Q3 2024 Roche Holding AG Earnings Call
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Speaker Change: One last one if you'd like to follow the presented slides on your end as well, Chris you're free to go to grocery com slash investors to download the presentation.
Speaker Change: At this time, it's my pleasure to introduce you to tell machine to come see our West group Mr. Shinnecock the status yes.
Speaker Change: Thank you very much and good morning, and good afternoon, where ever you are an.
Speaker Change: Extremely excited to share with you.
Speaker Change: Very strong Q.
Speaker Change: Q3 results with you today again very strong growth in this quarter.
Speaker Change: Yeah.
Now year to date the group sales are at a plus 6% at constant exchange rates really driven by strong base business growth of 8%.
Speaker Change: The fact is still from Q1 in fact in Q2 and Q3, we had no COVID-19 effect in.
Speaker Change: Both quarters were growing 9%.
Speaker Change: So overall pharma doing well with 9% in diagnostics with 8% growth in the base business. So this is a momentum that will carry us forward into the fourth quarter, but also into next year.
Speaker Change: COVID-19 sales decreased by roughly 800 million and Hello.
Speaker Change: Hello, Ian pegged was also about 800 million and both are in line with guidance and they'll make more comments about that later in the presentation.
Speaker Change: Q3 was also very strong quarter in terms of portfolio progress on the pharma side with five regulatory approvals of our medicines three positive phase III readouts in two acquisitions.
Speaker Change: Five regulatory pool as you see here.
Speaker Change: If the U S approval of <unk>.
Speaker Change: Toffee.
And I thought he was approved six weeks ahead of schedule.
Speaker Change: Video also showing.
Speaker Change: How convincing the data was beyond that we had <unk> sub cut to centric sub cuts approvals in the U S. EU approval for the device more in retinal vein occlusion and sky in Pn H.
Speaker Change: On the pharma Readouts, we had positive positive readouts I would like to just highlight <unk> in lupus nephritis.
Speaker Change: Devastating disease, where there are not many very good treatment options and here with.
Speaker Change: CD 20, we have an opportunity to.
Speaker Change: Really a new medicine for these patients.
Speaker Change: On the diagnostics side, we had two important approvals one is a respiratory reflects this is based on the tax technology that we have developed which enables in.
Speaker Change: In this case 12 different.
Viruses to be detected in a single sample.
Speaker Change: On a single test and also the <unk> Pro serology solution, which enters us into the U S market for blood banking serology, which is the biggest market in the U S and in a lot of parts of the world in Europe, but we've actually gained massive amounts of market share. So I'm really hopeful that we can continue. This momentum then also in the U S.
Speaker Change: I already mentioned two deals one is the CDK portfolio from you guys sorry could you ask the other one is the wind portfolio, which is a very important pathway in ophthalmology, but also other diseases for ancillary and we close the Nomura Dx deal, which has a very.
<unk> innovative technology in point of care.
Speaker Change: Which would really look forward to bringing to patients around the world.
Speaker Change: Will be news flow in this year I would like to call out the Sky One day that will come. So this year, they transcend data and property data we have still some exciting launches the heads on diagnostics with the mass spectrometry, the Ics to one fully automated.
Speaker Change: Which will come so this year. The next version of <unk> thousand 808800, which as we know played a significant role in the pandemic and here we have our next update which will be launched this year.
Again here just looking at it from a divisional perspective, you can see.
Speaker Change: Sales, including and excluding Covid, but really fantastic momentum.
Speaker Change: These in both divisions that will continue to drive growth also into the future.
Speaker Change: Here on the <unk>.
Speaker Change: <unk> side.
Shown this slide multiple times now you can see the group sales development over the last four and a half years.
Speaker Change: On the right side, you see the development if you exclude COVID-19 and this is relevant because the COVID-19 effect.
Speaker Change: We will not play a significant role going forward now there is one effect in Q4 that I just want to highlight which is on the diagnostic side. There was a rapid antigen order in Q4, and 2023 last year and that was roughly around $300 million and so we will see that impact in Q4, which is approximately.
Speaker Change: 2% of our sales so not a major so it's something that we can digest, but as we look into 2025, there will be zero impact for us on the Covid side.
Speaker Change: Here you can see the quarterly developments on the pharma and diagnostics side on the pharma, we see really an acceleration over the last one and a half years into high single digit range on the diagnostic side continuously a very good growth between 7%, 8% so well bill.
Speaker Change: <unk>. We can also continue with a good momentum going forward, Matt will shortly talk a little bit more about the last quarter and some impacts in China, but given the new products that we're launching we're confident also about the outlook in diagnostics.
Speaker Change: Yeah.
Speaker Change: Here you see the key.
Speaker Change: Both drivers of the Roche portfolio in the quarter.
And going forward you talked.
Speaker Change: Clearly the U S approval in the U S. U S approval is very positive for US we look forward to getting an approval in Europe next year I already talked about the century sub cuts that approval and zebra, we continued to gain market share now climbing to 42% we are.
Speaker Change: Also have a phase III, enabling a readout for the nexgen by specific called Nx T series, There were seven which is expected in 2025 on the neuroscience side, we already talked about the U S approval for ocular sub cuts and also a review this is really starting to.
Speaker Change: To accelerate with more than $100 million in sales.
Speaker Change: Just in the last quarter.
Speaker Change: Then going to the left hand side going to ask all their hit again, we see very strong pickup of solar for food allergy with already more than 30000 patients on treatment and we don't expect any biosimilar launches in 2025.
Speaker Change: And if a bypass side and I know Teresa will comment on that as well, we see a very rapid conversion.
Speaker Change: From the ER to the pre filled syringe in the U S.
Speaker Change: Infosys FEMA, we talking several hundred implants in 2020 for diagnostics, we talked about it very strong base business growth and significant launches that have happened and that will continue to come up now.
Speaker Change: Now going to the outlook again this year, we have launched two new enemies with P. S Guy and I taught me and as you can see on the right hand sides.
Speaker Change: The new and young portfolio, that's very innovative and that's going to carry us into the next years is now making up 56% of our overall pharma sales so very good momentum with our new products.
Speaker Change: Yes, the key opportunities for growth beyond 2025, and let me just comment on a couple first I thought it.
Speaker Change: With EU approval that we are expecting next year the risky Jim three to nine readout that we are also expecting that next.
Speaker Change: Next year and the recent data from scholar Rock also is quite exciting for us in this regard and so let's see what will come out of that Fanapt roots of nib.
Speaker Change: We presented at <unk>, the fed not the open label extension showing near complete suppression of disease activity and disability progression for up to 48 weeks again, I think a good indicator here <unk>, we talked about.
Positive phase III, we're now going to talk to the regulators about these results and we hope to file next year and get approval as soon as possible.
Speaker Change: For NTT <unk>, we started phase III trials in.
Speaker Change: And you see and also we will start soon the Crohn's disease phase III trial.
Speaker Change: There will be additional information on further trials should be shared in first half of next year.
Speaker Change: Let me start we expect the readout in 'twenty five and.
Speaker Change: We have given you a updates on our obesity portfolio, which we continue to believe in very strongly.
Speaker Change: On the diagnostics side I mentioned, the <unk> Pro Serology solutions.
Speaker Change: This is a.
Speaker Change: That we've had on the market outside of the U S for quite some time and have gained a lot of market share in this space. Now this is a completely new market opportunity for us in the U S.
Speaker Change: Because we've not been on the market now we've received FDA approval and so we can gain some momentum there I talked about the rest of your flex tests and <unk> opportunity as well.
Speaker Change: So overall I think we.
Speaker Change: We can say 2024 is a very good year for US we continue to have very strong base business growth and we believe this will continue.
Speaker Change: Q4, but also into next year, we do expect the full year COVID-19 sales declined to be $1 1 billion for the $300 million effect, you'll see in the fourth quarter on the diagnostic side, which was a rapid antigen order last year.
Speaker Change: And we also believe that we will have to see what really happens in Q4, but we believe there will be some acceleration in terms of impact.
Speaker Change: The impact in Q4 because of Actemra Biosimilar launch.
Speaker Change: Finally, let me reiterate the guidance.
Speaker Change: Which we have raised that half year on the earnings per share.
Speaker Change: Group sales growing mid single digits and I Hope you understand also with the Covid effect in Q4.
Speaker Change: You know why we believe it will be in the mid single digit range, we have very good cost discipline.
Speaker Change: So we are confident in achieving our core EPS growth and with that we will further increase dividend in Swiss francs.
Speaker Change: I hand over to Allen to take you through the financials in a bit more detail yeah. Thanks, Thomas and today its a sales call.
Allen: I will be brief.
Allen: Hi to everybody.
Allen: It's great to see you asked.
Allen: As Thomas said can fully agree I think great performance in Q3 I.
Allen: We'd like to thank everybody, who has contributed to this uncertainty for most of the employees, we have really done great things for patients so let's jump into it.
Allen: First a little bit of advertising I think you will you get used to this in the meantime.
Allen: We have a really down seven investor events.
Yeah, you'll see that on the lower part of the slide and we will have two more that highlighted on the slide I think really next week, we will have in your urology event, focusing on our alzheimer disease pipeline.
And that's phase one phase II trial, 10 are up data, which we will present at <unk>.
Speaker Change: And what does that include I think includes new data from part one.
Speaker Change: It includes the cohort four at 28 weeks and we're showing initial data from the ongoing expansion cohorts in part two so it will be exciting.
Speaker Change: Please take a look at it and then I think we will close the year at November 25th are with.
Speaker Change: With the Digitization Digitalization day, and this will be around really are using AI and using digital really in R&D development, especially more on the early side. So Avi fragile will present, a and you will see especially the use case a lapping of loop.
Speaker Change: Good with that let's go into the numbers.
Speaker Change: Not going to talk a lot about the sales because.
Speaker Change: Do you have you signed met will shortly cover that masterfully.
And we have achieved good sales growth as you heard from Thomas in both divisions and you see that on the left hand side. When you put it together you get to the plus 6% at CER, which you'll see in the middle of the slide and then you see on the right hand side the impact coming from currencies, which is minus four percentage points, leading us to Ah.
Rose in Swiss francs of 2%.
Speaker Change: I think that's a perfect segue to the next slide so keep the minus four percentage points in mind. So here you would see now on the left hand side, the plus 6% on the right hand side, the plus 2% in Swiss francs I've talked about already and then you see really the major impacts from currencies in the Midland and I think it's pretty evident evident in our case the U S dollar.
Speaker Change: Has the highest impact followed by the Japanese yen the Chinese one.
Speaker Change: In APAC and certainty.
Speaker Change: Oh.
Speaker Change: Good leads me to the point, Okay. What can we expect for full year based on a relatively trivial modeling that we are following on the left let me first say you can see the 2024 average currency rates remain below 2023 for both the U S dollar and the euro which.
Speaker Change: There is additional impact.
And when you then go to the right hand side and you know what we're doing there we keep.
Speaker Change: Currency rates end of September 2024 stable until the end of the year and then look at the impact and do you see already for Q4, we expect a minus five percentage points impact when you look at year to date full year. If you like at the full year in total we expect a minus four percentage points a minus.
Speaker Change: Six percentage points on cooperating profit at a minus seven percentage points on core EPS and I think what is a bit encouraging I think if you look at 2025 and you do the same thing I take today's currencies and keep them stable really over the period of 2025, it would have on sales and impact of minus two.
Four percentage points certainly this is very very speculate if we will see what's going to happen Bothwell, you'll see already what we what we guess we will end up with and suddenly I think as we now progress to you and this is much more stable compared to the previous quarters.
Speaker Change: Good with that let's go once again to the guidance and I think Thomas has had a lot let me be specific about the core EPS grows because the impact from the resolution.
Speaker Change: Resolution of tax disputes in 2023 was a minus $774 million I think that's important to our India itself plus $774 million for 2024, its a minus $774 million I think Thomas talked about Colgate Colgate cells are the 1.1 billion. He talked about the loss of exclusivity impact of mine.
Speaker Change: One 4 billion, which looks conservative at first sight, but includes Actemra and I'm sure. Terry is that makes a comment about it and then I think to be very clear what have been the Kobe sales Q4 2023 and.
That was in diagnostics of 337 million and in pharma 5 million. Yeah. That's why we are going to surround a numbers of 300 million approximately but the Q4 2023 numbers are a fact, that's why I mentioned that I think we also saw if it's perhaps are also interesting to make a comment about 2025, and certainly we're not giving any guidance.
Speaker Change: And see at this stage, we will do that at our full year Press conference, but when we look into 2025 and what we know now we consider the current growth rates for 2025 that we find in the consensus for sales as well as for core EPS reasonable that's what we can say at this stage.
Speaker Change: It looks okay, but it's something that we can achieve with it it's still a lot of stuff, which is going to happen. Then we would change that picture potentially and especially on the core EPS side, because very clearly M&A will play a role and how much debt. We will have on the balance sheet plays a major role here. So I think we feel okay with the consensus looks reasonable yeah at this stage.
Speaker Change: Still I think there are lots of things that can move around good and with that I think I hand over to Teresa great. Thank you so much John.
Teresa: Okay. So year to date pharma delivered 7% growth at constant exchange rates, reaching $34 3 billion Swiss francs in sales, excluding <unk>, we achieved 9% growth at constant exchange rates all regions. Excluding Japan showed strong growth I think we can all understand that sales in Japan were impacted by a basis.
Teresa: About 600 million Swiss francs, and Rhonda <unk> sales in Q1 of last year, excluding one opinion, Japan declined at 3% at constant exchange rates and that's primarily due to mandatory price cuts overall pharma volumes were up by 14%.
Teresa: Our young best in disease portfolio continues to deliver strong prowess led by our innovative brands. The buys them I'll first go OCA vests in Libra polygamy everything together they added about 3 billion at constant exchange rates and new sales so far year to date.
Teresa: Instead, <unk> maintain impressive growth trajectory is continuing to exceed market expectations and as Thomas noted <unk> makes its first appearance on this chart in Q3. It is now launched in six countries outside the U S and has already generated sales of 137 million. So far this year in our international.
Teresa: What region.
Teresa: So with that quick overview, let's start taking a deeper dive into our individual therapeutic areas starting with oncology.
Teresa: <unk> sales increased by 2% to 11 9 billion Swiss francs, and the first three quarters of the year in terms of key news. We're very excited that I tells me also known as end of illicit received U S approval in September for first line P&C kinase mutated hormone receptor positive breast cancer that is as Thomas mentioned more than them.
Teresa: Ahead of that to dissipate and was really based on that strong and over 120 data that showed a doubling.
Teresa: Of PFS.
Teresa: I told you a peripheral was our first step towards expanding our breast cancer franchise into HR positive breast cancer and as you heard it from a day, we have a broad and innovative development program. In this area that we recently augmented Ah via the rigor deals that added CDK I portfolio QR pipeline I'll expand on both I Tobey and the rig ordeal in.
Teresa: Subsequent slides that before we move on let's take a quick look at our on market. Her two franchise again the her two franchise outperformed market expectations kept siloed delivering 6% growth in physio, 58% growth year to date that says go global conversion rate continues to climb reaching 43% in Q.
Teresa: Three that's up from 41% just last quarter and this positions us extremely well for a conversion rate of more than 50% by 2026.
Speaker Change: Moving onto to centric there were two to three developments that we'd like to highlight so as Thomas mentioned, the subcutaneous formulation received U S approval and we are also very happy to report that we had positive phase III data, he and Forte trial in <unk>.
Speaker Change: Extensive stage small cell, which further underlines the strong clinical profile of to centric in small cell lung cancer and finally before we move on regarding the outlook I just wanted to confirm that we continue to expect the skyscraper one final OS results for tiered volume up next.
Speaker Change: By the end of this year.
Speaker Change: So moving on to breast cancer do I tell the approval in the U S. Not only came earlier than expected, but we were also granted a very strong U S label. All endocrine resistant patients are included not only those developing endocrine resistance within 12 months of endocrine therapy, we expect EU approval in the first half of 2025, and we look forward to making this transformative medicine.
Speaker Change: Baltimore patients I'm also pleased to share that I tell people receive Chinese breakthrough designation and priority review.
Speaker Change: As you can see that the treatment paradigm on the right hand of the slide the additional studies with I tells me it will expand the addressable patient pool pool with N. P. I say kinase mutated hormone receptor positive breast cancer with Novo in 'twenty, one 'twenty one 'twenty two and 123 combined we are convinced that I told him. He has a peak sales potential of more than 2 billion in HR positive.
Speaker Change: S cancer alone and please remember beyond these trials. We are also actively looking at other tumor types, where PD three kinase mutation plays a significant role.
Speaker Change: This slide on the left also highlights our on market portfolio and are in development breast cancer portfolio for those of you who joined US at Pharma day, you will recall that breast cancer is perhaps are furthest along end to end a disease area with both a strong our on market presence as well as and ongoing expansion.
Speaker Change: Two hormone receptor positive breast cancer, and while you're very familiar with our oral started your desk trend, which we do expect phase III data in next year am I did want to talk a little bit more about the C. D K.
Speaker Change: For two I portfolio that we acquired with regard.
Speaker Change: So we're extremely excited about this addition into our breast cancer portfolio.
Speaker Change: The lead asset from regret is called RG tea for one nine B and it's currently in phase one as you can see on the slide our G. T 419, B is a highly potent CDK inhibitor that also inhibits CDK importantly, currently available CDK inhibitors do not show a significant activity against CDK and we believe that this M O.
Speaker Change: Way May help set RG tea for one night be apart from currently available options by addressing a key mechanism of resistance well.
Speaker Change: Well the molecule is currently completing its phase one trials were already moving rapidly to think about ways to expand it into other development options and this will include phase two combinations with endocrine therapy, but importantly, also combinations with I tells me I in hormone receptor positive breast cancer as well as in combination with your desk right. We're very excited for the.
Speaker Change: Potential that this portfolio recommend that this portfolio brings including the phase one ready our G. T 587 molecule mm and we're excited to continue to provide you updates that you bring these to patients with urgency.
Speaker Change: Moving onto hematology, we had a strong growth in hematology of 12% in Q3, and we now stand at $5 8 billion.
Speaker Change: Swiss francs in sales, so let's start with Libre Hmm.
Speaker Change: Libra U S. EU five patient shares further increased to 42% this quarter and we've now treated over 27000 patients globally. We saw very strong U S Q3 performance due to a buying pattern reversal that had negatively affected us in previous quarters.
Speaker Change: We can now confirm that the M. P. S trends are back on track and that we are looking at the low to mid single digit sales growth for the U S for full year that we had talked about at the beginning of 2024 at the same time, we remain on track to achieving mid single digit growth globally in 2024 forehand Libra.
Speaker Change: Quite exciting I think is also our follow on next generation bi specific in hemophilia a next level of seven we did share some preclinical data at pharma day that gives us confidence in next tableau seven's potential specifically the potential to achieve zero treated bleeds without the need for factor eight treatment. So please stay tuned for the phase.
Speaker Change: Three enabling phase III data, which we expect will read out next year.
Speaker Change: So switching over to malignant.
Speaker Change: Well it is launched keeps on reaching new milestones. We now have 35000 patients treated globally in U S patient Sharon first 90 L. P. C. L has climbed to 28% I'd like to highlight that we will be presenting a five year OS data for per live in first line <unk> B C. All at the upcoming Ash Conference oral presentation. In addition to the launches for both.
Speaker Change: Our bi specifics Columbia analyst, who meal are on track and progressing as expected with strong uptake in their initial indications. Additionally, there are some important regulatory updates for both that I wanted to share Columbia's positive phase III Star Globe results in second line D. L. P. C. All had been filed with global regulators and we're excited about the potential of moving moving Colombia.
Speaker Change: Earlier lines of therapy and for La Simi all of the positive results for the subcutaneous formulation in third line Follicular are expected to be filed later this year in the U S and the EU. This new formulation builds on the benefits of the available IV formulation, including the need for no hospitalization and a fixed duration of treatment.
Speaker Change: But it is expected to ease of administration and has the potential to require less stare radius. We are excited to bring subcutaneous formulations to patients and we believe that the combination of moving them send me into earlier lines of treatment in Follicular lymphoma, and TWC all with data that we'll be expecting next year. In addition to the sub cut formulation can really help realize it.
Speaker Change: Full potential.
Speaker Change: So now let's move on to neurology and.
Speaker Change: Our neurology franchise continues to deliver strong growth of 14% at constant exchange rates, achieving $7 billion in sales in Q spiky three Oh Griffith has strong growth momentum continues at 9% driven by all regions.
Speaker Change: Furthermore, the Oh Purvis, our de Novo subcutaneous formulation achieved approval in the U S. After receiving its EU approval.
Speaker Change: Last quarter.
Speaker Change: <unk> offers all of the benefits that we've come to expect from <unk> in terms of a strong clinical profile and every six months ago, saying well further easy administration burden recruiting our confidence that this is going to expand OCA versus footprint in the Ms market and that we will seize in novo as an incremental 2 billion sales opportunity already we're seeing very promising.
Speaker Change: For signals about the uptake of the Novo in the U S with about 80% of our new patient starts beginning honestly never being new to brand and not switches from okra vis IV. We expect this strong momentum to persist into the last quarter, meaning high single digit growth for <unk> for the full year.
Speaker Change: And that says you know that was one of our end to end disease areas and therefore, it's also great to see the progression of our oral B Teekay Senate Britain. It is making good progress we see as I believe Thomas mentioned positive data from the Phase Twos Synopsis study was presented at <unk>, showing near complete suppression of disease activity and disability progression for up to 48 weeks and as a reminder, the anja.
Speaker Change: <unk> phase III trials are expected to read out in 2025.
Speaker Change: Moving on to SMA as Rusty had strong year to date growth of 21%. It remains the global market leader for SMA with more than 16000 patients treated as expected Q3 came in a little softer than Q2 and this was due to a one time tender effect in the international region that we mentioned last quarter. We also showed the two year Rainbow fished out.
Speaker Change: As presented at World muscle and showed sustainable efficacy sustained efficacy and safety in newborns with pre symptomatic SMA.
Speaker Change: Going back to <unk>. The first approved gene therapy for DMD has now been used to treat and more than 50 patients ex U S. And let me just say this is such an amazing milestone. These boys and their families are in so much need and it's really tremendous to see how quickly we've been able to to get <unk> to patients.
Speaker Change: <unk> also recently presented a muscle MRI outcomes from the phase III embark city at world muscle and the results are consistent with the benefits seen for the inbox functional secondary endpoint. So I'm continuing to see a good body of evidence building up for Leds on the outlook. There are three key items to cover here in neurology for content you may have been a D. A.
Speaker Change: The updated phase one two data will be shared at sea Tac. So this dataset will contain safety data for an additional 100 patients from the expansion cohorts and longer efficacy and safety follow up for the first 60 patients which had originally been presented earlier in the year at 80 P D.
Speaker Change: As communicated before we expect to have sufficient data on trying to and you might have been a day by the first half to make a decision on taking this molecule into pivotal phase III trials and as Thomas said I'm sorry, as Allen mentioned there is also an IR event to see that on the 31st that we would encourage you to join.
Speaker Change: The phase two put over readout for <unk> is also expected in Q4 and as a reminder, we consider this high risk, but also high reward and also the the interim readout for the phase two every seat plus game three to nine which is our anti myostatin in SMA was moved into 2020 five as was communicated in pharma day, but again with the new data from scholar rock.
Speaker Change: I think we remain excited about what that what that trial could show and so with that let's move on to immunology total half year sales for immunology and reached $4 6 billion, which represents a 1% increase at constant exchange rates.
Speaker Change: Thomas mentioned, a key highlight is certainly the positive phase III data here for it because I have it in lupus nephritis. The study met the primary endpoint of complete renal response, demonstrating superiority over standard of care, we will be sharing these results with global health authorities in the near term and beyond lupus cause either is also in development for many other diseases of the kidney.
Speaker Change: And there are three phase three trials in SLE M N and I N S with the SLE data expected in 2025 and that study just recently achieved L. P. I this quarter.
Speaker Change: Equally exciting is the ongoing launch of Xolair in food allergy I think we shared with you how our how bullish we were on on Xolair.
Speaker Change: Xolair is opportunity she had a strong impact on families facing food allergies, we now have roughly 30000 patients on treatment for food allergy and Xolair, achieving overall Q3 growth rate of 12% and we do accept expect further growth acceleration in the remainder of 2024 and for 2025.
Speaker Change: This growth momentum is expected to continue to deliver a year over year growth rate for solar in the mid teens and as Thomas mentioned earlier, we do not expect a U S. Biosimilar launch in 2025 for a camera you will notice that we are continuing to grow 5% year to date, that's driven by sales in the chronic indications.
Speaker Change: At the same time, we do know that Biosimilars are coming for Actemra and the launches in the U S and the EU. We're frankly, just slower than were expected and that's not only by US I believe that's by the market as well and last but not least let's quickly talk about our anti T O N E and immunology. This quarter, we initiated the phase three trials and you see and we expect to initiate the <unk>.
Speaker Change: Phase III Crohn's trials in the Q1 of next year.
And as Thomas mentioned, we are also working on starting additional trials in this indication, which will be announced at the beginning of the year.
Speaker Change: Up next is ophthalmology fight franchise performance here continues to be strong with the franchise, reaching 3 billion Swiss francs in sales with an impressive growth rate of 47% at constant exchange rates. The franchises led by the buys which continues to expand its U S market shares compare to last quarter the A&D shares.
Speaker Change: <unk> by three percentage points to 30% in D. M E, 3% I'm, sorry, the AMD shares increased by 3% to 30% <unk>, 3% to 22% and RVO by 5% to 20% at the same time, we see that our new to brand share is about 50% naive patients which is up from them.
Speaker Change: Round, 40% in earlier quarters.
Speaker Change: Still more growth to come in September we launched our next generation pre filled syringe in the U S and already we're seeing about 80% conversion clearly, indicating that hcp's are very eager to use the simplified a one handed administrative option.
Speaker Change: We're working to bring the pre filled syringe to the EU as well we're filing is currently ongoing.
Speaker Change: Moving onto says female our AMD commercial relaunch in the U S is underway and let me give you an idea how we're tracking progress with a few bucks and it just comes up quite a bit the way we think about it is it in 'twenty 'twenty four we're targeting several hundred implants and 2025, we're targeting several thousand implants and in 2020.
Speaker Change: Six we target a range of roughly about 10000 implants, focusing on driving implants at this point in the launch is really the goal.
Speaker Change: Because that sets patients up for actually getting therapy.
Speaker Change: Therapy going forward and already we can see that patients that have one implant are highly interested in getting one for the fellow eye about 50% of our new implants since really since relaunch or actually for the fellow eye.
Speaker Change: In terms of outlook for phase two readouts for Nicky Bart as we mentioned Afirma day are now in 2025, and this will help inform our future development and this completes our look at our on market franchise, but of course, there is one key in development franchise that we certainly would like to highlight.
And here I wanted to share our continued efforts to strike a strength in our pipeline in obesity and now. This is a slide you saw at pharma day, a couple of weeks ago and you've also heard a lot of detail about the obesity pipeline E. S. D. So I'm only going to briefly touch on a couple of details here.
Speaker Change: In Q4 of this year, we expect additional phase one data from C. T 388 from cohort 13 in type two diabetes in patients with obesity. This data is expected to be overall confirmatory and as such is planned to be presented at a conference in 2025 beyond this no further readouts are planned for 2024.
Speaker Change: For 2025 the focuses on early phase two data for C. T 868 in type one diabetes as well as additional phase one data for <unk> 99, six in type two diabetes. So now, let's take a step back and take a high level look at the pipeline overall, so here I just want to highlight our continued efforts to strengthen the pharma pipeline you saw the slide.
Speaker Change: And my half year presentation in Q3 again, we had some turnover in the enemy side, we removed eight enemies three in oncology one in neurology for an infectious disease and one in immunology. One of these is what we would call a happy removal P. S. Guy has been approved to P. N. H. So it's no longer an enemy in our pipeline, but moves over to our on market poor.
Speaker Change: Folio and on the other hand, three enemies were added to an oncology and one in neurology and this includes the phase one CDK for me GOR as well as in LTV are antagonist in solid tumors.
Speaker Change: So as we prepare to wrap up let's have a quick look at our 2020 for Kenya's news flow slide you can see here that we've added quite a few green checks since what we showed at half year and we've added some additional 2024, new slow below the table all the new entries in the table below it I've covered on previous slides, so I'm not going to rehash here, but let me just quickly.
Speaker Change: Remind you that the one phase III readout that we are awaiting in 'twenty 'twenty. Four is the phase is the final OS readout for tiered volume out in first line non small cell and then the additional data for our property and trustee.
Speaker Change: And one last quick slide before I hand over to Matt I'm here, we have the expected news flow for 2025, which we also shared at pharma day and there are quite a number of long anticipated regulatory and clinical events that are anticipated in 2025, I'm just going to highlight a few of them. The gear a desperate phase III results in first line HR positive metastatic breast cancer.
Speaker Change: When Sumi island, polygamy and Ah phase III Readouts in second line D. L. P. Seattle, the okra have as high dose phase III and M. S defended brute nib phase III NMS, the ethical a mab phase III and C. C. O P. D. These are all significant potential market opportunities and potentially game changing for there.
Speaker Change: For their therapeutic areas and we also have multiple phase two is reading out which will enable phase III decisions that includes trying to which we've talked about before next double of seven in hemophilia ends up Easter on an uncontrolled hypertension. So I'm sure you can understand that we're very much looking forward to next year and sharing with you along the along the way are the results of.
Speaker Change: All of these important trials, but for now I'm going to hand, it over to Matt to take us through the diagnostic section.
Speaker Change: Teresa.
Matt: So it's my pleasure to present, the Q3 diagnostics division sales results.
Matt: And let me start with the year to date topline so with sales of $10 seven 2 billion Swiss francs. The diagnostics division increased at 5% or point 6 billion Swiss francs at constant exchange rates compared with year to date September 2023, now. This increase is mainly driven by the strong base business growth of 8%.
Matt: And partially offset by the decline of COVID-19 testing sales so for 'twenty 'twenty four as I've said before we have an ambition for mid to high single digit base business growth and I would continue to reinforce our confidence in the base business performance and in achieving this vision ambition. This is an ambition we will carry forward into 2025 as well.
Speaker Change: And so as you heard from Alan and Thomas I would call out that in Q4 2023, we did have a government order of COVID-19 rapid antigen tests that will not repeat in Q4 of 2024.
Speaker Change: So with that let me walk you through the sales results by customer area. So sales in our core lab increase at 9% with strong momentum driven by immuno diagnostics at plus 10% and clinical chemistry at plus eight as well as custom biotech at plus five.
Speaker Change: Our molecular lab had an increase of plus 4% due to strong growth in our broad based business at plus 12.
Speaker Change: And our blood screening molecular blood screening business at plus 15%. This was offset by lower COVID-19, PCR lab based testing sales. However, excluding all COVID-19 sales our molecular lab grew strongly at plus 8%.
Speaker Change: Now our new customer area near patient care had a decline of minus 10%, mainly due to lower COVID-19 rapid antigen testing and as you see on the slide.
Speaker Change: And the decline of our blood glucose monitoring business by minus 5% due to the market shift to continuous glucose monitoring now we did receive CE mark for our own CGM solution. The Acura checks Smart guide in July and we're continuing with the staggered launch across selected European countries. However, we do not expect material sales contribution from C. G.
Speaker Change: In 2024 and 2025 as we are currently scaling up our manufacturing. However, we do have strong expectations for this product in the future.
Speaker Change: Sales in pathology lab grew strongly at plus 15%, mainly driven by advanced staining reagent growth at plus 11% and by a personalized health care business or companion diagnostics business at plus 35%.
Speaker Change: So now I'd like to take a step back and do the regional view on the commercial performance, excluding the COVID-19 business, we see good base business growth across all our regions.
Speaker Change: Now in North America, the base business, excluding COVID-19 grew up plus 10%.
Speaker Change: In EMEA, our the base business, excluding COVID-19 grew at plus 6%.
Speaker Change: In APAC the base business, excluding COVID-19 grew up plus 5% and here I'd like to call. It what you heard from Thomas earlier, we did see the anticipated slowdown in our sales in China due to the macroeconomic situation.
Speaker Change: Which we expect to continue through 2025, I would call out that China is still a critical market for us and we continue to be the market leader.
Speaker Change: Now Additionally, I would as I mentioned earlier, given the strength and resilience in our base business, our ambition to grow mid to high single digits in our base business will carry forward.
Speaker Change: Into 2025.
Speaker Change: Yeah.
Speaker Change: So now I'd like to transition to some of the key launches for 2024.
Speaker Change: First I'd like to talk about our cobalt pro serology solution, which will enable us to enter the serology testing segment of the U S donor screening market.
Speaker Change: This segment constitutes more than 40% of the global serology market, which is valued at approximately 900 million Swiss francs.
Speaker Change: Arco boss Pro solution is a combination of the cobalt pro integrated E N O one now.
Nine Alexis donor screening assays as well as a new software solution to cobalt Pro Serology controller now altogether. This solution is critical for our success in blood safety in the U S. As Roche can now offer the full package of nucleic acid testing serology and workflow automation, putting us in a very differentiated position in this.
Speaker Change: Critical market segment.
Speaker Change: And now I'd like to move on to another exciting bit of innovation in our R&D pipeline, which is the recent FDA self collection approval for the cold box HPV test so in the United States over 13000, new cervical cancer patients are diagnosed and about 4000.
Speaker Change: Every year.
Speaker Change: This disease is entirely preventable through timely screening however, 30% of eligible women do not get screened regularly so individual cultural and health system factors have been identified as primary barriers to the uptake of cervical cancer screening.
Speaker Change: Now with HPV soft collection, we can now offer women the option to privately collect their own sample in health care settings. So across countries in multiple clinical studies self collection has been shown to nearly double the likelihood of participation in screening programs and especially in under screen populations.
This will enable market penetration of this already critical parameter and our molecular diagnostics portfolio.
Speaker Change: And I would also call out that this takes advantage of our large installed base of X 800 fully automated molecular diagnostics platforms, which are widely disseminated across the United States.
And so now sticking with the theme of innovation in molecular diagnostics.
Speaker Change: I'd like to speak about another key innovation in this portfolio, the respiratory flex, which brings flexible syndromic panel testing to the existing X 800 installed base.
Speaker Change: We received CE mark for the cobalt respiratory flex in August of 'twenty 'twenty four.
Speaker Change: So the respiratory flax leverages, our proprietary tags technology. You know this is an acronym called temperature activate a generation of signals a technology that enables us to identify up to 15 targets within a single PCR well in a single patient.
Speaker Change: This assay will enable custom target panels on the X 800.
Speaker Change: This allows health care systems to customize the pathogens targeted with the panel and enables customized patient centric panel testing.
Speaker Change: So by automating this on our X 800 family of instrumentation, we now have the capability to offer automated syndromic panel testing in time for the 'twenty 'twenty four northern hemisphere respiratory season.
So lastly, as you also heard Thomas mentioned.
Speaker Change: We completed the acquisition of Humira Dx.
Speaker Change: In July of this year and we're looking working forward are for the full integration of the mirror Dx within our near patient care portfolio. So humira the acts as a multimodal technology that can perform a clinical chemistry.
Speaker Change: Oh assay and potentially in the future molecular diagnostics and a multi flex format on a single consumable on a single instrument.
Speaker Change: And Lou mirrored the axis attributes have broad applicable ability across decentralize health care and have the potential to enhance access to testing in low and middle income countries. So while we do not expect immediate material contribution to sales from a mere Dx, we expect a significant contribution to the diagnostics division sales in the coming years.
Speaker Change: Yeah.
Speaker Change: And so now I'd like to conclude with the key launch list for the Diagnostics Division I think you've heard at some of our earlier calls. This year. This is one of the biggest years if not the biggest year for launches that we've had in diagnostics for the 12 launches you see on this slide we achieved nine by Q3 of 'twenty 'twenty four and we plan to deliver the remaining launches on schedule by the end of 'twenty two.
Speaker Change: 24, so I look forward to providing future updates on our progress in the future and with that I would pass it back to Thomas Thank you very much.
Thomas: Okay. Thanks, a word that we open the Q&A on the first questions go to Emily field from Barclays.
Emily Field: Hi, Thank you for taking my question I will ask two the first is on LIFO.
Emily Field: If you are expecting any impact.
Emily Field: Impact on the at restaurants, Amgen Biosimilar Eylea.
Emily Field: Dynamics in the United States.
Emily Field: This impact your share switches.
Emily Field: I believe on the call. This morning headline, noting that you have.
Speaker Change: That sounds.
Speaker Change: Cause us to.
This franchise continuing to grow over the next few years. So I was just wondering if you could provide a bit more context for those comments you know should we think about the centric it's flat declining any additional color would be helpful. Thank you.
Speaker Change: Sure.
Speaker Change: Starting with your first question on the the Amgen Biosimilar launch of Eylea. So I mean, let's just remember the dynamics of this market to begin with so that is the ethanol you because it has been about 50% generic biosimilar with Avastin and Lucentis Biosimilars available, we would expect that that dynamic will continue to.
Speaker Change: Lay out we are not anticipating to see any material impact to have a bias.
Speaker Change: So buys most growth trajectory with Eylea biosimilars entering we have a highly differentiated product and one that offers I think a very compelling benefit to patients. So I think we would expect that 50 50 dynamic to continue to be the case, we're not seeing any payers at this juncture implement a biosimilar step throughs.
Speaker Change: And so we remain quite confident in the future growth potential for both eyes mouth.
Speaker Change: Regarding to centric so I I think my comments this morning, where that we actually expect it to centric to continue to grow low single digits for for the next year or so we are starting to reach peak in some of our indications right. Now I think consensus is something like 4.3 billion for to centric.
Speaker Change: That's pretty close to what our own interests internal estimates are as well the place where I think we are beginning to feel the competitive pressure. We've said this before is adjuvant lung in the U S. We are.
Actually quite holding our own here right at the moment. So I don't think that we should assume that the centric has already peaked I think they will continue to be growth and this is pretty consistent with the messages that we've been delivering for the last couple of quarters.
Speaker Change: And then you have any additional questions.
Speaker Change: That's great. Thank you.
Speaker Change: Okay.
Speaker Change: And we will move on the next one would be Matthew Weston from UBS.
Matthew Weston: Thank you Bruno can you hear me yes.
Matthew Weston: So two questions for me please Thomas again, referring to the media cool. It was reported this morning that you said you think the FTC should block the Novo Catlin transaction, despite having no exposure Rosh I guess, it's very unusual for an executive to comment in such a way so I very much and.
Troy.
Matthew Weston: Understanding the color to your thinking on why you made those comments.
Speaker Change: Then secondly, a number of times on this call both Thomas and Theresa I've highlighted Zoe land no Biosimilar entry assumed in 2025.
Speaker Change: We were expecting on November 25 launch are there any specifics around your view is there a settlement is there a legal barrier that you think is particularly bad or is it simply competitive intelligence on the Biosimilar timeline.
Speaker Change: Okay. Let me answer the first question regarding the vehicle I was asked around manufacturing a four hour specifically the C. T 388, because the oral molecule is a small molecule. So we have all of the manufacturing capacity that we need and here we have agreements with.
Speaker Change: A C D moes.
Speaker Change: And Ah or Cmos and yet and we will continue to build up our own manufacturing now.
I think in general Uh Huh.
Speaker Change: Companies start buying up C. M OS that will limit the amount of competition that there can be.
Speaker Change: Given that there are also a lot of smaller companies that may not have as much access to CMO is as we have and that's where my comment came from and I stand behind that I think it's it doesn't make sense from a.
Speaker Change: Perspective from antitrust authorities, who wants competition.
Speaker Change: And in terms of solar we can't be more specific but I can confirm that there will be no biosimilar entry in 2025.
Speaker Change: If you any additional questions follow on questions.
Speaker Change: Yeah, I'm, just kind of a push on xolair. So no comment because something illegal is in the pipeline will never understand or just a confirmation full stop oh, you're willing that you wont understand at some point I assume that's probably not today.
Speaker Change: They want it.
Speaker Change: Sorry, Dave.
Speaker Change: So then the next question would come from making Dapsang from Goldman Sachs.
Speaker Change: Hi. This is James maybe you can go back thanks for taking my questions.
Speaker Change: Two please the first on <unk>.
Speaker Change: <unk>.
Speaker Change: Pretty strong both of them.
Speaker Change: So there or thereabouts, so how does this compare to your expectations.
Speaker Change: Which countries are you seeing the most traction so far.
Speaker Change: And then how are you expecting.
Speaker Change: Development.
Speaker Change: <unk>.
Speaker Change: With respect to.
Speaker Change: Are you back to growth.
Speaker Change: And my second question is I'm trying to be de Minimis.
Speaker Change: Yes.
Speaker Change: In the back of the presentation. This is the primary endpoint CDP.
Speaker Change: And annualized relapse rate.
Speaker Change: Can you talk obviously, we're just spending must be realized.
Speaker Change: So firstly have you just as a primary endpoint of the trial.
Speaker Change: What are you calling out the complete.
Speaker Change: If you see a similar directional result is going to be cheap.
I mean, if it does.
Speaker Change: CDP benefit.
Speaker Change: They are on loans these neutral.
Speaker Change: What could be the regulatory implications.
Could you still get a premium.
RMS.
Speaker Change: Steve.
Thank you.
Speaker Change: Great. So for elevate is we are primarily a proved in the Gulf States right now so that is where we're seeing you know.
Speaker Change: Large number of patients being treated and interestingly, we are seeing what was it all sort of and health tourism with families with these boys actually go into countries, where there is approval to.
Speaker Change: To have their children treated.
Speaker Change: So we have.
We have four of the six countries approved have patients with either treating or in screening.
Speaker Change: And four of the six countries actually also got the same expanded label as the U S. Overall. When you include the you asked me about 500 patients that have been treated globally and I would say this is very much in keeping with what we had hoped to see we do believe that there's a significant amount of unmet need held up for these boys.
Speaker Change: And their families, we see payers being very sympathetic to the situations with these families find themselves in and so you know we're we're very pleased with the adoption that we're seeing at the moment.
For Senate Brittain of it I'm, sorry, I had to add a little bit of a difficult time understanding. The question. So we're very pleased with the results that we have seen so far and with the improvement that we're seeing at a R. M. A R or at 46 weeks are at 48 weeks, rather and we at this at this juncture, we do not have plan.
Speaker Change: <unk> to change the primary endpoint.
Speaker Change: Got it.
Speaker Change: I was more referring to the back of the slide this is the primary endpoint.
Speaker Change: This is.
Speaker Change: We are progressing and IRR.
Speaker Change: So again, that's pretty rapidly.
Speaker Change: Okay.
Speaker Change: And James if Theres answer all your questions or do you have any follow up questions.
Speaker Change: Thank you everyone. Okay. Then we go on.
Speaker Change: Next one on the ROE is Luisa Hector from bedrock Lisa.
Luisa Hector: Thank you Bernard cool and a couple of feet on the neuro pipeline I Wonder whether you could just.
Luisa Hector: Talk a little bit about the the kind of the GCB and then perhaps just to highlight just watch.
Luisa Hector: We should be looking out for.
Luisa Hector: In both the Trump Panama.
Luisa Hector: He taught and then matching them up by the end of the year like what would be a good outcome for each day.
Speaker Change: Alan you mentioned M&A.
Speaker Change: M&A in the context of 2025 earnings.
Speaker Change: Okay and could you just update us on capacity at the deal and whether you are okay.
Speaker Change: Cause primarily on achieving perhaps more of that end to end of the day.
Speaker Change: These areas.
Speaker Change: You talked about at the moment I think.
Speaker Change: Great.
Speaker Change: So for UCB the decision to return the asset was one based on on business reasons and portfolio prioritization, we still remain very committed to the Tau pathway. So there there's no nothing more behind that decision in terms of trying to in your mouth I think we want to consider.
Speaker Change: We want to continue to see the the strong efficacy that we've seen in in terms of plaque removal and the consistent and and very clean safety profile that we've seen with Trump and I think should we continue to see that profile I suspect you'll be hearing us talk about moving into phase III trials are quite quite soon in the first.
Speaker Change: Half in terms of probably really the.
Speaker Change: The trial is designed tisch to demonstrate a slowing of motor deterioration in patients with Parkinson's and so what we would really hope to see is a greater than five point improvement in in the M. D. S U P.
Speaker Change: Oh gosh, what's the Oh, you P. D. R. S. I'm sorry is it does not roll off the tongue, but.
Speaker Change: But that is the primary end point that very unique time to event a time to event our primary endpoint and I think if we can see that we do believe that that will be clinically meaningful.
Okay.
Speaker Change: Yeah.
Speaker Change: We sent that this answer your questions or.
Speaker Change: I wanted to helping us open M&A one.
Speaker Change: Oh, Yeah, Yeah happy to do this through yourself very fair questions not much of a change here to what we have said previously I think you gave you have capacity for deals I've seen so it's clear when I look back to 2023 and the three deals we have done there from the I think really I think nobody would argue that that was not a success with the T. O N E. I think really was carpet.
Speaker Change: Suddenly also with Sotheby's run so I think really a good characteristic here well, having something like that in 2024 to two suddenly grade was other suddenly with other compounds and other targets here well there'd be a focus on those therapeutic areas. We've talked about it up from a day. So I think that's one element and suddenly I think we're also keeping an eye on diagnostics, so as you'll see.
Speaker Change: I am just still o'meara deal and overall I can say, yes, we'd be we well our radars running we will remain opportunistic if you like about.
Speaker Change: But that said I think 2023 is perhaps of goods.
Speaker Change: A good pattern because if he would like to follow.
Speaker Change: Okay.
Speaker Change: Thank you.
Speaker Change: Okay.
Speaker Change: Next one is Peter Welford from Jefferies.
Peter Welford: Hi, Thanks for taking my question.
Peter Welford: Just first of all wants to start on the <unk> stuff.
Peter Welford: <unk> you made a comment that you're very encouraged by the scholar rock.
Peter Welford: Yeah.
Speaker Change: I guess just curious if you could just talk a little bit about that that'd be because I guess, firstly I believe I'm right in saying that you are looking at ambulatory and non ambulatory patients in your study so I guess, how how that potentially could impact the read across.
Speaker Change: So are we still right.
Speaker Change: We got next year will be the phase two part of the trial.
Speaker Change: Dose volume day, and can you give us timelines when could we actually get the efficacy and the beat I guess for that given obviously that we would we see clear evidence.
From scholar rock.
Speaker Change: It has been in fact from the disease.
Speaker Change: Secondly, then just on good returning back something about for outside the curative you've reiterated several times now does the phase III go decision that will be in the first half of next year I guess curious how should we take from that that well, we're going to see it see Todd concludes that some of the higher dose.
Speaker Change: This is nearly a cohort are encouraging enough that you want to see the follow up safety data from then because you already have the follow up data from a lot of the initial briefs and so I guess what is the initial information you need I guess to make that phase III go to see.
Speaker Change: If that makes sense.
Speaker Change: And then finally, sorry, if I could just ask then elevated any any way at all you could you quantify do you think there's any warehousing effect here in total when we look at the I guess the risky.
Speaker Change: You can extrapolate the ramp that we see is there anything you would like to listen to.
Speaker Change: The sweetest from looking at there and what we've seen with the elevate it sounds like the first three quarters. Thank you sure. So maybe I'll start I'll start with question three and work my way backwards. So with elevate is I think that you know certainly there are families who are who have been anxiously awaiting these approvals and our and are waiting for their opportunity.
Speaker Change: To receive this treatment, we do believe though just sort of the way that the labels will ultimately get approval and the the way that we will actually be able to bring this this treatment to market is it is not likely to see that huge bolus that you might think of with gene therapy, and then and then a big fall down because everybody has been treated.
Speaker Change: We do believe that there is going to be sort of more of a longer study a longer steady revenue flow just because of the age ranges the different types of patients that we would treat the way in which the approvals will happen and so you know I think we are where we're fairly confident that this is gonna be a sustain.
Speaker Change: <unk> business for awhile.
Speaker Change: In terms of what we would need to see for content you map them, we're going to wait for data from 200 patients and then take the decision again, we're very pleased with what we see so far in terms of the rates of plaque removal area rates remaining low and we will hit the data that we need to hit by the first half of 2025 and so.
Speaker Change: We are where we're excited to be able to get get all the data in house and actually I'd make that decision in terms of in terms of the SMA trial. So you are correct. This is a phase two trial of give three to nine in combination with ever see them, but we do expect data from the.
Speaker Change: Trial next year and the reason that I think we are excited about it is that the scholar rock.
Speaker Change: Molecule.
Speaker Change: The antibody is fairly similar to the game through two nine antibody and so I think we are a we're excited by what they've seen and and hope that we hope that we will actually see a read across to our own molecule mm. So more to come we've got a we've got a little bit longer to wait, but we are where we're eager to see those results. It is important.
Speaker Change: To note that in general SMA in F. D. S. H are actually more challenging diseases to see benefit in because they are not out there. They don't have as much myostatin and so there that there's these are just going to be a little bit more challenging patients to actually see a see a benefit in but where we're hopeful based on what we know about our own.
Speaker Change: Molecule and what we've seen in competitive data.
I'm sure that there is at least one person on hold who is waiting to ask the question. So then what does this mean for our study in obese patients. So as you know we currently have a dose ranging study going on right now with our anti myostatin in overweight and obese patients and that data will read out by the end of the year, we are not planning to release that data, but it will.
Inform a phase III decision next year.
Speaker Change: Yeah.
Speaker Change: Because it sounds like with your questions.
Speaker Change: Yes, that's great. Thank you Peter a follow up question is no.
Speaker Change: Okay, and let's move onto the next one S M. Steve Scala from Cowen Steve.
Steve Scala: Thank you so much two questions what should be our expectation for the rate of conversion of a grievous IV to sub two for instance, good 50% of current sub acute patients ultimately be converted to say within a three to five year period.
Steve Scala: And then secondly during last month's pharma day. The word diagnostics was used 51 times at the same meeting two years previously it was used four times.
Steve Scala: A difference of more than tenfold Betta pharma day, I'm curious why the heightened focus on diagnostics both meetings were during or after the pandemic. So it can't be that does Roche now have some profoundly increase viewer diagnostics or is there. Some other reason for this.
Steve Scala: Big change thank you.
Steve Scala: Okay.
Speaker Change: Should I take the last question you can take that one.
Speaker Change: So first we're very excited with that.
Speaker Change: The diagnostics business I think that's one reason.
Speaker Change: As you've seen over the last year's diagnostics has done very well and with the upcoming launches of mass spec keep but it also CGM.
Speaker Change: <unk> recently launched and also on the sequencing side I think we have really a good outlook for diagnostics.
Speaker Change: So with a new group strategy and the focus of our you know on certain disease areas like cardiovascular metabolic.
Speaker Change: Where we are the global leader in diagnostics.
Speaker Change: We have more synergies also that we can leverage across our pharma and diagnostics and so we're very much working very closely together between pharma and diagnostics to make sure that we can leverage those synergies.
Speaker Change: More effectively going forward and that's why I think it was mentioned so many times.
Speaker Change: And as far as <unk> goes we actually haven't provided a rate of what we believe the conversion will be and while we do think there will be some conversion from patients who are on IV to sub cut I think what we are actually more excited about is the opportunity to expand the use of <unk>.
Speaker Change: In settings, where for whatever reason I V isn't as available and so from my perspective, I think it you know if if we can offer the convenience of I V. Two out of sub cut to IV patients, that's wonderful, but I'm actually even more excited about offering the.
The efficacy benefits of <unk> to patients who may now benefit from a sub cut formulation. So I think what we're more likely to see or what would be more impactful is actually just a lot more patients actually coming entre openness, who previously for whatever reason, we're unable to to access IV capacity. So that's.
I mean, I think that that opening up of new patient populations is why we believe that there is there's such a large incremental upside for sub debt.
Speaker Change: And again that's it.
Speaker Change: That's we think that's somewhere around the 2 billion Mark and you don't get that by just converting IV you have to add new patients on top.
Steve Scala: Steve It yourself.
Speaker Change: Yes, it did and May I ask why the cough drug was dropped.
Speaker Change: I'm, sorry, I wouldn't say that one of the drugs, which dropped out of phase one assets. The calf crop do we know anything about it.
Speaker Change: We will we will follow up Steve what do you. Thanks, so much.
Speaker Change: Oh, Yeah, there was no clinically meaningful improvement that's what I just got as an information so it's because of data.
Speaker Change: Tolerated, but.
Speaker Change: It didn't see the efficacy we need Okay. Then we move on the next one in a row is Rajesh Kumar from HSBC.
Speaker Change: Right.
Rajesh Kumar: Hi, good afternoon, thanks for taking my questions the.
Rajesh Kumar: The first one is could you talk a little bit more about the anti PD L. One opportunity, which you were expecting.
Rajesh Kumar: Flagging as a catalyst.
Next year.
Rajesh Kumar: What should we expect from <unk>.
Rajesh Kumar:
Rajesh Kumar: In terms of the market opportunity and the positioning.
Rajesh Kumar: And what is the.
Rajesh Kumar: In the market.
Rajesh Kumar: So.
Rajesh Kumar: The second one is.
Rajesh Kumar: More than once you've highlighted sky one readout.
As a catalyst.
Speaker Change: Can you characterize what sort of catalyst because it above two and a negative or.
What should we expect from that catalyst.
Speaker Change: And just finally on the COVID-19.
Speaker Change: Molecular lab and overall diagnostic business.
Speaker Change: Can you help us with the run rate contribution from COVID-19 tests and you know apart from the 300 million you flagged, which will not repeat next quarter.
Speaker Change: Uh huh.
Speaker Change: Does it mean, what is your view in terms of you know better that's a stable base or should we expect further declines in time.
Speaker Change: Right.
Speaker Change: That's for sure. So you heard out in say last year, we had approximately 340 million Swiss francs and are in the fourth quarter from Covid, We had the 300 million order.
Speaker Change: And I think it's reasonable to assume we see that kind of molecular lab business in the fourth quarter, Although again it all depends on the respiratory season, which is highly variable and we're still waiting to see develop in the northern hemisphere going forward, we expect to see COVID-19 on an endemic basis, however overtime.
Speaker Change: This will reach a very stable plateau, and we think we're very close to that at the moment, but I think it's gonna have to see.
Speaker Change: See how this develops over the coming years, but really a lot of it depends on the severity and the timing of the respiratory season in the northern Hemisphere in terms of how this plays out on a year by year basis, but I think clearly we're reaching the endemic state. So I think we can probably assume that the rates will be more or less stable, but again it will very much depend on.
Speaker Change: The severity of those seasonal outbreaks.
Speaker Change: I would just add that for 2025, we will not.
Speaker Change: On any code number because it's completely irrelevant right. So it's going to be part of our normal business like all the other tests that we have so 25, there will be no impact whatsoever on Covid right.
Speaker Change: And one last thing before I and again just to be clear.
Speaker Change: Talking about the molecular lab business. This rapid antigen business and government antigen orders, we do not see this recurring in the future.
Speaker Change: Great.
Speaker Change: In terms of Sky one that's more just indicate that the trial will read out we will have a less by the end of the year and so don't bet that that's really all that's meant to convey is just that that we will have a final readout. This year in terms of tier one eight so the.
Speaker Change: The IBD market overall is probably about a 10 billion dollar opportunity over time and I think there is a remaining a very significant remaining unmet need for these patients. While there are some some efficacious therapies on the market today, most patients actually have a recurrence and are unable to be control 50% of patients.
Speaker Change: Factor unable to be controlled over the long term on the drugs that are out there today and so when you think about the immense physical and frankly.
Societal and an emotional toll that this disease takes.
Speaker Change: The need for more efficacious treatments is is really quite profound in IBD. The T. L and a pathway is a well validated one in IBD. We believe that we have the potential we have a molecule that potential has that has the potential to be best in disease were head to head in terms of timing with Merck and and we are very are very full.
Speaker Change: I'm getting these molecules I enter into phase three and getting those phase threes and hold as quickly as possible and bringing them to patients and it's also worth noting that the Tijuana a pathway is a very well defined one in other autoimmune diseases and so there are a number of other places that you could potentially take this molecule we're looking at a number.
Speaker Change: Two of them already we will plan to share at least those initial first a first exploratory steps with you at the beginning of next year, but we do believe that this molecule has the potential to be in a very significant contributor over time as additional indications are added on top of IBD.
Okay. Thank you.
Okay. Then we go on the next one in a row is irregular Barry go from Stifel Erik.
Speaker Change: Yes. Thanks, Bruno good afternoon, two questions first on the N V. This again or is that you said you are not seeing kind of a bullish signs of the market. So how much indicative as the current quarter of around 100 million and should we take this.
Speaker Change: As a base going forward and see this maybe analyzing already into the 400 million already with four to six countries and with Europe coming that will be additive to this hopefully next year, how much would you see coming from Europe versus rest of the world under <unk> responsibility.
And then the second.
Speaker Change: Question on BT cases versus CD 20, you're talking about the sub Q formulation of accretive as I think about 2 billion, but there's also kols, suggesting since we've seen bertolli Britney data U S. P. M S.
Speaker Change: It could be some overlap in population and that by default. Some CD <unk> might be used currently yes, but not with solid Britney that could be some shifts from one into the other do you have any idea how much could that represent and how much of the risks that could be thank you.
So with elevate is I think we've said pretty consistently that we expect this to be you know a couple billion dollar market outside the U S. I think we we we stand by that we stand by that assumption at the moment. It will very much depend on how regulatory approvals flow and and reimbursement for the pro.
Speaker Change: <unk> flows so I guess, it's a little hard to tell you exactly what to expect next year, but I would say that we should continue we should continue to see more and more patients get added by the time, we get to full year results I think we'll be able to give you a much better picture about what we're expecting into 2025 and 2026 as we have a better sense.
Speaker Change: What our regulatory approval landscape looks like but there's definitely pent up unmet need here and so we're we're excited to to actually be able to come.
Speaker Change: With this option for families. So in terms of be Teekay, we actually expect fairly little overlap.
Speaker Change:
Speaker Change: We would expect Senate Bruton nib to take share from the end of the 30 or 40% of the oral market share versus the <unk> versus the share that <unk> is in today.
Speaker Change: How much we might see from new oral is kind of cutting into the anti CD 20 share it.
Speaker Change: We're honestly not anticipating that that would be a huge number to be honest. It's I think that the anti CD 20 high efficacy market has been fairly stable over time, the entry of new of new of new options is really only expanded the market, which is exactly what we had hoped would happen.
I think you know, we're we're not we're not particularly worried about this maybe as another are another way to answer the question.
Speaker Change: Yeah.
Speaker Change: Okay.
Speaker Change: Eric any.
Speaker Change: Just a question.
Speaker Change: Yes, no no no.
Speaker Change: Granularity in terms of Europe versus rest into the 2 billion peak sales fulfilled not.
Speaker Change: Not at this time and then we have provided US okay. Thank you.
Speaker Change: Yep.
Speaker Change: Okay.
Speaker Change: Then the next one would be Richard Parkes.
Speaker Change: Richard.
Richard Parkes: Thanks Brent.
Richard Parkes: Just got a couple left so firstly on enough Elisa sorry, I have learned from them hopefully.
Richard Parkes: Could you just update us on physician feedback given the label limits used to.
Richard Parkes: Obviously, a clip as it backbone and I'm, just wondering if you're going to be able to.
Richard Parkes: If it's 'cause Scully prescribers to shift.
Richard Parkes: Prescribing as well and what are you doing too.
Richard Parkes: Expand the label to include of the CDK four six inhibitors and then on Arqiva.
Richard Parkes: I appreciate it's early but are you seeing any impact on expansion of the prescriber base, so well or new sites.
Richard Parkes: So prescribing all crew archivists since that launch.
Richard Parkes: Yeah.
Speaker Change: So in terms of additional prescribers, absolutely and particularly in the U S. So I think you know and in the U S. <unk> already has a very well entrenched.
Speaker Change: Customer base and academic settings in hospitals and larger community practices, where IV facilities are either in the practice are available, but for small smaller community neurologists and or in settings, where patients have to travel a long distance or otherwise just don't have access to IV therapies.
Speaker Change: I think with OCA Vascepa, we open up a whole new prescribing base in the U S and I think that is that is also true in other parts of the world again, we're just IV capacity is constrained and now the ability to to get your M. S treatment in a 10 minute sub cut dose is.
Speaker Change: Is every six months is really just a huge benefit for our patient populations and for health care systems moving onto analyst said, so today Paolo is the global standard of care in frontline.
Speaker Change: H R.
Speaker Change: Hormone receptor positive breast cancer, and so in order to provide a triplet therapy to.
Speaker Change: All patients additional safety data, including combinations with Vesta and rigor that MA are all currently being generated but I think right now we what we are hearing from the Kols community is a lot of excitement around the approval for Nols at and I don't suspect that the backbone will will fully limit utilization, but we are act.
Speaker Change: Really working to generate additional data with other CDK four backbones.
Speaker Change: Do you care for six backbones to fill that data gap, but I think we are a we are very excited about what we're hearing from the community and in terms of their level of interest in using the strike with their patients.
Speaker Change: Oh, sorry.
Speaker Change: Any questions follow up questions.
Speaker Change: No that's great. Thank you.
Speaker Change: And the next one would be Richard Foster from J P. Morgan Richard.
Richard Foster: Thanks Brittany.
Richard Foster: A couple of questions. Please just coming back to present as a map if you manage to get that five point benefit that you talked about how.
Richard Foster: How are you thinking about the ability to take that to regulators or do you think you would need to.
Richard Foster: To generate a thought that maybe one or two phase III trials, depending on that date.
Richard Foster: The data of course, and then just didn't see me I am yeah.
Richard Foster: Maybe you could give us some thoughts on the trajectory that in in the third line and who will say you know.
Speaker Change: How we should think about the second line opportunity, which is clearly baker might not come through as well. Thanks very much sure. So in terms of to me I mean, I think it's important to remember that certain line Follicular lymphoma is actually a very small patient population and so the real opportunity is for la Simi L. R. As it moves into second line D. L. B.
Speaker Change: C. L second line Follicular first line and so you know we will we will get some of those datasets in 2025, and 2026, and we'll be able to to greatly expand the patient population that we can see meal can't can impact and I think the combination of the fact that you don't have to go to the hospital you have a very good.
You have a very good dosing schedule.
Speaker Change: Got the sub cut potential of steroid use with that sub cut.
Speaker Change: I think theres a lot of opportunity for let's see me, but it just has to get out in third line third line is just not not a significant patient population.
Speaker Change: And so when it comes to so moving on to property as we would with any phase two program. If we have positive results, we will speak to the regulators about it and I think it would be too early to speculate without seeing the results.
What we believe are our chances of success would be I think you know, we will definitely need to run confirmatory trials.
Speaker Change: And and and that is certainly our expectation, but depending on the strength of the results as we always would we will of course doctor regulators.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Additional questions, yeah, and and and and I just I do want to just continue to underscore that while exciting to finally get to stay at it because I think we waited for it for a long time. This is a very high risk trial.
Speaker Change: And so high risk high reward but.
Speaker Change: We'll know soon.
Speaker Change: Okay.
Thank you very much thanks Theresa.
Thanks.
Speaker Change: I think actually that we are at the end of our Q&A. Then we worked to close the session I think for the first time, we made it earlier than what we had assumes in terms of time wise, what we would need.
Speaker Change: I will hand back to Thomas for a final remark on our staff.
Thomas Catlin: Thank you very much Bruce.
Speaker Change: Bruno.
Thomas Catlin: And I believe a person that's a that's at pharma day, we mentioned diagnostics I think 51 times I'm surprised at how many times, we mentioned obesity today, which was not a lot so compared to some of the previous calls we didn't have as many obviously question.
Thomas Catlin: Delighted to answer those questions as well.
So overall I believe we have a very positive momentum in our business and this will carry us into next year and also the years to come.
Thomas Catlin: I also want to highlight we are very cost disciplined and you can count on us that we will continue to do so also in the future.
Thomas Catlin: We have as Teresa mentioned, some exciting Readouts next year and also in diagnostics, we have exciting launches still coming this year and in the years to come so very good overall momentum there on the on the pipeline and let me just finish by saying that we will deliver thank.
Thomas Catlin: Thank you very much.
Thomas Catlin: Yeah.
Thomas Catlin: Yes.
Thomas Catlin: Yes.
Thomas Catlin: Goodbye.