That understand only mode during the call. After the presentation, there will be a question-and-answer session. You're invited to send in questions for this throughout the entire session using the Q&A functionality of Zoom. In addition to that, you may also raise your virtual hand to address your questions verbally. For participants joining via phone, to raise your hand, use star nine on your phone's dial pad. When you then get selected to ask your questions, please follow the instructions from the phone and press star six to unmute yourself. One last remark: if you'd like to follow the presented slides on your end 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 of Roche Group. Mr. Schinecker, the stage is yours.
Thank you very much, and I'm happy to share our Q1 2025 sales with you today. Now, let's look at our performance. We had really a good start in 2025 with group sales growing 6%, and this was driven by pharma, with, again, very strong sales growth of 8%. You can see that we continue our very strong momentum on the pharma side. Diagnostics was flat, and this was due to healthcare pricing reforms in China. Matt will cover that. This did not only impact us; it impacted the entire industry, and this is something that we had flagged also at the full-year results presentation in January. The LOE impact was also in line with guidance. Now let's look at the key milestones in Q1.
On the pharma regulatory side, we had EU approval of Columvi, plus GemOx in second -line DLBCL, and this is based on the very strong phase III STARGLO data, and it's the first and only bispecific with an EU approval in second line DLBCL. We also had the U.S. approval of Susvimo in DME, so the second indication, and TNKase in acute ischemic stroke. We have the filing in the U.S. and in the EU for Gazvya in lupus nephritis, and this is based on the positive phase III REGENCY data, which was presented at WCN and is also published in the New England Journal of Medicine. We had the filing in the EU for Lunsumio in third line follicular lymphoma. We've had a number of positive phase III readouts.
Let me highlight the SUNMO phase III readouts from Lunsumio and Polivy in second- line DLBCL, and we are now excited to move now our second bispecific into chemo-free combination with Polivy into early line of treatment of DLBCL. More information on the positive outcome will be shared later in this year at a medical conference. We've also taken a number of phase III decisions. As we mentioned at the full-year call, we said there are potentially seven NMEs that could move into phase III, which would be a record in terms of how many NMEs we move into late stage, and these are all based on the Bar criteria. In Q1, we did make two decisions to move two of them into the last stage of development into phase III based on the latest data, trontinemab being one of them in Alzheimer's disease.
The positive data was shared at ADPD , and phase III is expected to start later this year. The second one is NXT007 in hemophilia A, and the phase II data for this will be presented later in this year. We also had a very exciting business development deal, this collaboration with Zealand Pharma on petrelintide, the leading long-acting amylin, and there will be more on this in a couple of slides from myself, but also Teresa will share more information on this. On the Diagnostics side, we had menu expansion on the cobas liat, so our point of care PCR system with lab-like performance with CT/NG really building out our menu specifically here on STI, and we continue to place more of these systems in the market.
Also, very excitingly, we had the unveiling of a novel SBX sequencing technology, so sequencing by expansion, and I will also provide a little bit more context as well as Matt will provide more context. We shared real-world and live experience of customers here at the AGBT. We have significant new flow upcoming in 2025 for both pharma and diagnostics, and Teresa and Matt will go into more granularity here. Clearly, there are a number of phase III readouts coming, including multiple NMEs that could lead to launches next year across oncology with giredestrant, neurology with fenebrutinib, immunology, astegolimab, and ophthalmology with vamikibart. Equally, we still have a number of phase III enabling readouts coming, which could enable us to move another five molecules into phase III, again keeping to the Bar criteria.
Diagnostics is looking forward to several key launches still in 2025, including the Elecsys pTau 181 and the high-sensitive troponin T next-generation assays. Now, let's move on and let's take a closer look. We've had strong sales of 8% on the pharma side, so continuously very strong momentum. Diagnostics is flat, and I already mentioned that this was driven by healthcare pricing reforms in China, not only impacting us, but the entire industry. Now, I used to have a favorite slide, and I have a new favorite slide, which is this one, which really shows that over the last four quarters, we've had a significant growth of 8% across our entire business. If you go back until 2023, we really had an underlying growth of 8% consistently. We have consistently performed very strongly over the last two years and one quarter.
This is a strong pickup in our growth versus the 2020 to 2022 timeframe. Now, let me go to the key growth drivers, and I will start at the right top. Perjeta/Phesgo conversion is now at 47%. Both of our, on the hemophilia side, or hematology side, both of our CD20, CD3 bispecifics are advancing now into second line DLBCL, and this is increasingly increasing our opportunity significantly. Columvi, GemOx receiving EU approval, and the positive phase III results from SUNMO. NXT007 moving into phase III, as already mentioned. On the neurology side, very importantly, Zunovo received the permanent J-Code granted on 1st of April, so we should definitely see a pickup here. As mentioned before, we do believe that the subcutaneous version of Ocrevus will add CHF 2 billion incremental sales, and right now the consensus is at about CHF 8.5 billion.
We feel very comfortable with that consensus, and the CHF 2 billion incremental will obviously be, there will be more sales for the subcutaneous version, but there will also be some switches. Evrysdi receiving U.S. approval for tablet formulation, and Xolair still doing extremely well with now more than 50,000 patients on treatment. Vabysmo keeps expanding market share in all approved indications, and Teresa will talk about that as well, and she will also talk about the market contraction in the branded segment because of less funding for co-pay assistance foundations. We keep seeing very strong momentum, as you can see here with 17%, or I think Vabysmo is 18% growth, and we do believe that we can continue this kind of momentum going forward. Diagnostics, I've already mentioned as well. Now, the young portfolio continues to drive growth in the near to midterm.
If you look at the right-hand side, now the young portfolio accounts for 59% of our sales, up from 55% the year earlier. We have four pivotal NME readouts for new NMEs, as I mentioned also before, astegolimab in COPD, vamikibart in UME, giredestrant in breast cancer, and fenebrutinib in multiple sclerosis. We do believe that this new portfolio will continue to drive growth at least until 2028, and we know that diagnostics will continue to contribute positively in terms of growth, especially with the new products, and all positive readouts that we should expect over the next years will then add to this growth. We do not have a cliff situation, and with that, we are at a more favorable starting position than many of our peers. Now, let me just highlight a couple of things on the recent announcement that we have made of our investment in the U.S.
We have a strong legacy of partnership with 130 countries around the world. We basically have the full value chain present in most of our key markets, such as the U.S., in Europe with Germany, Switzerland, Japan, and China. It has always been our strategy to build out a full value chain in each of these markets to be present where the patients are. Key parts of this legacy of investment is also our research and development and manufacturing footprint in the United States. Now, Tuesday's announcement to invest a further CHF 50 billion into R&D and PP&E in the U.S. until the end of the decade, let me put that into a bit of context. This would be almost a doubling of our investment in the U.S. over the next five years compared to the previous 10 years where we invested CHF 67 billion in R&D and PP&E.
Let me also say this does not mean that we change what we've said before in terms of CapEx availability between CHF 3 billion and CHF 4 billion annually. This is already included in any of these comments that we've made in the past. It also doesn't change what we've said in the past in terms of R&D spending. You can expect R&D to be flat this year and that we keep very disciplined when it comes to our spending. Currently, we have 13 manufacturing and 15 R&D sites in the U.S. across pharma and diagnostics, and we are planning to add two new sites. First is this announcement of investments, including the construction of a new R&D site in Boston. We've discussed this as a team that we have a very strong presence on the West Coast in terms of R&D, but we didn't have a presence on the East Coast.
We strategically said we wanted to tap into the ecosystem in the Boston area, which is, I would say, next to San Diego and San Francisco, the third key ecosystem that we want to be present in. That is why we have committed to make an investment here and also in collaboration with Harvard. There is also one new manufacturing site that we will establish in the U.S. where we have been in negotiations with different states in the U.S. We have not named the location yet, but we will do that soon. This is basically also for the manufacturing of peptides, so the incretins and also the amylin. Both of our new sites will have a strong focus on CVRM.
Let me also highlight that we are probably in a much better position than most other companies in terms of our manufacturing capacity that already exists in the United States. Our drug substance capacity utilization is at 50%, which truly gives us a lot of flexibility to adjust our manufacturing volumes. This is due to the fact that, and you can see it on the right-hand side, that we've driven a five-fold productivity increase in terms of yields from our cell lines. What that enabled us to do is actually some of our medicines that we already produced in the United States, we could increase the manufacturing in the United States basically overnight of these medicines.
The only remaining medicine that we have to tackle when it comes to tariffs is one that's currently not being produced or produced in the U.S., and we already started the tech transfer of this medicine a number of weeks ago. Let me also highlight that when we acquired Genentech, not only did we keep manufacturing there, so we didn't move to Ireland, for example, we also kept our IP there, and with that, we've been a significant taxpayer in the U.S. Again, I would just highlight here, we're probably in a better position than many others.
Taken together, I do believe this sets a stage for our next era of growth and innovation for us as a company to benefit patients in the U.S. and abroad, but I also just want to reiterate, we'll also continue to invest in countries like China where we're also expanding our manufacturing footprint. Now let's move to the outlook, and I want to highlight two areas. One is Roche sequencing, and the other one is our efforts around CVRM. I know both Matt and Teresa will go into more details on this. At AGBT, we unveiled our novel sequencing solution, which combines our high-throughput sensor module that we developed over the last years. Now comes the secret sauce. That's the SBX chemistry, the sequencing by expansion chemistry, which actually expands the DNA 50x so that you get a better signal-to-noise ratio.
With that, you increase the accuracy significantly, and you increase the speed and throughput because you do not actually need to slow down this molecule as it goes through the pore. It goes through very quick, and you get a very clear and clean signal. With that, we have a very high accuracy, which is fit for clinical applications. We are extremely fast, and we have a lot of throughput. What also is unique is the flexibility because with technologies that are used today, you have to run a full plate to get the benefit of the price and cost. You do not have to do that with this technology. We do believe that we are in a pretty good position here as well. Let me talk about our commitment to become a leader in CVRM.
In pharma, we now have a broad portfolio of differentiated assets that address unmet needs in obesity, diabetes, and a number of adjacent indications. Let me just highlight there are probably more than 200 comorbidities that are linked to obesity. The GLP-1, GIP from the Carmot acquisition, and also in Q1, we announced a collaboration with Zealand Pharma to develop petrelintide, a long-acting amylin analog. I know Teresa will go into that detail. Also, in Q1, we announced our plan to build a Boston Innovation Center in partnership with Harvard, and this will be focused on CVRM drug discovery and development. On the diagnostic side, again, let me highlight this. We are the global leader in this space. We know all of the key opinion leaders. We have the leading portfolio of cardiac and metabolic markers. We develop holistic solutions for the management of diabetes and cardiac indications.
This includes CGM that offers unique smart algorithms and easy one-step application. I know that both Matt and Teresa will cover more here. Let me just highlight here on the 2025 pipeline for pharma, the positive news flow and also the negative news flow. In green, you see the positive, and in red, the negative. On the negative side, let me just highlight SKYSCRAPER- 07 in ESCC, which missed its primary endpoint. I also want to highlight that when SKY-06 failed middle of last year, we stopped all of the tiragolumab studies that were still in progress and could be stopped, as we mentioned at the time in this investor call, and we only let the ones run where it was not appropriate to stop these trials anymore.
On Ocrevus high dose, which missed its primary endpoint, again, I just want to say we're comfortable with the Ocrevus consensus where it is right now, which includes the CHF 2 billion incremental sales, which are driven in the combination of a subcut and IV. Let me also say that we don't see a cliff situation also for Ocrevus beyond the end of the decade because of Ocrevus subcuts and Ocrevus high concentration, which you see in green here as well.
On the positive side, again, I just want to mention trontinemab and NXT007 moving into phase III, Columvi with the EU approval, Lunsumio with the positive phase III readout in second line DLBCL, obesity for GYM 329, where we are starting a phase II combination with incretins and atopic dermatitis and MASH, two new indications for vamikibart, DMD for Enspryng, and the high concentration Ocrevus that I mentioned. Let me just close by saying that we confirm the 2025 guidance. As you can see on this slide, sales growing mid-single digit, core EPS growing high single digit, and dividends to further increase. With that, thank you very much, and I hand over to Alan to take us through the finance slides.
Yeah, thanks, Thomas. Yeah, as everybody knows, a sales call today. I hope everybody's well. So my contribution will be brief today.
Yeah, let me jump into the sales. What you see here, the reported sales in Swiss francs quarter one 2024 compared to quarter one 2025. In total, a 7% increase. Let me start with the highlighted 6% in constant currencies. You see we have different factors here. I think one element is really here on the diagnostic side. You see the China healthcare pricing reform that Thomas has mentioned already, which was a reduction for sales on diagnostics. On the other hand, excluding China, they've grown by roughly 5%, which I think is quite an achievement. Matt will dive into this. You see on the pharma side, I think really good underlying growth. As expected, the loss of exclusivity impact with a certain erosion in Q1. As you know, we expect more erosion for Actemra in the quarters to come.
Still, we stick to our expectations that we're going to lose CHF 1.2 billion in that segment over the year. You see currency is a positive in Q1, translating into Swiss francs. Get to the + 7%, and I will dig into that, but let me say enjoy the moment. When you look really then at the exchange rate impact here on the sales growth, and that is the 6% on the left-hand side in constant rates that you know already. It's now 6.4% as we added the decimal. You see on the right-hand side in Swiss francs, a 7.2% growth. You see really the currency fluctuations in between, and you see a major contributor to the performance has been the U.S. dollar, which has strengthened in that period.
We all know what happened in April, and I will talk about that in the next slide, and here it is. Because as you know, what we do is we keep all the currencies stable at the end of Q1 and then basically project them until the certain quarters, but also until the end of the year, and then measure the impact and announce that here. Let me see, I'll say one thing after end of March, as mentioned, I think we have seen a major volatility and a major weakening of the U.S. dollar. I will get to that. When you really look at full year 2025 impact as of April 23, so really recently, and you assume all these currency rates remain stable until the end of 2025, we will have a currency impact at full year on group sales of minus five percentage points.
Quite significant, but as said, we're also not alone. I think other companies will be affected by this as well. I know it is of interest what that means for core operating profit and for core EPS. Let me give you these projections, which are certainly highly speculative and very unlikely that they will really realize. For core operating profit full year, it would mean a minus seven percentage points and on core EPS, an impact of minus eight percentage points. That's quite significant. As I've said, you see Q1, enjoy the moment. I think for the next quarters to come, if the currencies stay where they are basically today, I think we will see a much worsened picture. Good. I think Thomas said everything about the guidance. I don't want to just reiterate here that we confirm the guidance for 2025. With that, happy to move over to Teresa.
Great. Thank you, Alan. In Q1, pharma delivered CHF 11.9 billion in sales with an 8% growth at constant exchange rates. You see the U.S., Europe, and international all delivered strong growth with 6%, 5%, and 18% respectively. Japan is now returning to growth with a 3%, up 3% in Q1. Overall, pharma volumes were up by 13% in Q1. Let's kick things off with a look at the sales growth across the pharma portfolio. Please note that all absolute values and year-over-year growth rates are presented in Swiss francs at constant exchange rates. As Thomas mentioned, our young portfolio continues to deliver strong growth led by the key brands, Phesgo, Vabysmo, Hemlibra, Polivy, Ocrevus. Together, these added CHF 700 million of new sales at constant exchange rates in Q1.
For the first time, Phesgo is our number one growth driver, and that's thanks to the very strong performance in our international region. Now let's take a closer look at our key therapeutic areas, starting with oncology. Oncology sales increased by 2% to CHF 3.9 billion in Q1. This growth was primarily driven by the HER2 franchise. Phesgo continues to impress with incredibly strong 52% growth in Q1. The global conversion rate continues to climb. We're now at 47% across our 58 launched countries, with the growth in China accelerating noticeably following the NRDL listing earlier this year. Perjeta conversion to Phesgo is ongoing, and we are looking forward to sharing the final APHINITY analysis, which is that 11-year follow-up at an upcoming conference this year. Kadcyla continues to deliver good growth driven by uptake in the adjuvant setting.
Switching gears over to Tecentriq, sales in the first quarter remained stable. As we mentioned at full year, we believe Tecentriq is close to peak with limited to no growth going forward. The U.S. launch of Itovebi is continuing as planned, and we are expecting EU approval later this year. Looking ahead through the end of 2025, we have two highly anticipated phase III readouts for giredestrant, with evERA and persevERA expected in the second half. Additionally, we are looking forward to initiating our phase III trial of divarasib, our KRAS inhibitor on top of standard of care in first-line non-small cell. Now let's move on to hematology. Hematology growth remains strong, starting the year with 14% growth, CHF 2.1 billion in sales. Hemlibra showed strong growth momentum across all patient segments.
As expected, the U.S. Q1 year-over-year sales were flat, and that follows the very strong growth we saw in Q4. We had 20% growth in Q4 in the U.S., and that was impacted by a buying pattern from one of our largest distributors. We sort of expected this and signaled it as we head into, as we signaled it at full year. Ex-U.S., however, we saw very strong growth in Q1 with the international markets growing 72% and the EU markets growing 7%. Basically, all countries contributed across those regions. For a full year, we are confirming the ambition of mid-single digit global sales growth for Hemlibra. There is also some exciting news on our next generation bispecific in hemophilia, NXT007, which I will cover in the coming slide. For now, let's move on to our malignant hematology portfolio.
Polivy, first-line DLBCL continues to drive strong growth, and we've reached yet another milestone with more than 50,000 patients treated globally. U.S. first-line DLBCL patient share continues to climb. We're now at 31%, and we are looking forward to presenting the updated phase III POLARGO data in relapsing remitting DLBCL in an upcoming medical conference at mid-year. Columvi and Lunsumio, our CD20, CD3 bispecifics, launch performance is on track for both in their lead indications, third-line plus DLBCL for Columvi and third-line plus follicular for Lunsumio. We expect to achieve the combined peak sales potential of CHF 700 million in those initial indications, which are relatively small. I do want to highlight that both of these bispecifics are making good progress to move into earlier lines of treatment and therefore bigger markets, specifically those first moves into second-line DLBCL.
As Thomas mentioned, Columvi recently achieved EU approval based on STARGLO, which demonstrated an OS benefit with a hazard ratio of 0.59, making it the first and only bispecific in the EU approved in second-line DLBCL. In the U.S., we are still expecting FDA approval around mid-year. As mentioned before, we're also excited about the positive phase III SUNMO data for Lunsumio and Polivy in second-line plus DLBCL, which offers patients another chemo-free treatment option, and we are looking forward to sharing that full dataset with you in the near future. Staying with Lunsumio, there is quite the rich outlook in 2025 for hematology. We have the U.S. PDUFA, as Thomas mentioned, for the subcutaneous formulation of Lunsumio in third-line follicular, and that is set for September 22nd. We are also expecting the phase III CELESTIMO readout in second-line follicular later this year as well.
Additionally, we are expecting phase III readouts for Venclexta in first-line MDS and PiaSky in aHUS. As promised, let's take a look at NXT007. Certainly, the key news here is that we are moving NXT007 into phase III trials. This is the next generation Factor VIII bispecific monoclonal antibody that we have in development with Chugai. Pre-clinical results indicate that it has the potential to achieve zero treated bleeds for hemophilia A patients without the need for additional Factor VIII treatment. We've mentioned before that NXT007 is 30 x more potent than Hemlibra, and we believe that this really could be a game changer for hemophilia patients. As aforementioned, we are moving into phase III. We are launching three phase III trials this year, including one head-to-head with Hemlibra.
I think this gives you a very good sense of our excitement for NXT007. Quite frankly, it really only makes sense to be including Hemlibra, which is the standard of care, as the comparator for any new trials in hemophilia A. All of these trials are expected to initiate in 2026, and we are also exploring device options. Phase II data for NXT007 will be shared in an upcoming medical congress and as covered as part of the IR event on June 23rd. Up next, let's head over to our neurology franchise. Neurology continues to deliver strong growth of 10% at constant exchange rates, achieving CHF 2.4 billion in sales. Ocrevus growth momentum remains strong at 6% globally. A lot has happened with Ocrevus in Q1, so let's delve a little bit deeper into the Q1 news flow.
As you know, the permanent J-code for Ocrevus Zunovo , our subcue formulation, was granted on April 1st in the U.S. We believe that this will lead to an acceleration of U.S. uptake, particularly in the second half of the year. The early market response has been very positive, and we know that some practices were not only actively waiting for the permanent J-code, but were also deciding against adding additional infusion shares in favor of starting on or switching patients over to Ocrevus Zu novo. Importantly, based on internal patient claims data, we see that about 50% of Zu novo patient starts are naive to Ocrevus. That continues to give us confidence that this new formulation will open up new patient populations to Ocrevus and not simply cannibalize existing share. Of course, in Q1, we also shared the negative Ocrevus high-dose readout in RMS.
While disappointing, I think it is important to remember why we ran this trial. The purpose of the high-dose trial was really to understand if patients would experience greater efficacy with a higher dose of Ocrevus. While this trial did not meet its primary endpoint, the results clearly support Ocrevus standard dose as the optimal dose to slow disability progression. This is actually great news for patients. Now that we have the answer to what is the optimal dose of Ocrevus, we are quickly moving forward with the development of a novel subcutaneous formulation that has a higher protein concentration, which will significantly reduce injection volume, which allows us to move into a more convenient on-body device with the goal of bringing Ocrevus closer to home.
More on this exciting development will be shared at a later stage, but we are moving with urgency into this next phase of the life cycle for Ocrevus. In the meantime, Ocrevus franchise modeling remains largely unchanged. We predict the franchise to peak at the end of the decade and do not expect, as Thomas mentioned, an abrupt cliff situation due to Ocrevus subcut providing some level of protection to the franchise. For 2025, we continue to expect high single-digit global sales growth, and we continue to be comfortable with the Ocrevus consensus peak sales of CHF 8.5 billion, including the CHF 2 billion incremental sales opportunity for Ocrevus subcut. Moving on to Evrysdi. Evrysdi continues to deliver strong growth, and we expect the full-year growth rate to be at roughly the same level as the 18% that we achieved in Q1.
The tablet formulation received its U.S. approval in February, which offers patients a simplified storage option, eliminating the need for cold chain and easing administration. EU approval is expected before mid-year for the tablet. The early launch momentum for Elevidys and DMD continues to be strong in ex-U.S. and ex-EU countries with CHF 43 million in sales in Q1. We were profoundly saddened that a young man with Duchenne's passed away following treatment with Elevidys, having suffered acute liver failure. Following this event, ongoing studies were put on temporary clinical hold by EU regulators. Roche and Sarepta are focused on doing what is most important for patients, and patient safety is always our paramount concern.
Based on the totality of data, however, we do remain confident in the efficacy and safety profile of Elevidys, and we are not changing forecast guidance at this time, and we will work with EU regulators to minimize any potential delays to the program. Trontinemab in Alzheimer's, we presented the more mature phase I two dataset at ADPD, and more on that on the next slide. Importantly, we have made the decision to move trontinemab into phase III and look forward to initiating that trial later this year. On the outlook for Neuro, we expect a steady news flow through the end of the year. The phase III readouts for fenebrutinib in RMS and PPMS are expected at the end of the year, and there are two phase II readouts for GYM 329 expected in 2025, one in combination with Evrysdi and SMA, and one as monotherapy in FSHD.
Before we leave Neuro, let's take a closer look at the two molecules we highlighted at the recent ADPD conference, tronti and prasinezumab. Starting with tronti, as we mentioned, we presented updated data from our phase I to Brainshuttle trial of tronti in Alzheimer's, and you can see that that rapid and deep amyloid clearance continued to be achieved at different doses. Importantly, 81% of patients on the 3.6 mg per kg dose achieved amyloid PET negativity within just 28 weeks. At the same time, the safety and tolerability profile remained very favorable. ARIA E and ARIA H rates were below 5% across the 114 patients treated in parts one and two.
Based on these very positive results, we've decided to move tronti forward into phase III with the trial start planned for later this year, and we would expect final readout of that phase III trial in 2028. Now let's briefly move on to Parkinson's. At ADPD, we presented the phase II- B PADOVA data. Despite missing the primary endpoint, the results show a delay of confirmed motor progression in PD, especially in L-DOPA treated patients. We are waiting for additional data from the ongoing label extension, and with the benefit of that additional data and in close alignment with regulators, next steps for prasi will be decided around mid-year. Just to remind everyone, we continue to see prasi as a high-risk, high-reward opportunity. Now let's continue on to immunology. Our immunology franchise achieved CHF 1.6 billion in sales and grew 8% at constant exchange rates.
This growth was primarily driven by Xolair and its strong launch trajectory in food allergy. Xolair's benefit in food allergy was further confirmed by positive updated data from OUtMATCH, which showed that Xolair is more effective and has fewer side effects than oral immunotherapy for treating food allergy. For the full year, we expect growth in the mid-teens for Xolair. As a reminder, we do not expect any biosimilar launches in 2025. Actemra saw a minor decline of 1% due to biosimilar impact. U.S. biosimilar launches continue to be slower than we expected, while EU biosimilar penetration is increasing as planned. We anticipate that the overall biosimilar impact will accelerate in the second half of this year. As Alan mentioned, we are confirming that 1.2% biosimilar impact for the full year across the portfolio.
More on Gazvya on the next slide, but let me just mention here that the positive REGENCY results were recently published in the NEJM. Our TL1A program had quite the busy start to the year. First and foremost, we have finally received our INN just last week, and so we are now officially known as afimkibart. We also started trials in three indications, all of them achieving FPI in Q1, phase III in Crohn's disease, a phase II in atopic dermatitis, and a phase I in MASH. Further indications are currently being evaluated. Afimki is one of our internal fast-track molecules where we work across all levels of the organization to ensure development at speed. This is a direct outcome of our R&D excellence work, and afimki is one of the programs where you can really see the impact of that.
Considering the outlook for the rest of the year in immunology, we have phase III trials for Gazvya in SLE, and astegolimab in COPD expected to read out. For astegolimab, as a reminder, we continue to see this as a high-risk, high-reward opportunity. Now let's take a closer look at Gazvya in lupus. We shared the positive REGENCY results at the WCN conference in February. Gazvya demonstrated a superiority over the standard of care with a clear benefit and complete renal response. Safety was in line with the very well-characterized profile of Gazvya with no new safety signals, and the U.S. PDUFA has been set for October, and EU filing has been completed. Phase III readouts for additional indications are expected in 2025, ALLEGORY in SLE, and INShore in INS. Obviously, the MN trial is ongoing. Moving on to ophthalmology.
Ophthalmology grew by 17% in Q1, achieving CHF 1.1 billion in sales. Vabysmo is now the most prescribed treatment in nAMD in the U.S. Market shares in the U.S. continue to expand with nAMD now at 33%. That's up 3%, DME up 2%, and RVO up 3%. This is also true for ex-U.S. launch countries where we continue to see market share increases across all indications. Additionally, the share of treatment naive patients starting for Vabysmo in the U.S. is now approaching 60%. I think this further confirms Vabysmo's positioning as a first-line treatment. As Thomas mentioned, at the same time, U.S. sales were impacted by a contraction of the U.S. branded market, and this is primarily caused by funding shortfalls from the Copay Assistance Foundations.
This dynamic in the U.S. is likely to persist, and the overall impact of that constriction will likely take several quarters to wash out. Outside the U.S., we see very strong uptake. EU conversion to the recently launched PFS is rapidly increasing. It's already at greater than 70% in all the markets where it's available, and the China launch accelerated markedly after achieving NRDL listing in January for all three indications. Taken all together, we still expect roughly 20% sales growth globally for Vabysmo this year, but we do have to caveat that there is a difficult-to-predict development or that it is sort of difficult to predict how the U.S. branded market will develop in the coming months. Some good news for Susvimo. U.S. approval in DME was achieved, and EU filing for nAMD is expected later this year.
Similarly, we expect data for our IL-6, vamikibart in UME, later in 2025. Wrapping up our tour of the therapeutic areas with a quick look into our CVRM franchise. Like Thomas, I am very excited about our recently announced collaboration with Zealand to partner on petrelintide in obesity. Together with Zealand, we believe that monotherapy petrelintide has the potential to become a foundational therapy in weight management with improved tolerability and a mode of action differentiated from GLP-1s, as amylin work by increasing that feeling of satiation, while GLPs work by reducing hunger. Petrelintide's favorable physiochemical properties will allow for easier co-formulation and co-administration with other peptides. Thus, in addition to just exploring as a monotherapy, we are also exploring different combination opportunities starting with a fixed dose combination of petrelintide and CT-388.
Our belief in the best of class potential is also based on the strong phase I results shown here. Placebo-adjusted weight loss of up to 6.9% was achieved at 16 weeks, and at the same time, safety and tolerability were quite favorable, with the vast majority of treatment emergent adverse events reported as mild. A phase II in obesity without type 2 diabetes is currently ongoing. The Zealand collaboration very nicely complements our existing obesity and diabetes portfolio, and we see great potential for monotherapies and combinations to address the various unmet needs in obesity, diabetes, and the linked comorbidities. We are making very good progress with multiple molecules expected to advance in 2025. It is quite a list. The interim data for CT-388 in obesity will become available this year and will inform our phase III go decision in the second half.
I did want to reiterate what we shared at half year, that we only plan to share the final phase II results for this study, which are expected in early 2026. We will, however, announce a phase III decision once it is taken. Data for CT-868 phase II in type 1 diabetes with overweight and obesity is also expected this year. Our phase II trial for CT-996, our oral, will also begin this year, as will our phase I for CT-173, our PYY in obesity, and the phase II trial for GYM 329 plus a GLP-1 in obesity. For 2026, as I mentioned, we expect the CT-388 plus petrelintide phase II study to be initiated. As Thomas mentioned earlier, Roche is committed to becoming a leader in CVRM, and the scope and speed at which we are expanding and developing our portfolio, I think really underscore this.
To close my section, let's look at the key news flow side. We've added quite a number of checkmarks since we last showed you the slide at the full year presentation. I won't go through them in detail since we covered most already. Just a quick run-through. Columvi received EU approval in second-line DLBCL. Gazvya completed U.S. and EU filing in lupus nephritis. Susvimo achieved U.S. approval in DME. Lunsumio with positive phase III results in second-line DLBCL. NXT007 in hemophilia A and trontinemab in Alzheimer's are both moving into phase III. As Thomas mentioned, TNKase achieved U.S. approval in acute ischemic stroke.
Of course, we also had to add a red cross for the Ocrevus high-dose study in RMS with the GAVOTTE trial in PPMS still ongoing, but of course, our hopes for a positive trial in that indication are diminished somewhat with the result that we saw with MUSETTE. That is all for me, and I have the pleasure of passing it over to Matt to cover diagnostics.
Thanks very much, Teresa. Good morning, good afternoon, everyone. It's my pleasure to present the Q1 2025 Diagnostics Division sales results. As you heard already from Alan and Thomas, with sales of CHF 3.5 billion, the Diagnostics Division sales were stable versus Q1 2024. This was really driven by the healthcare pricing reforms and volume-based procurement in China. As Alan mentioned, excluding China, the growth of the business was + 5%.
Let me walk you through that on a customer area level. Sales in our core lab decreased at -1%. This is really impacted by the reimbursement reductions and the VBP in China. This resulted in a decrease of immunodiagnostics by 3%, which was partially offset by 4% growth of our clinical chemistry business. Excluding China, core lab grew at 8%. Sales in our molecular lab increased at +2%, and this is due to strong growth in our blood screening segment at +6%, but this was offset by a -5% in our infectious disease business. This infectious disease decline was driven by a decrease in our HIV business in Africa. This is a result of the USAID funding pause for testing.
Now, excluding this effect, molecular lab grew at + 6%, and we are optimistic that the USAID pause will end and that this business will resume. We will keep you updated in the coming quarters. Now, sales in our near-patient care business decreased at minus 5%. This is mainly driven by the decline of our blood glucose monitoring business at minus 7% due to the market shift to continuous glucose monitoring. This was partially offset by a healthy + 6% growth of our molecular point of care liat business. We'll talk about the STI approval for CT/NG later. I would note that we are confident that our CGM solution and cobas liat will drive growth of our near-patient care business in the future.
As I've said at the full year, we don't expect material contribution from CGM in 2025, but our manufacturing scale-up is going as planned, and our launches are going as planned, and look forward to updating you on that in future calls. Now switching to the regional view, I'll take you through the business performance by geography. In North America, we saw strong growth of +7%. In EMEA, the business grew at +4%. In LATAM, we saw strong growth at +11%. In APAC, we saw a decline of -15%. As previously mentioned, sales growth in Q1 was impacted by the healthcare pricing reform and VBP in China. As a result of this, the sales in China declined by 23%. We expect this effect to continue over the course of 2025.
Since this is primarily due to the price decrease, there is obviously a corresponding impact on the profitability of this business. I would call out that we are implementing operational excellence and cost discipline measures to offset this. I would also call out that we had a strong quarter in terms of instrument placements in China and that China is still a critical market for us and we remain the market leader. Our ambition, again, for the division for this year is to grow by low to mid-single digits. I would like to talk to the engine of our growth for the future, which is really our instrument placements. Here in the full year of 2024, we saw strong growth across all of our customer areas versus 2023. Let me point out a few areas of growth by customer area.
In the core lab, notice is our cobas pro, which is our high-throughput serum work area, and our cobas pure, which is our mid-throughput serum work area. Placements grew by 65%. In our molecular lab, placements of our fully automated cobas 5800, 6800, and 8800 systems for low to high-throughput testing and molecular diagnostics grew at +22%. I would call out here that we've seen continuous growth of these platforms even through the pandemic into the endemic phase, which really shows that they are the standard for automated molecular diagnostics testing in the clinical laboratory. Moving to pathology lab, we saw placements of our Benchmark ULTRA and ULTRAPLUS have combined growth of +10%. In digital pathology, our DP200 and DP600 grew by 36%.
I would call it we got the primary diagnosis claims for these last year, which is going to accelerate our position in digital pathology. Our primary staining business, the HE600 placements, grew at 4%. In near-patient care, placements of our cobas liat, our lab equivalent PCR solution, grew at 7%. I look forward to updating you in the future on some of the growth of our newer platforms in the next year. Lastly, we also saw strong growth of pre-analytics and connectivity by 12% and our Navify lab operations with good growth of 16%. Now I'd like to come to some of those new launches that you heard Thomas mention and start with our cobas mass spec solution, which got a CE mark at the end of 2024.
With this launch, we plan to establish and shape the IVD market for automated, simplified, end-to-end mass spectrometry testing. This will drive market expansion and a transition from a segment dominated by lab-developed tests to one with mass spec as a part of the routine core laboratory environment. I'm pleased to report that we've had significant progress since launch with a number of placements throughout Europe. We also achieved CE launch for our system and steroid assays on track and vitamin D assays in February 2025. We delivered some of the key installations already this year. I'm pleased to share that the initial sites reported a very fast installation time and positive system performance in terms of uptime and serviceability.
I would call that we are on track to launch approximately 40 assays in the first wave throughout 2025, which will cover the vast majority of routine testing for mass spec, and a second wave will come in the following years. Now going back to some of that innovation that you heard Thomas mention about our sequencing solution, which is the really exciting unveiling we had at the AGBT conference. What really makes this solution so exciting is, as you heard, the marriage of the Genia technology with the Stratos SBX technology. The Genia technology is a nanopore technology, which is complementary metal oxide semiconductor. It allows for extremely high-resolution nanopore signal-to-noise ratio. You combine that with the Stratos SBX technology, which is a surrogate polymer encoding what's called an expandermer.
As you saw from Thomas's slide, it's 50x larger than a native nucleotide and also enables really high signal-to-noise ratio. Combining these together, you're going to get high throughput, high unprecedented throughput, high accuracy, and high flexibility, which you don't have in standard next-generation sequencing. The NGS market, which is valued at $6.4 billion , is projected to grow at around 9% per year over the next three years. The clinical segment will experience strong double-digit growth driven by applications like therapy selection and minimal residual disease monitoring in oncology. Our Roche SBX technology has the potential to really be transformational. You see here on this slide some of the data presented at AGBT from the Broad Institute.
Now here, the Broad Institute demonstrated the high-speed potential of the technology, completing the entire sequencing workflow from library preparation through a whole genome sequence analysis with variant calling in under seven hours with the SBX fast workflow. I would call out, as you heard from the founder of Stratos Genomics, Mark Kokoris, at the AGBT webinar, that this was not even an optimized protocol, and we're hopeful that we can even improve this in the future. I would emphasize that this data showed a level of accuracy that could lend itself well to clinical applications, as demonstrated by the strong Q and F1 scores. This workflow could be practice-changing in clinical environments where a fast genome is important for decision-making, such as the NICU. As you heard me say before, this sequencing chemistry enables batch flexibility and makes it cost-effective to run small batches.
We demonstrated flexibility in read length with one workflow operating the classic short read range and the other having the potential for longer reads to improve coverage. The unveiling of our XPEX technology showcases our commitment and the capability to deliver innovations that could transform the sequencing field. Now moving to our near-patient care business, I'd like to speak about our cobas liat CT/NG, for which we received FDA clearance with CLIA waiver in January of 2025. The molecular STI market is valued at about CHF 1 billion in 2023. There are over 2 million STI infections for chlamydia and gonorrhea in the United States and it affects over 200 million people yearly worldwide.
With the cobas liat CT/NG, we'll offer the first FDA-cleared, CLIA-waived molecular diagnostics point of care solution for CT/NG and expand Roche's menu of lab-equivalent PCR solutions for rapid and accurate diagnosis at the point of care. With this launch, we can leverage our installed base of over 13,500 liat analyzers to drive access to our point of care molecular menu. Now, following Teresa, I'll provide a report on our key launches for the Diagnostics Division. The 14 launches shown here, we achieved two in Q1, the liat CT/NG, as I just covered, and our chest pain algorithm, which helps triage in the emergency room for suspected myocardial infarction. We are making good progress towards the other launches, which are on track, and I look forward to providing further updates in the future.
Last but not least, I'm also pleased to invite you to our Diagnostics Day on May 27th, a hybrid event in London and also online. Here we have a prepared and exciting agenda, and we will further discuss our forthcoming Roche Sequencing Solution, as well as our pipeline and portfolio highlights across our customer areas. With that, I will pass it over to Bruno, and thank you very much for your attention.
Thanks, Matt. Just quickly to summarize here, Matt already mentioned the next upcoming IR event will be the live diagnostics event in London again. As mentioned already by Teresa, on June 23, we will have a hematology update basically covering all the data for malignant and non-malignant hematology, which are presented at the summer conferences, including ASCO, EHA and ICML, and also ISTH.
That's the first time when we will show the clinical data for 007, which were the basis of the decision taken now to move the molecule into phase III. With that, I think we are ready to open the Q&A session. The first one in the row is Sachin Jain from Bank of America. Sachin, please.
Hi, Matt. Can you hear me?
Yes, we can hear you.
All right, thanks. Two questions, please. First, I'm going to kick off with Vabysmo, if I may. Teresa, if you could just comment to how you see U.S. sequential growth from here. Should we expect continued sequential decline through the year, given comments for several quarters to wash out?
If that is the case, to get to the 20% global growth that you are sort of roughly guiding to, is the bulk of that coming from ex-U.S., where we have low visibility? The second is a big picture one you would expect, Thomas, on sort of U.S. policy. You commented on the wires that tariffs you thought were absorbable. What assumptions within that have you made, given the wide variety of scenarios? On your U.S. manufacturing R&D commitments, you and others have made commitment for U.S. in recent months. Is there an expectation that this commitment from the industry can reduce or influence tariff proposals from the administration, or just what is the big picture intent? Thank you.
You want to go ahead with Vabysmo?
Sure. Starting with Vabysmo, basically the dynamic that is happening in the U.S., we all know that within the U.S. retinal space, there has always been a very large sort of unbranded market dominated by Avastin. Over the course of the last couple of years, what we've seen is a decline in that portion of the market and more patients funneling into the branded therapies. With the early closure of the Copay Assistance Fund, or the CAF, we are now seeing the unbranded market, and in particular, the Avastin share continue to grow while the branded market constricts. Within that branded market, however, Vabysmo is growing in every indication that we have. We will continue to see growth in the U.S. It may just be at a lower rate since the overall branded market has shrunk, if that makes sense. We will definitely continue to see our share of that branded market continue to grow. We do also anticipate significant growth outside the U.S.
As new countries come online and as the prefilled syringe continues to enter into new markets. Overall, we think it is a story of growth everywhere in the world, and that dynamic in the U.S. will likely just take a little time to wash out.
Good. Yeah, Sachin, thanks for that excellent question. What I can say is that we've looked at a very wide range of different scenarios, and I think we cannot go through all of the scenarios today, although I'm sure that everyone would like to. We've put in mitigation measures to mitigate against these different scenarios. What I can say already is if we look at the first half of the year and also in Q2, we will not see much of an effect from the tariffs. One reason is that we've shifted inventories, and that should mitigate a significant impact already this year.
The other part is we already started to increase manufacturing of a number of medicines in the United States. We are very actively working on mitigating all of these topics. We also in our budget are making sure that we can absorb potential tariffs throughout the year. We are really working hard on all of those different topics. Regarding our engagement with the U.S. government, I can just say that we are in exchange with the U.S. government. We are in exchange with the U.S. government through the Industry Association, but also with other governments like the EU and certain EU member states. I do not want to disclose all of those conversations at this stage, but I can just tell you that we are on the case.
Okay. We move on. Next questions would come from Matthew Weston, UBS.
Thank you, Bruno. Can you hear me?
Yes, we can hear you.
Perfect. It's just one question from me, please, and it's for Teresa. It's a follow-up to Sachin on Vabysmo. You made clear the success that Vabysmo has as the market leader in nAMD in the U.S. I just want to dig into this charitable foundation issue. The previous ophthalmology market leader was a leading donor in the charitable access foundation market. Now that you're a leader, shouldn't we expect that Roche steps up its contributions to the charitable foundations? If not, why not, Teresa? Is it potentially linked to the DOJ's continued investigation into charitable donations? It seems that after the recent court win and appeal win, that looks like it's broadly resolved.
Matt, as I'm sure you can appreciate, all charitable foundation giving is done through our foundation, which is completely separate, and it would be inappropriate for me to comment on how they do their giving. Unfortunately, I really can't answer your question.
Okay, understood. Can I just quickly follow up? Your answer to Sachin's question suggested that you felt that the CAF market was just winding down. Can I just check that there's no structural reason why we should assume that CAF from everybody's donations should wind down? It's simply that at the moment, the charitable foundations are short of money.
At the moment, the charitable foundations seem to be without money.
Thank you.
To say that, I mean, that will be just a rebasing of the market and just will take a couple of quarters to wash out.
Okay, thank you.
Overall, I mean, the growth rate you saw in Q1 with 18% is round about what we expect for the full year.
Understood. Many thanks for the detail.
Okay, then let's move on. Next one is Emily Field from Barclays.
Hi, thanks for taking my question. Maybe one on NXT007. What dosing intervals will you be targeting in the phase III studies? For the comparator study versus Factor VIII, will you be using a long-acting Factor VIII as one of the comparator? Going back to obesity on CT-996, I was wondering if you could make any comments on the back of the high-level Orforglipron data that we saw last week.
If you're able to comment on any structural differences between the two molecules and if that is sort of the framing of targeting what you think you could achieve with CT-996 in a pivotal study. Thank you.
Great. With regards to the NXT007 trial design, both in terms of dosing and in terms of which factor we would use, those are both great questions, which when we have the phase III trial design, I will be able to answer for you. Right now, it would be premature. In regards to your question around the Lilly molecule and our CT-996, that structure has not yet been disclosed. I think as we've sort of repeatedly said, reducing everything down to just structure sometimes is a little bit overly simplistic. One molecule or one atom here and there can really, really make a big difference.
I think we are very confident in the data that we've seen thus far with our oral molecule, and we are looking forward to advancing it in other trials. At this point, we've seen just phase I data, just to be clear.
Emily, did this answer your questions?
Yes, thank you.
Okay. Next questions come from Justin Smith from Bernstein.
Yeah, thanks very much. Just one from me. Sorry if I'm being slow. On Vabysmo, are you basically saying that the global area under the curve of the drug is the same, or it's just going to come down?
The overall size of the U.S. If you think about the U.S. market as a pie, the size of the pie will likely remain the same. The amount of that pie that goes to the unbranded options is likely to get a bit bigger. The slice that's left for the branded market, we would expect Vabysmo to continue to take share. I just want to continue to underline, we do believe that Vabysmo will continue to grow. As Thomas mentioned, the same level of growth that we saw in Q1 is the level of growth that we're hopeful to see throughout the rest of the year.
This is just now a base effect for a couple of quarters, and then it will wash out, and we will see continued growth like we've seen now in first quarter. We'll continue to see growth going on.
Thank you. Just very quickly, I get that. In terms of ability of ex-U.S. to pick up any slack, does that help as well?
I mean, remember ex-U.S., we still have a number of markets that aren't yet approved or reimbursed, and we're still in the midst of launching the prefilled syringe ex-U.S. There is actually a tremendous amount of opportunity that remains. We're still in very early days in very big markets like China, which just launched in January with NRDL coverage for all three indications. There is still a tremendous amount of room for Vabysmo.
There's a significant amount of growth left in Vabysmo.
Exactly.
Thank you.
Okay. Next questions go to James Quigley from Goldman Sachs.
Great. Thank you for taking my questions. I've got two on some of the upcoming news flow for the second half of this year. Firstly on giredestrant. Again, I know this isn't necessarily the best indicator, but primary completion dates listed on clinicaltrials.gov for persevERA and evERA have now slipped into 2026. You have already confirmed 25 readouts, but is there any risk of slipping into 2026? Similarly, on the SERD space, we've seen some data from Astra, Lilly, and Pfizer. Just wondering what your take is on this, particularly with continued success in the ESR1 mutation population and then what your thoughts are on the commercial opportunity.
Secondly, on fenebrutinib, we spoke to some KOLs recently that suggested that in terms of Aubagio's apparent overperformance in recent phase III trials relative to the original phase III program, patient population was the biggest change there. From what you've seen, is there anything sort of different or novel for your trials versus what we've seen for the other two competitor trials in their populations? When you're planning the studies, to what extent did you assume an uplift in efficacy for Aubagio? Thank you.
I'm sorry, James, could you repeat the first part of your second question? I didn't catch it.
First part, second question. We spoke to some KOLs recently who said that in terms of Aubagio's apparent overperformance in the current phase III or in the phase III trials for your competitors versus its own phase III program, the key change there was patient population. Is there anything different in your patient population versus what we've seen for tolebrutinib and/or evobrutinib?
I'm still not sure I totally understand what your second question is. The first one's fairly easy. The giredesinant trials are event-driven trials. It is possible that we may see slippage just because they are event-driven. As soon as we have concrete information, we will certainly share that. We continue to believe that our SERD is materially differentiated from a structural standpoint from the other SERDs out there. While I think the additional data from other trials is certainly informative, it is not definitive. I think that would probably be the way that we would look at it. You are talking about fenebrutinib. Okay, got it. The second question was fenebrutinib, and did we see anything different in our phase III patient population?
In fenebrutinib, Aubagio has done better than people thought, right? That seems to be the reason as to why tolebrutinib and evobrutinib were not successful. KOLs we spoke to have said that is because of the patient population. Have you adjusted for that patient population in your trial? What were you expecting in terms of the Aubagio efficacy when you originally planned the trials as well?
Got it. I would say that based on the phase II data that we have seen from fenebrutinib, based on the fact that it is a materially different BTK from the other BTKs that are out there, it's non-covalent. We believe preclinically that it's more potent, that it's more selective. We've seen very strong phase II data with fenebrutinib. We are quite confident that we have a molecule that is very different from the other molecules that are out there. From a patient population, I'm not entirely sure that there is anything materially different in the patient populations that we're looking at.
I think we do believe that we just frankly have a better BTK and one that we were able to bring forward into phase III is at what we believe to be the most appropriate dose. I think that's the other thing that has potentially impacted some other trials is they just weren't able to get to the level of dosing that they needed. We believe we've gotten to the level of dose that we need. Obviously, the trial is still ongoing, so we haven't been able to formally look at the baseline characteristics for all the patient populations. There wasn't anything in how we structured the trials that we think would be materially different.
Got it. Thank you.
Yeah, maybe James, I can quickly add here. Your first question was this referring to giredestrant timelines?
Yes, on clinical trials.
There's no change there. Just to confirm, they both will read out in 2025 with evERA expected to come in before persevERA. You would have these, we expect these data still to come in from mid-year towards second half, one after the other. The other question on the Aubagio performance, I think this was widely debated. I think once the competitor data were out and several KOLs communicated on it, I think due to the changes in the treatment paradigm in the meantime, you can expect these effects. It is not that we would have known the extent upfront and would have fundamentally differently designed our studies or selected the patients.
Great. Thank you.
I think the dose is a very important point in terms of the ability to go to higher dose.
Yeah. Okay, we move on. The next one is Kerry Holford from Berenberg. Kerry.
Thank you, Bruno. A couple of questions for me on obesity, please. CT-388. In the context of what is now your interest in a triple approach with Zealand's amylin, can I ask do you still remain committed to pursuing the dual agonist alone? Can we anticipate a phase III start for CT-388 next year? In the context of your incremental U.S. investment, I wonder if you would be willing to tell us approximately how much of the CHF 50 billion will be allocated to obesity? Can you confirm whether you ultimately plan to manufacture 100% of the Roche obesity assets in-house or indeed whether you do intend to use CMOs for API and fill finish? Thank you.
With CT-388, we certainly do remain committed, and that phase III will actually start most likely this year. We are anticipating the phase III go decision for the CT-388 phase III this year. Thomas, do you want to take the?
Yeah, just wanted to say around the CHF 50 billion R&D investment, so around 80% of that is or close to 80% is actually R&D investment in the United States. The remainder is CapEx investment. This includes all the different sites investments that we highlighted in the press release.
Your plans with manufacturing of obesity assets going forwards in-house?
In the transition, as we are working in the different phases through development, we will also work with CMOs, but this gives us enough time to build up our manufacturing plans, which we will announce very soon. Let me just highlight again what I said during my presentation, just to be clear and to be very sure that everyone gets this message. This investment that we're making in the United States is included in all of the messages we have made in the past in terms of our annual spend on CapEx. There is no change of any of the messages that we've made in the past. We believe we have enough space in our CapEx because we've put a lot into manufacturing over the last decades in our network. We have a lot of space in our CapEx to make those investments. The same goes for R&D. When we talk about R&D investment, flat this year and very disciplined in the future years.
Got it. Thank you very much.
Okay. We have next in the row, Sarita Kapila from Morgan Stanley. Sarita?
Thanks for taking my question. Just on the Zealand amylin, how are you viewing the upcoming competition from Lilly's amylin where we get phase II data, sorry, in Q3? I would also be interested to get your thoughts on the Hemlibra molecule and if you or why you passed on it given 8% weight loss posted at week six and the much smaller upfront contribution from AbbVie. A follow-up question on 007, please. If the phase IIIs are initiating in 2026, how soon can we expect it to be on market? Are you targeting before the Hemlibra patent expiry in 2030? Do you expect NXT to expand on the current Hemlibra peak sales opportunity where I believe consensus is touching CHF 5 billion? Thank you.
Start from the back and move up. 007 phase III is I think when we have the announcement on the phase III trial designs and starts, we'll be able to tell you when we expect those trials will read out. We are obviously, as we would with any molecule that we believe has this kind of transformative potential, we will be moving as quickly as possible to bring this to patients. It would be premature to comment at this point exactly when it will come into market and what our plans would be. We do believe that this could potentially expand the number of patients that are on prophylactic treatment just based on what we believe it may be able to do from a clinical standpoint. From the Zealand perspective, I mean, certainly we would expect the amylin space, as every space in this market is, to be competitive.
That having been said, we think that the data that we've seen from the Zealand molecule has the potential to be best in class and certainly to be first into the market. We don't yet have data from the follow-on compounds. I think we're extremely excited about the opportunity in front of us. This is going to be a competitive space, but we feel like this molecule is well positioned to compete. I don't know, Thomas, do you want to take the?
Yeah, I would like to just add that when we screened the market for potential partnering opportunities, we obviously looked at all partnering opportunities, and we saw this one as the best and first choice for us in terms of partnership because of it showing the best data versus the other available potential amylin that we could partner with.
Yeah, the combinability too here is really important.
The combinability and safety. Exactly.
Sarita, let me also here quickly add the patent expiry for Hemlibra is actually not scheduled for 2030, but it is beyond 2030. That is the guidance we have previously given.
Okay, thank you.
Yeah, okay. We move on then to Simon Baker from Redburn.
Thank you, Bruno. Good afternoon, everyone. Two questions, if I may, please. Just going back to Vabysmo, your commentaries about being comfortable with sales expectations in light of a larger slice of a smaller pie would imply that you have reduced expectations for the competition in that category. Is that indeed the case that you simply see that Vabysmo market share is likely to be higher than previously thought?
Secondly, for you, Thomas, going back to the question on CapEx, you indicated that the total level of CapEx is the same, the total level of OpEx is the same. The amount being spent in the U.S. is higher than before. I'm assuming that was not in the budget. Definitionally, you will end up with a happy U.S. government because more money is being spent in the U.S. Therefore, there will be less money spent ex-U.S. I just wonder, am I thinking about that the right way? Where is less money going to be spent going forward? Are there any political implications for doing that? Thanks so much.
Should we take the last question first? If you look, for example, at our manufacturing network, we have completely modernized our manufacturing network over the last decade. If you look at our R&D network, for example, in Switzerland, if you've been here recently, it's completely modernized. A lot of the investments that we had in other areas, we can now also redirect. It was very clear if we want to enter the peptide manufacturing with incretin and amylin, we also have to build out manufacturing. This was part of our budgets when we made the acquisition. The same goes for CGM. In terms of CGM manufacturing, that was also part of our business plan. These are all investments that we've made, and we've decided to make those investments in the U.S. also because it's the biggest market in terms of obesity medicines, but also in terms of CGM. I think it's just a very logical step in terms of the investments that we wanted to make.
The simple answer to your question is I would just reiterate what I've been saying now for a number of years, which is I do believe that Vabysmo is the new standard of care in retinal disease. We are steadily increasing our market share in every indication. We continue to grow our first-line share. The prefilled syringe has extremely high adoption in the U.S., is growing in adoption in those markets where it's launched. This is the drug on the market to beat. I just fundamentally do believe that we will be taking share from others in that branded space.
Right. Thanks so much.
Okay. We have Richard Vosser from JP Morgan. Richard?
Thanks, Bruno. A couple of questions, please. Firstly, on Perjeta and Phesgo, I wondered if you could give us an idea of the share of the two products between metastatic and adjuvant and whether the switching of Phesgo is greater in adjuvant or in metastatic or very similar. Secondly, on Perjeta as well, biosimilars were highlighted in the annual report as coming in 2026. Could you give a bit more color on the timing and whether we could anticipate that being pushed out? Xolair was. I'm just trying to ascertain that. Finally, one question on 996. We saw danuglipron from Pfizer having liver enzymes and being discontinued. Could you just talk about how you're thinking about that in relation to 996? Thanks.
Sure. For your first question, I don't believe that we've broken down Perjeta penetration by line of therapy. I don't have that information. In terms of biosimilars, we expect that the biosimilar exposure for Perjeta is going to be relatively limited. Right now, we only see one that has the opportunity to come in at around the time that it would be eligible to do so. We do not think that they're likely to enter the market until sort of the end of 2027 or later. Right now, it's not a threat that we're super worried about for Perjeta. We will obviously continue to keep an eye on it and keep you informed. In terms of 996, obviously, our number one concern with any new molecule is patient safety. With all of our molecules, we pay very, very close attention to the potential risks, and liver risk is certainly one of them.
Right now, there isn't anything that's necessarily giving us undue pause here, but it is clearly something that we will continue to monitor as we would with any of our molecules.
Yeah. Let me just add that there is no biosimilar expected in the midterm for Phesgo. Very important.
Yes, that is true. Yeah.
Maybe here to add one thing, Richard, I think in terms of the split you asked about adjuvant versus metastatic, the only number we once mentioned is it's a roughly 60/40 split over the entire franchise, but we have not specified whether there is a big deviation now between Perjeta or Phesgo in the early versus the late setting.
Splendid. Thanks all. Very kind.
Thank you.
Okay. Next one in a row is Peter Verdult . Peter?
Yeah, thanks, Bruno. Peter Verdult , BNP Paribas. Two questions for Teresa, please. Teresa, I'm going to be sort of positive on one and perhaps a little bit negative and cynical on the other, forgive me. Look, starting on a positive note, just on fenebrutinib, the conventional wisdom out there is that the trial won't work because you've seen two comparative failures. We've had hypotheses already put on the call as to why that may be, but the one that we get from KOLs is that basically the T1D lesion reduction was just that efficacy waned for your competitors. Can you remind me, sorry to be gnarly, can you just comment whether the suppression you've seen with fenebrutinib is sustained beyond the early cuts of data and just whether you're cautiously optimistic or optimistically cautious about beating Ocrevus in PPMS? That's the sort of positive-spirited question. Just being a little bit cynical on 007.
In your prepared mark, you talked about 30x more potency. That sounds very much like the Novo pitch on Hemlibra. And to be fair, you've got to admit you've been talking down the advantages of Mim8 versus Hemlibra over the last few years with those sort of arguments. I just want to better understand where 007 differentiation is coming from. Is it just that, or are there other things that you didn't mention in your prepared marks? Thanks.
Yeah. No, I think so let's start with 007. I mean, I think fundamentally 007, yes, we believe that it is more potent, but it also has the recycling and sweeping technology built into it. And so, I mean, it is just fundamentally a next-generation molecule. I don't know how much we've actually disclosed on the actual composition of that molecule. Bruno maybe can remind me. It is just fundamentally a different molecule from Hemlibra. This is not just, I think, a little bit better than. I think this is a different than.
I think, Peter, what you should read into the announcement is also if we made the comment that we would benchmark versus Hemlibra. I think this was missing with competitor studies, and I think that is the ultimate test to really see whether we can establish a new standard of care.
Absolutely. I mean, I think we have been very clear that we believe that Hemlibra is the gold standard for treatment in hemophilia. We are putting our money, as we always do, where our mouth is in these trials and running our next generation up against the current standard of care. We love nothing more than beating ourselves. We are excited for that possibility.
Yeah, that's something we can then discuss in more detail at the June 23rd meeting.
Exactly. In terms of fenebrutinib, I mean, again, just to reiterate, I think we just fundamentally believe that we have a different molecule than the other BTK inhibitors that are out there. It is a different composition. It's a different structure. It's more potent. It's more selective. It's non-covalent. I think we have more phase II data than most of our other competitors have had. I'm just referencing here, we have longer-term 48-week open-label extension data that really shows that we're able to suppress disease activity. The open-label extensions here will go out to 96 weeks. We'll get that later this year. I think we do believe that we have something different on our hands, and the phase II data is playing that out.
Again, when we get that 96-week open-label extension data, hopefully that will be another piece of the puzzle. This is really one area where I do not think you can compare our molecule to someone else's molecule because they just are different.
Teresa, just I know I asked three parts. Just PPMS, I mean, are you cautiously optimistic or optimistically cautious you can beat Ocrevus?
I think I am cautiously optimistic. Ocrevus really is the standard of care for these patients. If it beats Ocrevus, I think we really know we have something. That having been said, orals comprise 30% of the MS market. There is a very good spot for fenebrutinib, even if we do not see superiority to Ocrevus, understanding it is a slightly different population.
Thanks.
Okay. We move on. David Evans from Kepler. David?
Thanks very much, Bruno. Yes, two questions, please. One on petrelintide and one on Brainshuttle . On petrelintide, in your slides, you refer to looking for high-quality weight loss. I was just wondering how convinced or confident are you that amylin can be differentiated on less muscle loss and more fat loss? How much of the rationale was that for you going into amylin? Is that in practical terms how amylin you think can really differentiate? On Brainshuttle , we've seen amazing proof of concept data from trontinemab so far, but where are you on your Brainshuttle CD20 in MS? Might we see data on that anytime soon? Are there any other Brainshuttle projects in the way that we should know about? Thanks.
Yep. As you mentioned, we do have the Brainshuttl e anti-CD20 in very early R&D. I don't believe we've disclosed when that first dataset will come out, but it's likely not to be for some time. That's relatively early stage. We are certainly looking at the brain shuttle technology in other diseases where we believe crossing the blood-brain barrier is going to make sense to do so. Clearly, a technology that has really proven itself in AD, we will be bringing forward other opportunities to look at that in other diseases. In terms of petrelintide, the amylin class does work fundamentally differently, obviously, than the incretins do. It is, I think, very likely that we could see a different kind of weight loss with patients on these drugs. Clearly, the data are early days, but the clinical hypothesis is solid.
I think we are very hopeful that this could be a fundamentally different kind of weight loss than what you saw with GLP-1s.
Thanks very much.
David, did this answer your questions or any follow-on?
Yeah, perfect. Yeah. Thanks very much.
Okay. I think with that, we are at the end of today's call. I will hand back to Thomas for a final remark. Thomas, please.
Yeah, thank you very much, Bruno, and thank you very much to this team. I really appreciate everything that you are doing every day. And to all of you, also thank you very much for your interest. I can just say we are implementing our strategy that we have rolled out last year with a lot of discipline and also with a lot of speed, taking out costs out of the system where possible and shifting it into new areas, staying very cost-disciplined. We are focusing on our pipeline, and we are also focusing on commercial execution. I can only say we will deliver.