Q4 2024 Roche Holding AG Earnings Call
expense, which has risen, that's a minus 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 it, the driver is clear operations.
Leads us to an eye for S. Operating profit of $13 4 billion and then you see the total financial result in Texas. When you put it together. So that's 1.4 billion more compared to 2023 in total as I've said and outlined at the beginning already leads us to an IRS net income of 9.2 billion.
Good Yeah I think this is not just the number. This this last slide I love. The most when I look at 2024, and that's the cash generation of cash generation has been outstanding and he looked at concentrates from $15 8 billion, a $221 2 billion and I reported on the right hand side at $20 1 billion.
I think radiant outstanding number and what excites me. The most is I think very well as expected operations drove that number and do you see that in the first Green bar was $3 7 billion. But then we also worked on the networking capital now and you'll see net trade working capital a $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 created other net working capital movements I seem that has helped us well investments in intangible assets. What we wanted to do so invest we invested 600 million more here.
Speaker Change: Yeah. So overall I think a fantastic achievement.
When we look really at the at the cash flow margins they jumped as well.
Speaker Change: And as I've said I think both divisions contributed.
Speaker Change: Group that net net debt development. So what does this cash flow generation mean for the net debt development.
Speaker Change: Let me first outline wherever you land at the end of December 2023, and minus $18 7 billion net debt <unk>.
Speaker Change: End of 'twenty for a minus $17 3 billion, so really an improvement of $1 4 billion. Yeah. So really the overcompensated ever seen so I think that's it that's a great message how does that work I think the operating free cash flow, yeah, I've talked about that.
India is an investment in intangible assets of 1.5 billion I think just to just to mention that when you look at the non operating free cash flow taxes was $3 7 billion treasuries $1 1 billion and then you see suddenly dividends and M&A dividends paid 8 billion M&A and transactions $3 1 billion. So you can argue including the one.
Speaker Change: Five 5 million for intangible assets, we have invested into M&A and in terms of assets, which certainly drives the pipeline of $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 in the balance sheet, yeah on the debt side, because 70% of our debt and we have $34 7 billion gross debt on.
Speaker Change: The balance sheet, 70% of that is in U S dollars and one's a dollar strength since I've seen as that number gets higher and then you see a couple of other effects yet so that leads us to the $17 3 billion are certainly very pleased with that as well based on the strong cash flow that I've explained already.
Speaker Change: Good with that let's go quickly through the balance sheet first time, we have more than 100 billion in assets and the balance sheet.
Speaker Change: And what you see as cash and marketable securities. Yes, we brought that up we had a kind of a couple of fronts.
Speaker Change: Emissions shot that helps us and 77.3 billion give you a lot of assurance that they can pay the dividend.
Speaker Change: Other current assets I think are very clearly slight decline by Vacaville. Yeah went away I think that 600 million and inventories went down about 300 oven, which I think is a great message when the non the non current assets slightly up $4 8 billion here very clearly deferred tax US has played a role here.
Speaker Change: With our restructuring plans I think the the intangible assets impairments all of that contributes to this as well as the acquisitions that we have done on the current liabilities. So we moved to the right hand side our crews.
Speaker Change: The reason for the increase on the current liabilities and the non current liability is very clear that's across debt gross debt increased from $29 2 billion to $34 7 billion. So by $5 5 billion and that's reflected in that number and do you see overall the equity has increased by 2.9 billion.
Speaker Change: Good with that currency, yeah, a little bit of a pain in the last two years and when you look at 2024, you'll still see that on the left hand side shows. This orange line is below the black line and the Black line is the average for 2023 and <unk>.
Orange line is the average for 2024 and whenever these lines are below that's not a good impact for US now if you like so you see on the right hand side. The results for the full year, a minus four percentage points impact on sales and minus six percentage points impact some core operating profit and a minus six percentage points.
Speaker Change: The impact on core EPS I think when you when you really look at you know we do that exercise we assume really idea ends at every currency rates stays the same during the year and we predict and for the full year, which is very very hypothetical. But then we did we expect any impact for 2025 for it yourself.
Speaker Change: Encouraging if we were looking at today, we even have a positive impact, but well. We all know currencies are very very volatile, but it looks like a better year compared to the last two.
Speaker Change: Now, we're very pharma side, I know, yeah, and a little bit boring, but important yeah to get to the right starting point for 2002 25. So let me start really with the core EPS as reported in 2024 of 18.8 Swiss francs.
Speaker Change: And to what we have to or what do you have to adjust for is the foreign exchange losses, which are so far not really reflected in that number or another affect the number so in the green bucket, what you see as an adjustment of <unk> five three of Franks fifty-three Robyn.
Speaker Change: Exchange rate effect. This is a result of dividing the 2024 currency losses of 291 million Swiss franc as well as the 2020 for losses on net monetary position in high painful inflationary economies of 163 million Swiss francs. This is shown in note four of our content.
Speaker Change: <unk> financial statements on page 62 of the Finance report 2024, this number net of taxes and noncontrolling interests by the number of diluted shares of 802 million 802 million shares you'll get in note 29 of the financial report page two 121, so when you do that exercise.
Speaker Change: You'll get to the 53, but if you do that exercise you might ask yourself Oh. This implies a pretty low tax rate for that impact that when you do that so you can do the math yep.
Speaker Change: It would imply a tax rate of 6.4%, let me take that topic right away because of.
Speaker Change: The the one impact of 163 million has no tax impact. So that's one element, yeah and and the other piece is the 291 has a tax impact putting the holding and the holding we have suddenly another tax rate compared to what we have in the group.
Speaker Change: So that leads you to the 53 wrap them in the adjustment here, so they're starting to figure out.
Speaker Change: For the outlook for 2025 is 19.33 Swiss francs per shack.
Speaker Change: Good with that yeah, that's a bit formula I know and 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 talent. So apologies for the basket is not a fashion statement I'm feeling a little bit under the weather and so I want to make sure that I'm protecting our colleagues.
Teresa: I'm very pleased to share with you the 2024 results for pharma.
Speaker Change: Let's kick things off with a look at the sales performance in.
Speaker Change: In 2020 for pharma sales grew 8% at constant exchange rates to $46 2 billion, excluding Ron appraised sales grew 9% all regions, excluding Japan delivered strong brand from 9% in the last 8%, India and extremely impressive 17% and international on a constant exchange rate.
Speaker Change: Excluding rounded premium Japan declined just 2% and that is primarily due to mandatory price cuts and as Alan already mentioned overall pharma volumes were up 14%.
Speaker Change: Going into a little bit more details the core operating profit for Afirma increased by 13% versus an 8% sales increase with a margin of 40.
Speaker Change: 47, 7%.
Speaker Change: And going through the lines in a little bit more detail you can see the cop 300000. This is really driven by cost us a permanent R&D and SG&A.
Speaker Change: Are they running near as Alan mentioned increased 16%. This was primarily driven by.
Speaker Change: By the increases in profit sharing income to the higher sales of Xolair outside the U S and as he mentioned that clock starts 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. The fact that that random pre provision released from last year.
Speaker Change: As well as that 14%.
Speaker Change: Volume increase I think overall really good performance on cost of sales.
Speaker Change: Our R&D cost.
Cost increased only by 1%. This is not 24% of sales and SG&A costs increased by 5% in pharma as a percentage of sales decreased to around 15%.
Speaker Change: As Alan mentioned this was due to increased investments, including marketing and distribution costs to support ongoing launches, particularly if a buys now sounds like xolair in food allergy. So I think as Alan mentioned money well spent.
Speaker Change: And then on the operating income and expenses decreased by 25% and that is solely due to lower gains on disposals of products.
Speaker Change: So Thomas and Alan shared with us their favorite slides. This one is mine are.
Speaker Change: Our young portfolio continues to deliver strong growth led by our key brands. The bias now Francisco okra rest from Levered Xolair parity.
Speaker Change: And then Christi combined these added $3 9 billion of new sales last year, it's really impressive for the first time for what he has achieved blockbuster status, making it our 17th blockbuster of 'twenty 'twenty four when you increase in collection.
Speaker Change: Now, let's take a deeper dive into our therapeutic areas and let's start with oncology.
Speaker Change: College sales increased by 3% to $15 8 billion in 2024, let's start by highlighting some of the latest news flow for our most recently launched enemy.
Tobey: Hey, Tobey.
Tobey: On Tuesday, we shared with you in the final analysis of the never 120th I Tobey met the key secondary endpoint of OS benefit me I'm very much looking forward to sharing the store that future medical congresses and with regulators around the world.
Tobey: Let me address launches I'm doing we expect EU approval in the first half of this year.
Tobey: With the Hurricane franchise, we finished strong and fiber delivering 7% growth in fans Guy was 62% growth global conversion rate for Transco has climbed to 46% from 46% in Q3, and we would fully expect to exceed 50% in 2025.
Tobey: Moving onto to centric in 'twenty 'twenty four sales overall were stable, that's primarily driven by small cell in HCC. I mean do you believe as we have mentioned previously that the center is getting close to peak and we expect sales growth to be in the zero to low single digit range going forward.
Tobey: Looking ahead at what's to come in 2020 five I want to specifically call out the two highly anticipated phase III readouts for gear desperate persevere AR in Q4 any merit in Q2, and we are very much looking forward to sharing the outcomes of these potentially as standard of care changing studies.
Tobey: So, let's turn our attention to hematology.
Tobey: Hematology continues to deliver strong growth we ended the year at $7 9 billion in Santos with 15% growth and let's start by looking at him Libra and 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 <unk>.
Tobey: Specialty pharmacy order just very similar to the pattern that we've seen in previous years.
Tobey: Going forward into 2025, we would expect a mid single digit growth globally for him Nebraska.
Tobey: Staying with that of our hemophilia portfolio for the moment as Thomas mentioned, we have the phase two readout of our next generation bi specific in hemophilia next several months seven that is anticipated around mid year. If positive. This would lead to the initiation of the phase III development program later in 2025 and as a reminder, we believe that next level of seven which is 30 times.
Tobey: More potent than him Libre has the potential to receive zero zero treated bleeds without the need for additional factory treatment. So this would really allow us once again to change the treatment paradigm for patients suffering from suffering France and Australia.
Moving onto plenty.
Tobey: In the U S. First 90 L. D C L. A patient shares keep on climbing we're now at 29% for live me has been used in more than 42000 patients globally. We also recently shared the five year Polaris data, indicating a positive trend in OS hazard ratio improving from 0.852 point improving to 0.5 from 0.9 43.
Tobey: Or data, which we believe will further support uptake.
Tobey: Colombia, and then Simeon launches are progressing on track for let's see me only completed U S and EU filing of the subcutaneous formulation, which has all the benefits of the available IV formulation with the added is the sub Q.
Tobey: Looking ahead into 2025, there is quite a bit happening in.
Tobey: It was an apology, we expect to move those Colombian I'm Sami I went to second line D. L. P. C. L. A much bigger opportunity is for Colombia. This means the U S. EU approval based on the positive Starwood data with the particular set for July 20th and for them and saying, Yeah, we're expecting that phase three son of a data in second line data PCL for.
Tobey: Tim you know there are two additional events in the U S approval of the subcutaneous formulation in third line, Follicular, which I just mentioned and the phase III readout in second line Follicular.
Tobey: We're also expecting phase III readout surfing clocks that in first line Mds N P or Scott.
Tobey: So lot starts to look forward to and hematology this year.
Tobey: Next up let's talk a little bit more about our recent acquisition of the cider and its allogeneic car T portfolio.
Tobey: We've long believed that the beside of Allo car T technology could potentially be best in class and malignant hematology. The early data in multiple myeloma suggest very strong clinical activity comparable to the auto be CMA car Ts now with this acquisition, we're going to be moving quickly to bring this approach into M. S. N ethylene as well with I N D has already granted and we're excited about.
Tobey: 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.
Tobey: So with that let's move on to our neurology franchise.
Tobey: The neurology franchise continues to deliver strong growth of 13% at constant exchange rates, achieving $9 3 billion in sales starting with <unk> as the market leader in enough and more specifically <unk>, our recently launched subcutaneous formulation.
Tobey: The launch is progressing as planned and we continue to see very positive signals in the U S more than 50% of never patients are naive to OCA of us and we see accounts that have not used <unk> IV in the past prescribes now though as.
Tobey: As we said earlier <unk> expands the addressable market for OCA person, it's not simply just about converting IP patients subcutaneous so.
Tobey: So far we have more than 25000 patients globally on okra. This novel and while we are waiting for a permanent J code to be issued in April of this year. We are in the U S. We would expect is 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 some yellow.
Tobey: Yeah.
Tobey: Looking at <unk> 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, therefore averages IV administration capacity.
Tobey: Well, it's a modest year in 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.
Tobey: And risky maintains its strong global position in SMA, achieving 18% growth in 2024, and we expect similar global growth rate in 2025.
Tobey: We are anticipating approval of the tablet tablet formulation a franchisee later this year.
Tobey: Tablet simplify storage eliminates the need for cold chain and increases the ease of administration three great benefits for patients.
Tobey: 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 adversity best in disease profile.
Speaker Change: Our meeting is the first gene therapy for DMD has now been used to treat over 80 patients in ex U S. Ex EU region. Additionally earlier. This week, we shared positive topline results from the two year follow up of the embark study, which will be shared with the regulators and I will talk a little bit more on that in a minute left.
Speaker Change: Last December we also shared the top line results for the Phase <unk> study in Parkinson's. This is well I'll cover in more detail in an upcoming slide.
Speaker Change: So another big outlook here in 2025 for neurology in particular this is going to be a quite a year for MF. Okay. That's high dose data is expected and has the potential to be best in class best in disease, setting a new standard care in EM as well.
Speaker Change: We also have the long anticipated phase III readouts for Fanapt rooting them in RMS and P. P. M asks which we continue to believe is best in class potential based on the strong phase two data that we've seen.
Speaker Change: Are there are two phase two readouts for against 329 expected in 2025 in combination with a risky and SMA and as monotherapy in F. S. H D.
Speaker Change: And last but certainly not least we expect to share additional phase one two data cuts for contacting them in Alzheimer's disease at ADP ANSI pad gated. Upon these results we are planning to move <unk> into phase III by the end of year and with Spi to be achieved in the second half.
Speaker Change: So, let's take a little bit of a closer look at the two year embarked data.
Speaker Change: Leds, which we shared on Monday.
Speaker Change: The phase three embark two year data clearly reinforced the significant and sustained functional benefit for DMD patients. This benefit is seen across the primary and two key secondary functional end points and that's a a time to rise in the 10 meter walk run when compared to propensity matched external cohort control.
Speaker Change: As you can see in the graph on the left <unk>. His favorite in all three of these functional endpoints and functional differences between patients treated with elevators in the external control are getting larger between one year and two years after dosing.
Speaker Change: Additionally, pulled three year data from the studies went to 1102 in cohort one of setting 103 demonstrated consistent and durable clinically meaningful benefits compared to external control.
Speaker Change: Bind we believed that this underscores the positive impact that <unk> can have for DMT patients their families and caregivers we plan to present those data updates at M. D E and share the embarq to your data with regulators to support ongoing approval processes.
Speaker Change: Moving on to profit and Parkinson's and December of last year, we shared that we shared the qdoba 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 pre specified analysis in these patients for accounted for 75% of the trial population.
Speaker Change: For the data evaluation is ongoing and we're waiting additional insights from the open label extension together with regulators and except for possibly 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 mother.
Speaker Change: So with that let's move on to immunology.
Speaker Change: In 2024, our immunology franchise achieved $6 3 billion Swiss francs in sales and grew at 5% at constant exchange rates.
Key growth driver here is certainly it's all there and its launch into food allergies. We are very pleased with the launch uptake having reached the milestone of 40000 patients on treatment as I mentioned in Q3, we expect a year over year growth momentum in the mid teens for 2025.
Speaker Change: Our second key growth driver here was a camera.
Speaker Change: 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.
Speaker Change: Okay.
Speaker Change: We have previously shared with you the exciting news of positive phase III data for <unk> in lupus nephritis. The program and you all know that I'm very fond of.
Speaker Change: We look forward to presenting the full dataset 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.
Speaker Change: Going to our immunology outwork and staying with us either for the moment, we expect phase III data from our allegory trial in SLE later this year as the Golar Madden C. O. P. D is also expected to read out later this year and there are multiple upcoming developments in our <unk> portfolio, which I will talk about now.
Speaker Change: So I am very excited to share the progress that we've seen with our tea on when a program recently as you know till when a is a highly validated pathway. That's important in a number of disease areas.
Speaker Change: Previously shared that our phase III, and you'll see as ongoing and enrolling rapidly and that our phase III in Crohn's is expecting a sky 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 J P. M that we are initiating a phase two b trial in atopic dermatitis and a phase one b trial in Nash in Q1 with additional indications.
Speaker Change: Under consideration.
Speaker Change: Also added an anti.
Speaker Change: P 40 T on when a buy specific to our pipeline in that phase two in IBD will initiate later this year.
Speaker Change: Okay.
Speaker Change: Now moving on to ophthalmology.
Speaker Change: So in ophthalmology sales reached 4 billion Swiss francs last year with an impressive growth rate of 44% at constant exchange rates.
Speaker Change: As franchises led by buys now which continues to expand its U S market share across all three indications.
Speaker Change: Before we get started I did just want to call out that after our last IR call. We werent formed 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 on other products included in the market definition, primarily aliquot of action.
Speaker Change: Accounting for this the Q3 values were restated to improve accuracy because of this change you can't directly compare the Q values here Q4 values here to the ones that we shared at Q3.
Speaker Change: If you do compare the restated Q3 values to the Q4, but by some market shares we expanded in each of its three indications by roughly three percentage points. We expect that you will once again be able to see the expanding market share. So when comparing Q1 2025 to the Q4 of 24.
Speaker Change: You see here.
Speaker Change: We remain confident that the biosimilar was 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 ophthalmologist by smell in the frontline setting.
Speaker Change: Performance in the U S. In Q4 was impacted by the significant channel filling we saw immediately after the launch of Prefilled syringe.
Speaker Change: So we saw a little bit of a spend down in Q4, but we are seeing a strong trajectory for her lifestyle and our January sales today.
Speaker Change: Staying on the topic of our next generation pre filled syringe, we achieved EU approval in Q4 U S conversion rates continue to climb to above 85% clearly, indicating the ACP is are very eager to use the simplified administration option.
Speaker Change: 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 bias now is well on its way to being the standard of care.
Speaker Change: Moving on to assist with IMO, our A&D commercial relaunch in the U S is on track with roughly 100 implants completed in 2024.
Speaker Change: As a reminder, in this stage to launch its all about getting new ophthalmologist exposure to assist with email and trained on how to perform the implant and refill exchange procedures. This is very much a story of going slow to ultimately go fast for.
Speaker Change: For 2025, we aim for a few thousand implanted eyes also in 2025, we expect to complete the E filing an empty.
Speaker Change: And lastly, our new and it needs a niki part, which could become the first I'll fix in ophthalmology is expected to have pivotal results for Nuomi later this year.
Speaker Change: And finally before I get to our 'twenty 'twenty four 'twenty five news flow I wanted to take a quick look at how our pipeline reshaping is progressing.
Speaker Change: Complementing on what you saw from Thomas earlier, I'd like to highlight our continued efforts to strengthen the firm.
Speaker Change: The pharma pipeline.
Speaker Change: You can see the different additions and removals over time and there are two recent additions in Q4 that I just want to call out the allogeneic car T that we added as part of the site acquisition and the ADC DLL, three and small cell, which was added to our pipeline via a deal with an event at.
Speaker Change: All in all we brought in 10 assets via high value partnerships. Since Q2 2023 and at the same time, our internal R&D engine T. Reg G rented chugai delivered 14 new entities.
Speaker Change: Next I want to quickly show you those final 2020 for me as well.
You know this slide well from all of our quarterly results last year. There were three final updates in Q4, which you are aware of the tiered volume either in first line PD Lone positive non small cell was negative as previously mentioned the readout for property and then trying to in the Mab and <unk> had positive interim data cut which we did present at sea Tac.
Speaker Change: And so with that let's take a look at what we can expect in 2025.
Speaker Change: As mentioned by Thomas We expect 12 key phase III Readouts. This year and this includes four enemies, but also importantly, seven phase III, enabling readouts.
Speaker Change: So let me just quickly highlight some of the key phase III Rehabs, we have your industrial program in first line and second line HR positive metastatic breast cancer, we have one semi O plus <unk> in second line D. L. P. C. L. O curve is high dose arm in arm S. N. P. P. M S Britain in RMS and P. P. M S. As the Golar Mab in COPD and then Mickey bar.
Speaker Change: In addition, we also have multiple phase III, enabling readouts, including next subtler southern in hemophilia, a chunky and a D. M 329 in SMA and Fsh D. So obese or on an uncontrolled hypertension C. T 868 in type one diabetes with obesity and Cte 99, six in obesity with type two diabetes.
And 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 Tech.
Speaker Change: And that is for the limb tsuneo sub Q filing in Europe, and now I will hand, it over to Max to guide you to our diagnostic results.
Speaker Change: Yep.
Max: So good morning. Good afternoon, everyone. It is my pleasure to present, the full year 'twenty 'twenty four diagnostics division financial results.
Speaker Change: So as you heard from Alan and from Thomas Our diagnostic sales grew 4% at constant exchange rate in 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.
Max: <unk> has transitioned to an endemic state.
Max: And so now I'll walk you through the results by our different customer areas. So first sales in our core lab increase at plus 8%.
Max: With strong momentum driven by immuno diagnostics, which grew at plus nine and clinical chemistry, which grew at plus eight <unk>.
Max: <unk> diagnostics had an increase of plus 4% due to strong growth in our Barology 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%.
Max: 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 four due to the market shifts to continuous glucose monitoring.
Max: Our point of care business grew at plus our base point of care business grew up plus 6% and this is really driven by our point of care molecular diagnostics business, excluding COVID-19 sales near patient care declined minus 1%.
Max: 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%.
Max: So now I'd like to shift gears and walk through the sales results across the different regions. So first excluding COVID-19 business, we see strong base business growth across <unk>.
Max: North America, EMEA, and Latam and in North America, the base business, excluding Covid grew at plus 8%.
Max: In EMEA the base business, excluding COVID-19 grew at plus 6%.
Max: 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%.
Max: 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.
Max: As a result of the headwinds from B B P and the reimbursement reductions in China. Our ambition for 2025 is to grow the business by low to mid single digits, which would be a one year dip with the return to our consistent ambition and the years beyond.
Max: I would also call out that China is still a critical market for us and we continue to be the market leader.
Max: So now let me walk you through the diagnostics divisional P&L line by line.
Max: So core operating profit on sales of $14 3 billion Swiss francs increased by 12% at constant exchange rate versus 2023.
Max: Cost of sales increased by 1% this was driven by favorable product mix.
Max: Really due to lower sales of COVID-19 rapid antigen tests.
Max: R&D costs increase at plus 2%, mainly driven by the integration of the mirror Dx as well as investments in some of our upcoming late stage launches such as sequencing mass spec in continuous glucose monitoring.
Max: SG&A increase of plus 3% driven by those high distribution costs, you heard from Alan as well as increased sales volume in the commercial costs associated with the preparation of these upcoming launches.
Max: This resulted in core operating profit of $2 4 billion Swiss francs with a margin of 16, 8% in reported currency.
Max: So now I'd really like to talk about some of the exciting intervene into our innovation that we launched in 2024, specifically starting with our core lab and our mass spec.
Max: Our mass spec system. So I'm very pleased to announce that we successfully received the CE mark for our cobalt mass spec system, along with the wave one steroid assays. The current mass spec market, which is valued at 3 billion. Swiss francs is predominantly composed of lab developed tests that require.
Max: Especially trained technicians special laboratory arrangements and with this launch we intend to establish and shape the IBD market for automated.
Max: Simplified end to end mass spectrometry testing and drive a market expansion.
Max: Our ambition is to reach 1 billion Swiss francs and sales by the end of the decade.
Max: 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 a second wave of tests will follow in the coming years.
Max: 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.
Max: So on the theme of expanding our leadership I'd like to talk about our cobalt 6800 8800 version two <unk>.
Max: Now I'd highlight that the launch of our version two update of our high throughput PCR systems that cobalt 60, and 8800 will further extend our competitive lead in the molecular lab in his field upgradable to our installed base of thousands of six to 888 hundreds around the world. These were the workhorse systems, where we responded to the COVID-19 pandemic and.
Max: We're going to be an engine for our growth into the future.
Max: This update is fully compatible with our new tags multiplex assay, such as our respiratory Syndromic Syndromic panel flex tests, which we launched last year, which tests for 15 different viruses from a single well sample and will 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 Syn <unk>.
Max: <unk> panel testing.
Max: With this update we introduced increased testing flexibility such as the addition of a stat lane for urgent samples greater automation of molecular work throws close through being able to batch up to six assays in a single run and we will offer customizable quality controls that will enable improved run costs. So in addition to those upgrades will also improve the throughput.
Max: Cobalt 6800 will increase from 384 to 576 task for eight hour shifts. This further solidifies and provides an opportunity to expand our leading position in molecular diagnostics.
Max: So not only are we lead it on the platform side I'd like to talk about so the innovation that we're introducing as well in terms of the next generation of diagnostic assays.
Max: Specifically present, the recent clinical study results for Alexis amyloid plasma panel, which consists of two blood based biomarkers pita wanting one and April life of proteins.
Max: 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.
Max: However, two thirds of people experiencing cognitive symptoms.
Max: Main on diagnose and diagnosis, usually takes more than a year and up to two years, requiring subjective cognitive tests as well as imaging analysis.
Max: In this study we enrolled 492 patients with suspected cognitive impairment across 30 different study sites.
Max: Our results demonstrated excellent clinical performance in a negative predictive value of over 90% independent of Comorbidities demographics for both the a P. P panel as well as pizza hut wanting one as an individual biomarker.
Max: Pending regulatory clearance, we hope this test will provide a minimally invasive blood based test rollout 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.
Max: So we talked about favorite slides, I guess and I I'd like to say this is certainly my favorite slide you know last year. We said Ah 2024 was going to be the biggest year for diagnostic launches and what I'm proud to say that we achieved all of those we received all 12 key launches shown here, including our first CGM Yaqui check smart.
Max: Guide, our serology blood screening solution for the United States, we're already taking significant market share and winning and winning business. The first clinical mass spec solution as I mentioned earlier as well as our next generation clinical chemistry and IC solutions.
Max: Now in 2025, we have.
Max: Additional important launches I like to call. It a few by customary the first is what we just spoke about are a Lexus pita 181, which as I mentioned before could provide a convenient test to rollout out to rollout Alzheimer's disease. Furthermore, we will expand our mass spec menu with more than 40 assays in the first wave.
Max: For the molecular lab, we will launch cobalt BV CV is the molecular test to aid in the diagnosis of bacterial Vaginosis and Canada, Vaginitis, which will help complete our menu in the rapidly growing STI market segment.
Max: Now we're also approaching this from the point of care side for near patient care I'd like to call out our cobalt Lee at CTG, which is our first green tick of year, a rapid multiplex <unk> test that can detect a differentiate chlamydia and gonorrhea at the point of care in a CLIA waived setting.
Max: Which we just received FDA approval.
Max: In pathology, we will have a major update to the Roche digital pathology platform with.
Max: With enhanced image management, a fully redesigned user experience and enhance interoperability with third party scanners combined with the primary diagnosis claims for our DP 200, a DP 600 scanners last year this positions us well for the rapidly growing digital pathology market segment.
Max: And last but certainly not least I'm pleased to invite you to our upcoming diagnostics IR events, we at a GBT will be unveiling our core sequencing technology and I'd like to invite you to an IR event, taking place virtually on February 20th during this event, we will provide an update of our sequencing technology.
Max: As well as hold a Q&A session.
Max: 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 Roche forthcoming road sequencing solution as well as our entire pipeline across all customers. So I look forward to seeing you there.
Max: And with that I will hand, it over to Bruno.
Bruno: Thanks, Matt and I will just quickly use the opportunity to have your final slide to sum up on the upcoming IR event. There's a couple of them we touched upon already the next want us to come already next week Friday February 7th just will be immunology, the data because iva in lupus nephritis, which are presented at the World Congress of Nephrology, which.
Bruno: We'll have some time to discuss then the update that <unk> mentioned.
Bruno: And then on April 4th.
Bruno: Have a neurology update here, we have a couple of topics to cover first of all it's a D and if he just embark two year data in DMD, where we just had the top line release, which we expect will be presented at MDA and then two additional datasets from ADP D. Crossing these them off the Pandora data from end of last year and.
Bruno: The latest data cut for the brain shovel.
Matt: You see them as mentioned already by Matt again that diagnostics days scheduled for May 20, San Fran says a live event again in London, which NGL.
Speaker Change: <unk> solution being the highlight at this time and then we already said also a date for pharma day in the second half, which is now scheduled for September 20 seconds. So that you can put it in your calendars.
Speaker Change: Just looking at the you know it tends to be slow ahead of us in the 25 I think there will be many more IR calls, especially in the second half I can't imagine we would have something about hematology.
Speaker Change: Midyear.
Speaker Change: So I would say a S. D C tax just to call out of you.
Speaker Change: Upcoming medical conferences I can talk about like are likely to have additional cold and.
Speaker Change: And with that I think we can open the Q&A session.
Speaker Change: First question would go to Richard Vasa from J P. Morgan Richard Please.
Richard Vasa: Thanks very much for your next two questions from me please.
Speaker Change: Let's see one on the buys my Ah.
Speaker Change: I think we understand the temporary weakness in the quarter, but I wanted to ask about the launch of a pre filled syringe for high dose Eylea and how you would see that affecting <unk>, Mike, obviously, very key and you're doing really well with yours, but in Europe. They have a a pre filled syringe for hydro Celeste.
Speaker Change: Thinking about how that might affect you in 'twenty five.
Speaker Change: And then second question just on Jimmy that strength.
Speaker Change: Maybe a little bit of a push out on the passive there are data into Q4 and October on clinical trials, just what do you see as the implications are for that on your thoughts around the the expectations for the results of the trial. Thanks very much.
Speaker Change: Okay.
Speaker Change: That was the last one so I don't think that that hasn't really any implications on the results just sometimes these things take a little bit longer and that's what we saw sort of strength.
Speaker Change: The Prefilled syringe, so I would just like to say right now, we're really not seeing any impact in any part of the world from high dose Eylea.
Speaker Change: The Prefilled syringe that we have in the market is materially different than the pre filled syringe that eylea has.
Speaker Change: It has won a one hand administration, which when you think about it if you're getting 1000 shots are 100 shots a day, having that really ease of administration is super important.
Speaker Change: I would say, we definitely have a device preference scaling on our side and quite frankly, I think just what is inside the syringe matters a lot and a.
Speaker Change: <unk> is clearly continuing to distinguish itself from an efficacy and safety standpoint, with the added convenience of the Prefilled syringe I would just continue to see it growing and continue to establish itself.
Speaker Change: Maybe Richard let me could be added to your first question into a restaurant I think there was no real change in the underlying timelines that small you know an issue with when a certain things get updated them at.
Speaker Change: <unk> Dot Gov.
Speaker Change: For the both studies it'd be around passive euro we expect the data to come in somewhere around you know midyear second half we cannot be more specific as you know these studies I, then driven but nothing really fundamentally changed here.
Speaker Change: Any additional questions from you know pretty nice Andres you. Thank you very much that's great. Thanks, a lot. Thanks, Richard Thanks.
Speaker Change: Then the next question will go to Emily field from Barclays Mlps.
Speaker Change: Okay.
Speaker Change: Great. Thanks for taking my question and just on that last point.
Speaker Change: Thank Teresa said during the prepared remarks that person here would come in Q4, So I just wanted to clarify that and make sure that's correct.
Speaker Change: Yes, and then my last two questions.
Speaker Change: Firstly on the high dose <unk> sees hopefully quantify the incremental revenue opportunity that you see from subcutaneous OCA rest of that I was just wondering if you could help us frame how to think about the commercial potential for hydro silk reverse obviously this trial as you know versus the standard dose. So do you see this as an.
Speaker Change: Additive to the franchise are just transferring patients over.
Speaker Change: Does how does not provide any opportunity to extend IP and then.
Speaker Change: Secondly.
Speaker Change: I know that.
Speaker Change: Expecting first pivotal readouts from <unk> later, this year and you'll be getting if successful a royalty from that.
Speaker Change: But I wanted to ask Mark just on you know whether you see the success or failure of that compound is having a read across to see T mine insects.
Speaker Change: And if you could just remind us on how the two mile closer to differentiate it. Thank you.
Speaker Change: And maybe just to quickly add I think asset on the timelines of your restaurants are midst the mid year. So second half of it of course.
Speaker Change:
We cannot be more specific right now S F event driven.
Speaker Change: You will get the information as soon as we are.
Speaker Change: And then the other question yeah, so as far as hydro snows I don't think we've actually shared what our commercial expectations are for hydrous. Once we get the data we'll be able to share some additional information with you soon.
Speaker Change: I mean that that data are positive.
Speaker Change: From a 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.
Speaker Change: Okay.
Speaker Change: Because I think that's now yeah.
Speaker Change: So on that one I would say the difference clearly is that a C. D 99, six is actually a small molecule. So from a production standpoint has adventures as far as our peptide. So it's very different in terms of the two molecules.
Speaker Change: Regarding the royalty income that would not be obviously this year, but in some cases positive then in future years that would be additional royalty income.
Speaker Change: Okay.
Speaker Change: And I need you to answer your questions are do you have a follow on question yes.
Speaker Change: That was great. Thank you.
Speaker Change: Okay.
Speaker Change: And then we move on next one and the ROE is Sachin Jain from Bank of America.
Sachin Jain: Hi, guys. Thanks, taking my questions toothpaste that Tracy just on the sense. The T series, where we just give a bit of a big picture on how they route Pennsylvania right. How are you thinking about the probabilities of those two studies different and perhaps you could just touch on the commercial opportunities of both I think.
Speaker Change: Is generally perceived as quite Shmuel if.
Speaker Change: If not you can correct. If you could just clarify and then Thomas just a big picture question. Your second favorite slide onto cash I think it was the group sales slide.
Speaker Change: Sequential growth of nine nine and 11 of the last few quarters. So I just wanted to touch on what you think the 25 headwinds I'll just slightly to mid single digit for this year other than Actemra, which I think is less than 1% is there anything we're missing there. Thank you.
Speaker Change: Do you want to start with that and I'll sure I can I can go first I think one of the headwinds.
Speaker Change: And by Mats and so the volume based procurement that's happening in China.
Speaker Change: And other than that I would say look we're at the beginning of the year, we have almost one month behind us and let's see how the year goes.
Speaker Change: And in terms of GERD restaurant I think you know we do believe that this has the opportunity to be a multi billion dollar franchise.
Speaker Change: When you look at.
Speaker Change: When you look at all of the different indications and I think persevere has that Ah patient population as first line insensitive that 60% of first line patients are the pioneer are.
Speaker Change: Patient population is the first time endocrine resistant that's another 40% of patients. So between the two of them, we really get the full the full first line covered and you Vera again gives us another.
Speaker Change: It gives us another.
Speaker Change: Net of a <unk> of that patient population that we would need to cover the entire spectrum of endocrine sensitive patients.
Speaker Change: So I think we.
Speaker Change: 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.
Speaker Change: Yes.
Speaker Change: Just anything on the relative probabilities of the two cities defending you're willing to comment.
Speaker Change: Yeah, I think the.
Speaker Change: I think when you know essentially 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.
Speaker Change: 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 should have some level of a systems, which was building up over time, it's not only <unk>. It's also other resistant mechanisms, which come to play and I think this just leads to an overall lower.
Speaker Change: That affects us likelihood.
Speaker Change: <unk> and 'twenty six so I think this is the big one the adjuvant study to watch out and I think there is also the.
Speaker Change: The most.
Speaker Change: Tennessee, which will allow us if successful and really to reshape the landscape in the treatment paradigm.
Speaker Change: Thank you.
Speaker Change: Any other any other questions or there's a little from your side.
Speaker Change: Perfect. Thank you yep okay.
Matthew Weston: Then we move on our next question, we'll go to Matthew Weston from UBS Matthew.
Matthew Weston: Thanks, Good afternoon, everybody two for me. Please the first on a previous de Novo.
Matthew Weston: It's clearly launching Wow, one thing Thomas called out in terms of the sustainability of growth at Rosh was the limited Biosimilar exposure, obviously, one of those in the future will be a normal dose of <unk> can you help us understand or any additional IP that novo brings what should we be thinking off in terms of the long term.
Matthew Weston: Potential there.
Matthew Weston: 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. Zola Biosimilar entry in 2025 can you give us an understanding of how far you think about protection will go, especially given you called out investing in.
Matthew Weston: Xolair is one of the reasons for investing in significant SG&A in Alan's comments, great two good questions. So.
When you look at the Okra Ms franchise between the.
Matthew Weston: Between the between the de Novo between other device 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 <unk>. So I can't say more now, but I think you should continue.
Matthew Weston: You should take comfort in the fact that we're looking at this quite actively.
Matthew Weston: In terms of patent expiry for Xolair, we can confirm that there will not be biosimilar entry in 2020 five.
Matthew Weston: Yeah.
Yeah.
Matthew Weston: And maybe to add Matthew on the IP situation.
Matthew Weston: Tuition for Fokker was I think in our case upper was hydro's would work hours I think just would've given them additional patterns. If a combination of orca was high dose and subcutaneous more than being another development opportunity would come with a newly developed our injector for example would give another layers of IP. So I think there are several layers, which should help us too.
Matthew Weston: Along with the franchise.
Matthew Weston: But you know if I'm allowed to us.
Matthew Weston: I apologize to others. If I can just ask one additional follow up yesterday as you you raised high dose accretive Assembly asked about it is while it's obviously one of the next Readouts for rush.
Matthew Weston: Yeah.
Speaker Change: You've got two arms the people who are I guess, let's call it overweight and I understand why you hope it will work in the normal weight cohorts. What evidence gave you confidence that moura <unk> might give you more efficacy because I recall in the past rush always being very.
Matthew Weston: <unk>.
Matthew Weston: Striking about the fact that accretive escape full CD 20 inhibition in this setting so what can more brain.
Speaker Change: Yeah, So I think as.
Speaker Change: And as we are as we designed 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 point. So I think we are that certainly would make sense in an overweight patients but.
Speaker Change: But I think we are or our assumption is that that that might actually also extend into <unk>.
Speaker Change: And to normal way patients and that's just based on the data that we've seen today.
Speaker Change: Thank you. Thanks, Mike It was a retrospective analysis, which we did a Matthew I think and we have looked into or you know confounding factors and imbalances in the different subsets, but it's not that we believe that the effect. We have seen will be primarily driven by by weight exactly in it and it now and you know again.
Speaker Change: And those exploratory analysis post the phase III, what we did see was just.
Speaker Change: Just slowing of disease progression with higher exposure to fresh so hence the inside of the study.
Speaker Change: Yeah.
Speaker Change: Thank you will.
Speaker Change: Then the.
Speaker Change: Next questions would go to Simon Baker from restaurant Simon.
Speaker Change: Thank you Bruno and thank you everyone else. Good afternoon, two questions. If I may please.
Speaker Change: Firstly, one for Alan I know you don't guide on the cost lines, but I was just wondering if descriptive.
Speaker Change: If there is some indication of the movement.
Speaker Change: We should expect in the various cost lines to get to the implied margin expansion within the 25 guidance.
Speaker Change: Secondly.
Speaker Change: On the IMTT I E. The move into March.
Speaker Change: We see a very very interesting and potentially very large categories. I think you're the first person with this company to move into the clinic in that indication I was just wondering if you could give.
Speaker Change: Give us some color on the basis for moving into mesh with the Tim. Thanks, So much.
Speaker Change: You want to take the cost question Okay.
Yeah, I think first of all I have to say Simon our guidance is the guidance I think put yourself in that 25.
Speaker Change: Orient ourselves on.
Speaker Change: Everything in between and suddenly need flexibility.
Speaker Change: Will allow us to have I think we have said that we want to be how should I said flattish about R&D I think that's pretty clear that that's why I can mention it I can also mentioned that in other operating income yeah, we expect a little bit less gains from product disposals I think that's another one.
Speaker Change: 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.
Speaker Change: And I think as he mentioned he a tailwind a has a very clinically validated target in an immune disease, but it also has an anti fibrotic component and so I think as we were considering where where are there opportunities to expand our looking at diseases that have fibrotic have fibrotic.
Speaker Change: With Genesis It just made sense to kind of look at something like Mashups, Illinois.
Speaker Change: Okay. Thanks, so much.
Speaker Change: Okay.
Speaker Change: I am starting to have a technical issue I cannot open my screen window right now.
Speaker Change: Hidden somehow so I don't know what to do.
Speaker Change: Yeah.
Speaker Change: Okay.
Speaker Change: Yeah.
Speaker Change: I think we probably have to stop the call.
Speaker Change: For some technical reasons.
Speaker Change: Yeah.
Speaker Change: Okay.
Speaker Change: It's basically a chemical complex anymore.
Speaker Change: Yeah.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: So let me start maybe someone else correction.
Speaker Change: Yes.
Speaker Change: Are you going to start creeping up from Goldman Sachs.
Speaker Change: Two questions for you so first one on.
Speaker Change: Margin. So I mean, you had some nice increase in the margin.
Speaker Change: Of course, both divisions this year.
Speaker Change: Given this increase and with the move over time away from specialty pharma areas.
Speaker Change: Higher margin, maybe just some more primary care areas, how does it impact your ambition to defend the margins.
Speaker Change: Keeping R&D flat as you just mentioned and 20 fives, but how should we think about the margin levers are you better than the medium term.
Speaker Change: Secondly, I'm proudly.
Speaker Change: You mentioned youre going to see some next steps this year, but what are the potential options here.
Speaker Change: Given the data you've seen so far.
Speaker Change: What is the probability that you could potentially move straight to a registration or would you need to run a.
Speaker Change: Is it more likely to run a phase III and then again, how long could that last.
Speaker Change: Thank you.
Speaker Change: I can I can take the first question as I stated before.
Speaker Change: The goal is to at least keep the margins as a percent of sales are stable that means of course in absolute terms will continue to increase the margins.
Speaker Change: And that was 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 'twenty to 'twenty five actually intend to expand our margins. So we'll give you more updates then as we get to the 20 states at about 26, and so on but the long term that would be it might be.
Speaker Change: Our guidance.
Speaker Change: And as as far as probably goes so the open label extension study is continuing.
Speaker Change: 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 trials sort of continues to reveal itself.
Speaker Change: A decision on what we will actually do with that trial I think will come after we see more and more information it would be highly unlikely that wouldnt, we wouldnt straight registration.
Speaker Change: This remains I think as we've all said a very high risk high reward program.
Speaker Change: Yeah.
Speaker Change: Okay.
Henry: Henry maybe you can please take over any moderation and just off the next one on the road to.
Richard Parkes: Open the line and Oh awesome to ask questions sure. So next one of the largest Richard Parkes them, so with that I open though your line.
Speaker Change: Hi, Thank you very much for taking my question.
Speaker Change: First one I just want to push a little bit more on your desk shrunk because generally investors are skeptical about the causes potential outside of the <unk> mutant population. So you can you just help us understand what gives you optimism in the tissue there are today around.
Speaker Change: Around broader potential outside the U S. All want Mi patients and can you confirm that the there.
Speaker Change: There are studies powered to show a benefit in that population, therefore, obviously, we'd be low risk.
And then secondly on tier one I am.
Speaker Change: She was another competitors showing proof of concept for the potential of that classes became a lot more visible to investors.
Speaker Change: Speaking to Kols it sounds like developments of a biomarker is an important aspect to.
Speaker Change: Driving uptake of the Clos, 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 a biomarker in ha IOL stuff is to the other companies. Thank you.
Speaker Change: So let's start with <unk>. 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.
Speaker Change: We are we are very excited about this molecule and this pathway and to your point are.
Speaker Change: Prior experience in IBD, and our experience with biomarker development or experience in many different.
Speaker Change: Therapeutic areas in diseases, where a tailwind it could potentially be relevant it makes us very excited about the full opportunity of this molecule over time.
Speaker Change: As you know we're in a head to head race with with Merck. We've got another molecule that sort of further behind and I think all of the data that we continue to see across the different molecules are out there reinforces that this is a valid pathways that these molecules have benefit.
Speaker Change: And I think we're yeah. We're we're we're really eager to actually see what it can do in in Ah patients. So definitely more to comment T O N E.
Speaker Change: To answer your last question first so he very is powered for both ITT and ISR. One unit. So we are confident that we have powered the trial appropriate appropriately just to.
Speaker Change: Mind, everyone why I think we are so.
Speaker Change: While we were still excited about the I guess aren't in it.
Speaker Change: When the program kicked off I mean, it is the highest preclinical potency of any or all started that's out there.
Speaker Change: It seems to be combinable with all city tiers.
Speaker Change: And it's well tolerated at all doses, which I think again it makes it makes it quite different it has true endocrine bathroom potential.
Speaker Change: Which is very different than what we've seen with some of the listener.
Speaker Change: Some of the other drugs that are out there. They are desperate has shown robust data in an early trials.
Speaker Change: And in metastatic settings, and as a monotherapy and in combination. So I think the trials that we have out there right now there they start to answer some questions.
Speaker Change: B the big Kahuna, that's kind of coming in 2026, but I think this is a molecule which.
Speaker Change: We've seen evidence of efficacy and so now we just need the trials to read out.
Speaker Change: Thank you can I just ask one follow up can you just confirm that with you.
Speaker Change: They don't want you to have a biomarker integrators into the phase III trials that are underway and plump yes.
Speaker Change: Yes.
Thank you.
Speaker Change: So Richard I hope that answer all your questions in that case. The next person in line would be redressed Kumar from I'll give you now.
Speaker Change: Possible to Chaucer question.
Alright.
Speaker Change: Thank you very much for taking my question.
Speaker Change: On the game.
Speaker Change: Okay.
Speaker Change: Talk through what two emissions are in the combination with.
Speaker Change: Obesity development please.
Speaker Change: That would be very helpful. And then you know.
Speaker Change: Firstly visiting drawn to new Mab.
Speaker Change: Uh huh.
Speaker Change: Can you give some color on the timelines of.
Speaker Change: No.
Speaker Change: Are we going to hear from you again, and what should we be looking out for.
Speaker Change: When you update us on your go no go decision.
Speaker Change: So like you mentioned Ginter Tonight is active in and a number of places so we've got.
Speaker Change: We've got the combination trial with adversity as well as the the monotherapy trial and Fsh D. But we are also looking at it in combination with our obesity assets we have.
Speaker Change: Have some preliminary data in house, we have made the decision to move forward into a combination trials and it's still very early days, but I think we are 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.
Speaker Change: With regards to 'twenty will share additional data cuts of the ongoing dose finding study at 80 P. D and have wanted to see Tad in half two we're currently awaiting the completion of the part two expansion cohorts Sheila.
Speaker Change: She will inform the final dose once we have the final dose will be able to move into phase three.
Speaker Change: Thank you heard at pharma day last year, and I reiterated at J P. Morgan at the beginning of the month the continuum out as 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.
Speaker Change: Two actually do as much of the Frontloading for that phase III trial as we can so that once we get the final dose will be able to move very very rapidly into phase III.
Speaker Change: So expect expect to hear more about more from us on that this year.
Speaker Change: Thank you.
Speaker Change: Do you have any follow up question Ralph.
Speaker Change: No. Thank you.
Speaker Change: Alright.
Speaker Change: Thanks, So much and the next one in line will be then drifting Smith from Bernstein.
Speaker Change: Okay.
Speaker Change: We can hear you yeah. Thanks, So I was going to ask.
Speaker Change: Can you hear me.
Speaker Change: Yeah, Thanks, Steve from a justice with Bernstein number one just on Diablo seven I'm, sorry, if I missed this but it seems as though since the CMT its been moved up to a non risk adjusted peak sales target of over 3 billion Swiss He's just wanted some color on that.
Speaker Change: Just wanted to ask the Golar, Matt might be a little bit too early to ask but one of your competitors sort of suggested that.
Speaker Change: COPD is most sufferers, but efficacy of the biologics is probably like likely to be lower than in severe asthma. So just wondered if you hadn't had any thoughts on my many thanks.
Speaker Change: Yeah. So I'll answer the asking question first I mean, that's why you run the clinical trial right. So we'll see them. We think there's a good scientific rationale for why this could work in C. O P. D. We're covering a very broad patient population and an area of very high unmet need so yeah.
Speaker Change: We will 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 next level of seven.
Speaker Change: If this.
Speaker Change: If this molecule lives up to what we believe it can do it will for sure become a new standard of care and in hemophilia, a and therefore easily a multibillion dollar indication.
Speaker Change: But you know it is the data that we've seen so far is exciting it's early days more to come.
Speaker Change: Yes.
Speaker Change: Thank you.
Speaker Change: Yeah.
Speaker Change: Okay I'm back so finally I made it.
Speaker Change: Have to restart in the country.
Speaker Change: I think we have one final analysts in the ROE I think it's a Ben Jackson from Jefferies and placement.
Speaker Change: Yeah.
Speaker Change: I think he may be on mute.
Speaker Change: We can't hear you Ben.
Ben Jackson: Yes, we hear you perfect. Thank you sorry about that.
Speaker Change: Just two quick ones for me Okay.
Speaker Change: The first would be if you're able to draw it provide any color about the shifting blocker submit your bra and DMA.
Speaker Change: <unk> six is there any particular reasons behind that and perhaps is there any competitive.
Speaker Change: So what's behind that decision and then second just to finish off.
Speaker Change: Any additional changes in thinking about BD, especially with areas of interest following the episodic acquisition does that perhaps are associated and the Friday more oncologists about long or is that all still within scope. Thank.
Speaker Change: Thank you.
Speaker Change: Yeah, Let me just answer the second question first and then I can hand over to you.
Speaker Change: I mean, you've seen the five therapeutic areas that we are really focusing on.
Speaker Change: Cardiovascular metabolism oncology neurology those fees contributing about 50% of global disease burden.
Speaker Change: Immunology really plays across many disease areas.
Speaker Change: 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 it 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.
Speaker Change: How much data is available.
Speaker Change: That gives us the confidence like we've had the data available for Q&A.
Speaker Change: And 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.
Speaker Change: Acquisitions now let me just highlight on Posada, because we already had the partnership with us either in oncology.
Speaker Change: And we.
Speaker Change: 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.
Speaker Change: Where we see that there is a big role for car Ts in the future. We also said we will go into this into.
Speaker Change: Into this acquisition so it feels like that I think are really the sweet spots are and you can see that we will continue to be very disciplined and we'll continue to make sure that the deals fits into the our strategic agenda.
Speaker Change: Okay and in terms of Finicky bar, we expect to have data in house.
Speaker Change: Later this year and we'll 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 I'll fix in ophthalmology, including bi specifics and Tri specifics of the Nike brand is certainly only one molecule in.
Speaker Change: And in a whole collection of molecules that could potentially bring IL six promise and ophthalmology.
Speaker Change: Okay.
Speaker Change: Ben did we answer all your questions. Okay. If there any additional questions.
Speaker Change: If there are no additional questions.
Speaker Change: Then I would hand back to Thomas for a final remark Thomas please.
Thomas: Thank you very much Bruno and thanks to everyone for your great questions I believe.
Speaker Change: 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.
Speaker Change: And we have a great momentum as we go into this year.
Speaker Change: And we also have a rich pipeline use coming this year and as mentioned, we're very focused we're very disciplined so that we continue to deliver the.
Speaker Change: For our investors. Thank you very much.
Speaker Change: Yeah.