7/27/2023

speaker
System
Recording System

Recording in progress.

speaker
Operator
Conference Operator

In addition to that, you may also raise your virtual hand to address your questions verbally. For participants joining via phone, to raise your hand, use star nine on your phone's dial pad. When you then get selected to ask your questions, please follow the instructions from the phone and press star six to unmute yourself. One last remark, if you would like to follow the presented slides on your own as well, please feel free to go to roche.com slash investors to download the presentation. At this time, it's my pleasure to introduce you to Thomas Schienecker, CEO, Rush Group. Mr. Schienecker, the stage is yours.

speaker
Thomas Schinecker
CEO, Roche Group

Thank you very much and hello and welcome everyone to today's call. I'm looking forward to sharing our half year 2023 results with you. For the first For the first half year of 2023, we saw the base business of both pharma and diagnostics divisions grow very strongly with a total of 8%. Group sales declined 2% at constant exchange rate, and this was due to the expected decline of sales from COVID-19 products. And this was in line with the guidance that we gave out in the beginning of the year of roughly 5 billion Swiss francs for the year. Pharma grew very strongly at 8%, and this was driven by key products and new launches, such as Vabaismo, Ocrevus, Hemlibra, Evristi, Fesco, Ticentric, and Polyvii. For the first half year of 2023, we really saw an outstanding performance of the Bias Mall, which reached sales of roughly 1 billion Swiss francs and is on track to achieve more than 2 billion Swiss francs for the year. The diagnostics-based business grew very strongly with 6%. However, overall sales were impacted by the expected decline of COVID-19 sales. For the half-year profitability, we had obviously the COVID-19 sales decline and also a base effect from an altimerous patent settlement that happened in the first half of the year. Now, coming to the news flow. We've achieved in Q2 numerous very important milestones. Covidimab, or Columv, was approved in third-line diffuse large B-cell lymphoma in both the US and in Europe. This is the second CD3, CD20 bispecific antibody that entered the market after we launched Lunsumio last year. In June, the FDA also granted accelerated approval for Levitas, the first gene therapy for Duchenne muscular dystrophy. Together with Serapta, we're excited to bring this medicine to patients, to young boys who have today no treatment options. And we're looking forward to the additional readout of Levitas later in the year. And we can now bring it to markets that accept FDA approval. We had several important data reads out also in this quarter. Let me highlight Ocarina 2, which was the study for six-month subcutaneous Ocrevus that showed positive data. And this will be presented at the next medical conference, and we also will submit to regulatory authorities towards the end of the year. or we will expect actually approval at the end of the year. We also had a very strong readout for feniprutinib, our BTK inhibitor, the only reversible BTK inhibitor in development in multiple sclerosis. And this again showed extremely strong efficacy data in reducing brain lesions in patients with relapsing forms of this disease. Another readout which I think is worth highlighting is Morpheus. which demonstrated outstanding efficacy of teragolamab, ticentric, and avastin in first-line liver cancer. Based on this data, we decided to initiate a Phase III study. I'm also excited to share that we've entered two new partnerships. In our most recent deal, we brought Sudaceron, an angiotensin RNA inhibitor for hypertension, which is in license from Analum. This medicine has best in disease potential. We also added KSQ4279, which is a potential first-in-class USP1 inhibitor for solid tumors. This protein is involved in DNA damage repair. There's a number of upcoming news flow in the second half of the year. They face three EMBARQ data for elevated endogenous muscular dystrophy and a number of other late-stage readouts. For diagnostics, we also expect a number of updates towards the end of the year. On this slide, you can see that at half year, our sales reached close to 30 billion Swiss francs, minus 2% at constant exchange rate. But if you exclude the impact from COVID-19, you see very strong growth of 8%. Pharma grew 8%. At this stage, pharma has no impact from COVID-19. The entire impact at the moment is within the diagnostics division, which had an impact of 2.7 billion on COVID testing sales in the first half of the year. Without this effect, the base business is growing strongly at 6%. The quality rates, growth rates are impacted by COVID-19 and H&R erosion, but both impacts are in line with our expectations and the guidance that we provided at the beginning of the year. I would like to mention that there is one impact in Q4 of about 1.1 billion Swiss francs in the business of pharma. This was the RonaPrieve order in Japan last year in Q4. Now, this slide is another opportunity for us to really dive more deeply into the sales movements. As you can see, both pharma and diagnostics are growing well. Diagnostics-based business is growing with 421 million. This is a 6% base business growth. You can see the loss in diagnostic testing sales for COVID-19 at 2.7 billion Swiss francs and the AHNR erosion of 635 million. Again, both factors are completely in line with our expectations and our guidance for the year. You also see the impact of the foreign exchange rate, which was close to 2 billion. Our portfolio rejuvenation is progressing very nicely with ophthalmology, neuroscience, hemophilia gaining momentum. And again, wanting to highlight Vavaismo, which is really taking bigger and bigger share, and we expect more than 2 billion of sales for Vavaismo this year. This slide we've been showing throughout the pandemic, and it really shows the performance of the underlying base business. And we see continued strong performance of the base business in both divisions. And especially in Q2, both divisions reached high single digit growth in the base business. In pharma, you can see the orange and gray line being identical this year. So far, there's no impact or no net impact of COVID-19 so far, but there is an impact that we're expecting Q4. In diagnostics, we see the impact, but the impact will get smaller and smaller throughout the remainder of the year. And overall, the impact from COVID-19 will be done for both divisions by end of Q1 2024. With the washout of COVID sales this year, we expect 80 to 90% of the sales to have washed out, and the remaining impact will be in Q1 next year, which we estimate to be roughly about a billion. Now, looking at the profitability, cooperating profits declined 6%. And this was driven, on the one hand, by the decline of COVID-19-related sales, but also the base effect of the ultramarital patent settlement, which happened in the first half of last year. And you see, without this base effect, actually, we had 0%, so the cooperating profit was stable. Similarly, the core EPS declined here by 5%. Again, driven by the same effects. Again, excluding the ultramarine patent settlement in the first half of last year, this would have been minus 2%. Again, this is an effect that will not repeat itself in the second half of the year. So we are completely in line with what we said in the beginning of the year in terms of our guidance. On this slide, you can see the very young portfolio that we have in pharma. We actually have one of the youngest portfolio of all the different pharma companies with 20 new medicines that we've launched since the end of 2015. And these medicines will carry us forward for the next years. I already mentioned Elevitis, which recently received accelerated approval for Duchenne muscular dystrophy from the FDA, and Columv, which is now approved for third-line DLBCL in the US and Europe and will take it into earlier lines. On the right-hand side, you can see that this portfolio of medicines, of 20 medicines, now accounts for more than 50% of the pharma sales, which is up 9 percentage points from half-year 2022. You can see the increasing contribution, again, of Abysmal as well. I'm excited to share that we have signed two new partnerships agreements, one in the late stage, one in the early stage. We announced the in-licensing of Silbacerin from Alnylam Pharmaceuticals. This is an antisense, or this is an RNAi molecule targeting angiotensinogen, and this really has the potential to change the way hypertension is being treated. There are 1.2 billion people in the world that suffer from hypertension, 80% uncontrolled, so obviously the existing medicines do not work appropriately, and the effect on patients is a reduction in life expectancy by five years. By targeting further upstream and by being able to only give this medicine twice a year, we believe not only will we achieve better adherence, but we will also achieve more consistent, durable blood pressure control. This is already in phase two stage of development with more data reading out in the second half of this year. This asset has the potential to be best in disease, and we are looking forward to providing more updates in the future. I've already mentioned also KSQ-4279. This is a first-in-class small molecule inhibitor. And what this molecule does, because USP1 is actually involved in DNA repair mechanisms, what it does in combination with other medicines, it makes the tumor more susceptible to cell death by adding cancer medicines. And with that, we believe we can increase efficacy of medicines. With that, let me also take the time to invite you to our Roche Pharma Day, which is our annual event focusing on pharma division, strategy, and portfolio. It will be in London, and the event will take place in person and virtually. I would like to also call out two other events. One is an IR event around ECTRIMS, where we are planning to share more data on the Ocvos six-month sub-Q formulation results, and also the phase two data from fenabrutinib. Later, we'll also share at CTAD at the end of October, more data on trantinamab, our brain-child Alzheimer medication, and we're looking forward to sharing that data with you as well. Now, let me provide a quick update on the remaining news flow. We recently announced positive results for Ocubus, as mentioned earlier, and Theresa will speak more about the benefits of this. We've had a negative result on TNKs. And in addition, we will have a number of readouts that will still happen this year. I know one is on top of mind of everyone, that's SkyOne. This is an event-driven trial. Readout is expected for Q4 or Q1 at the end of this year or beginning of next year. With that, let me say we confirmed the guidance. We have a very strong positive sales trajectory, both in the pharma and the diagnostics division in both the base business. And we expect roughly 5 billion Swiss francs of COVID-19 effect, as we have mentioned in the beginning of the year. And we are also confident that our guidance in terms of H&R was correct as well. With that, again, I would like to confirm the guidance, low single digit decline in sales. Core EPS growth broadly in line with sales decline and a further increase of the dividend. With that, I hand over to Theresa.

speaker
Theresa
Head of Pharma Division, Roche Group

Great. Thank you so much, Thomas. So as anticipated, it was another strong quarter for pharma with significant momentum behind our key strategic products and some exciting advances in our pipeline. So let's get right to it. With sales of 22.7 billion, we've had strong growth of 8% at constant exchange rates. We had strong performance across all regions. One thing to call out here, you see a very strong performance in Japan. This is partly attributable to about a $600 billion Ron-approved transaction, which was the last tranche of the sale that happened at the end of last year that Thomas mentioned. Without that, growth in Japan would have been 9%, largely driven by two launch products, Vibismo and Polivi. Overall, farmer volumes were up by 14%, price mix impact was a negative 6%, and we faced increasing currency headwinds of about negative 6%, which Alan will go into more detail with momentarily. Moving on to our P&L slide, please note that this is the first time that we're using our new reporting structure to actually show the P&L. So we mentioned this last year. This is the first time you're seeing it in this new format. Core operating profit increased by 5% at conscient exchange rates versus that 8% sales increase. with a core operating profit margin of 48.6%. Other revenue decreased by 45%, and that's primarily a result of the Altamira settlement, which was booked in the first half of last year. And then other operating income, you see a significant increase here as well of 79%, and that was primarily driven by higher gains on two divestments, Rosefin in China and Zelota in China and Japan. Moving on to the performance of our individual products, again, just to comment on the graph, recall that all of these are absolute values and growth rates at constant exchange rates. You can see, just as Thomas mentioned, just incredible momentum behind our key strategic products. Fabizmo, Okravis, Hemliva, Evrizdi, Fezgo, Tricentric, Polivi, all growing extremely significantly. Combined, they added $2.6 billion of new sales. That's more than compensating for the $0.6 billion in generic erosion that we saw with Avastin, Herceptin, and Mabthera in the first half of this year. A couple of specific comments here. Let's start with Polyvi at 114% growth. This is certainly spurred on by the FDA approval of first-line DLBCL in the U.S., but what we are seeing is everywhere where we get approval and reimbursement per polyvi, it is quickly entrenching itself as a standard of care. Some of the comments that we're hearing from our physicians are things like it's the easy choice for a patient with first-line DLBCL because it's their best chance for a cure. We're also increasingly hearing from both regulators and from clinicians that when new trials and first-line DLBCL are being initiated, there is a desire to have Polivi and the Polarix regimen at least as an option in those trials. And I think that's a really great indication that people do see this as the next standard of care. And then obviously, as Thomas mentioned, the standout on this slide just has to be Vibismo. It is now our number one growth driver, getting to that blockbuster status in constant exchange rates. And there's really just one word for Bovizemo, that's momentum, and we'll talk about it more a little bit later in the presentation. But let's start with oncology. Oncology sales increased year-to-date at 4%, adding $9.8 billion in revenue. Starting with the HER2 franchise, as we have been signaling, Katsila is essentially flat. Ex-US, we're seeing growth, especially in China and Brazil, in early breast cancer, compensating for a loss in the metastatic setting in the US and in the EU. This was something that we fully expected to happen. We're seeing that dynamic play out in the market. Right now, we're at about 70% early breast cancer, 30% metastatic, and we would expect this dynamic to continue going forward and for Kedsilis sales to remain stable. Progetta continues to grow at a healthy 9%, both in the U.S. and international, but the real standout here is Fezgo, growing at 69%. We are now at 35% conversion in our early launch countries. We would expect this to grow to over 50% over time. But I think what's really most exciting about the Fezgo launch is what we're seeing is actually in places where Fezgo is gaining traction, we're seeing increased usage of Progetta. And so combined, I think this is just a tremendous story. We added eight new early launch countries for Fezgo since Q1, and that's sort of why you're seeing that global conversion rate remain stable, despite the fact that we have now had an increase in U.S. share. But going forward, we would expect to see continued strong growth for Fezgo and therefore for Progetta. We'll talk about Dicentric a little bit later. Hematology franchise, I think we've been consistently saying that hematology is a place to watch. This gives you a sense of why. Gaziva up 22%. We talked about the incredibly strong performance of Polivi, and we'll talk more about Linsumio and Columbia in the following slide. And then finally, just to last but never least, Alicenza, strong growth in the first-line ALK-positive cancer setting, and we see the long-awaited Alina adjuvant data in just a couple of months. And so very, very likely that we'll continue to see good, strong growth in Alicenza in the adjuvant setting. Moving on to tiragolumab, we continue to have a high level of commitment to tiragolumab, and that is our confidence is reinforced by those positive early results we saw in first-line HCC. We're just recently presented at ASCO. The phase 1-2 Morpheus study showed a very significant PFS and overall response rate benefit for the tiragolumab plus Dicentric plus Avastin combination. with no new safety signals. This has encouraged us to start a Phase 3 trial, Skyscraper 14 in this area. And then I think Thomas mentioned earlier the readout of Skyscraper 1 in first line non-small cell. That is an event-driven trial, and those results are now expected in Q4 or Q1. moving on to columbia so columbia is now approved in third line dlbcl in the us and the eu it is the first and only by specific offering a fixed duration treatment in third line dlbcl those complete response and overall response rates are very significant with a very healthy duration of response. The fact that this is an off-the-shelf treatment that provides this level of complete response in addition to this level of durability in less than 50% of the visits that we see with competition I think make this just an incredibly competitive molecule and definitely one to watch. You can see on the right side of this slide that we have a very robust CD20-CD3 development program for both Columbia and Linsumio. This is really designed to ensure that we get into earlier lines of therapy as quickly as possible with both of these drugs and combinations that make sense because both have a really important role to play in the treatment of patients. Moving on to Ticentric. Ticentric is the first PDL1 PDL with pivotal sub-Q trial results, which have now been filed in both the U.S. and the EU. We expect the U.S. PDUFA to be on September 15th. The subcut, just to remind you, reduces administration time to seven minutes, from 30 to 60 minutes for IV. which offers far more convenience to patients and HCPs, as well as freeing up resources in highly constrained systems. As you recall, the Fesco conversion in countries like Great Britain is up to 92%, which actually shows that when you actually have a dosing formulation that increases convenience and administration in this way, you could actually see very significant uptake, and we would expect to see something similar with Ticentric. Sales growth for Ticentric is driven primarily by first-line HCC in some European markets and the ongoing adjuvant non-small-cell launches, as well as global expansion. Looking forward, we are expecting to see the results in adjuvant head and neck later this year. Moving on to hemophilia A and Hemlibra. What is there to say about Hemlibra? It remains the global standard of care and frankly just keeps extending. USEU patient share has now reached 39%. We have more than 21,000 patients on therapy. We are getting increased penetration across all approved patient segments. And I think what is actually so exciting about Hemlibra at the moment is that we're seeing in certain countries, I think Great Britain is one of these, France is another, where we're just seeing the peak non-inhibitor sales surpassing 60%. And so these are already places where the inhibitor population is fully penetrated with almost every eligible patient being on Hemlibra. And we're really starting to test our own assumptions about what peak share for Hemlibra ought to be. Just understanding that the high level of effectiveness, the high level of patient satisfaction, the fact that two-thirds of our patients are already on every other week or monthly dosing, it just starts to give you a sense of what Hemlibra is really done in terms of changing the face of the hemophilia A market. We expect to present some additional data on Hemlibra at the upcoming ISTH conference, which again just continues to demonstrate the high level of confidence that we have in prophylaxis and the quality of life data. I did just want to note here that the SPARC8011 pivotal phase 3 gene therapy trial has been initiated. This trial is expected to enroll patients in both the inhibitor and non-inhibitor populations. We look forward to being able to share more data with you about that in the very near future. In terms of immunology, not too much to say here. Negative 11% growth for the first half, primarily driven by generic and competition in Esprit. We expected that to go quickly. It did. The Actemra has no more COVID-19-related sales. Thomas mentioned this a little bit earlier. But that shift from IV to sub-Q continues. Sub-Q share is now at about 60%. Modest growth in this space, but clearly holding its own in terms of RA share. For Xolair, we have a very respectable 4% growth, primarily driven by CSU. But interestingly, there's some exciting data coming out for Xolair later this year. The phase three outmatch study, this is Xolair and food allergy. We expect to see those results. And then we also expect to see the U.S. approval of the Xolair auto injector in the U.S. In terms of other updates in Q2, we launched the phase 3 imagination trial, which is our ASO factor B and IgA nephropathy has now been initiated, as has the phase 3, our NASA study, which is the second phase 3 study for astagolamab in COPD. So ASTA is one of the newest entrants into our Phase III portfolio in development for COPD and has the potential to become a first-in-class anti-ST2 receptor antibody. Unlike other biologics that are in development for COPD, astagalumab targets the ST2 IL-33 receptor as opposed to the ligand. So this is expressed on various immune cells, but it doesn't actually... intercept the signaling protein IL-33 itself. This gives it a very differentiated mechanism of action relative to the other things that are in the clinic right now for COPD. And what gives us confidence about ostegolamab in this area? I mean, I think that's largely driven by the results that we saw in the phase two COPD STOP trial. And again, you can see here that you had respectable AER reductions, higher in our xenophilic low population, as well as a reduction of SGQR and increased FEV. results. This trial was not powered to actually provide sort of more statistically significant results, but what it did do is directionally tell us that we really believe that there's an opportunity for ostegolamab to be quite transformational in the COPD population. I think everybody knows that COPD is a very significant disease. has high mortality and morbidity. It is a very large population and right now there really are very few, there's no biologics approved in COPD and really very few treatments for these patients. We are enrolling a broad patient population including former and current smokers as well as the xenophilic low and high patients. And we really do truly believe that we might have something very special here with astagolamab and COPD, which will be the first thing that could potentially help the entire breadth of patients who suffer from this quite devastating disease. Moving forward into multiple sclerosis, on July 13th, we announced positive top-line results for the Phase 3 Ocarina study. This is our six-month subcut study with Ocrevus. All the primary and secondary endpoints were met, and detailed data have been submitted to an upcoming conference. Results will be filed with regulators globally at the back half of this year, and we expect approval in 2022. We expect the introduction of subcut for Ocrevus to expand the usage of Ocrevus, the standard of care in MS and high-efficacy therapies, to clinics with limited or no IV capability. But it can also be an option for those larger clinics who currently may have IV capacity but would actually like to be able to expand the number of patients that they treat. I think there has been some confusion about what this program actually entails, and so let me try and clarify. The Ocarina original study was Ocrevus every six months, designed to support the potential for an HCP, a neurologist, a nurse, a pharmacist, to administer either inside or outside of the clinic setting at their discretion. The initial launch will be a syringe pump and will be administered by a healthcare professional, either at home or in the office. We are currently evaluating a self-administration option that can actually be delivered via an on-body injector, a patch pump. And we expect this option to be available in the midterm. Details on this program will be provided a little bit later, but it is definitely something to watch. In other news, Ocrevus continues to be a market leader, 22% share globally, over 300,000 patients treated. We are the market leader in the US and the EU5. Again, the data that we have in NMS continues to be untouchable from a relapse and remission perspective. We have extremely high persistence and compliance and extremely high patient satisfaction. We also would like to report that the Phase III high-dose studies have now been fully recruited, and we would just continue to see the high-efficacy market for multiple sclerosis expand in general and for the okravis share of that market to continue to be dominant. Thomas indicated that we also saw in phase two, I'm sorry, we also saw in Q2 positive phase two trial results for phenotopia for phenobrutinib in RMS. And so let's take a look at those. So these were recently presented at the EAN Congress. And I think there's, you know, they're just stunning results. As you know, phenobrutinib is a highly selective and the only reversible non-covalent BTK that is currently in development in phase three for MS. You can see from the data that was presented from the phase two trial that we have significantly reduced brain lesions. Patients on fenobrutinib are four times more likely to be free from lesions at four, eight, and 12 weeks versus placebo. These are not only comparable to anything that we've seen on the market, they are not only better than what we've seen, they're actually comparable to what we see with high efficacy treatment, including Ofravis, which is really, really impressive considering that this is an oral medication. The safety profile has remained consistent. As you are all aware, fenabrutinib has been in trials in multiple indications over time. We have more than 2,400 patients who have now been exposed to fenabrutinib, over 1,000 MS patients, and we continue to see a very consistent safety profile. While we do see some liver elevations, they are transient and reversible, and we have seen no cases of Hyde's Law, though we continue to very closely monitor our patients as safety is our number one priority. The phase three trials, both in RMS and PPMS, are ongoing, and we are very excited to see what this could mean for MS patients around the world. Spinal muscular atrophy, Evrizzi remains on track to become the number one treatment for children living with spinal muscular atrophy. We're now at over 8,500 patients globally. As a reminder, we were at about 7,000 patients at the end of last year. Evrizzi is well tolerated. We continue to see very high retention in the first 12 months of therapy. And excitingly, we are now starting to see that penetration into the older patient population. And that's really where the majority of SMM patients SMA patients sit, patients who have never actually been on treatment for their disease. And we are starting to see penetration there, which is great. The new firefish data were presented at CURE SMA and I think just draw a double underline under the very strong efficacy and safety profile that we are seeing with SMA across all ages and across all types. Thomas mentioned Elavides. I share his excitement for this drug. We now have the first approval in the U.S. for our first DMT gene therapy with our partner, Serapta. This approval was based on a pooled analysis of a number of studies that had demonstrated functional and clinically meaningful results. The U.S. accelerated approval is in that four- to five-year-old ambulatory patient population. As Thomas mentioned, we do have the opportunity now. We hold the ex-U.S. rights. We do have the opportunity to file in selected countries that reference U.S. approval, and those initial filings are underway. You can see on the right hand of the slide that we have a very significant development program underway for LAVDs looking across all ages and ambulatory statuses. As we have always said, we believe that we will need the Phase 3 and BARC results to file XUS. Those are expected in Q4 of this year. And we are really looking forward to the opportunity to bring this very promising treatment to boys and their families all over the world. And now going into Vibismo. So again, as I mentioned earlier in the presentation, there really is no other word for Vibismo than momentum. We have now reached U.S. market shares of 15% in AMD, 9% in DME, billion-dollar sales and constant exchange rates by the middle of this year, well on track to be a $2 billion brand in 2023. A couple of things that I think are particularly interesting, you know, when we talked in Q1, we were kind of in the teens on the number of naive patients that were getting Vibizmo. We are now at about a third of patients of naive. In Vibizmo, you're seeing about a third of patients who are naive receiving Vibizmo, and most of our switches are coming from Aflibircept. Everywhere we launch and gain reimbursement, we are seeing very fast uptake. We have double-digit market shares at this point in many of our early launch countries. And really what we just continue to hear from people is that Vibismo is the new standard of care. They try it. They love it. Their patients love it. They use more of it. It's really fantastic. In Q2, we also filed for the third potential indication for Vibismo, RVO, in the U.S. That PDUFA date is set for the 22nd of December, that EU filing date. is happening in the second half of this year. And starting tomorrow, actually, at ASRS, we do plan to present a significant new tranche of data that really looks at and I think gets to the heart of why we think vobizemo is such a special medication. And I think that has to do a lot with the actual nature of the molecule, that bispecific design. I think we all know that in these diseases, neovascularization is caused by that elevated VEGF in the system. And that's why those anti-VEGF therapies, they work fairly well. But what we have in Vibismo that is so special is we have that ANG2 arm. We have the ability to block Ang2, which we know leads to vascular leakage, inflammation, fibrosis, things that are anatomically are very, very important to retinal specialists when they think about actually being able to control those things to preserve vision for patients. And so, you know, Vabizmo's dual pathway really does, I think, make ultimately a very big difference when we think about the benefits that we see for this drug in the drying, in the duration. That dual pathway is certainly something that is really proving to make a difference. And last but not least, Sylvesteron. So I am just so excited about this partnership. Thomas touched on it earlier. But this is a place, hypertension, again, Thomas mentioned this, there's 1.2 billion people around the world who suffer from hypertension. About 80% of those people are unable to control their hypertension with the drugs that currently exist in the market today. And Zobicerone acting in the liver upstream of the traditional Ras cascade really gives us the opportunity to have a very different level of control for these patients. The phase one results were published in the New England Journal of Medicine. about a week ago, and those phase one results, again, I think you would just have to call them stunning. The ability to reduce by 90% serum endotoxinogen for up to six months with a single dose is just really incredible, and providing that consistent control both during the day and during the night. Again, I think this is a drug that, as Thomas mentioned earlier, has the potential to be absolutely transformative for a significant number of patients. As Thomas mentioned, we have two phase two studies that are currently already ongoing with CELBISERON, CARDIA-1, a monotherapy study in mild and moderate hypertension, and CARDIA-2. which adds on to standard of care. We expect data from CARDIA-1 sometime in the next quarter and in early 2024 for CARDIA-2. So definitely a partnership that we're extremely excited about. We think that the partnership with adenilam is really destined to be a really fruitful one and we're excited for the opportunity to bring Zalbiceran to patients in the future. And then finally, let me just quickly just touch on some major updates since Q2. So we talked about our regulatory approval with Columbia. We mentioned the phase three pivotal trial readout for Timeless. Thomas did that right up front. We have a couple of studies that have now shifted into 2020, 2024, Skyscraper 1, the GER-Produce study, which is Dicentric and TNBC, the Starglow study, and Lunsumio and Polyvian second-line BLECL. We have a couple of remaining readouts in H2. We talked about dyscentric and adjuvant small cells, I'm sorry, and adjuvant head and neck. The ALENA trial, which is allicenza and adjuvant ALK positive patients, again, something that we think is going to be potentially really impactful. And then Ben Klextel will read out two additional studies in multiple myeloma and MDS, two studies that I think we've been excited and waiting for for quite some time. And so with that, I will pass it over to Matt.

speaker
Matt
Head of Diagnostics Division, Roche Group

Thanks, Teresa. So it's my pleasure to present the half-year 2023 Diagnostics Division sales and P&L results. And with that, and with sales of 7.1 billion Swiss francs, the Diagnostics Division declined by 23 percent, or 2.3 billion Swiss francs at constant exchange rate. And this decline is entirely driven by the decrease in COVID-19 testing sales by minus 2.7 billion Swiss francs at constant exchange rate and offset by good base business growth of plus 6%. So you saw this slide earlier in Thomas' presentation, and here you see the performance of the diagnostics business over the last six quarters. I'd like to start by focusing on the orange line. This represents our base business performance, and you'll see in Q2 of 2023 an 8% growth. Now, In Q2, or excuse me, this includes a tailwind effect from the lockdowns in China in Q2 of 2022. But this was offset by the headwinds of our COVID-related business impact, such as Custom Biotech, where we make testing components for other companies involved in COVID-19 testing, which has declined along with COVID-19 sales. So when these two effects are taken together, the strong plus 8% base business growth reflects the underlying performance and growth in our base business. So now I'd like to turn your attention to the blue line. This is the total diagnostic sales, which includes COVID-19. Here, the impact of COVID-19 is less in the second quarter, with total sales declining by minus 17%. And this trend confirms that the COVID-19 business is starting to wash out of our overall diagnostic sales. So for the second half of 2023, we're expecting mid to high single-digit growth of our base business, while COVID-19 testing sales will continue to decline. And now I'd like to take you through the sales results by product category. And really starting with our main driver, which is the core lab. Here, the business increased by plus 10%, with very strong momentum, driven by immunodiagnostics and clinical chemistry. Additionally, the base sales, excluding COVID-19, such as custom biotech, increased by plus 12%. Molecular lab, as you see, had a decline of minus 40% due to lower COVID-19 PCR lab-based testing sales. As the COVID-19 pandemic has ebbed, clearly this has had an impact on the sales in molecular. However, excluding the COVID-19 related business, our core base business growth was plus 6%. And this is due to strong growth in cervical cancer testing, plus 24%. Our blood screening business, plus 13%, and our core virology-based business, which also grew at plus 5%. Next, you'll see our diabetes care business, which had a 5% decline. Now, this decline is driven by the shift from traditional blood glucose monitoring to continuous glucose monitoring, and we expect this to continue as this market trend continues. Sales in the pathology lab grew strongly at plus 12%, and this is mainly driven by advanced staining, immunohistochemistry reagent growth, and companion diagnostics. Our point of care business had a decline of minus 74%. And this is, again, entirely driven by lower COVID-19 rapid antigen and COVID-19 molecular point of care sales. Our base business grew at plus 4%. And this is really driven by the Q1 sales of our point of care molecular LIAT business, which was supported by the strong respiratory season in the northern hemisphere in the earlier part of the year. And so with that, if we look across the different regions, what you'll see is the impact of the lower COVID-19 testing sales across every region in which we operate. But excluding this COVID-19 effect, we see really strong growth of our base business. So in North America, the divisional base business excluding COVID-19 related business grew by plus 5%. In EMEA, the base business excluded COVID-19 related business also grew by plus 5%. In Asia Pacific, our base business grew by plus 13%, excluding COVID-19 related business. And in Latin America, sales grew by plus 20%, excluding all COVID-19 related business. So really great performance across all the regions. Now I'll walk you through the restated P&L in its new format. And what you see here is core operating profit declined by 36%. And again, this was driven by the strong decline of COVID-19 sales, but partially offset by improved margins and a declining SG&A. Our cost of sales declined at 26%, faster than sales. And this is due to lower sales of COVID-19 rapid antigen tests, as well as productivity gains. R&D increased by plus 2%, and this is driven by higher investments in the area of innovative instrument developments and as well mass spec and digital solutions. Excuse me, including mass spec as well as our digital solutions. SG&A decreased by minus 2%, and this is thanks to lower distribution costs associated with rapid antigen, but also good cost discipline across all our SG&A lines. And so now I'd like to turn to the topic of some of our innovative developments, particularly instrumentation, and specifically our new analytical mass spec instrument. So at Euromed Lab, we exhibited this highly anticipated Cobos I601, the first fully automated analytical mass spec unit, which will revolutionize mass spec testing in the clinical lab. So today, mass spec is the gold standard in applications where the highest level of sensitivity and specificity is required. And until now, mass spec testing has been run in a separate area of the laboratory due to its very highly specialized manual workflow, and its current use is limited by the manual and time-consuming procedure of running a test. The i601 will be fully integrated to our existing serum work area workflow, which means it'll be combined together with our ClinChem and immunoassay and can be put on a line containing those other systems. It will be fully automated, random access, and capable of delivering up to 100 samples per hour with more than 40 key parameters such as vitamin D, therapeutic drug monitoring, immunosuppressives, and steroids available at launch. The instrument will be launched at the end of 2024 in countries accepting the CMARC, and we would plan to launch in the U.S. the following year. We expect a second wave of menu additions with 20-plus assays in development, which would include drugs of abuse testing following shortly thereafter. And the customer feedback on this system has been very positive, and we're really looking forward to the launch. So now turning to another key focus for diagnostics, which is access, and really highlight the positive progress we're making to provide access to critical diagnostics in low- and middle-income countries, specifically the X800 molecular HPV test, where we received WHO prequalification in May of 2023. Cervical cancer, as many of you know, is slow-growing and very treatable if caught early. But today, the global health disparity is large, with 9 in 10 cervical cancer deaths worldwide occurring in low- and middle-income countries. 91% of women in low- and middle-income countries have never been screened for cervical cancer, as opposed to 16% in high-income countries. Now, in 2020, the WHO launched the cervical cancer elimination agenda and issued guidelines recommending HPV DNA primary screening for all women. Receiving the WHO pre-qualification is a good step to increase access because many countries require this as the regulatory standard and it opens access to tenders and further establishes Roche Diagnostics as a global leader in this space. I'd like to call out that currently 36 of the countries that rely on the WHO pre-qualification already have X800 instruments, and we can move quickly to respond to national tenders for cervical cancer screening. We will also continue to shape the local environments to ensure cervical cancer screening is a health priority in these countries. So now I'd like to turn to another key part of our Roche strategy, which is precision medicine, and in particular, oncology. We've recently launched two important diagnostics in the brain cancer space, IDH1 and ATRX immunohistochemistry screening. Glioma constitutes today around 340,000 cases per year, and 75% of those are malignant disease. These two tests allow laboratories and physicians to quickly, accurately, and cost-effectively identify mutations into very important genes for patients affected with gliomas, the most prevalent type of brain cancer. And identifying a patient's mutation status in these genes more precisely subtypes the glioma patient's diagnosis. And as you can see in the WHO algorithm on the left, This subtyping is important as these biomarkers are both prognostic and predictive, allowing a glioma patient and their clinicians to better understand the most optimal care decision. So the IDH1 and ATRX launch brings our portfolio of neuropathology biomarkers to 29. These assays run on our benchmark series of instruments, the ULTRA and the ULTRA+. thus making them currently available to laboratories in the US and beginning in 2024, available worldwide. And now I'd like to just briefly cover the launches in the first half of the year. So in the first half of the year, we launched three of our key launches for 2023. The other ones are on track and I very much look forward to updating you in subsequent meetings. So thanks very much for the attention and now I'll turn it to Alan.

speaker
Alan Hippe
CFO, Roche Group

Yes, thanks, Matt.

speaker
Matt
Head of Diagnostics Division, Roche Group

Thanks, Alan.

speaker
Alan Hippe
CFO, Roche Group

It's my pleasure now to lead you through the Finance Week. I hope everybody's well and safe and healthy. When you look really at the highlights, I would touch on all of them. Yeah, let me just say, I think great progress for Roche in the first half year. You will see the underlying sales growth and you've heard about it already, which has done really, really well. It gives us certainly a great perspective. The pipeline has improved and I would argue the overall results are pretty solid. I think as Tarida and Matt said, I think we have made some changes in our P&L. So the new income statement presentation is effective now of January 2023. And at full year 2022, we have shown you the impacts already. But nevertheless, let me lead you through what we have changed. First of all, we have merged MND and GNA to SGNA. A simple reason, we want to be really comparable to our peers, and I think that makes it easier. The second bullet point, I think this is something which came in from IFRS. It's a move here. So we really came in now with the line other revenues. You will find here basically the royalties and the royalty income. And we have introduced another operating income and expenses, and that's where you normally will find the disposal gains. And then, in total, we have simplified our allocations. We have quite an extensive allocation structure that we have followed. We simplified that really radically, and that has an effect on the divisional results. Consequence of what we have done is, well, when you look at it, I think the key metrics for sales group operating profit and EPS are unaffected, so really comparable to the past. We have not changed the core reporting concept, so that's the same. The changes to allocations will reduce the allocated costs to divisions and increase the divisional margins by around four to five percentage points. Good, with that, let's get into the numbers. When you look at the group performance, and here is really the overview, you see the sales decline on the right-hand side in constant rates by minus 2%. You see, by the way, the impact when you look at Swiss franc from currency, and I will come up with a statement later on and we'll talk about currency. So when you look at the minus 2, I think as said, the underlying growth is great. Dyer plus 6%, pharma plus 8%. Overall, plus 8%. And then I see we have lost the 2.7 billion COVID sales. That leads us to the minus 2. You see the cooperating profit down minus 6%. Normally, we would always have the aspirations that should be in line with sales, at least halfway in line with sales. Here, the argumentation is Altamiris. a patent settlement income of the first half 2022 if you were adjusting for it i think that accounts for 5.3 percentage points of the minus six percent you would be basically flat so i would argue a pretty solid um cornet income with a minus seven percent here interest charges play a role which have increased You see core EPS is minus 5%, so you ask yourself, okay, cooperating profit down six, cornet income down seven. Why is the core EPS just down by minus five? And that's really also Altamiris because Altamiris comes from Shugai and we own 60% of Shugai. So that's a minorities effect which comes in here. IFRS net income is the minus 9, certainly a result of the operating results, as well as the higher interest charges. And then you see the cash flow still solid with 8 billion. Nevertheless, a minus 8%. Minus 8% is basically the Altamira's impact, which plays a role here. And you see the minus 18 is currency as well. But as I said, I will talk about it. Free cash flow, just down by minus 2%. Here's an effect from tax payments, which we have moved into the second half of the year. Good. With that, let's move to a bridge slide that Thomas has talked about already. I don't want to stress it again too much. I think here you see very well outlined the diagnostics, what we have lost, the 2.7 billion. You see the base business in diagnostics, which has grown so well. You see the pharma base business, which is 2.4 billion, which is really impressive. You see there was basically no impact from RonaPrieve. And you see certainly the erosion coming from AHNR and the significant currency impact. When I started here, and that's the right-hand side, in 2011 we had three blockbusters. Today we have 16 blockbusters. So I think quite well diversified and quite some significant growth of the company over time. Good. With that, let's go to the P&L. And let me start on the right-hand side because these are the numbers which are familiar to you with the minus 2% on sales and the minus 6% on cooperating profit. And now you see where it comes from. So let me move now into the middle column with the absolute CR numbers. You see sales down 540 million. Other revenue down by 685 million. Altimarius once again with the 668. Then the cost of sales, a positive of $1.1 billion. I think you've heard from Matt. Dyer down 26%. Their volume came down by 23%, and they even overcompensated it by their cost decline. Pharma plus 3% with a volume growth of 14%. You see R&D. It was a minus 486. That's driven by pharma. and basically solely driven by pharma. Computational biology, oncology, neuroscience, that all played a role, have initiated quite some phase three trials. You see SG&A up 392 million. I would argue one half of it is really M&D on the pharma side. So really we supported our launches and our current products. And the other piece is coming from GNA, that's informatics, with roughly 100 million. We have applied really new things in the company due to business needs, and then a little bit coming from other areas. And then you see other operating income and expenses, And as said, I think these are basically the gains from disposals, and they are $305 million higher compared to previous year, which leads us to a core operating profit decline of $704 million. Good. With that, once again, this other revenue topic, don't want to stress it too much, but it's quite significant what role Altamira has played here. So from $1.6 billion down to $837 on the right-hand side, And then you see that huge red bar in the middle with a minus 691, and the 668 of this is coming from Altamiris. And then you see the royalty income, which is down, which is driven by Lucentis, and that's quite a natural development with successful Vubaismo. Good, cooperating profit and the margins. You know, we have the mantra to defend the margin, and I would argue that has happened. Because when you look at Roche Group, yes, there is a decline of 1.6 percentage points. But when you exclude Altamiris, I think you get to a plus 0.5. So I think mission accomplished at half year. When you look really at the pharma division, when you exclude Altamiris, there's quite a significant increase. And then you see diagnostics, where we have lost 2.7 billion in sales recently. And then it's pretty clear that you also take a hit on the margin. Good. Let's go to the Cornet financial result with a moderate decrease in the reported numbers of 24 million. When you look really in constant currencies, it's a 75 million. And you see where it comes from. The equity securities have done rather well. So the Roche Venture Fund, I think, illustrates where the market has gone. and that valuations in the market have gone up. You see the net interest income. Well, we get some interest net now for our liquidity, first time for a long time. You see really currency. It's a base effect from last year. We had some currency gains last year. And then the interest expenses, which moved up by 147 million reported, which is clear with the rising interest rates. With that, let's go to the tax rate. And when you look at the tax rate, I think very clearly on the left-hand side, you see we had last year a release of a tax provision of roughly 300 million. That certainly brought the tax rate significantly down to 16.1%. Half-year 2023, we ended up with 16.9%. Now you ask yourself, okay, how can that go if there is no special effect in here? And once again, it's Altamiris because Altamiris, as said, stems from Shugai. Shugai has a higher tax rate in Japan compared to the group tax rate. So when we now miss it in the first half of 2023, certainly that has a negative effect on the group tax rate overall. So we ended up at 16.9%. Good. Core EPS development, the bridge. So a little bit of a summary here. And you see it half year 2022 with 1177. And you see half year 2023 with 1123. So a decline. You see the operations, which is basically the residual here of the minus 5%, here minus 4.6% decline. You see Altamiris had an impact of minus 3 percentage points. You see the gains and losses on equity securities. You have seen the 151 million positive had certainly a positive impact. I explained the tax rate change and then the small impact from other. Good. Non-core items, equally important because it illustrates how we get from the cooperating profit to the IFRS operating profit and then to the IFRS net income. First, when you look at the right-hand side, you see there is not much of a difference. You go from the cooperating profit minus six to the IFRS operating profit with minus seven. And when you really look into the absolute numbers, not much of a movement overall. I go to the details in a second. When you see the minus 7% to the minus 9% for IFRS net income, that's driven by higher interest charges. So let's look a little bit into the specifics. You see the global restructuring plans with a minus 678 million, increase of 400 million. But nevertheless, I would argue still in line with historical measures here, but nevertheless, certainly we're driving improvements in the company and want to do this. That results in future benefits that help us. Amortization of intangible assets, we've done a couple of write-offs in the last years. I think that helped here to bring that number a little bit down. You see 110 million improvement. The impairment of the intangible assets, you know they come when they come and when we have study results. So 260 million at half year 2023, 163 million better than last year. M&A and alliance transactions very small. And then legal and environmental, we had a release here of a rather significant provision for a trial, so quite successful. of roughly 130 million, and that drove that number to a positive 150 million here. So as I said, IFRS operating profit down minus 7% in constant rates. That leads to the IFRS net income down by minus 9%. Okay, let's look at cash and the balance sheet a little bit. And when we look at cash asset, there is a reduction from $9.8 billion to $8 billion. The major part really is Altamiris. The rest is currency, I can say, but I will come to this. You see the pharma division quite successfully in half year 2023, and then you see the decline on diagnostics, which certainly is driven by the lower volume and the lower sales driven by COVID. Good. Let's look into the group operating free cash flow. So from 9.8 to 8 billion, as mentioned, and you see the operating profit net of cash adjustments came down by 946. Very clear, lower sales, significantly lower sales, therefore lower operating profit, and certainly no Altamiris. So that's the explanation here. All the rest balances out pretty well when you look at networking capital, which contributed positively. Investment in PP&E, investments in intangible assets, pretty balanced. And then the foreign exchange impact of a minus $978 million leads us to the solid $8 billion. When you look at the group net debt development, first let me start on the right-hand side with the net debt of 17.9 billion at half-year 2023. When you compare it to the status last year at this time, we had minus 20.9 billion. So we reduced that in a one-year timeframe. by roughly 3 billion, so I think that's a nice achievement. When you really look at the left-hand side, that is the net debt position beginning of the year, the minus 15.6 billion. We have increased a little bit, and that's certainly, you know that, that's always the same rhythm. We pay the dividend in the first half and the dividend in 7.8 billion, and then the rest of the year, if you like, we work against that with the free cash flow. So I think it's fair to assume that we can improve our debt position further until the end of the year in the absence of of significant M&A. Then let's move to the balance sheet. When you look at the balance sheet, certainly I can make here a lot of comments if needed, but I think when you look in constant rates, not a lot has happened here. I think it's pretty stable. The only outlier is cash and marketable securities with minus 16%, and that is really driven by the payment of the dividend. As mentioned already, all the rest is pretty stable. You see equity ratio 36%, net debt to total assets at 21%. A lot forget that we have 25.6 billion of grots debt on the balance sheet. Good, with that, let's go to the outlook, and let me start with currency. And I know that's a topic. And let's focus first on the left-hand side. And you see, really, the Swiss franc to U.S. dollar development. And you see, really, in Q2, the U.S. dollar has weakened significantly against the Swiss franc. You see, really, the impact in Q1 was zero. And then in Q2, a half year, then it was minus 3 percentage points. So really, really significant here. When you look at the Swiss franc to euro, you see basically the situation remains with a minus 4 percentage point and a minus 4 percentage point. And now I come to the right-hand side, where you see once again the half-year impacts with a minus 6 for sales, minus 8 percentage points for cooperating profit, and a minus 9 percentage points for core EPS. And now we're going to assume, as always, that the exchange rates of the end of June remain stable until the end of 2023, which is not very likely, but just from a modeling point of view and from an assumptions point of view, that would leave us in September year-to-date with a minus 6 percentage points on sales, and on full year with a minus 7 percentage points on sales, minus 9 percentage points on cooperating profit, and minus 10 percentage points on core EPS. Let me make here a comment about how concerned should we be about this. Because, well, at the very end, it's really about cash and cash impact. And you've seen this. There is a cash impact, at least from an accounting point of view. You know that we have a pretty good natural hedge globally. That means the markets where we have high sales, we normally also have a very high cost position in. Predominantly, that's the U.S., And you can come up with Euro, so really in the Euro currency, but also China. In all of these regions, we have full value chains, and that means there's a pretty good hatching between these things, though that's more of an accounting impact, so not too concerning from today's point of view. And the Fed has increased the rates yesterday when I remember it well, so I think there is some hope that the U.S. dollar will strengthen in a certain time frame. Good. With that, once again, we confirm the guidance, as Thomas has said already. I don't want to dig more into this because, well, we would like to answer your questions. And with that, I hand over to Bruno.

speaker
Bruno
Head of Investor Relations, Roche Group

Thanks. Thanks a lot, Alan. I think we have 11 analysts here in the row raising their hand. I think we just agreed that we will do 40 minutes of Q&A to give all of you the opportunity to ask two questions. Two questions, please. And I would also like to ask the speakers to be crisp in their responses. So first one would be Sachin Jain from Bank of America. Sachin, please, two questions.

speaker
Sachin Jain
Analyst, Bank of America

Hi, thanks, Bruno. And I'll stick to the two questions. So just two big picture ones, if I may. So firstly, for Thomas, should we view recent VD deals focused at phase one, two? as a sign of where your greatest focus is in stage of doing BD, or could you comment on the potential of doing later stage assets, phase three launch ready? Just wondering now that you're six months into the group's year, what's your assessment of need to bolster the later stage pipeline or add further growth drivers short term? And then the second question is for Alan, just to get a sense of sustainability of this growth into 24. So second half growth is looking mid-high single digits. Could you just talk about a very high level of sustainability of that into 24 initial perspectives on pushes and pulls? As we see it, the key drags next year will be eczema, biosimilars, and COVID. Anything else we should be aware of? And any new positive drivers you'd like to flag? Thank you.

speaker
Thomas Schinecker
CEO, Roche Group

Hi, Sarjan. Happy to take the first question. First, let me again highlight the on-market portfolio. We have 20 new medicines launched since the end of 2015, and these medicines will continue to drive growth. Second, and I think Theresa did a great job of highlighting a number of very interesting assets that are in a late stage pipeline. Third, when we look at M&A or licensing deals, we look at all stages of development, and we every year look at hundreds of companies and we look at the science we look at the financials and if they make sense then we'll go ahead with that with that you know it could be phase one it could be phase two but it could also be a phase three ready assets so we're open to all kinds of assets as long as they make sense financially and scientifically over to you ellen

speaker
Alan Hippe
CFO, Roche Group

Yeah, thanks. Well, Sachin, I think we know each other for a long time and I cannot give any guidance on 2024. That's pretty clear. But having said this, I think the underlying growth is quite impressive. I think that's pretty clear when you look at the pharma side. And it's really, really coming really broadly from a lot of products. You make a good point about a couple of them. I think some might be a little bit weaker, but others will be a little bit stronger. um let's see how it plays out for me it's important 2023 we shouldn't forget about the rona brief impact in q4 that we don't forget about this yeah but i think really uh uh looks promising yeah for 2024 and and you know i'm enthusiastic about met and diagnostics uh i i think that looks good i think he always explains his underlying numbers and they they look great as well And he has even more technologies to come. They might not play the major role in 2024, but certainly for the distant future. So I think really that looks fine.

speaker
Bruno
Head of Investor Relations, Roche Group

Very good. And with that, we would move on. The next two questions come from Matthew Weston, Credit Suisse or now UBS, I have to say. Matthew, please.

speaker
Matthew Weston
Analyst, UBS

Thank you. Can you hear me, Bruno?

speaker
Bruno
Head of Investor Relations, Roche Group

Yes, sure.

speaker
Matthew Weston
Analyst, UBS

So two product questions for me, please. The first is on Hemlibra. So U.S. growth momentum in particular slowed, and we're obviously seeing Altuvio launch and add a new treatment option in the category. Sanofi Management has made some statements that they're seeing patient switches off Hemlibra. I'd love your perspective as to the market dynamics and how you expect that to play out going into the second half and into 24. And the second is around Vibismo and what is clearly a spectacular launch. And Theresa used the word momentum. But if you actually look at quarterly incremental absolute dollars, then 2Q actually was less of an incremental ad over 1Q versus the same quarter previously. And that seems quite odd this early in the launch. Japan looks relatively stagnant with Q2 pretty much flat over Q1 and Q4. So I just wondered whether there was anything unusual about Q2 and whether we should expect some acceleration going into the second half of the year. And I realize I'm being picky, so I want to make that clear. But getting Vibismo right is clearly quite critical.

speaker
Theresa
Head of Pharma Division, Roche Group

Well, Matthew, I appreciate you acknowledging your pickiness, but I think both of your questions are super valid. A question about the sales in both sort of the sales cadence, if you will, for both Hemley-Brandon Buys Mo comes a little bit down to buying pattern. Q2 is always a little bit funky when it comes to buying pattern, and I think that's a... I think that's a reason that you may see the difference that you see in the Hemlibranvibizumab shares or sales there. Again, I think when we look at market shares, the U.S. market share is growing quite significantly. We're at 50% now in AMD, 9% in DME. We have greater than one year of real-world data, more than a million doses in market. I mean, I think we've just got tremendous, again, momentum here. But I think, you know, as always, when you have products that are, and I'm speaking specifically to Devizemo here now, that have contracts associated with them, you always can sometimes see a little bit of quarterly fluctuation. When it comes to Altivio, I mean, honestly, right now we're not hearing about switches. There's really no reason for a patient on Hemlibra to switch. They're very well controlled from a disease perspective. They're highly satisfied. They are in many cases and two thirds of the cases already on an every other week or monthly dose. So there's very little incentive for a patient on Hemlibra who's well controlled to switch. So, I mean, it's just, it's not something we're hearing a ton about actually in the market, to be honest.

speaker
Matthew Weston
Analyst, UBS

Many thanks.

speaker
Theresa
Head of Pharma Division, Roche Group

Thanks, Matthew.

speaker
Bruno
Head of Investor Relations, Roche Group

Okay. And we go on. Next one would be Mark Purcell from Long Stanley. Mark.

speaker
System
Recording System

Yeah, thank you very much, Bruno. Good morning, good afternoon, everyone. So two questions. Firstly, on Polyvi, the update seems to have been stronger than you anticipated. And obviously, competitors are now going to use Polyvi in a first-line trial. So is there upside to the $2 billion peak sales target you gave on this product? And can you help us just at this stage think about sales aspirations for Columbia and for Lunsumio as well? Obviously, there's combinations of Polyvi and Lunsumio, so it's quite difficult for us to model. Secondly, in terms of a Crevis subcut, Could you sort of help us understand what's going on here as well? Because brumvi uptake has been pretty strong based on obviously shorter infusion time. So when you think about a crevice in the syringe pump, followed by a crevice in the patch pump, can you help us understand the administration times of both? The ease of at home usage with both? Presumably patch pump is a lot easier. And then can you confirm whether the patch pump will be a part D medicine as opposed to just part B? Thank you.

speaker
Theresa
Head of Pharma Division, Roche Group

Okay. So in terms of Polivia, I think we are seeing great uptake. I'm not sure I would say that it's stronger than we anticipated because I think I can sort of remember being back on this stage a number of years ago when the data first came out and us thinking this will be the standard of care. I mean, that incremental benefit over a highly effective standard of care in our mind, I think, was a game changer in first-line DLBCL, which we know when patients relapse their outcomes are much worse. So upside to $2 billion, I would say I'm still feeling pretty good about the $2 billion. I mean, I feel like we need to get there. But based on the fact that we're seeing uptake in all IPI statuses and we are seeing rapid adoption, it's possible that there may be upside here. And again, I think we're seeing quite a bit of really exciting uptake with polyvine. When it comes to Columbia and Linsumio, I mean, I think it's important to remember that both of them right now are in relatively small patient populations. So both third-line plus DLBCL for Columbia and third-line plus follicular lymphoma for Linsumio, these are relatively small patient populations. But as we move into bigger and bigger patient populations, I think these both have quite significant potential and may in fact be a little bit undervalued by the market. So again, maybe something to take a look at, particularly when you look at the profile of these drugs. Sorry, Bruno, I know I'm not being crisp in my answer, but... For Columbia, that fast, deep, durable response rate in a fixed-dose therapy with your visits to the clinic, that's an incredibly attractive profile. And then when you think about Lansumio, it has a profile that is sort of perfectly designed for the chronic populations in which it's looking at. Yeah. you know, more to come there. In terms of Okravis subcut. So, I mean, we're talking about going from, you know, an hours infusion to a twice a year, 10 minute subcut. I mean, that's pretty good. And I would suspect that this will be, you know, quite competitive in the market. To be honest with you, I know we've heard this, you know, Breamby's having a great launch. Honestly, we don't see it. We just don't see it or hear it in the market in the same way that we hear it reflected back at us. I think in a lot of instances, the numbers that are being cited, frankly, are coming from survey data, and survey data is never as accurate as actually sales data. The way we kind of look at the MS market at the moment is exactly what we had hoped would happen is happening. The high efficacy anti-CD20 market is expanding. It's now over 60%. This is of the MS patient population. This is what MS patients deserve, the best possible chance to control their disease. And we still see Ocrevus having the lion's share of that. And we think that we have an opportunity to actually continue to expand our lead with the advent of Subcut.

speaker
System
Recording System

and the expansion into Part D? Could you help us understand that, Theresa?

speaker
Theresa
Head of Pharma Division, Roche Group

Oh, so I think with Part D or Part B, I think it's a little hard to say at the moment because it could either be in the office or at home. And so I think more to come on that, more details closer to launch.

speaker
System
Recording System

Thank you.

speaker
Bruno
Head of Investor Relations, Roche Group

Thanks, Theresa, for your crisp answers. I think also if my counting was right, these were actually three questions. So I would ask the next one here in the row, Michael, please, to stick to two questions. Michael, please. Michael Leuchten from UBS.

speaker
Michael Leuchten
Analyst, UBS

Thanks, Bruno. Yeah, I'll stick to two. So two questions, I think, for Theresa. Just your comment about Polyvi and first-line DLBCL trials now requiring a Polyvi option in it. How does Roche deal with that? Do you facilitate that? Or is that effectively a blocking option you have to not allow others to maybe run these trials and not run as quickly as otherwise they could? And a clarification on Ocovus sub Q. Does it require nurse resources with it? And does it require a sort of an infusion chair? Or is it completely removed from the infrastructure we would normally see with Ocovus IV? Thank you.

speaker
Theresa
Head of Pharma Division, Roche Group

Great question. So on the first one, we would never do that. We would never do that. So if someone wanted to use Polivi for a competitive trial, that's very common in the industry. We make our drugs available for competitive trials all the time. It is worth noting, however, that first-line DLBCL trials are long, and they're relatively large. And so we believe we have a four- to five-year... We have a four- to five-year lead time for anybody that would potentially want to come into the first-line DLBCL space. So we think we've got a really good place for sort of Polivi to really entrench itself. In terms of Ocrevus subcut, with the initial syringe pump that is either in the clinic or in the office, that does require a healthcare professional at first. So it would require a nurse, a physician, a pharmacist, a GP. A healthcare professional is required. and an IV chair, but that is something that will be, you know, hopefully in the second generation with the patch pump will be something that will no longer be required.

speaker
Bruno
Head of Investor Relations, Roche Group

Thank you. Maybe, Teresa, here's one question coming in. by email. It's from Madison and it's about, and it goes to Ocrevus as well. Could you elaborate on your commercial strategy for the sub-Q Ocrevus? Are you thinking this would expand the market from our perspective through a competition with competitor subcutaneous products or other IV CD20s? So how do we see the market developing once we launch?

speaker
Theresa
Head of Pharma Division, Roche Group

So I think for sure, we will see some patients who are on Ocrevus switch to the different formulation. I think we will see patients who are currently on other anti-CD20 subcues switch to this one. I think we will see naive patients switch to Ocrevus subcut. And I honestly, sincerely hope that more MS patients will get on a high-efficacy therapy over time. This is the best possible option that we have for MS patients right now to control progression, to control relapses. And so I believe that Ocrevus subcut, given the breadth of the efficacy data, the breadth of the safety data, the convenience that we already supply within every six-month infusion, now moving to an every six-month, 10-minute injection, I sincerely hope that more patients of all types will go on this therapy because it is their best possible chance to live their fullest life.

speaker
Bruno
Head of Investor Relations, Roche Group

Thank you. So next two questions would come from Richard Fossum. Richard, please.

speaker
Mark Purcell
Analyst, Long Stanley

Thanks, Bruno. Two questions, please. First one on to Centric. Just thinking about the outlook going forward, really. Could you give us an idea of the penetration in liver and small cell lung cancer and how the rollout's going in adjuvant lung? And on the basis of that, how do you see the outlook going forward for the product? And then a follow-up on Vizmo. Obviously, high-dose ilea has been delayed. What incremental warehouse patients do you think you can capture because of that delay? Thanks very much. Great questions.

speaker
Theresa
Head of Pharma Division, Roche Group

So, Ticentric has done a great job of penetrating the indications in which it has differential efficacy. So, you know, indications like small cell, we are largely penetrated. When we look at HCC, I think there are parts of the world on which we are getting relatively fully penetrated, but there are actually other countries that we have not even yet launched or are still awaiting reimbursement, and so we would still expect some growth in HCC. Currently, in adjuvant non-small-cell, we still have about 40% or 50% share. This is enough for market leadership. This is a relatively new market. We would expect that we will continue to retain share here. We have very compelling data, particularly In the PD-L1 high patients, we see and hear very positive feedback from the physicians who use it. But I think we do have to acknowledge that there's competition in this space. So I think this year we would continue to expect Ticentric to deliver double-digit growth and We do continue to believe that it has it has the ability to continue to grow. I wouldn't underestimate the impact of something like to centric subcut. Again, the ability to do what we saw with Fesco, particularly in more resource health, more resource constrained health care systems. You know, it has the opportunity, again, from a 30 to 60 minute infusion to a seven minute injection really has the opportunity, I think, to capture some more market in that way. So it certainly wouldn't count to centric out by any stretch. In terms of the bismuth, I think there has been this question of were people warehousing patients waiting for high-dose ilea? I think our impression in talking to retinal specialists is that may have been happening in some pockets, but certainly not here. not in any sort of massive way. We are hearing, we are hearing that those physicians saying, well, there's really no reason to, you know, why would I wait when I have a great option right now with Vobizmo? And, you know, I think it just gives us the opportunity to continue to make sure that as many retinal specialists as possible are getting experience with Vobizmo, that they're getting patients on it, that they're seeing that the benefits and that they're having the opportunity to expand it in their practice. And I think that, you know, that, We will take the advantage of every opportunity to make that happen because we believe it's in the best interest of patients.

speaker
Bruno
Head of Investor Relations, Roche Group

Thanks. Next one would be, Richard, does this answer your questions?

speaker
Mark Purcell
Analyst, Long Stanley

Yeah, absolutely fine. Sorry, I was just muting. Thanks, Richard.

speaker
Bruno
Head of Investor Relations, Roche Group

Then let's move on. The next one would be Richard Parks from BNP Paribas. Richard.

speaker
Richard Fossum
Analyst, BNP Paribas

Thanks, Bruno. Yeah, just two questions. Firstly, the partnership with Alnylam in hypertension obviously represents departure in terms of therapeutic focus. So I just wondered if you could walk us through your thinking there and criteria required for new programmes that would warrant an expansion in terms of commercial presence and maybe from a business development perspective, what other new areas might you consider as potential opportunities? Then the second question was on brain shuttle Gantanerimab. I think you mentioned data at CTAD. I just wonder, should we see that as just a proof of concept for the platform? Or do you think that's an asset that you could think about taking forward? I've had the impression in the past, you might prefer to maybe focus on other amyloid targeting antibodies if you chose to progress in Alzheimer's. Thanks.

speaker
Thomas Schinecker
CEO, Roche Group

Thank you very much, Richard, for the questions, and I'll take those two questions. First, if you look at OCWOS, we were not in multiple sclerosis before we launched OCWOS, and we defined the standard of care. If you look at Evristi, we were not in spinal muscular atrophy before we launched Evristi. We redefined the standard of care. If you look at Hemlibra, we were not in hemophilia before we launched it and we redefined the standard of care. I think what's important for us, and that's our key focus, we want to find first in class, best in disease, transformational medicines. When you have an opportunity to deliver transformational medicine, I think that's the opportunities that we are looking for. And clearly, with this medicine, that is the case. It's a very proven pathway. You've seen from Teresa the data with more than 90% decrease of this protein, angiotensinogen. and a sustained response for six months. When you know that 1.2 billion people in the world and 80% of them not being controlled, you can see that there is a big opportunity with a transformational medicine. So we are looking for these opportunities that are interesting, that are also big opportunities, really opportunities where we could change the standard of care. And we think this is one of them. And so we're looking at that in different areas. Regarding Trontinumab, we have data. So this is basically a brain shuttle, a version of an antibody connected to a brain shuttle. And we all have this blood-brain barrier. And the reason why we have the blood-brain barrier is because our brain is important, and our body tries to protect it. And with that, it's very hard to bring antibodies into the brain. Now, we have seen data where we can see that it's much... better much faster at a much higher dose although you submit a much smaller dose it's much easier to get into the brain in much more homogeneous way so we see that as a big opportunity and we'll be very going very fast with this molecule and so we will share more data at CTAD but yeah it's very exciting for us thank you Richard all your questions answered then yes thank you

speaker
Bruno
Head of Investor Relations, Roche Group

Then we would move on to questions from Peter Welford from Jefferies. Peter.

speaker
Peter

Hi, thanks for taking my questions. Firstly, for Alan, I think, just on the margin, consciously becoming defending the margin, but I guess if we take out the Altamira, as you said, actually in the first half of the year, you delivered an underlying margin expansion. I guess we think about the second half and think about the phasing there. But then we think about the reiterated outlook for EPS. What are the sort of headwinds we should be thinking in the second half of the year for the margin that result in some mitigation, perhaps, and the conservatism as to why, you know, you still see EPS growth to be broadly in line with sales for this year? If you could just sort of talk us through that. And then secondly, on diagnostics or I guess sort of strategy to some extent, just looking at the various elements of diagnostics, particularly diabetes, where I think you made the comment it was decreasing and that decrease is likely to continue for the foreseeable future. Curious, are there elements within diagnostics such as that that could be considered non-core? And is this an area Roche really needs to be in? And perhaps you could talk a little bit about, you know, are there areas within diagnostics that perhaps, you know, are potentially not part and don't have synergy with the pharma business? Thank you.

speaker
Alan Hippe
CFO, Roche Group

Yeah, I think, look, could come up now with a lot of things and certainly headwinds that we could face, but feel good. We're well positioned. I think cost discipline, that's the major point that we have to apply in the second half. But the organization is aware. I think our plan stands. And I think if we follow that plan, I think we will come in within the guidance that we have in mind that we have placed in the market. So it's not like that I see specific headwinds coming up in the second half. Okay, we can always mention inflation and whatever. But as said, I think that's something we deal with and that we will manage. No, we feel good about the guidance once again for the full year.

speaker
Matt
Head of Diagnostics Division, Roche Group

I'll maybe touch on the diagnostics portion. So Yes, we see this decrease in diabetes care, but what I'd say is similar to what I said in the Q1 call is we are also continuing to look into continuous glucose monitoring, and diabetes care is a key part of our overall strategy. Diabetes is a major health burden worldwide, and it represents an attractive market for us to be in, and we will continue to be there, first part. Second part, to the comment about other areas within our portfolio that not delivering value i mean we are constantly looking at our portfolio and i think we're really happy with our overall market leadership and the strong portfolio we have so um no there aren't any areas that we're currently looking on uh on exiting very good um next two questions would come from simon baker from redburn thank you bruno um thanks for taking the questions uh two if i may please

speaker
spk05

both on two of the newer products. So firstly on Zilbesaran, the appeal of a superior product dosed far less frequently than a cheap but ineffective oral tablet is clearly very appealing. But as your neighbors have found from a commercial point of view, certainly in cholesterol management, it can be challenging. So I'm just wondering if you could talk us through the, not the clinical risks on Zilbesaran, but the commercial risks going forward I know it's early but I thought I would ask it nonetheless and then moving on to ksq4279 I just wondered what your if you have rights to an interest in non-oncology indications because USP1 has been implicated in a number of cardiometabolic indications is that something that you're interested in and do you have the ability to exploit that thanks so much

speaker
Theresa
Head of Pharma Division, Roche Group

Do you want me to start with the first one?

speaker
Thomas Schinecker
CEO, Roche Group

Do you both? I can take it. Go for it. So first of all, I want to congratulate you on the pronunciation. It's not the easiest one. But joke aside. So one of the things that is very different to the other medicine that you mentioned, which actually targets the same target as the medicines that are available, this actually targets a very different mechanism. It's really targeting at the start of the cascade. And with that, you don't have these compensating mechanisms, but you really hit at the very top of the pathway and you hit it specifically in the liver where you need to hit it versus the other medicines. They basically all over your body. So we see a definitely very different mechanism of action. And with that, we do believe that there is a significant opportunity to really change also the effectiveness of these medicines. On top of that, if you have to take it by sub-Q only two times a year, so every six months, The point is that you cannot take the tablets during the night, so you have really sustained lowering of the blood pressure. And with that, we think we have the right impact. Regarding KSQ and USP1, so we licensed it in because of the oncology indications, but thanks for the heads up. So we will have a discussion on that. But that's not what we had planned to be direct. Do you want to add anything?

speaker
Theresa
Head of Pharma Division, Roche Group

So I think the only other maybe thing to add on Zilbisran is that it One of the, I think, big differences is that we do sort of expect that we will need cardiovascular outcomes at launch and that that is an important thing that we will need to come to the market with in order to have sort of the ability to affect the most number of patients possible. So I think that's very much on our mind, Simon.

speaker
Bruno
Head of Investor Relations, Roche Group

Thank you very much. Okay. Next one would be Andrew Baum from Citi. Andrew.

speaker
Andrew Baum
Analyst, Citi

Thank you. A couple of questions. So first on Zilbesteran, cardiovascular outcome trials are lengthy and expensive. So within your modelling, I'm just curious, what are your assumptions for the IRA in terms of how long you last before price negotiation happens? It's currently nine, but you're modelling 13. And then second, potentially, by the time this comes to market, you may have lots of patients on Lequio Are you confident you can selectively reverse Zilbesaran without impacting Lekvio if patients are co-medicated? And then just one word answer. Could you just tell us when your autologist CAR-P cells are going to enter the clinic for autoimmune disease? Okay, great.

speaker
Theresa
Head of Pharma Division, Roche Group

I didn't, I didn't, I didn't catch that one.

speaker
Andrew Baum
Analyst, Citi

Sure.

speaker
Theresa
Head of Pharma Division, Roche Group

So for the IRA assumptions and exactly what our development program would look like, particularly in the phase three, I think that's something that we'll be able to share with you in the future. Right now, the deal is about a week old. So certainly we've given this some thought, but I think this is something that it would be more appropriate to discuss in the future. In terms of do we believe that you would need to be reversible and how would you... How would you think about that for patients who are in concomitant medications? Again, it's something that I know that we have been thinking about, but that's another something that I think as we get further into thinking about what the ultimate phase three trials would look like, we could share more details with you. In terms of T-cells and autoimmune diseases, yes, we have thought about this. It's very early in research, no timelines yet.

speaker
Bruno
Head of Investor Relations, Roche Group

Thank you. Henry, did we answer all your questions?

speaker
Andrew Baum
Analyst, Citi

Yeah, that's fine.

speaker
Bruno
Head of Investor Relations, Roche Group

Thank you. Then we go on. Next one would be Emily Field from Barclays.

speaker
Emily Field
Analyst, Barclays

Hi, thanks for taking my question. First one, just kind of ask a little bit differently. There was a deceleration growth in the U.S. this quarter, and I was wondering if you could provide a little bit incremental color around that. And then also, should we expect that the driver to get to double-digit growth both this year and the year ahead would be primarily coming from outside of the U.S.? ? And then on Lansumio and Columbia, do you have an update on the subcutaneous formulations for both and just, you know, any indication of when we could see first-line studies given that that would be the most significant commercial opportunity? Thank you.

speaker
Theresa
Head of Pharma Division, Roche Group

Got it. Okay. So if I understood your question correctly, Sorry, you were breaking up a little bit. It's deceleration of growth overall in the U.S. in the beginning, in the first half, is that?

speaker
Emily Field
Analyst, Barclays

More just asking sort of, you know, is the primary driver to get to decenter double-dip of growth going forward going to be ex-U.S.?

speaker
Theresa
Head of Pharma Division, Roche Group

Yes. So I think we, yes. So when you continue to think about where sort of the bolus of patients are who are not yet ontocentric but could be ontocentric, those will largely be coming from outside the U.S., We would expect that we will be able to maintain the patient share that we have in the U.S., but again, the growth will come from outside the U.S. And then in terms of the bispecific sub-Q formulations, both have sub-Q formulations in process. Lunsuvia was a little further ahead. We expect to have data about that next year, and I think, I'm not sure that we've disclosed data timelines for the subcut?

speaker
Bruno
Head of Investor Relations, Roche Group

No, we have not disclosed timelines, but we have disclosed that we have development programs ongoing. Thank you. There was another question, Theresa. I think our next development steps in first line, DLBCL.

speaker
Unknown
Analyst

Mm-hmm.

speaker
Bruno
Head of Investor Relations, Roche Group

But I think we already have been communicating that you should get an update, I think, soon. I think since we have now a new standard of care established in first-line DLBCL, we have the bispecifics moving into second-line setting with the Somno study or Starglow studies. I think the obvious next step is that you will soon get an update on what combinations we will test in first-line. Perfect. And were these all questions, Emily, or did we miss one now?

speaker
Emily Field
Analyst, Barclays

Thank you.

speaker
Bruno
Head of Investor Relations, Roche Group

Okay. Can we go on? Next one would be Louisa Hector from Birnbach.

speaker
Luisa Hector
Analyst, Birnbach

Thank you, Bruno. I wanted to go back to the ALNILAM collaboration, please. I wondered how much incremental data you've seen through your due diligence, whether you've seen any phase two at this stage, and just a comment around how much safety data is in hand, like number of patients, duration that would allow a fairly fast move into phase three from this point. And then perhaps a question on any comments you can make on the burden of the potential development milestones and whether the deal washes its face in this high risk, hypertension subgroup alone. Thank you. Okay.

speaker
Theresa
Head of Pharma Division, Roche Group

So, no, we haven't seen any phase two data. The phase twos are currently ongoing. They're blinded. We clearly haven't seen any. The safety data that we've seen is largely from the preclinical and the phase one data that would have been available as those trials had already read out. In terms of the burden of and so far, it looks quite clean, actually. In terms of the burden of development milestones, I have to say I've not heard does it wash its face before? That's a new one. So I assume that means do we do we believe that it will pay for itself? And I think we absolutely do. Again, this is an extremely large market. I mean, we've been talking about the sort of one point two billion people population. who have hypertension, the 80% who are uncontrolled. But if you want to get really specific about the number of people who are actually not only uncontrolled, but at increased risk for bad cardiovascular outcomes, and you only want to look at the EU5 in the US, that's still 20 million people. And so, you know, even if you just look at sort of the highest risk people in a relatively small number of countries, I think you can see that there is potentially a very large and high need market that actually just isn't being served by the current standards of care. And so, you know, the development milestones, the cost of development, that's sort of all been factored into our thinking because we just do believe that this could be not only a transformative molecule for patients, but, you know, clearly a multi-billion dollar opportunity at peak.

speaker
Thomas Schinecker
CEO, Roche Group

maybe just to add so the upfront milestone i think was around 310 million and to get to the end of the phase two we have maybe another 275 million so we have 585 million potential investment for then hopefully phase three ready asset so i think from a deal perspective that's that's pretty good and well de-risked and again i just want to highlight that you know this is a proven pathway And so talking to our scientists, looking at the data that we have seen, we believe very much in this molecule. And that's why we've done this deal. And I think it's pretty well de-risked from a cost perspective.

speaker
Bruno
Head of Investor Relations, Roche Group

And maybe, Luisa, also, Add-on from my side, I think there was an IR call by our partner company, Alignum, where they basically outlined the development programs or the next steps, Cardio 1 and 2. These are the studies to read out soon. in the second half, early 24, then we have cardiac free. And the parameters this study is looking at then basically determines the phase three development program. And this is only the core indication. But I think over time, there is, of course, additional indications, for example, heart failure and other opportunities, which then can be put on top. So just maybe something to look up. I don't know, Luisa, did we cover you? Did we answer your questions?

speaker
Luisa Hector
Analyst, Birnbach

Yeah, I think just on the number of patients in phase two and the duration of dosing, just from that regulatory perspective, based on how it stands today, you're confident you should be able to move into the phase three pretty quickly from here.

speaker
Theresa
Head of Pharma Division, Roche Group

Yeah, the phase twos are quite well-sized. One's 600 patients, the other's 300 plus patients. The duration is sufficient. They're well-designed studies.

speaker
Bruno
Head of Investor Relations, Roche Group

Yeah, there is the CARDIA-free study in between, which will start soon. And this is then the study which will inform the pivotal phase three.

speaker
Theresa
Head of Pharma Division, Roche Group

Great. We haven't actually talked about Cardio 3, but Cardio 3 is the third phase 2. It is for patients who are uncontrolled on two standards of care. So it's really your patients who are at highest risk for poor cardiovascular outcome.

speaker
Bruno
Head of Investor Relations, Roche Group

Yeah. We collect combination data. Exactly.

speaker
Theresa
Head of Pharma Division, Roche Group

Thank you.

speaker
Bruno
Head of Investor Relations, Roche Group

Okay. Then let's move on. The next one on the row would be Holger Blum.

speaker
Holger Blum
Analyst, Partindex Management

I'm Holger Blum from Partindex Management. I'd like to get some more color on the development of the diagnostics divisions over the last four years. If I look at your Q2 23 diagnostic sales number, it seems 6% below the level of Q2 2019, which would be a clean pre-COVID comparison base. In most quarters, you would have a healthy and aligned growth of your core diagnostics business. And if I do the math of the growth rate of the base diagnostics business, It would be nearly 1 billion higher for Q2 revenues in diagnostics. Currency could be an explanation, but I still don't get the data, which seems pretty big between the healthy growth in the underlying and the reported numbers.

speaker
Bruno
Head of Investor Relations, Roche Group

Holger, maybe I just quickly jump in. I think this is a bit difficult to answer. I think we would really have to look at the numbers and we're happy to assist you here if you come back to us and then we can have a look.

speaker
Thomas Schinecker
CEO, Roche Group

I mean, I can clearly say at constant exchange rates, I think our growth rate was between 5% to 7% on average, sometimes in double digit over the last couple of years. So let's look into that. But there seems to be something wrong in that analysis.

speaker
Alan Hippe
CFO, Roche Group

Perhaps currency.

speaker
Thomas Schinecker
CEO, Roche Group

Currency is a fair point.

speaker
Bruno
Head of Investor Relations, Roche Group

So, yeah, we'll have to look into currency. Fine. Thank you. Okay. Then we maybe move on with Eric Labarigo from Stifo. Eric? Eric, are you still on the line? doesn't look like. So I think then we can move on and have next one, Rajesh Kumar from HSBC.

speaker
Rajesh Kumar
Analyst, HSBC

Hi there. Thank you for taking the question. Just one follow up on the capital allocation on M&A, which, you know, at the beginning of Q&A, you said that you are open to all areas of asset early to late stages. And then, you know, and then hypertension partnership, you said that you're going to start with some indications and then expand into other in the future. And then with the IRA around the corner, could you run us through how you're thinking regarding capital allocation on deal-making has changed And second would be in terms of product development cycle, do you think it's a logical way still to go, you develop one indication and then add other indications later on? Or do you think you need to move a bit more parallel so that you can tap into a bit more of the pre-negotiation period? earnings from the crowd.

speaker
Bruno
Head of Investor Relations, Roche Group

I think this question is basically about capital allocation, a big picture.

speaker
Thomas Schinecker
CEO, Roche Group

So the first thing, when we look at internal programs and we look at external programs, when we do our NPV calculations, we include all aspects of IRA. So when we make decisions whether or not to invest in an internal program or an external program, we take those things into consideration. Clearly on external programs, as mentioned before, it has to make sense scientifically, but also financially. And so we'll have a strong financial discipline from that side. Anything that you would like to add, Alan, on that one?

speaker
Alan Hippe
CFO, Roche Group

No, I think that describes it well.

speaker
Thomas Schinecker
CEO, Roche Group

I think there's nothing to add here. And the second thing, just, I mean, we are really looking at our product development from early stage to late stage and end to end. really looking at ways on how we can accelerate our own product development. I mean, just one example of something that we're doing is we're actually developing our own internal large language model. ChatGPT, just a Roche-owned ChatGPT. So we can really accelerate a number of things within our organization. It's just one of those examples. So there are opportunities to accelerate our product development also in other areas using artificial intelligence. But we do that also irrespective of the IRA because we always want to aim to be faster. Yeah.

speaker
Bruno
Head of Investor Relations, Roche Group

Thanks, Thomas. And then I think we have a final question, which comes from Sachin Jain. So Sachin, you opened the row and you closed the row. Back to you. One question.

speaker
Sachin Jain
Analyst, Bank of America

Thank you very much for fitting in. Just two very quick product questions. One on your digit slide where you list news flow. Sky 06 isn't listed as a 24 event. CT.gov has primary completion in May 24. So just wanted to check whether we should think about Sky 06, which is a chemo combo study 1H next year. And then the second question is just back to L2VO. When the initial data came out, you were fairly vocal that the study design was potentially selecting patients for low-risk inhibitors. Just wondering if you've seen that play out in real life, i.e., are you seeing L2VO patients developing inhibitors, which impacts the competitive landscape? Thank you.

speaker
Theresa
Head of Pharma Division, Roche Group

Great. It's somewhat serendipitous that you got the opportunity to open and close because then I'll get the opportunity to give you my standard answer, which is that we actually we have not actually disclosed the the readout date for the chemo combo study for competitive reasons. So more to come on that. But that isn't actually something that we have disclosed.

speaker
Sachin Jain
Analyst, Bank of America

It's on CT.gov, Teresa.

speaker
Theresa
Head of Pharma Division, Roche Group

But I don't know that we have actually confirmed that. And oftentimes things end up on clinicaltrials.gov.

speaker
Unknown
Analyst

OK, thank you.

speaker
Theresa
Head of Pharma Division, Roche Group

And in terms of Altubio, I mean, I think it would be inappropriate for me to comment on the safety of another product. But I would say that our concerns about the trial design hold. They specifically designed a trial to limit patients or to screen out patients who were more prone to developing inhibitors. And so logic would conclude that you might see something different in the real world, but it would be quite inappropriate for me to comment on what has happened with their patients.

speaker
Sachin Jain
Analyst, Bank of America

Thank you.

speaker
Bruno
Head of Investor Relations, Roche Group

Very good. I think with that, we are done and close the Q&A session. And if there are any remaining questions, then of course, please reach out to us anytime. We are happy to assist you and look for the answers and hope to talk to you soon. Bye.

speaker
Michael Leuchten
Analyst, UBS

Thank you. Bye. Bye.

speaker
Bruno
Head of Investor Relations, Roche Group

Bye.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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