7/23/2026

speaker
Operator
Conference Facilitator

I'd 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, you'll star 9 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 www.woosh.com slash investors to download the presentation. At this time, it's my pleasure to introduce you to Thomas Schinecker, CEO of Woosh Group. Mr. Schinecker, the stage is yours.

speaker
Thomas Schinecker
Chief Executive Officer

Thank you very much and good morning and good afternoon everyone. I'm very much excited to share our half year 2026 results with you. We again had a strong performance and we truly made significant portfolio progress in the second quarter. Now, let me take you through this slide. I think the headline says everything. Co-operating profit growth at plus 10% ahead of sales growth at plus 6%. Again, increasing our margin, similar to what we have done over the last couple of years. Performance driven really by both divisions, both pharma and diagnostics. Diagnostics without the China impact is growing 6%. And let me just also reframe the impact of the flu season. The flu season had about a 1% or more than 200 million impact on the group results. So without that also, we will be growing at 7%. I already mentioned the strong bottom line performance with cooperating profit plus 10%, cooperating margin plus 1.7 points. Core EPS plus 9%, very strong performance. We had significant milestones that we have achieved in Q2. We have five US FDA priority reviews in, for example, for Ticentric, but also in Gaciva. We have made a number of progress in terms of filing, for example, in end-spring thyroid IDCs. So overall, extremely good regulatory progress. On the pharma readouts, we had two positive phase three results as well. Overall, the phase three success rate in this year is 80%, and with that significantly above the average of the industry. So I think here also we're making very good progress. On the business development side, I would highlight two that I'm going to also mention later. One is PathAI, the other one is New York Therapeutics. On the diagnostics launches, we've had also significant amount of launches that I'm also going to go through and I know Matt's going to go through as well. We have significant news flow ahead, including phase three readouts for ITOFBI and Lunsumio and potentially a new enemy, Sifoxersen. So in the pipeline right now, we have three new enemies that we're going to launch, but with Sifoxersen could be a fourth one. And then some phase two readouts. So overall, quite a lot of news flow in the second half of 26. But even more... If you then look at 27, 28, 29, we have really huge amounts of new flow coming with really a lot of potentially very big medicines and also a lot of de-risked assets. So we're really excited as we look into the next years when it comes to our pipeline. Again, let me just highlight the numbers, 6% pharma, 3% diagnostics. I already mentioned the impact of the flu season and also the healthcare pricing reforms. So overall, very good track. Here you can see the sales growth over the last quarters and we'll continue to see good uptake also in the rest of the year. And as we move into the end of the decade and into the next decade, as I've shown to you in previous presentations, We believe that we will continue to have a good momentum and we feel comfortable with where we are at the moment. Really good growth across the different parts of our portfolio. We have a very diversified portfolio. We have in total 16 blockbusters. We're globally number one in diagnostics. We also have a very strong market position in many of the areas like haemophilia, ophthalmology, neurology, oncology, et cetera. And here you see just some of the news. We continue to see good global growth at 6% in market share gains. There is, of course, the US market, which is only growing low single digit, but where we keep gaining market share. Also in the immunology portfolio with Xolia and Gaciva, we have really good progress. And just to point that out, with TIL1A, of course, next year, it's new medicine coming into this portfolio. On oncology as well, Fesco, Coversion, Ongoing, the HER2 breast cancer franchise, will peak in 2026 with a strong tail. Decentric, we see accelerated growth driven by new indications. And Alicenza, we expect flat growth for the full year. Continuing with PolyV, continued strong first-line DLBCL uptake. Columbia driven by second-line plus DLBCL and also by third-line follicular lymphoma. and Libra very strong growth in the first half year double digit and also in the neurology franchise we're growing quite well. So let me talk a little bit about portfolio progress and portfolio progress is a combination of our own R&D and also bringing in external assets like we've done in the second quarter Thank you very much. You can see a couple of acquisitions we've done. You see a number of those have already moved into phase three. The latest one is the BTK degrader in hematology, but potentially also in immunology and urology. Phenobrutinib. is a PTK inhibitor with a degrader. We see even more reduction of the protein and we believe that this could be a next generation molecule here with a proven mechanism of action. So we feel this was a very good move for us, especially also because of our strength in hematological cancers and also in immunology and neurology. And here, usually, you know, when I talk through the slide, you have some red boxes. We had no red box in the second quarter, which really also shows that we've had really good pipeline progress. And just to take you through here, gerodestrin, we have filing acceptance by the FDA. We have FDA priority review. We expect the launch towards the end of the year. NXT 007 moved into phase three. This is the next generation of Ham Libra. Feedback has been very positive so far. It's about 30 times more potent, but also very safe. I already talked about the BTK degrader. Diveracep, I know Theresa will cover that, very good data. Also Sevastimab has continued to progress well as well as the HER2 tyrosine kinase. This is a brain penetrant molecule for HER2 positive breast cancer, really also addressing one of the biggest unmet needs there is to tackle the brain metastases that are developed in HER2 positive breast cancer. So also very exciting. And on the obesity side, we've also had interesting data on petrolintide, specifically when it comes to tolerability, placebo-like tolerability. And we know that on current medicines, most of the patients never go to the highest dose. They actually end their dose in the mid-range, where you would get to the same kind of weight loss as petrolintide. But we also know that creatinine has a higher level of side effects. And this is really a medicine that's extremely tolerable. Now, let me go to the diagnostic side and just show you some of the external activities that we've done over the last couple of years. And I would like to pick one from the last years. That one is STRATOS, sequencing by expansion technology, which we have acquired in 2020, which is really the basis for the Xelios sequencing. and I've always promised that we will deliver and we did deliver on the sequencing with really a differentiated product and now Matt will go through that. In addition we've done two additional acquisitions in more of the oncology space. One is Saga Diagnostics for ultra sensitive minimal residual disease testing. You know the market cap of some of the companies out there that are working in the space The really interesting thing about this is not only the really ultra high sensitivities, but you actually sequence the cancer and we have Xelios. And then you monitor by specific primers and you do it on digital PCR, which is highly cost effective. And we have a digital PCR system. So we are extremely well positioned here to really scale this on a global level, much better than some of the other players. On PATH-AI, this is really AI-driven diagnostics, AI-powered diagnostics, specifically in a pathology lab, reading the slides and really improving the diagnostics. And with that, also improving the treatment. And I know Matt will talk about that as well. So really excited about the progress. and this is just a beautiful slide, three major launches. Each of them, even for pharma terms, would be a blockbuster. Really differentiated when it comes to mass spec for sure and sequencing. And if you look at the industry, you know, at times maybe you have a company having one of such launches, but we have had three in such a close period of time. It just shows you how productive our R&D is, as well as adding new assays. And I just picked two out of here. One is the Alexis P-Tau 217. For Alzheimer's disease, where we have a significant head start versus our other major competitors out there. So really excited that especially in combination with Trantinumab and you have seen some data just lately that we presented in London on Trantinumab, which continues to impress. and then Alexis Interfering Gamma Release Assay for tuberculosis. This is detecting latent tuberculosis. About 25% of the patients or of people in the world actually have latent tuberculosis. These are both really great opportunities in the scale of what you have in diagnostics when it comes to potential sales volume for a test. Now, let me finish with the outlook. Mid-single-digit sales growth currently growing 6%, core APS growth, high single-digit core APS growth growing 9% currently, and we further will increase dividends in Swiss francs. So I think we're very well on track. And with that, I hand over to my team, and I want to thank them for all the great work. Ellen, Theresa, and Matt, thank you very much. So over to you, Ellen.

speaker
Alan (CFO)
Chief Financial Officer

Thomas Schinecker, Wafaa Mamilli, Bruno Eschli, Claudia Bockstineger, Maria Cristina Wilbur, Nicolas Dunant, Boris Zaitra 3% in Daya, as Thomas has said, 6% excluding China, Pharma with 6%, so really doing well. And look at the Swiss francs, the minus 2%, just for the sake of completeness. In US dollars, we would have grown 8%. Cooperating profit up 10%, as Thomas has outlined as well, very good cost containment, I will explain that. Cooperating profit to the core net income, we keep the momentum. That means the financial result as well as taxes were not in the way. Nevertheless, I can say stabilizing the tax rate in the first half is a little bit of an outlier and I will come to that. And then Cornet Income to Core EPS, well, the momentum slows a little bit with the plus 9%, but these are just the outstanding results from Shugai. As you know, we own 60%, so we have to take 40% from the performance away. So I think that brings the Core EPS to the plus 9%. IFRS net income, I will explain, plus 6%. Still here, a couple of impairments in there. And then the operating free cash flow, plus 21%, plus 2% in Swiss francs. Let me outline this. So happy with that number. And then the free cash flow is plus 58% and plus 26% in Swiss francs. This is a timing effect as well. Here we had some tax payments or we didn't have the tax payments in the first half that we will have in the second half. Good, with that, let's go through the sales growth. And you see really on one hand, the 6% in CER. You see that the currency effect, which is a minus 8 percentage points, which brings us to the minus 2% in Swiss francs. Let me talk about the plus 6% at CER. On one hand, you see pharma. Excluding LOE, you see the LOE with a minus 244 came in a little bit better than we all expected. It's also a reason why we updated our outlook for the full year or our additional information for the year and said we expect to lose roughly 600 million due to loss of exclusivities, so a lower number than we had at the beginning of the year. When you put the two together, you get to plus 6% in CR. Diagnostics, plus 6%, excluding China, minus 15% in China as well. And then you really put it together and you get to the plus 3% that were mentioned before. When we go through the P&L, sales is clear, other revenue. Other revenue is increasing by 258 million. There are a couple of elements in it. When I start with pharma, I think on one hand, there's a settlement on a royalty claim, which is in here, roughly 70 million. We have in here an expected milestone income from Shugai for Fondayo. That's one element here. And then we have a cross-licensing settlement in Pharma of 126 million. When you put everything together, you get roughly pretty well to the 258. When you look at the cost of sales and the cost of sales, both divisions have grown their costs by 5%, which is quite an achievement because overall volume has grown by 8%, pharma by 9% volume growth and diagnosis by 5% volume growth. And when you look really at the two divisions, the cost of sales and pharma were driven by higher profit share expenses based on higher sales of XOLA and royalty expenses from the increased sales of Okravis and Evristi. and the cost of sales in diagnostics were driven by the increase in stalled instruments, the manufacturing rent up of the new launches and then certainly the US tariffs of roughly 43 million. When we look at R&D, R&D plus 1%, I think really here a lot of cost discipline in the game here, but certainly I think also, let's say quite some investment in key therapeutic areas like oncology, CVM and neurology. SG&A has increased by 3% and let me on one hand say really in pharma we had an increase in M&D so we really put money behind our products in marketing and distribution. Admin was really really fledged as even a small saving here so I think very disciplined approach here as well. And then other operating income and expenses here really lower income from product disposals compared to last year. Let me make an additional comment about other revenue. I think really when you look really a little bit at our history and where we stand at the moment, other revenue normally represents roughly 3% of our sales. I think certainly now with the Foundeo element coming in for the next couple of years, we expect that ratio to grow to 5% until the end of that decade. Good, I think I hope well explained how we get from 6% sales growth to 10% corporate profit growth. So when you look at the margins itself, I think that looks fine. I think even in Swiss francs, I think we are able to increase the margin. So as you can see, margin has increased by 1.7 percentage points in constant currencies. And that was driven by strong performance in both divisions. Pharma increasing by 2 percentage points. and Daya by 0.6 percentage points. Let me outline here that both divisions benefited from the further centralization of SG&A, especially on the legal side under corporate. That represented a benefit for pharma of 105 million in the first half benefit and diagnostics for 24 million in CR, less costs compared to half year 2025. What does that mean? I'm certainly well over the way of the fact that we have said basically it's 300 million for the full year that we're going to shift. I'm not going away from that number. It could be a little bit lower, but we will see a little bit of a ramp up of that effect in the second half. Cornet financial results. Quantate Financial Results, improvement of 42 million, and surprisingly in Swiss francs as well as in CER, so the numbers are equal. And you look at the equity securities, I think that's a nice improvement here for the Roche Venture Fund. Net interest income, we had lower cash, so a little bit less compared to last year. Interest expenses, certainly US dollar helps here with plus 43%. and then in other we have the increase in losses from currency results and other effects. Cortex rate. Well, first of all, I think really it's great that it came in at 17.5%. You see just a very slight increase compared to half year 2025. Let me say here, it's a timing effect. The timing effect that we benefited from came up late. So very clearly there will be an increased tax rate in the second half. And just to give you additional information here, I'm pretty convinced we will get to around 20%, perhaps a little bit lower for the full year nevertheless. Core EPS. When you look at the core EPS and at the bridge, and you see here the 9.3%, which represents the rounded 9% for the core EPS growth we've talked about already, you see operations is the major driver here. Then the product disposal and disposal of subsidiaries, as mentioned before, a decrease of 104 million. The financial income and expense here really positive with 42 million. Then the tax rate, which was pretty much stable. And then all other effects, once again, Shugai, with an effect of minus 1.6 percentage points. So really the overperformance, if you like, from Shugai, when you take it out, and that's what we do in the Core EPS, where we take the 40% out that we don't own, then you get to this effect. Non-core and the IFRS income. You see really co-operating profit up 10%, minus 1% in Swiss francs, and then the IFRS net income up by plus 6%, minus 6% in Swiss francs. And what are the drivers? A little bit less restructuring charges compared to half year 2025. The major difference are the impairments here. Let me outline that we have an explanation for the in-payments in Note 9 intangible assets in the Interim Consolidated Financial Statements on page 65, where we really go through it. Good. When you look at operating cash flow, I think really a great result here with plus 21%, plus 2% in Swiss francs when you really take the whole range of the bars that you have here on the slide. You see really operating profit net of cash adjustment, significant increase. Networking capital is basically effect from payables. On the pharma side, I think that will wash out, so I think that looks promising. Investments in PP&E flat, investments in intangible assets a little bit less compared to last year. You remember last year we had Sealand with 1.2 billion cash out and that leads us to the plus 21% and then you see the currency effect clicking in bringing us to the plus 2% in Swiss francs. Good. When we look here at the margins, I think overall a great development. Both divisions contributed to what you see really on the left-hand side of that slide and the increase of 21%. So what does that mean for the group net debt development? First of all, you see really that net debt has increased here from end of the year 2025 until end of June 2026. And the increase here is 5.9 billion. Having said this, when you look at gross debt, gross debt is stable. Just to mention this, gross debt is stable. Year end, it was 31.6 billion. This was not on the slide, that number. And at half year, it was 31.8 billion. So really stable gross debt, which means we have reduced our cash position. I will come to that on the next slide. When you look really what drove it, I think the operating free cash flow is clear. Then we have really taxes and the treasury is minus 2.1 billion. And then certainly the dividend kicks in, as always. I think that's the driver normally for the net debt increase in the first half that we will work against in the second half. Good balance sheet. I will keep that short. Two things to mention. As said, cash and marketable securities, I said less cash available. We've paid the dividend. And then the other piece is really the equity. The equity goes down, which is a normal phenomenon for Roche because we deduct the dividend payment from the equity. And then as the profits come in the second half, we hopefully, we will not just hope, we will wash that out and equity will increase. Good, currency. Yeah, interesting. When you really look at half-year itself, I've mentioned the currency effects, I think, quite a bit. When you look at year-to-date September, keeping all the currency rates stable at the end of June, we get to minus 5 percentage points. And when you look at full-year for sales, cooperating, profit and core EPS, we get to minus 4 percentage points, minus 6 percentage points and minus 6 percentage points, which is exactly the same prediction that we had in Q1. So the situation is stabilizing a little bit. Let's see what happens. But the volatility is still huge when it comes to currencies. Good. With that, let's go to my last slide, which is the guidance slide. As said before here, Thomas has made the confirmation already. But let me mention here the LOE impact of roughly 600 million now expected for 2026, which is a reduction to what we had at the beginning of the year 2026. Everything else is confirmed as we had it at the beginning of the year. And with that, happy to hand over to Theresa.

speaker
Theresa
Head of Pharma Division

Great. Thank you, Alan. So let's jump straight into pharma. So pharma sales, as Alan and Thomas both mentioned, grew by 6% at constant exchange rates, reaching 23.6 billion at half-year. That's 8% in U.S. dollars and minus 1% in Swiss francs. All regions delivered growth with international and Japan growing at double digits. You'll notice that the EU also returned to growth after Q1 was impacted by a number of pricing and one-off effects for specific products. As Alan mentioned, overall pharma volumes were up by 9%. I'm not going to belabor the P&L too much because Alan made most of the comments that I would have made, only to reiterate the core operating profit is up by 10% at constant exchange rates versus that 6% sales increase with a cut margin of 53%. And just to underscore the extreme cost discipline, particularly effective cost management in R&D lending to that. So now let's jump right into our individual brands. So my usual comment on the graph, all absolute values and year-over-year growth rates here are presented at constant exchange rates. In the first half of the year, our top brands, Zoller, Hemlibra, Okravis, Fezgo, Vibizmo, and Evrizdi generated roughly 1.4 billion in new sales at constant exchange rates. I'm going to share the details on all growth dynamics for our key brands on following slides. So let's jump right into oncology. Oncology sales increased by 1% to 7.4 billion Swiss francs. Fesco continues to deliver strong growth with a global conversion rate now at 54%. You may notice that this is 1% less than we had in Q1, and this is the dynamic that we normally see. We added two more countries into the global conversion metrics this quarter. We would expect that that will correct itself over time. as those countries now come fully online. And to reiterate, we are aiming for at least 60% conversion rate to Fesco at peak. Moving to CAD Silo, we are in line with expectations and we continue to see competitive pressure in the US and the EU. This is also a good time, I think, to reiterate our HER2 franchise outlook. We do expect the HER2 franchise to peak at around 9 billion, and that's 9 billion at 2024 constant exchange rates, just as a reminder. in 2026, followed by a steady decline through the end of the decade with a solid tail of around 4 billion, primarily Fezgo, around a billion for Cadsila and a bit of Herceptin plus Progetta. We do not foresee a biosimilar for the US for Progetta before 2028 and then the EU before 2027. Let me also confirm again that we do not foresee any cliff situation in the HER2 franchise. The ITOFB launch is ongoing with good momentum, and we had an exciting Q2 news flow for Gira Deftrant with the PDUFA date for Ladera and adjuvant ER-positive HER2-negative breast cancer set for November 30th. To briefly remind everyone, for Avera, the PDUFA had already been set for December 18th. Now let's shift gears into lung cancer, starting with Alicenza. As we signaled previously, competitive pressure continues to increase, especially in the EU and the US, and therefore we are, as Thomas mentioned, expecting flat growth through the end of the year. Moving on to Ticentric, the new indications are driving global growth, especially in forte and small cell lung cancer. Building on this, we're adding further indications with the successful U.S. approval for Invigor O11 in muscle invasive bladder and have filed Atomic in DMMR calling cancer with U.S. and EU regulators. I also want to confirm our full year outlook of low single digit growth for Ticentric. Finally, we're very happy to report the positive outcome of the Crescendo 1 trial of D-viracib in second line plus KRAS G12C positive non-small cell. And let's take a look at that in more detail on this slide. So to reiterate, we recently shared the good news of the positive phase 3 Crescendo 1 trial of D-viracib in second line plus KRAS G12C positive non-small cell lung cancer. Importantly, this was a head-to-head study. against the currently approved G12C inhibitors, and the results clearly show devirassive superiority in terms of PFS and OS improvements versus the approved G12C inhibitors. Let's also take note that that OS statistical significance was already reached at interim, which is very impressive. The devirassive safety profile remained consistent with previous data and was overall manageable. The data will be submitted to health authorities and will be presented in an upcoming Congress. So certainly strong results that reinforce our conviction that D-Viracib has best-in-class potential. However, this wasn't the only good news for D-Viracib this quarter. At ASCO, we shared the results from the Phase II Crescendo 170 study in first-line non-small cell. Here, the combination of D-veraspib plus Pembro achieves strong efficacy results across the PD-L1 positive and negative cohorts, and this bodes well for the ongoing Phase III Crescendo II study in the same regimen in first-line non-small cell. As you can see on the right side of the slide, we have a broad development program for Ras-targeted molecules. This includes D-viracib in first-line, second-line, and adjuvant non-small cell, but also a G12D-specific and several pan-mutation assets. So we don't only have one single mechanism of action, but we're bringing in potentially best-in-class molecules and different mechanisms, allowing us to think about unique combinations, addressing the efficacy concerns, as well as tolerability and combinability. We're extremely excited to see the progress that Diva Raseb has already made, and there is more to come. So next up, let's move into the hematology franchise. The hematology franchise delivered strong growth of 14% at constant exchange rates, achieving 4.6 billion Swiss francs in sales. Our key growth driver for the franchise remains Hemlibra. We are seeing impressive continued global growth driven by an increasing adoption in non-inhibitor patients and an increasing penetration amongst older adults. Based on the strong performance so far, we're updating our full-year growth outlook to mid-single digit from previously low single digit. I should note that this is a conservative projection, which takes into account increasing headwinds later this year due to upcoming competitor launches. In that context, let me also tease that we're looking forward to sharing more in the in-development Hemlubar Auto Injector at Pharma Day in September. A little bit of an aside, we did a demo device at the recent ISTH conference in Paris, and it was so popular that we literally had to position someone at the booth to prevent people from prying it off the wall because people were so eager to get their hands on it. So we're clearly excited to be able to bring you more information on this program and ultimately to bring it to patients. So next up is malignant heme. Polivi keeps on achieving new milestones in first-line DLBCL with globally expanding market shares and now over 120,000 patients treated globally. That's up from 95,000 patients at Q1 in this setting. For Lunsumio, we achieved U.S. filing for the positive Sunmo data of Lunsumio plus Polivi and second-line plus DLBCL, and that PDUFA date has been set for February 9th. Staying on the subject of second-line DLBCL, I wanted to briefly highlight our conviction and the potential for both Lunsumio and Columbia in the setting. Lunsumio SunMo delivers a best-in-class safety profile with significantly less CRS, making it highly preferred by US clinical advisors for outpatient and community oncology settings due to its manageable profile. Columbia Stargo is supported by proven survival data with mature long-term follow-up and many advisors regard it as curative. It enjoys a two-year plus first mover advantage, XUS, and post-reimbursement is the standard of care. So now let's take a look at gaziva. As I mentioned in our last call, we do see increasing competitive pressure in CLL and follicular lymphoma impacting gaziva's performance and hematological indications. This is essentially masking the ongoing gaziva launch in immunology. However, we have the first early indicators of the launch in lupus nephritis showing a positive impact on overall gaziva performance. And in fact, we see the gaziva quarterly growth in countries like the US, Germany, and the UK where lupus nephritis is launched and reimbursed is ahead of the global average. More on gazivin immunology in the coming slides, but let me repeat, we will show a sales split by therapeutic area in the future as those data sources mature. Now let's take a look at the newest addition to our hematology pipeline. We recently announced and have now closed our partnership with Nurx Therapeutics to collaborate on the development of Bexta-Brutidag. Bextag is a BTK degrader with the best in class potential in the BTK targeted therapy space, so including BTK inhibitors. As you know, BTK as a target has been validated for different hematological malignancies, but also in neurology and immunology. More on that later. Importantly, Bextec is a BTK degrader and via degradation, all functions of BTK are removed. This is unlike existing BTK inhibitors where some function may remain. Additionally, BTK degradation has been shown to overcome BTK inhibitor resistance mutations. Furthermore, Bextec has strong data showing it is highly selective and potent against BTK, as well as has the ability to cross the blood-brain barrier. Taken all together, we believe that Bextec has the potential to deliver best-in-class efficacy, safety, and tolerability. Our belief in the best-in-class profile is demonstrated by the recently initiated Phase 3 and Firstline Plus CLL, which is running head-to-head versus protobrutinib. Speaking of the development program, we have a broad development program in malignant heme. We're moving at pace together with Neurext. and let me highlight that this includes a basket combination trial where we will explore different combination options in CLL. Additionally, we're planning to investigate Beckstag's potential in MS and CSU in upcoming phase two trials. In short, a very exciting molecule to be added to the portfolio and we're looking forward to updating you on the progress going forward. So now let's move to neurology. Our neurology franchise delivered 9% growth at constant exchange rates, reaching 5 billion Swiss francs in sales. Ocrevus global growth remains strong, and the subcutaneous formulation known as Zenovo in the US is the key growth driver. We now have roughly 44,000 patients on subcut, which is a significant increase versus the roughly 24,000 patients we shared at Q1. And for the US, we're excited to see that Zenovo is now the fastest growing anti-CD20 MS brand. underscoring the strong differentiation of being the only anti-CD20 with every six-month subcut dosing. Let me also quickly update the outlook. Beginning of the year, we had provided a 2026 growth outlook for the Ocrevus franchise in the high single-digit to low double-digit range. However, we're currently experiencing some competitive dynamics in the anti-CD20 space that are at the upper end of our previous assumptions. So therefore, we now expect to come in at the lower end of that high single-digit to low double-digit range for the full year growth outlook. However, this does not change our peak sales assumptions, and we continue to be very happy on how we track towards achieving that ambition. As a reminder, our peak sales expectations for the Okravis franchise are $9 billion by 2029, and this includes $2 billion in incremental sales from Okravis Subcut, but there will be, of course, some switching from IV to Subcut on top. In the spirit of teasing PharmaDay topics, we're pleased to see that the development of the on-body injector for the Subcut formulation is on track, and we're excited to share more on this subject at PharmaDay. Briefly staying with our MS franchise, I'm sure you are eager to hear more on our Phenobrutinib filing efforts. Let me just say that we expect to complete US filing in the coming weeks, and once we have filing acceptance later in Q3, we will confirm this milestone via press release as always. And finally, we also shared positive updates on Trontenumab and Alzheimer's disease at last week's AAIC in London, as Thomas mentioned. This includes long-term data from the Phase 1-2 study, which continues to underline the strong potential for Tronti and the advantages of our brain shuttle technology, where specifically this long-term data confirmed the impressive amyloid clearance speed and depth as well as a strong safety profile for Tronti. Furthermore, we shared the study design of Preventron, our phase three study of Trontinumab in preclinical AD. Preventron is enrolling cognitively unimpaired individual at high risk of progression to symptomatic AD and highlights our ambition to maximize the potential impact of Tronti in Alzheimer's. Next up is our immunology franchise. Immunology reached 3.3 billion Swiss francs, growing 8% at constant exchange rates, with Xolair being our key growth driver. Staying with Xolair, we have reached yet another significant milestone in food allergy. By now, more than 130,000 patients have been treated with Xolair for food allergies since launch, a truly impressive number. Our 2026 outlook remains unchanged, and we expect around 20% growth for Xolair. This includes the expected impact of a first biosimilar entering the market in the second half of the year, which is currently projected for September based on our latest knowledge. Actemra sales declined by 9% at half year driven by bio-cylinder impact as expected. And Gazaiva has had a lot of positive news flow this quarter, but we'll cover this in greater detail on the next slide. But before we get there, let me quickly just comment once again on the ongoing launches in lupus nephritis. So as I mentioned on the hematology slide, despite the increased pressure on Gazaiva in hematology, we do see strong uptake of the newly launched lupus nephritis indication as I mentioned we see because I have a sales growing faster in those three markets where LN is already reimbursed. We see patient shares approaching 10% across those same markets. Underpinned by strong early adoption in the hospital setting, we see a real inflection in particular in the U.S. And in the coming quarters, we expect strong momentum to be driven by three New England Journal publications for SLE, lupus nephritis, and the INS Phase III results, two FDA breakthrough therapy designations, and growing lupus nephritis access and inclusion in clinical society guidelines. Taken together, we are confident in realizing the up to a two billion opportunity for gaziva across all of its immunology kidney indications. And finally, I'd like to mention the upcoming phase three interim readout for cefaxircin and IGAN, which is expected for later in the year. So now let's take a look at gaziva in more detail. Starting with the phase three majesty study and MN we recently shared at ERA, gaziva clearly demonstrated superiority over tacrolimus on complete response, as you can see on the graph on the left. Based on the strong results, we believe in Gazeiva's potential to become the first approved treatment for MN and therefore the new standard of care. With that in mind, we're happy to report that we achieved US and EU filing in MN, and moreover, the FDA granted breakthrough therapy designation and priority review in the syndication with the PDUFA of the 15th of November. As you can see, we have now successfully filed all immunology indications in the US and the EU, and we are looking forward to regulatory decisions in the second half of this year, starting with INS in September. The new indications will further fuel Gaziva's uptake in immunology, and we're extremely excited for the impact that it's going to have on patients. So up next, let's take a look at ophthalmology. Ophthalmology grew by 6%, achieving $2.1 billion in sales. Vibismo continues to expand its global market share and position itself as the preferred first-line treatment. This can clearly be seen, for instance, by the fact that more than 60% of U.S. patient starts are naive to treatment. I will spend a little bit more time discussing Vibismo's growth outlook on the next slide, but here I also wanted to highlight the positive Phase III Poyang readout in Vibismo and myopic carital neovascularization. This is the potential fourth indication for Vibizimo and while a smaller opportunity is highly relevant for patients, especially in Asia. We are looking forward to discussing next steps with health authorities and data will be shared in an upcoming medical conference. Moving on to EndSpring, our aisle six, where we are in development for TED, thyroid eye disease. We are excited to not only have achieved US filing, but also to have been granted priority review. This underlines the significant remaining unmet need in TED and EndSpring's potential to provide a much needed additional treatment option for these patients. We're looking forward to the FDA decision by October 15th. This leaves us with one more potential new ophthalmology medicine that we plan to file later this year, Vimikibart and UME, and we will, of course, update you once those filings have been completed. Now, as promised, let's take a closer look at Vibismo growth. Let me start by confirming that we expect continued global market share gains and growth for Vibismo. Furthermore, and as briefly mentioned on the previous slide, we see that Vibismo has established itself as the preferred therapy for first-line treatment of AMD and DME. This is in large part due to the strong and consistent clinical as well as real-world data. This data has shown time and time again that the BISNO delivers strong anatomic outcomes like drying paired with high durability across all of its improved indications. And the survey data you see on the left supports how the BISNO's anatomic outcomes and durability are perceived. The survey comes from ASRS, that's the American Society of Retinal Specialists, and is in the 2026 edition of their Preferences and Trends Survey amongst roughly a thousand retinal specialists in the U.S. and ex-U.S. So this obviously gives us confidence in the global market share gains and growth, but there are some regional dynamics that need to be considered. In the US, we do believe the branded market has now stabilized, though at a lower level than before. We do see this as the new normal and don't expect a full rebound to previous levels, but do expect strong volume growth from here. As Vibismo is perceived as the most efficacious drug, this will drive sales growth in the low single to mid single digit range in the US. In the EU, we continue to see strong share expansion across all key markets, and Vibismo's strong volume growth is overcompensating for price effects in this region. And in the rest of the world, we see significant untapped potential and are encouraged by strong growth momentum across key markets. In summary, we are expecting low double-digit growth globally for Vibismo, driven by ex-US, with US growing in the low single to mid-single-digit range for the year. Let me also say that we continue to consider consensus peak sales expectations for Bovismo of around 6 billion as very reasonable and we're confident that we're on track to achieve this number. So now let's move on to CDRM. The CVRM pipeline is making good progress, and following ADA, we hosted an IR call to cover the latest pipeline developments. So let's just focus on what happened in Q2. On petrolentide, we presented positive Phase II Supreme I data at ADA and shared our Phase III GO decision. The data was well received with a lot of excitement about the placebo-like tolerability profile paired with double-digit weight loss that petrolentide demonstrated. We believe in the potential of petrolentide as a monotherapy to provide meaningful weight loss at a level desired by many patients. Combined with the exceptional tolerability that doesn't interrupt the daily life of patients and promotes long-term adherence, a critical factor for sustained health outcomes and chronic weight management, we continue to think this is going to be a very important option for patients. And together with Zeeland, we're looking forward to initiating the Phase 3 in the second half of the year. On N-acepatide, which is formally known as CT388, we presented positive Phase 2 data at ADA which I will cover in more detail in the next slide. The phase three trials Enith 1 and 2 for n-acepatidin and obesity are ongoing and we announced plans to initiate phase three trials in glycemic control as well as a CVOD. On CT868, we announced at ADA that we decided to discontinue the development of CT868 and type 1 diabetes. It's important to note that this decision was entirely unrelated to the safety or tolerability of CT868. We did have positive phase 2 results, but ultimately we believe we have better options in our portfolio to address the unmet needs. for patients with type 1 diabetes. For example, based on the latest data, we believe that N-acepatide may have best-in-disease potential for glycemic control. We look forward to sharing the details of our plans in type 1 diabetes at a later stage. There is a lot of news flow for the remaining of the year, in particular, phase 2 results for N-acepatide in obesity with type 2. Phase 2 CT996 results in obesity or oral therapy. The Phase 2 Ziprem 2 results for petrolentide and obesity with type 2. And finally, the Phase 2 Geminda results for azimuthrazar plus trisepatide and obesity. We plan to provide updates for all of these at Pharma Day, upcoming conferences, or by top-line releases when the data is available. And let me quickly finish this slide by commenting on further pipeline progress expected to happen in the second half. The phase two study Zenergy for N-acepatide plus petrolentide in obesity is about to be initiated. This study is designed in a comprehensive way so that we can find the ideal combination of the two for the best efficacy and tolerability profile. And that, of course, is key to select the best fixed-dose combination for the potential phase three. The decision for phase 3 initiation for petrolentide monotherapy in obesity has been formally taken in Q2, and that study is expected to start in the second half. And finally, the phase 3 initiation for CT996 remains scheduled for half 2 following the phase 2 readout, which is soon to come. Now, as I mentioned, let's take a closer look at the N-acepatide phase 2 data presented at ADA. I do believe it is worth in reinforcing some of the key insights from the phase two results that were shared at ADA, and in particular highlight why we're so excited about n-acepatide, which we believe has a clearly best-in-class weight loss profile. First, on the left side of the slide, you see the weight loss curves. So clearly the 24 milligram dose did not reach a weight loss plateau at 48 weeks. Therefore, we see the potential for additional weight loss with longer treatment. That's something we hoped to see in the phase three, which includes longer treatment durations. We have also shared at the ADA IR call that we will explore dose levels higher than 24 milligrams as we've not seen the tolerability ceiling at the highest dose tested. Secondly, the right hand of the graph shows what percentage of patients achieved what weight loss at a certain dose. What you can see here is that the highest 24 meg dose tested, 48% of patients achieved greater than a 20% weight loss, 38% of patients achieved greater than a 25% weight loss, and 26% of patients even achieved a greater than 30% weight loss. Based on these results, we believe that ns-epatide has clearly the potential to develop weight loss approaching the efficacy seen with triple G drugs in development. And with the tolerability profile, and line with that of the dual GLP-1 GIP agonists. So overall, we are very excited to further develop N-acepatide as a monotherapy, but let me also highlight that upcoming phase two combination trial of N-acepatide and petrolentide. Combining these two molecules with their respective strong clinical profiles and the potential to address unmet needs for patients beyond just the scope of monotherapy. in particular for patients needing greater weight loss and or better glycemic control with better tolerability. We have strong conviction in the combined potential of these already individually strong assets, hence the name of the trial, Zynergy. We expect to initiate that trial in the second half of the year. And now onto my last slide for the day. So as usual, let me close with the 2026 PharmaKey news flow. All of the updates here I have already covered on previous slide, but there is one piece that I want to highlight. So far this year, we have achieved five FDA priority reviews so far, which is really impressive. And that, of course, helps with speeding up regulatory processes and bringing medicines faster to patients. Just to reiterate, these five priority reviews were granted for Girodestrin in the adjuvant early breast cancer. Enspring and Ted, Dicentric Atomic and DMMR and MSH, colon cancer, Gazeiva in INS, and most recently, Gazeiva in MN. So with that, I am happy to hand it over to Matt.

speaker
Matt
Head of Diagnostics Division

Thanks a lot, Teresa, and congratulations for the strong half of the year. So with that, good morning, good afternoon, everyone. It's my pleasure to present the half-year 2026 Diagnostics Division results. So as you heard from Thomas and Alan, with sales of 6.7 billion Swiss francs, the diagnostics division grew sales at 3% or plus 228 million Swiss francs compared to last year at constant exchange rates. Now, this growth was achieved despite the ongoing impact of the health care pricing reform in China, which continued to impact sales in 2026, excluding the effect of the health care pricing reform in China. Sales would have grown at plus 6%. Additionally, as you heard from Alan and Thomas, we had the impact of the weak respiratory season in the Northern Hemisphere, which impacted diagnostic sales by an additional $50 million. So with that, let me go through the results by customer area. So sales in our largest franchise, the CoreLab, increased at 4%. This is impacted by the previously mentioned policy impact in China. Excluding this effect, the CoreLab grew at 8%. Sales in the Molecular Lab grew at plus 3%, and I would call it the strong performance of our transplant business, which grew 18%. However, again, this was offset by the previously mentioned mild respiratory season, which lowered the overall testing volumes. and sales in the near-patient care business area, or customer area, excuse me, decreased at minus 5%. This was driven by lower Cobas-Liat sales, again due to their weak respiratory season, but offset partially by growth in our blood glucose monitoring business at plus 3% following competitive wins. Sales in our pathology lab grew strongly at plus 11%, mainly driven by advanced staining growth of plus 7% and companion diagnostics growth of plus 24%. So now allow me to take you through the performance at a regional level. So we saw growth in North America at plus 8%. In EMEA, the business grew at plus 3%. LATAM grew at plus 10%. Now in APAC, the business declined at minus 5%. As previously mentioned, sales growth was impacted by the healthcare pricing reform in China. As a result of this, China sales declined at minus 15%. Excluding China, APAC sales grew at plus 6%. Now, as you heard in our full year and Q1 earnings calls, we expect a lessened impact of the China pricing reforms in 2026. And I would call out again that our ambition this year is to grow sales at mid single digits. Looking forward into 2027, our ambition will be to return to mid to high single digit sales growth. Now, I'd like to take you through our P&L line by line. and Alan went through the cost of sales in some detail. And as you mentioned, cost of sales increased 5% first, driven by the impact of the pricing reform in China, the cost of manufacturing ramp up for our new launches, as well as the tariff impact in the United States. R&D increased at 3% as a result of the increased spend on our innovative systems, including our Xelios sequencing solution and our i601 mass spec. SG&A increased at 3% due to higher distribution costs associated with increased sales volume and also commercial investment into our new launches. As a result, core operating profit on sales of 6.7 billion Swiss francs was 1.2 billion Swiss francs, increasing at plus 6% at constant exchange. As you heard earlier, this was also benefited by 126 million Swiss francs in extraordinary income from patent licensing. I would like to reiterate our ambition from previous calls that while our consistent ambition for diagnostics is to grow profit faster than sales, our ambition for full year 2026 is to keep our margin broadly stable at constant exchange versus the 14.4% from full year 2025 as we absorb the impact of the healthcare pricing reform in China and the US tariffs. I would also like to mention that in 2026, we again anticipate a negative impact, or excuse me, we have a negative impact from currency headwinds on our cop margin. Now, I would like to turn to some of the exciting developments in the diagnostics pipeline, specifically Thank you very much. Thank you very much. I would also like to briefly highlight the performance we achieve with our Accelio sequencing solution as you can see on the left hand side of this page and why we feel the solution is so highly differentiated. We have two run modes utilizing our SPX sequencing by expansion chemistry and our SPX duplex as well as our SPX simplex workflow. Now this enables us to achieve flexibility, speed, and scalability That is unprecedented and deliver what we feel is very, I'd say, differentiated cost effectiveness. Now, as we previously demonstrated with the technology, we are able to achieve 1.8 terabases of SPX duplex output in four hours of sequencing time. And this is equivalent to around 16 whole human genomes. I would mention that this is also combined with a high level of accuracy with a Q score of 38, which translates to approximately 99.98% accuracy. Additionally, the simplex mode offers an ultra high throughput and also longer reads of up to 1500 bases, which can enable isoform detection and structural variance combined with our differentiated price position. And here I would call out that in one four hour run, we're able to generate 40 billion reads with an average of 175 base pairs, which is an unprecedented amount of data output. Thomas mentioned this a bit earlier, how Accelios really fits in across our entire vision for oncology. Our strategy in oncology with diagnostics is to build an end-to-end portfolio that follows the entire patient journey via a combination of internal innovation and purposeful M&A. This is everything from early cancer detection, precise diagnosis of cancer, therapy selection, as well as disease monitoring. So here I'm delighted to discuss the definitive merger agreement we've signed with PathAI earlier this month. which completes our offering in primary and advanced staining for cancer diagnosis. PathAI is the leading provider of digital pathology image management systems, which enables pathologists to augment their existing IHC or primary, which is H&E staining workflows with AI-powered digital algorithms and tools to automate slide analysis and provide deeper patient insights. The combination of AI power digital pathology image management combined with clinical decision support algorithms will integrate seamlessly with our Ventana solutions and augment our PHC business to increase our leadership position in companion diagnostics. Thank you very much. Teresa mentioned briefly AAIC, and now I'd like to switch to our assay pipeline, specifically the launch of the C-mark we received for our Lexus PTAU217 test, which we received on May 12th. Alzheimer's disease is the leading cause of dementia worldwide. We anticipate that it will affect over 80 million people by 2030. However, diagnosis takes approximately three years after symptom onset and routine diagnostic methods are either invasive or difficult to access. They involve imaging methodologies that are not readily available and lead to this significant backlog in patient diagnosis. So with our Lexis 217 assay, we provide a rapid, minimally invasive, Thank you for joining us. By bringing this test into healthcare systems worldwide, particularly primary care, we will help physicians to identify Alzheimer's disease earlier, which will facilitate timely intervention and potentially reduce healthcare costs. So now I'd like to transition to latent tuberculosis and continue with an update on our Alexis Igra TB test, which received C mark earlier this month. And why this test is important is around the world, approximately 25% of the world's population is estimated to be a carrier of tuberculosis infection. And as a consequence, this is one of the world's largest public health challenges. With Alexis TB, we enable high-throughput testing, automated result generation, and a three-tube workflow, which is superior versus existing systems that are available, while maintaining comparable levels of data performance in the clinical setting. And in the near future, we plan to integrate our Cobos Ultra solutions to automate the pre-analytical steps, further improving laboratory efficiency for tuberculosis testing, and it will also help facilitate our entry into the high throughput segments of the market such as the US. This test has the potential to expand global access to latent tuberculosis infection testing and also help advance progress towards the WHO elimination targets. And I would call out here that we have the broadest install base of immunoassay analyzers anywhere in the world and we will leverage our install base to grow and expand with this test. So to conclude, I would like to report the progress on our key launch list for the diagnostics division. Of the 11 launches shown here, we've achieved seven by half year 2026. We're making good progress on those that remain. And I look forward to updating you on this in future calls. And with that, I would like to hand it over to Bruno Eschli. Thank you very much.

speaker
Bruno Eschli
Head of Investor Relations

Thanks, Matt. And let me quickly close here with the next event, which is scheduled for investor analyst community. We have Pharma Day coming up at the 28th of September, again, as a live event in London. Similar setup as in previous years and a couple of highlights here to call out. In the morning session, we will again cover our pharma strategy and provide an update on our commercialization efforts. We will provide an update on the R&D excellence initiatives, on the KPIs we have shown in recent years, and then also have a focus on our cost saving initiatives and reallocation on the investments. And then I think a special highlight is we have Aviv Rechev joining on the implication of AI in early drug development. We'll take you through all the stages of early drug development and how AI there comes to life and where we stand. And then in the afternoon sessions, a bit of similar setup like last year, we will take you through the five therapeutic areas with new area heads being present. And until the end of September, we also would expect a couple of additional data points to come in and as Teresa mentioned already, we have then the opportunity also to touch on some of the assets of the obesity franchise like 388 or 996 and provide updates on them. And with that, I think we are done with the presentation and we'll open the Q&A session. First questions would go to Graham Perry from Citi. Graham, please.

speaker
Graham Perry
Analyst, Citi

Great, thanks for taking the questions. So there's a question on Diveracid. You've obviously started now the Crescendo 2 trial. Primary completion date on clinicaltrials.gov for that is October 2028. I was just wondering, though, just given the very long PFS that you saw in the phase 2 of 19 months, whether you feel there could be separation of the curves and an earlier readout on that? And then secondly, you still have this as a 1 to 2 billion peak sales opportunity in your slides. despite the strong phase two data in phase one and hitting the primary endpoint in the second line as well. Is that now just achievable with the second line indication? And when would you provide an update on whether you see that as going higher given the strong PFS, long PFS you're seeing in these studies? Thank you.

speaker
Theresa
Head of Pharma Division

Great. Thanks, Graham. Well, I think Pharma Day is going to be for you. So we will be able to provide an update on the entire Devoracib clinical trial program, as well as the fact that we are currently now based on the strength of the Crescendo 1 data. We are reevaluating what we believe peak sales might be. So we're talking with thought leaders, thinking about what our ultimate clinical trial program will look like, and we'll be able to provide you an update at Pharma Day. Though for right now, we are confirming one to two billion, but stay tuned.

speaker
Graham Perry
Analyst, Citi

Thank you.

speaker
Bruno Eschli
Head of Investor Relations

Graham, did we answer all your questions?

speaker
Graham Perry
Analyst, Citi

Just the potential for early readout in 2028.

speaker
Theresa
Head of Pharma Division

So, I mean, I think we've just initiated the trial, so we'll see how we go. And as always, with an event-driven trial, the data will tell us.

speaker
Graham Perry
Analyst, Citi

Great, thank you.

speaker
Bruno Eschli
Head of Investor Relations

Okay. and we move on. Next question go to Simon Baker from Redburn. Simon, please.

speaker
Simon Baker
Analyst, Redburn

Thanks so much, Bruno, for taking my questions. Two, if I may. Firstly, I see for Lunsumio it's entered phase two for SLE. I just wonder if you could give us your thoughts on Lunsumio in that setting and also the interplay with Gaziva in that space. and then secondly on Vibismo. Tracey, you gave us some color on the dynamics within that market. I just wonder specifically if you could give us an update on any activity you're seeing with respect to patient assistance foundations, either by yourself or others and your expectations of that for the rest of the year. Thanks so much.

speaker
Theresa
Head of Pharma Division

Great. So in terms of Lunsumio for SLE, so SLE is a very... Thank you for joining us. Whether or not with a slightly different mechanism, we can actually achieve even greater results for these patients. So stay tuned on Linsumio, but deeper and deeper B-cell depletion is likely what these patients needs or what these patients need. in terms of the Copay Assistance Foundation. So again, I will just reiterate that these are charitable donations and they're certainly not meant to drive sales. But I think what we are seeing is that there has not been a recovery to the overall market. We are seeing sort of that two to 3% growth in the overall retinal market. We do expect that this is going to be the new normal and we don't expect a rebound to previous levels.

speaker
Simon Baker
Analyst, Redburn

Great, thanks so much.

speaker
Bruno Eschli
Head of Investor Relations

Okay. Then we go on. Next questions go to Sachin Jain from Bank of America. Sachin.

speaker
Sachin Jain
Analyst, Bank of America

Hi there. Thanks for my questions. I've got a few, if I may. So firstly, just another one on Lidera launch. At one key, you talked optimistically about launch and discussion by risk group. My question for this quarter is what visibility you have on a bolus of patients that could be fast adopters, so specifically patients who over the course of the last three or four years have discontinued CDK46 due to toxicity and they're back on just an AI. So any sense, firstly, at how big that bolus is that could be rapid adopters and would usage in that switch group be consistent with an expected label? Second question is Ocrevus. You're calling out in competition. I'm guessing that's Brionvi. So why don't you just give us a bit more color as to why that's impacting now, given it's a launch for a while and why you think it's temporary? and then just one question for Alan. I think it's the first time you've called out the expected growth in other revenues mid-term, 3% to 5%. That kind of implies 2 billion growing to about 4 billion. That's all EBIT. So is that a driver of margin expansion or is it funding investments within your commentary of margins being stable? I'm just going to dovetail that with Bruno also mentioning an entire cost-focused session at the Farmer Day. Thank you.

speaker
Theresa
Head of Pharma Division

Okay, so let's start with Gerard Estrom. So first of all, Sachin, I think you're spot on to something here. But let's start by sort of looking at what does the treatment of ER positive hurt to negative early breast cancer really look like. So there's sort of four risk groups of patients. There's the low risk patient group, which is between 55% and 60% of patients. There's the intermediate risk group, which is about 10% of patients, the medium risk group, which is between 15% and 20% of patients, and then the high risk group, which is 15% of patients. We would expect that one of the first places we would gain utilization is patients who just aren't on CDK4-6 inhibitors right now. That's 90% plus of that intermediate group. It's 80% plus of the medium risk and 50% plus of the high risk. And so there's a tremendous opportunity within that group that has just never gone on a CDK4-6. But you are right. There's about 50% of patients today who can't tolerate their CDK4-6 treatment. I mean, it's part of the reason that we see such bad outcomes for people with this type of cancers. They just can't tolerate the treatment. And so for those people who either can't tolerate and maybe who have come off and are waiting, we would absolutely see this as a potential patient population. And we wouldn't see this to, you know, it wouldn't be in conflict with any, likely with any kind of label problem. The switch question is not usually something that comes up in the label. We are generating, however, switch data. So for patients who are on CDK460 today and want to switch, we will generate that data. And we are also generating data for that low-risk population, which is the majority of patients, that 55% to 60%, none of whom are currently on treatment. and then our own combination data is also forthcoming. So we do believe that when you look at the totality of the geodesterant data that we have in our hands already between Lidera and Averro, we've already got about 80% of the market covered. We're doing trials to cover the rest and sort of really looking at what is the clinical data that we need to make sure that we have The ability to answer all of the physicians' questions in terms of other ways that gerodestrin might be utilized. But we do certainly think that there is quite a bit of opportunity for gerodestrin. And in terms of competition with 3MV, I mean, it's just, you know, normally we don't comment on individual competitors. We generally, we're just seeing a higher level of competition in the market. And we certainly believe that based on the clinical attributes of Okravis, we are very well positioned to compete. Okravis remains the leader in MS with Zenovo as the key growth driver. It is the fastest growth driver in MS. It's the first and only twice yearly MS therapy that's approved in RMS and PPMS. It has over a decade worth of experience. We see that 80% of first line RMS patients don't experience progression. 90% don't need walking implements. We're the only high efficacy therapy that has robust family planning data in hand. and, you know, frankly, that outstanding patient convenience with six months dosing available as a 10 minute subcut just twice a year. I mean, that's an incredible value proposition for patients. So I think in any given situation, you will see little bursts of competitive activity. But at the end of the day, these aren't driven on clinical differentiation. Ocrevus remains the most differentiated product. We strongly believe in our ability to compete and win for patients who deserve to be on the best therapy.

speaker
Alan (CFO)
Chief Financial Officer

Let me take the margin point, Sachin. I think you make a great point. I think very clear once we grow from 3% of sales to 5% of sales, that makes a difference until the end of the decade. There's no doubt about it. I think for the time being, nevertheless, I think we stick to the point to say either we stabilize the margin or we grow it. I think now things come nicely together. We'll see how that plays out. And yeah, I think that gives even more substance to our statement.

speaker
Bruno Eschli
Head of Investor Relations

Sachin, did we answer your questions? Yes.

speaker
Sachin Jain
Analyst, Bank of America

Yeah, perfect. Thank you so much.

speaker
Bruno Eschli
Head of Investor Relations

Then we move on. Next one in the row is Colin White from UBS. Colin, please.

speaker
Colin White
Analyst, UBS

Hi, Colin White from UBS here. Thanks for taking my questions. Just to go back to Vibismo, you talked about being confident of the stabilisation of the branded market. I was wondering if you could talk about the dynamics related to the reduced Vibismo growth expectations between Charitable funding assistance and the increased use of biosimilars. And if biosimilar market share is shift, what percentage of the market do you expect to be biosimilars going forward? And why do you have confidence that the branded market is now stabilising? And then just a second question on Firstline DLBCL, if I may. There's a big competitor readout for Ip Kinley coming up in Firstline DLBCL. So if that study reads out positively, I just wondered what you're thinking about in terms of the impact that might have on Pallavi and how it fits in with your own firstline study for your anti-CD20. Thanks. That's my question. Thanks.

speaker
Theresa
Head of Pharma Division

So, I mean, let's talk a little bit first about the biosimilar market in ophthalmology. I mean, it's just a little bit different than in other places. But where we are seeing biosimilar impact happen, it is impacting sort of directly the molecule that it's replacing. So, you know, a biosimilar to Lucentis took Lucentis chair, biosimilars for other molecules are taking specifically that chair and really impacting that part of the market. We're not really necessarily seeing the bleed over that you might see in other places. We saw 8% growth with Vibizimo in sales this half, but we saw 30% increase in volume globally. So we really do believe that Vibizimo has entrenched itself as the preferred therapy of choice. I think you can very clearly see that from the ASRS data. Thank you so much for joining us. How are they running their practice and how they're utilizing the resources available to them and their patients? So we do think that 2% to 3% overall growth in retina will accommodate the biosimilar entry. It will accommodate other things. But clearly, the baisamo is continuing to grow in the US, and it is continuing to take a disproportionate share of that branded share growth. With regards to the competitor entry, So they are about a year ahead with first-line DLBCL, but we do see Polarix being just a much better tolerated regimen in first-line. So we wouldn't necessarily expect to see a terrible amount of impact there. Polarix has well established itself in first-line DLBCL.

speaker
Colin White
Analyst, UBS

Thank you.

speaker
Theresa
Head of Pharma Division

I meant Polarix, not Linsumio, because that's really the first-line DLBCL.

speaker
Bruno Eschli
Head of Investor Relations

um Colin did this answer your questions so we also have our own uh study coming up next year yeah yes you know skype yeah okay then we uh move on uh next one in a row is justin smith from bernstein um thanks yeah just a very quick one on uh 007 um sorry this is a bit ignorant just any kind of qualitative um conviction you can give us as to why

speaker
Justin Smith
Analyst, Bernstein

360 patients means you're well-powered in that sort of head-to-head versus Hemlibra in phase three.

speaker
Theresa
Head of Pharma Division

Yeah, I mean, I think we've done the statistical analysis based on what we know about the performance of Hemlibra and what we believe to be true about 007, given, as Thomas mentioned, the incredibly high level of potency. And we feel confident in the design.

speaker
Bruno Eschli
Head of Investor Relations

Yeah. Maybe what I can add here in terms of the timelines, I think for this study, which now has seen the first patient in, we would expect data, I think, at around year end next year, beginning of the year after, so N27, N28, which I think also puts us in a very favorable situation here to bridge to the next generation. Any additional questions, Justin?

speaker
Justin Smith
Analyst, Bernstein

All good. Thank you.

speaker
Theresa
Head of Pharma Division

Thanks, Justin.

speaker
Bruno Eschli
Head of Investor Relations

Yeah. and we move on and next questions go to Sarita Kapila from Wong Stanley.

speaker
Sarita Kapila
Analyst, Morgan Stanley

Thanks for taking my questions. At ASCO you talked about new indications for giridestrin, so the Heredera trial and the Novera trial. Could you quantify how large you think these opportunities are and whether these are upside to the Swiss franc 9 billion peak commentary? and how, if I can squeeze in, do you see positioning specifically for Heredera or Gyridesterin in HR-positive HER2 breast following positive data for Pfizer's Ibrans in the PATINA trial? If I could just squeeze in a quick follow-up on Duvarasib. If you're re-evaluating peak sales, this is the KRAS G12 DC, how should we think about it versus emerging pan-RAS agents, including pipeline or programmes within your own pipeline? Thank you.

speaker
Theresa
Head of Pharma Division

Yep, absolutely. So when we think, I'll start with the second question first and then go up to your adjustment. So when you think about KRAS mutations, KRAS mutations are present in about 25% of patients with lung cancer. G12C mutations are present, they represent 40% of the KRAS mutations, which means you're at about 12 and more than 13-ish percent of overall non-solacelle patients have a KRAS G12C mutation. So the potency, the selectivity, the safety profile of DVRAS we believe positions it very well in patients with those specific mutations. And I think we've seen that in the When 70 data, we're seeing it in Crescendo 1, and it's something that we expect will play out in other trials as well. So I think because of the strong specificity for that mutation and the fact that mutation is so prevalent, I think if you had that mutation, you would be more apt to use a therapy that would target that mutation directly. Certainly, there's going to be a place for pan-RAS inhibitors. We have several of them in our pipeline as well. and we look forward to developing them and seeing what their results are for patients. We have a very diverse pipeline here, which is great. When you talk about the opportunities within 4G or Death Strand, as I mentioned previously, between Ladera and Avera, we already have 80% of the ER positive HER2 negative market covered. So the other trials that we have in place that are looking at the different aspects of first line in different combinations, those really give us the opportunity to cover pretty much 100% of this patient population. So the peak sales that we've mentioned, they sort of encapsulate the fact that we do have a pretty broad program already in place for gerodestrin, but certainly if some of these other programs came in. That could potentially be upside as well. And as I mentioned, we'll be able to give you a very good and thorough update of what our development plans look like for geodesterin at Pharm-A-Day in just a couple of weeks.

speaker
Thomas Schinecker
Chief Executive Officer

And I mean, the upside on diviracib is also in other cancer types, right? Beyond non-cancer. In fact, RAS is one of the best known or most known and most mutated genes in cancer in different cancer types.

speaker
Theresa
Head of Pharma Division

Absolutely.

speaker
Bruno Eschli
Head of Investor Relations

Did we answer all your questions, Saria, or your follow-on questions?

speaker
Sarita Kapila
Analyst, Morgan Stanley

Yes, thank you.

speaker
Bruno Eschli
Head of Investor Relations

Okay, then next questions go to Richard Foster from J.P. Morgan.

speaker
Richard Foster
Analyst, J.P. Morgan

Thanks very much, Bruno. A couple of questions, please. Just a follow-up on Ocrevus. Zenovo uptake seems very strong and very fast. So you mentioned again the 2 billion for Zenovo. But could this actually be larger and protect more of the franchise from biosimilars? So just thinking about that. Second question to follow up on for Buysmo, I don't think you mentioned pricing impacts. Just wondering about, we've seen, you know, biosimilars to other agents affect pricing in the classes. Obviously, there's very low dose of Aston here, but are you seeing anything in, or very low price of Aston, but are you seeing anything there in terms of pricing maybe in the XUS markets? and then one final question just on other revenues coming back to that. I think there are probably some milestones there in this quarter for some of the new agents. You've got quite a lot of new agents from other companies launching. Just should there be other milestones that we should think about in the next few years that could boost the trajectory from actually the royalties that you're getting in? Just some thoughts there as well. Thanks very much.

speaker
Theresa
Head of Pharma Division

Yeah, great. Thanks, Richard. So I promised you guys a hockey stick for Okra vs. Zenovo, and we have delivered the hockey stick. We're well on our way. We do think that as people, as I mentioned in many other calls previously, as practices and patients get experience with Zenovo, it fits into the practice flow very, very well, and it's intensely convenient for patients. So is there additional conversion opportunity? Quite probably. Thank you so much for joining us. In terms of Vibismo, I mean, certainly we've seen pricing impacts outside the US, but those have largely been related to volume because Vibismo has been doing exceptionally well in generating patient share outside of Europe or inside of Europe. Alan?

speaker
Alan (CFO)
Chief Financial Officer

Yeah, I think really in general, no. That's the answer. I think there can always be stuff, but that's why we have said we go from 3% to 5%. And I would argue that includes everything.

speaker
Thomas Schinecker
Chief Executive Officer

And it's mostly royalty-driven, not milestone-driven, just to be very clear. But also, I mean, Richard, to you.

speaker
Alan (CFO)
Chief Financial Officer

There are a couple of milestones included here.

speaker
Thomas Schinecker
Chief Executive Officer

Yeah, there are a couple, but the majority is royalty by far. but on the Okovo side also you were talking about switching to Sunovo also to make sure that we can protect that franchise into the next decade as well and beyond. Here I just want to say that we have a couple of other options in play as well within the Brutnup but a number of things that we have in the pipeline where we believe that we can extend that as well.

speaker
Theresa
Head of Pharma Division

Absolutely.

speaker
Richard Foster
Analyst, J.P. Morgan

Very good. Richard, any additional questions? No, perfect Bruno. Thank you very much.

speaker
Bruno Eschli
Head of Investor Relations

Thanks Richard. Then next questions come from James Gordon from Barclays. James, please.

speaker
James Gordon
Analyst, Barclays

Hello, James Gordon from Barclays. Thanks for taking the questions. A couple, please. One was duodestrin and adjuvant and the launch expectations. So I'd ask, there was some mixed discussion feedback on Ladera and talk about need for longer term PFS data and OS and more data versus CVKs. So do you think that view is typical? Could that blunt the initial uptake at all? Or do you think that's atypical? And where are you on ex-US regulatory? Might you need longer term data there? And I think Bloomberg consensus is about 300 million Swiss next year, which doesn't look a lot versus the size of the very big hormonal breast cancer market. Are there any roadblocks we should be aware of if we're modeling out the launch or is that plausible? The second question would be Fenn & Bruton Regulatory. So latest confidence on U.S. approvability. I know some investors still have quite a big safety and tolerability concerns, but I know you've had a bit more time to have some interactions with regulators. Anything concerning there? And where are you ex-U.S.? Any interactions there? I saw Toler Bruton has been EU approved despite its liver profile. How are you thinking about timing for ex-U.S.? and then finally it was just obesity update so we've got updates on your GLP-1 GIT and your amylin at ADA but I think you've got your anti-myostatin and your oral GLP-1 imminently presumably at the pharma day or before so how are you thinking about differentiation and of the four assets in obesity which is the one that's most exciting because you've given similar peak sales estimates for the mobile which is the one we should be most excited about?

speaker
Theresa
Head of Pharma Division

Oh, James asking me to pick my favorite kid. That's harsh. Wow. Okay. There's a lot in there. So in terms of jurisdiction adjuvant, I would say that we are spending a lot of time with KOLs and with potential treaters sort of asking what their confidence is in the data. And I think what we are hearing is that people are excited about having Thank you so much for joining us. I think we are increasingly confident that physicians are excited about gerodestrin and will find a place to use it in their practices fairly easily. So my writing is not great here. So ex-US, we are currently assembling the data package that we believe will be the most robust data package to allow us to file in Europe and achieve a sustainable reimbursement value. And so that is coming and we would expect that we fully intend to file in Europe and are just waiting for that data package to mature. In terms of the consensus numbers, so we don't generally comment on specifically on launch projections, but what I will say is that we should remember that this is a chronic therapy. And so while we do expect a strong launch, clearly the big numbers will build over time as they do with any chronic therapy. We would expect patients will stay on gerodestrin for five years plus, given what we've seen in the market and what the tolerability profile is for gerodestrin. In terms of Phenobrutinib regulatory, so as I mentioned, we're well on track to file first in the U.S. We'll use that U.S. package then to springboard off of for other regulatory filings. We are collecting the additional data that we need for the EU, and again, we have every intention of filing. And again, our focus has been on getting the U.S. package ready, and then we'll go from there. While I won't comment on the specifics of any regulatory interactions, we haven't seen anything that would indicate that a filing in the US is going to be at all problematic. And then in terms of picking my favorite child, that's really, really unfair. I think that, you know, what we saw in What we saw at ADA with just the really impressive weight loss data from from antiseptide and the very interesting and positive Thank you for joining us. I think what we are finding is that the nature of both of these medicines in different ways are making them differentiated and are giving them opportunities to really find a very unique space in obesity in ways that will ultimately really help patients with what they need. And I think that's actually super exciting. as we head into our phase three programs. Clearly, we'll have the data on the anti-myostatin and CT-996 quickly. I mean, having an oral option is of course important, so we're excited to see 996. But I would have to say, I don't think I can pick a favorite because I think what I really love about the obesity portfolio that we've built is it's delivering on exactly what I talked to you all about last year at Pharma Day, the ability to build a broad adaptive portfolio that regardless of what a patient's obesity, where they are in their obesity or health journey, we have a medicine that can help them and could help them throughout their entire weight loss journey. And so I'm just really excited about what we've seen in the data as it's come to maturity and I'm increasingly getting excited about bringing the entire portfolio to patients.

speaker
Thomas Schinecker
Chief Executive Officer

Let me add two points, one on Geodestrin and one on Feniprutinib, also that increases my confidence level in those molecules. You already pointed out the safety profile of Geodestrin, specifically against CDKs. I would like to point out not only the potency advantage it has versus another SIRT, but also the label and safety aspect that it has. versus another surge. So I think from a safety perspective, it is quite differentiated as well. And then on the fenabrutinib, we mentioned that before that the FDA allowed open label extension for fenabrutinib for initially PPMS patients. And so people that were on the fenabrutinib arm continued, but people who were on the control arm were switched to fenabrutinib. Now the same happened for RMS. So the RMS patients that were on feniputinib continued the open label extension as well as on the control arm patients moved to feniputinib. So I think these are good indicators, I would say. It gives us a certain level of confidence in that, but ultimately we'll see.

speaker
Bruno Eschli
Head of Investor Relations

Very good. Any additional questions, James?

speaker
James Gordon
Analyst, Barclays

I'll leave it there. Thank you very much for the answers.

speaker
Bruno Eschli
Head of Investor Relations

Thanks, James. Then we move on to the next, James. James, quickly from Goldman Sachs.

speaker
James

Great, thanks for taking my question, Bruno. I have two as well. So again, both for Teresa. So the BTK degrader, from the data you've seen so far, where do you think the asset can be differentiated in cancer indications? Is it efficacy, safety, combinability, dosing? and then also as you move into immunology, where do you hope to be differentiated on the immunology side and how quickly do you think you can move there into MS and CSU depending on when you see the data? Secondly, gaziva in immunology, I think I asked this last time as well, but when we hear you speak, Teresa, you sound very excited about the opportunity when you look at the four indications, 2 billion, it looks like it might be on the low side, so What is holding you back at the moment in terms of looking at peak sales here? Is there anything in the indication size? Is there anything in terms of segmentation that might be holding you back on the potential peak sales for Goziva? Thank you.

speaker
Theresa
Head of Pharma Division

Great. Okay. A lot of immunology questions. I love it. Okay. So Bextag, all of those things, right? I think we're excited about the potential. I think we're excited about the efficacy. I think we're excited about the safety, the tolerability, the combinability. I think we really believe that a BTK degrader could be a real game changer in some of these indications, particularly in oncology. And so I think we're very excited about to get this into trials and to see where it can go. Now that having been said for all of those same reasons having the degrader versus the inhibitor we could see a really differentiated efficacy profile in immunology. Immunological diseases are notoriously difficult to tackle. I mean, as I mentioned previously, they're very heterogeneous. And so, you know, having a degrader versus an inhibitor, I think we could very well see that incremental efficacy, which in immunological indications can really be quite meaningful. So time will tell. It's a brand new asset to us. We'll give you a little bit more insight as to what our plans are at Pharma Day, but I think we're really excited to have this partnership with Nurex to be able to bring this molecule forward. In terms of gaziva for immunology, You know, a couple of those indications are quite small. So membranous and INS are quite small indications. Lupus nephritis, while more sort of on the medium size, is also not huge. SLE is clearly a bigger opportunity, but there are some highly entrenched therapies there. So I think it's more just about sort of thinking about where we can actually make inroads. The pricing for gaziva is also not... Any additional questions, James? That's it. Thank you, Bruno.

speaker
Bruno Eschli
Head of Investor Relations

Okay, then next question is Gary to Luisa Hector from Burnbrook. Luisa, please.

speaker
Luisa

Thank you, Bruno. A couple, please. I just wanted to check, are you expecting an advisory committee meeting for Jura Destrant? And then you highlighted your excellent 80% phase three success rate year to date. I just wondered if you can tie that into your latest thoughts on capital allocation so where are you targeting now any future M&A business development and also that kind of relative external versus internal R&D spend given the intensity of your phase three starts as well how should we be thinking about those two items thank you

speaker
Theresa
Head of Pharma Division

Excellent. Well, I'll take the easy question first and then pass off the capital allocation question. So, no, we, because Jira Destrin received, as you know, priority review. We've been in close conversations with the agency and we haven't had any indications of an ad board at this time.

speaker
Thomas Schinecker
Chief Executive Officer

To the second question, we feel very good where we are at in terms of our pipeline. We've increased the value of our pipeline by 93% versus end of 2022. So we are now at an all-time high in terms of pipeline. Thank you very much. For example, also speed of trial recruitment, speed of trial closure, the white spaces between the different phases of development, etc. We see a significant progress here as well. Also, in terms of reallocation of our resources within R&D, we've now reallocated and brought out efficiencies in our organization of about 1.3 billion R&D. and we could allocate that to all these phase three trials into other parts of our pipeline. I mentioned one example of that in the past. For example, we negotiated with contracts with CROs. In the past, we were quite fragmented in that. We negotiated new contracts, which gives us a couple of hundred million. Another one that I already mentioned in the past was Flatiron used to make losses of close to 250 million. We are now profitable with Flatiron. These are all things that we could reallocate in terms of money. So you can see that we are really going after inefficiencies in the organization and making sure that we put money behind the project. Now, that doesn't mean that we won't do any more BD or that we don't want to do BD, but we are very disciplined when it comes to BD. We always make very detailed due diligence. We always have material transfer agreements where we really test the molecules in our own hands. These are all things that I would say where I've seen other companies lose a bit of discipline in this space. But we don't do that. And maybe it's also because we are not with the back against the wall and we are not on the same level of pressure as maybe some others. So you will continue to see us doing deals. but really deals that make sense and also make financial sense and where our team negotiates well. I mentioned that in my presentation. Most of the time when we want the deals, we're not the highest bidder in terms of money, but we bring other things like expertise to the table and we are a trusted partner. And I think these are all elements that also are playing in our favor. So you will continue to see that kind of behavior from our side.

speaker
Bruno Eschli
Head of Investor Relations

Very good. Luisa, your question is answered. Perfect, thank you. Then we have questions coming from Emanuel Papadakis, Deutsche Bank.

speaker
Emanuel Papadakis
Analyst, Deutsche Bank

Thank you for taking the question, so I'll try to be brief. Maybe a follow-up on gerodestrin pricing, given we're getting a little closer to commercialisation. CERDs have launched above $300,000 in metastatic. That seems a little prohibitive for broad adjuvant access. So we've seen examples in the past where you've been prepared to make concessions to ensure that. Could you just give us some latest thoughts on pricing direction, should we see approval at the end of November? and maybe a follow-up on Zuma Simig, given the official start of the phase three, the head dead. It looks like Hemlibra can be used to discretion the physician in terms of frequency and if I recall, median ABRs were pretty close to zero. So are you confident in showing superiority on the primary endpoint or is this more about showing improvement on secondaries? And perhaps you could also just remind us your latest thoughts on the clinical significance of anti-drug antibodies we saw in phase two. Thank you.

speaker
Theresa
Head of Pharma Division

Great. So obviously we won't comment on pricing prior to launch. We don't ever do that with any of our products. I will say that I think you can expect us to do what we have done in the past, which is to make a reasonable pricing decision based on the clinical benefit that our medicine provides. In terms of Hemlibra, so we do have multiple dosing frequencies approved in the label, so Q2 and Q4. So, I mean, the patients and physicians can choose what their dosing frequency is. We haven't actually commented on the head-to-head versus whether the head-to-head with Hemlibra is either superiority or inferiority at this point. But we do believe that there is an opportunity for that greater durability and convenience to be very meaningful to patients in the future. though certainly that can't be the only thing that we bring. In terms of ADAs in the phase one, two, the ADAs had no impact on the Pharmaconnecticut's efficacy or safety and didn't have any cross reactions. So at this point, we're not viewing them as clinically meaningful, but obviously we do continue to monitor.

speaker
Bruno Eschli
Head of Investor Relations

Emmanuel?

speaker
Emanuel Papadakis
Analyst, Deutsche Bank

Kind of, thank you. All right.

speaker
Bruno Eschli
Head of Investor Relations

Good, and we move on. Next questions go to Peter Fadult from BNP.

speaker
Peter Fadult
Analyst, BNP Paribas

Yeah, thanks Bruno. Peter Fadult here, BNP Paribas. Just two for Theresa, just back on Jura Destrant. Huge potential, but also Roche's first major launch in a post-MFN world. Now, I heard your answer to the last question, so I'm not going to ask you for numbers, Theresa, but could you maybe just remind us what the ballpark USX, US net price difference is for your current on market breast cancer franchise and how your US pricing strategy might evolve for Geodistrant in this new environment that the industry is operating in. That's question number one. Realize you're going to go through the specifics, but just want to understand that a little bit better. And then secondly on obesity, we share your enthusiasm on 868, but I'm just struggling to see how you're going to differentiate your oral GLP-1 offering given what's currently on the market. And on Petri, I'm just struggling to see how you're going to position that asset given Data from other amylin-targeting compounds who also have good weight loss at lower doses or with good tolerability. And I just want to understand, or do you have a better understanding as to why there was just no dose response seen in the Phase II Petri dataset? Thank you.

speaker
Theresa
Head of Pharma Division

Yep, great. So in terms of your gesture, you're right. I won't give you specifics. I can tell you that in general, our US-XUS corridors are tighter than others. Thank you very much. Thank you very much. In terms of 996, I mean, the data will tell us. So I think we are, you know, we're excited to see the phase two data to share that. But we remain confident that, you know, given the design attributes of CT996, that we will have a competitive profile and that we'll be able to bring it to market as quickly as possible when you see the data, you know, when we are able to share the data, when we have it in hand. will be able to have a more robust conversation. were, you know, could really reasonably tolerate over time. You know, 50% of patients, you know, don't complete therapy as you would want them to on standard treatments. They don't get to max doses. And so, you know, this has always been the problem, you know, the promise of the amylin class. And I think we see petrolentide delivering here a very reasonable profile and one that's exciting. And I think it was exciting at ADA for people to think about where this could be used How it could be used and in the different patient populations we could potentially go into. So I'm excited about Petri. I think it actually has the potential to be a really meaningful option for patients. And I think I mentioned this already in my overall comments, but the 996 data that will be available later this year. So it won't be too much longer before we can have a more robust conversation about why we think 996 might be differentiated.

speaker
Bruno Eschli
Head of Investor Relations

I think also to add, I think on the missing dose response, which you were asking about, I think this phenomenon has been seen before with other gut hormones, and I think we commented on it in the IR call. So there's probably a biology behind, which we don't fully understand. That's all we can say.

speaker
Theresa
Head of Pharma Division

Yeah, at this juncture. Thanks, Bruno. Sorry, I forgot that point.

speaker
Bruno Eschli
Head of Investor Relations

Okay, then we move on. Our next question goes to Rajesh Kumar from HSBC.

speaker
Rajesh Kumar
Analyst, HSBC

Hi, good afternoon. Got two questions for Theresa, actually. I know it's very, it's next to impossible to predict the future, but if you were to speculate the uptake curve for gerodestrin, would that be a very fast uptake in your opinion, or would that be a more gradual one? and would that differ between US and Europe? That's my first question. The second question is around obesity. I fully appreciate that your portfolio has something for everyone and that looks very interesting from a scientific perspective. As we are learning from the current generation of anti-obesity medications, These are subscription models, you know, direct to consumer seems to be a much bigger part of the equation. So when you think about, you know, the commercialization strategy, are you thinking in terms of efficacy, in terms of product design, in terms of What works for reimbursement channels only? Or are you thinking it from a consumer product design as well? Because in reality, at the moment, about half of the patients in the US seem to be paying out of pocket. And, you know, they probably don't want to understand all the scientific gobbledygook we love. They probably want to think through, you know, I want to pay this much, I want to lose this much weight, right? Tolerability is excellent, but what's your thought process on the commercialization strategy and how that fits within Roche's organization?

speaker
Theresa
Head of Pharma Division

Great. Two good questions. So in terms of the uptake curve, I think I alluded to this. A little bit earlier, I mean, as with any chronic therapy, sales build over time, right? So, you know, people get on therapy, they stay on therapy, and then, you know, those curves build over time. So I think there are a number of patients who are out there who are, you know, ready for geodesterin and waiting for it. But, you know, those really big sales numbers will take some time to generate as we have to build up with adherence and compliance, right? We have to build sales up over time. So just to kind of give that a little bit of a feeling. To answer your question, yes. I think we, as we think about commercialization without going into specifics, we understand that there is a reimbursable market. I mean, that's certainly something that NS Appetite is probably very, very well suited for. But we also understand that there is a large direct-to-consumer market, and we are absolutely thinking creatively about how we can reach patients wherever they are accessing their medicines and however they are thinking about managing your health. So just know that we are not approaching this in a traditional Roche way.

speaker
Rajesh Kumar
Analyst, HSBC

Okay, so you think your competitive advantage will not only come from what the product clinical profile is, but in terms of how you commercialize it as well? I think...

speaker
Theresa
Head of Pharma Division

I think in the obesity market, those things have to be two halves of a coin or two sides of a coin, right? You have to be able to have the clinical differentiation and you have to be able to show the value from a clinical perspective, but you also have to create a consumer experience that meets the customer where they're at.

speaker
Rajesh Kumar
Analyst, HSBC

And what skill do you have in the organization to do that in terms of have you hired people around that or is it an existing skill or muscle within the organization somewhere?

speaker
Theresa
Head of Pharma Division

So since we have entered into the cardiovascular franchise, we have hired several hundred people from the outside, specifically with the kinds of experiences that we have not had historically. But we also have some great experience to lean on in the diagnostics organization in CVRM that is much more consumer oriented. And we're certainly taking full advantage of everything that Matt has to offer.

speaker
Thomas Schinecker
Chief Executive Officer

Absolutely, I wanted to actually underline that point. I mean, in diagnostics, we are the leader in the space and we have a lot of direct access to type 2 diabetics, type 1 diabetics. So a lot of people moving also onto our MySugar platform, etc. So we do have a lot of access and know-how in that space. and so I think we're actually quite well positioned and the feedback that we're getting from KRLs is that they're actually quite excited about having postpartum diagnostics at the table.

speaker
Theresa
Head of Pharma Division

Yeah, absolutely. It's a real differentiator actually.

speaker
Rajesh Kumar
Analyst, HSBC

Thank you. Thank you very much.

speaker
Bruno Eschli
Head of Investor Relations

Very good. So then we have the final questions here coming from Michael Leuchten from Jefferies and then we will close the call. Michael, please. Michael? Doesn't look like that he's in the call anymore. Then with that, I think we are ready to close the call. Over to you, Thomas.

speaker
Thomas Schinecker
Chief Executive Officer

Thank you very much and thank you for attending the call today and thanks to the team. We have great momentum in terms of sales. We have even better momentum in terms of profitability. If you look at the last couple of years, we always delivered what we said. and what you can now see is a significant amount of pipeline progress. Pipeline progress that gives us visibility in terms of sales growth for the next years and into the next decade. But even more exciting is then the pipeline readouts between 27 and 29 that are going to set up really well for future growth and many more.

Disclaimer

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