenarios where they'd show the redundancy of Pertuzumab in that setting, your degree of confidence in sustaining growth for Jeter and Fezgo in the midterm? Thank you.

You want to take those questions? Also on obesity, on the manufacturing, et cetera.

So I would need just quickly to repeat the manufacturing question.

on devices and are we accelerating some of those?

Oh, yes, absolutely. So devices is one of the places that we are actually focusing on with a lot more emphasis going forward. Just to be perfectly frank, devices is not a place where we have historically been strong. And we recognize as we go into obesity, as we go further into immunology, And just frankly, as the site of care shifts and healthcare in general move more away from the clinic and into the home, we must get much better at devices. And so you'll hear a lot more about this at Pharma Day, but it is absolutely a place where we are doubling down and putting a lot more effort and attention going forward. And then do you want me to go straight into breast? Okay. And so going straight into the breast question. So I think, you know, these are trials that we've been awaiting for quite some time. And the reality is it could go either way. We'll have to see the clinical data. Regardless, we believe that, you know, as we have sort of been saying over the years, we believe that there is a pretty sustainable, about a 40% tail for the HER2 positive breast franchise. And that comes down to just the stickiness of the therapies. It comes down to how patients will be sequenced. So we're just not expecting to see a dramatic cliff. We think treatment patterns will be much more a softer decline and that we will be ultimately maintaining just a lot more of those patients than people are thinking. And again, we're very much focused on the conversion into Fesco, which provides a lot of stickiness and that we would fully expect Fesco conversion to be above 50% in many markets. So I think that the dynamics in the HER2 space are frankly just going to play out a little bit differently than people might be thinking.

And let me just comment on the other questions around obesity just one more time on manufacturing. If you look at the CT996, which is a synthetic small molecule, we can use our existing manufacturing network that we can reach patients much faster. We're also investing in manufacturing for peptides as well. So you'll see us accelerating that. We have discussions with partners on devices, et cetera. So one of the things that I mentioned before is by doing what we've done in terms of portfolio prioritization, we can really move certain programs in fast track. And Manu, who's heading this area and joined us from Karmat, he gets what he needs to really move this in this fast track lane. And so we tend to be on the market much earlier than the current assumptions that are out there. But maybe we'll disclose it at Pharma Day. Maybe that's one of the surprises than at Pharma Day.

Mal, any additional questions?

I'll hold them for September.

Yeah. You got one surprise already. Yeah. Very good. If there are no further questions from your side, then we would move on. Next one would be Mark Purcell. Mark, please.

Yeah, thank you very much, Bruno. First question on pazonizumab and the Padova study. Could you help us and remind us of the trial design here? What level of benefit you would need to follow the phase two data and go for an accelerated approval? And in the marketplace, what percentage of patients are biomarker positive? So that's the first question. And then the second question, two parts on obesity. Could you still help us understand how representative the Phase 1 data that you've shown on your two assets are ultimately going to be. Obviously, there's quite a forced titration regimen, particularly on CTU996 in Phase 1, and you're talking about an optimized titration regimen, presumably for both assets in Phase 2. And then in phase two, the patient baseline characteristics might be different in terms of baseline BMIs and percentage of males and things like that, which have been quite selective in terms of some of the early data from Carmot. So how representative is 18.8%, for example, at 24 weeks when you actually get your phase twos? And then the second part was just in terms of theoretical differentiation. So obviously the carbon approach with both acids, it's been focused purely on cyclic AMP, full agonism and limited impact on beta-restin. So theoretically that could improve weight loss, but that could also lead to less impact on inflammation, which could be very important in kidney disease and heart failure, as we've seen with semaglutide, where you see limited weight loss providing really strong benefits. So could you help us understand what you might lose out on in terms of reduction in the amount of inflammation you see with those two assets. Thank you.

Want to go ahead on PRAZI?

Sure. So in terms of the PEDOVA study, so this is a Phase IIb that's evaluating the efficacy and safety of PRAZI in patients with early-stage Parkinson's on a stable symptomatic PD Parkinson's medication. And so The actual trial design, I'm not sure if someone has that handy, but we can certainly follow up with you on that. And then in addition, I'm so sorry, I don't have the biomarker positivity at my fingertips. I don't know if anyone has that handy. So it does have a function. It's a study with a functional endpoint scale as improvement, and it has time to meaningful change on MDS on one of the scales in part three. So I think we just may need to get back to you with a little bit more detail on that.

Yeah, I think the study was designed in a way that it took the previous signal into account, which we had seen in the first phase too. But the difference is, I think this time, that the treatment is on top of the standard therapy. So either MOA inhibitors or Levodopa. It's also a bit longer. It's going 18 months. And this is only the first look which we will have. There will be, of course, then I think follow on for another two years. as this is a progressive disease, and you might see the effect becoming more pronounced over time. I think the standard composite endpoint is here as a secondary endpoint. And I think, as Teresa mentioned before, the MDS-UPDRS part three is the primary endpoint for this study.

And I think the other thing just to kind of keep in mind is while accelerated approval is a possibility, it is certainly not our base case. And so I think Thomas has mentioned a couple of times that this would be a very high risk, high reward program. And so I think we should, while it would be exciting if it were positive, we should control our expectations because this is a very tough space.

Yeah, you asked the question on CT996 and CT388, how representative is that? I mean, if you look at the statistical significance of the data, it looks very promising. And if you look at the mechanism of action of these GLB1s, GIPs, they will, you know, you see a certain decrease in weight loss. And then depending on the molecule, it will stabilize at a certain level. And the titration scheme will then help you also to make sure that people get into the highest dose. Now, if you look at both the CT-996 and CT-388, actually all of the people continued the study to the end. So there was no one actually that was dropping off here. So we believe this is very representative and that you can get to a significantly lower level in terms of weight loss. But on top of that, we have a couple of other molecules in our pipeline, which we can also combine these with. So we also believe that there is... some differentiation here as well. Now, your question on the binding to the, or minimal to no binding the beta-arrestin recruitment on either receptor, we actually believe that this will give prolonged pharmacological activity And with that, we can actually get to these weight losses. So we do believe that this is a positive differentiation compared to some of the other molecules that are on the market today.

Yeah, and I think your point about the reduction of inflammation with the incretin class, I think, is a really important one when you start thinking about what the implications of the use of these molecules could be in areas outside of obesity. And I think this was one of the things that has sort of kept us very interested in this space when you look at things like Alzheimer's or even Parkinson's, for example, places where systemic inflammation could potentially be mitigated here in those combination therapies. I mean, I think this is one of the more interesting scientific questions that we'll be seeking to answer over time.

And as you also saw, CT868, which is in phase two, specifically designed for diabetes patients. So this is also, I would say, a molecule that's differentiated because it's very much focused here. So in addition, with CARMA, we didn't only acquire these three assets. There are a number of also other assets that are targeting other patients. or looking at other targets in obesity. So we believe with these combinations, we have good opportunity, but at the same time, we're screening the market for potential other molecules that we can combine these with.

Mark, did we answer all your questions or was there something left over?

No, that was great. Thank you, Bruno.

Okay. Then we will move on. Next one would be Richard Parks. Richard, please.

Thanks for taking my questions, Bruno. It's Richard Parks from BNP Paribas. I've got a few questions. Firstly, on tirugolumab, I think this is the first trial you've been up against, K-trudro, with tirugolumab. So I'm just wondering if your analysis suggests a reason for the worse outcomes. I'm wondering if that's an issue with adding tyrogolumab to chemo or whether there's any risk that this just reflects to centrics a weaker background backbone i'm just wondering if we can be confident that that data when it's presented won't undermine to centric and its existing indications then secondly on the oral glip one um just to ask the question more directly are you do you think you can achieve better weight loss than the other oral glip ones that we've seen today which has been So broadly in line with with Wigovi, do you think you can better that? And then final questions just on trontinamab. I'm just wondering what you're waiting for in terms of additional data to make that phase three decision. I think you said you'll make that by Q1 next year. I'm just in what scenarios would you decide not to to to progress trontinamab? And can you also remind us what you've seen in terms of infusion reactions so far with the drug? Thank you.

Yeah, sure. So Thomas, I'll start. So Tronte, I mean, I think the profile of Tronte thus far has really held very well, very sort of minimum infusion reaction, safety looks good, efficacy looks good. I mean, really the point at the moment is just to make sure we get the right dose. And so what are we waiting for? I think we're just waiting to make sure that we've got enough information that we are achieving the most effective dose and that's the dose that we would take forward. In terms of tiragolumab, I mean, I think this is, again, there's always dangers, particularly with cancer immunotherapy. We have seen time and again that different molecules in different settings perform differently. And so I don't think that we should... we should do too much of a cross-trial read on Sky 6, which is at a very particular setting, with Ticentric in its approved indications. I think we continue to have confidence that in the indications where Ticentric is approved, that they are providing quite a bit of benefit to patients. We are certainly still in the midst of analyzing this data. It's relatively new having it in-house, but there isn't anything that we've seen to date that would lead us to believe that we need to question to Centrix effectiveness and the indications that we are currently on the market for.

Good. Then the question to the oral GLP-1. I mean, based on the data that we've seen, we do believe it has the best in disease potential. And that's why we are accelerating that program.

Thank you. Okay. Then we move on. Next one would be Simon Baker from Redline. Simon.

Thanks very much, Bruno, for taking my questions. Two if I may, please. Firstly, Therese, you mentioned on centric subcutaneous the strong reception that's received in the UK. The other strongly received subcutaneous formulation in the UK recently has been Ocrevus. According to the to the media, there have been suggestions that there is very considerable demand for Ocrevus subcutaneous. So I was just wondering if you could give us an idea of how generalizable that UK experience is. I know the UK has a particular passion for subcut formulations. And what does this mean for Ocrevus subcutaneous beyond the UK, across the world? And do you see maybe the US-XUS sales split balancing up between now that we get to a subcut formulation? And then the second question is a slightly bigger picture one. We've seen a very strong performance by the marketing portfolio. We've seen a more of a commercial edge, it seems, to the R&D process. it's clear that this hasn't been achieved by simply throwing money at the problem because cost containment has been very strong. So I'm just wondering if you could give us some tangible evidence of what's changing. It feels like the commercial ethos and approach of Roche has changed for the better. Any examples of how that's manifesting itself would be really appreciated.

Sure.

Maybe I can answer the last question very directly. I get a sales report every day, so I know exactly how the sales are developing every single day. That's one example. But there is a clear focus on performance.

Absolutely. And when we look at, so it's a great question on, on to centric subcut. So I think that in terms of the UK experience, you know, we saw great uptake with Fezgo. We've seen strong uptake with, with to centric subcut. I think that is quite generalizable for the UK market. I think anything that removes patients from having to go in to the system and allows them to go home or to get a faster, to get a faster infusion or a faster injection that actually frees up chair time and frees up office time, those are going to be very attractive to the UK system. And frankly, attractive to any system that's under financial pressure, which is most global healthcare systems around the world. So, you know, I think this is why we are, again, really doubling down on devices going forward. In terms of Ocrevus subcut, I do believe that bringing the subcut formulation to Europe and to the rest of the world will provide additional opportunities for Ocrevus to reach patients. The initial out-of-the-gate orders for OkraVis in those countries that have the ability to move quite quickly after approval are already quite strong. Again, you'll start to see the sales for OkraVis play out in the coming quarters. But I think this could be something that does equalize that US-EU rest of world balance as we start getting reimbursement for OkraVis subcut around the world. Again, we think that in and of itself, it's a $2 billion opportunity. And so that's $2 billion on top of what we've already gotten from the IV space. So this isn't just going to be about cannibalizing our IV business. This is going to be about both in the US and outside the US expanding to new patient pools. So it's very attractive on the Okravis side. Just to control expectations a little bit on the Ticentric side, I know I mentioned it in my presentation, but we think with Ticentric, it's largely going to be a conversion strategy. And so that's probably about an incremental $200 million upside for Ticentric, while the opportunity for Okravis, we believe, is much, much larger.

Yeah, and let me just comment to the other part where you mentioned how we are changing and how we work on R&D, but also on the sales side. I'm a very strong believer that if you get the basics right, if you're very focused, you will do much better than most organizations because many people get very fancy and they we have to cut that out and make sure that we move towards goal with the fastest possible way. And I think there's a lot of opportunity for us still to get even more efficient and better. And so we're very much working on that. For some people on this team, I think some of them know that I'm a big soccer fan. Sometimes you have these players that do a lot of pirouettes and they dance a little bit on the on the soccer field but at the end what counts is you score a goal and no one will remember how fancy it was you have to go and score the goal and uh that's a big focus on getting the basics right salmon uh did we answer your questions any follow-on questions yeah no that was that was really really helpful just one very quick um follow-on um going back to aquavis subcutaneous only if you just remind us what the ip situation is it looks like it's

Patent protected to September 2030, but any additional comment on that would be really helpful.

Yeah, so I think clearly Okravis is sort of end of the decade, but we shouldn't make any broad sweeping statements about where we think that might go with new formulations and new doses.

Okay, thanks so much.

Okay, then we go on. Next one is Emily Field from Barclays.

Hi, thanks for taking my questions. Surprise, another obesity one. But just, you know, as you're taking all these assets forward, they're going to need large studies and also, you know, particularly the cardiovascular outcomes trials require thousands of patients. So are you expecting any dampening effect on the pharma margin in the coming years as these assets both advance? And then a quick one just on elevitis, now that you've completed the filing in Europe, Are you expecting any sort of accelerated review process or when do you expect that you would be able to launch in Europe? Thanks.

So let me take the first question on the margin. As I mentioned before, we will definitely defend the margin. If we can do better, that's great. But there will be no margin erosion. If I look into the system, we have opportunity to be more efficient and to make sure that the money really is effectively used. And that's what we're very much focused on. And that gives us the room to also invest in these things.

And from an LLVD's perspective, we're working very closely with the regulators to review this data as quickly as possible because we do believe that this is very important for these boys and their families. And we are expecting CHM, we're expecting approval next year.

Emily, any additional questions?

That's great. Thank you.

Okay. Next questions would go to Peter Welford from Jefferies.

Hi, thanks for taking my question. Sorry, I started with obesity yet again, but I bet you're not bored of it. So first of all, if we just go to 996, just to understand that the phase two is starting in 2025. Is that because during the second half of this year, there's still work to be done in terms of safety database in terms of, you know, findings or is that related to to manufacturing or what is it perhaps that you know giving your commentary to move quickly what is it perhaps dictating that 2025 and and i guess you've talked about your appetite to go broader in obesity quite extensively but i guess given you now have this oral what about as well your appetite do you think to to need to have other cardiovascular oral medicines in addition because i think that's something obviously some of the competitors are talking about obviously something that that your pipeline lacks with regards to potentially having a one pill for all, I guess, strategy, which could be important for the future. And then secondly, if we could just talk, I guess, more broadly about the overall business. Clearly, you've talked about the growth of some of the key sort of franchises like, you know, Ocrebus and Libra, where I think Teresa has sort of given, you know, mid-single digit sort of outlook growth for the longer term. And I guess with that in mind, can you sort of talk to what is the aspiration for the pharma business, do you think? I mean, we've heard on diagnostics, mid to high single digit is the ambition and the higher end of that. For pharma, I mean, should we be thinking mid single digit over the next few years, given some of the things Teresa's outlined and some of the headwinds you face? Or do you think that, you know, is that too conservative potentially when we consider some of the pipeline readouts that you've talked about that could come during 24, 25? Thank you.

I can start with that one because it's pretty easy. We don't actually give forward looking guidance, but we are reconfirming our growth outlook in that sort of mid single digit for this year.

Yeah, so let me just add to that. I mean, the momentum that we have is a very good momentum, and obviously that will help us also carry into next year. Now, if you look at the diagnostics business, it's much easier to give a long-term guidance because some of the development is de-risked in much earlier years, right? On the pharma side, we always plan with scenarios. So there are blue-sky scenarios, et cetera. There are scenarios... you know, in case some of the trials failed. And our job is to make sure that we are prepared for all the scenarios and that we make sure that our pipeline delivers the best possible outcome. And that's why we don't give a longer range outlook here. Then your question was on CT996. And here we still have a second part of the trial ongoing, which is in type 2 diabetes. But we will try to accelerate all of our activities here as well. So let's... see how things go. On the other cardiovascular medicines, we've had actually very good phase two readouts on subaccharin, the siRNA in hypertension. There will be a second one that will come this year as well. And that will inform the phase three. So we are looking at building that portfolio out. But again, as I mentioned earlier, we have to make sure that we do the right due diligence and that we bring in the right assets. Because at the end, there are probably more opportunities out there than we have money. And so we need to make sure that we put it to best possible use.

Peter, any additional questions?

Just to follow on to that, I'm sorry, I guess with regards to orals, though, because I guess, you know, with regards to a one-pill approach, I appreciate Zilabestrin brings a cardiovascular franchise, but, you know, with the orals obviously comes a much bigger opportunity potentially, but you could be going against companies that could well be looking at, you know, one-pill combinations potentially for other sorts of diseases too.

Like what type of diseases?

I guess I'm thinking anything from cholesterol to potential kidney disease to even hypertension as well, potentially locking in other sort of comorbidities of obesity.

Yeah, so on the hypertension side with the orals, there are orals available, but obviously they're not working well enough because you have 1.2 billion people in the world that have hypertension and it's one of the biggest risk factors for earlier death. So obviously that's not working. And with the siRNA, you have the ability to dose once every six months, and you can really control then potentially your hypertension. I mean, the data so far looks really excellent. So I think, you know, there is definitely a better opportunity for these siRNAs. On top of that, in terms of combining the pill with other things, I would say it's probably for obesity much more interesting to combine it with things that reduce the muscle wasting. So it really depends on the strategy that you take. And here we do believe that the muscle piece is a much more important piece. Why to combine it with a tablet for lipids, I don't really know because I don't think it's very... First of all, you would want to take the best obesity medicine. You don't want to be bound to something that's not so differentiated on the lipid side. And if it means that you would have to take two pills, I don't know if that's really a problem for the patient. So I don't really understand the idea of putting everything in one pill. I think the key question is how differentiated it is.

That's very clear. Thank you.

I think with that, we move on to Matthew Weston. Matthew from UBS.

Thank you, Bruno. Can you hear me? Yes, we can hear you. So two questions from me. I'm going to start with the obligatory obesity one. Thomas, you've said moving fast. Everybody's touched on how you could move fast. The one thing that strikes me is the control arm is going to make a huge difference to your ability and speed to operate, because either you're going to have to run very, very big studies if you're including current GLP-1 therapy in your control arm, or you're going to have to take studies that run for a much longer time than we're used to. So can you confirm that you are assuming you aren't going to have to use semaglutide as a control arm going forward? Or if you are going to, then the studies are going to have to be really big? And then secondly, one for Teresa on Ticentric. Small cell, I think, is a very important category for Ticentric. It's an area, I think, where you're currently the market leader. Now that your main competitor has the unique Adriatic indication about to come on the label, is there a risk that clinicians move to a single small cell regimen and that that puts very significant pressure on your Ticentric small cell revenue from 2025?

So maybe I'll just jump in and start there. So I think we are likely to see some competitive impact in small cell. I don't think people will move to just one regimen. We have many, many years of very entrenched experience with Decentric and small cell. I think our data in this indication are quite good. And so while I do expect we would see some competitive impact, I don't foresee a wholesale switch.

Yeah. And let me just comment on your obesity question. Yeah. So based on discussions that we have had with regulators, we're confident that we can run the trials that are placebo controlled.

Many thanks. I'm done, Bruno.

Yeah. Okay. I think if there are no further questions, then we are coming to the end of the Q&A session. Okay. Then I will hand back to Thomas for a final remark.

Thank you very much, Bruno. Thank you to the team. And thank you for everyone attending today. You can be assured that we'll continue to remain focused and diligent in our resource allocations in the company. And that we'll continue to drive forward our sales as we did in the first half year and also on the profit side. And that we'll continue to work on innovation to continue also to deliver growth, good growth for the years to come. Thank you very much.