Roche Holding AG (ROG) Earnings Call Transcript & Summary

So welcome to our Annual IR Diagnostics Day 2025 here in London. Let me quickly first take you through the agenda of today. We have today 8 speakers with us. We'll take you through our business strategy, individual customer areas, new technologies such as sequencing by expansion, key instruments and also for the most relevant assays. We will again have 2 sessions. As you can see here, the first session, 90 minutes, a second session of 60 minutes and both sessions will include 15 to 20 minutes of Q&A with the respective speakers of each session coming onstage. So let's have a quick look at the first session, which is scheduled from 1 p.m. to 2:30 p.m. This session will be opened by our CEO, Matt Sause. Matt will provide a quick overview on the overall strategy and the future ambitions of our Diagnostics division. The second speaker will be Palani Kumaresan, our Global Head of Roche Diagnostic Solutions, who will outline in more detail the strategic portfolio priorities for each customer area individually. This will be followed by a presentation given by Moritz Hartmann, our Global Head of Roche Information Solutions, who will show how digitalization drives integration of our hardware offerings and also creates new product opportunities. And finally, the first session will be closed by the highlight of the day by Josh Lauer, our Global Head of Customer Area Molecular Labs, who will present our truly revolutionary and game-changing SPX next-generation sequencing technology and its future applications. Following these presentations and after the sequence has been -- and has entered the stage, we will have a 20-minute Q&A followed by 15 minutes -- followed by a 15-minute break. And then we will start at 2:45 p.m. the second session. The second session will be opened by Jill German, our Head of Pathology Customer Lab area. Jill will provide an update on our leading pathology lab offerings highlighting some really exciting new multiple immunohistochemistry offerings where spatial distributions of various cell types within tissue sections get analyzed and are found to be predictive of later treatment success. The second speaker will be Ildikó Amann-Zalán, our Head of R&D Roche Diagnostic Solutions. Ildikó will cover the Near Patient Care portfolio, providing also a quick update on our early CGM launch. The highlight of her presentation, however, will be the presentation of the LumiraDx technology, a handheld device with multimodality -- where multi-modality assays can be run and this includes immunoassays, clinical chemistry assays and in the future might also then include molecular assays. Next will be Benjamin Lilienfeld, our Lifecycle Leader Serum Work Area Systems, whom you might remember from last year when he unveiled our mass spectrometer onstage. He will quickly walk us through the Core Lab and the latest instrument updates, including first feedback from our early launch days for this unique offering. And finally, we'll close to the second session with Olivier Gilliéron, our Lifecycle Leader Cardiometabolic and Neurology with an update on the Core Lab assay pipeline where we'll focus on CVRM and the novel Alzheimer's disease tests, which are to be launched soon and also on the infectious diseases. Following the second session, we will have a 15-minute Q&A. Participants on site will have the opportunity to meet all our key management at the closing [ upper row ], immediately following the broadcasted part of the event. And let me also mention here another housekeeping item. We have again prepared a short survey to collect your feedback. Participants joining online will be invited to join the survey 10 minutes before the final Q&A ends. A pop-up window with the questions will show up. Whereas participants on site will receive an invitation to participate in the survey by e-mail roughly 1 hour after the event closed. With that, let's kick off today's event, and I quickly wanted to bring up a few slides, some of them you know already. And this slide here, you've seen before, I quickly wanted to remind you of our 10-year ambitions from a group perspective. For Pharma, we aim, as you know, to deliver 10 -- 20 transformative medicines addressing diseases with the highest societal burden. So basically, this implies launching 2 transformative medicines per year plus building an industry-leading R&D engine and pipeline. And for Diagnostics, we aim to firstly double patient access to novel, high medical value diagnostic solutions; secondly, launch 75 novel differentiated medical value assay, so this implies 7 to 8 such assays a year; and thirdly, to double the overall amount of patients tested. The next slide, I think you're also familiar with. We had it shown last September on Pharma Day. This is our outlook here, a solid base to deliver future growth. As you can see here starting with the Diagnostics business at the bottom, our ambition is to grow the Diagnostics business in the mid- to high single-digit range with the core operating profit growing ahead of sales. I think you will have the opportunity today to learn more about the underlying growth drivers as we see them unfold in the future. And moving to Pharma here. Our young on-market portfolio, colored in light blue is now expected to deliver growth until 2028. That's up from the '27 time line, which we provided last September. And thereafter, actually, we expect this portfolio to reach a steady-state until 2030. And we don't foresee here, that's the message, any patent cliff situation. And we forecast the annual generic sales erosion of CHF 1 billion to CHF 1.5 billion to be always overcompensated by this on-market portfolio. And in addition to the on-market portfolio, you can see what is highlighted here in gray is, of course, hopefully, some additional contribution from pipeline successes. And this upside potential, of course, comes from our current in-house pipeline, but we also continue to focus on business development, as you know, where it makes scientific, and of course, business sense. And just to finish this slide, I think it's also important to complete the picture. We target to keep the Pharma core operating profit margin at least stable throughout the time period shown here. Maybe one little final add-on to the slide. As you see written here on the left side, this is illustrative. And I just pointed out because in this volatile world where we have every day something else published on -- through social, I think it's just here to be pointed out that we were not able to take these scenarios into account when showing this outlook. The next slide, I think, might be of more interest to some of the analysts here present because I think this is an updated version of the slide, which we showed previously at Pharma Day. So we have pushed out now this 5-year time frame from '23 to '28 to '24 to '29. And what you see here is on the left side, we have now forecasted a generic -- so this is basically based on the consensus numbers, which were used. So it's your estimates as they were collected past the full year results. And what you see here is on the left side, there's now a forecasted generic gap -- generic erosion gap of CHF 6.2 billion until '29. That's pretty much in line what we have been guiding CHF 1 billion to CHF 1.5 billion of annual generic erosion. And then you see in the middle part, based on the consensus, the additional sales until 2029 primarily coming from the key growth drivers of our young on-market portfolio, but also then some selected late-stage pipeline assets. And important to note here is that these pipeline assets, they have to be Phase III and they need to be covered by more than 50% of the analysts. Altogether, these additional sales sum up to CHF 16.3 billion, CHF 3.5 billion thereof from the late-stage assets listed on the bottom. And so they easily make up for the gap of CHF 6.2 billion, which you see on the left side. And as we always do on the right side, you see some additional assays, which currently have no to low coverage in the sell-side models, which could create an upside once they get moved into late-stage development and then get picked up. One example here, for example, is just NXT-007, our second-generation Hemlibra, which we just announced at Q1 that we will take it into late-stage development. And with that, I'm at the end of my introductory remarks. Let me also quickly make a few comments here and to thank a couple of people before handing over to Matt. I would, first of all, like to thank our speakers again for their time and their commitment and also IR team members who made this event possible. First to name, Birgit Masjost, who's leading the Diagnostics within the IR team. Birgit had the overall lead for this event, and she will also moderate both Q&A sessions. In addition, let me thank [ Giulio Matzota ] for managing the master deck, [ Simona Mino ], who is Chief of Staff at the Dia CEO office, [ Margaux Pzira, John Bayar, Anita Tang and Andres Linas ] for speaker support and slide preparation. And last but not least, [ Iva Losa, Daniela Stojanova, Melanie Wolf and Beatrice Hau], who were responsible for the event organization. And with that, let me hand over to Matt for providing us an update on the Diagnostics strategy and our ambitions. Matt, please.

All right. Thanks, Bruno. So welcome, everybody. On behalf of Roche Diagnostics, I'd like to welcome you all to our Di Day 2025. As you heard from Bruno, today we're going to spend a bit of time talking about our strategy, our portfolio and our industry-leading pipeline. And we're going to talk also about how this really sets us up to continue to be the leader in, in-vitro diagnostics. But I think it's important before we get into that to really take a step back and look at the macro environment, look at what's shaping health care and a bit how that informs our strategy. So starting at the upper left corner, you see the increasing disease burden. And this is really driven by the fact that basically 50% of disease by 2035 is going to be driven by cardiometabolic disease, neurology and oncology. That shift in disease burden is going to create a significant burden on health care systems worldwide in terms of cost, especially as they emerge from the COVID-19 pandemic. And so -- which is really what you see in the second column on the right side there, which is that average health care cost outgrew GDP growth for the last 20 years. So that's also causing a shift in care as health care systems need to manage their costs outside of that centralized environment into a more decentralized environment closer to patients where costs are more easily managed. This is a massive trend that started before the pandemic, but we've really seen accelerate. And another key lever for cost management by health care systems is really moving more to preventative care. Earlier diagnosis, earlier intervention leads to better outcomes and decreased costs. But then there's a problem, access to health care. Over half of the world lacks access to health care. And if you focus on diagnostics, 47% of the world lacks access to basic diagnostics. At Roche, we believe that transformative technologies, things like artificial intelligence, remote patient monitoring, flexible sequencing chemistry is going to enable greater access to health care. It's going to let us address some of those burdens to the health care worldwide environment that you saw on the previous call-outs. And we really feel it's a critical aspect of our strategy moving forward. And this is true at our group level. As all of you are familiar, Roche has 2 divisions: Pharmaceuticals and Diagnostics. And what we have together is one of the leading portfolios in health care around the world, leading R&D capabilities; our dedicated digital engine with Roche's Information Solutions, you're going to hear more about this from Moritz. But a common focus on those 3 common disease areas, cardiometabolic disease, neurology and oncology, and bringing the breadth and depth of our organization together, we are best and uniquely positioned to deliver solutions to address those challenges. So behind that is our Roche Diagnostics strategy, which has remained unchanged for the last 5 years, and that consists of 3 key pillars. The first is our focus to deliver innovative, high medical value diagnostics that change the standard of care, the rewrite the medical textbooks around diagnostics. And the second is to deliver clinical decision support tools that improve the clinical decision-making from physicians, but also for patients. The third leg of our strategy is how we weave those together, how we create end-to-end solutions that enable improved clinical decision-making support together with high medical value diagnostics to really help both patients and caregivers better deliver -- better navigate their episode of disease. So when we think about our strategy at the group level, but also at the divisional level, that informs on very clear goals for us as an organization. So the first is really that we're #1 in the clinical lab, and our goal is to both maintain and expand that #1 position. But second, to address what you heard about the shift of health care and the expenses in the centralized setting, that really we need to become a leader in decentralized testing. How are we going to do that? We have to be able to deliver those differentiated comprehensive solutions across those areas with the highest disease burden. Then finally, deliver entire disease management solutions that transform clinical practice. And we're going to walk you through how we are set to accomplish all of that over the course of today. But before we do that, I'd also like to talk a bit about how we're set up as Roche Diagnostics. And here, I'll walk you through this slide from left to right. We are organized by technology and also by the setting in which those technologies are used to better align with our customers and patients. So on the far left, you see our Core Lab, which is our largest business unit. This consists of our Serum Work Area, you'll hear more about this from Benjamin, but this includes our immunochemistry, clinical chemistry and our new Serum Work Area. The Molecular Lab, where we have our long legacy of PCR testing, this includes our high-throughput PCR systems, the 68/8800, which were featured quite prominently during our response to the COVID-19 pandemic, but also our GenMark business, which is syndromic panel testing as well as Foundation Medicine. And I guess, as Bruno said, the highlight of today, which is going to be our sequencing solution, which you're going to hear more about from Josh. But then also our Pathology Lab. This is where we offer solutions to health care systems around the world, and we are the industry leader in better diagnosis of cancer. You're going to hear more about this from Jill, but this is our advanced staining, our primary staining, our growing digital pathology business, which I know Moritz is going to be excited to talk about, but also our companion diagnostics business, which is a growing service we offer to pharmaceutical companies around the world. And then finally, our newest business area, which is Near Patient Care, which combines our former Diabetes Care unit with our Point of Care to deliver solutions, again, to deliver remote patient monitoring and moving more into that chronic disease management space. This is our blood glucose monitoring business, continuous glucose monitoring as well as the full set of technologies to enable point-of-care testing. And again, underpinning all of this, systems and assays as well as our digital clinical and lab solutions. So taking a look back at the performance of Roche Diagnostics over the last 5 years, what I would call out is consistent sales growth of 6%. We've consistently outgrown the market in Diagnostics and that is our intent to continue to do in the future. And that informs on our financial ambition as Roche Diagnostics. Our ambition is to grow our sales by mid- to high single digit and continue to grow our profit faster than sales. How are we going to accomplish that? That's by the ongoing performance of our core business, success with our pivotal new launches and our ongoing commitment to operational excellence. So that takes us to our Q1 results of 2025. Here, you saw that we had stable sales in the first quarter. And the driver for this performance was the health care reforms that we've seen in China. Volume-based procurement as well as reimbursement cuts resulted in stable performance of our overall sales with our sales excluding China growing at plus 5%. As a consequence of this, our ambition for 2025 is to grow at low to mid-single digits. And our profit, we would refer you back to our group guidance. This doesn't change the ambition for Roche Diagnostics over the longer term, but I would note that for this year, our ambition is low to mid-single digits. Now I'd like to dive in to specifically how we intend to accomplish our goals. And I'll start with how we want to maintain and expand our #1 position in the clinical lab as well as become a leader in decentralized testing. So you may remember this, a similar slide from last year. And what's important for me to note here is our delivery on our commitments and our delivery on our pipeline. If you look at the far left, as we said, to be -- continue to be a leader in the clinical lab, we need to double down on the areas where we're ahead and continue to deliver in our areas of strength. Specifically in the Core Lab, that was the launch last year of our new ISE Neo as well as our c 703 for clinical chemistry. I would also note the updated cobas 6800 and 8800, giving a refresh with new additional capabilities for those core systems. And as well, our forthcoming pipeline, you're going to hear more about this from Benjamin. But in order to outgrow the market, we recognize we need to disrupt with transformative solutions. Here, I would call out the Q4 launch last year of our mass spec system and our forthcoming launch of our Roche sequencing solution, again, you'll hear more about both of these later. But as we look towards our impending intention to become a leader in decentralized testing, I would call out the acquisition of LumiraDX, which we closed last year, giving us a truly multimodal technology with the ability to do clinical chemistry, immunochemistry, and in the future, molecular. You'll hear more about this from Ildikó. As well as our Accu-Chek SmartGuide CGM and our cobas liat, which has lab like performance at the Point of Care for Molecular Diagnostics. Underpinning all of this, our commitment to deliver world-class automation as well as digital solutions. And what I would also bring you back to and emphasize, a big part of our story about how we intend to outgrow the market are these 3 pivotal launches: the Accu-Chek SmartGuide CGM, which we launched in Q4 of last year; the cobas mass spec, again, launched last year; and our forthcoming 2026 launch of the Roche sequencing solutions. You can expect from us to continue to outperform with our core business, but a big lever for our future growth is going to be these 3 key launches. So now I'd like to talk about those differentiated medical solutions that we plan to use to really continue to expand our position and grow into the future. Taking it back to that disease burden view. Here, I'd like to bring your attention to the fact that by 2040, we anticipate that 45% growth in terms of morbidity and mortality will be the result of these 4 key disease areas: infectious disease, neurology, cardiovascular and oncology. Together, these are going to result in 53 million deaths worldwide. We feel that diagnosis is going to be a key factor in how society and health care systems around the world are going to be able to address these by offering early detection leading to better outcomes, more precise diagnosis, optimal therapy selection and patient monitoring outside of the health care system, bringing care closer to patients and reducing costs. And a key part of these systems, really, the future is also going to be how we deliver a robust and strong assay pipeline, again, in those areas with the highest unmet need. I would call your attention to the fact that we intend to launch over 130 new tests in the next 3 years. In the Core Lab, our biggest area, you see 77, a big part of that is going to be the menu growth in the mass spec. But I would also call out a couple of key areas where we plan to introduce new tests with 2 blood-based tests for Alzheimer's disease, which you'll hear more about from Olivier, as well as our Elecsys TB IGRA test, again, addressing the high unmet burden around the world of latent tuberculosis. Moving on to the Molecular Lab. You see 2 panels coming from our GenMark syndromic panel testing business rounding out our menu and making us even more competitive, as well as the launch of the cobas BV/CV one of the fastest-growing parameters in diagnostics. In Pathology Lab, you see our intent is to launch 21 new assays. And I would call out many of these launching from our PHCS business, partnered with other pharmaceutical companies offering unique content on our immunohistochemistry platform and really setting ourselves to address unmet therapeutic targets, but also expand our platform with unique content. And in Near Patient Care, here, I would call your attention to our liat portfolio. We're expanding this because we recognize the tremendous growth in Molecular Diagnostics at the Point of Care. And here, you see significant investment and expansion of that menu. Not to be outdone is our digital business, where we have the leading on-market portfolio of parameters with the intent to add 34 new solutions in the next 3 years. I know that Moritz is going to go into some depth on this, but I would call out things like our navify Clinical hub, which is going to introduce multimodal aggregation of different tests as well as longitudinal patient data for optimal patient management as well as a great number of new algorithms; our new Digital Pathology 3.0, which I think we will be covering today; as well as digital infrastructure in key areas such as security. We are committed to delivering an industry-leading digital portfolio. So finally, I'd like to come where we bring all this together and deliver full disease management solutions that are going to transform clinical practice, and I thought what -- a perfect example for this would be our Accu-Chek SmartGuide CGM that we launched in Q4 last year. And here, you see a little bit of the road map for product development for the Accu-Chek. And here, I'll just give you a couple of highlights. For '25 and '26, we plan to introduce factory calibration. We're currently scaling our manufacturing capacity. We're going to integrate the predict app into our mySugr app platform. And we're really going to launch in a number of countries, again, Ildikó is going to come to this. Looking a couple of years into the future, 2027 to 2029, here, we're going to launch the second version of our sensor and focus on integration of our CGM with automated insulin delivery platforms. Now looking even farther out into 2030-plus, here, we're focused on even further innovation on the sensor side to a semi-invasive or noninvasive format and the introduction of multiparameter testing to help patients and caregivers even better navigate cardiovascular disease and set ourselves up in a real long-term position to manage chronic care outside of the health care system. So in summary, I would like to emphasize that Roche Diagnostics is the leader in the IVD industry. And we have a clear strategy to continue to outgrow the market. And we will accelerate our growth trajectory in part from these 3 key pivotal launches. And I would also -- if you were going to get a sense for today all that we're going to deliver, we have innovative solutions to tackle the largest burdens from health care systems around the world. And finally, these solutions will be enhanced for clinical decision support and clinical workflows using digital tools powered by artificial intelligence. So on behalf of the entire Roche Diagnostics team, we're delighted to have this opportunity to deliver this to you today. And it's also my pleasure to turn it over to Palani Kumaresan, our Head of Roche Diagnostic Solutions. Thanks. Palani.

Thank you, Matt. A very warm welcome from my side as well. Really happy to be here with you today. My name is Palani Kumaresan, I'm the Global Head of Roche Diagnostic Solutions. In the next few minutes, I'll walk you through our strategic priorities across 4 of our customer areas that Matt laid out: Core Lab, Molecular Lab, Pathology Lab and Near Patient Care. After me, Moritz will come and share the strategic priorities and pipeline across our Roche Information Solutions. And then we'll come back and dive deeper into the 4 customer areas. Now together, the 4 customer areas cover the vast majority of the in-vitro diagnostics market. And given our rich history as well as our continued commitment to innovation across all of these 4 customer areas, we continue to maintain a leading position in, in-vitro diagnostics. So how do we think about growing our business across these 4 customer areas? The core of our business model is really our instrument placements and our installed base. So for example, you can see on the left-hand side, for Core Lab, we have had high double-digit growth of placements of our flagship, cobas pro and cobas pure family of instruments. In Molecular Lab, coming out of the pandemic, we have continued to show strong growth of our family of cobas 5800, 6800 and 8800 instruments. And Matt also mentioned about the improvements that we have brought to 6800 and 8800 instruments as well as we continue to build the assay menu on these instruments. Talking about assay menu, we think about assay menu in basically 2 parts. One is smart gap fills to ensure our customers have a full suite of assays available in the instruments that they have invested in. So basically, in their capital investments that they have made, they can have a broad menu of assays available. On the other hand, we are also looking at differentiated novel medical value assays across those 4 disease areas that Matt highlighted that are differentiated and meet unmet medical needs in the market. So talking about unmet medical needs and high-value assays, here already you heard about the disease areas with the highest disease burden, cardiometabolic, oncology, neurology and infectious diseases. You also heard about how we think across the entire disease continuum starting from early detection, diagnosis, therapy selection and patient monitoring. And in each of this, we go in and take a look where are the key unmet needs and where can we bring a differentiated value. And here, I bring you some examples that you see on this slide that are coming to the market. Some of them are highlighted and we will dive into the details of those in the subsequent presentations. A couple of them are not mentioned here. We will, of course, cover them because last time we saw there was a lot of interest. For example, interferon gamma release assay for tuberculosis, but also vector borne diseases where we see their prevalence increasing around the world, for example, dengue fever, Lyme disease and so on. Now with that framing, let me dive into the specific strategic priorities for each of the 4 customer areas, starting with Core Lab. And here, what you see and what I'll do for the remaining 3 customer areas as well is to link those strategic priorities back to the Diagnostic goals. So you can see for Core Lab, our strategic priorities for Core Lab link nicely into our diagnostic goal number one and number three, maintaining and expanding our #1 position in clinical lab and differentiating through comprehensive solutions across highest burden disease areas. Now on the left-hand side of the slide for Core Lab, you can see the market size for core lab, the growth rate, our share of the market. And in the bottom, you can also see our revenue in 2024. On the right-hand side, we have the next 5-year strategic priorities distilled down into 3 focus areas. Subsequently, I'll have very similar slides for the remaining 3 customer areas as well. So number one focus, continuing to invest in that next-generation system portfolio. So cobas pro and cobas pure family of instruments, so bringing in new analyzers into those. So c 703, ISE neo, mass spec and also [ smart E ]. Benjamin will, of course, talk about these in greater detail in his presentation. Importantly, our customers are also looking for greater automation and greater productivity in their lab, and I'll spend the next couple of slides talking a little bit more about lab automation. And last, but not the least, continuing to expand our menu focusing on high medical value assays. Now we are reimagining automation in the lab through cobas ultra. Modularity, flexibility, space efficiency and ultra-high throughput are the key tenets for cobas ultra. Now we see a clear trend in the market towards automation as we move into the next decade with over 60% of analyzers, core lab analyzers, connected via automation in some shape or form as we head into the 2030s. And accordingly, cobas ultra will allow for ultra-high throughput movement of tubes in multi-direction, but also deep integration of those tracks, these layouts where we can move tubes across different instruments, deep integration into those analyzers. Not only Roche analyzers, but also third-party analyzers. On the other hand, we will also be bringing out autonomous mobile robots to bring another level of flexibility into the labs and also work towards the concept of dark labs where our customers can continue running their labs all hours of the day with or without the presence of personnel. Now as we work towards cobas ultra, next year we will already be launching cobas ultra pre-analytical workstation. This is a bridge from our current highly successful lab automation system, p512 and p612. Now this will include 5 important modules. You can see them here on the left-hand side, the input module, centrifuge, aliquoter, output and track connector for pre-analytical work in the core lab. The important point here is modularity. So different labs have different requirements. And in many of the core labs, for example, centrifugation is a key late rate limiter. So a lab can have multiple centrifuge modules instead of having to buy the whole set multiple times over. Another important call out here is upward compatibility. So when we launch this pre-analytical solution, it will work with our current track system to move tubes in the lab today in the market, which is our cobas connectivity module, CCM. But in the future when we launch cobas ultra, our customers will be able to change out the track to cobas ultra without having to reinvest in these modules so they can actually leverage their capital investments that we'll make with this pre-analytical system. A quick word on our medical value assays. We have a rich pipeline of over 5 asset launches per year expected in Core Lab in the coming years, you see some numbers here. You also see some highlight assays called out. As Matt mentioned, Olivier will go into more details here, so I won't spend a lot of time here. But before I move on to Molecular Lab, I did want to touch on an important topic: how are we leveraging generative AI and foundational model in protein and antibody engineering? Now some of you may have joined, in November of last year, we had an Investor Day, Digitization Day, that was run by Aviv Regev, who's the Head of our Genentech Research and Early Development, and she talked about this concept of lab in a loop. Here, we have our own foundational model where we essentially use it, the basic ideas that we use it in-silico for identifying highly specific either protein or antibody designs for specific epitopes -- targeting specific epitopes. And we use that to guide our wet lab work. And then the data that we generate in the wet lab is fed back into the model to further train it for additional iterations in the future. And something like this would not be possible without leveraging our strengths as well as our vast repository of data that is available to us across both Pharmaceutical and Diagnostics division. Now moving on to Molecular Lab. Similar to Core Lab, our Molecular Lab's strategic priorities link up very nicely with the first and third diagnostic goals. In Molecular Lab, we have our lab PCR business and we have our sequencing business. Now lab PCR you can see built on our cobas 5800, 6800 and 8800 family of instruments, we are still leading the market with these instruments and the menu that we have on these instruments. On the sequencing side, today, our presence is primarily in sample preparation. So this is library preparation and -- library prep and target enrichment. And as we look at our strategic priorities over the next 5 years on the PCR side, the focus is to continue building a rich menu of assays on our family of 5800, 6800 and 8800 instruments. And here, we are also bringing in new innovation like the TAGS technology, which increases the flexibility of our assays on these existing platforms. On the sequencing side, we are staying absolutely laser-focused on the launch of our SBX, sequencing by expansion sequencer next year. So a couple of words around these 2 strategic priorities. When we think about our menu on our lab PCR instrument, we clearly see that sexually transmitted infections is a fast-growing segment. You can see here it's already over CHF 1 billion in market size and growing rapidly by 10-plus percent. And specifically within STIs, vaginitis is a very fast-growing sub-indication with close to 25% growth. And accordingly, we will be launching later this year our bacterial vaginosis and candida vaginitis assay to complete our STI panel. Additionally, an important focus for us is home sample collection. Now you might be already aware, we have approval for sample -- patient cell sample collection in a health care setting, but we do see the value and the convenience of home cell sample collection. And towards this -- earlier this month, Teal Health got the first FDA approval for home cell sample collection for HPV, and it was approved with our cobas HPV test. So this is something that is of high importance to us, and you will hear more from us in the coming months and years. On the sequencing side, I'll keep it very short because you will hear a lot more from Josh later on and you will also get to see the instruments. The main point, I will make here is because of the versatility of our sequencer, highly flexible run setup, ultra-high throughput, we are able to address a whole range of applications that you can see on the left-hand side, DNA, RNA and multiomic applications across research, translational and clinical settings. So let me switch over to Pathology Lab now. Here, you can see our strategic priorities in Pathology Lab line up nicely with the first and the fourth Diag goals, so maintaining and expanding our #1 position in clinical labs and delivering disease management solutions to transform clinical practice with a specific focus on oncology. Now on the left-hand side, you can see we have a strong presence in the pathology lab and this is built on our advanced staining portfolio so immunohistochemistry and in situ hybridization family of assays and tests. And accordingly, as we look at our strategic priorities, a key focus for us is to continue advancing -- or strengthening our advanced staining business, and this is by increasing our installed base, and driving workflow efficiency via connectivity and automation. Matt also mentioned digital pathology. This is an important -- another focus area for us. And continuing to drive high medical value solutions by leveraging, and I'll talk a little bit about it later and Jill will also touch on it, is by leveraging our strong pipeline of pharma funded CDx and PHCS collaborations. On this slide on advanced staining, I really want to call out 3 points. We have the largest installed base of our advanced staining instruments. So I'm primarily talking about Benchmark ULTRA and Benchmark ULTRA PLUS. We launched Benchmark ULTRA PLUS a couple of years back and that installed base is growing very nicely. On this installed base, we have the world's largest menu of IHC and ISH assays. And as I was mentioning earlier, our pharma partnerships, over 60-plus collaborations, that you see here not only help address the needs of our pharma partners, but also really feeds our menu on our advanced staining platform. And we are also looking to improve the workflow efficiency in the labs through software solutions, such as we continue to add features into our navify Lab Advantage software as well as we are bringing hardware automations for histology and cytology slide preparation, such as our SP400 that will be -- that we will be launching later this year. One slide on digital pathology from my side. When we think about digital pathology, we are thinking end-to-end and then there are really 3 key elements of our digital pathology offering. On one hand, we have the scanner, which is our DP 200 and DP 600 scanners. In the middle, we have our image management solution, navify Digital pathology, NDP. And then on the right-hand side, we have our AI-enabled image processing algorithms. Now DP 200 and 600 towards the end of last year, we got the primary diagnosis claim from the FDA, which is an important differentiator. NDP, our navify Digital Pathology image management solution, later this year we will be launching an important update to our image management solution that Matt mentioned, the 3.0. And on the right-hand side, you can see we have a really nice collaboration with several third-party partners to build an ecosystem of several AI algorithms that can be brought to our customers in a unified way through our image management solution. So we have 13 partnerships here you can see through them, we have over 20 algorithms available and also we build our own algorithm. So this allows to bring in a more simplistic way for our customers the algorithms in one place. Last but not the least, Near Patient Care and here you can see our strategic priorities for our near patient care customer area line up with the second, third and fourth diagnostic goals. So becoming a leader in decentralized testing, differentiating through comprehensive solutions across high (sic) [ highest ] burden disease areas and delivering disease management solutions specifically in diabetes management. Now our Near Patient Care customer area comprises of Point of Care that you can see on the left and also our Diabetes Care. And in point of care, we have our hospital point of care and molecular point of care. And together, you can see they are close to 10% of the market. And in Diabetes Care today, our presence is in blood glucose monitoring, BGM. So as we were building out the strategic priorities for our Near Patient Care customer area, 3 things bubble to the top. First, continue to bring out a portfolio of clinical chemistry and immunoassay platforms. This is going to be key in different settings, both hospital as well as decentralized settings. On the Molecular side, continue to build the menu on our liat platform. And very importantly, on the Diabetes Care side, the successful launch of our CGM and bringing an end-to-end disease management for diabetes. Now I'll keep it short in Near Patient Care because you will hear a lot more from Ildikó about this. But I wanted to leave you an impression with the 6 key platforms that underpin our Near Patient Care strategy. Now on the left-hand side, you have cobas sense, cobas pulse and cobas vital are for immunoassays, for blood glucose detection in a hospital setting and blood gas and electrolyte. And these largely fit into a decentralized hospital setting, for example, an ER or an ICU. And as you then come to cobas liat, you're starting to look at not only a hospital setting, but also a GP's office where you're looking at quick detection and quick and accurate diagnosis of some of the infectious diseases like respiratory, STI, but also HAI in a hospital setting. And then that takes us to Lumira Diagnostics, which is our recent acquisition that Matt talked about. This is a very exciting addition that really takes us to very decentralized settings, outpatient care as well as pharmacies and so on with immunoassay and clinical chemistry offerings, but also potentially molecular offering in the future. And last but not the least, the Accu-Chek's SmartGuide CGM, which is a holistic solution, which has digital components that Moritz will touch upon. And of course, the sensor itself, sensor patch that Ildikó will talk about a little bit more. So with that said, I hope in the past 20 minutes or so, I was able to give you an overview of what are our strategic priorities across 4 of our customer areas, but also what are our portfolio focus areas. So thank you very much for your attention. I will hand it over to Moritz to now talk over the digital part of our portfolio, and I'll be happy to take any questions during the Q&A session. Thank you.

Thank you. Palani, and thank you, Matt. My name is Moritz Hartmann, I'm the Global Head of Roche Information Solutions. And I'm excited to speak today about our digital health solutions and why we believe that this is a major opportunity for us. I'll be covering 3 areas: first, our 3 focus areas for digital health portfolio. I'll then speak about how we advance monetization. And thirdly, I will summarize on how already today AI and machine learning are driving patient outcomes and improve lab efficiency. As Roche, we are uniquely positioned and have an area of strength for digital health because we uniquely combine a Pharma and Diagnostics division under one roof, and this allows us to implement digital health solutions across the entire patient journey. And to do so, we are focusing on 3 areas: the connected lab, the informed clinician building on clinical workflows and decision support and the empowered patient. So let me start with the connected lab, which is a foundation of strength for Roche. And our digital solutions will not only help us to maintain, but also expand our #1 position in the clinical laboratory. We combine our high-performing IVD solutions, which Palani just introduced, with cutting-edge digital solutions to improve the lab performance. It is clear that our lab customers today are facing the ever-increasing pressure to reduce costs and to increase their efficiency. And our portfolio is really there to deliver on exactly these needs. We have an industry-leading middleware and a suite of performance-improving solutions for our customers to meet these needs. And we're continuing to build solutions that address these like at the recent launches that include a performance analytics for Core Lab, Point of Care, Molecular Lab and Pathology Lab. And we'll be rolling out later this year an advanced quality assurance and a security plan that we know are very critical and important to our customers. So here are a few very concrete figures that demonstrate how we're boosting the laboratory efficiency and performance and help our customers to optimize their resources. As you can see, we're continuing to significantly reduce the manual task, the turnaround times, the execution times and inventory management times. Those represent significant savings to our customers, and they reduce the complexity in their operations. Now something like turnaround time may sound a little bit of a technical term. But if you think of what's behind it, it's actually the time that a patient waits for his results to come back to receive his diagnosis and to get on treatment. So in some of our disciplines, this is absolutely critical. And such huge improvements in time can make a real difference and drive patient outcomes. The second area of focus is the informed condition. We offer comprehensive solutions for high-burden diseases such as oncology and cardiovascular and we're also delivering disease management solutions to transform clinical practice. Within our navify portfolio, we offer the navify Algorithm Suite. As you can see, we have a number of on-market clinical algorithms, and there's even more in our pipeline. These offerings span across different areas that include oncology, liver disease or as well kidney disease. And I'd like to focus on 2 of our on-market algos here. Chronic kidney disease is a growing challenge, and it affects more than 850 million people worldwide. The KFRE, or kidney failure risk equation is an algorithm or a risk score that can predict the likelihood of a patient reaching end-stage kidney disease between 5 -- 2 and 5 years in advance. This allows clinicians to bring more attention to higher-risk patients and to plan earlier for treatments and interventions, and also send these patients to the right -- at the right time to specialist care. Let's look at another area, sepsis, that affects approximately 50 million people and accounts for 11 million deaths. Early diagnosis is vital because this is really a critical medical emergency. The Sepsis ImmunoScore is a machine learning algorithm that aids to identify patients at risk, to develop sepsis and this can actually be assessed 24 hours in advance. So once again, there is the opportunity to bring patients into critical care much earlier. I'd also like to spotlight on 2 additional algos that we're launching this year. Chest pain is one of the most common reasons for hospital visits, and it's one of the major challenges at managing costs. And also the very busy emergency departments always have a very critical availability, actually of length. And so the length of stay is a very critical moment here to identify if patients actually suffer from a heart attack or can be released. Now the chest pain triage algorithm can help doctors to quickly decide who needs urgent cardiac care and who can be discharged. With the early rule-out pathway, we can actually cut down the emergency department visits by over 3 hours and help reducing the emergency department to overcrowd, but more importantly, have people released from thinking they may be suffering from a heart attack. The CE Mark for this algorithm was issued in February this year. And coming back to kidney disease, we're also able to predict kidney malfunction or function decline within a period of up to 5 years with our Klinrisk algorithm, which helps to support a risk-based patient care decision. And again, allows early intervention and also drive up the adherence of patients to their respective treatments. And we're expecting for Klinrisk the CE Mark In Q4 this year. Now building on the strong foundation of our existing lab customers and our solutions for clinical decision support, disease management is another opportunity for Roche. And in oncology, you often have many different data points and sources for each patient that need to be brought together. The navify Clinical hub offers a way to pull all of this together and to create a comprehensive picture for the clinician. First, the solution integrates fragmented diagnostics and clinical workflows across pathology, molecular and the clinical setting. In the second step, it then integrates those insights into a clinician workflow. And finally, it links directly into patient care plans and reported syndromes. This means that we can create a single patient summary from multiple sources of data, which is a critical benefit for oncologists. In terms of recent highlights and expansions of the Clinical hub, the integration of the Foundation Medicine report is now in place. We've also added faster access to longitudinal patient data to a standardized patient summary for a streamlined case review by oncologists. And we have an AI-driven clinical case summary. And of course, we're continuously looking to adding new functionalities and features to this tool. This includes multi-disease workflows, integration of more complex data sources and further creating an intelligent layer with AI-powered workflows. And that's also a good example on how with the right digital solutions in place, we can continue to expand the offering seamlessly and provide continued updates and releases to our customers. Now I'd like to discuss our third focus area, the empowered patient, which brings together 2 of our ambitions, becoming a leader in decentralized testing and also to deliver disease management solutions that transform clinical practice. And Roche can help to empower patients to take more control of their disease management and stay connected to their physicians and their health care providers. In 2024, you've already heard that we've launched our Accu-Chek SmartGuide is a key component to our exciting CGM offering. And it's a key differentiator for Roche with our CGM solution. The 3 predictive solutions, the Glucose Predict, the Night Low Predict and the Low Glucose Predict use AI to help people living with diabetes to make more informed choices about their disease. And in 2026, we're expecting to launch the Smart Meal manager, which will provide a bolus advice to people living with diabetes without the need for them to count carbs. This is laying an important groundwork for the future, remote -- the diabetes management through tools like mySugr and the enlarged suite of clinical decision algorithms for patients. Now that I've shared more on our portfolio across our focus areas, I'd like to turn the attention to how we monetize our digital offering. Our go-to-market approach builds on 2 main pillars. Pillar 1 is a platform approach. This approach means that we can easily download and activate new products and features and applications to our customers while also generating revenue from our proprietary and third-party products. Our platforms are highly scalable with an increased focus, of course, on cloud-based solutions for a global reach. The Pillar 2 defines how we will enhance the digital solution selling. We have recently launched software plans, bundling multiple solutions into an easy-to-implement subscription for our customers. This means our customers always have the latest software -- the latest version and they can keep the plan and they can choose the plans right for them. We've launched the performance plan in April this year. Now let me summarize on how we are leveraging artificial intelligence and machine learning across our portfolio already today to optimize workflows and to improve patient outcomes. You've heard already and you'll hear more about digital pathology, where we're really using imaging recognition technologies to advance decision-making. In terms of the clinical decision support, another highlight I could call out here is our LGI flag, which helps in the early detection of colon cancer and actually helps to identify patients at risk and sends them for further diagnosis. In terms of our clinical workflows, you already heard me about the clinical case summarization, which saves a lot of time for clinicians that they can actually deploy for more meaningful tasks. And so that's a good use of an LLM that is already in use today. And also, you've heard already about the predictive and AI-based algorithms that we're using to help people living with diabetes to make more informed choices about their future outlook of their development, of their glucose levels so that they can take proactive action on their health. We're excited about the continuous growth of digital health, and we're focused on 3 main areas: the connected lab, the informed clinician and the empowered patient. We have a strong portfolio that is growing, and we also have a plan in place for our monetization. And so very an exciting area of growth for us in the years to come. But now I want to actually hand over to what was previously announced to be the highlight of that first section. So Josh, over to you. Thank you.

Thanks, Moritz. Hello, everyone. My name is Josh Lauer, and I am the Head of the Molecular Labs Customer Area. It's my pleasure to take you through a very brief overview of the Molecular business, but then, of course, as promised, a deeper dive into sequencing. So as Palani outlined a little bit, our portfolio is something we're very proud of in Molecular. We have the broadest set of instrumentations to cover the gamut of molecular analysis. The workhorse, of course, is our molecular work area. These are mid- to high-volume systems, the 5800, 6800 and 8800, where we're proud to have had a growth in our installed capacity base of 22% in the last year. But of course, we have a lot of other systems as well. On the bottom, you'll see our open molecular systems. These are research platforms. They're typically lower volume, but they're open systems and they allow customers to develop their own lab-developed tests across qPCR, dPCR, et cetera. This is where our acquisition a few years back of TIB Molbiol is very useful because it allows customers to get up and running very quickly with an expanded menu on these platforms. Rounding out the PCR side of the business, of course, we have the syndromic testing from the GenMark acquisition and the liat business more on the Near Patient Care side. And of course, sequencing is the big thing we're going to talk about. But before we get into that, a couple of highlights on the molecular portfolio. As Palani mentioned, sexually transmitted infections are the largest and fastest-growing area of the PCR business. And so without repeating all of the detail here, what we're very excited to highlight is the launch of a BV/CV assay for vaginitis in 2025. This is an extremely important assay, not only because it's a fast-growing area, but most women will be affected by this disease at some point in their life. What we find very exciting about this assay is it will be differentiated by being a multiplex assay and having a consistent workflow with our already high-volume CT/NG assay. This will make it very easy for labs to adopt it and integrate it into their workflows. On the GenMark side, as Matt described, we will launch 2 new assays, a gastrointestinal panel and a meningitis encephalitis panel. These two are very important and they will be differentiated for multiple reasons. On the assay side alone, we've been very thoughtful about which targets are included so that they are differentiated from other panels that are on the market. But they both share common differentiation by virtue of running on the ePlex system. This has less than 1 minute of hands-on time, no pre-analytic workflows, dynamic panel ordering, and of course, automated reflex capabilities. This is why we're so excited about adding to this menu with an already competitive platform. Now the GI assay is scheduled to launch in 2026 and the meningitis encephalitis panel will come after that. But once these panels are launched, the ePlex menu will cover 95% of the syndromic testing market. So we're very excited how this will accelerate the growth that we're not only seeing in the U.S. but internationally as well. Okay. Now to sequencing. Before we talk about why we're so excited about by SBX, let's talk about why we have continued to remain committed to and excited by the sequencing market. As you can see from the publicly available data, the sequencing market continues to remain large and sustained double-digit growth. Now in the past, a lot of that growth was in the research market. But what we've seen is that in recent years, the majority of the market has flipped over to clinical, obviously, a strong area for Roche. And most of the growth we see going forward, it will continue in research, but the stronger growth will be in the clinical market. It's important to note that 90% of that clinical market is still served by RUO instruments, and we will initially launch an RUO instrument as well. But as we think about disease areas, the predominant drivers of clinical use in sequencing are, of course, oncology and rare diseases. And we'll talk about examples in both of those coming up. Research continues to be dynamic, though, with new applications driving continued growth in research. A great example here is single cell sequencing, which is also growing at double digits. And we'll give an example of that as well. So how will our solution come together? We are going to talk a lot about the sequencer, and it's important to note 2 things about our strategy. The first is that this will be an open system. It's not going to be a closed system and we intend to support application workflows across a variety of workflows for the sequencing community. But the second thing that's important to note is that we do have an end-to-end strategy. We are a clinical diagnostics company and we have assets to utilize across this chain, starting with KAPA library prep and automation from AVENIO Edge, all the way through as Moritz described, navify Mutation Profiler in our suite of tools. So we will both launch an open system and be building towards a road map of an end-to-end solution that really helps customers democratize sequencing and make it easy to deploy at scale. Now to SBX. What is sequencing by expansion? If you didn't see the earlier webinars or some of the information at AGBT in February, simply, it is the combination of 2 innovations. The first is the Xpandomer technology, which turns a DNA molecule into an Xpandomer, which is 50x longer than the original DNA molecule. This makes it very easy to have high signal-to-noise when doing single molecule sequencing. It's the first time you've been able to get that sort of accuracy from single molecule sequencing. The second is an innovation that came out of the Genia acquisition and was further enhanced by Roche. This is a high-throughput CMOS chip that allows precise control of 8 million wells at a time. Putting these 2 together results in something that the sequencing industry simply hasn't seen before. Not only do you have a high-throughput, highly accurate sequencing platform, you have incredible speed and incredible flexibility. So why are customers so excited about SBX? I'll highlight a few of the things that have been talked about a lot since our reveal just before AGBT. First and foremost, accuracy right out of the gates. I think people have been impressed and we are very proud that the performance is already competitive with leading platforms in its initial incarnation, and this is only our first version. But beyond accuracy and high throughput, which by the way, we're capable of throughput higher than any other system on the market today, as high as 7 genomes in an hour, what I think is really standing out is the flexibility that SBX provides. Batch flexibility is one of the key underseen benefits of SBX. Most people think about high throughput sequencing because that's where the volume is and that's where the costs are most efficient. But SBX has the unique ability with its reusable sensor module to allow customers to run either low volume or high volume, all on the same platform without paying high-cost penalties. This is unique, and there is no other system on the market that allows that flexibility. We also have flexibility in applications with different read links, which we'll talk about in a second; and speed, as I mentioned earlier, with the ability to get a genome out in actually significantly under 7 hours, as I will show. We will show you the instruments in a little bit, but to review, there are 2 instruments. One takes a library pool and turns it into Xpandomer molecules, as we described before. This is called Xpandomer synthesis. We have a synthesis instrument. The second takes those Xpandomer molecules and runs it through that high-throughput CMOS chip and reads out each reporter code to quickly generate base calling for sequencing. I'll walk you through each of those in a little more detail. On the Xpandomer synthesis side, we have flexibility in how customers can batch and run samples through here. Anywhere from 1 to 4 library pools can be simultaneously synthesized. And then a complex chemical process, if you want to know more, you can watch the webinar to learn how the magic is done, but that molecule has turned into an Xpandomer. The one thing I would like to highlight here is that the original DNA bases are replaced by reporter codes, which, as we said, are 50x larger. The reason we keep talking about 50x larger is this size enables you to have only 1 reporter code inside a nano pore at a given time. Other nano pore technologies have multiple bases at once, which makes it harder to accurately call the signal. For the sequencing, these Xpandomer are run through the high-throughput chip. Now initially, the pores are formed and a second attribute of the Xpandomers comes into play. We have something called a translocation control element, and this works in conjunction with the CMOS chip to essentially ratchet the molecule through 1 reporter code at a time. And those pulses use the CMOS chip to tightly control the signal. So we know when we're advancing molecules and we can get highly accurate reads. But of course, the really impressive thing about this is not just its throughput and control, it's the fact that the sensor module is reusable. And as you can see in the cycle in the middle of the slide, we are actually able to clean the system and repore it for additional efficiency. How will customers use SBX? We've talked about 2 workflows at a high level. The first is a highly activate duplex sequencing. This is meant to compare more to your short read applications, and it's useful for lots of clinical applications where accuracy matters most. The second mode is a simplex mode. This enables either very, very high throughput of short sequences on charted throughput for things like single cell RNA sequencing or it can also enable much longer reads. And here, we're not talking about the long, long reads, but we're talking about high yield that you just can't get anywhere else of 1,000 base pair stranded DNA that you can sequence very quickly. On the duplex side, these are the accuracy numbers we showed back in February and this is what has made everyone so excited that this technology is competitive right out of the gates. I won't go through all these statistics. But suffice to say what we were very proud of is the fact that the performance was consistent not only across multiple reference samples, but also across multiple variant caller algorithms that exist in the field. Now a special case of SBX duplex is something that we've been collaborating with Broad Clinical Labs on. As you may have seen, we announced last week an extension of our work with Broad Clinical Labs in a broader research collaboration. And one of the areas we're focusing on is a modified workflow, what we call SBX-Fast. This is a moving target for us. The numbers you see on the screen were the numbers we presented back in February. Doing a human genome from library prep to variant calling in roughly 6.5 hours, is competitive with the former world records that were out there. But we've moved a lot since then. And just recently, our teams in Seattle actually showed that they could do that same workflow now in under 4.5 hours. This obliterates world records, and this is something we believe customers will be able to do routinely as part of their normal workflows, not as a one-off gimmick or world record-breaking stunt. Why is this useful? It's worth pausing for a second. Where is the speed really important? It's always appreciated by labs, but it's especially important in settings such as the NICU, neonatal intensive care. These are children who often have rare diseases, and time is of the essence to figure out what is wrong with these children. So one, you can treat them appropriately; and two, get them out of the NICU. So what's often done, the workflow you're seeing here is what's called solo where you're only sequencing the patient. But what's commonly done is you sequence the parents as well. So you have a higher sense of the heritability of the disease and where it came from. So the same improvements we've been working on for the solo workflow apply to trio. And here, you can see that we've taken the time to sequence 3 genomes from a little over 12 hours to now a little over 7 hours. This is extremely fast. Now our teams are continually working on improving the performance of SBX to show what the technology is capable of. And as you look across these numbers, you can see they're speeding up each step of the process. But you might notice that most of the improvement has actually come in the analysis stage. This is part of our strategy. As we talked about, our -- we have 2 strategic goals when it comes to analysis pipelines. The first is, as we said earlier, to make sure this is an open system and make sure that customers can leverage open source tools or other tools that they may have for bioinformatic pipelines. But the second, not to get too detailed into this diagram, is to take as many steps as possible and accelerate them by putting them on the onboard compute, which we'll show you here in a second. Suffice to say, a system that can produce higher throughput than any other system has to deal with very high data rates. So we have a large amount of onboard compute and we can put that to good use by accelerating bioinformatic pipelines. That's what leads to innovations such as SBX-Fast. The partnership we announced with the Broad is broader than just SBX-Fast though. We also talked about other research applications, and the slide you're seeing here is something we presented with Broad back at AGBT and it's also part of our research collaboration with them. It highlights the benefits of the simplex mode of SBX. And here, there are 2 examples. On the left-hand side, when you're still doing shorter reads, which are very common in single cell, you can generate even crazier throughput numbers. And here, we're showing over 30 billion reads in just 4 hours. That is unheard of. But the -- the right-hand side is something even more novel. It's the ability to do something other short-read sequencers cannot do, which is novel isoform detection when doing RNA sequencing. A novel isoform is a different form of transcription. And you can identify different mechanisms of disease. So researchers do this to understand what's really going on in a pathogenesis and better understand the mechanisms of disease that are going on. Typically, this is done with longer read platforms, but it's very expensive and it's often very slow. There is no other platform that can generate over 200 million thousand base pair reads in just 1 hour of sequencing, and this is very cost efficient as well. Now one new piece of information that just was presented over the weekend at the European Society of Human Genetics by our team is extending our view of applications that SBX can be applied to. As I said at the beginning, oncology is one of the largest clinical areas. So of course, it's very important that we demonstrate to the community that SBX is fit for purpose in oncology. We've done this in 2 ways. The first on the left-hand side is to look at the most commonly used sample type, which is not fresh frozen tissue, but formalin-fixed paraffin-embedded tissues. These are the common clinical sample. And it's important to show that SBX performs very well, in fact, better in FFPE. The example on the left was just homopolymer links. And of course, you can see the blue as Roche is our quality scores at those various lengths. Another hot application is minimal residual disease. And here, the fundamental nature and what this proof of concept is demonstrating is the ability of SBX to accurately call rare single nucleotide variants at a very low noise level, and that helps you differentiate a tumor signal from the background in a sample. Here, you can see that in this experiment, 15 out of 15 MRD samples were called correctly with SBX. And while this is not a clinical assay yet, we are seeing the noise floors are pretty good and can get very competitive. So how do we feel about this? Obviously, this is a platform for the community and we want people to see these examples and develop their own applications, but Roche is better positioned than any other company to fully realize the potential of SBX. Not only are we going to produce an open platform and produce end-to-end workflows that can help support applications, we also can leverage the benefits of our internal drug development use cases that help us understand how translational research can be effectively utilized in drug discovery. We have a strong personalized health care business that supports companion diagnostics with the entire drug industry. And beyond our own product development, we look to work with leading clinical labs, such as Foundation Medicine and others to support their application development and that growing clinical sequencing space. So where does that leave us? I know there's a lot of anticipation around next year's launch. I'm sure people want to know more specifics on timing, but we are not going to share that today. I do apologize. 2025 remains an early access year. And we are working to demonstrate, as I just showed you, a variety of workflows that cover all the primary things customers would like to do with the sequencer. We will continue engaging with those sites and with KOLs and expanding early access. But 2026 is the launch year. We will start in selected markets in the U.S. and Western Europe, and we'll go a little further. But as we move beyond, we will continue to flesh out applications more broadly. And I just want to emphasize, we believe SBX is a generational technology and we are only seeing the first instantiation of what this technology can do. So there's a long road map ahead of us for how we intend to continue developing and expanding the utility of SBX. So with that, I would like to introduce you to Axelios. [Presentation]

Okay. So first thing is first, the name. We chose Axelios for an obvious emphasis on acceleration. As we keep saying, speed is something very unique about this platform and something no other short-read sequencer is able to match. Now let's go through the instruments here a little bit. Obviously, you saw them on the slides. They look pretty similar. But to reorient you, customers take normal library prep steps and they'll take a pooled library tube and load it directly on the synthesis instrument. This is where that magic of Xpandomer synthesis happens. It happens on a consumable we are purposely not showing yet called an XP chip, that is where the synthesis occurs. This process only takes a few hours. And of course, in special cases like SBX-Fast, we've optimized it to be even faster. But it can take up to 4 hours on this system. But before we go over to the next system, it's also important to recognize that because this system can process up to 4 at a time, 1 instrument can support multiple sequencing instruments. You don't have to pair them one-to-one. Customers can flexibly adapt their infrastructure depending on their volumes and their workflows. Once the Xpandomer are generated on the synthesis instrument and up to 4 hours, they are then loaded on to the sequencing instrument and this is where that sensor module sits and it feeds those Xpandomers through. And here, the timing is very different. It can be anywhere from as short as 10 minutes depending on what you need to 4 hours for a given run. And then after 4 hours, we can repeat the cycle by generating new pores and doing another 4-hour run. So as you can hear from the run times, it's both very fast and very flexible. Now I'd like to call out just a couple of other things about these instruments. One is that, as you see, we've got a bench top over here and this unit sits on what is a lot of compute underneath. Now you might say, well, there's 2 instruments. We just talked through why there's flexibility there on what's used. But it's also important to note that there is no system on the market that is anywhere near the throughput of this. And what's very exciting and interesting about this, to remind you, is not only can this go toe to toe with any high throughput systems in any lab, it can also be used for low volume, which makes it extremely applicable to a wide variety of customers, not only the highest volume sequencing labs in the world. The last thing I'd like to say about these instruments is just a note from our early access experiment. Some of you may have heard that we have instruments installed at Broad Clinical Labs and at the Hartwig Medical Foundation in the Netherlands. In both of these instances, these instruments were quickly installed, up and running and able to sequence samples within 1 or 2 days. We think that's a great early sign of how easy to use this platform can be and not combined with its transformational performance is why we and the community are so excited about Axelios. So with that, I want to say thank you very much, and we'll bring Birgit up for the Q&A.

Hello, and a very warm welcome from my side as well. My name is Birgit Masjost, and I'm the leader of the Diagnostics IR team. So we're ready now to take your questions. If you have a question and you're in the room, please raise your hand. [Operator Instructions] So first question goes to Richard Vosser from JPMorgan.

Two questions, please. Firstly, just you mentioned upfront the pressure on health care budgets. And I just wanted to get your thoughts on potential pressure in different areas, maybe the Protecting Access to Medicare Act in the U.S., where we are with implementation, what the impact on pricing might be for Russia and your business? And then any other geographies outside of, obviously, China where there's been some pressure already? And then second question, just on the sequencing. Just thinking about future and completing the offering into long reads, when that might come and think about methylation as well, that's some differentiation from others. So your thoughts there.

Sure. So I'll take the first question, then I'll hand it to the team to take the second one on the sequencing side. So yes, very aware of PAMA. And as you all know, there was a 1-year extension on any sort of PAMA reimbursement cuts. I would note that Roche is very active in the industry associations, that's ACLA as well as AdvaMed, and we have been advocating for legislature to really ensure that there's adequate recognition of the need for appropriate reimbursement in diagnostic testing. As you know, there's been multiple extensions of the PAMA cuts. And I think there's been some substantial activity in terms of helping to educate policymakers on the importance of appropriate reimbursement. So that's an ongoing battle to ensure that this happens. We are focused and we are very active within the industry associations to ensure this happens. I wouldn't call out any other areas that I would say are worth noting. However, this is something that's been a perennial topic and one that we're very engaged in. Before handing it to the team on sequencing, I would just like to thank Ildikó, Palani, Josh, and [ Marka Kors ], the inventor of the entire team in Roche sequencing. This has been a tremendous effort, tremendous teamwork, tremendous collaboration. I would also call out our operations team as well in Pennsburg for the work they've done to transfer this. I just want to say you all really a big thank you from my side. And with that, Josh, you want to start off.

So I believe you asked 2 questions about it. One is about long-read sequencing and the second was about methylation. So on the first, it's important that we are very clear. We don't want to cause confusion. We do not refer to this as a long-read sequencer in the typical industry parlance. And the reason for that is that traditional long-read sequencers are known to be capable of multiple kilobases of sequencing at a time. It could be 5 kilobases, for example. We don't know what the limit of SBX is yet, so I don't want to rule out what's possible. But I would say that we are seeing lots of fragments greater than 1 kilobase, but I don't think we're in the multiple kilobase region yet. And I think we want to be very upfront and clear about where we fit. Some industry observers are denoting like mid-length sequencing. I don't know what the right term is yet, but what we're seeing are very clear advantages to how our longer fragments can be used in multiple ways. One of them is if we do a standard genome, we are better able to map some difficult regions of the genome, which can boost our variant calling scoring over traditional short-read applications. And the second is, as we talked about like novel isoform detection, that's not really the only benefit. One of the key gaps that researchers are looking to do in single cell sequencing is, for example, tracking V(D)J regions. And this is a hot topic, especially when you're doing things like immune profiling. And we have not yet tested all the limits of everything, but we're very excited about the benefits that these longer reads can bring to these applications. On the methylation front, look forward to more data coming from us. We've got a series of academic conferences as we move towards launch in 2026. And so just as we showed with FFPE and MRD and others, look forward to seeing more data from us on methylation over time.

I mean, I'll just say that any standard methylation workflow can work with our sequencer as well. So this is just a matter of time, as Josh said, that the data will come forth.

Okay. Next question goes to Jack Meehan from Nephron Research.

I appreciate all the color and hosting the event today. Had a follow-up on sequencing. So it feels like the sweet spot is on the clinical side, given Roche's Diagnostic positioning. That's also where most of the growth is going to come from, if you look at the forecast. These are also pretty sticky customers, sometimes with regulated workflows with the FDA. So can you just talk about how you knock down those barriers to get the system installed? Maybe you can talk about Foundation Medicine as an example there. And then any updated color on pricing, commercial strategy?

Sure. Okay. So there are 3 parts there. Let me take the first one and then we'll figure out what to do with the other 2. So on the first one, as you know, I have some experience with this. The fundamental thing we need to do is make sure customers see a clear value proposition. I think given the dynamics of SBX that we've already shown and the feedback we're hearing from customers, that's already pretty clearly out there. There's a strong reason to believe in the benefits of SBX. But of course, we have to prove that this is compatible, and we are starting that journey, but we'll continue generating more and more evidence to remove any anxiety customers have. One thing I would emphasize is right out the gates, we are seeing very high accuracy. And so I don't think customers need to wait for improvements to feel confident that this can be a clinically relevant solution today. Of course, over time, we will partner with others to make sure that applications are developed as well. So this is not just partners like Foundation Medicine. We want to partner with the whole industry. This is an open platform for everyone. And so we are in active conversations with multiple customers around how SBX might fit into their businesses. And the third part was pricing, yes. That's a really easy one because, unfortunately, I'm not going to comment on any pricing at this point. However, I will emphasize for those who weren't at the AGBT workshop and didn't hear what we've communicated, obviously, we're very comfortable with the dynamics of what SBX can do and the cost efficiency it affords. We know a lot about what it takes to build this instrumentation. So what we have said is that we intend to be very competitive. And what we mean by that is high throughput systems, and we believe we will be competitive on both CapEx and on marginal reagent costs.

And if I could maybe make an additional note to that. I agree with everything you said on the foundation side, again, they have in their independent capacity, the ability to select which technology platform they would choose to utilize. However, if in the event they do choose to utilize SBX, their track record in terms of getting CDx claims as well as clinically developing assays would potentially enable us to move much quicker into a decentralized format for the SBX platform.

And just quickly on the market commercial strategy standpoint, if you saw like Josh presented the first slide where we see the clinical market growing very nicely, but also there is pockets of research market that are growing. And accordingly, we will basically make our sequencer available to all those customers. So it will be looking at these more commercial sequencing providers, but also looking at academic medical centers across these different applications.

Next question goes to Hugo Solvet from BNP Paribas Exane.

I have two, one quick follow-up on Richard's question. On the mid-single-digit to high single-digit growth ambition. How much of that relies on test running on instruments and platform, which have already been launched as opposed to instruments and assay, which have yet to be launched. Just curious about that. And given what's going on at the FDA, just keen to hear a bit more on your discussion with the agency and the risk that we see some launches being delayed a bit. And maybe for Josh, on the eplex dynamic panel configuration, is that flexible pricing strategy? And maybe can you expand a bit on the rationale for moving into that direction?

Thanks, Hugo. Good to see you again. I would call out that we do expect robust growth from our core portfolio as well as additional growth coming from the new portfolio. What we see is really -- we talked about some of the headwinds we're facing. We feel that the net of the new launches together with the growth of our existing portfolio is what's going to be what powers us to that mid- to high single-digit range, right? Because that's how a big part of how we digest some of these headwinds, will be the additive power coming from those launches, but we're not going to break that down discretely, but we'll just say that putting them together is what we feel it's going to get us to that target. Does that make sense? Do you want me to touch on the FDA? Or would you guys want to comment?

Maybe -- I don't know the exact FDA -- sorry, I mean, I need to understand the FDA part of the question before we go to the eplex. No, not right now. I mean, we continue to stay closely connected to the FDA. We are well connected with the reviewers who are looking at our submissions. So we don't have any indications right now of any such implications.

On the eplex front, a couple of points to note. The first is that what we've largely seen the U.S. being the largest market for syndromic testing is a lot of this is already kind of priced under DRGs. And so that kind of sets the tone for how a lot of pricing is done. However, thinking about how to account for customer needs, that's why the dynamic panel ordering was constructed so that customers have the ability to essentially only run what they want to run, and certainly, that supports a more customized workflow for them. We do not necessarily speak about pricing, but we wanted to think about enabling this type of functionality so that customers only test what they need.

Next question goes to Simon Baker from Redburn.

Two quick ones, if I may. Just really going back to the question that was asked earlier on sequencing. Can you give us an idea what the launch customer profile looks like? Who are you going after? I'm guessing if someone's been on team Illumina for 20 years, that's probably not something you're going to target initially. So some thoughts or maybe it is. Some thoughts on that would be great. And then a slightly broader question. Moritz, you mentioned about software subscriptions. Software as a Service been transformative in lots of other areas of a totally unrelated markets. What about diagnostics as a service? How much is CapEx of barrier to customer adoption of new technology in this space? And is there an argument for moving to new models where it's essentially on a subscription volume basis rather than upfront expenditure on new equipment. Any thoughts on that, would we great?

I can take that one. I think we have built all our systems to provide a lot of flexibility so that it's basically not us telling customers how they can access our innovation, but it's the healthcare systems and respectively, the system -- or the customers that define how they can purchase. So we have a multitude of systems that provide them to my area is a software monetization platform. It's a tool that allows us to accommodate to the different business models so that customers don't have initial barriers to their system imposed to them to access these innovations.

Right. Do you want me to mention the Diagnostics as a Service? or -- I would just say we engage with health care systems around the world, and we engage in flexible financial negotiations to best meet the needs of those healthcare systems, because our goal is overall expanding access. It's not a one size fits all, but certainly, we always want to meet our customers where they are.

On the sequencing front, yes, just to answer that question. It's a good question. I would say both the blessing and the curse of SBX is that, frankly, we haven't run into any short REIT applications that we don't think this technology is suitable for. So that does present a little bit of a challenge, which is where do you go first. My first inclination is to answer your question by saying, I don't think we would segment by customer type per se because as we've described, it's suitable in a broad range of settings. I think what we would probably emphasize first is the application areas where we can make the strongest difference and where we can show the most utility out of the gate. Over time, I don't see any shortage of application or appetite there, but I think we'll start in some of the areas you're seeing us demonstrate first and then expand use cases over time.

And the quick statement I'll add is coming out of AGBT, where we had a lot of our customers. I mean there is just interest across the spectrum. So to Josh's point, it's really application-driven. We don't necessarily see that it has to be one particular customer over the other, but there is just a broad spectrum of interest.

Next question goes to the lady there in the second row.

This is Aisyah Noor from Morgan Stanley. My first one is on Latent TB. You announced the development of this test a year ago in your last Diagnostics Day. So just curious where you stand in the development of this test. Any performance KPIs you can share and how it stacks up against the QuantiFERON incumbent? Second question is on China. So in the core lab section, you called out China as a key strategic market for you over the midterm. Given the pricing headwinds you're facing in this market this year and the steady rise of local Chinese competitors, what gives you the confidence that this is strategically a market to stay in?

Maybe - do you want to take the interferon gamma or...

Yes, take that.

So yes, last year, we talked about our interferon gamma release assay TB test. You will hear actually more about it in the second half. Olivier will talk about it, so I don't want to steal his thunder. But nevertheless, I would just say that we are absolutely staying on course for the launch next year in CE Mark countries. We don't see any challenges. It fits very nicely with our Elecsys platform for the automated readout. If you remember last year, we said we are working with a partner for the stimulation tubes. So that's coming along very nicely with the partner. And then the readout assay for interferon gamma release is also coming out very nicely on our Elecsys platform. And if you remember, we actually launched interferon gamma release assay first for SARS-CoV-2. So we are actually building on that experience for TB. And in due course, you will also see our performance metrics and so on. So we will be, of course, sharing it in due course. And the China part, Matt?

So I mean recognize the challenges in China, and they are significant. But I would say there's 1.4 billion people in China that need healthcare. And this is a market that recognizes innovation. I would also highlight our strong partnership in China with our investment in Suzhou, where we have research, manufacturing, and development, all-in-one location. And that really is illustrative of our long-term commitment and our China for China menu that we're continuing to develop at that site. I would say we recognize that there's challenges, but if you look at the recent VBP, we actually increased our market share. While we, of course, all will take a hit as a result of the austerity. Long term, we expect this to return to growth. And we're really, I would say, committed for the long-term in China because we recognize it's a location that is always going to need healthcare, and we want to be a partner.

Okay. Great. I think we are at the end of the first section of presentations and Q&A. We'll have a second set of presentations, followed by a Q&A as well. And now we're going into the break, which I would like to shorten to 10 minutes because we're a little bit behind schedule. So if we can be back here like 5 minutes to 3, and then we can start with the second set of presentations. Thank you very much. [Break]

Okay. Hello, everybody. Can we please all get back to our seats so that we can start with the second set of presentations, and I'm very happy to introduce Jill, for our presentation on pathology lab.

Well, welcome back, everyone. It's really great having you here. And Josh, thank you for the exciting unveiling of Elecsys. It's fantastic. I'm glad everyone gets a chance to see this. I hope you can all feel the excitement that we do around sequencing because as Josh described, it will really enable us to improve the patient journey, especially in oncology. And especially when coupled with tissue testing, which is going to remain vital because as I'll show you later, the spatial context of biomarkers continues to provide really important diagnostic information. I'm Jill German. I'm Head of the pathology customer area, and I'm excited to tell you today about the great strides that we're making in the pathology lab and how that's shaping the future of cancer diagnostics. In 2024, the global clinical tissue testing market grew to CHF 4.4 billion, growing at 7%. Now when I was here with you all last year, I shared the strength that we have in this area, and we expanded that reach last year, growing 17% and ending the year with more than 13,000 instruments in use around the world. We maintained our strong position in the #1 market, which are the #1 segment, which is advanced staining. And we continued to really build on our key relationships with our pharma partners, as was mentioned earlier and really expanded our collaborations to include digital solutions. Now transforming patient care through personalized approaches, it takes a lot more than just moving instruments of varying technologies into one room. It requires significant expertise, experience, and investment. And we continue to really invest in this area. In fact, we opened our new CAP/CLIA laboratory last year, tripling our capacity. And we're very proud to couple that with our extensive experience in developing biomarkers and assays, our extensive global clinical trial design, our regulatory experience, our vast commercial footprint, and our digital ecosystem. You can see here that we have a broad array as well of unique biomarkers that we have developed over those years, and it really helps our pharma partners very rapidly create access when they want to get out into the market with their targeted therapies. Now I said that we expanded our digital approaches, and you heard Palani talk a little bit about this. Our navify digital pathology image management system is the centerpiece of our digital pathology ecosystem. This is really offering us an open content platform with a really efficient clinical workflow. At the end of this year, we expect to launch our next generation 3.0, which will enable comprehensive workflows. It will empower interoperability and scalability solutions with scanners, LIS and PACS around the world. And it's the ideal bridge connecting labs to AI content. You heard Palani talk about the breadth of our content providers around the world. We have now 13 partners across 10 countries, and we have 12 more in the pipeline. And we also have this, what I would call, really strong and growing portfolio of digital pathology algorithms. What's really important is around the world, regulatory agencies today require end-to-end validation for digital pathology solutions to ensure diagnostic performance. Now what does that mean? It means from the scanner optics, to the image management system, to the algorithmic itself that you have complete traceability. And our digital pathology ecosystem is designed for exactly that. This becomes even more important as we continue really driving medical value algorithms with our pharma partners. You may have seen recently the FDA breakthrough device designation that we received on our TROP2 QCS algorithm. This folks is truly groundbreaking, because it's the first computational pathology device for companion diagnostics. And it really sets, I think, a landmark in integrating AI into cancer diagnostics. It also actually sets a milestone for how regulatory agencies think about integrating AI into diagnosis. So we're really proud of the work that has gone on here, and we're excited about the deep pipeline that we have as we go forward. Now diving into the disease area a bit further itself. A lot of you cover pharmaceuticals. So you know that there have been great advancements in cancer treatments. This is an illustration of the growing FDA-approved lung cancer treatments. And it's really great news. It also highlights a key challenge. These biomarkers can now be interrogated by multiple modalities. And as that happens, it really puts pressure on the patient sample, which can now need to be split between molecular and tissue. And as I mentioned before, the tissue remains vital because of what it shows us in spatial context to -- within the cell. So what can we do? Well, IHC multiplexing is emerging as a really important tool as we look to really solve some of these questions. Instead of taking multiple slides for multiple biomarkers, we can combine these on one and really preserve the tissue, especially for, Josh mentioned in the NICU, some of those really small sample sizes that are so important. Now beyond tissue conservation, we can also analyze the characteristics of markers within a single cell. It really allows us to dig in and see what's happening within co-expression within the cell. In this particular case in the middle, you can see that when multiple markers are there, and co-expressed, it can have important implications. In this case, with the co-expression of p16 and Ki-67, it can actually indicate risk to cervical cancer. And then critically, multiplex IHC can really help us see the spatial relationship of biomarkers within this cell. In this case, you can see the relationship between PD-L1 and PD-1, which can have a really important implication on prognosis and therapy effectiveness as you'll see on the next slide. Here is a concrete example of how this spatial orientation can really impact outcomes to the patients. The research in colorectal cancer as an example, shows that when PD-1 and PD-L1 dependent on where they are spatially, it can actually give indication to whether the patient will respond to therapy. In fact, it will -- the research shows that it will show you responders and non-responders, which can really help in patient stratification and understanding whether patients will ultimately respond. Now this is really important as we think about the ever-growing immuno-oncology and ADC market, because this whole spatial proximity can be very important. Now with this multiplex IHC, you can imagine that it requires tools that go beyond what humans can then just see. And so within Roche, what we've done is develop proprietary translucent chromogens. These chromogens create a third color when overlapping. This really then reveals the biomarkers that would otherwise be obscured with traditional methods, which is pretty cool. What it allows us to do? You can kind of see there on the left bottom, it allows us to digitally pull out the signal for each of these biomarkers. And then we can analyze them as a single biomarker or as a multiplex biomarker. In this case, what you can see is that Ki-67 really indicates cell proliferation. And then the co-expression of ER/PR illustrates and gives insight to the response to therapy. These chromogens have been really optimized for digital pathology platforms, and really make it -- make us able now to see deeper into the cell. This is really an important breakthrough. And what we've done is taken these innovations, we've made them available just like we have -- we intend to a sequencing. We've made them available as research use only. And we have ongoing IVD programs right now that will bring certain products to market. We're also working with our pharma partners on programs to move this forward within the digital pathology arena. So coupling multiplexing with digital pathology will really allow us to get to some of those challenges we spoke about earlier. We are really honored to have had the opportunity to impact more than 41 million patients in 2024. And you have our commitment that we will continue these innovations to really reach our mission as we go forward. So thank you very much. And Ildikó, it's over to you.

Thank you, Jill, for this exciting news from the area of pathology. Switching gears now to near patient care. My name is Ildikó Amann-Zalánd. I'm heading the Research and Development Department. And today, I would like to talk a little bit about the near patient care market, our strategy, and any upcoming launches. Now as Palani and also Matt already said, our ambition is to be a leader in near patient care. And for that, we recently have analyzed our near patient care strategy, and we ask ourselves three questions: in which disease area do we want to play, in which location we want to play, and with what type of technology. We are convinced that providing test and solutions in close proximity to the patient is essential and will improve clinical outcomes in disease areas like cardiovascular, infectious disease, and in diabetes. Looking in the near patient care market, we have to confess that it encompasses a wide range of different locations, including emergency rooms, in the hospital, general practitioners, pharmacies, and also the home testing. A nuanced understanding of the different needs of the customer and patients in this different location is essential to provide the optimal solution. And as a matter of fact, already today, we do have a wide range of technology that we can utilize. For example, we can differentiate in the emergency room with our molecular point-of-care assays infectious diseases -- respiratory infectious diseases. We do have access to blood gas, electrolyte, and also blood glucose monitoring and measurement technologies in the emergency room. Moving more on to the highly decentralized testing, we have access to immuno and clinical chemistry technologies. And also in the home area, we actually provide a pretty comprehensive portfolio for blood glucose monitoring for patients with diabetes. Now in the future, new and cutting-edge technology will enable us to provide even more and newer holistic solutions for the emerging needs of all of these settings. And here, I would like to highlight four platforms: the cobas liat, our molecular point-of-care platform; the cobas sense, and the LumiraDx, our immunoassay and immunoassay clinical chemistry platform for the hospital setting, and the decentralized setting, respectively. And last but not least, I would like also to talk about the launch activities of the Accu-Chek SmartGuide CGM solution. Now let me set the stage with a global epidemic, a silent global epidemic. And you have heard about that already a couple of times, and this is sexually transmitted diseases. As of today, 374 million patients are affected with sexually transmitted infections every year. This translates into more than 1 million infections per day, and that translates into more than 11 infections per second. Now chlamydia and gonorrhea pose a particular problem because they affect 200 million patients. These numbers underscore the urgent need for an accurate and an accessible solution for these patients. And we are committed to enhance our portfolio on the liat to also sexually transmitted diseases. There are two reasons for that. One is that the physician gets really quickly an accurate diagnosis and can initiate the right treatment. And the second one is that we really also support the stop of this epidemic. Now we have launched in Q1 of this year, the cobas liat CT/NG and the cobas liat CT/NG/MG panel. And this panel really comes with the accuracy that we are used from our liat assays. It comes with a 20-minute results time and the physician only needs a 1-minute hand on time in order to get the information of the right diagnosis. He can perform that with one single test and can really initiate the treatment while the patient is in the emergency room or in his GP office. Now moving on and looking a little bit more into the future. There is another panel in our pipeline, and that is the cobas liat lesion panel for which we are seeking EUA approval. Now lesions can be in particular, difficult to diagnose because of the overlapping presentation. And this is why we are currently developing a 5-plex assay. They contain the five most important key pathogens. And these five key pathogens consist of viruses and also bacteria. And obviously, the right treatment modality need to be initiated. So the test will give the physician the information, what kind of treatment is necessary for the respective patients. Again, with the well-known gold standard lab quality and the PCR accuracy from our liat system and again, with less than 1 minute hand on time. Now the cobas 5-plex Lesion panel really fits seamlessly within our very strong infectious disease portfolio, which spans from the core lab through the molecular and now also into the point of care setting. I would like now to switch gears a little bit into our NPC immunochemistry platform. I have talked about that last year, and this is the cobas sense, our platform for the emergency room that we have in our development. And the goal of this system is really to provide the first IFCC-compliant high-sensitive troponin TSA with lab-like performance and comparability across the point of care and the core lab. It will come then also with further very high medical markers for the emergency room, markers in the cardiac field, sepsis and also for TBI. Now we have made really great progress in the last year, generating data from clinical samples, which show a great correlation between the cobas sense, high-sensitive troponin T assay and the sixth generation of Elecsys high-sensitive troponin T assay for the core lab. And Olivier will talk about that further. Now why is that important? Obviously, the emergency room physician, for example, he needs to observe the trend of high-sensitive troponin T for a patient that has a suspicion of myocardial infarction. And he can now make critical decisions quickly and fast, completely independent, which Roche system he is using, either the core lab system or the point-of-care system. And that actually will also improve his decision-making in the emergency room and subsequently will reduce the overcrowding that we currently see in the emergency one. Moving on to our newest addition in our portfolio. And I'm really proud about this solution. It is our solution for the highly decentralized settings like urgent care clinics, mobile clinics, or also GP settings. And that is the LumiraDX. The LumiraDx is really not just another decentralized platform. The most powerful advantage of LumiraDX is, as already said by Bruno, the multi-modality. We can do immunoassays, clinical chemistry assays, enzymatic assays on this system and in the future, potentially also molecular assays. It comes with multiplexing modality. So three immuno assays can be done at the same time, which obviously reduces time, but then also the volume. And as you can see here, I don't have the same music as Josh has, but at least I can show it here. This is the LumiraDx platform. It weighs only 1 kilogram. It fits into the palm of my hand. And it comes together with assays, which do not need refrigeration. So this is a game changer, in particular for the highly decentralized setting. Now in addition, it only needs a small amount of blood, which enables us to say that today, we are the only provider of an anti-proBNP assay, which has a fingerstick sample type approval. And last but not least, we are also enlarging our menu to new assays. I mean, as of today, we have already assays in the field of cardiovascular. As you can see, coagulation, infectious disease, very important infectious disease assays with multiplexing capabilities like the SARS-CoV-2 flu A/B assay. And in the future, we will extend that to the lipid panel for the decentralized testing and the HbA1c version 2.0. Now I hope that you agree that this makes LumiraDX a future-proof investment for setting where flexibility is key. It is very versatile. It is scalable, and that truly supports the growing trend that Matt was talking about towards decentralized patient care. So we are super excited about this one. I can just say this. And now moving on to the last one, the Accu-Chek SmartGuide CGM. And here, I would like to give you an update on our launch activities. The main message here, our launch phase progresses according to plan. We had an early and controlled launch in three countries. The three countries were Switzerland, Germany, and the Netherlands. We expand that now until the end of Q2 to 10 countries. And by the end of the year, we will have 30 countries in our launch -- or where we have launch activities. We are committed to increase our manufacturing volume. We will increase that in Europe tenfold compared to the start of this year. And we are also committed to spend USD 0.5 billion in the U.S. to build up the CGM manufacturing hub in Indianapolis. And last but not least, we are also committed to further improve our CGM system, Matt has already mentioned how our version 2 and 3 will look like. But what I also can also say today that it is our plan to provide sensor factory collaboration within the next year. As you can see and to summarize, we are very confident in our updated near patient care strategy and in our portfolio that we are currently developing to become a leader in the decentralized setting. And with the patient and the customer always in the center of what we are doing. With that, I'm happy to hand over to Benjamin.

Thank you, Ildikó. Good afternoon, everyone, and a very warm welcome from my side as well. My name is Benjamin Lilienfeld, I'm responsible for our clinical chemistry, immunochemistry, and mass spectrometry systems. The total IVD market size 2024 was CHF 65 billion, out of which CHF 5 billion were still derived from COVID sales sharply declining. The serum work area market size was CHF 28 billion, growing at 5%, outperformed by a strong Roche growth of 8%. We are a clear market leader with 26% market share, more market share than #2 and #3 combined. This 26% translate into CHF 7 billion sales with CHF 5 billion derived from immunochemistry and CHF 2 billion from clinical chemistry. Now Matt and Palani already told you that we had been launching a lot of new instruments in the past several years. And 2024 was really a peak launch year. In CE markets, we launched a new high-throughput clinical chemistry analytical units, cobas c 703 and cobus ISE neo, which are part of our well-established cobas pro integrated solutions. Later this year, we will bring these solutions into the U.S. as well and in 2026 into China. Also, we launched the cobas pro serology solution for infectious disease, serological screening of blood and plasma donations in the U.S. And we launched the China -- localized China manufactured cobas e 801 in China for China in order to address some of the requirements that we have to fulfill for some tenders, asking for a locally manufactured product. Of note, we will do the same in 2026 with the cobas c 703 and cobas ISE neo, really committed to being successful in China. Of course, 2024 was also the launch here of our revolutionary cobas Mass Spec solution. We launched it in CE markets at the end of the year. And this year, we will start launching it in the U.S. with the lower regulated assays, the so-called class 1 exempt assays, also submitting to the U.S. for full FDA approval expected in 2026. In 2027, we will then bring this revolutionary new solution also to China. Last but not least, we're also investing into a low-volume immunochemistry solution, the so-called cobas smart e. We are planning to launch this in CE markets in 2027, and I will talk at the end of my presentation a little bit more about this. As you can see on this slide, since the launch of our new generation instruments, cobas pro and cobas pure integrated solutions in 2019 and 2021, respectively, we have seen a huge uptake of these new generation systems. Last year alone, we installed over 4,500 cobas pro analytical units, a growth of 60% and over 2,500 cobus pure analytical units, a growth of 77%. This really forms a strong basis for a continued revenue growth that we will see in the years to come. And it is a very important step for us to move away from our older generation system to our latest generation of systems in the market. Now last year, I was standing here, also with music and launching the Mass Spec solution. This year, I will talk a little bit in more detail about this revolutionary cobas Mass Spec solution. The first and only fully automated, fully integrated, and easy-to-use IVD solution for clinical Mass Spec testing. It is also part of the well-established cobas pro integrated solutions and therefore, seamlessly integrates into clinical chemistry, immunochemistry and the whole routine lab environment with lab automation and IT. With the cobas Mass Spec solution, we fully automated and simplified the whole process, all the way from sample input to resolve output with an IVD compliant standardized result for the laboratory and the physician. In the next few years, we're planning to launch over 60 different analytes to get a broad assay menu of high medical value analytes on this cobas Mass Spec solution. This year alone in CE markets, we will launch 40 different analytes, and we'll talk a little bit more about that in a second. All of this will increase the patient access to standardized Mass Spec testing and will allow us to enter into a completely new business segment with the goal to reach CHF 1 billion yearly sales at the end of this decade. But it's not just about the sheer number of assays that we want to bring to cobas Mass Spec, it's really also about its clinical utility. And one application that is important is shown here. And that's the estradiol measurement in breast cancer patients. Many breast cancer patients are treated with endocrine therapies, suppressing estradiol production for several years. Now this suppression is not always 100% efficient. And that's why it's important to regularly monitor the estradiol levels in the blood of these patients. Doing that with a standard immunoassay with a relatively low sensitivity and the high limit of quantification might mean that you see an insufficient estradiol suppression relatively late. On the other hand, using a high sensitivity assay with a low limit of quantification, such as the cobas Mass Spec estradiol assay means you can earlier detect ovarian Escape as well as early breast cancer events and, therefore, potentially reduce the risk for cancer recurrence. Coming back to our ambitious launch plans for our assays that we market under the brand name Ionify. On top of this slide, you see our rollout plan for this year for CE markets on the lower part for the U.S. I mentioned before that we got approval for the system, the Cobas i 601 as well as the first 4 steroid hormones, including estradiol at the end of last year. Early this year, we received CE approval for Vitamin D. We're very close ahead of receiving the immunosuppressive drugs, CE approval as well as approval for 7 additional steroids. And in the second half of this year, we plan to launch the rest of these 40 analytes in CE markets, including important therapeutic drug monitoring analytes, including antiepileptics and antibiotics. In the U.S., in '25, we will focus on the lower regulated assays, the so-called class 1 exempt assays. We already submitted vitamin D to the FDA for clear categorization, and we expect that to happen in the next 1 to 2 months. The other six steroid hormones that are under this class 1 exempt category will be submitted to the FDA during the course of this year, and we expect to have them available by the end of 2025. Also, towards the end of 2025, we will then submit additional wave 1 assays as well as the instrument to the FDA for full clearance expected next year. Looking overall at the regulatory approval time lines, I mentioned CE approval received at the end of last year. Important to note that we are focusing our commercialization approach to selected markets with a really high business potential. Later on, we will then go also into additional markets to expand our commercial activities. Outside of the U.S., we also have -- sorry, outside of CE, we also have received a number of local approvals, including Canada in North America, Brazil in Latin America, Saudi Arabia, in the Middle East and Japan in Asia Pacific to just name a few. Of course, we have started to successfully install commercial placements for cobas Mass Spec solution around the world. And the feedback from customers is extremely positive. But before I talk to you about how much our customers love the cobas Mass Spec solution. I'd rather have you hear from them directly. [Presentation]

Now before I hand over to my colleague, Olivier, who's going to talk about our reagent portfolio, I would like to come back to our new low-volume immunochemistry analyzer, the cobas smart e, which we'll plan to launch in CE markets in 2027. The cobas smart e is designed to have a throughput of up to 60 immunochemistry tests per hour. It's a really compact benchtop system with less than 1 square meter footprint. And on this very compact footprint, it has space for 36 sample and 36 reagent positions. That means the laboratory can run a really broad assay menu simultaneously. Importantly, it uses the very same reagent carrier as cobas e402 and cobas e801, making it a suitable backup analyzer as well as a suitable analyzer for satellite labs. This cobas smart e will help us to keep our strong foothold in the low-volume market that has a market size of roughly CHF 1 billion and where today, we have installed more than 18,000 cobas e 411 analyzers. It is also designed to be suitable for remote areas, very easy to use, minimal maintenance and service needs, low water consumption without the need to continuous -- for continuous water supply as well as dust protected. And with this, I'd like to thank you very much for your attention, and I'm happy to hand over to Olivier.

Thanks so much, Benjamin. It's great to see the success of our new instrument lines. My name is Olivier Gillieron. I'm the life cycle leader of cardiometabolic and neurology, and I'm pleased to be here to provide the overview of our assay pipeline in Core Lab. As presented earlier by Palani, our key focus disease states are cardiometabolic, oncology, neurology and infectious diseases. We have 2 complementary strategies to drive our menu expansion. First, we have competing disease-specific menus, which allows customers to consolidate the testing and drive the efficiency in the lab. And secondly, we're developing highly differentiated medical value solutions, which have the potential to improve the standard of care and patient outcomes. In the next few years, we plan to launch more than 5 new assays per year. This includes a total of 24 new solutions in the next 3 years and up to approximately 50 new solutions until 2030. In my presentation today, I will focus on the key portfolio highlights, which you see outlined on the left side and which will all come to market between '25 and '27. So let's kick it off with cardiometabolic diseases. Our ambition is to set a new standard in the diagnosis of an acute coronary syndrome. How do we want to achieve that? First, we're launching a new generation of our troponin assay. And secondly, we're building an integrated solution, which combines biomarkers, technologies and digital solutions. Our new troponin assay will be the most sensitive assay on market. We will launch it later this year in Europe. We have validated the assay in a global trial across 89 sites, which will enable us to validate additional biomarkers with the potential to further improve the rollout performance of troponin. On the technology side, as mentioned by Ildikó earlier today, our goal is to have unified cutoffs across settings and technologies, including our highly innovative platform, cobas sense at the point of care. And finally, on the digital side, linking back to Moritz presentation, we are automating and standardizing the calculation of the 1, 2 and 3 hours algorithms through our navify chest pain triage solution, which is part of our navify algorithm suite. By combining and implementing these solutions, physicians have the potential to reduce overcrowding in the emergency department, improve workflows, optimize resource utilization and standardize the diagnostic process across settings. Now let me move to lipoprotein A. One in 5 people have an elevated Lp(a) globally. This is why it makes sense to measure Lp(a) at least once in a lifetime in every adult to assess the cardiovascular risk. Our Lp(a) assay is the first FDA-cleared molarity assay. This is important to highlight because modularity as per all major guidelines is the unit of choice when it comes to measurement and reporting of Lp(a). We believe that Lp(a) testing will significantly increase over the next years, not only because of the screening application, which I mentioned, but also because there are 6 novel Lp(a) lowering therapies in late-stage clinical trials, which will come to market soon. Our Lp(a) test will help identify those patients who may benefit from these treatments. We are leveraging our extensive expertise in pharma collaborations, which was mentioned by Jill earlier today, to drive specific partnerships with multiple pharma companies in this space. Speaking about pharma, I'm truly excited that Roche Pharma is reentering the cardiovascular and metabolism space. Through our acquisition of Carmot, our collaboration with Zeeland and our partnership with Alnylam, we get access to a broad portfolio of differentiated assets spanning across obesity, diabetes and hypertension. Earlier this year, we have also announced our collaboration with Harvard University to launch an innovation hub in Boston. Internally, we are leveraging our deep understanding of the disease area on the diagnostic side to drive the pharma diagnostic collaboration. This includes our leading biomarker portfolio, our technologies for solutions across setting and our extensive network of global key opinion leaders. I'm truly excited about this collaboration opportunity, and I'm convinced that moving forward, we will make an impact on patients together. Now let me shift gears and move into liver disease. This is an area where as Roche, we are providing comprehensive solutions along the patient journey spanning across diagnostics, pharmaceuticals and digital solutions. MASLD, which is metabolic dysfunction-associated steatotic liver disease is the most common cause for chronic liver disease, and it affects approximately 30% of the world's population. Here, a suite of algorithms may help with the patient triage, including the FIB-4 score, the ADAPT score and later in the patient journey, the GAT score. Our latest addition to the portfolio is our Pro-C3 biomarker, which was launched early this month in Europe and is part of ADAPT. ADAPT is composed of age, diabetic status, Pro-C3 as a biomarker and platelet count. And the algorithm is used to assess the severity of liver fibrosis in patients with MASLD. This will enable physicians to early identify patients who may benefit from existing treatments, but also novel treatments which are emerging. Again, this is a space where we have closed the first collaboration with our Pro-C3 assay with a big pharma company, and we believe there's more opportunities to come in the near future. I will move now from liver disease into neurology and more specifically, Alzheimer's disease. Our goal here is to drive the timely diagnosis of patients with amyloid pathology so that these patients get early access to novel disease-modifying therapies such as lecanemab, donanemab, but also our own internal and very promising asset, trontinemab moving forward. We have complementary solutions along the patient journey, including our cerebrospinal fluid tests, which are used for the confirmatory diagnosis of amyloid pathology and our exciting blood-based biomarkers, phospho-tau 181 and phospho-tau 217. Phospho-tau 181 is used for the rule out of amyloid pathology and will be launched later this year, whereas phospho-tau 217 may be used for both the rule out and rule-n of amyloid pathology and will be launched next year. Let me take the opportunity to share the most recent data, which we have also presented at CTAD last year and ADPD earlier this year. Phospho-tau 181 has a strong rule-out performance at a negative predictive value of 96%. We have validated the test in a population across settings, which we believe will facilitate and enable implementation into clinical practice. On the phospho-tau 217 end, we have shared first promising results, which suggests that the test can be used for both rule-out and rule-in at a reduced gray zone compared to other available assays. We are further expanding our solutions into the digital space, where we are validating solutions for cognitive screening, which may serve as an entry point into the patient journey. And we continue to drive our collaborations with pharma to further expand our menu, both in amyloid pathology but also beyond. I will move now to the last disease area, which is infectious diseases. Infectious disease testing is actually the biggest market within Core Lab, and this is also one of the reasons why we continue to invest into this space. I will share 3 examples. Tuberculosis is a global health challenge. Approximately 25% of the global population is infected with latent TB. This is why establishing testing is really critical. With our interferon gamma release assay, we're addressing a highly attractive market, and we believe that we're in a strong position to drive the adoption of the test because we can leverage our large installed base, we can automate and consolidate the assay on single platforms, and we are providing solutions for different settings, such as highly automated solutions for high throughput labs and as presented by Benjamin earlier today, benchtop analyzers, which are smaller, which can be leveraged in decentralized settings or smaller labs. The test will be launched, as Palani outlined in the Q&A in 2026 in Europe. The next 2 examples are dengue and Lyme disease. These are diseases with an increasing prevalence globally based on the climate change. Dengue on the left is the most common mosquito-borne viral disease globally with up to 400 million infections per year, whereas Lyme on the right side is the most common vector-borne disease in the Northern Hemisphere with approximately 0.5 million new cases per year in the U.S. only. We are developing all relevant tests in these 2 diseases, including the dengue antigen test, which is used for the acute infection, but also all relevant immune response test. We plan to launch these solutions in the next 2.5 years in Europe. And with that, we will be in a strong position to drive menu consolidation and tap into 2 highly attractive market segments. So let me close my session with a summary. Until 2030, we plan to launch approximately 50 new tests in Core Lab. This includes a total of 20 differentiated medical value solutions. With that, we're addressing important unmet needs in key focus disease areas. We believe we are in a strong position to drive the adoption of these tests because we can leverage our large installed base of more than 47,000 Lexis instruments and our direct presence in more than 150 countries around the world. And I hope that I was able to show you how we are taking a differentiating approach by building integrated solution, but also systematically leveraging pharma partnerships to expand our menu. With that, thanks a lot for your attention, and I would like to hand over to you, Birgit, for the second Q&A and invite my colleagues on stage.

Okay. I think we are now ready to take questions on the second set of presentations. First question goes to Emily Field from Barclays.

The first is just on the CGM. Given the expanding obesity portfolio with the recent Zeeland collaboration, I was just wondering how are you thinking about expanding CGM uses outside of type 2 diabetes and into obesity, if you plan to incorporate that into any of the therapeutics clinical trials? And then a second question just on CapEx. The $50 billion announced investment in the United States, I believe it just for diagnostics specifically mentioned the build-out of CGM capacity in Indiana. I was wondering if you could elaborate on if you're expecting any of the tariff announcements thus far to change the rest of your diagnostics CapEx or development plans at all?

Sure. Maybe Ildikó, if you want to take the CGM and I'll talk about CapEx. Does that work?

Yes, sure. Thank you for the question. I mean, as Matt actually showed on his slide, obviously, we don't want to stop just with CGM in insulin-treated patients, right? We want to also expand that to MDI patients. We're also looking actually into other disease areas in comorbidities, how can we tackle really a diabetes patient and patients that have diabetes and potentially renal disease or also heart disease holistically. That includes potentially other biomarkers that includes also other digital solutions, for example, and also other areas, let's say. And from that point of view, yes, absolutely, we go further than just the indolent treated diabetes patients with our CGM solution. And maybe I think Moritz wants to add something here.

Just to add something very specific as well to your question. So there's areas of, for example, managing the titration into those type of therapies that offer large areas of synergies, all the way to thinking about an ecosystem for patients with supporting services that can be attached to that.

Yes. So it's good to have so many alumni of our diabetes program in here today. To address your question of CapEx, so I would just first say, we're full-scale manufacturing. We're full steam ahead for our facility in Manheim, right, for rest of world. For the U.S. That investment is specifically targeted towards the U.S. confirmation of this product, which will be different than the one we launched rest of world. So it is independent of any sort of tariff-related topics. It's a specific strategic investment. On the tariff-related topic, I would just refer you back to the comment Alan Hippe made at our Q1 results that as far as it relates to our understanding of the tariffs today, it in no way changes our guidance for 2025.

Okay. Next question goes to Harry Gillis from Berenberg.

Starting on the mass spec, could you perhaps discuss in a little bit more detail maybe how the launch has progressed so far relative to your expectations this time last year? Maybe both on instrument placements and the assay rollout time line. And you highlighted the positive feedback from your customers so far. So with these early adopters, have you seen any customers place additional orders after gaining hands-on experience with the solution? And just a final one, going back to the sequencing, if I may. So you helpfully provided the ambition for $1 billion mass spec sales contribution by 2030. I was wondering if you can give any figures or metrics that you're targeting with the sequencing launch. I appreciate specific sales is something you might not give at this point, but any other metrics that we should keep an eye on over the coming years?

Yes, sure. So thanks a lot for the questions on mass spec. I think thinking back 1 year, we're really nicely on plan with our placements. In fact, what I think is worth highlighting is that it's not just the number of placements, which is in line with our expectations, but we have really a broad global coverage already. They have placements in several countries around the world, and that's a really good sign. We had 8 different multicenter evaluation sites. Some of them are still running. And it's always a good sign if the multicenter evaluation decides to keep the instruments later on. So to your point about positive experience, this is really positive experience and maybe a little anecdote here. Someone stated that this system is really boring because it's so easy to use. So I think that's exactly what we want to reach.

And I'll take the question on the sequencing side. So if you remember last year when we gave that out, that was the year of launch. As we said, this is going to be in 2026, and I think we'll continue to provide more detail as we get closer. But I would echo back to what you heard from Josh and Palani. The feedback from the community has been very positive. You've seen the unprecedented throughput, the ability to approach applications in a very novel and flexible way. So I think we see tremendous potential for this platform, and we look forward to talking more about it as things get closer.

Okay. Next question goes to the gentleman here.

Kyle Mikson from Canaccord Genuity. A couple of questions. First for Jill on like AI diagnostics. You were talking about that a bit, the RxDx device too. Any like -- is that a bottleneck, especially in the U.S., like reimbursement for AI-based diagnostics? How do you think about that? Secondly, on the neurology business. So the pTau217 assay, you mentioned that could like reduce the gray level or gray zone by a bit. I mean, can you just provide some like quantitative metrics like competitively speaking, what that means for that intermediate zone? And secondly, just on that point, would you ever consider using mass spec for Alzheimer's disease diagnostics? Or is Elecsys the method of choice there?

Maybe I'll start with the response to the AI and diagnostics. Any time that you have a brand-new technology, you can always expect that you have to create the access and the reimbursement, and we're actively in that space right now. So I have confidence actually that the diagnostic device and solution itself creates the value that will need to be seen. So I feel really good there. And remember, this is not a launched product yet. So we still have that time to really create the right adoption that we would want to see when we get to market. So definitely on our radar and definitely something that we will accomplish. Does that answer your question?

Yes, that was great. On the neurology side too, maybe you want to take...

I'll start off. So the data we have shared so far is a meta comparison in the CREAD 2 population that was back at CTAD. And there, we basically showed a reduced gray zone of around 12%. Now the gray zone will always depend on the prevalence in the respective population. So it's really important to highlight this fact. And moving forward, we expect actually more and more data to be generated on our phospho-tau 217 assay. So really stay tuned as well. We plan to present more data also at AAIC in July this year.

I can quickly comment on mass spec. Look, I mean, it comes down to the performance of the assay. And currently, we feel very confident about our immunochemistry assays, the phospho-tau 181 as well as the 217, the early data that we are seeing and what we're expecting to see. So we have to kind of go with what's really needed. Now in the future, last year, during the same -- when we came together, I was mentioning where mass spec can be very interesting in the future when we are looking at large molecules is post-translational modifications. If you're looking for those kind of modifications, there mass spec can play a role. And that's something that we will down the line, keep in our minds to how we might want to look at large molecules as well with mass spec. But we don't necessarily need to bring a mass spec if it's not needed if the performance is really good with our assays.

Yes. And I would call out that the R&D organization with Ildikó and Palani is looking even beyond mass spec to different future methodologies, we could even get to attomolar levels of protein concentrations and we build out our long-term R&D road map. So I guess I would completely agree with the comment. It's going to be driven by the need and we're going to address the clinical need with the right technology. I think that's the power of Roche is that we have such a broad portfolio of technologies, and we will apply those in the ways back to where we started the kickoff today to those areas with high unmet need as appropriate.

Okay. The gentleman here in the third row.

Tejas Savant from Morgan Stanley. Just a couple of quick follow-ups for me on the sequencing side of things. So would you consider launching a separate box for the mid-throughput setting? Or is the primary focus just high and ultra-high throughput? The reason I ask is there is some sort of rationale to capturing those customers early and sort of growing with them as their volume needs increase. And secondly, how do you view the fact that having Foundation Medicine as a captive, albeit arm's length subsidiary complicates that sort of selling process for other clinical customers? So Brian, do you want to take the first one?

Palani, do you want to take the first one? I'll take the second.

I can take the first one. Look, that's the thing. I think there is sort of a mind shift change that has to happen with our sequencing technology versus a sequencing by synthesis method that is most prevalent right now. And as Josh was sharing earlier, we don't necessarily see the needs for different essentially instrument for different throughputs or so on and so forth. At the end of the day, cost-wise, it has to make sense to the customer. But our sensor module with the reuse of the sensor module, also the way we are also modularizing our compute modules because the compute modules can be -- the needs may be different for different kinds of customers. And we are also modularizing it so that customers invest based on what's needed for them. So we are not thinking along those lines of like how traditionally in sequencing by synthesis, there is this kind of small, mid, large, that kind of. So that's -- and that's the beauty of our technology is you don't need to kind of go in that direction.

And to take your question about does it complicate our relationship with our customers? No. As I said earlier, Foundation Medicine has the option to choose whatever technology that they would use for -- to best meet their development program needs. If there's an opportunity for us to collaborate on decentralization of their products, that's something that we can look at. But again, would double down that they have the independent option to choose the technology platform that's right for them.

Okay. Great. I think we are at the end of the hour. So I would like to really thank the team for the great collaboration on the event. And then I would like to thank everybody in the audience for their attendance and for their interest in the Diagnostics division of Roche. And please join us for an [ up row ] after the event. Thank you very much.