Roche Holding AG

Thank you very much. And hello and welcome. I'm looking forward to sharing the Q1 results together with my team with you today. In Q1, we had a very strong base business growth of 7% growth across both divisions. And overall group sales, including COVID, were at plus 2% constant exchange rates. The base business in both divisions, as said, was very strong, pharma at plus 7%, and diagnostics at plus 8%. The COVID-19 sales decreased by 0.7 billion, and with that, we have the COVID sales decline largely behind us, and we've had a LOE impact of 0.4 billion, and with that, both is very much in line with our guidance. This quarter, we have achieved a number of very important milestones. First, we received the U.S. approval for Xolia in food allergy as the first and only medicine in food allergy. And we already see an uptick in sales, and there's a lot of excitement in the medical community, and Teresa for sure will share more about that. Just last week, we received FDA approval for Alicenza in early stage in adjuvant setting for positive lung cancer. and very strong data here as well with a 76% reduction in the risk of recurrence of disease or death. We filed for U.S. accelerated approval for Invalicip in first line PIK3CA mutated HR-positive breast cancer, and we do expect approval later this year. In terms of key pharma readouts in Q1, we reported positive OS results for the Phase 3 Star Glow Study for column B in second line DLVCL. And we had very good data for the Phase 2 Cardia 2 results for Silvacerin in hypertension. And this was presented at ACC 2024, and Teresa will comment more on that. But this was on top of standard of care. In diagnostics, we've had U.S. regulatory approval for the first molecular screening assay for malaria for blood donations, so this is the first and only assay available to test malaria in blood donations. We've also received breakthrough device designation for the PTAL 217 ruling assay for Alzheimer's disease, and Matt will cover more of that as well. We have four remaining pivotal readouts this year, and importantly, we have 12 Phase III enabling readouts that will come this year, all of them addressing large opportunities, such as in Alzheimer's, Parkinson's, et cetera, and I will cover that in a later slide. Also, after discussing with regulatory agencies, we've made a decision to file the Phase III EMBARQ data for Elevitis in Degene Muscular Dystrophy. Finally, in diagnostics, we have a number of key launches ahead of us. This is a very important launch year for diagnostics, and Matt and the team will share more at the diagnostics investor event on May 22nd. As mentioned, Q1 base business sales growth was very strong, 7% for pharma, 8% for diagnostics, and 7% for the group. As mentioned, the headwinds from COVID are diminishing, this growth will shine through for the coming quarters. Here, you can see that our base business is really overcompensating both for the COVID-19 effect and the LOE effect. And you also see here that in first quarter, we still had a 8% effect on the currencies. Now, this is the base effect because The currency appreciation of the Swiss franc really happens after Q2 last year. And we should see, and Alan has a slide on that, a significant improvement here. Again, it's very hard to forecast currencies in a world with a lot of geopolitical tensions. But as it states today, in terms of currencies, we should see a significant improvement in the quarters to come. And as Alan will show the projection for the whole year at this stage is a minus 2% only. Now here you see the group sales over the last number of years. And you can see that in 23 and in 24, we've had high single digit growth in our base business. You see in the blue line, our total business, including COVID and for the coming quarters, you will see that the blue and the orange line will merge. and the blue line will go up to the orange line. Also, if you look on a divisional level, you can see that on a diagnostic side, we've delivered seven to 8% growth for quarter over quarter over the last number of years. And in Pharma, we really accelerated our business over the last year. So we do believe also that this will continue. On the pharma side, we continue to strengthen our pipeline, focusing on projects with high impact and with first-in-class and best-in-disease potential. In Q1, we terminated early-stage developments for five enemies based on clinical data, as well as prioritizing assets that deliver high value and high PTS. So if you look over the last three quarters, we've removed 20% of total enemies, really focusing our assets and our priorities and at the same time we thought in a number of assets from the outside with high PTS and high value in areas such as hypertension inflammatory bowel disease and also obesity and You can expect this kind of prioritization and partnering deals to continue over the course to come In addition to the pipeline prioritization and We're also working on opportunities to improve operational performance across the Rush Group. Now, let me highlight a couple of examples. Last month, we announced the divestment of our Vacaville biologics manufacturing facility in the US for $1.2 billion. And this divestment is a direct consequence of the ongoing efficiency gains for biologics manufacturing. We are also optimizing our geographical footprints here with facilities closer to the end markets, US, Europe, and Asia. In total, we now have 11 manufacturing sites with over 530,000 liters of biological manufacturing capacity online. And with that, we still have the largest manufacturing capacity in the industry. On this slide, you can see why we're doing this. On the x-axis, you see the time scale on the Y axis, the tighter that we get out of our cell lines. And what you can see here is that we have significant productivity improvements in our manufacturing. In total, we have about five times higher productivity. And with that, we don't need as many manufacturing sites as we've had in the past to produce even more products. In addition, we have a portfolio shift to smaller volumes because of higher potency enemies. So with that, we can optimize our manufacturing network going forward. In addition, we've also made other additional adjustments to improve operational performance. FMI moved from pharma to diagnostics, where we see a lot of opportunities in terms of leveraging synergies and also improving our operational cost position. We can combine the broadest portfolio that we have in the diagnostics industry to the benefit of FMI, and we can also leverage our next-generation sequencing capabilities across diagnostics and FMI. In addition, we've integrated point-of-care and diabetes care into one organization, into one business area called near-patient care. This allows us to take advantage of the fact that we have complementary patient and customer segments and also technologies. And we can then operate more impactfully as one organization and we can reinvest the savings into growth areas such as accelerating our CGM projects. Now moving to the future. We've launched 20 new medicines since the end of 2015. Now, 55% of our portfolio sales are from the new portfolio. With that, we have one of the youngest portfolios in the industry. You may wonder why it's only a 5% increase. You can see that Rona Brief dropped out. Without Rona Brief, the increase would be significantly higher and also a distance in Swiss francs. Just want to highlight that. We have two NME launches this year. One of them is Kravallamab. The other one is Navalisib. So we keep launching two NMEs per year. On this slide, what you can see is that the washout of COVID-19 is basically over. We have washed out 700 million in the first quarter alone. So it went out completely on the pharma side. and also on the diagnostic side, we'll continue to see some revenue, but basically the effect for the remaining of the year is in the range of only around 0.6 to 0.7% on the entire growth rate. So you can see the growth rate will no longer be materially affected when we go into the next quarters. And let me just say, we contributed significantly during this pandemic with sales almost 20 billion, and we washed out those sales without ever dropping into negative territory in terms of sales. Now, this will be the last time that I will show you this slide. On this slide, you will see what are the growth drivers beyond 2025. These are the enemies with significant potential, and also on the diagnostic side, these are only the launches of this year and next year where we have significant potential growth. And this slide, you will see it more often going forward, and we'll keep updating you on the different progresses that we've made in these enemies. And with these enemies, we really target the high disease burdens and areas with higher medical needs. So in this last quarter, we hosted a neurology IR call. where we highlighted new clinical data for phase one, phase two, which had been presented at the ADPD conference. There was new dose-finding data for Tritonimab, our anti-amyloid beta brain shuttle. Now, what you see is that within only a few months, the detection levels of the blocks, or the level of blocks are below detection level. So, you see a significant, very quick drop of plugs of these patients. And with all the data we know, we know that plug removal automatically has also a benefit. We also have shown the four-year open-label extension phase two data for PRASI in Parkinson's disease. We've also shown lately data in a conference from a phase two of a cardio two study of sebastarin And that's on top of standard of care where we see a significant benefit for these patients. Finally, on the diagnostic side, at the ATTD conference in March, we presented data on the AquaCheck SmartGuide CGM solution. So you can see we're nicely progressing on our pipeline, and I'll continue to give you more information on this. Now, let me just say that we still see very strong base business growth in our both divisions. COVID-19 sales decline is largely over. The rest of the year will not have any material effects. LOE is very much in line with our expectations. With that, we confirm our guidance in terms of mid-single digital growth. Also here on this slide, on the core EPS, we confirm our guidance as well as our intention to further increase the dividend interest ranks. With that, thank you very much from my side, and I hand over to Ella.

Yeah, thanks, Thomas. And thanks to everybody who has contributed, I think, to this great result in Q1. And we have made, I think, really significant progress. So let me dive into it right away. Another sales bridge was the same message here. I think when you look at the former side with the plus 2%, I think you see good growth in the U.S., Europe, international. Teresa will talk about it. You see a dip in Japan with Shugai, and this is really Rona Brief we had last year in constant rates, Rona Brief sales of 519 million. This is all here in Swiss francs in constant rates. So the other piece is coming from a price cut in Japan. So I think Theresa will shed some more light on this. Then the Dyer division, also here with the plus 2%, but also here is 194 million of sales losses due to the loss of COVID sales embedded. Without that, I think we know Pharma would have grown at 7%. Dyer would have grown at 8%. And when you look at the group in CR, plus 2% without the COVID sales impact, we would have been grown at 7%. You see the impact from currencies. I will come back to that later. Thomas made a couple of comments, and I will add a little bit more information to that one. And that leads you then to the development in Swiss francs at a minus 6%. So still quite a significant impact. And let me go back to the point about manufacturing in pharma and the sale of Vacaville. And I think Thomas has outlined the rationale why we have done that. But I think there's another element to it, and let me show you this. On the left-hand side, what you see on the slide is the sales development that we had between 2018 and 2023 in pharma. And you see cumulatively a plus 20%, which basically also highlights how well we have done given the patent cliff that we have mastered. On the other side, you see what we have lost in Avastin, Herceptin, and Rituxan, a minus 72%. So I think really the plus 20% is the point. When you then go to the right-hand side, you see the volume increase in that timeframe, which has been a plus 68%, so a significant increase on the volume side. And then I think you see the testimony to everything Thomas has said. I think certainly we have benefited from better efficiency in the production itself, but also, let's say, we came up with very good cost containment in our manufacturing network. And therefore, we could keep the cost of sales stable, so the cost of goods sold, including the period cost. So quite an achievement here. Let me add to this. It was not so simple as it looks like because we had to include new modalities as well. So I think quite some complexity here, very well mastered. By the way, certainly I think it fuels our ambition to defend the margin moving forward. Good. Exchange rates, exchange rates, exchange rates, exchange rates. Let me start on the left-hand side. Once again, the group growth in constant rates was plus 1.6%. That's the plus 2% that you've seen all the time. Right-hand side, you see the minus 6% when you look really at actuals in Swiss francs. And then you see the impacts. And the Swiss franc has strengthened, admittedly, against basically all the currencies that we're dealing with. It has really significantly strengthened against the RIMIMBI. That's an APAC, what you see. Do you see the U.S. dollar? And still, I can just mention it again and again. We have roughly 46% of our sales in U.S. dollar. So that's for us the dominating currency. And then you see Japan, where we got another hit. That certainly, I think, underlines where the Swiss franc is going. There is some hope at the horizon, and I will come to that. And here it is. Let me go through what Thomas has mentioned already. I think on the left-hand side, you see that these curves, that means the average year-to-date 2024 and the average year-to-date 2023, they're converging. for the U.S. dollar as well as for the euro. And that means the comparator gets better. So that's one element, which certainly helps us. You see on the right-hand side the model we're always running. And let me emphasize the fact that we keep all the currency rates at the end of March stable and then project what – the currency impact would be at the given timelines on this slide here. This is certainly highly speculative. I think what fuels our expectations that the currency impact might look a little bit better is certainly the fact that the comparative last year looks a little bit better. Everything else remains to be seen. But let's assume for a second our model is true and the currency rates stay where they They have been at the end of March. What would that mean for half year? You see a minus 5 percentage points on sales, a minus 7 percentage points on cooperating profit, and a minus 8 percentage points on core EPS. You see already on the sales, when you look really at the impact in the quarter itself, that the impact comes down quite significantly. And then when you look at full year, you see a minus 2 percentage points for sales, a minus 4 percentage points for all cooperating profit. and a minus 5 percentage point for core EPS. And you see really in Q4 and Q3, we would even see a positive impact given our assumption. As said, highly speculative, but I think fueled a bit by the comparator as well. Good. I think Thomas confirmed the outlook. Let me say, excluding the impact from the resolution of the tax disputes, the number has been in constant rates, 774 million Swiss francs, just to get that straight again. A little bit from a formal point of view, from reporting, we have a new customer area structure. In diagnostics, it affects pharma as well, as you can see. So what you see is we brought FMI into the diagnostics division, and in the diagnostics division, we brought it together with molecular lab. So in the diagnostics division, moving forward, you see my molecular lab, and that includes really the former molecular lab and FMI. And then you see really what happened on the diabetes care side. We brought point of care together with diabetes care, and this is now the organization new patients care and we will report and we'll certainly adjust the statements here also for previous year once we go through the upcoming quarters. Another reminder, we had that slide at the event. The restatements will be applied in 2024 as well. And this is nothing else that we move FMI from pharma to diagnostics. I think certainly no impact for the group, but certainly impacts for the divisions as well. And you see really the impact here as we had that slide already mentioned. Good. Upcoming IR events. I think while we're all excited about the Diagnostics Day, and I can assure you Matt is working on it and his team quite a bit, so that will be exciting. And then we have ASCO where we want to look really at the malignant hematology portfolio but also at solid tumors, so really a little bit of a comprehensive view on what we're doing in oncology. Ophthalmology will be exciting in Stockholm. We have a couple of new things here. And then the Pharma Day, big event because there will be an update on the group strategy as well as on the pharma strategy. And I think that's the perfect segue to hand over to Teresa.

Thank you, Tom Salen. As both of you mentioned, in Q1, pharma sales reached 10.9 billion Swiss francs, growing by 2% at constant exchange rates, or 7%, excluding Ronapreve. All regions, excluding Japan, delivered strong growth. Sales in Japan were impacted by a base effect of 0.6 billion Swiss francs in Ronapreve sales, which occurred in Q1 of 2023, excluding Ronapreve. I think, as Alan mentioned, Japan declined at 6% in constant exchange rates, and that is primarily due to mandatory price cuts. As Thomas mentioned, there is no further wrong or pre-impact expected for pharma for the remainder of the year, so the COVID-19 effect is officially behind us. Overall, pharma volumes were up by 9%, and the price-mix impact was a negative 8%. Our young portfolio continues to deliver strong growth, led by our key brands, Babismo, Fezgo, Okavis, Polivi, and Hemlibra. Combined, these five products added a billion in additional sales in Q1 alone. So BISMO continues its excellent growth momentum, which is consistently beating market expectations, and Fesco has now become our second-strongest performer, thanks to its outstanding growth. Moving on to oncology, and starting with the solid tumor franchise, where total sales increased by 1% in Q1 to 3.9 billion Swiss francs. One key highlight here is certainly the completed, accelerated U.S. filing of inovalisib, as Thomas mentioned, in first-line PI3 kinase hormone-receptive positive breast cancer, where we reported a progression-free survival hazard ratio of 0.43 at San Antonio last December. We would now expect accelerated approval for this indication toward the end of the year, and EU filing is also expected later this year. I mentioned on the previous slide the strong momentum for FESGO, and you can see here that this is evident in the conversion rate, which has reached 41%. U.S. conversion is reaching 25%, which is just extraordinary when you think about the amount of patients who are now benefiting from this device. And hot off the presses, just last week on Friday, Alicenza achieved U.S. approval in adjuvant ALK-positive non-small cell lung cancer based on the very strong Phase III ALENA results that showed a disease-free survival hazard ratio of an outstanding 0.24, which unlocks an additional growth opportunity for ALENA. In terms of outlook, the Dicentric subcut PDUFA was set for the 15th of September, and we are expecting the Allicenza Alina EU approval in Q2. As Alan just mentioned, we will host an IR event at ASCO. That event will cover both our solid tumor and hematology TAs, and we'll focus in on our late-stage pipelines. So speaking of hematology, you can see that our hematology franchise achieved a strong Q1 growth of 12%, reaching $1.8 billion in sales. in Q1. Q1 hemp lever sales grew by 8%, which is driven by the EU, which had 17% growth in constant exchange rates, and international, which had a staggering 51% growth in constant exchange rates. U.S. sales were a bit down, about 1%, but that really primarily was driven by a buying pattern and a little bit of softer demand. Growth of the hematology franchise is also driven by the strong continued uptake of Polivi and first-line DLBCL in the U.S. and the EU5, with U.S. patient shares climbing to 23%. We're well-positioned to move into standard of care here. One more piece of positive news to cover is Columbia, which Thomas mentioned on his first slide. It's currently launched in third-line plus DLBCL, but we recently announced that the StarGlo Phase III and second-line DLBCL met its primary endpoint of overall survival. Those results will be submitted to global healthcare authorities and have been submitted for presentation at EHA as a late-breaking abstract. Of note, we also achieved Japan and China approval for Krivalumab and PNH, and those U.S. and EU approvals are expected later in the year. So on this slide, let me highlight a little bit further the additional investments that we're making in Hemlibra, particularly with regards to new convenience options to be launched later this year and into 2025. I think we all know that Hemlibra has established itself as a global standard of care in hemophilia A, with U.S. and EU market shares now exceeding 40%. Hemlibra's strong efficacy and safety profile across clinical trials has been confirmed by a substantial and continuously growing base of real-world evidence. We now have over 100 publications that really underscore the safety and efficacy of Hemlibra. In the real-world data that we see, about 80% of patients have zero bleeds, They have a very favorable safety profile. There is no risk of inhibitor development, and it's quite easy to use with more than 60% of patients already on every other week or every month dosing. This, by the way, includes pediatric patients who are now able to administer down to the age of seven with appropriate training. As a lifelong condition, we do know that convenience is highly important to hemophilia A patients. And today, 90% of our HemLabor patients are satisfied with our current convenience options. However, we continue to invest to find ways to offer additional convenience to those patients. And again, more options will be available later this year and in 2025. We just launched two new vial options and are introducing a new administration kit shortly. And in addition, we are developing additional administration options. So please stay tuned for those announcements at ISTH in June of this year. Moving on to neurology. Our neurology franchise achieved 2.2 billion Swiss francs in sales in Q1, representing a very strong 9% growth at constant exchange rates. Okravis grew strongly with 8% driven by all regions. I'm also very pleased to share with you that the U.S. PDUFA date for the Okravis every six months subcut has been set for the 12th of September. And RISD has now become the global leader for SMA and grew strongly by 7% in Q1, driven by the U.S. EU in Japan, which overcompensated for a 29% decline in international, which was solely caused by a delayed tender. We are also happy to announce that the EU filing of LLVDs and DMD, as Thomas mentioned, will begin this year, and we're looking forward to bringing this highly impactful therapy to EU patients. I am very pleased to report that the first ex-U.S. patient has already received LLVDs and UAE. And additional treatment starts are expected in the coming weeks. So very exciting for these boys and their families. In Q1, we also presented additional early trontinumab dose finding at ADPD. Again, Thomas mentioned this as well, with a 3.6 milligram dose, confirming the previously seen safety profile and rapid amyloid plaque clearance. There are multiple neurology news flow items for 2024 to watch out for, including the updated data for trontium, Alzheimer's disease, and prosy in PDE. The combination study of RISD with GIMP329 or antilatin, myostatin, and SMA is expected to have interim data in Q4. GIMP329, as you know, is also being explored in the context of obesity. And to this end, we are planning to initiate a phase one in healthy volunteers with obesity, and that FPI should occur in Q2. So switching gears and moving from neurology to immunology, total Q1 sales. And in the analogy, we're 1.4 billion Swiss francs. That represents a 3% decline in constant exchange rates. It's primarily driven by LOE impacts, particularly for metharituxin. Xolair clearly stands out here with very strong 10% growth at constant exchange rates. There's more good news on the horizon with Xolair for food allergy. We'll talk a little bit about that in a moment. But before we get there, let me mention one key upcoming news flow piece, and that is that the GAZAIBA Phase III study in lupus nephritis is expected towards the end of the year. And those data could be very, very promising for patients with this very severe form of lupus. So moving on to Zoller and food allergies. So this is the first medicine to reduce allergic reactions to multiple foods. And I think the results here, frankly, really speak for themselves. A significantly higher share of patients could consume the threshold dose of peanut, milk, egg, or cashew when treated with Zoller versus placebo. I think we truly believe that Zoller has the opportunity to redefine the way that food allergies are managed. The U.S. launch is just kicking off, and we can already see a very high excitement amongst patients and doctors, and we look forward to sharing more with you over the coming quarters. Our ophthalmology franchise reached $0.9 billion sales in Q1 with an impressive growth of 58% at constant exchange rates. Bovizmo remains our key driver, now reaching U.S. market shares of 25% in AMD and 18% in DME. That's up three percentage points versus the previous quarter. The U.S. RVO launch is showing strong momentum. We've already achieved 8% market share after only four months. Overall, the BISMO is continually increasing penetration into new patients, and I think just underscoring this, the expansion into new market segments is really exemplified by the fact that 15% of accounts not using the BISMO or using vobizomib have not used Lucentis previously. So you can really see that vobizomib was not only moving up earlier in the treatment paradigm, but it is moving in to physicians that have not had historic Lucentis experience. We have two key Q1 updates for vobizomib that I will cover in separate slides in just a moment. But before I do, let's cover quickly the outlook for 2024. So a couple important things to mention here. So SUSVMO, the U.S. commercial relaunch for SUSVMO and AMD is set for Q3 of this year, and the filing for DME and diabetic retinopathy is planned for the second half. And there are two Phase II readouts in second half for NMEs, which, if positive, could lead to Phase III initiations. That's the MICIBART, which is our IL-6 and DME, and then the ASO Factor B in geographic atrophy. Before I move on to the Vabizmo deep dive slides, let me also just reiterate that we do have another IR event at ASRS on July 23rd, and there we will present some long-term follow-up data for Vabizmo. So this slide looks at a network meta-analysis and a systemic literature review that was recently performed that shows Vabizmo improved anatomical results versus a Flivercept 8-milligram. These types of tools are validated to make comparisons across clinical trials, and this particular one by Lange et al. analyzed seven clinical trials, including pivotal trials of the BISMO, a Flibercept 2 milligram and a Flibercept 8 milligram, and AMD and DME. The combined studies cover more than 5,000 patients, and the key outcome of the analysis, as you can see on the right, is that the BISMO achieved greater CST reduction in both AMD and DME compared to a Flibercept high dose. and 2MIG during the loading phase at 12 weeks. This analysis adds to the growing body of evidence that Vobizmo's unique MOA leads to the superior anatomical outcomes and the drying of eyes. Supporting Vobizmo is the preferred choice for first-line treatment in AMD and DME. Speaking of that growing body of evidence, let me briefly highlight the rapidly growing body of real-world evidence for Vobizmo. Currently, more than 50,000 Vibismo patients have been analyzed across more than 10 real-world data publications. The combined insights from these real-world data studies clearly substantiate Vibismo's real-world treatment benefit. ARVO is taking place in just a few days, and you'll be able to see 36 abstracts covering real-world data on Vibismo. We continue to see that real-world clinical evidence is absolutely mirroring what we saw in our clinical trials. And, again, well-positioning Babizmo as standard of care. Moving on, I'm happy to highlight the positive phase 2 cardio 2 data results for Zolbiceron and hypertension. A single sub-Q dose of Zolbiceron showed clinically significant reduction in 24-hour systolic blood pressure at three months when added to three different standard of care regimens. You can see in the graph that this positive effect was seen in both mean ambulatory and office blood pressures. Furthermore, the positive effect on systolic blood pressure was persistent at six months, including at the maximum dose of omasartan. The results support the potential of twice-yearly dosing and the safety and tolerability of the profile continues to be very encouraging. And I'm proud to say that we recently just achieved FPI for our third Phase II study, CARDIA-3. The patient population here differs from CARDIA-2 in that the CARDIA-3 patients will be on two to four standards of care and are patients that are at a particularly high risk of CV events. The CARDIA-3 results will inform the upcoming Phase 3 cardiovascular trial study, which we hope to be able to share with you later this year. And last but not least, let's have a look at our 2024 key news flow. You can see we've added quite a few green check marks in Q1 for positive regulatory and clinical results, and I've covered the majority of them in previous slides. But let me highlight one additional piece of upcoming news flow that we are excited about. We expect to have phase one data for CT388. That's our lead asset in obesity from Carmont at half year in 2024 and aimed to present at USAT in September. This new data will cover cohorts 11 and 12, which is in patients without type 2 diabetes. And I'm looking forward to sharing this additional CT388 data as well as upcoming readouts on the other two assets, CT868 and the oral CT996 later this year. And with that, I will let Matt guide you through our diagnostics results.