Roche Holding AG ($ROP)
Earnings Call Transcript · April 23, 2026
Earnings Call Speaker Segments
Operator
OperatorMy name is Henrik, and I'm the technical operator for today's call. Kindly note that the webinar is being recorded. [Operator Instructions] One last remark. If you would like to follow the presented slides on out as well, please feel free to go to roche.com/investors to download the presentation. At this time, it's my pleasure to introduce you to Thomas Schinecker, CEO Roche Group.
Thomas Schinecker
ExecutivesThank you very much, and good morning and good afternoon to everyone. I'm very much excited to share our Q1 2026 results with you. Overall, a very strong performance in sales in the first quarter. And including there are some clinical and regulatory milestones that we have achieved. Now let's start on the performance side. Q1 was strong with group sales at plus 6%, driven by pharma with plus 7%. Diagnostics grew plus 3% despite headwinds and from the China health care pricing reforms, which we are still experiencing in the first half year. Excluding China, Diagnostics was at plus 5%. In addition, a weaker and earlier flu season impacted the sales of Xofluza and on the diagnostics side, the respiratory sales in point of care, but also -- or patient care and the molecular business. This is across both divisions, approximately CHF 170 million, which more or less also explains the difference to the consensus. Now moving to key milestones. Q1 was very busy with significant pipeline progress. On the pharma side, we filed giredestrant in adjuvant ER-positive for 2 negative breast cancer in the U.S. using a priority review voucher. And we do expect approval across two indications in the adjuvant and in the second line plus before the end of this year. Lunsumio was filed in the U.S. Gazyva, we had a series of filings in the U.S. and EU across [ SLE ] and [ I &S ]. There's still a number of important readouts or there have been a number of important readouts, for example, the positive FENhance 1 results in RMS. This is the last one from three fenebrutinib Phase III studies that -- where you also saw the results presented at [ AAN ], and there was an IR call yesterday as well on this topic. Now together with FENhance 2 and [ fenebrutinib ], this is the first and only [ BTK ] inhibitor with positive Phase III across both [ RMS ] and [ pipedness ], and we do expect a filing in the next couple of months. I know that Teresa will go into more details here. Gazyva, I think, is very much a success story. We've had four positive readouts in a row. The latest one was in MAJESTY in [ membranes nephropathy ]. And it follows positive readouts in [ LN ], so the [indiscernible], [ SLE ] and [ NIS ]. In obesity, we announced positive Phase II results for petrelintide. In the study, we've shown excellent tolerability. In fact, we had more dropouts in the placebo than in the control arm. And this tolerability makes it an ideal candidate to combine with our very strong [ CT3 ], which the GLP-1 [ GIP ], which actually showed at week 48 similar weight loss than a leading other player after week 72. So we have a very strong GLP-1 [ GIP ]. We have a highly tolerable amylin, and we find this is a good combination. Now moving to business development. I just want to highlight two deals. On the pharma side, we extended our collaboration with C4 Therapeutics on the greater antibody conjugates. And this is a promising novel platform, which could potentially overcome certain therapeutic windows and resistance issues that other drug mortalities have. On the Diagnostics side, we acquired Saga or we're in the process of acquiring Saga Diagnostics. And they provide a minimal residual disease test to really monitor disease progression and so that we can pick out those patients and where we need to then change the therapy. On the regulatory side, we've had CE marks for a new test for blood screening, which includes hepatitis E. We had the Elecsys APOE4p and the Elecsys Nfl for neurology portfolio. Looking ahead, we still have a couple of important Phase III readouts this year and also some launches in diagnostics. There are two more [ NME ] readouts. One is divarasib, it is a lung cancer and sefaxersen in IgAN. We have two readouts for [ Itovebi ] coming in breast cancer and also Lunsumio in second-line follicular lymphoma. In diagnostics, we are very excited that AXELIOS sequencer is coming this summer. And I hope that we can see you at the Diagnostics IR Day because we will certainly highlight this there. We'll also launch the Elecsys pTau217, the Elecsys IGRA tuberculosis test cobas HDV, so hepatitis D, the [ ePlex ] gastrointestinal panel and so on. So we have quite a lot of launches and exciting things ahead for this year as well. Now this slide I've shown over the last couple of years. And what you can see is that we have shown consistent strong growth over the last quarters. We have post pandemic average growth of 8% and even in '23 and '24, if you strip out the pandemic sales, we did also have an underlying growth of 8%. So we continue to have a good performance on the sales side. and we will continue to drive this as we go into next quarters as well. Now let's look at the numbers in detail. At the group. I mentioned that we grew at 7%. This was driven by Pharma with 7%, Diagnostics grew 3%. And as mentioned, this is due to the health care pricing reforms in China and excluding China Diagnostics was at plus 5%. Overall, the impact on the flu season is about 1%. It's about CHF 170 million that I was mentioning before. Now let's take a closer look behind the drivers as well. First, all segments delivered growth. And now looking at it one by one, I will start with the oncology strong Fresco conversion from Project continues. The HER2 franchise grew 2.5% in the first quarter. And we do expect the total two franchise to peak this year with a strong tail remaining. Tecentriq returned to single-digit growth, and this was really driven by new indications. The sense I had an exceptionally strong Q1 with double-digit growth. We are expecting overall low single-digit growth for full year 2026. In hematology, Polivy sees continued strong uptake in first-line DLBCL and Columvi and Lunsumio continue to grow in later lines of DLBCL and follicular lymphoma. Hemlibra saw a very strong Q1 with market share gains and volumes. On the neurology side, Ocrevus keeps growing nicely by the strong uptake of the subcutaneous formulation. I know Teresa will go into more details here as well. And Evrysdi is expanding its global leadership position in SMA globally. On the immunology side, Xolair continues with a strong uptake in food allergy. We're expecting strong growth for the full year 2026 despite the first biosimilar launch in half year -- in the second half year. This will be the first, and there will be no other biosimilars that will come in for the next 2 years after that. Gazyva, we are still very much excited about all the positive trials we have. I mentioned four positive Phase III in a row. And we're excited about the launches in lupus nephritis, which is ongoing. On the ophthalmology side, we saw an acceleration and continued market share gains here as well. And then now Teresa will go into details here as well. Diagnostics, strong growth in pathology, but also collab growing despite China health pricing reforms, I think I mentioned all of this already. Now let me briefly talk about our expanding NVIDIA collaboration with this large-scale AI factory. So we've had a very long-standing collaboration with NVIDIA, over a number of years, and this collaboration really started in 2016 together with NVIDIA, specifically on the DNA sequencing side because given the amount of data that we're going to produce, and specifically also with the chemistry from [ Stratos ] that we brought in, demand data needs to be digested and converted and you need really high-performing chips in order to be able to do that. There's no sequencer in the world that actually produces as much data as our sequencer. So we really needed to go now steps. And here, the partnership with in NVIDIA was really critical. And since then, we've also made a number of acquisitions in this space like present, for example, but also entered into strategic collaborations for drug discovery as well. And we've significantly built up our internal capabilities when it comes to AI as well. Now with the recent agreement, we are expanding our GPU compute infrastructure. And with that, we have the largest AI factory in the pharma industry. And also, what's important earlier in this month, we joined forces with Entropic, IBM, Meta and Microsoft to launch a collaborative licensing so on for the development of AI foundational models called shared AI license foundations or sale. Now [ Russian ] tech is the only pharma company among the founding members. And you can see we're really pushing forward on the AI side. And why are we doing this? Because we believe that AI will have a disruptive potential across the entire value chain in our company from drug discovery through manufacturing, diagnostics imaging and we're really pressing forward on this with all the great people we have in this space in our company. Now this will allow us to accelerate the development of therapeutics and diagnostics. Now let's turn to the outlook. We've made substantial progress across all the therapeutic areas at the start of the year. You see a lot of green ticks. There's strong momentum from a very strong year of pipeline readouts in 2025, now also going into 2026 with a number of key milestones that have been achieved. On the regulatory side, we have just submitted giredestrant in adjuvant breast cancer. We used a priority review voucher and with that, we're expecting a launch later in this year, so still in this year. We've also filed a Gazyva and SLE in the U.S. On the key readouts in Q1, I would like to highlight on the one hand, giredestrant in the first line, your positive breast cancer persevere, the study field, but we saw a numerical benefit in curves separating will be presented at [ ASCO ]. Again, I want to reiterate that more than 70% of the opportunity is in the adjuvant setting. This is really a smaller patient population. And we still have another trial in the setting ongoing that could still allow us to enter in the first-line setting as well. Now with fenebrutinib, we have the first and only BTK inhibitor with positive Phase III studies across RMS and PPMS and we will be filing in the coming months. petrelintide, excited about the clean placebo-like safety profile with double-digit weight loss to be achieved. This makes petrelintide a good candidate to combine it with a very strong GLP-1, the CT-388. The Phase II in this combination will be initiated. And just to say, we are making very rapid progress with the CT-388 molecule. We've just also initiated another 2 Phase III studies here. Looking forward, we still have six pivotal Phase III studies reading out, including two NMEs, divarasib and sefaxersen. We have a very exciting pipeline. So I do believe that given all the readouts we had in the last couple of years, this will give us a much better view in terms of growth in the next coming years. And then between '27 and 2030, we have up to 19 NMEs that could launch. And as you can see, many of these NMEs have quite significant sales potential attached to them. And we wouldn't stop there. We will continue to do [ BD ] activities. We'll continue to try to speed up more molecules so that we can even increase this number. So I think this will really lay the foundation than also for growth in the next decade, which makes us confident that we can continue to have a good growth momentum. Now let me reiterate a couple [ giredestrant ], you will see already on the market at the end of the year. There are two more NMEs that we'll read out this year. In addition, with divarasib and sefaxersen. In addition, we expect two NMEs to be filed in the coming months. One is fenebrutinib and the other one is [indiscernible]. And again, the implication is that we don't only have a good short to midterm outlook, but also a very solid base to deliver long-lasting future growth as well. On the diagnostics side, we have outlined several platforms. On the left-hand side, these are all 1 billion-plus opportunities. So in diagnostic terms, blockbuster opportunities. And very, very excited about sequencer coming just is just around the corner. And we will show it to you at [indiscernible] day. Here with the sequence, we have clear differentiation on speed and accuracy, specifically also on cost because you don't have to have a full plate to achieve lower costs if you compare that with some other leading companies in this space. On the test side, and this is just a small selection of the test that we're launching. But you can also see the complementary to the pharma portfolio with Elecsys NfL in combination with multiple sclerosis, pTAU217 with Alzheimer's, we really have a good strategy to combine and bring together diagnostics and pharma. And I know Matt will cover more on what's coming your way on these slides as well. Now let me wrap up with the guidance. The guidance is confirmed at mid-single-digit sales growth and high single-digit core EPS growth and further increase in dividend in Swiss francs. With that, very happy to hand over to Alan.
Alan Hippe
ExecutivesYes. Thanks, Thomas. Sales call today. So just a brief comment on sales itself, currency and then once again confirming the guidance. When we look at sales, yes, let me start really with the big frame. I start on the left-hand side, you compare to the right-hand side, the sales on Q1 2026, I think minus 5% when you look at Swiss franc. You see on the right-hand side, this big currency impact from the conversion. Then you shift a little bit to the left and then you see the plus 6% in CER, and I will go into currencies on the next slide. But let me talk very quickly about the plus 6% at CER. You see it split down on pharma with a plus CHF 842 million, excluding the loss of exclusivity product and then loss of exclusivity, minus CHF 63 million. When you put the two bars together, you get to the plus 7% in CER, the minus CHF 63 million, I think, is a small number. You've heard we are expecting a lot of exclusivity impact on sales of roughly CHF 1 billion negative. We stick to that. Certainly, it was a good start. [ Actemra ] helped us [ Meera ] helped us, but we think these two products will slow down really for the rest of the year and that I think makes the CHF 1 billion still doable, if you like, and still realistic. When we go to the right-hand side diagnostics, Thomas framed it well, and I'm sure Matt will talk a lot about it. Diagnostics was a plus [ 148 ], excluding China. That is representing the in CER. And then you see the China health care pricing reform is minus [ 60 ]. When you put the two together, you get to the plus 3% in CER, and there has been also an effect from respiratory. Good. Now as promised, let's talk about currency, and that's the next slide. And here you see it, and it's very clear that the Swiss franc has appreciated basically against all currencies. So you see on the left-hand side, the CER growth was plus 6%. And you see on the right-hand side, the minus 5%, respectively, the minus 4.7%. And in Swiss francs. You see really, I think that the major driver here is the U.S. dollar. You might have noticed that we have used the U.S. dollar now carefully to bring that in. when you look at the plus 6% in CER and the minus 5% in Swiss francs, if we were converting to U.S. dollar, we would have grown with 9% which I think supports the constant currency growth, clearly. Good. With that, let's go to the outlook here. And that is certainly always challenging because we're always assuming that currency rates remain stable until the end of the year, and that makes this outlook, how should I say, not very probable. Nevertheless, we want to give you an orientation. So first of all, as shown on the last slide, significant impact in Q1 with the minus 11 percentage points on sales. When we assume that the currency rates at the end of March remains stable until the end of the year, then I think really you see what you had to see at half year with the minus 7 percentage points on sales and the minus 10 percentage points on cooperating profit and core EPS, when you look really at the full year, with a minus 4 percentage points on sales and minus 6% on core operating profit and core EPS, respectively. If you were taking today's rates, I would argue that's broadly in line with what you see in the full year projection. So let me remind everybody, I think last year in Q1, we had a positive impact from currencies. So I think the volatility is enormous. Why do I say this? Because the projections for full year, we will see what we really end up with I also respect the point. It's very hard to follow our numbers with this volatility that we're going to see knowing that we have roughly 50% of our sales in the U.S. dollar. I don't want to dwell too much about the guidance. I think guidance is confirmed. We are very well on track here to achieve the guidance let me reiterate once again that the loss of exclusivity impact of roughly CHF 1 billion is still expected for the full year 2026. And that gives me the pleasure to hand over to Teresa.
Teresa Graham
ExecutivesGreat. Thank you very much, Alan. Okay. Let's get started. So as you have now heard a couple of times, pharma sales grew by 7% at constant exchange rates, reaching CHF 11.5 billion in Q1. We saw a strong performance in the U.S., international and Japan with the latter two achieving double-digit performance growth. The EU was impacted by a number of pricing and one-off effects for specific products, which I'll mention more about in the following slides. But overall, pharma volumes were up by an impressive 17%. . My standard comment on this graph, graph has all absolute values and year-over-year growth rates presented at constant exchange rates in the first quarter of the year. Our top brand, Xolair, Phesgo, Hemlibra, Vabysmo, Ocrevus and Polivy generated roughly CHF 800 million in new sales. We are going to cover the growth dynamics for all of these brands in following slides. But let me pause here for just a quick moment and talk a little bit about Xofluza. So as a reminder, we had a very strong flu season and the for very strong Xofluza sales in Q1 and Q4 of 2025. As I mentioned at our full year call earlier this year, we did anticipate a decrease in flu-related sales in China for Q1 relative to what we saw in Q1 of last year. And that is exactly what we saw materialize and you can see that here in the graph with decline in Xofluza. So that was fully attributable to just a weaker flu season. So now let's continue by having a closer look at our key TAs. And as always, we will start with oncology. So oncology sales increased by 3% to CHF 3.7 billion. Phesgo continues to deliver strong growth with the global conversion rate climbing to 55%. As previously shared, we are aiming for at least a 60% conversion rate at peak. For Kadcyla, we see increasing competitive pressure in both the U.S. and EU in line with our expectations. Additionally, Q1 performance in the U.S. was negatively impacted by some purchasing patterns. Itovebi launch momentum continues to be strong. And before we move off of breast cancer, let's turn to giredestrant. So a lot happened with giredestrant in Q1. So we'll take a little time here to review the program in some detail. So unfortunately, the Persevere study in the first line read out negatively, though as Thomas mentioned, we did see a numerical improvement in PFS. We will present those results at ASCO in June, including at a separate IR event. At the positive side, we successfully submitted the U.S. filing for [ Ladera ] in adjuvant ER-positive HER2-negative breast cancer. And again, as you heard Thomas mentioned, for this filing, we used a priority review voucher which should speed up the regulatory process significantly, enabling approval by the end of the year. We previously shared that we had filed [ Evera ], our positive Phase III in post CDK ER-positive HER2-negative metastatic breast cancer in the U.S. and the PDUFA has now been set for the 18th of December. Let me also remind you of our perspective on the commercial opportunity for giredestrant because it seems that post Persevere there has been some confusion here. So let's start by taking a big step back and reminding ourselves of the composition of the overall breast cancer market. So hormone receptor positive HER2 negative breast cancer accounts for about 70% of breast cancer patients. So just to put that in a little bit of context, HER2 accounts for only 15% of patients. So we're already talking about a much larger patient population. Let's translate that into the actual commercial opportunity. We believe that the total [ SERD ] opportunity across all lines of therapy is somewhere between USD 20 million and USD 30 billion. Within that ER-positive population, adjuvant ER-positive breast cancer is by far the largest piece with more drug traded products than patients than in first-line metastatic and a much longer treatment duration, so around 5 years. And again, I think this has been really sort of misrepresented in some of the coverage post per Persevere. And of course, while we had hoped for a positive Persevere trial, it is really important to remember that the first-line metastatic breast cancer setting only represented around 10% of the overall giredestrant opportunity. Adjuvant is by far the larger market, and we believe there, our data is both strong and compelling. With the positive [ Ladera ] and [ Evera ] trials, we believe we have captured around 80% of the overall SERD opportunity with Ladera accounting for roughly 70% and Evera for another 10%. Let me also remind you that we have one additional Phase III and first-line endocrine-resistant patient [ pioneer ], which reads out next year. Now this represents 40% of the first-line population. So still a significant portion of that first-line population. Giredestrant is combined with the physician's choice of CDK4/6. And in this study, we expect 40% of patients are going to carry an ESR1 resistance mutation compared to just the 5% that we saw in Persevere. So overall, we see ourselves very well positioned to capture a meaningful share of this significant market giving us confidence in the overall commercial potential on giredestrant, you saw in Thomas' slide peak sales well north of CHF 3 billion. And I think, in fact, you've heard us say before, this could be our largest selling product, and that certainly does seem to still appear to be very possible. And with that, we invite you to join us at ASCO to learn more. So now let's shift to [ Alecensa ]. Alecensa had a very strong Q1, partly driven by buying patterns in the international region. We did signal at our last call that due to increasing competitive pressure, especially in the U.S. and EU, we do expect low to single-digit or low single-digit growth for the full year for Alecensa, and that continues to be the case. Moving on to Tecentriq, growth is driven by our new indications, in particular, [ IMFORTe ] in small cell. Additional new indications like [ IMVIGOR-11 ] in muscle invasive bladder cancer and atomic and MMR colin cancer are expected to help carry this growth momentum forward. Let me mention here that we saw one-off buying pattern that negatively affected EU performance in Q1, and we do expect that, that growth is going to gradually recover over the next quarters. With our performance in this quarter, I also want to confirm our full year 2026 outlook for low single-digit growth for Tecentriq. And finally, looking forward, as Thomas mentioned, we expect Phase III readouts for Itovebi as well as the first Phase III readout for [ KRASG12C ] inhibitor [ divarasib ] later this year. Now let's move on to hematology. The hematology franchise delivered strong growth of 18% at constant exchange rates, achieving CHF 2.2 billion in sales. Hemlibra continued strong global growth momentum from last year. driven by increasing adoption in non-inhibitor patients. Of note, the U.S. performance benefited from a base effect due to buying patterns, which negatively impacted Q1 sales last year. As we have previously shared, we expect single low-digit growth for 2025, and this is driven by the anticipated headwinds from competitor launches later this year. Let's stay briefly with hemophilia A and take a look at the latest [ X 007 ] developments. We have initiated the Phase III trials in [ Zebra ] 1 and 2, which compared X 007 2 Factor VIII in HEMLIBRA, respectively. And for both trials, we are using an auto-injector from day 1 for enhanced administration convenience for patients. Moving on to malignant heme, [indiscernible] uptake in first-line deal BCL continues to grow steadily. We're now at 39% of U.S. patient share with more than 95,000 patients treated globally. Please note that the EU Q1 performance here was negatively impacted by a base effect due to the release of sales accruals in Germany in Q1 of last year. Overall, Gazyva delivered solid growth in Q1, but its performance does bear a little bit of explanation given our launch in immunology and the delay in the data that allows us to tease out performance between the two therapeutic areas. So what is it that we see happening. In oncology, because Gazyva sales in the U.S. and EU were negatively impacted by the launch of [indiscernible] and [ acalabritinib ] combination in first-line CLL, which increased competitive pressure on the [ Venclexta ] Gazyva regimen. We believe this dynamic is masking the uptake that we see in immunology, which I'll discuss in just a little bit. We are eager to show Gazyva sales by TA, we're actively working on getting that data, and we'll be able to have more visibility into the immunology uptake in the future. So again, more to come in a few slides. And finally, rounding out heme, our CD20, CD30 bispecifics, [ Colombia ] and Lunsumio continue to see good uptake in their respective indications. Importantly, we completed the U.S. filing of Lunsumio in second-line plus DLBCL based on the positive [ Sunmo ] results, and we expect the readout for the Phase III CELESTIMO study of Lunsumio second line plus follicular later this year. So now let's move on to neurology. Neurology started the year strong with 10% growth at constant exchange rates, reaching CHF 2.4 billion in sales. For Ocrevus, we see continued good growth driven by the subcutaneous formulation, which is known as de novo in the U.S. As anticipated, subcut furthered its acceleration, and you can see in the global patient count, which has increased roughly 24,000, this represents an increase of 7,000 patients compared to last quarter, and that's almost 2,000 more patients than the increase we saw in Q4. So that acceleration is starting to happen. As previously shared, the U.S. de novo uptake is a very good indicator of how we're expanding the addressable market for MS, roughly 60% of the de novo volume is coming from community practices and roughly half of patient starts are now new to the Ocrevus brand. One more comment on the U.S. performance. Q1 sales were negatively impacted by some payer dynamics, which we often see in Q1, largely around recertifications and lower sales days relative to Q1 2025. I -- all of that having been said, for 2026, we continue to expect high single-digit to low double-digit growth for Ocrevus as a whole. So a reminder that we upgraded our peak sales expectations for Ocrevus franchise for CHF 9 billion by 2029, and that includes CHF 2 billion incremental sales from Ocrevus subcut. So more key updates for the MS franchise. We are very pleased to report a positive outcome for the ENHANCE study of fenebrutinib in RMS. And just a few days ago, the full results for FENhance 1 and 2. We're presented at [ AAN ], and I will share those highlights briefly on the next slide, but let's round out quickly with the other products in our neurology portfolio. Starting with [ EVRYSDI ], off to a very strong start to the year, partially boosted by tender-related buying in international. And we continue to see [ EVRYSDI ] expanding its strong global position, thanks to the global rollout of the tablet formulation. Moving on to [ Elevates ] and DMD. We continue to believe strongly in the positive risk-benefit profile in the ambulatory population. And therefore, we have made the decision to initiate a new Phase III trial to enable regulatory resubmission in the EU and other regions globally. This new trial encore includes a placebo-controlled arm and just focused on early ambulatory patients. We're confident that this is the most viable path to achieve EU approval and that it will allow us to bring this new treatment option to patients. And another highlight of the quarter is the positive 3 spring data in [ Mogad ], which was presented just a few days ago at AAN, and I'll cover that in more detail. So now let's move on to fenebrutinib. So with the positive readout of ENHANCE-1, we now have three positive Phase III trials for fenebrutinib in MS, FENhance 1 and 2 and RMS as well as Intrepid and PPMS. I will take you through the details of the RMS results in a moment, but let me make one thing really clear up fine. We are confident that fenebrutinib has the potential to become the first and only high-efficacy oral treatment for both RMS and PPMS. And we also reaffirm our belief in the potential peak sales of more than CHF 3 billion. Now let's provide some background on where this conviction comes from, and we'll start with RMS results. So fenebrutinib met the primary endpoint, showing significant reduction of relapses, 51% in FENhance 1, 59% in FENhance 2 compared to [ teriflunomide ]. Together, these results translate into one relapse approximately every 17 years. Additionally, when looking at key secondary endpoints for disability progression, there is a constant trend favoring fenebrutinib. This is true for CCDP12 as well as the modified CCDP12, which is focused on EDS to the 9-hole peg test, these findings further support fenebrutinib positive impact on progressive biology as seen in the fenebrutinib trial for PPMS. Let me also cover the safety profile of fear. The percentage of patients with liver enzymes and FENhance-1 and 2 is lower than what we saw in fenebrutinib trial and is broadly similar to what we saw in [ teriflunomide ]. There was one Hila case in each of the fenebrutinib and teriflunomide arm of FENhance 1. Both cases were asymptomatic and resolved after study drug discontinuation. There were no additional Hilo cases across all the other fenebrutinib trials in MS or any of the autoimmune indications where it has been studied after implementation of liver monitoring every 2 weeks during the first 20 weeks of treatment. Lastly, to mention, we did see an imbalance in fatal AEs across the fenebrutinib arms of 1 and 2 as well as in intrepid various causes and time points were observed for those fatal AEs as were presented and discussed at AAN in more detail. Again, let me be very clear. Patient safety is our #1 priority throughout the study. There was a continuous exchange with the FDA and the IDMC, including on AEs. And we are confident in the favorable risk-benefit profile of fenebrutinib in RMS and PPMS, and the totality of data from those Phase III trials will be submitted to regular authorities in the coming months. So now let's move on to Enspryng. As previously mentioned, we're quite excited about the positive Phase III results for Enspryng and Mogad. I'm guessing that not everyone is familiar with Mogad or Mylan Aglio Dendriocyte, Glycoproteiantibody Associated Disease. There will be a test on that later. So let me share some background. Mogad is a demyelinating rare autoimmune disease that can cause severe neurological disability in children and adults. Includes loss of vision, cognitive dysfunction and loss of ambulation. There are currently no approved therapies and disease management frequently relies on acute treatment with high-dose corticosteroids, primarily aimed at reducing relapses. IL-6 signaling is implicated in the pathophysiology of Mogad and so therefore, Enspryng, our anti-IL-6 antibody sort of makes perfect sense in this disease. As I mentioned, full year, we believe Mogad represents at least CHF 500 million peak sales opportunity for Enspryng, and now let's look at the data and what has us so excited. So here it is, what the meteorite study just presented a few days ago for the primary endpoint, the portion of patients that are relapse-free and spring achieved a strong risk reduction of 68% versus placebo. Patients demonstrated a response as early as 8 weeks and Enspryng achieved a significant reduction in annualized relapse rates active MRI lesions and rescue therapy. Safety was comparable to placebo nicely rounding out these results, which have been extremely well received at AAN. And I think you can see why we and the KOL community are so excited for Enspryng and Mogad and the opportunity that we have to bring a very meaningful benefit to patients. We expect to complete filing in the U.S. and EU for this indication later this year. And so with that, let's switch over to immunology. Our immunology franchise grew at 8% at constant exchange rates, it's $1.5 billion in sales. The key growth driver here is Xolair, which continues to show exceptionally strong uptake in food allergy as well as continued growth in. In terms of 2026 outlook, we continue to expect around 20% growth for Xolair this year, and this includes the expected impact of the first biosimilar entering the market in the second half of 2026. October sales declined by 4% in Q1, driven by biosimilar impact in the U.S. and EU. Now again, there is a lot of positive news flow around Gazyva, so we're going to take this step by step. I'm going to go into the details of SLE and INS on the next slide. whoever here, again, I want to briefly comment on the ongoing launch of [ busnephritis ]. As I mentioned earlier, we are looking at splitting out the data between immunology and hematology sales. Once that happens, you will see because I have a begin to appear on this slide. In the meantime, let me share with you some qualitative insights on how the launch is going. Across early launch countries in the U.S. and EU, we see positive feedback from doctors and patients, including awareness and treatment satisfaction. And what we're hearing in the field also gives us good confidence that Gazyva is off to a strong start in immunology. For example, a doctor in the U.K. as remarked that there's no reason to just use MMF and steroids anymore because it is clearly a better option. So safe to say, I continue to be excited about the potential for Gazyva in immunology, and we remain confident that this is up to a CHF 2 billion opportunity across all of the immunology indications. And finally, I'd like to mention the upcoming Phase III readout for factors and IgAN which is now expected for later in the year. So let's take a look at Gazyva in a little bit more detail. Gazyva is on a tremendous round achieving 4 out of 4 positive Phase III trials in immunology since we reported the first results back in 2024 in LN. The positive Phase III Mads membranous nephropathy -- but we're going to talk about more of that in a minute. First, I want to highlight the strong Phase III results from allegory and SLE, which were just recently presented at SLA euro. You can see on the left, the primary endpoint and key secondary endpoints all show a clear benefit for GAZYVA treatment relative to placebo. And on the back of these results, we believe Gazyva has the potential to be the new standard of care in Again, when you look across these four indications, you can clearly see why we believe in the potential for that CHF 2 billion CSF upside opportunity comes from. You can also see that we are progressing our filing activities at PACE. LN is already approved and the U.S. and EU launches are ongoing. SLE has been filed in the U.S. and the EU and the U.S. PDUFA has for the fourth of December. MN will be filed in the U.S. and EU later this year, and INS has been filed with the U.S. and EU filing is expected later this year. So a ton of momentum for GAZYVA in immunology, and we are excited to update you. So let's move on to ophthalmology. Ophthalmology grew by 10%, achieving CHF 1.1 billion in sales. The Vabysmo started this year with a strong quarter with 13% growth at constant exchange rates. While we continue to see global market share gains across countries, I did want to highlight the U.S. performance here in particular. Q1 marks a return to growth in the U.S. In fact, we see 4% sales growth with low double-digit volume growth and a steady market share expansion. Vabysmo continues to establish itself as a standard of care across AMD, DME and RVO as underscored by the fact that roughly 60% of Vabysmo starts are treatment naive. Regarding the branded market contraction we saw in the U.S. over the last quarters. We are now beginning to see the first signs of recovery, but for now, they are only the first signs. We continue to expect to see a gradual recovery of the branded market going forward. And last but not least, we are excited to have received an updated FDA label for the RVO indication, and that update adds the flexibility for treatment beyond 6 months based on long-term data. for [ Embelaton ] and [ Camino ] studies. Let me also say a few quick words on the EU performance in Q1. In Q1, we had to digest a negative impact due to price impacts, but we saw quite good volume growth in the EU. So therefore, we do expect a return to growth in Europe in the coming quarters. In 2026, the outlook for Vabysmo is a growth acceleration compared to the 2025 growth rate of 12%, which is what we have messaged earlier. Let me highlight that we expect to file two new potential medicines in our ophthalmology franchise later this year, the [indiscernible] in UME and Enspryng and fibroid eye disease. So up next, let's cover the CVRM portfolio. We continue to progress our CVRM assets at pace, and there are two highlights for Q1 that I want to discuss in more detail. Let's start with petrelintide in Q1, together with our partner [ Zealand ], we shared the positive results of the Phase II SUPREME 1 study of petrelintide obese patients without type 2. These results showed that petrelintide delivered meaningful double-digit weight loss. Importantly, this weight loss was accompanied by a placebo-like tolerability profile. So therefore, we believe in the potential of petrelintide to address key unmet needs for people living with overweight or obesity, namely to meet their expectations for weight loss and significantly life-limiting adverse events, thereby improving treatment persistence. Moving on to the newly named enicepatide, formerly known as CT-388. At the full year event, we showed the positive Phase II top line results for the once-weekly enicepatide in people with obesity. That was study 103. Let me just remind you the highlights from that data using the enicepatide demand eased in achieved a placebo-adjusted weight loss of 22.5%. We saw a clear dose response relationship with weight loss. And importantly, we are pleased by the absence of the physical efficacy plateau at 48 weeks for the 24 mg dose, which is the highest dose tested. On the back of this strong Phase II data, we have successfully initiated 2 Phase III trials in obesity, it 1 and 2 in Q1. For both petrelintide and enicepatide, we are looking forward to presenting the results at ADA in June, including at a separate IR event. In regards to what's to come in 2026, you will see we have quite a few milestones. So we expect additional Phase II readouts for enicepatide in obesity with type 2 and CT-996, our oral GLP-1 and obesity and finally, as data [ Gamida ] for [ Mugabarintera ] enicepatide in obesity. We also expect multiple trial starts. We plan to initiate a Phase II combination study for enicepatide and petrelintide with the FPI expected towards midyear and the first Phase III studies for petrelintide plus CT-996. As you can see, there continues to be a lot happening in our CRM portfolio, and we will be sharing additional updates throughout the year. So moving on to the news flow slide. So here as we have what is happening this year. I believe I've covered all of the changes shown previously with one exception. Earlier this quarter, we shared that we made the decision to discontinue development of emugrobart in SMA and FSHD. This follows a rigorous assessment of data from the Phase II studies, Manati and Maneuver. We plan to present these data at upcoming conferences. And just to be clear, there is no impact from this decision on the ongoing Phase II obesity trial reading out towards year-end. So let's go to my final slide. To close my section today, I wanted to walk you through an update of our well-known consensus GAAP analysis slide. As we've recently had a series of positive readouts representing significant commercial opportunity. To briefly orient ourselves the value shown here are now based on the post full year 2025 consensus numbers from sell-side analyst models. And we've pushed out the time frame by 1 year to look at 2025 to 2030. according to consensus, Roche has a biosimilar gap of CHF 6.7 billion by 2030. However, if you look at the middle section of the slide, you can see where consensus sees sales growth coming from during the same time period. Taking the on-market portfolio and the pipeline together, consensus expects a total of CHF 5.9 billion -- sorry, CHF 15.9 billion and additional sales by 2030, which compares quite favorably to that projected biosimilar gap. If you take a closer look, these additional sales come from the on-market portfolio where future growth is expected to deliver an additional billion in sales with [ Vabis and OTOVI ] being at the top of a long list of growth contributors. And for the late-stage Phase III pipeline, the consensus forecast a total of CHF 8.4 billion in additional sales with giredestrant, fenebrutinib and enicepatide all projected to be post growth drivers, where most of our other Phase III assets all have rather modest sales projections at this point. In addition, there are still a number of other assets in our pipeline that are not really covered yet by the consensus, presenting potential upside. These are on the right side of the slide, including Enspryng spring and Mogad with the compelling data we just talked about today and Enspryng and [ TED ] to be filed later this year, or Gazyva in SLE again with very compelling data that has just been released. So in summary, if you remember Thomas' slide from earlier, we have the potential to launch 19 NMEs by 2030. There's, of course, also the possibility that BD might contribute more over time. And I hope this makes you at least as excited as I am for the future of Roche Pharma. We have a lot to look forward to. And with that, I will turn it over to Matt.
Matthew Sause
ExecutivesAll right. Congratulations, Teresa. With that, good morning, good afternoon, everyone. It's my pleasure to present the Diagnostics financial results for the first quarter of 2026. So with sales of CHF 3.3 billion, the Diagnostics division grew sales by 3% or plus CHF 88 million compared with 2025 at Constant Exchange. So this growth was achieved despite the ongoing impact of health care price reform in China, which continue their impact in 2026. Now as you heard earlier from Alan and as well from Thomas, excluding China, the growth of the business was plus 5% and was additionally impacted by approximately $40 million lower sales due to the weak Northern Hemisphere respiratory season. Now with that, let me walk you through sales by custom area. Sales in our core lab increased at 4%. Now this was impacted by the previously mentioned policy impact from China. Excluding this, Core Lab grew at plus 8%. Now sales in molecular lab were flat, with strong growth in transplant at plus 15%, but this was offset by the previously mentioned mild respiratory season which lowered testing volumes. Now while blood screening decreased at minus 9%, this is due to the ongoing conflict in the Middle East, and this impacted some customer deliveries. Sales in near patient care decreased at minus 5%. This was driven by lower [ coboculiate ] sales, again due to the mild respiratory season, but this was partially offset by growth in our blood glucose monitoring at plus 8% following some recent competitive wins. Sales in pathology lab grew at plus 12%, mainly driven by advanced staining growth of plus 9% and companion diagnostics growth of plus 23%. So now I'd like to shift and take you through the regional view. I'll take you through the performance by geography. In North America, the business grew at plus 6%, in EMEA, the business grew at plus 3%. As previously mentioned, this growth was impacted by the decrease in the blood screening business due to the Middle East conflict, in LatAm, the business grew at plus 10% and as previously mentioned, sales growth was impacted by the health care pricing reform in China. As a result of this, China sales declined at minus 14%. Now as stated at the full year, we expect a lessened impact of the China pricing reform in 2026, and our ambition is to grow sales in the Diagnostics division at mid-single digits this year. So now I'd like to continue with some updates to our assay pipeline, starting with the CE mark for our [ Cobos ] MPX test which we announced in March. The blood screening nucleic acid testing market represents approximately CHF 800 million market globally and screening for hepatitis E or HEV is growing in APAC as well as EMEA due to increasing incidents. With the [ Cobos ] MPX, we will enable labs to efficiently integrate HEV screening into their existing workflow and this will address a growing demand for comprehensive blood donation safety worldwide. Our test will improve lab efficiency by simultaneously detecting HIV, and HCV, HPV and HEV from a single sample, and this will eliminate the need for retesting and reduce turnaround times, again, helping patients around the world have access to blood supply. This test will expand Roche's fully automated blood safety solution portfolio and strengthen our leading position being the only company with a full nucleic asset and serology testing solution in our portfolio. So now I'd like to move to our leading neurology portfolio, starting with the CE Mark of our blood-based neuro film and light chain assay. So as you heard quite a bit from Teresa, MS is a progressive disease, affecting around 2.8 million people worldwide. And about 45% of patients are currently managed with low efficacy treatments, and disease monitoring relies heavily on expensive and resource-intensive MRI scans. Our NFL test will enable detection of neuroinflammation in patients with relapsing remitting MS, which will support more informed treatment decisions. And with specific and differentiated about our test is we have established age-specific NFL percentile from a comprehensive reference data set. And this is critical for clinical interpretation because NFL values increase with age. And this provides a more robust approach as opposed to other approved tests that rely on a single cut off. This test will broaden Roche Diagnostics neurology portfolio with a simple, reliable and accessible test. So continuing with our neurology portfolio, I'd like to talk a little bit about the data from our pTAU217 blood-based biomarker study readout. So this is data that was presented at the ADPD Conference in March. And here, we assessed our blood-based test across primary, secondary and tertiary care settings. Evaluating its performance throughout the full Alzheimer's disease continuum in two cohorts with a total of 675 participants. Our test demonstrated high diagnostic accuracy consistently across all clinical stages and health care settings. And it will be the first pTAU217 test with the potential to be approved across primary and secondary settings. Again, differentiating our neurology portfolio through the clinical evidence. This test will enable rapid, minimally invasive diagnosis across care settings, allowing clinicians to identify Alzheimer's disease earlier. So now you heard a bit about this from Thomas, and now I would like to talk a little bit our forthcoming [ Exela ] sequencing solution. Talk a little bit about some of the data we presented at AGBT, which is the leading genomics conference in February of this year. On the left-hand side of the page, you can see the SPX DUPLEX performance data from a large internal study of over 1,000 human genomes that were processed over 65 runs. Here, we demonstrated unprecedented throughput. As you can see from the chart, the systems baseline is very robust, reliably generated an average of 2.3 trillion bases of concordant duplex basis in 4 hours. So as you heard earlier, one of the key differentiators of our system will be the unprecedated throughput, unprecedented throughput. Now on the right side, you can see data presented by one of our early evaluators the [ Hartwig ] Medical Foundation, they compared performance of our SPA technology with a leading on-market technology for 118 tumor normal pairs. The results demonstrated high throughput and improved batch flexibility per run and 99% concordance with the leading technology. These results reinforce the potential of Roche's SPX technology set a new standard in next-generation sequencing, unprecedented throughput and accuracy on par with leading technologies. And I would also like to highlight a little bit of our recent acquisition or excuse me, our merger agreement with Saga Diagnostics. So Saga Diagnostics path like tumor-informed MRD or minimal residual disease testing platform is currently available for early breast cancer and colorectal cancer. It relies on DNA sequencing followed by digital PCR assessment of structural variants for monitoring disease relapse. Path lights tumor-informed ultrasensitive MRD platform will be fully integrated into our Foundation Medicine organization. Foundation Medicine, we using our colleagues at Foundation Medicine team, we also plan to leverage the [ AXELIOS ] and our Roche Digital LightCycler PCR platform to develop a decentralized MRD solution, enabling international expansion and improved patient access. This minimal residual disease market is projected to grow at 31% and compound annual growth rate, making it one of the fastest-growing segments in diagnostics overall. This acquisition will strengthen our leading oncology portfolio and support our ambition to build an end-to-end offering, spanning early detection, diagnosis, therapy selection and now disease monitoring, powered by our core technologies such as [ AXELIOS ]. So to conclude, I'd like to report on progress of our key launch list for the Diagnostics division. For the 11 launches shown here, which you heard a little bit about earlier, we achieved three by Q1, and we're making good progress towards the other launches, which are on track. I look forward to providing future updates at our next meeting. And now I'd like to hand it over to Bruno. Thank you.
Bruno Eschli
ExecutivesThank you, Matt. And just quickly to point out upcoming IR events. Next events, which are scheduled now will be the diagnostics day on May 12. This will be, again, a live event in London. We will have Thomas opening the day with a group and strategy update. And then we, again, will take you through the entire portfolio. And as Matt already mentioned, sequencing will be, I think, in the center. We have then two other events scheduled beginning of June. We will have an ASCO event, which will be live out of Chicago. So if you want to join us, you can come along. On the second of June, we will here primarily be focused on [ delustrant ], the key data again and also a bit the clinical future development program. And then on June 8, we will have an event around ADA, which will focus on the obesity franchise. Key data to present will be our 3 Phase II data in petrelintide and then also here an update on the next steps in terms of our combination development where we expect the Phase II to start around midyear. And then I think, finally, in the second half, Pharma Day is now scheduled for the 28th of September. Again, a live event in London, we will have a plan for a similar setup like last year, taking you through pharma strategy then also the primarily late-stage pipeline and the portfolio, we also have included an update on our AI investments, especially focusing on early drug development here as well. With that, I think we are closed with the presentations and would open the Q&A. First questions here would go to James Gordon from Barclays. James, please.
James Gordon
AnalystsJames Gordon from Barclays. First question was about giredestrant. So failure of the persevere trial. Is that at all surprising light of Ladera and how do you reconcile the differences in the outcomes? Do you think it could be anything to do with whether there's background CDK4/6 therapies? Or do you think it might be more about prior patient experience to hormonal therapies in the Persevere trial but not the Ladera trial. That will be the first question, please. And then the second one would just be about [indiscernible] there's lots of different things going on in your pipeline. But we've seen some very low-cost GLP-1 generics launched in some places already such as in India. How do you think about obesity price in the next decade and what that might mean for your next-generation therapies is by the time you launch, there could be some or shortly after some much lower priced therapies. Where do you think a drug like petrelintide will be used and could pricing going to be tougher?
Teresa Graham
ExecutivesGreat. Thanks, James. So let's start with Persevere versus Ladera. So I mean I think one of the most important things to always remember in oncology trials is that the context and the biology of the line of therapy really does matter a lot. Tumor biology differs across lines of treatments, especially in early breast cancer versus later-line setting. In EBC, tumor burden is low versus the metastatic setting, the tumor burden increases, the environment becomes more genetically complex resistance mechanisms are more prevalent sort of the later line in therapy that you go. And so -- it's really important that we evaluated giredestrant and [indiscernible] in all of these different lines and settings in multiple different ways because is really -- there's differences in the tumor biology. Although the study didn't reach its statistical significance in PFS and new Oracle improvement was observed. So we do believe that giredestrant is active in the first-line metastatic setting. And we are confident in its potential certainly in early breast cancer, and I think we're very curious what we'll see in Pioneer, which is the Persevere covered 60% of the first-line setting Pioneer covers the 40% remaining. And I think we're very curious what we'll see in the Pioneer setting. So there isn't anything about Persevere that changes our confidence and our belief in the importance of giredestrant in early breast cancer. Again, where 70% of the opportunity sort of sits. So very yes, just to be super clear about that. In terms of obesity pricing, this is very foreseeable. I mean, I think as we -- when we made the decision to enter this market, we assumed that by the time we got there, there would be significant price erosion. It's not unexpected that in certain parts of the world, you would have very low priced options. But regardless, I think given the portfolio that we've put together, the clinical benefit think our products will provide the clinical differentiation that we believe that they'll represent. We do believe that there continues to be a very robust opportunity for us in obesity.
Bruno Eschli
ExecutivesJames, did this answer all your questions?
James Gordon
AnalystsYes.
Bruno Eschli
ExecutivesYes. And we move on. Next one is Sachin Jain from Bank of America.
Sachin Jain
AnalystsSo [indiscernible] BTK. So Teresa, the introductory comments on. I just had two around Ladera and then one on BTK. So online, how should we think about the cadence of launch as you prepare for sort of commercial towards the end of this year early next year. Do you think this is a market which will require a lot of community oncologists, education versus CDK4/6 AI? Or that the data will be easily understood and we should think about this as a strong launch. And then secondly, you and Thomas have commented this could be one of Roche's top drug, which I guess alludes somewhere in the $5 billion to $10 billion range. So just interested in your thoughts as to what factors you see that's going to dictate where in that range you end up. Some of the factors we hear back would love your perspective on is adoption of low-risk patients, whether you get any combination use of CDK4/6 and then impact from other adjuvant studies, notably the SWITCH studies that are due next year, Cambrian 1 and before. That's an idea. And then just a very quick one on BTK. You say you've been in continuous exchange with the FDA, IDMC. Any color you can give on the tone of those discussions. Clearly, part of your just comment, I guess, is referencing safety where investors just seen the death in balance and I guess, lack of color on the suicides, driving concerns on approvability.
Teresa Graham
ExecutivesYes. Great. So in terms of cadence of launch, I mean, we would expect that giredestrant will have a strong launch. I mean I think there's quite a bit of excitement and interest and this is a therapy for patients living with ER-positive HER2-negative breast cancer. I mean, where we expect to have the quickest uptake is in that sort of mid-risk population. And from there, there's quite a reasonable there's quite a reasonable belief that we would then move into the high-risk population, given the talk with the CDK4/6 over time, patients have a difficult time tolerating it. They drop off. We'll have additional data that we will generate in these areas as well in terms of combination therapy. But it is very tough to remain on these regimens over time. And given the safety profile that we saw with giredestrant, we would believe that there will be a number of patients even in that high-risk population that we'll want to make the switch. Low risk. I mean, again, we hear KOL intent to use in this low-risk population. I mean with -- as with any kind of oncolytic indication, you really want to come out of the gate swing. What is your strongest weapon that you can use against the cancer. And I think the Ladera data very clearly show that we are highly efficacious and very tolerable in this setting. So I think we intend to resource and go after this indication, assuming that it is going to be strong right out of the gates. In terms of the switch studies, I mean, I think this is -- it's an interesting question. I mean, the switch study is assumed that after 3 to 5 years of therapy, you're going to make a Switch. Why would you save your biggest gun to last? I mean it doesn't kind of totally compute that that's what people would necessarily want to do. I mean I think at the end of the day, with Ladera, we asked a very clear scientific question. We got a very clear answer. And I think that very clear answer is one that's been quite well received by the KOL community. I mean in terms -- so switching over to BTK in terms of the tone of discussion, obviously, we don't discuss ongoing communications with regulators. But I would say, as always, we've been very transparent with our data. They've been very productive discussions. And again, we believe that we've shown a very good benefit risk profile. There is no medicine out there that doesn't carry some amount of risk, but we believe that given what we've shown from an efficacy standpoint, we've got a really good treatment for MS on our hands. I mean, let's talk for a minute about suicides and suicidality. I mean, first, I think it's just important to put in context that the MS population, unfortunately, does have a higher risk of side and suicidality. And so sort of the backdrop under which you have to sort of consider some of this data, and I think you've heard that from the KOLs who've presented on the podium. These are -- there's not a huge number of these events. We clearly are trying very hard to understand them, but it's likely going to require more data and more time. And I think what's also important to remember is that we didn't see any suicide or suicide in our Phase II trial, including long-term extension. And we haven't seen any in any of the autoimmune indications that we have studied as well. So I think there are certainly questions that we have to ask and answer here. Patient safety, as I've said previously, is always our #1 priority. We are looking into this very, very closely. And as we have more information, we will certainly share it.
Thomas Schinecker
ExecutivesYes. Maybe, Sachin, I can add two things here as well. One on giredestrant and on the Switch in studies. Well, first of all, just on order, giredestrant has demonstrated the highest preclinical potency among the sets. Second, if you look at Switch in studies and people have been pretreated for 3 to 5 years, you are just also in a different setting. So I don't think that the data that we have shown necessarily needs to translate to another set, which is tested in a very different setting and it's a very different molecule. And if you then look at when the next study will come in terms of true adjuvant study, this is a number of years away. On the BTK, one thing that I can also give as an indicator is that on the PPMS side, we have already achieved the approval of getting all of the patients that happen on the trial into the open-label extension. And not only that, also the people that were in a placebo arm have switched to fenebrutinib. I think this is at least a good sign if you ask me because it shows that the benefit is seen and yes, these people are allowed to be on this medicine.
Alan Hippe
ExecutivesDid you mention that fenebrutinib was used in other indications as well?
Teresa Graham
ExecutivesYes.
Bruno Eschli
ExecutivesVery good. Let's move on in the queue. The next question go to Peter Verdult from BNP Paribas.
Peter Verdult
AnalystsYes. BNP, just Teresa, a couple of questions on your [indiscernible] portfolio. If we look through the lens of your R&D bar strategy about prosecuting best or first-in-class assets. I get it why you're proceeding in its petite forward interested to him more about the Phase III development plans there. But I don't see how the amino petrelintide can be considered first or anywhere near best-in-class. So interested to hear more your go-forward strategy there on [ Am-lin ]. And just to check, is there any debate internally at Roche, whether to make that sort of CHF 2 billion commitment to petrelintide for a full Phase III development program? .
Teresa Graham
ExecutivesSure. So I mean, I think, first, we should talk about the fact that the [ Am-lin ] class is fundamentally different than the GLP, GLP-1 class. It serves a very different role in what we think is going to be a very heterogeneous obesity market. We do see a very different tolerability profile for [ petrelintide ]. And so when you think about the over -- when you think about the 50% of the population globally, that is going to be obese by 2030, 2035, there are certain portion of them that are not going to tolerate any kind of adverse event. And [ petrelintide ] in combination or in other uses [indiscernible] in the low teens, which is exactly where we saw the data come out for Petri along with that placebo-like efficacy profile. So I think for us, as we look across the entire portfolio and the kind of offering that we want to bring to the market in terms of having a differentiated holistic portfolio that addresses all of the different needs that patients will have. We think that there is a role for [ Amylin ] play and a role for petrelintide to play. And so more to come on exactly what our Phase III trials will look like in the coming months. But I think we still continue to believe that there is a place for petrelintide.
Thomas Schinecker
ExecutivesAnd we have announced that we will do a Phase II combination of petrelintide and CT-388. And especially in the combination, I think it's important to have molecules that are tolerable in the combination. And especially in the conation, we do see the potential between the molecule. Something very different unit.
Bruno Eschli
ExecutivesOkay. Then let's go on. The next questions come from Sarita Kapila, Morgan Stanley.
Sarita Kapila
AnalystsJust one for me. headed the Q4 data in DME, how should we think about competition to [ Vabysmo ] from Merx M300. So the early data suggested a similar visual acuity improvement at 12 weeks versus 52 weeks for the [ Vabysmo ]. And how should we think about potential read or risk to AMD?
Teresa Graham
ExecutivesSo I mean I think the Vabysmo has done an exceptional job over the course of the last couple of years establishing itself as the standard of care in these in retinal disease. And we see that being consistently reinforced in all of the interviews and information that -- and exchanges that we have with our retinal specialists. So while it's always interesting to see another mechanism of action kind of entered the space. I think Vabysmo has set a high bar and they will have to sort of demonstrate that they can cross over that over the long term with their safety and efficacy data. Again, we also have a win. So we're in this race as well. Ophthalmology is a core area for us, but we do believe that at the end of the day, people will need to see something that works better than Vabysmo. And as of yet, we don't have anything in a Phase III that's proven that.
Bruno Eschli
ExecutivesVery good. Then let's move on. The next questions go to Luisa Hector from Berenberg.
Luisa Hector
AnalystsSo I have a question around the derisking really of the legacy pipeline and your levels of confidence in those drugs. Has that changed your ambitions in terms of business development, R&D investments and your thoughts around the longer-term sales and margin. Just any color you can give there.
Teresa Graham
ExecutivesWhen you refer to sort of legacy pipeline, what are you referring?
Luisa Hector
Analysts[ Fannie and grades ] strengths. So hearing your levels of excitement around those assets and the positive data that you have, does that lead you to behave differently and think differently towards future business development?
Teresa Graham
ExecutivesYes. So I mean, both fenebrutinib and giredestrant in what we call end-to-end disease areas and our pharma strategy. So MS and breast cancer are two areas that we have said we have a long-term strategic interest being leaders in both today and tomorrow. So I think it doesn't change our interest. We remain deeply interested in both of these spaces. And are going to be constantly on the hunt for opportunities to really improve patient efficacy in both breast cancer and MS.
Thomas Schinecker
ExecutivesI mean from an M&A perspective, I can say that we'll continue to do M&A like you've seen in the last couple of years, but we're not dependent on it, right? I mean if you look at the last couple of years, we could actually finance our M&A that we did with the earnings that we had in that year. And I think there are other companies that are in a much more different situation where they actually do have to do M&A. So continue to see what we've done over the last couple of years, very disciplined spending and again, we are in a good position. We will have continued growth even in absence of M&A.
Alan Hippe
ExecutivesAnd we don't have a patent clip, correct?
Teresa Graham
ExecutivesWe don't have a patent clip.
Bruno Eschli
ExecutivesLuisa, did we answer all your questions?
Luisa Hector
AnalystsYes.
Bruno Eschli
ExecutivesAnd next one is Graham Parry from Citi.
Graham Glyn Parry
AnalystsJust going back to giredestrant at [indiscernible]. At 70% of the market opportunity in adjuvant over CHF 20 million to CHF 30 billion would imply CHF 14 billion to CHF 20 billion opportunity in adjuvant. Just could you clarify how much of that would assume CDK4/6 combo use or erosion? Or how much is just essentially what is currently a monotherapy aromatase inhibitor market, which is aligned with your Ladera study and, therefore, fairly easy to go after. And then secondly, do you think that you could get a label which would allow aromatherapy switches on launch or just de novo patients per the Ladera study? And then thirdly, one for Alan. Just the thoughts on the margin trajectory of Rush as you go forward and have this multibillion-dollar in-house developed asset that's a small molecule at a high price, driving your revenue growth.
Teresa Graham
ExecutivesYes. So you have asked two sneaky questions. So we will not comment on what we -- on the label negotiations that we're having with the FDA. So more to come on that. Right now, about 20% to 25% of early breast cancer patients get CDK4/6 combination therapy, but there are very high discontinuation rates due to adverse events. And so we are -- we don't provide peak estimates for our products at this stage, but I will say that we would expect that we will have a significant share of that market. I mean in the stores.
Alan Hippe
ExecutivesYes. Well, look, I think from the margin point of view, as Thomas always said, I think we defend the margin or increase it. I think these are the [indiscernible] so at least, we defend the margin moving forward. I think we've said it also for this year already. I think without increasing the margin, honestly, I think very hard to do and to fulfill the guidance. I think we have a higher burden coming from the tech side. We have a higher burden coming from the financing side that we have to cover. So we're going to do that. So that's automatic. . And I think really now distinguishing what's a small molecule or whatever mechanism it is, when you look at the longer term of Roche, I think we've been pretty, pretty solid when it comes to the gross margin, especially on the pharma side, roughly 80%. That's something that we always had somehow here, was it small molecules or even other mechanisms. So I think that looks fine. Certainly, I think that's a great opportunity. We love duration. I think that's a huge opportunity moving forward. And very clearly, I think that looks promising.
Bruno Eschli
ExecutivesI think what's probably fair to mention that we are well entrenched on the commercial side in these areas. So we have a bit breast cancer sales force and we have a modus grocer sales force, so there will be a benefit on...
Teresa Graham
ExecutivesExactly, from an M&G perspective, these are launching right in our sweet spot.
Bruno Eschli
ExecutivesYes. Graham, any additional questions, follow-on questions -- what's the [indiscernible]? . Then let's move on. Next question come from James Quigley, Goldman Sachs.
James Quigley
AnalystsGot two, please. And apologies, I missed the first one on the [ Vabysmo ]. What is the current bottleneck for the recovery or acceleration of [ Vabysmo ] sales in the U.S.? We've sort of seen increased funding towards the back end of the last year. but it seems to be taking a lot of flow through to patients. So what is the -- what is going on here? Is that normal from what you've seen before? And have you started to see the bottlenecks lifting as we've gone through the quarter? That's the first one. Second one, revisiting CT-388. So you started the Phase III trials now. So there's two of them have seen on clinicaltrials.gov, do you look like traditional Phase III designs, can you confirm to what extent there is any flexible dosing here did you also consider adding semaglutide as a reference arm or even an active comparator to the study? And then also related to 388, what was the progress? What's the next steps in developing combinations with petrelintide? Is that still the plan? And when will we start to see some of that data?
Teresa Graham
ExecutivesYes. Great. So [ Vabysmo ], just to reiterate, good quarter, 13% for the division back to growth in the U.S., 4% up. We continue to reiterate that we will see an acceleration from the 12% growth that we saw overall last year. To reiterate, patient assistance foundations are not strategy. And we do not look at them when we think about sales. That having been said, what we have been hearing from the market is that based on what happened last year, physicians have just gotten savvier about where to use patient assistance dollars and they're using them for patients who truly need them. And they're just thinking differently about how they're utilizing those funds as they're made available. But that is a completely different and separate thing to anything that we do on the commercial side. And I just want to be crystal clear about that. CT-388, you are right, the first two trials are relatively straightforward and standard against placebo. And that is because that is what is currently required for regulatory approval. So when you talk about bringing a new molecule in this space to the market. These are the trials that the FDA asks you run. And so therefore, that is what we are doing. We will be looking at other things going forward with CT-388 and more to come on our plans in that space. And then obviously, we're very excited about launching that fixed-dose combination you've now heard us talk about several types.
Bruno Eschli
ExecutivesI think, James, regarding the -- you had a question on the combination development. I think this has to be kicked off of midyear. So midyear, we would expect the first patient in. And I think we [indiscernible] to drill a bit more and go into it more into the details on the trial design. Okay. Then we move on, and the next one is Simon Baker from [indiscernible].
Simon Baker
AnalystsThank you, Bruno. Two if I may, please. Firstly, for Teresa. I just wondered if you could share some of the feedback from physicians following the presentations of fenebrutinib. We've had a few drugs recently where there's been a should we say, a disconnect between a negative market impression and a positive physician impression on drug. So I just wanted to know if that was the case here. And then a slightly different question, going back to the AI factory. I just wonder if you could give us an idea of how and when you will assess the impact? And how and when will we be able to assess the impact of your significant AI investments?
Teresa Graham
ExecutivesYes. So I will say, I was at [ ACTRIMS ] when we presented the PPMS data, and I have had multiple conversations with the team on the ground at [ AAN ] and the KOL feedback is extraordinarily positive. I think people are very encouraged by the data that they're seeing. They are they're reassured in some ways by what they're seeing on the safety side with the liver with the relative understandability of the liver enzymes and the fact that we're not really seeing a pattern with some of the other adverse events. So there is a huge amount of excitement here. I mean when you think about the MS population, 45% of patients today are either on orals or low-efficacy therapies. This is extremely low-hanging fruit for something like a fenebrutinib that acts on both the progressive and relapsing portions of the disease. So I think we see a ton of positive KOL excitement and enthusiasm. And I think they're really looking forward to having this tool in their armamentarium. And I can pass it on to you, Thomas.
Thomas Schinecker
ExecutivesYes. On the AI side, you saw on the slide from Bruno that you will have an update at Pharma day. And I know [ Aviv ] and some of our people will be there. So you see exactly how many molecules are ready in our pipeline coming through the use of AI tools in research. And how we're going to really track that in the future and how we can make it transparent for you so that you can see the benefit that AI has already today. But I can say our teams are now really utilizing AI constantly in research. And actually, a lot of the molecules have some sort of AI tools used in the development. Bruno, do you want to comment on that?
Bruno Eschli
ExecutivesYes, I can quickly comment. So really stay tuned for Pharma Day. We will have Avon stage, and I think we will roll out a bit our strategy here also and how track the progress in this field. I think it's fair to say it's early days. We have now generated, I think, a couple of names. Basically, all new enemies have another AI component to them. And we have established a system where we will track this progress. So these molecules, I think, are to enter the clinic within the next couple of quarters. And then, of course, we have to wait 1 to 3 years to really collect enough data to get a feel on how this has impacted success rates, for example, or whether we were able to identify new drug targets and many more questions to be asked. But I think September, that's the point in time when we really will kick off, I think, this AI communication and provide also some mid- and longer-term perspectives. Okay. Then we go on. Next question go over to Justin Smith from Bernstein.
Justin Steven Smith
AnalystsJust a couple of. Firstly, on Alzheimer's, just wondered if anyone could share any thoughts about how the launch of the pTAU217 test could actually expand the market for biologics. And then just second one on Polivy given potential competition coming up? How will you think about whether the sequential share gains we've seen in the U.S. would be sustainable or not?
Unknown Executive
ExecutivesSo yes, I'll take the first one on pTAU217. So if you think about the data set, as you heard on the slide, we have data across primary, secondary and tertiary care. Now one of the biggest challenges people need to be diagnosed with Alzheimer's is the availability of specialists. Oftentimes, it takes over 2 years. By having a primary care claim, potentially with the blood-based biomarker, you have the potential to greatly expand access. And for this to get into guidelines, it would need to have negative predictive value, 90% positive predictive value with a 90% sensitivity and 90% specificity. If that is achieved, then absolutely, that becomes possible. So that's how I'd characterize to incentive.
Teresa Graham
ExecutivesYes. And I would say from the pharma standpoint, we're extremely excited to have these assays in the market because we do think this has been one of the limiting factors to uptake, is that just getting proper diagnosis and being able to get those eligible patients in. So I think we're super excited to have that partnership. In terms of Polivy, yes, I do think those share gains are sustainable. And I think in addition, we will be releasing even additional data about combinations with Polivy. So we set the standard of care 20 years ago plus with Rituxan. We sent it again with Polivy. Stay tuned.
Bruno Eschli
ExecutivesYes. And also to remind you, we have our own first-line development program ongoing with [ Tigo ] so this is to come. So the other thing is, I think if you look at all the recent study starts, they all have basically been building on poly regimen. So I think this really tells you that this has been widely perceived as the standard of care in first line. Which is roughly CHF 2 billion opportunity, and I think we are really nicely tracking towards the scale. Justin, any other questions? Yes. And we move on with Richard Vosser from JPMorgan, Richard.
Richard Vosser
AnalystsA couple of questions, please. Maybe on HEMLIBRA. Teresa, you talked about very strong growth across the world, but also seeing switches back from [ Altivio ]. So I just wanted to think about the sustainability of those switches and how much that's contributing now? And just also, we're going to see a competitor to come later this year. So just thoughts on how you defend against that and what they could do to the growth, which is very good at the moment. And then the second question on Gazyva you alluded to the impact from competition in CLL. Just could you give us a context of what sort of drag that could be for the rest of the year as we think about the rollout into lupus, just so that we can get an idea of the growth there.
Teresa Graham
ExecutivesAbsolutely. So sort of exactly what we had thought was likely to happen with Hemlibra is what we're seeing happening, which is patients who were well controlled on HEMLIBRA, maybe were tempted to try [ ALTIVIO ]. We see actually a very large percentage of patients switching back. It's around 30% of patients who went to [ ALTIVIO ] have switched back. We do not see that trend have slowed down dramatically. The growth that [ ALTIVIO ] is getting is really coming from other Factor VIII at this point. And so I think what it boils down to is that patients who are on HEMLIBRA have an incredibly high satisfaction with their therapy. And it's not uncommon that they switch back after time. So that's -- this is a great therapy. It has changed the lives of many, many patients living with hemophilia. And I think we -- we expected to see a lot of people come back and that's exactly what's happened. We also know that Hemlibra has set a very high bar in the treatment of hemophilia. And we don't actually really see much clinical -- we don't really see any clinical differentiation to be frank with [ MME ]. And so the efficacy profile doesn't look differentiated in terms of ABR reduction patients with 0 bleeds. I mean we do expect increased competition, but we are also doing things to benefit the patient experience of HEMLIBRA with the new injection kit with the auto-injector that's in development. And so we are -- we remain confident that HEMLIBRA will continue to be the standard of care. That having said, we do believe that there will be competitive impact to the back half of the year, and we took that into account when we gave the outlook for this year. But as we are looking forward to next 007, I think it is worth pointing out that we are the only people who are -- have been kind of brave enough to go up against that standard of care, raising the bar on ourselves yet again. by going head-to-head with Hemlibra with X 007. So I think we're yes, I think we are -- we remain confident that we've got a great product on the market and that we'll be bringing you the next generation here in the coming years. In terms of GAZYVA, I think that the drag on the oncology side, it's probably a little too soon to tell. I'll have that have a better look for you as we get into half year. it's sort of been just enough to kind of tamper down, I think, what we think the initial uptake is in the immunology side of things. So again, it's earlier days, so maybe give us to half year, and then we'll be able to give you a better sense.
Bruno Eschli
ExecutivesYes, I think it was launched in the fourth quarter.
Teresa Graham
ExecutivesExactly. It's just a little soon to actually see the data in the market, but that is a they're just starting to get uptake.
Bruno Eschli
ExecutivesOne more comment on the Hemlibra to situation. I think what has also been driving switching back is that just remember that Hemlibra doesn't cause any inhibitors. And I think this has been an issue constantly. Richard, any other questions? .
Richard Vosser
AnalystsNo, that's perfect.
Bruno Eschli
ExecutivesThen next one is Matthew Weston from UBS.
Matthew Weston
AnalystsBruno. Two questions, please, both on giredestrant. Teresa, you laid out the market at the very beginning in your introductory comments. I'd be intrigued to know what proportion of ESR1 mutant patients, you think already know their status. Because you talked about a strong launch, I can imagine it's even stronger in that late-line population only if they know whether they're ESR1 mutant. And then the second question on giredestrant is a much more overarching one. I don't know it's for outers or whether it's for Thomas, based on the numbers you've laid out, you have 1 of the most exciting launches coming up in the next couple of years. And historically, breast cancer has been a setting where ex U.S. and U.S. have actually been quite balanced in terms of peak sales potential. So given MFN, how are discussions ongoing with European governments about the idea of accepting higher prices? And do you think we're going to see a rapid rollout of giredestrant ex U.S. as well as U.S.
Teresa Graham
ExecutivesSo I would say that within breast cancer, testing in breast cancer is actually quite high. And so in the more mature markets, I would say that it is pretty common that people would know what their statuses are. And so therefore, I think that very much enables us with the strong launch. Thomas, do you want to take the cars do you want me to take it?
Thomas Schinecker
ExecutivesSure, I can do that. So on the U.S., we know that we'll be on the market towards the end of the year. So this is when we set the price in the U.S. But of course, we are already in discussions with politicians across Europe. And they do understand that there will be a change in terms of how these messiness will be priced in the future. And the good thing is it's not a one-step change because medicines that they already on the market are not going to be priced higher. It's just for new introductions. So it's not a very rapid and steep increase in terms of spending that they have on medicines. But I do believe what will happen is you will have more differentiation between those medicines that have extremely strong data and maybe medicines that don't have a strong dealer I think with your giredestrant being, I think, one of the first molecules we have, where we will go through this process, we're actually in a beneficial situation that we have very, very strong data. And especially the breast cancer space has also a lot of patient groups behind it that are very interested to get this to patients as quickly as possible. So we are hopeful that with all of that, that we will get it to a point where we can get the right kind of pricing also in Europe.
Bruno Eschli
ExecutivesVery good. Matthew, did this answer your questions?
Matthew Weston
AnalystsPerfect.
Bruno Eschli
ExecutivesYes. Then next question go to Stephen Scala from Cowen.
Steve Scala
AnalystsI have three brief questions. First, it sounds like Roche still has confidence in the Pioneer trial post failure Persevere. And I'm just wondering what is the basis for that confidence Second, why isn't Roche doing a cardiovascular risk-reduction study of its IL-6 assets following in the footsteps of its competition. And then lastly, Thomas, I don't believe you have opened the diagnostics meeting in the past. I'm curious why the change this year?
Teresa Graham
ExecutivesSo just to reiterate, though Persevere didn't reach statistical significance at PFS, we did see a numerical improvement. We do believe that it's active in the first-line setting. And the reason that we continue to have confidence for Persevere just being studied in a very different population than Persevere. And so again, in that first-line setting, context really does matter. And so we still believe that biologically, there's a very good rationale on why we work with within persevere, 20% to 25% of patients in that setting are mutated and Pioneer has enriched CER mutation patients to 40%. So again, we're sort of designed to really uncover that signal. In terms of the IL-6 assets, I don't assume that we haven't looked. So I'll say that. And I don't know who would like to take questions.
Thomas Schinecker
ExecutivesYes. The last one, I can Yes, I just want to also reiterate the reason for our higher confidence in pioneer is simply because it's enriched with the ESR1 mutant population. And if you look at the hazard ratio in past trials in this population, then you would understand, of course, why we have a higher chance on this one. And regarding the diagnostics, I did open Diagnostics Day before because I was the CEO of [indiscernible]. But it's the first time that I will actually open it when I'm not the CEO of Diagnostics. And the way Bruno and I discussed it is that I would go once to the former day, once the diode, once the farmer day so that I just sit back and forth. And every time I give you more of a group update and would be available for questions in that setting as well.
Bruno Eschli
ExecutivesYes. Very good. Steve, maybe one comment on cardiovascular diseases. You might be reminded that we have other modalities we are focusing on. For example, we highlighted [indiscernible] as one of our key targets, and we can imagine that we have also looked into IL6 in that context. Any other questions?
Steve Scala
AnalystsMay I assume since you've looked -- can we assume that you looked in the trials were not successful with?
Teresa Graham
ExecutivesI would -- all I'll say is just don't assume we haven't looked.
Bruno Eschli
ExecutivesOkay. Then we have next in the row, Michael Leuchten from Jefferies.
Michael Leuchten
AnalystsTwo questions. One question, one clarification. The FDA's increased level of disclosure seems to be triggering some petitions for label changes. And I think OCREVUS is one of them. I just wondered if you could talk to the process here, time lines. Is this something that you think is going to happen more broadly? And how long does it take to get some clarity on that? And then a clarification question for Teresa, please. Just going back to the comment on by U.S. returning to growth. The revenue sequentially are and so the 3% growth in Q1, it was 7% in Q4. So when you say returning to growth, what's the variable that you're looking at that a lead indicator that we're seeing that?
Teresa Graham
ExecutivesYes. So just speaking to Vabysmo first, I mean we saw a 4% increase in the U.S. But we saw a more significant volume increase. So again, this is a highly contracted market. So those things can sometimes look a little bit different. We're also seeing the unbranded use of [ Avastin ] start to trickle down. So that's another thing that kind of gives us confidence that the branded market may be coming back or is coming back. In terms of the FDA, I assume that you're talking about the letter that was published by the British Medical Journal, is that what you're referring to?
Michael Leuchten
AnalystsYes, that's correct.
Teresa Graham
ExecutivesOn PPS. Yes. So I just want to be really clear that OCREVUS and PPMS has been used in 450,000 patients it was approved. We have 1.4 million patient years of exposure. We are approved in 130 countries, this is an approval that KOLs and patients in the FDA are not questioning. We believe strongly in the benefit and the safety of OCREVUS in the PPMS population that was reinforced with the OHAN study, which was just released September of last year, which is not at all mentioned in the letter that you're referring to. So I think we have an incredible level of confidence in the benefit and the safety of OCREVUS and PPMS. And I will leave it there.
Bruno Eschli
ExecutivesMaybe just, Michael, one add-on the Vabysmo side, how are we tracking our performance. I think if we just zoom in on the branded segment and exclude will biosimilars which are in the market, then I think we still keep gaining shares in all the indications, and that's a picture, I think you can see globally. And the run rate of share gains versus the other branded competitor in the market, I think, is very constant quarter-over-quarter. So I think, therefore, I think we are reasonably confident.
Teresa Graham
ExecutivesExactly correct. And that is, by the way, we continue to hear every time we pull KOLs that hands down Vabysmo is seen as the most efficacious drug that they have in their armamentarium.
Bruno Eschli
ExecutivesAny other questions, Michael? Yes. Then we come to the final questions, which go to Rajesh Kumar from HSBC.
Rajesh Kumar
AnalystsA couple of questions, if I may. First is on breast cancer opportunity, obviously, a very exciting opportunity for you on [indiscernible] oncology portfolio, looks a bit light on the pipeline side. Would you think -- or talk us through how you're thinking about capital allocation to augment your oncology portfolio going forward. Definitely interested in understanding if you need to add something more there to utilize your strong position in the market? Second is on the obesity clinical trials. What we have seen more recently is the patient churn increases once patients work out, they are not on an active arm. And when you're thinking of your Phase III trials, would you consider running active control trials for registrational purposes to ensure patient churn is not very hot, and you have credible data? Or have you found a work around that would be very interested in hearing your thoughts. And as always, being an analyst who can't count, the third question is I totally appreciate your excitement around enemies. If you can help us understand where in the financials will we start seeing the benefit of AI? Would it be in R&D intensity, SG&A intensity in the next 3 to 5 years? That would be much appreciated. Okay. Do you want me to start?
Thomas Schinecker
ExecutivesYes, sure. So first, let me start on the capital allocation. We have the five therapeutic areas that we're active in, and we continue to look for opportunities in all of those therapeutic areas that fits in terms of from a scientific perspective, we believe that it can be a medicine that could be best-in-class or first-in-class. At the same time, we also look at the financials. And the two things have to come together. We want to make sure that we are not in a situation that we overpay for some of these assets. And I think the combination is very important. And especially in oncology, what we have seen sometimes is that there has been quite large amounts of money being paid for very, very early stage assets. So we keep working on that. We brought in CDKs, we brought in a number of different ADCs. So you see we keep evolving also our oncology pipeline, but we are also disciplined, right? And the reason is there's just many more opportunities than money. So there -- if you don't get an opportunity where you pay a couple of billion, I can tell you, you will get another opportunity that may be as good or even better for less money. And so you need to keep looking. But what I can say is we look at everything. So everything that goes across the table, I can tell you we've looked at it, and we've made our own assessment on that. On AI. So we believe that AI will really impact us across actually all of our cost lines. So we already utilize AI in manufacturing, we use AI to really reshape processes in our organization, where we take processes that in the past will take maybe months, we try to limit that to weeks or even days. And we've seen that also across the entire R&D spectrum. So this is more, I would say, manual work that people have done in the past where we can really automate that in a very -- in a much better way. So you can really start to see that happening across the organization. And that's why I believe it's going to happen ever. It's going to happen or it is happening also on the commercial side. Where the big disruptive opportunity is, I believe, in AI is to really change on how fast we do drug development and also how many molecules we can screen. With these virtual molecules, you can screen through many more molecules, then you look deep into some of those, you test them in the wet lab, you feed back the data. And this is what we call lab in the loop. And so you can really continuously build up these models and these are proprietary models. It's not something that other companies have and where we believe we're quite far ahead compared to other companies. And as we continue to build these models, you will see increasing benefit over time. But from a process perspective, you already see some of the benefit in the organization and we'll continue to see more benefit. In fact, we've trained 100,000 people on AI. It's something we call every day. We've trained everyone using the tools. And feedback has been really amazing. People can really see the productivity benefits in the daily work.
Alan Hippe
ExecutivesYes. Let me quickly add here. We also -- how should I say it, we are investing heavily into our data infrastructure anyway. I think really, we have a huge ERP program running. And why do I say this? Because that will facilitate the use FII moving forward. As we will have the whole data in the cloud that we can really tap into this much more easily than we could in the past.
Teresa Graham
ExecutivesAnd to answer your final question, as I indicated earlier, placebo-controlled trials are still mandated by the FDA. That is why we run them. obviously, for anybody running large placebo-controlled trials, patient retention is quite key. We have a number of -- we have a broad suite of patient retention, tools and strategies to design to help keep patients in the CT-388 studies and for obvious competitive reasons, I won't say more.
Bruno Eschli
ExecutivesI think we had a third question, which was, is our next M&A deal and oncology deal?
Unknown Executive
ExecutivesI think I trust translated this bit question. No problem at...
Alan Hippe
ExecutivesDon't know what our next deal is. We will find out yes. But -- are we looking for opportunities, Thomas said it, Happy to do that. But you know how that is, it takes two to tango. And the question is, who will be our next partner do a great deal.
Bruno Eschli
ExecutivesSo we're looking at all therapeutic areas. Yes. With that, I think we have closed the Q&A session. I hand back to Thomas for the final words.
Thomas Schinecker
ExecutivesYes. Thank you very much for attending today's call. As you can see, we have continued strong sales momentum as we had over the last couple of years. And based on some recent readouts that we have seen, this gives us much more confidence also in the short to midterm that we can continue good growth outlook there as well. And you have also seen that we have between '27 and '30, the opportunity to launch up to 19 MMEs. That status today. We continue to work M&A so that we can increase the number in that time period, but this is really substantial, and many of those have a lot of value attached to them. So that also gives us confidence in the longer-term growth outlook of the company. All I can say is you can count on us, and we will deliver.
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