Roche Holding AG (ROG) Earnings Call Transcript
January 30, 2025
Earnings Call Speaker Segments
[Operator Instructions] 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 Roche Group. Mr. Schinecker, the stage is yours.
Thank you very much, and hello to everyone wherever in the world you are. I'm really excited to share with you the results of 2024 for the Roche Group because I believe they have been -- this year has really been an excellent year for us. So let's look at the performance. So overall, group sales was at 7%. The base business, meaning excluding COVID-19, GREEN with impressive 9%, Pharma 9% and Diagnostics 8%. We saw the last and final impact of COVID-19 sales in -- reduction in 2024. So there is no more impact going forward. The final impact was CHF 1.1 billion, so exactly in line with the guidance that we gave at the beginning of the year. The LOE impact was CHF 1 billion, so slightly better than the guidance we had given. To round out the very strong performance of the organization. Let's look at the third line here. Core operating profit growth plus 14%. Group core operating margin up 2.1 percentage points. Core EPS growth, plus 12% if you exclude the tax effect, which we guided for or plus 7% if you include it. Operating free cash flow up 34% at CHF 21.2 billion. Certainly, the number that Alan loves the most. Key milestones achieved in Q4. You see them on this list here. EU approval for Vabysmo prefilled syringe, we had positive readout for trontinemab and also in the prasi trial, we see a potential benefit in certain subpopulations with this disease. On the Diagnostics side, it was a very busy quarter with the mass spectrometry launch, the 68/8800 launch and so on. And also on the deal side, we made the progress introducing Poseida to our organization, allogenic CAR-Ts, not only for oncology, but also in the autoimmune diseases and the DLL3 ADC deal in small cell lung cancer. 2025 will really be a significant year for us in terms of Phase III readouts, but also in Phase III enabling readouts. So movement from Phase II and Phase III where we have up to 7 earning [Audio Gap] Can you hear me? Yes. Now, you can hear me. Okay. Perfect. Sorry about that. Good. So now let's look at how we did versus the guidance. At the beginning of the year, we talked about mid-single-digit sales growth for the year 2024. We definitely ended up at the upper end of this guidance at 7%. Also at the beginning of the year, we talked about mid-single-digit core EPS growth, excluding impact from resolution of tax disputes in 2023. We raised the guidance in midyear, and we've clearly exceeded this guidance with 12%. Again, if you include the impact, we are at 7%, which is in line with the sales growth. And we further increased the dividend. This means that we have increased the dividend for the 38th consecutive year. And as you will see at the end, we plan to do that also for the ninth consecutive year. Here, you can see the slide that we always show. You can see that the Roche Group grew 7%. If you exclude COVID, we had a very strong growth of 9%. So again, a very strong performance in the group. Now this is one of the slides that I like very much. On the left-hand side, you see the group sales growth over the last couple of quarters and years. And on the right-hand side, you can see the growth if you exclude COVID-19. Clearly, we are one of the companies that had significant sales of COVID-19 between 2020 and 2022. In fact, around CHF 19 billion. And we are also very proud of the contribution we did at the time. But also, it means that as COVID-19 went away, and we always communicated that, that it would go away. We had -- in 2023, the situation that we had to compensate this loss. And we did so with significant base business growth, so excluding COVID-19. And this growth has been very strong over the last 2 years. You see 2023, 8%. If you take the average of '24, you're at 9% growth. And in fact, in the last 3 quarters, we reported 9% growth each quarter. I think this is a very strong performance from the organization. Now let me quickly take you through this slide. A couple of highlights that I would like to make. First of all, we have now 17 medicines that have blockbuster status. Furthermore, in oncology, Phesgo: Conversion rate is now increasing to 46%. Polivy: U.S. patient share first-line DLBCL, now climbing to 29%, establishing itself to the new standard of care, and it's also an opportunity to further build upon it with combinations with the CD20 CD3 bispecifics that we have. Hemlibra patient share in the U.S., EU now reaching 42%. And we are now also looking forward to the Phase III enabling readout of NXT-007, which is the next generation of Hemlibra. In neurology, Ocrevus subcutaneous now with roughly 50% patient share being naive to Ocrevus and the J code is only to come in 1st of April limited with good launch momentum. And clearly, Teresa will touch on that and on the promising 2-year follow-up data from the Phase III EMBARK study. Xolair food allergy with continued strong uptake now at more than 40,000 patients on treatment. Mid-teens to be expected in terms of growth in 2025. Vabysmo prefilled syringe now also approved in EU and is set to become the #1 ophthalmology brand in 2025. In Diagnostics, strong base business growth of 8%, as mentioned before. Now let's take a brief look into the future. First, I can say that we have completed our strategic review and we are really now in implementation throughout the organization. So we're set for the future. I would like to touch on the formation of our near patient care organization in Diagnostics. So in Diagnostics, we have 4 customer areas: Core Lab, Molecular Lab, Pathology Lab and Near-patient Care. In the first 3, we're the #1 globally. The area where we want to become #1 is near-patient care. And here, we've done the acquisition of LumiraDX and this has been covered quite a bit by Matt and myself in recent presentations. What's really special about this platform, it's a handheld platform. And on this technology, you can do multiple different technologies in terms of measurement: Clinical chemistry, immunochemistry, coagulation, potentially molecular diagnostics. And it's room temperature, and it's really disruptive from a cost of goods position. Accu-Chek CGM was launched last year. This will enter us into a very fast-growing, very large markets. Cobas liat, we just recently announced the menu expansion into SDI, and we'll continue to build out the menu. But we have 2 more platforms in our pipeline. One is around blood gas, the other one around lab like immunoassay performance where we are to continuously invest into the new patient care segment, and we'll continue to build out that segment as we go into the next years. Now let's go to Pharma. You've seen the very strong momentum that we have in our organization, and this is really due to the young portfolio that we have in terms of medicines. And you can see on the right-hand side that in the meantime, 56% of our Pharma sales are coming from these new medicines. In fact, in 2024, we launched 2 new medicines: one is PiaSky and the other one is Itovebi. And I would definitely say Itovebi is best-in-class, and we have very high hopes on Itovebi. In 2025, we have a total of four potential NMEs that with a positive Phase III readout could lead to launches in '26. We have sixth one -- a fifth one, which is tiragolumab, but we didn't mention on here because as we know, the hopes for tiragolumab are lower. But there are still certain trials ongoing. Let's see how that runs out. But those are the 4 that we would like to highlight for 2025. What's also important is that we are one of the companies that has very little biosimilar exposure until the end of the decade. So we have less headwinds than many other companies have in our industry in this time period. Now let's look specifically at the Pharma pipeline in 2025 and what we can expect. Here, you see a list of a number of our key assets in our pipeline. In fact, we have more than 7 NMEs with a peak sales potential of more than CHF 3 billion and 4 with peak sales of CHF 2 billion to CHF 3 billion. We have 6 marketed products that each have trials ongoing with potential line extensions that could add another CHF 1 billion to CHF 2 billion each per asset. Now 2025 will be a special year because we have 12 key pivotal readouts. So approximately 1 per month. And we have 4 readouts that are linked to new NMEs that could be launched in 2026. And even more important, I would say, is that we are refilling our late-stage pipeline. We have 7 NMEs that could enter into Phase III, and that would be really for us a record, if I compare that to last 10 years or so to bring 7 additional NMEs into late stage would be really significant for us. Now let me finalize with the 2025 guidance. And you can see that we expect LOE impact of about CHF 1.2 billion, so slightly higher than what we saw in 2024. And we aim for group sales growth in mid-single-digit sales range and core EPS growth in the high single-digit range. And dividends, we aim to further increase in Swiss francs. Thank you very much. And with that, I hand over to Alan.
Yes. Thanks, Thomas. Hello from my side. Great to see everybody. I hope everybody is fine. Certainly, what I also hope is that Teresa is getting better soon. Very pleased with the performance this year and would like to thank the whole team and everybody has contributed to that performance on one hand, and certainly everybody has contributed to the well-being for patients. Good. Let's get into it, and this is the overview. Sales, you see plus 7%, 3% in reported in Swiss francs. I'm sure Teresa and Matt will do quite a thing to explain the sales and a bit deeper here, underlying, as you've heard from Thomas already. So without the COVID sales, plus 9%, quite impressive performance. And when you look at the core operating profit with a higher momentum, plus 14%. I think very clearly, good cost containment. And really, when you see the increases that we have in the cost lines well below the sales growth. Yes, then we get to core net income and core EPS. And I would hit the 2 right away. Very clearly, what brought the dynamic down the growth dynamic of these numbers are 2 elements. One is taxes. We have paid CHF 1.1 billion more taxes than last year. Part of that is the tax impact or the resolution of tax disputes we had last year as a positive the CHF 774 million, that certainly contributes to that increase. The other part is high interest charges, roughly CHF 320 million or CHF 400 million when you just look at interest that we had more, and that explains the core EPS growth of 7%. If you exclude the resolution of tax disputes from 2023, you go to a core EPS growth of plus 12%. IFRS net income down 19% in constant rates, minus 26% in Swiss francs. Two major impairments happened here, where we certainly have to acknowledge that the expectations of these investments and assets didn't fulfill compared to what we had in mind when we bought these assets. So we had to impair end of 2024. Yes. And then the number I love most, Thomas is completely right, is the cash flow, 34% up, 28% in Swiss francs. CHF 20.1 billion in constant rates in -- as reported and CHF 21.2 billion in constant rates. That's really -- it's not a record number. I think once we had a higher one, yes, but it's long ago, it's a fantastic number and certainly helps us to mitigate the debt increase and the interest charges. The free cash flow also on a high level, as you can see, so really money available to do further M&A, but also to pay the dividend. When you look at this group sales growth, and here you see the bridge full year 2023 on the left-hand side and full year 2024 with CHF 60.5 billion on the right-hand side. First, really, let's go through the divisions, just to give you the broad overview. I think you see the Dia base business has grown over CHF 1 billion, COVID impact, minus CHF 552 million, Pharma growth above CHF 5 billion, Ronapreve sales impact from last year with a minus CHF 522 million. And then you see really the loss of exclusivity, which is roughly CHF 1 billion with a minus CHF 952 million. And then you see the currency impact, which brings the 7% sales growth in constant rates to 3% in Swiss francs. When you look at the P&L, as I said, I think the cost discipline is obvious. I mentioned the sales. You see the other revenues with plus CHF 215 million. This is, as you know, the line where we have the royalties in, where we have the profit shares in and all of this. Here, I would argue Venclexta profit share contributed to that number. And then XOLAIR outside of the U.S. that caused an increase of plus CHF 215 million. When you look at cost of sales, with a 5% increase, a minus CHF 720 million impact. I think the 5% is a major achievement because we had volume growth of 11%. When you look at Pharma, 14%, Diagnostics at 3% volume growth. I think that's a very respective outcome. I think for Pharma, I can say CHF 640 million increase. Here, half of that -- basically half of that is triggered by a provision release we had in 2023. This is really the Ronapreve provision, as you know, that we released. I think that's a big explanation here. So they would have looked much better without that. Diagnostics, CHF 80 million, with quite some volume as well. Then you go for R&D. R&D, a modest growth rate with plus 1%. Very clearly, the reprioritization in the portfolio on the Pharma side is going on. And moving on, on the other hand, we have invested more on the cardiovascular side. And then you see really SG&A was plus 5%. Let me explain that. M&D plays a major role here in Pharma, an increase of CHF 319 million, very justified because when you look at the growth rates of Vabysmo, Ocrevus, Phesgo, I think that's where we have to invest and we did. And when you look at diagnostics, higher logistics costs of CHF 90 million on the M&D side. And then there's an element of corporate and you might ask yourself, okay, why is that coming? Well, 1 element is we centralized more in the company. So there were more costs coming from other units into SG&A. Diabetes Care is 1 element that we integrated, just to mention an example here. That's roughly CHF 100 million. And then the rest is informatics. In informatics, we have invested in artificial intelligence, ERP and other technologies, which I think is very justified. When you look at other operating income and expenses, the minus CHF 166 million decline solely is driven by less gains on disposals compared to last year, leads us to a core operating profit of CHF 20.8 billion with an increase of 14% compared to a sales growth in constant currencies of 7%. Well, you look at the margins, I think with such a performance. Certainly, the margins go up. And you see for the group in constant rates, 2.1 percentage points. Same applies to the Pharma division with plus 2.1 percentage points, and Diagnostics has grown with 1.3 percentage points. So really a great performance across the board, and you see both divisions improved their margins. When we go to the core net financial result, you see really an increase of CHF 310 million reported, major driver here is the interest expenses. As you know, the debt has risen. On top of that, yes, we have changed a couple of mature bonds with other bonds that have higher interest charges, which is clear, yes, in the current environment. So I think that was the driver here. Equity securities with something small, that's our venture fund, a small number. And then the net interest income is driven by the cash that we had on the balance sheet and that we just reinvested in a very cautious form. Good. The core tax rate, that's quite an interesting story. Let me start on the left-hand side with the 11.9% in 2023, which was certainly a great outcome. Very much driven by the CHF 774 million positive tax impact. So you have to readjust for that. That's a minus 4.3 percentage points brings us to 16.2% adjusted effective tax rate for 2023. When you compare that to the adjusted effective tax rate full year 2024, with 17.1%, I would argue, I think, really very comparable to last year, major change here is the profit mix that comes in with different jurisdictions and different tax rates. What came into it, on 1 hand, is certainly the 2 pillar -- the Pillar 2 top-up tax, the Swiss minimum tax, so to say, with plus 1 percentage point. And then we had a couple of resolution of tax disputes we cannot really budget for and it's very hard to foresee. That brought the tax rate down by minus 1.4 percentage points to 16.7%. I know everybody is eager to know what's going to happen in 2025. Guidance here is very clearly 19.5%. 18% for the, if you like, effective tax rate and then 1.5 percentage points for the minimum tax. So we stick to that. Core EPS development, and that tells the story a little bit about the year. I think, really, you see on the left-hand side, where we started with, if we deduct the effect of the resolution of the tax disputes, you get to 18.02. And the NGS operations is really -- that's the driver of the result in 2024. What worked against us, less product disposals, the minus CHF 181 million that I've mentioned already. You see the financial income and expense, which has risen, that's a minus CHF 320 million. And then you see the tax rate change I've elaborated about already. And that brings us to the 12% increase in core EPS, and you see the driver is clear operations. When you look at the noncore and the IFRS income, I start with the core operating profit. I've talked about with plus 14%. The outstanding performance that we have seen. You go to the IFRS net income line, you see the minus 19% in constant rates that I've mentioned already. And when you go through the lines, I think the global restructuring plan is very comparable to what we had last year, I might say, Alan, that's a difference. Well, we have a positive effect in that line in 2024 coming from the Vacaville divestment of CHF 240 million. Amortization of intangible assets, I would argue, pretty stable. And then you see the impairments of intangible assets, a decline of minus CHF 3.4 billion, very clearly here, as said, driven by 2 major impairments that we have taken, where the assets really didn't meet our expectations we had when we acquired them. And that really is the major driver. So goodwill impairment was CHF 3.1 billion and CHF 800 million additional impairments on the assets. M&A and alliance transaction is not much of a move here. And legal and environmental, I think in 2023, we had a positive impact because we released the provision for a court case, and I would argue in 2024 normal business. It leads us to an IFRS operating profit of CHF 13.4 billion. And then you see the total financial result and taxes when you put it together. So that's CHF 1.4 billion more compared to 2023 in total, as I've said and outlined at the beginning already, leads us to an IFRS net income of CHF 9.2 billion. Good. Yes. I think this is not just a number. This is the slide I love the most when I look at 2024, and that's the cash generation. The cash generation has been outstanding. When you look at constant rates from CHF 15.8 billion to CHF 21.2 billion reported on the right-hand side, CHF 20.1 billion, I think, really an outstanding number. And what excites me the most is, I think, very -- as expected, operations drove that number. And you see that in the first green bar with CHF 3.7 billion. But then we also worked on the net working capital. And you see net trade working capital, CHF 1.3 billion. And I can say both divisions really brought that number home, so to say, this is really a fantastic outcome. And when you then look really at other net working capital movements, I think that helped as well. Investments in intangible assets, what we want to do. So we invested CHF 600 million more here. So overall, I think a fantastic achievement. When we look really at the cash flow margins, they jumped as well. And as I've said, I think both divisions contributed. Group debt -- net debt development. So what does this cash flow generation mean for the net debt development. Let me first outline where we landed. End of December 2023, a minus CHF 18.7 billion, net debt, end of '24, a minus CHF 17.3 billion. So really an improvement of CHF 1.4 billion. So really, we overcompensated everything. So I think that's a great message. How did that work? I think the operating free cash flow, yes, I've talked about it. In here is an investment in intangible assets of CHF 1.5 billion. I think just to mention that. When you look at the nonoperating free cash flow, taxes with CHF 3.7 billion treasury is CHF 1.1 billion. And then you see certainly dividends and M&A, dividends paid CHF 8 billion. M&A and transactions CHF 3.1 billion. So you can argue including the CHF 1.5 billion for intangible assets, we have invested into M&A and intangible assets which certainly drives the pipeline, CHF 4.6 billion. Then you see a currency translation effect. As much as we love a strong U.S. dollar in the P&L, it hits us on the balance sheet on the debt side because 70% of our debt, and we have CHF 34.7 billion, gross debt on the balance sheet, 70% of that is in U.S. dollars. And when the dollar strengthens, I think that number gets higher. And then you see a couple of other effects here. So that leads us to the CHF 17.3 billion, certainly very pleased with that as well based on the strong cash flow that I've explained already. Good. With that, let's go quickly through the balance sheet. First time we have more than CHF 100 billion in assets in the balance sheet. And what you see is cash and marketable securities, yes, we brought that up. We had a couple of bond emissions that helped us and certainly the CHF 7.3 billion gives you a lot of assurance that we can pay the dividend. Other current assets, I think very clearly a slight decline. Why? Vacaville went away. I think that's CHF 600 million, and inventories went down by CHF 300 million, which I think is a great message. When -- the noncurrent assets, slightly up, CHF 4.8 billion here, very clearly, deferred tax assets has played a role here with the restructuring plans, I think the intangible asset impairments, all of that contribute to this as well as the acquisitions that we have done. On the current liability, so we move to the right-hand side, accruals are the reason for the increase on the current liabilities and the noncurrent liability is very clear, that's the gross debt. Gross debt increased from CHF 29.2 billion to CHF 34.7 billion, so by CHF 5.5 billion, and that's reflected in that number. And you see overall, the equity has increased by CHF 2.9 billion. Good. With that, currency, yes, a little bit of a pain in the last 2 years. And when you look at 2024, you still see that on the left-hand side, this orange line is below the black line and the black line is the average for 2023. And the orange line is the average for 2024, and whenever these lines are below, that's not a good impact for us, if you like. So you see on the right-hand side, the result for the full year, a minus 4 percentage points impact on sales, a minus 6 percentage points impact on core operating profit and a minus 6 percentage points impact on core EPS. I think when you really look and you know we do that exercise, we assume really at year end that every currency rate stays the same during the year, and we project them for the full year, which is very, very hypothetical. But then we expect any impact for 2025, which is certainly encouraging. If we were looking at today, we even have a positive impact. But well, as we all know, currencies are very, very volatile, but it looks like a better year compared to the last 2. Now a very formal slide, I know and a little bit boring but important to get to the right starting point for 2025. So let me start really with the core EPS as reported in 2024 of CHF 18.8. And what we have to or what you have to adjust for is the foreign exchange losses, which are so far not really reflected in that number or not reflected in the number. So in the green bucket, what you see is an adjustment of CHF 0.53, 53 [indiscernible] exchange rate effect. This is a result of dividing the 2024 currency losses of CHF 291 million as well as the 2024 losses on net monetary position in hyperinflationary economies of CHF 163 million. This is shown in Note 4 of our consolidated financial statements on Page 62 of the finance report 2024. This number, net of taxes and noncontrolling interest by the number of diluted shares of 802 million shares, you get in note 29 of the finance report, Page 121. So when you do that exercise, you get to the 53. If you do that exercise, you might ask yourself, "Oh, this implies a pretty low tax rate for that impact when you do that. So you can do the math here. It would imply a tax rate of 6.4%. Let me take that topic right away because the one impact, the CHF 163 million has no tax impact. So that's 1 element here. And the other piece is -- yes, the CHF 291 million has a tax impact, but in the holding. In the holding, we have certainly another tax rate here compared to what we have in the group. So that leads you to the 53 [indiscernible] the adjustment here. So the starting figure for the outlook for 2025 is CHF 19.33 per share. Good. With that -- yes, that's a bit formal, I know. With that, I think really nothing to say about the guidance Thomas gave that. And with that, it's my pleasure to hand over to Teresa.
Great. Thank you, Alan. So apologies for the mask. It is not a fashion statement. I am feeling a little bit under the weather. And so I want to make sure that I'm protecting my colleagues. But I am very pleased to share with you the 2024 results for Pharma. So let's kick things off with a look at the sales performance. In 2024, Pharma sales grew 8% at constant exchange rates to CHF 4.2 billion. Excluding Ronapreve, sales grew 9%. All regions, excluding Japan, delivered strong growth, 9% in the U.S., 8% in Europe and that extremely impressive 17% in international all at constant exchange rates. Excluding Ronapreve, Japan declined at just 2% and that is primarily due to mandatory price cuts. And as Alan already mentioned, overall Pharma volumes were up by 14%. Going into a little bit more detail. The core operating profit for Pharma increased by 13% versus an 8% sales increase with a comp margin of 47.7%. And going through the lines in a little bit more detail, you can see the comp grew ahead of sales, and this was really driven by cost discipline in both R&D and SG&A. Other revenue, as Alan mentioned, increased 16%. This was primarily driven by the increases in profit share income for the higher sales of Xolair outside the U.S. And as he mentioned, Venclexta in the U.S. Cost of sales increased by 8%, in line with sales growth, and remains stable at around 18% as a percentage of sales. And again, this is including the base effect of Ronapreve provision release from last year as well as that 14% of volume increase. So I think overall, really good performance on cost of sales. R&D Cost increased only by 1%, which is about 24% of sales and SG&A costs increased by 5% in pharma as a percentage of sales, though it decreased to around 15%. As Alan mentioned, this was due to increased investments, including marketing and distribution costs to support our ongoing launches, particularly Vabysmo, Phesgo and XOLAIR in food allergies. So I think, as Alan mentioned, money well spent. And then other operating income and expenses decreased by 25%, and that is solely due to lower gains on disposals of products. So Thomas and Alan shared with you their favorite slides. This one is mine. Our young portfolio continues to deliver strong growth, led by our key brands: Vabysmo, Phesgo, Ocrevus, Hemlibra, Xolair, Polivy and Evrysdi. Combined, these added CHF 3.9 billion of new sales last year, which is really impressive. For the first time, Polivy has achieved blockbuster status, making it our 17th blockbuster of 2024 when you include Venclexta. So now let's take a deeper dive into our therapeutic areas, and let's start with oncology. Oncology sales increased by 3% to CHF 15.8 billion in 2024. Let's start by highlighting some of the latest news flow for our most recently launched NME, Itovebi. On Tuesday, we shared with you in the final analysis of INAVO120 that Itovebi met the key secondary endpoint of OS benefit. And we are very much looking forward to sharing this data at future medical congresses and with regulators around the world. While the U.S. launch is ongoing, we expect EU approval in the first half of this year. With the HER2 franchise, we finished strong Kadcyla delivering 7% growth in Phesgo with 62% growth. Global conversion rate for Phesgo has climbed to 46% from 43% in Q3 and we would fully expect to exceed 50% in 2025. Moving on to Tecentriq. In 2024, sales overall were stable. That's primarily driven by small cell and HCC. We do believe, as we have mentioned previously, that Tecentriq is getting close to peak, and we expect sales growth to be in the 0 to low single-digit range going forward. Looking ahead at what's to come in 2025, I want to specifically call out the 2 highly anticipated Phase III readouts for giredestrant, persevERA in Q4 and evERA in Q2 and we are very much looking forward to sharing the outcomes of these potentially standard of care changing studies. So let's turn our attention to hematology. Hematology continues to deliver strong growth. We ended the year at $7.9 billion in sales with 15% growth, and let's start by looking at Hemlibra. In Q4, growth was strong across all regions and patient segments with good underlying market demand. We saw a very strong Q4 performance in the U.S., 20% at constant exchange rates, and that was driven by a large specialty pharmacy order, which is very similar to the pattern that we've seen in previous years. Going forward into 2025, we would expect a mid-single-digit growth globally for Hemlibra. Staying with our hemophilia portfolio for the moment. As Thomas mentioned, we have the Phase II readout of our next-generation bispecific in hemophilia, NXT-007. That is anticipated around midyear. If positive, this will lead to the initiation of a Phase III development program later in 2025. And as a reminder, we believe that NXT-007, which is 30x more potent than HEMLIBRA has the potential to receive 0 treated bleeds without the need for additional factor VIII treatment. So this would really allow us once again to change the treatment paradigm for patients suffering from hemophilia A. Moving on to Polivy. In the U.S., first-line DLBCL patient shares keep on climbing. We're now at 29%. Polivy has been used in more than 42,000 patients globally. We also recently shared the 5-year POLARIX data indicating a positive trend in OS with the hazard ratio improving from 0.85 to -- improving to 0.85 from 0.94 in the 3-year data, which we believe will further support uptake. COLUMVI and LUNSUMIO launches are progressing on track. For LUNSUMIO, we completed U.S. and EU filing of the subcutaneous formulation, which has all the benefits of the available IV formulation with the added ease of subcu. Looking ahead into 2025, there is quite a bit happening in hematology. We expect to move both COLUMVI and LUNSUMIO into second-line DLBCL, much bigger opportunities. For COLUMVI, this means U.S. EU approval based on the positive STARGLO data with the PDUFA set for July 20. And for LUNSUMIO, we're expecting that Phase-III SUNMO data in second-line DLBCL. For LUNSUMIO, there are 2 additional events, the U.S. approval of the subcutaneous formulation and third-line follicular which I just mentioned, and the Phase III readout in second-line follicular. We're also expecting Phase III readouts for VENCLEXTA in first-line MDS and PiaSky in aHUS. So a lots to look forward to in hematology this year. Next up, let's talk a little bit more about our recent acquisition of Poseida in its allogenic CAR-T portfolio. We've long believed that the Poseida Allo CAR-T technology could potentially be best-in-class in malignant hematology. The early data in multiple myeloma suggest very strong clinical activity comparable to the auto BCMA CAR-Ts. Now with this acquisition, we are going to be moving quickly to bring this approach into MS and SLE as well with INDs already granted. And we're excited about the possibilities for patients represented by these programs. And with the deal now closed, we'll be able to bring you more regular updates in the coming months. So with that, let's move on to our neurology franchise. The neurology franchise continues to deliver strong growth of 13% at constant exchange rates, achieving CHF 9.3 billion in sales. Starting with OCREVUS, the market leader in MS and more specifically, Ocrevus Zunovo, our recently launched subcutaneous formulation. The launch is progressing as planned, and we continue to see very positive signals. In the U.S., more than 50% of Zunovo patients are naive to OCREVUS. And we see accounts that have not used OCREVUS IV in the past prescribed Zunovo. As we've said earlier, Ocrevus Zunovo expands the addressable market for OCREVUS, and it's not simply just about converting IP patients to subcutaneous. So far, we have more than 25,000 patients globally on Ocrevus Zunovo. And while we are waiting for a permanent J code to be issued in April of this year in the U.S., we would expect that, that permanent J code will lead to an acceleration of uptake in the U.S. And we remain quite confident in our $2 billion incremental sales projections for Zunovo. Looking at OCREVUS as a whole, we closed the year with 9% growth. Q4 U.S. sales were negatively impacted by Hurricane Helene, which as many of you know, disrupted IV supplies and therefore, reduced IV administration capacity as well as some modest year-end buying patterns. That having been said, the first few weeks of sales in 2025 have been quite strong, and we expect global sales growth to be in line with what you saw in 2024. So overall, high single-digit growth. Evrysdi maintains its strong global position in SMA, achieving 18% growth in 2024, and we expect similar global growth rate in 2025. We are anticipating approval of the tablet formulation for Evrysdi later this year. The tablet simplifies storage, eliminates the need for cold chain and increases the ease of administration, which is 3 great benefits for patients. If needed, that tablet can be dissolved in water. We are looking forward to bringing this innovation to patients and to further expand on the Evrysdi best in disease profile. Elevidys, the first gene therapy for DMD has now been used to treat over 80 patients in the ex-U.S. ex-EU region. Additionally, earlier this week, we shared positive top line results from the 2-year follow-up of the EMBARK study, which will be shared with the EU regulators, and I will talk a little bit more on that in a minute. Last December, we also shared the top line results for the Phase IIb PADOVA study in Parkinson's. This as well, I'll cover in more detail in an upcoming slide. So another big outlook year in 2025 for neurology. In particular, this is going to be quite the year for MS. OCREVUS high-dose data is expected and has the potential to be best-in-class, best in disease setting a new standard care in MS. We also have the long anticipated Phase III readouts for fenebrutinib in RMS and PPMS, which we continue to believe has best-in-class potential based on the strong Phase II data that we've seen. There are 2 Phase II readouts for GYM329 expected in 2025. In combination with Evrysdi and SMA and as monotherapy in FSHD. And last, but certainly not least, we expect to share additional Phase I/II data cuts for trontinemab in Alzheimer's disease at ADP and CTAD. Gated upon these results, we are planning to move trontinemab to Phase III by the end of the year and with FPI to be achieved in the second half. So let's take a little bit of a closer look at the 2-year embark data for Elevidys, which we shared on Monday. The Phase III EMBARK 2-year data clearly reinforce the significant and sustained functional benefit for DMD patients. This benefit is seen across the primary and 2 key secondary functional endpoints of NSAA time to rise in the 10-meter walk run when compared to propensity matched external cohort control. As you can see in the graph on the left, Elevidys is favored in all 3 of these functional endpoints and functional differences between patients treated with Elevidys in the external control are getting larger between 1 year or 2 years after dosing. Additionally, pulled 3-year data from Studies 101, 102 and Cohort 1 of Study 103 demonstrated consistent and durable clinically meaningful benefits compared to external control. Combined, we believe that this underscores the positive impact that Elevidys can have for DMD patients, their families and caregivers. We plan to present both data updates at FDA and share the EMBARK 2-year data with regulators to support ongoing approval processes. Moving on to prasi in Parkinson's. In December of last year, we shared the PADOVA missed the primary endpoint. However, a suggested possible benefit in patients with early stage Parkinson's on L-Dopa treatment was observed. This was a prespecified analysis, and these patients were accounted for 75% of the trial population. Further data evaluation is ongoing, and we're awaiting additional insights from the open-label extension. Together with regulators, next step for prasi will be determined later this year. To remind us all, we continue to see this as a high-risk, high-reward opportunity. But given the unmet need, we did feel like it was important to let this trial play out a little bit longer. So with that, let's move on to immunology. In 2024, our immunology franchise achieved CHF 6.3 billion in sales and grew 5% at constant exchange rates. The key growth driver here is certainly Xolair and its launch in food allergy. We are very pleased with the launch uptake, having reached the milestone of 40,000 patients on treatment. As I mentioned in Q3, we expect the year-over-year growth momentum in the mid-teens for 2025. Our second key growth driver here was Actemra. As we mentioned in Q3, the U.S. and EU biosimilar launches continue to be slower than expected. We currently expect biosimilar erosion to pick up speed in the coming quarters, especially in second half of this year. We have previously shared with you the exciting news of positive Phase III data for GAZYVA and lupus nephritis, a program you all know that I'm very fond of. We look forward to presenting the full data set at the World Nephrology Congress in February. Our IR team is also preparing a call in parallel, and that data has now been submitted to the U.S. and EU regulators, and we would expect approval decisions later this year. Going to our immunology outlook and staying with GAZYVA for the moment, we expect Phase III data from our ALLEGORY trial in SLE later this year. Astegolimab in COPD is also expected to read out later this year. And there are multiple upcoming developments in our anti-TL1a portfolio, which I will talk about now. So I am very excited to share the progress that we've seen with our TL1A program recently. As you know, TL1A is a highly validated pathway that's important in a number of disease areas. We previously shared that our Phase III and you see is ongoing and enrolling rapidly. And that our Phase III in Crohn's is expecting FPI this quarter. It's safe to say that we're moving at pace with our IBD trials, but as you know, we are not stopping there. We did share a JPM that we are initiating a Phase IIb trial in atopic dermatitis and the Phase Ib trial in MASH in Q1 with additional indications under consideration. We've also added an anti-P40 TL1A bispecific to our pipeline, and that Phase II in IBD will initiate later this year. Now moving on to ophthalmology. So in ophthalmology, sales reached CHF 4 billion last year with an impressive growth rate of 44% at constant exchange rates. This franchise is led by Vabysmo, which continues to expand its U.S. market share across all 3 indications. Before we get started, I did just want to call out that after our last IR call, we were informed by the third-party vendor that provides our market share numbers of a restatement of the Q3 U.S. market shares. We believe that this was related to stock-outs of other products included in the market definition, primarily [indiscernible] and Avastin. To account for this, the Q3 values were restated to improve accuracy. Because of this change, you can't directly compare the Q4 values here to the ones that we shared at Q3. If you do compare the restated Q3 values to the Q4 Vabysmo market shares, we expanded in each of its 3 indications by roughly 3 percentage points. We expect that you'll once again be able to see the expanding market shares when comparing Q1 2025 to the Q4 '24 values you see here. We remain confident that Vabysmo is well on its way to becoming a new standard of care. Our share of naive patients within the new-to-brand patient segment remains greater than 50%, indicating a very strong preference of ophthalmologists to use Vabysmo in the frontline setting. Performance in the U.S. in Q4 was impacted by the significant channel filling. We saw immediately after the launch of prefilled syringe. So we saw a little bit of a spend down in Q4, but we are seeing a strong trajectory for Vabysmo in our January sales to date. Staying on the topic of our next-generation prefilled syringe, we achieved EU approval in Q4. U.S. conversion rates continue to climb to above 85%, clearly indicating that HCPs are very eager to use the simplified administration option. Regarding the 2025 outlook, we expect to see continued strong growth and further market share expansion. And as I said, we remain confident that the Vabysmo is well on its way to be a new standard of care. Moving on to Susvimo, our AMD commercial relaunch in the U.S. is on track with roughly 100 implants completed in 2024. As a reminder, in this stage of the launch, it's all about getting new ophthalmologists, exposure to Susvimo and trained on how to perform the implant in refill exchange procedures. This is very much a story of going slow to ultimately go fast. For 2025, we aim for a few thousand implanted eyes. Also in 2025, we expect to complete the EU filing in AMD. And lastly, our new NME, vamikibart, which could become the first IL-6 in ophthalmology is expected to have pivotal results in UME later this year. And finally, before I get to our 2024 and 2025 news flow, I wanted to take a quick look at how our pipeline reshaping is progressing. Complementing on what you saw from Thomas earlier. I'd like to highlight our continued efforts to strengthen the pharma pipeline. You can see the different additions and removals over time, and there are 2 recent additions in Q4 that I just want to call out, the allogeneic CAR-T that we added as part of the Poseida acquisition and the ADC DLL3 in small cell, which was added to our pipeline via a deal with Innovent. All in all, we brought in 10 assets via high-value partnerships since Q2 2023, and at the same time, our internal R&D engines, pRED, gRED and Chugai delivered 14 new NMEs. Next, I want to quickly show you the final 2024 news flow. You know this slide well from all of our quarterly results last year. There were 3 final updates in Q4, which you are aware of. The tiragolumab in first-line PD-L1 positive non-small cell was negative. As previously mentioned, the readout for prasi, and then trontinumab in AD had positive interim data cut, which we did present at CTAD. And so with that, let's take a look at what we can expect in 2025. As mentioned by Thomas, we expect 12 key Phase III readouts this year. And this includes 4 NMEs, but also importantly, 7 Phase III enabling readouts. So let me just quickly highlight some of the key Phase III readouts. We have the giredestrant program in first-line and second-line HR-positive metastatic breast cancer. We have LUNSUMIO plus Polivy in second-line DLBCL. We have OCREVUS high dose in RMS and PPMS, fenebrutinib and RMS and PPMS, astegolimab in COPD and vamikibart in UME. In addition, we also have multiple Phase III enabling readouts, including NXT-007 in hemophilia A, tronti in AD, GYM329 in SMA and FSHD, zilebesiran in uncontrolled hypertension, CT-868 in type 1 diabetes with obesity and in CT-996 in obesity with type 2 diabetes. As you can see, it is going to be quite a busy year, and I'm looking forward to sharing the news flow with you as updates come in. I am also pleased to say that as we get to the end of January, we already have our first green tick, and that is for the LUNSUMIO subcu filing in Europe. And now I will hand it over to Matt to guide you through our diagnostic results. Matt?
Thank you, Teresa. All right. So good morning, good afternoon, everyone. It is my pleasure to present the full year 2024 Diagnostics Division financial results. So as you heard from Alan and from Thomas, our diagnostic sales grew 4% at constant exchange rate, and our base business grew at plus 8%. Now the increase was mainly driven by our strong base business growth of 8%. But as you previously heard, this is the last time we will discuss COVID-19 sales separately from base as this disease has transitioned to an endemic state. And so now I'll walk you through the results by our different customer areas. So first, sales in our core lab increased at plus 8% with strong momentum driven by Immunodiagnostics, which grew at plus 9% and clinical chemistry, which grew at plus 8%. Molecular Diagnostics had an increase of plus 4% due to strong growth in our virology based business, which grew 10% as well as our donor screening blood screening business, which grew at plus 17%. Now this was again offset by lower COVID-19 PCR lab-based testing sales and excluding those, molecular lab grew at plus 8%. Our new customer area, which you heard about earlier, near-patient care had a decline of minus 17% and this is mainly due to lower COVID-19 rapid antigen testing as well as the steady decline of our blood glucose monitoring business at minus 4% due to the market shift to continuous glucose monitoring. Our point-of-care business grew at plus -- our base point-of-care business grew at plus 6%, and this is really driven by our point-of-care molecular diagnostics business, excluding COVID-19 sales, near-patient care decline of minus 1%. Not to be outdone, our pathology lab grew at plus 17%. This was mainly driven by our advanced staining business, which grew at plus 12% as well as companion diagnostics, which grew at plus 41%. So now I'd like to shift gears and walk through the sales results across the different regions. So first, excluded COVID-19 business, we see strong base business growth across North America, EMEA and LatAm. And in North America, the base business, excluding COVID, grew at plus 8%. In EMEA, the base business, excluding COVID-19, grew at plus 6%. In LatAm, the base business, excluding COVID-19, grew at plus 23%. Now in APAC, the base business growth, excluding COVID-19, grew at plus 3%. And sales growth in Q4 was impacted by volume-based procurement and reimbursement reduction for immunoassay in China. Now while our consistent ambition for the Diagnostics business is to grow at mid- to high single digits. As a result of the headwinds from VBP and the reimbursement reductions in China, our ambition for 2025 is to grow the business by low to mid-single digits, which will be a 1-year dip with a return to our consistent ambition in the years beyond. I would also call out that China is still a critical market for us, and we continue to be the market leader. So now let me walk you through the diagnostics divisional P&L line by line. So core operating profit on sales of CHF 14.3 billion, increased by 12% at constant exchange rate versus 2023. Cost of sales increased by 1%. Now this is driven by favorable product mix, really due to lower sales of COVID-19 rapid antigen test. R&D costs increased at plus 2%, mainly driven by the integration of LumiraDX as well as investments in some of our upcoming late-stage launches such as sequencing mass spec and continuous glucose monitoring. SG&A increased at plus 3%, driven by those high distribution costs you heard from Alan as well as increased sales volume and the commercial costs associated with the preparation of these upcoming launches. This resulted in core operating profit of CHF 2.4 billion with a margin of 16.8% at reported currency. So now I'd really like to talk about some of the exciting innovation that we launched in 2024, specifically starting with our core lab and our mass spec system. So I'm very pleased to announce that we successfully received the CE Mark for our cobas mass spec system along with the Wave 1 steroid assays. The current mass spec market, which is valued at CHF 3 billion is predominantly composed of lab-developed tests that require specially trained technicians, special laboratory arrangements. And with this launch, we intend to establish and shape the IVD market for automated, simplified end-to-end mass spectrometry testing and driving market expansion. Our ambition is to reach CHF 1 billion in sales by the end of the decade. And this year, we will launch over 40 new assays in our first wave, which will cover the vast majority of routine mass spec testing, and the second wave of tests will follow in the coming years. With our easy-to-use solution, which addresses the shortage of skilled labor, as I mentioned earlier, as well as the lack of standardization and automation, plus it has high level of synergy with our existing serum work area, the launch of mass spec presents a real opportunity for us to expand our existing leadership in the core lab. And so on the theme of expanding our leadership, I'd like to talk about our cobas 6800 and 8800 version 2. Now I'd highlight that the CE launch of our version 2 update of our high-throughput PCR systems, the cobas 6800 and 8800 will further extend our competitive lead in the molecular lab and is field upgradable to our installed base of thousands of 6800 and 8800 around the world. These were the workhorse systems where we responded to the COVID-19 pandemic, and they're going to be an engine for our growth into the future. This update is fully compatible with our new tag multiplex assay such as our respiratory syndromic panel flex test, which we launched last year, which tasked for 15 different viruses from a single well sample. And we'll strengthen our position in the mid- to high throughput segment of the molecular diagnostics market. We will have the only high-throughput platform capable of syndromic panel testing. With this update, we introduced increased testing flexibility, such as the addition of a stat lane for urgent samples, greater automation of molecular work flows through being able to batch up to 6 assays in a single run, and we will offer customizable quality controls that will enable improved run costs. So in addition to those upgrades, we also improved the throughput. The cobas 6800 will increase from 384 to 576 task per 8-hour shift. This further solidifies and provides an opportunity to expand our leading position in molecular diagnostics. So not only are we leading on the platform side, I'd like to talk about some of the innovation that we're introducing as well in terms of the next generation of diagnostic assays. And specifically present the recent clinical study results for Elecsys Amyloid Plasma Panel, which consists of 2 blood-based biomarkers, pTau181 and Apolipoprotein E. Alzheimer's disease continues to be a global burden, affecting more than 50 million individuals annually and is projected to reach over 80 million people by 2030. However, 2/3 of people experiencing cognitive symptoms remain undiagnosed, and diagnosis usually takes more than a year and up to 2 years, requiring subjective cognitive tests as well as imaging analysis. In this study, we enrolled 492 patients with suspected cognitive impairment across 30 different study sites. Our results demonstrated excellent clinical performance and a negative predictive value of over 90% independent of comorbidities and demographics for both the EAPP panel as well as pTau181 as an individual biomarker. Pending regulatory clearance, we hope this test will provide a minimally invasive blood-based test to rule out Alzheimer's disease and decrease the time to definitive diagnosis. This will have a significant impact on patients, their families and health care systems around the world. So we talked about favorite slides, I guess. And I'd like to say this is certainly my favorite side. Last year, we said 2024 was going to be the biggest year for diagnostic launches. And what I'm proud to say is that we achieved all of those. We received all 12 key launches shown here, including our first CGM, the Accu-Chek Smart Guide, our serology blood screening solution for the United States. We're already taking significant market share in and winning business. The first clinical mass spec solution, as I mentioned earlier, as well as our next-generation clinical chemistry and ISE solutions. Now in 2025, we have additional important launches. I'd like to call it a few by customer area, the first is what we just spoke about. Our Elecsys pTau181, which as I mentioned before, could provide a convenient test to roll out Alzheimer's disease. Furthermore, we'll expand our mass spec menu with more than 40 assays in the first wave. For the molecular lab, we will launch cobas BV/CV. It is a molecular test to aid in the diagnosis of bacterial vaginosis and Candida Vaginitis, which will help complete our menu in the rapidly growing STI market segment. Now we're also approaching this from the point of care side for near patient care, I'd like to call out our cobas liat CT/NG, which is our first green tick of the year, a rapid multiplexing test that can detect and differentiate chlamydia and gonorrhea at the point of care in a CLIA wave setting, which we just received FDA approval. In Pathology, we will have a major update to the Roche Digital Pathology platform with enhanced image management, a fully redesigned user experience and enhanced interoperability with third-party scanners. Combined with the primary diagnosis claims, for our DP 200 and DP 600 scanners last year, this positions us well for the rapidly growing digital pathology market segment. And last, but certainly not least, I'm pleased to invite you to our upcoming diagnostics IR events. We, at AGBT, will be unveiling our core sequencing technology, and I'd like to invite you to an IR event taking place virtually on February 20. During this event, we will provide an update on our sequencing technology as well as hold a Q&A session. And second is our annual Diagnostics Investor Day on May 27. This is going to be a hybrid event held in London and online. We have an exciting agenda covering all of our customer areas where we will further discuss our forthcoming Roche sequencing solution as well as our entire pipeline across all customer areas. So I look forward to seeing you there. And with that, I will hand it over to Bruno.
Thanks, Matt. And I will just quickly use the opportunity to have here a final slide to sum up on the upcoming IR events. A couple of them we touched upon already. The next one is to come already next week Friday, February 7. This will be immunology, the data, the GAZYVA in lupus nephritis, which are presented at the World Congress of Nephrology, which we will have some time to discuss. Then the update of NGS mentioned by Matt. And then on April 4, we'll have a neurology update. Here we have a couple of topics to cover. First of all, it's the Elevidys EMBARK 2-year data in DMD, where we just had a top line release, which we expect to be presented at MDA and then 2 additional data sets from ADPD prasinezumab, the PADOVA data from end of last year and then the latest data cut for the brain shuttle. You see them as mentioned already by Matt again, the Diagnostics Day is scheduled for May 27, as a live event again in London with the NGS solution being the highlights this time. And then we already said also a date for Pharma Day in the second half, which is now scheduled for September 22, so that you can put it in your calendars. Just looking at the intense news flow ahead of us in '25, I think there will be many more IR calls, especially in the second half. I can imagine we will have something on hematology midyear, but then also, I would say, EASD CTAD, just to call out a view of the upcoming medical conferences second half where we are likely to have additional calls. And with that, I think we can open the Q&A session.
The first question would go to Richard Vosser from JPMorgan.
Two questions from me, please. Firstly, one on the Vabysmo. I think we understand the temporary weakness in the quarter, but I wanted to ask about the launch of a prefilled syringe for high-dose EYLEA and how you would see that affecting Vabysmo, Obviously, very key and you're doing really well with yours. But in Europe, they have a prefilled syringe for high-dose EYLEA, so thinking about how that might affect you in '25. And then second question, just on giredestrant, maybe a little bit of a pushout on the persevERA data into Q4 and October on clinical trials. Just what do you see as the implications for that on your thoughts around the expectations for the results of the trial?
I'll start with the last one. So I don't think that has really any implications on the results. Just sometimes these things take a little bit longer, and that's what we saw with giredestrant. The prefilled syringe, so I would just have to say, right now, we're really not seeing any impact in any part of the world from high-dose EYLEA. And the prefilled syringe that we have in the market is materially different than the prefilled syringe that EYLEA has. It has 1 hand administration, which when you think about it, if you're doing 1,000 shops or 100 shots a day, having that really ease of administration is super important. So I would say we definitely have a device preference going on our side. And quite frankly, I think just what is inside the syringe matters a lot. And Vabysmo is clearly continuing to distinguish itself from an efficacy and safety standpoint. And with the added convenience of the prefilled syringe, I would just continue to see it growing and continue to establish itself.
Maybe, Richard, let me quickly add to your first question on giredestrant. I think there was no real change in the underlying time lines. That's more an issue with when certain things get updated at clinicaltrials.gov. For the both studies, evERA and persevERA, we expect the data to come in somewhere around midyear second half. We cannot be more specific, as you know, these studies are event-driven, but nothing really fundamental that changed here. Any additional questions from your side?
No. No, Bruno and Teresa.
Then the next questions go to Emily Field from Barclays.
Just on that last point, I think Teresa said during the prepared remarks that persevERA would come in Q4. So I just wanted to clarify that and make sure that's correct. Yes. So then Mike, I'll ask 2 questions. Firstly, on the high-dose Ocrevus. So you've helpfully quantified the incremental revenue opportunity that you see from subcutaneous Ocrevus. But I was just wondering if you could help us frame how to think about the commercial potential for high-dose OCREVUS. Obviously, this trial is versus the standard dose. So do you see this as additive to the franchise or just transferring patients over? And does high dose provide any opportunity to extend IP? And then secondly, I know that you were expecting first pivotal readouts from orfogliperon later this year, and you'll be getting if successful, a royalty from that. But I wanted to ask more just on whether you see the success or failure of that compound as having a read across to CT-996. And if you could just remind us on how the 2 molecules are differentiated.
Emily, maybe just to quickly add, I think I said on the time lines of giredestrant, midyear to second half, it's, of course, we cannot be more specific right now as that's event-driven. You will get the information as soon as we have it. And then the other questions.
Yes. So as far as high dose goes, I don't think we've actually shared what our commercial expectations are for high dose. Once we get the data, we will be able to share some additional information with you, assuming that, that data are positive. From an IP perspective, I think should high dose be positive, and we begin to look at putting it into devices, I think there is definitely some opportunity for expanded IP, and we'll be able to comment more on that once we get the results.
Can I take the last one?
Yes.
Yes. So on that one, I would say the difference clearly is that CT-996 is actually a small molecule. So from a production standpoint, has advantages versus a peptide. So it's very different in terms of the 2 molecules. Regarding royalty income, that would not be obviously this year. But in case it's positive, then in future years, there would be additional royalty income.
Emily, did we answer your questions? Or do you have a follow-on question?
Yes. No, that was great.
Okay. Then we move on. Next 1 in the row is Sachin Jain from Bank of America.
Two, please. Teresa, just on the 2 surgeries, maybe just give a bit of a big picture on evERA and persevERA. How you think about the probabilities of those 2 studies different? And perhaps you could just touch on the commercial opportunities of both, I think, evERA is generally perceived as quite small, if that's incorrect, if you could just clarify. And then Thomas, just a big picture question. Your second favorite slide after cash, I think, was the group sales slide showing sequential growth at 9% and 11% in the last few quarters. So I just wanted to touch on what you think the '25 headwinds are? The slowest to mid-single digit for this year other than Actemra, which I think is less than 1%. Is there anything we're missing there?
Do you want to start with that?
Sure. I can go first. I think one of the headwinds was mentioned by Matt, so the volume-based procurement that's happening in China. And other than that, I would say, look, we're at the beginning of the year, we have almost 1 month behind us, and let's see how the year goes.
And in terms of giredestrant, I think we do believe that this has the opportunity to be a multibillion-dollar franchise. When you look at all of the different indications. And I think persevERA has that patient population is first-line endocrine-sensitive that's 60% of first-line patients, the [indiscernible] patient population is the first-line endocrine resistant. That's another 40% of patients. So between the 2 of them, we really get the full first line covered. And evERA again, gives us another set of that patient population that we would need to cover the entire spectrum of endocrine-sensitive patients. So I think we believe that we actually have the trials that would allow us to cover every single patient population and ultimately get to that multibillion-dollar opportunity.
Just anything on the relative probabilities of the 2 studies? Teresa, are you willing to comment?
Yes, I think the...
I think when you know, Sachin, what we have been communicating is, of course, the success likelihood for the later lines is a bit lower than, for example, the adjuvant setting next year. This is just logical. If you look at it, you have the treatment on top of other treatments, and you have a more diverse patient population, which has some level of resistance, which was building up over time. not only ESR1 mutants, it's also other resistant mechanisms, which come to play. And I think this leads to an overall success likelihood. Next year, then '26, I think this is the big one, the adjuvant study to watch out. And I think this is also the most opportunity, which will allow us, if successful, then really to reshape the landscape and the treatment paradigm. Sachin, any other questions or that's all from your side?
No. That's perfect.
Then we move on. Next questions would go to Matthew Weston from UBS.
Two for me, please. The first on Ocrevus Zunovo. It's clearly launching well. One thing Thomas called out in terms of the sustainability of growth at Roche was the limited biosimilar exposure. Obviously, one of those in the future will be a normal dose Ocrevus. Can you help us understand any additional IP that Zunovo brings? What should we be thinking of in terms of the long-term potential there? And then secondly, sorry to stick on patent expiries. But one of the statements that captured a lot of attention at the Pharma Day was that you had high confidence that we would not see U.S. XOLAIR biosimilar entry in 2025. Can you now give us any understanding of how far you think that protection will go, especially given you called out investing in Xolair as one of the reasons for investing in significant SG&A in Alan's comments.
Great. Two good questions. So when you look at the OCREVUS franchise between Zunovo, between other device formulations that we might be looking at high dose. I think you can assume that we are considering ways to extend the patent life of OCREVUS. So I can't say more now, but I think you should take comfort in the fact that we're looking at this quite actively. In terms of patent expiry for Xolair, we can confirm that there will not be biosimilar entry in 2025.
And maybe to add to, Matthew, on the IP situation for Ocrevus. I think in case Ocrevus high dose would work out, I think just would have given the additional patterns. If a combination of Ocrevus high dose and subcutaneous would then be another development opportunity would come with a newly developed injector, for example, would give another layer of IP. So I think there are several layers which should help us to prolong the franchise.
Bruno, if I'm allowed -- apologies to others. If I can just ask 1 additional follow-up. Because you raised high-dose Ocrevus. Emily asked about it as well. It's obviously one of the next readouts for Roche. You've got 2 arms. The people who are, I guess, let's call it overweight, and I understand why you hope it will work there. In the normal weight cohort, what evidence gave you confidence that more Ocrevus might give you more efficacy? Because I recall in the past, Roche, always being very strident about the fact that Ocrevus gave full CD20 inhibition in the setting. So what can more bring?
Yes. So I think as we design the high dose studies, we looked very carefully at the Phase II studies where we actually saw the increased efficacy when you reach higher saturation points. So I think we are -- that certainly would make sense in overweight patients. But I think we are -- our assumption is that, that might actually also extend into normal weight patients, and that's just based on data that we've seen to date.
It was a retrospective analysis, which we did, Matthew, I think, and we have looked into all confounding factors and imbalances in the different subsets but it's not that we believe that the effect we have seen would be primarily driven by weight.
Exactly. And again, in those exploratory analyses post the Phase III, what we did see was just slowing of disease progression with higher exposure to OCREVUS. So hence, the high-dose study.
Okay. Then next question would go to Simon Baker from Redburn.
Two questions, if I may, please. Firstly, 1 for Alan. I know you don't guide on the cost lines, but I just wonder if descriptively give us some indication of the movement we should expect in the various cost lines to get to the employed margin expansion within the '25 guidance? And then secondly, on the anti-TL1A, the move into MASH. It's obviously a very interesting and potentially very large category. I think you're the first person or first company to move into the clinic in that indication. I just wonder if you could give us some color on the basis for moving into MASH with the TL1A.
Do you want to take the cost question?
Yes, I think, first, I have to say, Simon, guidance is the guidance, I think, for 2025, and that's what we orient ourselves on. Everything in between certainly needs flexibility and will allow us to have. I think we have said that we want to be, how shall I said, flattish around R&D. I think that's pretty clear. That's why I can mention it. I can also mention that in other operating income, we expect a little bit less gains from product disposals. I think that's another one. I would argue all the other lines, we will apply the best cost discipline, which makes sense to do that. But overall, the guidance is the guidance.
And I think as we mentioned, TL1A is a very clinically validated target in immune disease, but it also has an anti-fibrotic component. And so I think as we were considering where were there opportunities to expand, looking at diseases that have fibrotic pathogenesis, it just made sense to kind of look at something like MASH with TL1A.
I'm struggling here to have a technical issue. I cannot open my screen window right now. It's hidden somehow. So I don't know what to do. I think we probably have to stop the call for some technical reasons. Basically cannot help with anymore.
Bruno, if you [indiscernible], shall I ask question.
Yes, you please.
It's James Quigley from Goldman Sachs. So 2 questions, please. So first 1 on the margin. So I mean, you had some nice increase in the margin across both divisions this year. Given this increase and with the move over time away from the specialty pharma areas that have been higher margin maybe to some more primary care areas. How does it impact your ambition to defend the margins? You're keeping R&D flat as you just mentioned in '25, but how should we think about the margin levers over the medium term? And secondly, on prasi, as you mentioned, we're going to see some next steps this year, but what are the potential options here? Given the data you've seen so far, what is the probability that you could potentially move straight to registration? Or would you need to run a -- is it more likely that you need to run a Phase III? And then again, how long could that last?
I can take the first question. As I stated before, the goal is to at least keep the margins as a percent of sales stable. That means, of course, in absolute terms, we'll continue to increase the margins. And I always say at least ambition. It can always be higher than that, but the point is to at least keep it stable. And as you can see, for 2025, we actually intend to expand our margins. So we'll give you more updates then as we get to the '26 and so on. But long term, that would be my clear guidance.
And as far as prasi goes, so the open-label extension study is continuing and we will evaluate that data over time, talk with regulatory authorities and see if the signal that we saw in the first part of the trial sort of continues to reveal itself. A decision on what we will actually do with that trial, I think, will come after we see more information. I think it would be highly unlikely that we would move straight to registration. This remains, I think, as we've always said, a very high-risk, high-reward program.
Henrik, maybe you can please take over the moderation and just ask the next 1 in the row to open the line and ask them to ask the questions.
Sure. So next on the line is Richard Parkes.
First one, I'd just like to push you a little bit more on giredestrant because generally, investors are quite skeptical about the classes potential outside of the ESR1 mutant population. So can you just help us understand what gives you optimism in the persevERA study around broader potential outside ESR1 mutant patients? And can you confirm that the evERA study is powered to show a benefit in that population, therefore, obviously would be lower risk. And then secondly, on TL1A, obviously, with another competitor showing proof-of-concept data, the potential of that class has become a lot more visible to investors and speaking to KOLs, it sounds like development of a biomarker is an important aspect to driving uptake of the class, which seems to position you quite positively given your experience in inflammatory bowel disease and with biomarker development. So can you talk about where you're differentiated in development of the biomarker and how yours differs to other companies?
Yes. So let's start with TL1A. So I mean, I think that we haven't said much about the biomarker other than it's there, and we will consider it through the development program. I think we are very excited about this molecule and this pathway. And to your point, our prior experience in IBD and our experience with biomarker development, our experience in many different therapeutic areas and diseases where TL1A could potentially be relevant makes us very excited about the full opportunity of this molecule over time. As you know, we're in a head-to-head race with Merck. We've got another molecule that's sort of further behind. But I think all of the data that we continue to see across the different molecules are out there reinforces that this is a valid pathway that these molecules have benefit. And I think we're yes, we're really eager to actually see what it can do in patients. So definitely more to come on TL1A. To answer your last question first, so evERA is powered for both ITT and ISR 1 mutants. We are confident that we have powered the trial appropriately. Just to remind everyone why I think we are so -- why we were so excited about giredestrant when the program kicked off, I mean, it is the highest preclinical potency of any oral SERD that's out there. It seems to be combinable with all CDKs. And it's well tolerated at all doses, which I think, again, makes it quite different. It has true endocrine backbone potential which is very different than what we've seen with some of the other drugs that are out there. Giredestrant has shown robust data in early trials and in metastatic settings. And as a monotherapy and in combination. So I think the trials that we have out there right now, they start to answer some questions. The big kahuna is kind of coming in 2026. But I think this is a molecule which we've seen evidence of efficacy. And so now we just need the trials to read out.
Can I just ask one follow-up. Can you just confirm that with your TL1A you do have a biomarker integrated into the Phase III trials that are underway and planned?
Yes.
The next person in line would be Rajesh Kumar.
On the GYM asset, can you talk through what your ambitions are in combination with obesity development place? That would be very helpful. And then firstly, revisiting trontinemab, can you give some color on the time lines of where are we going to hear from you again? And what should we be looking out for when you update us on your go/no-go decision?
Yes. Great. So as I mentioned, GYM329 is active in a number of places. So we've got the combination trial with Evrysdi as well as the monotherapy trial in FSHD, but we are also looking at it in combination with our obesity assets. We have some preliminary data in-house. We have made the decision to move into combination trials. And it's still very early days. But I think we can easily say that this is definitely something that we'll be taking forward. So more to come, probably not too much more I can say right now. With regard to tronti, we'll share additional data cuts of the ongoing dose-finding study at ADPD in half 1 and at CTAD in half 2. We're currently awaiting the completion of the Part 2 expansion cohorts to inform the final dose. Once we have the final dose, we'll be able to move into Phase III. I think you heard at Pharma Day last year, and I reiterated at JPMorgan at the beginning of the month, the trontinemab is one of the fast-track assets that we've been really focused on through R&D excellence. And so we've been working very closely to actually do as much of the front loading for that Phase III trial as we can so that once we get the final dose, we'll be able to move very, very rapidly into Phase IIIs. So expect to hear more from us on that this year.
The next one in line will be then Justin Smith from Bernstein.
Justin Smith, Bernstein. Number one, just on 007, and sorry if I missed this, but it seems as though since the CMD, it's been moved up to a non-risk-adjusted peak sales target of over CHF 3 billion. Just wanted some color on that. And then just 1 on astegolimab might be a little bit too early to ask. But one of your competitors sort of suggested that severe COPD, there's more sufferers, but efficacy of the biologics is probably likely to be lower than in severe asthma. So I just wondered if you have any thoughts on that?
Yes. So I'll answer the aste question first. I mean, that's why you run the clinical trial, right? So we'll see. We think there's a good scientific rationale for why this could work in COPD. We're covering a very broad patient population in an area of very high unmet need. So yes, we'll know this year if it works. So stay tuned on that. But again, to your point, it's a little bit early to speculate. In terms of NXT-007, if this molecule lives up to what we believe it can do, it will, for sure, become a new standard of care in hemophilia A and therefore, easily a multibillion-dollar indication. But it is -- the data that we've seen so far is exciting. It's early days, more to come.
Okay. I'm back. So finally, I made it. I had to restart my computer. I think we have one final analyst in the row. I think it's Ben Jackson from Jefferies.
So just 2 quick ones for me, if okay. The first would be if you're able to provide any color about the shifting back of vamikibart in UME in '26, is there any particular reasons behind that? And perhaps is there any competitive thoughts behind that decision? And then second, just to finish off any additional changes in thinking about BD, especially with areas of interest following the Poseida acquisition, does that perhaps associate the need for adding more oncology to the pipeline? Or is that all still within scope?
Yes. Let me just answer the second question first and then I can hand over to you. I mean you've seen the 5 therapeutic areas that we are really focusing on: Cardiovascular, metabolism, oncology, neurology, those to be contributing about 50% of global disease burden. Immunology really plays across the many disease areas. And then we have, of course, a very strong franchise in ophthalmology. So you can imagine that these are the areas that we are looking into in terms of further strengthening our pipeline. Now as we've done over the last couple of years, we always look very much at the science. How much data is available that gives us the confidence like we've had the data available for TL1A. And then we also look at the financial terms, and we try to just think about whether or not it makes sense. I think we feel very diligent on that. And I think we've made a number of very interesting acquisitions. Now let me just highlight on Poseida because we already had the partnership with Poseida in oncology. And we actually saw some of the data in the lupus nephritis and there were some publications on that. And so in order to go and move into autoimmune disease, where we see that there is a big role for CAR-Ts in the future. We also said we will go into this acquisition. So deals like that, I think, are really in the sweet spot. And you can see that we will continue to be very disciplined, and we'll continue to make sure that the deal fits into our strategic agenda.
And in terms of vamikibart, we expect to have data in-house later this year and will then obviously be making decisions about how we move that program forward. I think it's worth noting that we have several different opportunities to advance IL-6 and ophthalmology, including bispecifics and trispecifics. So vamikibart is certainly only 1 molecule in a whole collection of molecules that could potentially bring IL-6 promise into ophthalmology.
We answered all your questions? Okay. If there are any additional questions? If there are no additional questions, then I would hand back to Thomas for a final remark. Thomas, please?
Yes. Thank you very much, Bruno, and thanks to everyone for your great questions. I believe we managed to deliver great results in 2024. And I hope it shows that we do what we say, and we also deliver, you can count on that. And we have a great momentum as we go into this year. And we also have a rich pipeline news coming this year. And as mentioned, we are very focused, we're very disciplined so that we continue to deliver for our investors. Thank you very much.
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