Q1 2025 Roche Holding AG Earnings Call

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Sandra: My name is Sandra academic technical operator for today's call kindly note that to walk in octane recorded.

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Thomas: Last remark if you'd like to follow the presented slides on your interests wall. Christopher you to go to worst of Com slash investors to download the presentation. At this time, so pleasure to introduce you to Thomas <unk> CEO of Roche group, Mr. Sidney the stages here.

Thomas: Thank you very much and I'm happy to share our Q1 2020 to 2025 deals with you today.

Thomas: Let's look at our performance.

Thomas:

Thomas: Really a good start in 2025 with group sales growing 6% and this was driven by pharma with again very strong sales growth of 8%. So you can see that we continue a very strong momentum on the pharma side diagnostics was flat and just forced you to heska pricing reforms in China.

Thomas: Matt will cover that again, just did not only impact us impacted the entire industry and this is something that we had flagged also at the full year results presentation in January.

Thomas: Hello impact was also in line with guidance.

So now let's look at the key milestones in Q1.

Thomas: I'm a regulatory side, we had a pool of Columbia, the gem ox in second line <unk> and this is based on the very strong phase III <unk> data and it's the first and only by specific with an EU approval in second line <unk> <unk>.

Thomas: Also had the U S approval of <unk>, India mute the second indication.

Thomas: Tnk's in acute ischemic stroke.

Thomas: We have the filing in the U S and in the EU <unk> in lupus nephritis and this is based on the positive phase III Regency data, which was presented at <unk> and it's also published in the New England Journal of Medicine, and we had the filing in the EU for assuming Youre in third line.

Thomas: Uh huh.

Thomas: Ah Follicular lymphoma.

Speaker Change: We've had a number of positive phase III phase III Readouts, let me highlight the sunblock phase III readout from <unk> and <unk> in second line <unk> and we are now excited to move now our second bi specific into chemo free combination with all of you.

Speaker Change: Earlier lines of treatment of <unk>.

Speaker Change: More information on the positive outcome will be shared later in this year at a medical conference.

Speaker Change: We've also taken a number of phase three decision as we mentioned at the full year call. We said there are.

Speaker Change: Actually seven enemies that could move into phase III, which would be our records in terms of hanmi in EMEA as we move into late stage and these are all based on the Bart criteria.

In Q1, we did make two decisions can move two of them into the last stage of development into phase III based on the latest data trends.

Speaker Change: <unk> being one of them in Alzheimer's disease.

Speaker Change: This data was shared at the 80 PD and <unk> is expected to start later this year and the second one is NXT series seven in hemophilia, a and the phase III data for this will be presented later in this year.

Speaker Change: We also had a very exciting business development.

Speaker Change: A collaboration with <unk> pharma in petrol inside the leading long acting.

Speaker Change: Emlen and there will be more on this in a couple of slides from myself, but also that Teresa will share more information on this.

Speaker Change: Gnostics sides, we had menu expansion on the cobot leader, So a point of care PCR system with that like performance with <unk> really building out our menu specific STI.

Speaker Change: STI and we continue to place more of these systems in the market also very Excitingly, we had the unveiling of our novel <unk>.

Speaker Change: S B X.

Speaker Change: Sequencing technology, so sequencing by expansion and I will also provide a little bit more context, as well as Matt will provide more context, and we shared that real world and life experience of customers.

Speaker Change: Yet the HPT.

Speaker Change: We have significant news flow.

Speaker Change: Upcoming in 2025.

Speaker Change: For both pharma and diagnostics and two recent Matt will go into more granularity here.

Speaker Change: Clearly there are a number of phase III, readouts coming including multiple enemies that could lead to launches next year across oncology with your desk trend neurology with Ibrutinib immunology as the golar them up in ophthalmology with <unk> equally we still have a number of phase III, enabling readouts coming.

Speaker Change: Which could enable us to move another five molecules into phase III again, keeping to the ball criteria.

Speaker Change: Looking forward to several key launches still in 2025, including the Lexus P. Tau 181, and the high sensitive Troponin T next generation SaaS.

Speaker Change: Now, let's move on and let's take a closer look.

Speaker Change: We've had strong sales of 8%.

Speaker Change: On the pharma side, so continuously very strong momentum diagnostic to flat I know you already mentioned that this was driven by healthy pricing reforms in China, but only impacting us but the entire industry now I used to have a favorite slides have a new favorite slides, which is this one which really shows that.

Speaker Change: Over the last.

Speaker Change: Four quarters, we've had a significant growth of 8% across.

Speaker Change: And our entire business.

Speaker Change: But if you go back until 'twenty, three we really had underlying growth of 8% consistently. So we have consistently performed very strongly over the last two years and one quarter and this is a strong pickup in.

Speaker Change: Growth versus the 'twenty to 'twenty to 'twenty two time frame.

Speaker Change: Now.

Speaker Change: Let me go to the key growth drivers and I'll start at the right top touch at the physical conversion is now at 47%.

Speaker Change: Both of our.

Speaker Change: The hemophilia side or hematology side, both of our <unk> bi specifics.

Speaker Change: <unk> now into second line <unk> and this is increasingly.

Speaker Change: Increasing our opportunity significantly column B gem ox, receiving EU approval and the positive phase III results from Sunbelt and X T series, there were seven moving into phase III as already mentioned and then urology side and very importantly, as Lenovo received a permanent J codes granted on first of April so we.

Speaker Change: Definitely see a pick up here.

Speaker Change: As mentioned before we do believe that the subcutaneous version of <unk> will add 2 billion incremental.

Speaker Change: Sales.

Speaker Change: And right now the consensus is at about eight and a half billion, we feel very comfortable with that consensus.

Speaker Change: Consensus and the two big incremental will.

Speaker Change: Obviously.

Speaker Change: There will be more sales for the subcutaneous version, but there will be also be some switches.

Speaker Change: Every city, receiving U S proof of tablet formulation and so they're still doing extremely well with our more than 550000 patients on treatment.

Speaker Change: Well the iPhone keeps expanding market share in all approved indications and Teresa will talk about that as well.

Speaker Change: She will also talk about.

Speaker Change: The market contraction in the branded segment because of that funding for copay assistance foundations, but we keep seeing very strong momentum as you can see here with 17, I think the base with 18% growth and we do believe that we can continue this kind of momentum going forwards diagnostics.

Speaker Change: I've already mentioned as well now.

Speaker Change: The young portfolio continues to drive growth in the near to midterm.

Speaker Change: If you look at the right hand side now the young portfolio accounts for 59% of our sales up from 55%.

Speaker Change: We have four pivotal enemies read outs for our.

Speaker Change: And your enemies as I mentioned before.

Speaker Change: Got them up and COPD, they make you Bart.

Speaker Change: M E T a desk strength in breast cancer and <unk> in multiple sclerosis.

Speaker Change: And we do believe that this new portfolio will continue to drive growth at least until 2028, and we know that diagnostics will continue to contribute positively in terms of growth, especially with the new products and all positive readouts that we should expect over the next years within <unk>.

Speaker Change: At the to this growth we don't have a cliff situation.

Speaker Change: And with that we are the more favorable starting position in many of our peers.

Speaker Change: Now let me just highlights.

Speaker Change: A couple of things on the recent announcement that we've made of our investment in the U S.

Speaker Change: A strong legacy of partnership with 130 countries around the world. We basically have the full value chain present in most of our key markets such as the U S.

Speaker Change: In Europe, with Germany, Switzerland, Japan, and China, It's always been our strategy to build out a fully value chain in each of these markets to be present, where the patients are.

Speaker Change: And key parts of this legacy of investment is also our research and development and manufacturing footprint in the United States.

Speaker Change: Now at Tuesday's announcement further $50 billion into R&D and PP&E in the U S until the end of the decade, let me put that into a bit of context. This would be almost a doubling of our investment in the U S. Over the next five years compared to the previous 10 years, where we invested 67 billion R&D in PP&E.

Speaker Change: Let me also say that this does not mean that we change what we said before in terms of capex availability between $3 billion to $4 billion annually.

Speaker Change: <unk> is already included in any of these comments that we've made in the past. It also doesn't change what we've said in the past in terms of R&D spending you can expect R&D to be flat this year and that we keep a very disciplined when it comes to our spending.

Speaker Change: Currently we have 13 manufacturing and 15 R&D sites in the U S across pharma and diagnostics and we are planning to add two new sites.

Speaker Change: First is this announcements of investments, including the construction of our new R&D site in Boston, We've discussed this as a team that.

Speaker Change: We have a very strong presence on the west coast in terms of R&D, but we didn't have a presence on the east coast and so we strategically said we wanted to tap in the ecosystem in the Boston area, which is I would say next to San Diego and San Francisco with the third key ecosystem.

Speaker Change: We want to be present in and that's why we've committed to make an investment here and also in collaboration with Harvard.

Speaker Change:

Speaker Change: And then there is also one many manufacturing sites that we will establish <unk> in the U S. A.

Speaker Change: Where we've been in negotiations with different states in the U S. We have not named the location yet, but we will do that soon and this is basically also for the manufacturing of peptides. So the cretins.

Speaker Change: And also the amylin.

Speaker Change: And so both of our new sites will have a strong focus on C. D. R M.

Let me also highlight that we are probably in a much better position than most other companies in terms of manufacturing capacity that already exists in the United States Oh drug substance capacity utilization is at 50%, which truly gives us a lot of flexibility to adjust our manufacturing.

Speaker Change: <unk> and this is due to the fact that and you can see it on the right hand side that we've driven a fivefold productivity increase in terms of yields from our cell lines.

So what that's enabled us to do is actually some of our medicines that we already produced in the U S. We could increase the manufacturing in the U S. Basically overnight of these medicines and the only remaining medicine, that's a well.

Speaker Change: We have to tackle when it comes to tariffs is one that's currently not being produced or produced in the U S. And we already started the tech transfer of this medicine, a number of weeks ago.

Speaker Change: Let me also highlight that.

Speaker Change: We are when we acquired it shouldn't take not only did we keep manufacturing Gary. So we didn't move to Ireland. For example, we also kept our IP there and with that we've been a.

Speaker Change: Significant taxpayer in the U S. Again, so I would just highlight here, we're probably in a better position than many others.

Speaker Change: Together I do believe this sets the stage for a next area era of growth and innovation for us as a company that could benefit patients in the U S and abroad, but also just want to reiterate we will also continue to vis in countries like China, where we're also expanding our manufacturing footprint.

Speaker Change: Now, let's move to the outlook and I want to highlight two areas. One is raw sequencing and the other one is our efforts around C. D. R M and I know, both mats and Teresa will go into more details on this at H B TV unveiled a novel sequencing solution, which combines our highest throughput sensor module that we did.

Speaker Change: Developed over the last years and now comes the secret sauce, that's the SPX chemistry, the sequencing by expansion chemistry, which actually expands the DNA 50 times. So that you get a better signal to noise ratio with that you increase the accuracy significantly and you increase the speed and throughput.

Speaker Change: So you don't actually need to slow down this molecule as it goes through the poor you go through a very quick and you get a very clear and clean signal with that we have a very high accuracy, which is fit for clinical applications.

Speaker Change: Extremely fast and we have a lot of throughput and.

Speaker Change: Also if you can.

Speaker Change: He is with.

Speaker Change: With the flexibility because with <unk>.

Speaker Change: I can honestly say used today you have to run a full plate benefits.

Speaker Change: If it does the price and cost and you don't have to do that with this technology. So we do believe that we're in a pretty good position here as well.

Speaker Change: Let me talk about our commitment to become a leader in C. D. R M.

Speaker Change: And if I'm right. We now have a broad portfolio of differentiated assets that address address unmet needs in obesity diabetes and a number of adjacent indications. Let me just highlight there probably more than 200 comorbidities that are linked to obesity.

Speaker Change: Once you're a pea on the comment acquisition and also in Q1, we announced Colorado coloration with pharma to develop petrol insights a long acting amylin analogue I know Theresa will go into that detail.

Speaker Change: Also in Q1, we announced our plan to build the Boston Innovation Center in partnership with habits.

Speaker Change: And this will be focused on CVR M drug discovery and development.

Speaker Change: And on the diagnostic side again, let me highlight this we are the global leader in this space. We know all of the key opinion leaders, we have the leading portfolio of cardiac and metabolic markers, we develop holistic solutions for the management of diabetes and cardiac indications and this includes C. G N that.

Speaker Change: Offers unique smart algorithms and easy one step application.

Speaker Change: But I know that both Matt and Teresa will cover more here.

Speaker Change: Let me just highlight here on the 2025 pipeline for pharma and the positive news flow and also the negative news flow in Green you see the positive.

Speaker Change: And in Red the negative.

Speaker Change: On the negative side, let me just highlight skyscrapers euro seven yes C C, which missed its primary endpoint, but let me also highlight that when sky six field middle of last year, we stopped all of the Ferragamo studies that were still in progress could be stopped as we mentioned at the time in this investor call and we.

Speaker Change: Only let the ones run where it was not appropriate to stop these trials anymore.

Speaker Change: <unk> high dose, which.

Speaker Change: <unk> missed its primary endpoint.

Speaker Change: Again, I just want to say, we're comfortable with the October consensus where it is right now which includes the $2 billion incremental sales, which are driven and the combination of sub cut in and IV.

Speaker Change: And let me also say that we don't see a cliff situation also volker bosse beyond the end of the decade because of kits and of course high concentration, which you see in green here as well on.

Speaker Change: On the positive side again, just wanted mentioning printed them up in X TCR series seven moving into phase III column B with you approval don't Sue meal with a positive phase III Readouts in second line Youll be feel obesity for Jim a feet to nine well we are starting a phase.

Speaker Change: Two combination with <unk>.

Speaker Change: And a topic dermatitis and matched to new indications for turnkey part D M D and spring and the high concentration of <unk> that I mentioned.

Speaker Change: Let me just close by saying that we confirmed the 2025 guidance as you can see on this slide sales growing mid single digit core EPS growing high single digits and dividends to further increase with that thank you very much and I hand over to Alan to take us through the finance side, yes. Thanks Thomas.

Speaker Change: Everybody knows the sales calls today I hope everybody is well so my my contribution will be brief today, yes, let me jump into the sales.

Alan: What you see here the reported sales in in Swiss francs.

Quarter, one 2024 compared to quarter, one 2025, so in total a 7% increase let me start with the highlight at 6%.

Alan: In constant currencies and you see if you have different factors here I think one element is really here on the diagnostics side, you see the China health care pricing reform that Thomas has mentioned already which was a reduction for sales on diagnostics on the other hand, excluding China.

Alan: Grown by roughly 5%, which I think it's quite an achievement. So met will will dive into this and you see on the pharma side I think really good underlying growth as.

Alan: As expected the loss of exclusivity impact with a certain erosion in Q1.

Alan: As you know, we expect more erosion for actemra in the quarters to come so still we stick to our expectations that you're going to lose $1 2 billion in that segment over the year, you'll see currency.

Alan: Is a positive in Q1.

Alan: Translating into Swiss francs, so it got to get through the plus 7% and I will dig into that but let me say enjoy at the moment.

Alan: When you look really then at the exchange rate impact on the sales growth and that is the 6% on the left hand side in concentrates that you know already saw a six 4% as we added the decimal and you'll see on the right hand side interest strength of seven 2% growth and then you see really the currency fluctuations in between and you'll see a major.

Alan: Contribute to it.

Alan: Two the performance has been the U S dollar, which has strengthened in that period and we all know what's happened in April and I will talk about that in the next slide and here. It is.

Alan: Because as you know what we do is.

We keep all the currency stable AR at the end of Q1, and then basically project until a certain quarters, but also until the end of the year and then measure the impact announcements yet, but let me see what say one thing after the end of March as mentioned I assume you have seen a major volatile.

Alan: Yeah, the MAGE, a weakening of the U S dollar.

Alan: And I will get to that.

Alan: When you really look at full year 2025 impact.

Alan: As of April 23rd.

Alan: So really recently and you assume all of these currency rates remain stable until the end of 2025, we will have a currency impact.

Alan: Full year.

Alan: On group sales of minus five percentage points so quite.

Alan: But that said we're also not alone I think other companies will be affected by this as well I know it is of interest what that means for cooperating profit and for core EPS. So let me give you. These projections with just that would be highly speculative.

Alan: Very unlikely that they will really realized but for cooperating profit full year. It would mean, a minus seven percentage points and on core EPS and impact of minus eight percentage points. So that's quite significant as Ive said, you'll see Q1 enjoy the moment I think for the next quarters to come I think if currency stay where.

Alan: They are basically today I think we will see.

Alan: Much worse picture.

Alan: Good I think Thomas that everything about the guidance I don't want to just reiterate here that we confirm the guidance.

Alan: For 2025 and with that.

Alan: Happy to move over to.

Ellen: Okay. Thank you Ellen.

Ellen: And he wanted from an delivered 11.9 billion Swiss francs in sales with 8% growth at constant exchange rates you see the U S Europe and international all delivered strong growth of 6%, 5% and 18%, respectively, and Japan is now returning to growth with a 3% up 3% in Q1.

Overall from a volumes were up by 13% in Q1.

Ellen: So, let's kick things off with a look at the sales growth across the pharma portfolio. Please note that all absolute values and year over year growth rates are presented in Swiss francs at constant exchange rates and as Thomas mentioned, our young portfolio continues to deliver strong growth led by the key brands. That's the I'm sorry, the first guy with a bias now Henry breadth delivery.

Ellen: Together these added 700 million Swiss francs that new sales at constant exchange rates in Q1 for the first time Pascal is our number one growth driver in that strength. That's thanks to the very strong performance in our international region.

Ellen: So now let's take a closer look at our key therapeutic areas starting with oncology.

Oncology sales increased by 2% to $3 9 billion Swiss francs. In Q1. This growth was primarily driven by the hurts. Your franchise says go continues to impress with incredibly strong 52% growth in Q1 that global conversion rate continues to climb we're now at 47.

Percent across our 58 launched countries with the growth in China accelerating noticeably following our delisting earlier this year.

Ellen: Forget it conversion defense that was ongoing and we are looking forward to sharing the final affinity analysis.

Ellen: Which is that 11 year follow up at an upcoming conference this year.

Ellen: <unk> continues to deliver good growth driven by uptake in the adjuvant setting.

Ellen: Switching gears over to test centric to our sales in the first quarter remains stable and as he mentioned that full year, we believe centric as close to peak with limited to no growth going forward.

Ellen: S launch if I tells me is continuing as planned and we are expecting EU approval later this year looking.

Ellen: Looking ahead through the end of 2025, we have two highly anticipated phase III readouts for your desk straight with you very impressive ore expected in the second half and Additionally, we are looking forward to initiating our phase III trial with either asset or a K RAF inhibitor on top of standard of care in first line non small cell.

Ellen: So now let's move on to hematology and hematology growth remains strong starting the year with 14% growth 2.1 billion Swiss francs sales.

Ellen: Labour showed a strong growth momentum across all patient segments as expected. The U S Q1 year over year sales were flat and that follows a very strong growth. We saw in Q4, we had 20% growth in Q4 in the U S and that was impacted by a buying pattern from one of our largest distributors can we sort of expected and signaled that as we head into <unk>.

Ellen: But we said nobody that full year.

Ellen: Ex U S. However, we saw very strong growth in Q1 with the international markets growing 72% and the EU market is growing 7% and basically all countries are contributing across those regions for a full year. We are confirming our the ambition of mid single digit global sales growth for him Libra Theres also some exciting news.

Ellen: On our next generation bi specific in hemophilia next step <unk>, seven which I will cover in the coming slide.

Ellen: But for now let's move on to our malignant hematology portfolio.

Ellen: Palladium first line there'll be Seattle continues to drive strong growth and we've reached yet another milestone with more than 50000 patients treated globally.

Ellen: U S. First line WC all patient share continues to climb we're now at 31% and we are looking forward to presenting the updated phase III <unk> data in relapsing remitting the RPC on an upcoming medical conference at mid year.

Ellen: How long the inland sea meal, our CD 20 city three bi specifics our launch performance is on track for both in their lead indications third line plus the MPC Alpha clumsy and third line plus Follicular Fillon Simi L. A we expect to achieve the combined peak sales potential of <unk> hundred million Swiss francs in those initial indications which are wrong.

Ellen: It's small.

Speaker Change: I do want to highlight that both of these by specifics are making good progress to move into earlier lines of treatment and therefore, our bigger markets are specifically those first moves into second line D. L. P. C. L. As Thomas mentioned Columbia recently achieved EU approval based on <unk>, which demonstrated an OS benefit with a hazard ratio of 0.59.

Speaker Change: The first and only by specific in EU approved in second line D. L. B C L and in the U S. We are still expecting FDA approval around midyear.

Speaker Change: As mentioned before we're also excited about the positive phase III. So no data often don't see me al <unk> in second line plus the L. P. C L, which offers patients another T Murphy treatment option and we are looking forward to sharing that full dataset with you in the near future.

Speaker Change: Staying with one semi L. A there is quite rich outlook in 2025 for hematology, we have the U S to do fast Thomas mentioned for the subcutaneous fortunate.

Speaker Change: Cutaneous formulation of Min Simi L. A in third line Follicular and that is set for September 22nd. We are also expecting the phase III is less them I'll read out in second line Follicular later this year as well and then Additionally, we are expecting phase III readouts for them and at Blackstone and first line Mds and P S Guy and Asus.

Speaker Change: So now as promised let's take a look at.

Speaker Change: Next <unk> seven certainly the key news here is that we are moving.

Speaker Change: Next I will have seven into phase III trials. This is the next generation factor eight by specific monoclonal antibody that we have in development with chugai.

Speaker Change: Clinical results indicate that it has the potential to achieve zero treated leads for hemophilia a patients without the need for additional factor eight treatment I always mentioned before the next tableau seven is 30 times more potent than him Libra.

Speaker Change: And we believe that this really could be a game changer for hemophilia patients.

Speaker Change: The aforementioned so we are moving in to phase III. We are launching three phase II trials of sharing thing one head to head with him Libra I think this gives you a very good sense of our excitement for next tablets at that and quite frankly, it really only makes sense to be including him Libre, which is the standard of care.

Speaker Change: As the comparator for any new trials in hemophilia a all of these trials are expected to initiate in 2026 and we are also exploring device options.

Speaker Change: There's two data for next several of seven will be shared at an upcoming medical Congress and as covered as part of the IR event on June 23rd.

Speaker Change: So up next lets head over to our neurology.

Speaker Change: Our neurology franchise.

Speaker Change: Realogy continues to deliver strong growth of 10% at constant exchange rates, achieving 2.4 billion Swiss francs in sales Oh Crevasse go through gross momentum remains strong at 6% globally.

Speaker Change: A lot has happened with OCA vest in Q1, so, let's delve a little bit deeper into the Q1 is slow.

Speaker Change: You know the permanent J code for OCA Vista Novo our sub Q formulation was granted on April 1st in the U S. We believe that this will lead to an acceleration of U S uptake, particularly in the second half of the year.

Speaker Change: The early market response has been very positive and we know that some practices, where not only actively waiting for the permanent J code, but we're also deciding against adding additional infusion shares in favor of starting on or switching patients over to OCA must now though.

Speaker Change: Importantly, based on internal patient claims data, we see that about 50% of Novo patient starts are naive to OCA best So that continues to give us confidence that this new formulation will open up new patient new patient populations to okra and not simply cannibalize existing share.

Speaker Change: Of course in Q1, we also shared the negative okra, that's high dust readout in Rms.

Speaker Change: And while disappointing I think it is important to remember why we ran this trial.

Speaker Change: And the purpose of the hydro trial is really to understand if patients would experience greater efficacy with a higher dose of OCA bes and while this trial didn't meet its primary endpoint the results clearly support OCA or a standard dose as the optimal dose to slow disability progression and this is actually great news for pace.

Speaker Change: So now that we have the answer to what is the optimal dose of OCA best we are quickly moving forward with the development of a novel subcutaneous formulation that has a higher protein concentration, which will significantly reduce injection volume.

Speaker Change: Which allows us to move into a more convenient on body device with the goal of bringing okra best closer to home. So more on this exciting development will be shared at a later stage, but we are moving with urgency into this next phase of our lifecycle for OCA mess.

Speaker Change: In the meantime of course franchise modeling remains largely unchanged, we predict the franchise to peak at the end of that and they ended the decade and did not expect as Thomas mentioned in Nebraska and abrupt cliff situation.

Speaker Change: Okay sub cut providing some level of protection to the franchise for 2025, we continue to expect high single digit level sales growth and we continue to be comfortable with the okra missed consensus peak sales of $8 5 billion, including the 2 billion Swiss franc incremental sales opportunity for Opus subtype.

Speaker Change: Moving on to every state every skinny continues to deliver strong growth and we expect the full year growth rate to be at roughly the same level as the 18% that we achieved in Q1.

Speaker Change: Tablet formulation.

Speaker Change: It's U S approval in February which offers patients a simplified storage option, eliminating the need for cold chain and easing administration I E. You approval is expected before midyear for the tablet.

Speaker Change: The early launch momentum for <unk> M. D. M. B continues to be strong in ex U S. Ex EU countries with $43 million in sales in Q1.

Speaker Change: We were profoundly saddened that a young men with Duchenne has passed away following treatment with <unk>, having suffered acute liver failure.

Speaker Change: Following this events ongoing studies were put on temporary clinical holds by EU regulators and as always Roshan strapped to are focused on doing what is most important for patients and patient safety is always our paramount concern.

Speaker Change: Based on the totality of data. However, we do remain confident in the efficacy and safety profile of <unk> and we are not changing forecast guidance at this time, and we will work with EU regulators to minimize any potential delays to the program.

Speaker Change: Continue mad in Ah and Alzheimers, we presented the more mature phase two dataset at 80 P D and more on that on the next slide but importantly, we have made the decision to move <unk> into phase III and look forward to initiating that trial later this year.

Speaker Change: On the outlook for neuro, we expect a steady news flow through the end of the year the phase III Readouts for Senate Britain Nib in our M. S. N. P. P. M. S are expected at the end of the year and there are phase two to phase two readouts for against 329 expected in 2025, one in combination with every city in SMA and one as monotherapy in F. S H D but.

Speaker Change: We leave neuro, let's take a closer look at the two molecules we highlighted at the recent ADT conference trustee and processes map.

Speaker Change: Starting with China as we mentioned we presented updated data from our phase one two brain shuttle trial of transient Alzheimers and you can see that that rapid and deep amyloid clearance continued to be achieved at different doses and importantly, 81% of patients on the 3.6 Meg per kg dose achieved amyloid pet negativity within just two.

Speaker Change: Eight weeks at the same time in the safety and Tolerability profile remains very favorable ARIA E and H rates are well below 5% across the 114 patients treated in parts one and two.

Speaker Change: Just on these very positive results, we decided to move <unk> forward into phase three with the trial start planned for later this year and we would expect final read out of that phase II trial in 2028.

Speaker Change: So now let's briefly move on to Parkinson's.

Speaker Change: At ADP, we presented the phase <unk> data.

Speaker Change: Spite missing the primary end point the results show a delay of confirmed about a progression in P D, especially in L dopa treated patients.

We are waiting for additional data from the ongoing label extension and with the benefit of that additional data and then in close alignment with regulators next steps for <unk> will be decided around mid year just to remind everyone. We can see we continue to see probably as a high risk high reward opportunity.

Speaker Change: So now let's continue on to immunology.

Speaker Change: Immunology franchise, a C achieved $1 6 billion Swiss francs in sales and grew 8% at constant exchange rates.

Speaker Change: This growth was primarily driven by Xolair and its strong launch trajectory in food allergy.

Speaker Change: So there's benefit in food allergy was further confirmed by positive updated data from outmatched, which showed that xolair is more effective and has fewer side effects and oral immunotherapy for treating food allergy.

Speaker Change: For the full year, we expect.

Speaker Change: Growth in the mid teens for Xolair and as a reminder, we don't expect any biosimilar launches in 2025.

Speaker Change: I count myself I'm honored mantra, a minor decline of 1% due to Biosimilar impact U S. Biosimilar launches continue to be slower than we expected about EU biosimilar penetration is increasing as planned and we anticipate that our overall biosimilar impact will accelerate in the second half of this year and as Alan mentioned, we are confirming that that.

Speaker Change: One point to a biosimilar impact for the full year across the portfolio.

Speaker Change: Cause either on the next slide, but let me just mention here that the positive Regency results were recently published in the in each of them.

Speaker Change: R. A T O when a program had quite a busy start to the year first and foremost we have finally received our I N N. Just last week and so we are now, especially now as I said goodbye.

Speaker Change: We also started trials in three indications all of them achieving F. P. I N Q1 in phase three in Crohn's disease phase two in atopic dermatitis and a phase one in Nash further indications or are currently being evaluated.

Speaker Change: He is one of our internal fast track molecules, where we work across all levels of the organization to ensure development at speed and this is a direct outcome of our R&D excellence work and he is one of the programs where you can really see the impact of that.

Speaker Change: Considering the outlook for the rest of the year in immunology, we have phase three trials for cause either an S. N V and aster Golem, AB and C. O P D expected to read out and for IFC. As a reminder, we continue to see this as a high risk high reward opportunity now.

Speaker Change: Now, let's take a closer look at cause either in lupus.

Speaker Change: We shared the positive regency results at the WCS conference in February because I have a demonstrated a superiority over the standard of care with a clear benefit in complete renal response safety was in line with the very well characterized profile cause either with no new safety signals and the U S. Producer has been set for October and E filing.

Speaker Change: That's been completed.

Speaker Change: Basically readouts for additional indications are expected in 2025 allegory in SLE and ensure N I N S. And then obviously and then trial is ongoing.

Speaker Change: Moving on to Ophthalmology ophthalmology grew by 17% in Q1, achieving 1.1 billion Swiss francs in sales, but <unk> is now the most prescribed treatment in A&D in the U S.

Speaker Change: Market shares in the U S continue to expand with AMD now at 33% that's up 3% D. M me up 2% in RVO up 3%.

Speaker Change: This is also true for ex U S launch countries, where we continue to see market share increases across all indications.

Speaker Change: Additionally, the share of treatment naive patients starting to buy some in the U S is now approaching 60% and I think that's further confirms for buys in those positioning as a first line treatment.

Speaker Change: As Thomas mentioned at the same time U S sales were impacted by a contract a contraction of the U S branded market and this is primarily caused by funding shortfalls from the co pay assistance foundations. This dynamic in the U S is likely to persist and the overall impact of that construction will look will likely take several quarters to wash out.

Speaker Change: Outside the U S. We've seen very strong uptake you conversion to the recently launched PFS is rapidly increasing its already at greater than 70% in all the markets, where it's available and the China launch accelerated markedly after achieving in our delisting in January for all three indications.

Speaker Change: Taken altogether, we still expect roughly 20% sales growth globally.

Speaker Change: It's more of a bias this year, but we do have to caveat that there is a difficult to predict development or it is sort of difficult to predict how the U S branded market will develop in the coming months.

Speaker Change: Some good news for assessing them on U S approval in Dnb was achieved and EU filing for a M. D is expected later this year and similarly, we expect data for our Isle sets then they keep are in U N E.

Later in 2025.

Speaker Change: Wrapping up our tour of the therapeutic areas with a quick look into our C. D. R M franchise.

Thomas: Thomas I am very excited about our recently announced collaboration with steel inch to partner on petrol and tied in obesity together was the L. And we believe that monotherapy petulant time has the potential to become the foundational therapy in weight management with improved tolerability in a mode of action differentiated from G. L. P ones as Amazon's work.

Increasing that feeling association bulge L PS work by reducing hunger.

Thomas: Petro one times favorable physiochemical properties will allow for easier co formulation and co administration with other peptides.

Thomas: So that's in addition to just exploring as a mono therapy. We are also exploring different combination opportunities starting with a fixed dose combination of petrol and tied in C. T 388.

Thomas: Our belief in the best of class in the best in class potential is also based on the strong phase one.

Thomas: <unk> shown here placebo adjusted weight loss of up to six 9% was achieved at 16 weeks and at the same time safety and Tolerability were quite favorable with the vast majority of treatment emergent adverse events reported as mild.

Thomas: It's two in obesity without type two diabetes is currently ongoing.

Thomas: Now the Zealand collaboration very nicely complements our existing obesity and diabetes portfolio and we see great potential for monotherapy and combinations to address the various unmet needs in obesity diabetes and colleague the linked Comorbidities and we're making very good progress with multiple molecules expected to advance in 2025.

Thomas: That is quite a list the interim data for C. T 388 in obesity will become available this year and will inform our phase III go decision in the second half I did want to reiterate what we shared at half year that we only plan to share. The final phase two results for this study which are expected in early 2026, we will however.

Thomas: Announced that phase III decision once it is taken.

Thomas: Data for C. T 868 phase two in type one diabetes is overweight and obesity is also expected this year our phase two trial for <unk> 996, or oral will also begin this year as well our phase one for C. T 173 R. P Y Y in obesity and the phase two trial for <unk> three to nine plus a G. L. P. One in obesity.

Thomas: <unk>.

Thomas: For 2026 at me as I mentioned, we expect to see T 388, plus petulant typeface you said it could be initiated.

Thomas: As Thomas mentioned earlier Roche is committed to becoming a leader in C. D. R M and the scope and speed at which we are expanding and developing our portfolio I think really underscore this.

Thomas: And so to close my section, let's look at the key news flow side.

Thomas: So we've added quite a number of check Mark since we last showed you. This slide at the full year presentation I won't go through them in detail since we covered most of it already so just a quick run through our Columbia received EU approval in second line deal Bcl cause I've, a completed U S andi filing in lupus nephritis.

Thomas: Nemo achieved U S approval in D. N me when semi Ellis positive phase III results in second line D. L. B C. L. Next double of seven in hemophilia, a I'm trying to embed punching the mab in Alzheimers are both moving into phase III and as Thomas mentioned Yankees Tnk's achieve U S approval in acute ischemic stroke of course, we also had to add a red cross for the <unk>.

High dose study in RMS with the Gavotte trial at P. P. M S still ongoing but of course, our hopes for a positive trial in that indication.

Thomas: Our our diminished somewhat with the result that we saw with Miss that.

Thomas: So now that is all for me and I have the pleasure of passing it over to Matt to cover diagnostics. Thanks very much Teresa.

Matt: So good morning, good afternoon, everyone. It's my pleasure to present, the Q1 2025 diagnostics division sales results.

Matt: Because as you heard already from from Alwyn Thomas with sales of 3.5 billion Swiss francs. The diagnostics Division sales were stable versus Q1 2024, and this was really driven by the health care pricing reforms and volume based procurement in China.

Matt: As Alan mentioned, excluding China, the growth of the business was plus 5%.

Matt: So let me walk you through that on a customary level. So sales in our core lab decreased at minus one but this is really impacted by the reimbursement reductions of the V. P of China. This resulted in a decrease of immuno diagnostics by 3%, which was partially offset by 4% growth of our clinical chemistry business excluding China.

Matt: Core lab grew at 8%.

Matt: Now sales in our molecular lab increase at plus 2% and this is due to strong growth in our blood screening segment at plus 6%.

Matt: But this was offset by a minus 5% in our infectious disease business now this infectious disease decline was driven by a decrease in our HIV business in Africa.

Matt: As a result of the U S. A I D funding pause for testing now excluding this effect molecular lab grew at plus 6%.

Matt: And we are optimistic that the U S. D pause will end and that this business will resume we will keep you updated in the coming quarters.

Matt: No sales in our near patient care business decreased at minus 5%, but this is mainly driven by the decline of our blood glucose monitoring business at minus seven due to the market shift to continuous glucose monitoring.

Matt: And this was partially offset by a healthy plus 6% growth of our molecular point of care business.

Matt: I'll talk about the STI approval for CTG later, and I would note that we are confident that our CGM solution and cobalt Samira will drive growth of our near patient care business in the future as I've said at the full year, we don't expect material contribution from CGM in 2020 five, but our manufacturing scale up is going as plan.

Matt: And our launches are going as planned and I look forward to updating you on that in future in future calls.

Matt: So now switching to the regional view I'll take you through the business performance by geography.

Matt: In North America, we saw strong growth of plus 7%.

Matt: In EMEA the business grew at plus 4%.

Matt: In Latam, we saw strong growth at plus 11%.

Matt: And in APAC, we saw a decline of minus 15% and as previously mentioned sales growth in Q1 was impacted by the health care pricing reform N V. P. In China as a result of this the sales in China declined by 23%.

Matt: We expect this effect to continue over the course of 2025.

Matt: And since this is primarily due to the price decrease there is obviously a corresponding impact on the profitability of this business I would call out that we're implementing operational excellence and cost discipline measures to offset this.

Matt: And I would also call out that we had a strong quarter in terms of instrument placements in China and that China is still a critical market for us and we remain the market leader.

Matt: And our ambition again for the division for this year is to grow by low to mid single digits.

Matt: And now I'd like to talk to the engine of our growth for the future is really our instrument placements.

Matt: And here in the full year of 2024, we saw strong growth across all of our customer areas versus 2023 and let me point out a few areas of growth by customer right. So in the core lab. Most of US are cobalt approach his or her high throughput serum work area and our cobalt pure which is our mid throughput serum work area placements grew by 65%.

Matt: And our molecular lab placements of our fully automated cobalt.

Matt: 5800, 6800, 8800 systems for low to high throughput testing and molecular diagnostics grew at plus 22% and I would call out here that we've seen continuous growth of these platforms even through the pandemic into the endemic phase, which really shows that they are the standard for automated molecular diagnostics testing in the clinical laboratory.

Matt: Moving to pathology lab, we saw placements of our benchmark ultra and ultra plus have combined growth of plus 10%.

Matt: In digital pathology or D. P 200, and D. P 600 grew by 36% I would call. It we got the primary diagnosis claims for these last year, which is going to accelerate our position in digital pathology.

Matt: Our primary staining business. The ASC 600 placements grew up plus 4%.

Matt: Now a near patient care placements of our cobalt, so yet our lab equivalent Pcr solution.

Matt: Grip plus 7%.

Matt: And I look forward to updating you in the future on some of the growth of our newer platforms and in the next year, but lastly, we also saw strong growth of pre analytics and connectivity by 12% and our NAV of five lab operations with good growth of plus 16%.

Matt: So now I'd like to come to some of those new launches that you heard Thomas mentioned and start with our <unk> mass spec solution, which got a CE mark at the end of 2024.

Matt: So with this launch we plan to establish and shape the IBD market for automated simplified end to end mass spectrometry testing.

Matt: This will drive market expansion and a transition from a segment dominated by lab developed tests to one with mass spec as a part of the routine core laboratory environment.

Matt: I am pleased to report that we've had significant progress since launch with a number of placements throughout Europe.

Matt: We also achieved C launch for our system and steroid assays on track and vitamin D assays in February 2025.

Matt: And we delivered some of the key installations already this year and I'm pleased to share that the initial sites reported a very fast installation time and positive system performance in terms of uptime and serviceability.

Matt: I would call that we are on track to launch approximately 40 assays in the first wave throughout 2025, which will cover the vast majority of routine testing for mass spec and a second wave will come in the following years.

Speaker Change: So now going back to some of that innovation that you heard Tom has mentioned about our sequencing solution, which is the really exciting unveiling we had at the <unk> conference and what really makes the solution. So exciting is as you heard the marriage of the Genia technology with the Stratos SPX technology.

Speaker Change: And the Genia technology is a nano poor technology, which is complementary metal oxide semiconductor allows for extremely high resolution a nano for a signal to noise ratio and you combine that with the Stratos SPX technology, which is a surrogate polymer and coatings, what's called an expand them or as you saw from <unk>.

Speaker Change: This slide is 50 times larger than a native nucleotide and also enables really high signal to noise ratio.

Speaker Change: Combining these together, they're going to get high throughput high unprecedented throughput high accuracy and high flexibility, which you don't have in standard.

Speaker Change: Next generation sequencing and so the NGL market, which is valued at $6 4 billion U S. Dollars is projected to grow at around 9% per year over the next three years and the clinical segment will experience strong double digit growth driven by applications like therapy selection and minimal rose each morning minimal residual disease monitoring in oncology.

Speaker Change: A roche SPX technology has the potential to really be transformational and you see here on this slide some of the data presented at <unk> from the broad Institute now here the broad Institute demonstrated the high speed potential of the technology completing the entire sequencing workflow.

Speaker Change: Library preparation through a whole genome sequence analysis with variant calling it under seven hours with the SPX fast workflow and I would call out as you heard from the.

Speaker Change: The founder of Stratus genomics Mark of course on the HPT webinar that this was not even an optimized protocol and we're hopeful that we can even improve this in the future.

Speaker Change: I would emphasize that this data showed a level of accuracy that could lend itself well to clinical applications as demonstrated by the strong Q in F. One scores. This workflow could be practice changing clinical environments, where a fast genome is important for decision, making such as the NICU.

Speaker Change: And third as you heard me say before this sequencing chemistry enables black batch flexibility. It makes it cost effective to run small batches.

Speaker Change: We definitely demonstrated flexibility and read lengths with one workflow operating the classic short read range and the other having the potential for longer reads to improve coverage.

Speaker Change: The unveiling of our <unk> technology showcases our commitment and the capability to deliver innovations that could transform the sequencing field.

Speaker Change: So now moving to our near patient care business I'd like to speak about our <unk> for which we received FDA clearance with CLIA waiver in January of 2025. So the molecular STI market is valued at about 1 billion Swiss francs in 2023, there's over 2 million.

Speaker Change: STI infections for chlamydia and gonorrhea in the United States and affects over 200 million people yearly worldwide.

Speaker Change: With the cobalt we at <unk> offer the first FDA cleared CLIA waived molecular diagnostics point of care solution for CTG and expand roche's menu of lab equivalent PCR solutions for rapid and accurate diagnosis at the point of care.

Speaker Change: With this launch we can leverage our installed base of over 13500, Liard analyzers to drive access to our point of care molecular menu.

Speaker Change: And so now a falling with Teresa I'll I'll provide a report on our key launches for the diagnostics division. So the 14 launches shown here we achieved two in Q1, the <unk> T and G. As I, just covered and our chest pain algorithm, which will it helps triage in the emergency room for suspected myocardial.

Speaker Change: Infarction, we're making good progress towards the other launches which are on track.

Speaker Change: Forward to providing further updates in the future.

Speaker Change: Last but not least I'm also pleased to invite you to our diagnostics day on may 27th a hybrid of out in London and also online here, we have prepared an exciting agenda and will further discuss our forthcoming rose sequencing solution as well as our pipeline and portfolio highlights across our customer areas.

Speaker Change: And with that I will pass it over to Bruno. Thank you very much for your attention.

Bruno: Thanks, Matt and just quickly to summarize here, Matt already mentioned the next upcoming IR event will be the lifecycle gnostics event in London again, and then as mentioned already by Teresa in June on June 20, <unk>, we will have in hematology update basically covering all the data for malignant and non malignant hematology, which at present.

Bruno: But at the summer conferences, so, including <unk> <unk> and then also Ista's. That's the first time, when we will share with D. A.

Speaker Change: Clinical data for us the only silver seven which were the basis of the does they should take them out to move that molecule into phase III and would that I think we are ready to open the Q&A session.

Speaker Change: The first one in the row is Sachin Jain from Bank of America section. Please.

Sachin Jain: Can you hear me, yes, Canadian alright, Thanks, I have two questions. Please so, especially going to kick off with my basically if I may.

Teresa: Teresa can you just comment on how you see U S sequential growth from here.

Teresa: We expect continued sequential declines through the comments for several quarters to work out and if that's the case to get to the 20% global growth that you sort of rough regarding T is the bulk of that coming from ex U S and we have low visibility.

Teresa: And then the second is a big picture one you would expect from us for the U S. Policy you commented on the warrants Hitachi footwear absorbable.

Teresa: What assumptions within that have you made given the wide variety of scenarios and then on your U S manufacturing, our R&D commitment you and others have made commitments to the U S. In recent months is there an expectation that this commitment with the industry can reduce or influenced tariff proposals from the administration with just sort of what's the big picture intent.

Teresa: Okay go ahead with the but I'm not sure.

Teresa: With somebody is now so.

Teresa: Basically the dynamic that's happening in the U S. We all know that within the U S. A retinal space. There is has always been a very large sort of.

Teresa: Unbranded market dominated by Boston over the course of the last couple of years, what we've seen is a decline in that portion of the market and where patients finally into the branded therapies.

Teresa: With the early closure of the co pay assistance on the Caf. We are now seeing the unbranded market and in particular, the avastin share continue to grow while the branded market constraints within that brand in the market. However.

Teresa: The business is growing.

Teresa: And every indication that we have and so we will continue to see growth in the U S. It may just be at a lower rate since the overall branded market has shrunk if that makes sense. So, but we will definitely continue to see our share of that branded market continued to grow and we do.

Teresa: Also anticipate significant growth outside the U S as new countries come online and as the pre filled syringe continues to.

Teresa: Enter into new markets. So overall, we think it is a story of growth everywhere in the world and that dynamic in the U S. Like we just take a little time to wash out.

Teresa: Yeah.

Speaker Change: Yeah. Thanks for the excellent question.

Speaker Change: What I can say is that we've looked at a very wide range of different scenarios and I think we kind of go through all of the scenarios today, although I'm sure that everyone would like to but we've put in mitigation measures to mitigate against these different scenarios, what I can say oh.

Speaker Change: Already is if we look at the first half of the year and also in Q2, we will not see much of an effect from the tariffs are one reason is that we've shifted inventories and that mitigates a significant impact already this year and the other part is we already started to increase manufacturing.

Speaker Change: A number of medicines in the United States. So we are very actively working on mitigating all of these topics and we also in our budgets and making sure that we can absorb.

Speaker Change: Potential tariffs throughout the year. So we're really working hard on all of those different topics regarding our engagement with the U S government.

Speaker Change: I can just say that we are an exchange with a U S government, we arent exchange.

Speaker Change: With a U S government.

Speaker Change: Industry Association.

Speaker Change: And but also with other governments like the EU in certain EU member States.

Speaker Change: And I don't want to disclose all of those conversations at this stage, but I can just tell you that we're on the case.

Speaker Change: Okay.

Speaker Change: And then we move on.

Speaker Change: Next question will come from Matthew Weston UBS.

Speaker Change: Okay.

Speaker Change: Thank you Bernard can you hear me yes.

Speaker Change: It's just one question from me please.

Speaker Change: It's a follow up this option on the buys mode.

Speaker Change: So you made clear the success that <unk> has as the market leader in AMD in the U S.

Speaker Change: But you I just wanted to dig into this charitable foundation issue. So the previous Optum market leader with a leading donor in the charitable access foundation market now that your leader Shouldnt, we expect that Rosh steps up its contribution to the charitable foundations.

Speaker Change: No why not Teresa is it potentially linked to the Doj has continued investigation into charitable donations or it seems that after the recent cold winter and appeal win that looks like it's broadly resolved.

Speaker Change: So Matt as as I'm sure you can appreciate all charitable foundation, giving is done through our foundation, which is completely separate and it would be inappropriate for me to comment on how they are how they do they're getting so unfortunately I really can't answer your question.

Speaker Change: Okay understood can I just quickly follow up your answer to <unk> question suggested that you felt that the cat market was just winding down.

Speaker Change: Can I just check that there's no structural reason why we shouldn't assume that calf from everybody's donations should wind down.

Speaker Change: Doesn't that moment the charitable foundations are short of money at the moment the charitable foundation.

Speaker Change: Seem to be without money.

Speaker Change: But.

Speaker Change: To say that I mean that will be just a re basing of the market and it just it will take a couple of quarters to wash out.

Speaker Change: Okay. Thank you, but overall I mean, the growth rate you saw in Q1 with 18% is round about what we expect for the full year.

Speaker Change: Understood. Many thanks for the detail Okay, let's move on.

Speaker Change: One is Emily field from Barclays.

Emily: Hi, Thanks for taking the question.

Speaker Change: Maybe one on southern what Duffy and different ones will you be targeting.

Speaker Change: These three studies, and then or the comparator study versus and factory.

Speaker Change: Using a long acting factor eight that was one of them.

Speaker Change: Hum.

Speaker Change: And then.

Speaker Change: Going back to obesity.

Speaker Change: On <unk> I was wondering if you could make any comments on the back of the high level off of core data that we saw last week.

Speaker Change: If you're able to comment on any structural differences between the two molecules and if that is sort of the.

Speaker Change: Framing of targeting why do you think you can achieve with Cte 96 independent study. Thank you.

Speaker Change: Right. So with regards to the next double a seven a.

Speaker Change: Trial design, both in terms of dosing and in terms of which factor. We would use those are both great questions, which when we have the phase III trial design I will be able to answer for you, but right now it would be it would be premature.

Speaker Change: In regards to your question around are.

Speaker Change: The the early molecule and R. R.

Speaker Change: <unk> 996 or that structure has not yet been disclosed and I think as we sort of repeatedly said, reducing everything down to just structure, sometimes there's a little bit overly simplistic one molecule or one Adam here and there can really really make a big difference and so I think we are very confident in the data that we've seen.

Speaker Change: Thus far with.

Speaker Change: Hi.

Speaker Change: With our with our with our oral molecule and we are looking forward to advancing and in other trials.

Speaker Change: And we've all at this point, we've seen just phase one data just to be clear.

Speaker Change:

Speaker Change: I believe that it sounds like your questions.

Speaker Change: Yes. Thank you.

Speaker Change: Okay.

Speaker Change: Next question will come from Justin Smith from Bernstein.

Speaker Change: Yeah.

Justin Smith: Yeah. Thanks, very much just one for me sorry, if I'm being slow on <unk> are you basically saying that the global area under the curve of the drug is the same or it's just going to come down.

Justin Smith: So the overall size of the U S. If you think about the U S market as a as a pie the size of the pie will likely remain the same the amount of that pie that goes to the unbranded options is likely to get a bit bigger.

Justin Smith: So the slice that's left for the branded market, we would expect the bias now to continue to take share.

Justin Smith: And so I I I just want to continue to underline we do believe that <unk> will continue to grow and as Thomas mentioned the same level of growth that we saw in Q1 is the level of growth that we are we're hopeful to see throughout the rest of the year and again, just a base now of base effect for a couple of quarters.

Justin Smith: Then it will wash out and we will see continued growth like we've seen now in the first quarter will continue to see growth going on in the basin. Thank you. So just very quickly so I get that and then so in terms of the ability of the ex U S to pick up any slack that does that help as well.

Justin Smith: I mean remember ex U S. We still have a number of markets that arent yet approved are reimbursed and we're still in the midst of launching the pre filled syringe ex U S. So there is actually a tremendous amount of opportunity that remains and we're still in very early days and very big markets like China.

Justin Smith: <unk> just launched in January with NR D. L coverage for all three indications. So there is still a tremendous amount of room for about lifestyle.

Speaker Change: A significant amount of growth left in my basement exactly thank.

Justin Smith: Thank you.

Justin Smith: Okay.

Speaker Change: Next question will go to James quickly from Goldman Sachs.

James: Great. Thanks.

Speaker Change: A couple questions.

Speaker Change: Two on some of the upcoming news flow.

Speaker Change: Second half this year, so firstly on <unk>.

Speaker Change: Again, I know this isn't necessarily the best indicator primary completion, thanks listed on Clinicaltrials Gov for persevering.

Speaker Change: Now slip into 2026.

Speaker Change: You've already confirmed.

Speaker Change: Five readouts, but is there any risk of slippage games 26.

Speaker Change: On the space, we see some data from Astra Lilly and Pfizer. So just wondering what you'll take them as particularly with continues.

Speaker Change: Our success in the somewhat mutation population and then.

Speaker Change: What are your thoughts for me.

Speaker Change: Commercial opportunity secondly on front ibrutinib.

Speaker Change: We spent some time most recently that suggested that in terms of apologize apparent over performance in recent phase III trial was relative to the original phase III program.

Speaker Change: Population was the biggest biggest.

Speaker Change: The biggest change there from what you've seen is there anything sort of different.

Speaker Change: Novel Free food for your trends versus what we've seen them together to come back to the trials.

Speaker Change: And there are populations and when you are planning in the studies to what extent did you assume an uplift in efficacy for them for a bunch of you. Thank you and I'm sorry, James could you repeat the first part of your second question I didn't catch it.

Speaker Change: That's my second question should we be sort of some kind of it was recently he said that in terms of apologize apparent over performance in the current phase III.

Speaker Change: Charles to your competitors versus it's its own phase III program. The key change there. It was patient population. So it is there anything different in your patient population versus what we've seen before.

Speaker Change:

Speaker Change: <unk> and <unk>.

Speaker Change: Bruno.

Speaker Change: Okay.

Speaker Change: So I'm still not sure I totally understand what your question. Your second question is the first one is fairly easy.

These are the trials are event driven trials. It is possible that we may see slippage just because they are event driven and as soon as we have concrete information, we will certainly share that.

Speaker Change: And we continue to believe that our third is materially differentiated from a structural standpoint from the other starts out there and so while I think the additional data from other trials is certainly informative it's not definitive and I think that would probably be the way that we would look at it you talked about center brighten up Okay got.

Speaker Change: It. So the question. The second question with Senate Britain them and did we see anything different in our phase three patient population.

Speaker Change: Biogen has done better than people thought right.

Speaker Change: That seems to be the reason as to why it.

Speaker Change: Didn't want successful and Kols, we spoke to so that's because of the patient population.

Speaker Change: Have you adjusted for that patient population in your trial, what were you expecting in terms of the.

Speaker Change: Efficacy when you originally planned metros.

Speaker Change: Got it so I would say that based on the phase two data that we have seen from the Senate brighten up based on the fact that it is a materially different PTK friendly other be teekay has that are out there its non covalent its my belief.

Speaker Change: We believe they clinically that it's more potent that it's more selective and we've seen very strong phase two data with with fed up right now virtually Ah.

Speaker Change: We are quite confident that we have a molecule that is very different from the other molecules that are out there. So from a patient population I'm not entirely sure that there's anything materially different in the patient populations that we're looking at them, but I think we do believe that we just frankly have a better.

Speaker Change: Better be Teekay and one that we were able to bring forward into phase III is at what we believe to be the most appropriate dose and I think that's the other thing that has potentially impacted some other trials as they just weren't able to get to the level of dosing that they needed. We we believe we've gotten to the level of dose that we need them, but obviously you know the trial is still on.

Speaker Change: Going so we haven't been able to formally formally look at the baseline characteristics for all the patient populations.

Speaker Change: But there wasn't anything in how we structured the trials that we think would be materially different.

Jay: Got it. Thank you so maybe Jay if I can quickly answer here.

Speaker Change: Your first question was just referring to <unk> timeline.

Jay: Yes.

Jay: There is no change there just to confirm they both will read out in 25, which easier are expected to come in before peso Euro and you would have to ease. We expect these days are still to come in.

Jay: From mid year towards second half.

Jay: One off together.

Speaker Change: I've got a question on the about your performance I think this was widely debated I think once the competitor data warehouse and several kols comment communicated on that I think due to the changes in the treatment paradigm in the meantime, and you can expect these effects, but it's not that we would tap.

Jay: Now the extent upfront and what have you know.

Jay: Fundamentally differently.

Speaker Change: Designed or all.

Jay: All the studies on the left of the patients.

Jay: Got it thank you.

Jay: The dose is a very important point in terms of the ability to go to a higher dose.

Jay: Yeah.

Jay: Yes.

Speaker Change: Okay. When we move them into the next one is Kerry holford from Bernbach coming.

Jay: Yeah.

Jay: Uh huh.

Jay: Questions.

Jay: If he pays.

Jay: Hey, Peter.

Jay: Hey.

Speaker Change: And in context, since putting higher interest in a transplant right.

Speaker Change: [laughter] clarity cleaning connected to pursuing material agonist.

Speaker Change: Can we anticipate facing Stoke.

Chad: Hey, Chad.

Speaker Change: And then secondly in your client.

Speaker Change: That's a real incremental investment.

Speaker Change: If you wouldn't be willing to kind of.

Speaker Change: And for 50 billion will be allocated to obesity.

Speaker Change: And can you confirm whether you can manufacture 100%.

Speaker Change: It should be.

Speaker Change: No.

Speaker Change: Or indeed, whether you did it in 10-Q.

Speaker Change: CMA API until.

Speaker Change: Okay.

Speaker Change: There's a free tier 388, we certainly do rate remained committed and that phase three will actually start most likely this year.

Speaker Change: We are anticipating the phase III go decision for the C. T 388 phase III. This year Thomas do you want to take that just wanted to say around the 50 billion R&D investment.

Speaker Change: So.

Speaker Change: Around 80% of that is close to 80% is actually our R&D investment in the United States. The remainder is Capex investment and this includes all the different sites investments that we highlighted in the press release.

Speaker Change: And then there are parents with manufacturing and maybe see assets going forward.

Speaker Change: So in the transition as we are working in a in the different phases through development. We will also work with Cmos, but it gives us enough time to build up our manufacturing plants.

Speaker Change: Which we will announce very soon and let me just highlight again, what I said during my presentation just to be clear and.

Speaker Change: Yeah.

Speaker Change: To be very sure that everyone gets this message this investment that we're making the United States is included in all of the messages. We have made in the past in terms of our annual spend on Capex. So when there is no change of any of the messages that we've made in the past. We believe we have enough space to no capex because we have.

Speaker Change: Put a lot into manufacturing over the last decades no network. So we have lots of space in our capex to make those investments.

Speaker Change: And the same goes for R&D, when you talk about R&D investments.

Speaker Change: Flat to this year and very disciplined in the future years.

Speaker Change: Alright, Thank you very much.

Speaker Change: Okay.

Speaker Change: Then we have an excellent ROE so retract a pillar for Morgan Stanley sorry.

Speaker Change: Hi, Thanks for taking my question, so just jumping to season and how long do you think the upcoming competition from the lease on it.

Speaker Change: Does it get patron Saint and thanks to you guys. Starting in Q3, and then also I'd be interested to get your thoughts there could be a molecule and if.

Speaker Change: And why you passed on it given 8% weight loss kit at week, six and the much smaller upfront contribution from apathy and then just a follow up question on W. A certain pace, if the phase III or initiating in 'twenty six how soon can we expect it to be on market. So are you.

Speaker Change: Targeting before the head Libra passenger expiring in 'twenty patchy and do you expect at NXP to expand on the comment Henry peak sales opportunity, where I believe consensus is touching five.

Speaker Change: Thank you.

Speaker Change: Yes.

Speaker Change: So.

Speaker Change: Start from the back into that so double a seventh phase threes I think when we have the announcement on the phase III trial designs and starts will be able to tell you. When we expect those trials will read out we are obviously as we would with any molecule that we believe has this kind of transformative potential we will be moving as quick.

Speaker Change: As possible to bring this to patients and so it would be premature to comment at this point exactly when it will come into market and what are what our plans would be but we do believe that this could potentially.

Speaker Change: Expand the number of patients that are on prophylactic treatment.

Speaker Change: Just based on what we believe it may be able to do from a clinical standpoint.

Speaker Change: From the the Zealand perspective, I mean, certainly we would expect the emlen space as every space in this market is to be competitive that having been said, we think that the data that we've seen from New Zealand molecule is has the potential to be best in class and certainly to be first into the market.

Speaker Change: And we don't yet have data from them.

Speaker Change: From the follow on compounds and so I think where we're extremely excited about the opportunity in front of us and again.

Speaker Change: Again, this is going to be a competitive space, but we feel like this molecule is well positioned to compete I don't know Thomas do you want to take that yeah, just I would like to just add that when.

Speaker Change: When we are screening the market for potential partnering opportunities. We obviously looked at all our partnering opportunities and we saw it. This one is the best first choice for us in terms of partnership.

Speaker Change: <unk> Oh, it's showing the best data.

Speaker Change: Versus.

Speaker Change: You have that available.

Speaker Change:

Speaker Change: Potential emlen, instead, where you could partner with.

Speaker Change: The ability to hear it's the reliability and safely.

Speaker Change: Yeah.

Speaker Change: And I'm sorry, let me also here quickly add the patent expiry for him and he brought his actually not scheduled for 2030, but it's beyond 2030, that's the guidance we have previously given.

Speaker Change: Yeah.

Speaker Change: Okay. Thank you yeah. Okay. Then we move on then.

Simon Baker: To Simon Baker from restaurants.

Simon Baker: Thank you Bruno.

Speaker Change: Good afternoon, everyone. Two questions for me, please just going back to.

Simon Baker: Two.

Simon Baker: Yeah.

Simon Baker: Two points.

Simon Baker: <unk>.

Simon Baker: Your commentary about.

Simon Baker: Being comfortable with sales expectations in light of some.

Simon Baker: <unk> largest slice of smaller pie would imply that you have a reduced expectations for the competition in that category is that indeed, the case that you simply see that.

Simon Baker: Nobody is my market share is likely to be higher than previously thought and then secondly for you Tomas going back to the question on Capex.

Simon Baker: You indicated that the the total level of Capex is the same the test 11 of Opex is the same.

Simon Baker: The amount being spent in the U S is higher than before I'm, assuming that wasn't in the budget. So.

Simon Baker: Definitions.

Simon Baker: You'll end up with a happy U S government because more money is being spent in the U S.

Simon Baker: Therefore, there will be less money spent X U S. I just wanted to.

Simon Baker: Am I thinking about that the right way.

Speaker Change: And where is that where there's less money going to be spent going forward not any political implications of doing that thanks. So much.

Simon Baker: The first the last question first.

Speaker Change: If you look for example at.

Speaker Change: Our manufacturing that words, we've completely modernized manufacturing network over the last decade, if you look at our.

Speaker Change: R&D.

Speaker Change: Network for example in Switzerland, if you've been here recently, it's completely modernized so a lot of the investments that we had in other areas. We can also redirect.

Speaker Change: And it was very clear if we want to enter the.

Speaker Change: Peptides.

Speaker Change: Manufacturing with Kristen and Emlen, we also have to build out and manufacturing. So this was part of our budget. When we made the acquisition. The same goes for CGM and Central CGM manufacturing. There was also part of our business plan. So these are all investments that we've made and we've decided to make those investments.

Speaker Change: But it's in the U S, mostly because it's the biggest market in terms of.

Speaker Change: Obesity medicines, but also in terms of CGM. So I think it's just a very logical step in terms of the investments that we did we wanted to make.

Speaker Change: And you know the simple answer to your question is I I would just reiterate what I've been saying now for a number of years, which is I do believe that our buys milk is the new standard of care in retinal disease.

Speaker Change: We are steadily increasing our market share in every indication we continue to grow our first line share. The Prefilled syringe is extremely high adoption in the U S is growing in adoption in those markets, where it's launched.

Speaker Change: This is the drug on the market to be and so I I just fundamentally do believe that we will be taking share from others in this brandon and in that branded space.

Speaker Change: Alright, thanks, so much.

Speaker Change: Okay.

Speaker Change: Okay, then we have Richard <unk> from JP Morgan.

Speaker Change: Thanks, very much a couple of questions. Please.

Richard: Firstly on progesterone FESCO I Wonder if you could give us an idea of the share that you've products between metastatic and adjuvant.

Richard: And whether the switching of Tesco is greater in adjuvant or metastatic all very similar.

Richard: Secondly on projector as well Biosimilars were highlighted in the annual report is coming in 2006.

Richard: Can you give a bit more color on the timing and whether we can anticipate that being pushed out so well. So I'm just trying to ascertain that and then finally one question on 99 six.

Richard: Tunnicliffe from some size are having.

Richard: Liver enzymes and being discontinued could you just talk about how youre thinking about that and with in relation to nine months. It. Thanks sure.

Richard: So your first question I don't believe that we've broken down per jetta penetration by line of therapy. So I I don't have that information.

Richard: In terms of Biosimilars, we expect that the Biosimilar exposure for a project is going to be relatively limited right. Now we only see one that has the opportunity to come in.

Richard: At around the time that it would be eligible to do so so you know we don't think that they're likely to enter the market until sort of the end of 2027 or later so right now it's not a threat that where we're super worried about for China.

Richard:

Richard: Well, obviously continue to keep an eye on it and keep you informed in terms of 99 six.

Richard: Obviously, our number one concern with any new molecule is patient safety and so we are with all of our molecules. We pay very very close attention to the potential risks and liver risk is certainly one of them right now there isn't anything that's necessarily giving us undue pause here.

Richard: But it is clearly something that that we will continue to monitor as we would with any of our molecules.

Speaker Change: Yeah, and let me just let me just add that there is no buy some they expected in the midterm for physical very important yes, that's true and maybe you have to add one thing Richard I think in terms of the split you asked about adjuvant metastatic the only number we once mentioned is roughly 60 40 split over the entire franchise, but we have not.

Speaker Change: Specified or whatever it is a big deviation now between <unk> and do it at a slight something.

Speaker Change: Splendid thanks, Phil.

Speaker Change: Tom.

Speaker Change: Okay.

Speaker Change: Next one on ROE as Peter if at all.

Speaker Change: Okay.

Speaker Change: Okay.

Speaker Change: Yes, thanks for enough people the BNP Paribas too.

Speaker Change: Two questions for to raise the police towards I'm going to be sort of opposed to the one and perhaps a little bit mix of incentive.

Speaker Change: But look stronger.

Speaker Change: Positive note just on kind of prudent conventional wisdom out there is the Troy work.

Speaker Change: Because you seem to compress.

Speaker Change: We have oh.

Speaker Change: She has already put on the board as to why that might be but the one that we got from Kols is that basically T. One lesion reduction which is good.

Speaker Change: He went for your competitors. So can you remind me sort of be known and used car.

Speaker Change: Comment whether it's compression you've seen in front of Ibrutinib is sustained beyond the early cuts of data and just whether you're cautiously optimistic or optimistic would be cautious about read.

Speaker Change: So that's the sort of <unk> question, and then just being a little bit cynical on double H oven.

Speaker Change: In your prepared remarks, you talked about 30 times more potency that sounds very much like the Nova pitch O&M libre and to be fair, but when you go to.

Speaker Change: You've been talking down its functions at midnight.

Speaker Change: Over the last few years.

Those sort of arguments I just wanted to understand with.

Speaker Change: Ah below seven differentiation is coming from is it just that or things that you mentioned in your prepared remarks, yeah. No I think so let's start with Douglas Elliman of anything fundamentally Devil of seven yes, we believe that it is more potent but it also has the recycling and sleeping technology built into it and so I mean, it is just fundamentally a next generation molecule.

Speaker Change: I don't know how much we've actually disclosed on the actual composition of that molecule, but maybe you can remind me.

Speaker Change: It is just fundamentally a different molecule from heavily Brown said this isn't just I think a little bit better that I think this is a different thing.

Speaker Change: I think Peter what you should read into the announcement. There's also if you made the comment that we benchmark versus somebody brought so I think this was missing.

Speaker Change: With competitor studies and I think that's the ultimate test to really see whether we can establish a new standard of care absolutely I mean, I think we've we've been very clear that we believe that heavily Brett is the gold standard for treatment in hemophilia and we are putting our money as we always do where our mouth is and these trials and running our next generation up against the current standard of care and we love them.

Speaker Change: I think more than beating herself.

Speaker Change: So we're we're excited for that possibility that's something we can discuss in more detail at the June 20 <unk>.

Speaker Change: Right.

Speaker Change: And then in terms of in terms of trying to Britain. It I mean again just to reiterate I think we just fundamentally believe that we have a different molecule.

Speaker Change: And the other be Tas that are out there. It is it is a it is a different composition, it's a different structure its more potent it's more selective it's non covalent and we have I think more phase two data than most of our other competitors have had I'm just referencing here we have longer term 48 week open label extension data.

Speaker Change: That really shows that we're able to to suppress disease activity. So the open label extension here will go out to 96 weeks, we'll get that later this year and so I think we we do believe that we have something different on our hands and the phase two data is playing that out and again when we get that.

Speaker Change: Antisense sneak open label extension data and hopefully that will be another piece of the puzzle them, but you know I think this.

Speaker Change: This is really one area, where I don't think you can compare our molecule to someone else's molecules because they just are different.

Speaker Change: Okay.

Speaker Change: And through.

Speaker Change: <unk>.

Speaker Change: I mean are you cautiously optimistic about Pacific Ocean, she could be accretive.

Speaker Change:

Speaker Change: I think I'm cautiously optimistic.

Speaker Change: And okra. This really is the standard of care for these patients. So if if it beats OCA. That's I think we really know we have something and that having been said oral is comprised 30% of the Ms market and so you know there is a very good spot for Fenner Bruton Nab.

Speaker Change: And even if we don't see superior superiority to from us.

Speaker Change: Understanding it's a slightly different population.

Speaker Change: Thanks.

Speaker Change: Okay.

Speaker Change: We move on and save it evens.

Speaker Change: Yeah.

Speaker Change: From Kepler.

Speaker Change: Yeah.

Speaker Change: Thanks, very much very nice I guess.

Speaker Change: Two questions. Please one on petrol inside minimum range also.

Speaker Change: So train size in your slides you fancy looking for high quality White loss I was just wondering how convinced are constant are either differentiators on less muscle loss more fat loss.

Speaker Change: How much is the rationale.

Speaker Change: That fee guidance level, and then is that in practical terms how are you.

Speaker Change: I think can really differentiate.

Speaker Change: And then and then on brain Schussel.

Speaker Change: What I've seen amazing proof of concept data from from Panama City fault, but where are you on.

Speaker Change: Brian Smith, who CD 20, and MFS might we see Daytona and anytime soon on that.

Speaker Change: Brian So some projects on the way we should know.

Speaker Change: Yeah.

Speaker Change: So as you mentioned, we do have the brain shuttle anti CD 20 in very early very early R&D.

Speaker Change: Don't believe we've disclosed when that first day. This that will will come out, but it's likely not to be for some time that that's relatively early stage and we are certainly looking at the brain shuttle technology in other diseases, where we believe crossing Brent Lane barrier is going to make sense to do so so clearly a technology that has really proven itself in a D and <unk>.

Speaker Change: And we will be bringing forward other other opportunities to look at that and other diseases in.

Speaker Change: In terms of French inland tied a M.

Speaker Change: Emlen class does work fundamentally differently, obviously than our than the acreage and is doing so it is I.

Speaker Change: Very likely that we could see a different kind of weight loss with patients on these drugs and clearly the data are early days, but the clinical hypothesis is solid and so.

Speaker Change: I think we're very hopeful that this could be a fundamentally different kind of weight loss than what you saw with J P. G. L. P. One.

Speaker Change: Thanks very much.

Speaker Change: Any questions or any follow on yes.

Speaker Change: Yeah, Thanks very much.

Speaker Change: Hey.

Speaker Change: I think with that we are at the end of today's call.

Thomas: I will hand back to Thomas for a final remark Thomas yes.

Thomas: Thank you very much Bruno and thank you very much. This team really appreciate everything that you're doing every day.

Speaker Change: And to all of you also thank you very much for your interest.

Speaker Change: I can just say we are implementing a strategy that we rolled out last year with lots of discipline and also with low speed taking out costs out of the system, where possible and shifting it into new areas staying very close to the disciplined.

Speaker Change: We are focusing on our pipeline and we're also focusing on commercial execution.

Speaker Change: I can only say we will deliver.

Speaker Change: Okay.

Speaker Change: Okay.

Speaker Change: Yeah.

Speaker Change: Goodbye.