Roche Holding AG

Ladies and gentlemen, welcome to Roche's third quarter sales webinar 2023. My name is Henrik and I'm the technical operator for today's call. Kindly note that the webinar is being recorded. I would like to inform you that all participants are in listen-only mode during the call. After the presentation, there will be a question and answer session. You're invited to send in questions for this throughout the entire session using the Q&A functionality of Zoom. In addition to that, you may also raise your virtual hand to address your questions verbally. For participants joining via phone, to raise your hand, use star nine on your phone's dial pad. When you then get selected to ask your questions, please follow the instructions from the phone and press star six to unmute yourself. One last remark, if you would like to follow the presented slides on your end as well, please feel free to go to roche.com slash investors to download the presentation. At this time, it's our pleasure to introduce you to Thomas Schieneker, CEO, Roche Group. Mr. Schieneker, the stage is yours.

Thank you very much. And hello, everyone. Good morning. Good afternoon. Good evening. I'm very much looking forward to sharing our Q3 2023 results with you today. Now, for the first nine months of 2023, we continue to see strong growth for both divisions, resulting in 1% at contract exchange rates for the group. If we exclude COVID, we're growing 9%. Combining COVID and the effects from AHNR, we are compensating 4 billion Swiss francs and we're growing, so you see this is a very strong performance by the organisation. Year-to-date, pharma grew 9% at constant exchange rates, with the newer medicines really as the key growth drivers, and Theresa will talk about that a bit more. And let me especially call out two medicines. One is Revizemore, where we now expect annual sales to be above 2 billion Swiss francs. Also, I would like to call out Polyvi in first-line diffused large B-cell lymphoma, where we see a rapid uptake in the US after the FDA pool, but not only there, but also in other countries. The diagnostics-based business is also doing extremely well, now growing at 7% year-to-date in constant exchange rate, much faster than the market. Again, you see the strong portfolio that we have in diagnostics. We expect COVID-19 sales now to decline with roughly 4.5 billion Swiss francs and the H&R by a similar erosion to be roughly 1.1 billion Swiss francs. Now, given our good base business growth and the headwinds of now about 5.6 billion Swiss francs, we'll end up at the upper end of our guidance. In Q3, we've also achieved a number of very important milestones. T-Centric for the subcutaneous formulation received its first approval in Great Britain. With that, we have the first PD-1 PD-L1 that is available in subcutaneous format. We received the EU approval for a RISD for babies under two months old, and this is now available for babies from birth onwards. For LVDs, for the first gene therapy in Duchenne muscular dystrophy, we received two approvals outside the US, and we expect the pivotal Phase III and BARC results for LVDs shortly. We also had a number of very important readouts. One is the pivotal phase three ALINA results for licenza in adjuvant out-positive non-small cell lung cancer. These results will be presented at the presidential session at ESMO on October the 21st. These are really unprecedented results if you look at the hazard ratio and in terms of improvement above the standard of care. Let me also highlight the positive phase two cardio one results for SILVASERAN in hypertension. Now, only two months after we signed the agreement with Alalim, we already had a positive phase two results. So very happy how this is progressing. We also had two important launches in the diagnostics division. the CCM Vertical, which is an automation that Matt will talk about that will enable more automation through different floors and in less space of laboratories. We are the first to market with an IL-6 immunoassay that detects early onset of sepsis in newborns, again filling our medical value pipeline on the diagnostic side. Finally, we have a number of important new flows coming up in Q4. Now let's take a closer look at the sales. So the year-to-date group sales are at 44.1 billion Swiss francs. You see we're growing at 1% in constant exchange rate, excluding COVID-19. That's very strong, 9%. And you see both pharma doing well with 9% and diagnostics doing well with 7%. You also see the currency headwinds that we had, especially also the headwinds got stronger in the third quarter. Now let's look at the quarterly results over the past quarters, and especially Q3 2023, where we're growing 7%, which again, very strong result. If you exclude COVID, we're growing 10%. Also, the H&R by similar erosion is slowing down. The negative impact of COVID-19 will now last only another two quarters. And I actually have one slide on that, so you exactly see how the COVID business will continue to develop. On this slide, it's easy to then also see the base business, the underlying business, and how this has been performing. And it's performing extremely well in both divisions. On the pharma side, you can see that the two lines are basically identical. So we had no COVID effects so far this year on the pharma side. On the diagnostic side, we had significant effects, but the base business is doing very well, as you can see on this slide. Now, going to the COVID effects. Let me highlight that Roche had played a very important role during the pandemic, and you can see that with 3 million patients treated, more than 2 billion COVID-19 tests sold, and more than 18 billion Swiss francs in sales generated, and that at a very ethical pricing. If you look at the development of the sales over the last quarters, You can see that we're now at a very low level of COVID-19 sales. And we believe this is the level that approximately we will continue over the next quarters. And you can see that in Q4 2022, we still had 1.7 billion Swiss francs of COVID sales. A large part of that, in fact, about 1.1 billion Swiss francs, was one Rona-proof order in Japan, so on the pharma side. And then you see another effect of about 0.9 billion that we have in Q1 2023. Again, we had a Rona-proof order in Japan of approximately 600 million. But this will wash out completely. And the underlying very strong performance of the organization will shine through as soon as we have those supporters behind us. Now, let me highlight the performance across the different parts of the group. Here, you can see a strong base business growth of diagnostics, the 7%, contributing almost 700 million Swiss francs. I mean, not many companies in diagnostics actually have that size, so you can see we're adding a company almost every year in our diagnostics business. On the pharma side, You know, the newer products are performing fantastically well. We're almost adding 4 billion. Here, you see the reduction in COVID sales. Corona-free, almost no effect so far. But what becomes very apparent is the foreign exchange effects of about 3.4 billion. On the right-hand side, you can see the portfolio diversification. H&R is now a much smaller slice of our sales. So we've really been growing through the erosion of biosimilars and actually also through the situation that we've had with COVID-19, really being able to replace those sales, as you can see in the first quarters. We've launched 20 new medicines since end of 2015. And with that, those medicines are really driving the growth. And on the right-hand side, you see that we now have about 50% of our sales that are coming from these medicines. And this share will go up also in the coming months. Now let's move to the news flow. As mentioned before, in Q3, we had positive readouts for Alicenza in adjuvant ALK-positive non-small cell lung cancer. We had a positive readout for Fesco, the on-body injector in HER2-positive breast cancer. We unfortunately had one negative readout for Van Clexta. And we expect additional readouts towards the end of the year for Dyscentric in adjuvant head and neck cancer, for Van Clexta in MDS, and very importantly, Elevitis in Duchenne muscular dystrophy. In diagnostics, we had two launches that are on this list, but Matt will talk about a number of additional launches and the other three will come before year end. So overall, we've updated our guidance on the diagnostic side in terms of good base business growth. We've updated our guidance in terms of COVID-19 sales with roughly now minus 4.5 billion Swiss francs. The H&R sales of roughly minus 1.1 billion Swiss francs. Now, given our goods-based business growth and the headwinds of now, in total for the year, 5.6 billion Swiss francs, we will end up at the upper end of the guidance. So overall, the sales guidance remains unchanged. And the same goes for our core EPS guidance, broadly in line with sales decline. And also, we will further increase dividends in Swiss francs. With that, I hand over to Theresa.

Thank you, Thomas. So, as Thomas mentioned, it was another strong quarter for pharma. Year-to-date, we had sales of 33.6 billion Swiss francs at a constant exchange rate growth of 9%. That was 11% alone just in Q3. All regions have delivered strong growth and new products more than offset biosimilar and generic erosion. As you heard from Thomas, accelerating currency changes in Q3 are likely the cause of some of the smaller sort of misses that we saw in consensus as the fundamentals of our core products remain strong. And let's talk a little bit about that in more detail. so as you know we have one of the youngest portfolios in the industry comprised of best in disease products the bismo okravis hemlibra polyvi evrizdi fezgo to centric these continue to drive significant growth and combined these added 3.9 billion swiss francs of new sales at constant exchange rates the bismo continues to be our number one growth driver and is well on track to achieve 2 billion in sales in swiss francs for the fiscal year okravis continues to deliver double-digit growth and we are excited by the recent sub-q positive data that was released and the opportunity that that twice a year subcut will provide to us in opening up new markets for okravis Polivi is the next drug that I'd like to highlight as it consistently beats consensus expectations. This strong growth performance of 126% at constant exchange rates really underscores the strength of the first line DLBCL launches that are happening around the world. And we'll talk about that in more detail in the coming slides. On the negative side, I'd also like to mention the total A, H and R erosion. Thomas highlighted this as well. We're at about 850 million Swiss francs, which is less than we had anticipated at the beginning of the year. We suspect we'll end at about 1.1 billion in erosion, which is a little better than we had anticipated as we begin to see a leveling off in some regions. So now let's start to take a closer look at our overall performance. And as always, we'll start with oncology. Oncology sales are up by 5% at constant exchange rates to 14.5 billion Swiss francs. That's up one percentage from half year. In honor in Breast Cancer Awareness Month, we're gonna start with a deep dive on the HER2 franchise. As we have previously guided, Kedsilah has modest growth, which is driven by international and early breast cancer compensating the decline that we see in the US and the EU in the metastatic setting. Kedsilah sales are expected to remain stable going forward. Progetta remains driven by international with conversion to Fesco ongoing. Fesco continues to impress 66 percent growth with a 37 percent conversion rate in our 44 early launch countries. We are seeing strong conversion in even some of our most difficult markets like the U.S., where you wouldn't necessarily expect strong conversion. conversion. We're 20% now in the U.S. We expect Fesco to achieve blockbuster status by the end of the year, and our ambition is to reach a 50% conversion rate for Fesco in the coming years. While it is noteworthy that we have, what's also noteworthy, I think, is that as Fesco has continued to gain momentum in certain markets, we actually see an overall increase in our HER2 positive breast cancer franchise there as more patients actually get more access to Fesco. So I think there were some questions about the performance of Progetta in Q3. So maybe I just want to pause here and try and address some of them. So first of all, I think when you look at that sort of dip in Progetta in Q3, that's actually not uncommon for Q3. We seem to have some phasing effect that happens with Progetta in Q3. Last year, I believe we were down 3.3% in Q3. uh year over year but i think largely what you're seeing is that the success of the of the fezgo conversion i mean i think spain is actually a really great example here spain launched in may of this year and already by september had a 21 conversion so what i think you're seeing is some of that progetta business moving more quickly into fezgo than maybe was anticipated um overall the her 2 portfolio has a strong and consistent growth of 14.4 and so i think there's you know there's really nothing nothing different underlying the fundamentals here. I'm going to skip to Centric and hematology as we'll talk about them in more detail in a coming slide and head straight to Allicenza, which continues to perform strongly with 9% growth in constant exchange rates and our core indication of first line ALK positive metastatic non-small cell lung cancer with a whopping 70% share in our major markets. I think we were very excited to share with all of you the ALENA data, which is our positive phase three adjuvant data in ALK-positive non-smell cell lung cancer, which you all got a little bit of a sneak preview on on Tuesday. So fortunately, that means we can share a little bit more detail with you now. The results that we saw in Allicenza in the ALENA trial were unprecedented. We saw a staggering 76% reduction in the risk of disease recurrence or death. with a hazard ratio of 0.24, which is really just amazing. Additionally, we saw clinically meaningful improvement in CNS DFS as well with a hazard ratio of 0.22. So these are really just breathtaking results. The full results were selected to be presented in the presidential session at ESMO this Saturday. So see you there. And we have a first in class global filing, which is currently ongoing. We would expect US and EU launches to commence in 2024, and we would expect to add about 50, I'm sorry, $500 million in sales with this indication. I think it is really noteworthy to just kind of pause and reflect on the fact that this is one of the patient populations that actually is more likely to get tested early on. About 45% of patients that we believe will be eligible for this drug will actually get tested early enough to take advantage of treatment in the adjuvant setting, which is a really great signal that many patients will be able to benefit from allicinza and actually have a better outcome with their cancer. But this is not the end for development with allicenza. We have additional growth possible through our ongoing phase three and unresectable non-small cell lung cancer. That's the HORIZON trial, as well as another ongoing phase three tapestry in the tumor agnostic setting. So allicenza is just a really tremendous molecule and something to definitely keep your eyes on. Moving on to hematology, I think we've said for some time that malignant hematology is a place to watch, and I think we now see a rejuvenation of this portfolio as new medicines begin to come into the market. I'm going to start here in the obvious place, which is Polivi. The strong performance of the first-line DLBCL launch continues, and we now have over 10,000 commercial patients on the Polarix regimen. We see strong first-line shares in The IPI 0 through 5 achieved. The U.S. is at 14%. Germany is at 29%. The U.K. is at 23%. Japan is at 32%. So you really see adoption beginning to take hold and accelerate in these key markets. In addition, we have four to five years before we would expect any additional competition in the first-line DLBCL space, which not only means that we can entrench Polivi as the standard of care, it also gives us our own opportunities to further improve that standard of care by developing new in-house combinations, such as Skyglo, which is the Kolinvi plus Polivi plus Archip trial, which was initiated in Q3 and has already had its first patient in. Similarly impressive is the growth that we're seeing with Gaziva. This is driven primarily by Gaziva in combination with fenclexta and imbrutinib in first-line CLL. And then, again, we have our two bispecific launches that are currently ongoing. Lunsumio, which is having just a really great launch in third-line follicular lymphoma. We are already seeing double-digit market shares in key early-launch countries, including the US, Germany, and Switzerland. And Columbia just recently approved in... in the us and the eu and q2 and third line plus dlbcl and that launch is ongoing and again going fairly well we do have additional opportunities for much more significant growth with both insumio and columbia as we look into the additional trials which will be launched in earlier line settings but again i think by these bispecifics are unique they have a great competitive differentiation and it will be very exciting to actually see them get their new data in and begin to be able to help patients in earlier lines of therapy. In terms of key data, we have two key data sets that have been submitted to ASH, the Phase 1 B Lunsumio and Columbia combos and DLBCL, and then we will also see some DLBCL subtype data for Polarix. So look forward to that. Moving on to Ticentric, I want to spotlight actually two new areas that have had the most activity during Q3, sub-Q and HCC. And to be fair, I should also mention that October is Liver Cancer Awareness Month, just so that everybody is treated equally. For Ticentric Subcut, we have achieved our first approval. We were the first sub-Q PDL PDL1 to be launched with approval in Great Britain. We dosed our first commercial patient several weeks ago. As a reminder, Fezgo in the UK is at 92% conversion rate, which shows high demand for something like this that can actually not only provide more convenience to patients, but also help patients. help increase freeing up resources in healthcare systems. Subcut reduces admin time from seven to seven minutes from a 30 to 60-minute infusion. And so we would really expect, again, for those healthcare systems where they have constraints, that we would see similar adoption to what we have seen with Fesco. We expect to receive EU CHMP opinion in Q4 for Dicentric Subcut and US approval in 2024. Taking the next step in HCC, our phase three to centric plus tiragolumab plus Avastin trial in phase one, I'm sorry, in first line HCC was also initiated in Q1. And that follows the positive phase one to Morpheus data that was presented earlier in the year. For our inline indication, sales growth is largely being driven by HCC and some EU markets, and the ongoing adjuvant non-small cell launches XUS, as well as just sort of general global expansion. Through the end of the year, we've mentioned that we are expecting the first approvals for CHMP with Decentric SubQ, but then also the data from the adjuvant head and neck Trial, which is coming in Q4. This is a very large potential indication in an area of very high unmet need. And then obviously the skyscraper one results with centric posterior goliumab in first line non-small cell lung cancer with those final OS results expected in Q1 of next year. And just as a reminder, that is an event driven trial. So moving on to hemophilia, in Q3, Hemlibra continued its trajectory of extremely strong growth, adding 17% in constant exchange rates, and we would expect this growth to continue. Hemlibra is unquestionably the global standard of care in hemophilia A, with more than 22,000 patients treated globally, and US and EU patient share increasing to 40%, and that's a single percentage point gain in just one quarter. Growth expected to continue globally with patient shares in France and the UK already exceeding 60% and continuing to climb. And why is it that we have such confidence in Hemlibra continuing to be able to entrench itself? It has just a fantastic profile. The key differentiators of Hemlibra remain extremely strong, which just does make it the treatment of choice for prophylaxis in heme. More than 60% of patients are already on every other week or every month dosing with zero risk of developing inhibitors over time. We have a wealth of long-term safety and efficacy data, which shows superior benefit versus the factor eights and an improvement in joint health. We are currently improved in over 100 countries for non-inhibitor. We're reimbursed in 60. So again, even more geographies could potentially seek to benefit. And so again, as we look forward into the rest of 2023, we would expect further patient share gains in that non-inhibitor population, as well as expanding share in key accounts. with additional growth potential. But I think when we ask around Hemlibar, the number one question on everybody's mind is actually what's going on from a competitive standpoint. So not unexpectedly, we're seeing very little, no impact from the first generation of gene therapies, which have been approved I think not unsurprisingly, we're not really seeing the pickup of those therapies at this time. And then with the approval of Altuvio, again, very much as we had expected, we're primarily seeing share being taken from other factor eights. And we're, you know, in the very handful of instances where we hear about these HemLibra switches, and I'm using air quotes for those of you who maybe are just listening, this is largely people who remain on HemLibra but just switch their factor eight. And again, we're talking about a very small number of patients even in that bucket. So again, we feel very confident about the growth trajectory and the potential option, the potential growth rates for HemLibra going forward just based on a very differentiated profile. Moving on to immunology, we see overall sales in immunology were stable in Q3, despite the loss of esbriant sales to generic competition. Zoller sales increased by 3%, driven primarily by the growth in CSU. Earlier this month, the FDA approved the Zoller Autoinjector, which provides patients with new options for dose inconvenience, very important in this very competitive field. You can see that Actemra delivered a very solid performance in its chronic indications, driven by the US and EU. It is worth noting there's no remaining COVID sales for Ektemra at this point, so its performance is really driven by its core indications. This is a little bit higher performance than we might necessarily have expected for Ektemra, and that's probably due to some turbulence in the year-over-year. sales as COVID has sort of washed out, but we really are seeing a good and positive growth in our core indications here. Through the end of the year, we look forward to updated phase two data for ASO factor B and AGI nephropathy, which will be shared at the ASN Kidney Week at the beginning of November. And then we are still awaiting the Zoller OutMatch study results in food allergy. Switching over to neuroscience, it has been quite a busy quarter for Ocrevus. Ocrevus remains the leader in MS market share in both the US and the EU. It is now at 24% global share and growing, which is supported by a much higher retention rate than we see with other MS medicines. We've seen strong year-over-year growth of 12% at constant exchange rates, and we do expect this momentum to continue for 2023 and beyond. Last week at ECTRIMS, we presented multiple new SEDA sets for Ocrevus and Phenobrutinib. I will talk about those in a moment, but before I move on, I would be remiss if I didn't highlight the fact that we have a neuroscience update call happening on October 30th that will discuss not only in more detail the trials that I'm about to cover at a very high level, but we'll also cover our R&D activities in other areas like Alzheimer's and SMA, including the data that will be presented in CTAD for Tarnitinumab. So now on to the data. So, Ocrevus sub-Q. In July, we announced the positive top-line results for Ocrevus subcut, and last week at ECTRIMS, we provided the detailed results. The study met all of its primary and secondary endpoints and demonstrated that Ocrevus subcut twice a year is non-inferior to Ocrevus IV and RMS in PPMS. This can be seen in the B-cell depletion graph on the left, as well as the MRI data on the reduction of brain lesions shown in the table on the right. Combining the safety and efficacy of Ocrevus IV with the added convenience of a subcut has the potential to expand overall anti-CD20 usage and really drive Ocrevus class share. As you know, we really think of the IV and the subcut markets as two very different markets, and this gives us the opportunity to reach a base of patients that we just simply haven't been able to reach with the IV formulation. This is going to be particularly meaningful in treatment settings that have limited infusion capacity, or will healthcare systems have more limited resources? The initial launch, which is expected in 2024, will be with a syringe pump, and it will be able to be administered at home by a health care professional or in an office or in a pharmacy. And in addition, we are currently evaluating self-administration options via an on-body injector, a patch pump, and we expect this option to be available in the midterm. More details on this program will be provided at a later point in time and a little bit closer to launch. Ocrevus subcut is a very significant potential new opportunity for Ocrevus, and we're excited to be able to bring that to patients next year. Moving on to our 10-year results in the real-world family planning data for Ocrevus, it's almost hard to underscore how important these data are when you really think about what is most meaningful to patient populations. The 10-year follow-up data for RMS and PPMS adds to the impressive body of evidence that we already have for Ocrevus in safety and efficacy. Over 80% of RMS patients were free from disability progression and 92 were able to walk unaided. For PPMS, we observed that more than a third of patients were progression-free after 10 years. And what is important to MS patients? It's important that that progression is delayed. It is important that they can continue to work, that they can continue to be active with their friends and their family. These are typically very young and active people who are stricken with MS. So these data are, again, frankly just stunning and put a lot of confidence into the need to treat early with Ocrevus. Similarly, using real-world data, we performed the very first analysis of the effects of anti-CD20 MS treatment on family planning. Again, highly relevant for MS patients who on average are 29 years old when they're diagnosed. This is the time of life when they're just starting to begin their family planning. These data showed minimal MS disease activity was observed in patients from preconception to pregnancy and in the first trimester postpartum and that okravis did not increase the risk of adverse pregnancy or infant outcomes as you might imagine we have been sharing these data quite extensively with physicians around the world and one physician shared back with us that okravis is the best treatment option for patients considering family planning and i think these data really really go a long way to giving young people who want to delay progression, who want to start families, all the reasons in the world to say that Ocrevus is the right therapy for them. And last but not least, before we leave MS, let me talk a little bit about phenobrutinib. As a reminder, phenobrutinib is a potent, highly selective, and the only non-covalent reversible BTKI in Phase III for MS. It has the potential to be a best-in-class BTK, and this is underlied by the positive Phase II phenoptin results in RMS, which met all the primary and secondary endpoints. We had previously presented this data based on MRI results for brain lesion reduction, and they show how Phenobrutinib patients are four times more likely to have no new T1 or T2 lesions at key time points versus placebo. And the efficacy that we reserved in this trial is consistent with other high efficacy disease modifying therapies in MS. At ECTRIMS, we added to this with the CSF data on brain penetration, sort of the Holy Grail in MS treatment. And the graph in the middle demonstrates that Phenobrutinib was able to efficiently penetrate the blood-brain barrier. And this is where we do believe we will be able to deliver potentially really differentiated efficacy outcomes. The updated Phenopta data was very well received, and it has actually been selected as a clinical highlight by ECTRIMS 2023. No new safety data. was identified in the study and across all, nor has any new signal been identified across any of our ongoing clinical trials. We have no confirmed cases of Hies' Law across any of our trials, and we currently have a large safety database with more than 2,500 people dosed across multiple indications. Our phase three studies in RMS and PPMS are ongoing and do include a head-to-head in Ocrevus and PPMS, and this is the only trial that is actually directly comparing with the current standard of care, which is Ocrevus. And those trials are expected to read out around 2025. So again, another important new molecule to watch. And before we leave neuroscience, we will touch quickly on Evrizdi. Evrizdi is on track to become the number one SMA therapy globally in the coming quarters. We are now at more than 11,000 patients treated globally. As a reminder, we were at just 7,000 patients at the end of last year, so a really great ramp rate. Evrizdi is well tolerated with a retention rate in the first 12 months of more than 90% globally, and we have already reached market leadership in the US with 25% share. In Japan, we are at a whopping 58% share for EvrizD. U.S. growth is driven both by switching in naive patients with increased penetration in that treatment naive patient setting. And again, as you've heard me say repeatedly, it's really important to penetrate that naive setting. Those are mostly adult patients. Those are patients that have not really ever treated their SMA. It is the largest group of patients that are out there. And we continue to see good inroads into actually helping those patients actually begin to treat their disease. We have the positive phase two Rainbow Fish results, which confirm that strong efficacy and safety in patients that are less than two months old. Those results were presented at WMS this year, and we achieved that EU label expansion just back in August. So what are we expecting throughout Q3? I'm sorry, throughout the rest of 2023, we would just continue, we would expect to see continued growth in market share gains, again, driven by both switch and naive patients. It's again, hard to underscore what a transformational drug SMA really is for SMA patients. And it's definitely another one to keep your eyes on. So no pun intended, something else to keep your eyes on, ophthalmology, and of course, Vibismo with strong growth. We've already hit blockbuster status year to date on sales. We are well on our way to more than $2 billion in sales for the full 2023. That growth is driven by the unique clinical profile of Vibismo. So those three Ds, the dual pathway, the drying, the durability, we're just coming off of EU Retina. And I think we heard in the hallways that the clinical experience that you see from physicians treating patients matches the real-world data experience that we see in things like Truckee, which match our clinical trial experience. So, you know, again, we continue to be really, really confident in Anvibisimo as a potential new standard of care. U.S. market shares in AMD and DME have further expanded to 19% and 12%, respectively, based on August claims data. That's up from 15% and 9% back in May. In the U.S., use and treatment naive patients has accelerated. It now accounts for 37% of all new treatment starts. In the ex-U.S., that is actually 40% of our patients are now naive, and that's up from the teens in the U.S. back in Q1. Outside of U.S., launches are also exhibiting very strong uptake. Many of our early launch countries have already achieved double market share just after a few quarters of launch, including Japan, Germany, U.K., Switzerland, Australia. And impressively, the U.K. and Switzerland have reached more than 20 percent market share in just one year after launch. In the second half, the global rollout will continue with several key EU markets getting reimbursement. By the end of 2023, we expect to have reimbursement in all of the EU5, which will drive further growth. And looking forward, the U.S. EU filing for the potential third indication of a BISMO has been completed and an FDA decision for RVO is anticipated by the end of this year. Before we leave ophthalmology, I think it's also good to mention where we stand with our latest developments for SUSFIMO. SUSFIMO, as a reminder, is that device that is implanted in the eye. The root cause for our voluntary recall last year has been identified, and a technical solution is now in place. SUSFIMO trials should restart by the end of the year. We anticipate a U.S. commercial relaunch in 2024, and ex-U.S., we would expect to be able to bring SysVimo to patients in 2025 and beyond. And then last but not least, I wanted to highlight our partnership with Alnylam and Zalbicerone, a potential best-in-class treatment for hypertension. Compared to existing hypertension treatments, Zalbicerone represents a novel drug modality, which also has a slightly different and potentially improved MOA. It has already achieved positive phase one results. Thomas mentioned earlier that in September, we saw the phase two CARDI1 study of monotherapy. Zalbicerone met its primary and key secondary endpoints, and those results will be presented at AHA in November. Zalbusuron has the potential of improved adherence and compliance to treat with a possible biannual subcutaneous detchling regimen, which when you think about the 1.2 billion people in the world, 80% of whom can't control their hypertension, and we know that leads to worse cardiovascular outcomes, the potential addition of Zalbusuron twice a year could really be incredibly meaningful for those patients. Working closely with Alnylin, we continue to assess the potential expansions of Zalbisteron, exploring other cardiovascular diseases, including things like heart failure or other potential opportunities to maximize this therapy's potential. The clinical development program, as you know, is ongoing. Cardio 1 has run out positively, Cardio 2 data, which is, in addition, an add-on to one standard of care data will come in the beginning of next year, CARDIA-3, which is a third phase two trial, which is an add-on to two standards of care that will initiate in 2024. And L-NILAM has recently announced that we plan a cardiovascular outcomes trial Patients who have uncontrolled hypertension at high risk for a negative CV outcome, these will have a MACE-type endpoint, and that trial design will be based on the CARDIA-3 readout. So more to come here. And finally, before I hand it over to Matt, I want to take a quick look at the changes in our key news flow side since half year. So from a regulatory perspective, we mentioned the RVO filing is complete for the EU for Vibismo and the PDUFA is set for the end of the year with the FDA. For our phase three readouts, we talked about the positive readout with Alina. Thomas mentioned the positive Fesco on body injector pivotal one phase one readout. A LITTLE BIT EARLIER, THOSE DATA ARE GOING TO BE SHARED AT THE BEGINNING OF NEXT YEAR. AND THEN WE DID HEAR FROM ABVEY A COUPLE OF WEEKS AGO THAT THE KANOVA TRIAL IN A RELATIVELY SMALL SUBSET OF PATIENTS WITH MULTIPLE MYELOMA DID NOT MEET ITS PRIMARY END POINT. WE HAVE THE PHASE ONE CARDIA ONE DATA THAT ALSO RELEASED POSITIVE RESULTS, AND THAT WAS IN ADDITION TO THE INITIAL NEWS FLOW SLIDE. And then through the end of the year, I think Thomas mentioned all of these, head and neck, venclexta, furtocentric, venclexta and MDS, alevides and DMD, long-awaited. And then, of course, we had one trial actually pull forward into Q4 2023, and this is our PA3 kinase in combination with palboin fulvestrant, the ANOVA 120 data, which is expected in Q4 of this year and could potentially be the first positive readout for P3 kinase in a volisib which is also in a broader development program. So sorry, Matt, I went a little bit over, but with that, I will hand it over to you.