Roche Holding AG (ROG) Earnings Call Transcript & Summary

March 23, 2021

SIX Swiss Exchange CH Health Care Pharmaceuticals investor_day 133 min

Earnings Call Speaker Segments

Operator

operator
#1

Ladies and gentlemen, welcome to the Roche Diagnostics Investor Day 2021. My name is Henrik, and I'm the technical operator for today's call. Kindly note that the webinar is being recorded. [Operator Instructions] Today's webinar is divided into 2 blocks of presentation. Each of these blocks will be a Q&A session we have in the afterward. [Operator Instructions] At this time, it's my pleasure to introduce you to Karl Mahler, Head of Investor Relations and Group Planning. Karl, the stage is yours.

Karl Mahler

executive
#2

Yes. Thanks a lot, Henrik, and welcome to our first, in that format, virtual diagnostic day. We have reserved 2 hours for you, 1 hour for presentation, 1 hour for Q&A. And I think you already had the first impression on this new format, this 360-degree format, and this will be available for your benefit for another 3 months on our website so you can walk through and go down. And more to come today. Today, we'll give an excellent overview of the world's leading IVD company. So IVD is a thing which is analyzed outside of the body. And I have to say, I have actually 2 hopes for today. The first one is that we've all, including myself, increased the knowledge base on the diagnostic business, when Diagnostics is always first and medication is following that. And the second is, my hope is that with this increased understanding, we see also, and this is my IR hat here, a bit more in the valuation of Roche. Because if I look at the sales multiples for other companies, and I look what our beautiful business gets for that in our multiples, I -- actually, I don't see everything fairly reflective, but this may be the destiny of every Investor Relations person. If you could kindly go to the agenda. So this is the agenda for the day. We will start off with the basics. Thomas Schinecker, the CEO, will walk us through the strategy organization, the diagnostic solutions and research represented by Ann and Palani. Then we will have Q&A. This will be led by Birgit. So any complaints, if you cannot raise your questions and so on, please direct it to her. Then, we have half an hour of Q&A. We have 2 blocks of it and Birgit will guide us through. We have in the later part, the business areas, systems, infectious diseases, cardiology and oncology, led by Benjamin, Michael, Andre and Jill. There will be a final Q&A and some closing remarks from Thomas. I have maybe, next slide, please, a few remarks from my side. Overall, the market -- the IVD market was growing mid-single digit and Roche was always growing either in line or slightly ahead of the market. There was a large consolidation ongoing in that market. I mean if you look at some prominent names like the J&Js and the Bayers of the past, they either disappeared or they will, going into other businesses, resolve into other businesses. If you look at the top 5 in 1998 or in 2000, it's always 50%. If you look at 2018, '19, it's again 50%. I have to stress here that Roche was growing here organically. It's the only company here, what you see in the top region, which grew organically. The dia business has high barriers of entry, so the capital requirements is high. It's higher than in pharma. And this is maybe also due to the razor/razorblade model. It is more a lower-risk business. I mean maybe Thomas will disagree with my statement, but if you compare the risk involvement in diagnostics as compared to pharma, pharma clearly has a higher risk attitude or attack. And I would say maybe the [ failures ] of pharma were [ 01 ], a decision that we [ made some weeks ] not least a delay in the diagnostics. And last, but not least, diagnostic is also helping us at the moment to get back to a new mobility in these very difficult times. It will provide, and thus, do already provide a major contribution to get society out of this pandemic mode at the moment. So the instrument of how can it be this one, I wanted to hand over to Thomas, please.

Thomas Schinecker

executive
#3

Thank you very much, Karl, and good morning, good afternoon and good evening, everyone. And yes, welcome also from my side for today's Investor Day event. Happy to take you through the first part of the presentation about the strategy and the organization. On the next slide, you'll see that Roche is the clear market leader in the IVD market, leading in most of the segments with 23.4 billion tests performed. That's more than 3 tests per inhabitant of this world. So diagnostics plays a huge role in the world to make sure that health care is effective. And on the right-hand side, you see an example for one of these installations that are highly automated and high throughput where you can analyze many different blood samples with many different tests at the same time without any manual labor. Now going to the next slide, you'll see that over the last 1 year, we actually went through a global transformation exercise. So we looked at our strategy and how we want to be set up best for the future. And for that, we looked at 7 different strategic segments. Of course, the customers because at the end, if -- only if our customers are happy, we will actually be successful. But we also looked at other things, what are the portfolio segments we want to play in; also, how do we want to fuel our innovation engine, et cetera. And we haven't done this innovation exercise or strategy exercise in isolation. We've actually done it with a lot of different employees, with customers, with experts around the world to make sure that we get a broad input. On the next slide, you see that overall, the health care system has a number of objectives that they want to fulfill. It's clear that there is strong need for health care and that also the related spending is continuously increasing. And in order for the health care system to fund innovation, they, at the same time, need to understand on how they can reduce costs. And only by doing that, they can make sure that the health care system is sustainable and affordable. So the system clearly has been focused to rewards for value for the patient and making sure that you -- that we as a company can improve outcomes and reduce the cost of care because this is what the system needs to do. And I think diagnostics has a huge opportunity here because with the different biomarkers we have, we can actually improve outcomes. And we have a number of examples in cardiology and oncology, and you will hear some later today. But also by targeting treatments much better, by reducing the amount of hospital stay days, we can also tackle the reduced costs. So really, diagnostics is a key lever for the health care system to actually achieve the objective that they have. Now on the next slide, I mean, to be able to address those needs of the health care system, it's clear for us that we need to understand the patient journey in the health care system. So if a patient is in a stage where they are healthy and they're screened, but later maybe in a diagnosis or a treatment and the monitoring setting, what are the different points in the health care system that are not effective? And where are the gaps in the health care system? If we address those gaps, we can either benefit the outcomes for patients or we can also benefit the system with reduced cost of care. And if we think about it also a bit more in the mid to long term, we also believe that today, you have very independent interactions with the health care system. But if we can really guide patients more in a patient-centric way, longitudinally, through the different stages of their disease, we can further improve outcomes and reduce cost of care. Because today, each intersection is like a onetime event and it's completely forgotten until the next time that you go to the doctor. So we believe that there's a huge opportunity here. Going to the next slide. And we want to address the needs from the health care system to improve outcomes and reduce cost of care really pulling on 3 levers. The first one is to deliver medical value on integrated testing solutions. Today, we have the most automated solutions in the markets. From our 6800, 8800 in molecular, but also in our core lab, we have highly automated solutions that really help us reducing the cost in the system, making also the quality of care higher because there are less mistakes that happen through manual interventions. But what we also have is we have the broadest menu of tests on these solutions. And our customers need that. They don't want to interact with too many different instruments, with too many interfaces. So they want to make sure that they actually deliver all of the medical value content that they need on as few systems as possible. And today, we have more than 500 markers across our portfolio, and we are constantly increasing this every year, and we really want to push the boundaries here because there's still so much unmet medical needs. And specifically, when we look at these patient journeys, we have clearly identified areas where we can improve outcomes and reduce cost of care. Now given that there is so much content that we can deliver on our systems and given that the health care system and the information about diseases and also the diagnostics capabilities, it really increased exponentially, it's almost impossible for doctors to always be able to make the right decisions because just there's so much data. And we believe through artificial intelligence, through health care decision support solutions, we can actually enable better and more confident health care decisions. The decision is still being made by the doctor. But through digital solutions, we can help guide those more like a navigational system. Now really to take then to the third step, to really improve care along patient journeys, really building more the health care system around the patient rather than everything being built around the health care system. This is really where the health care systems aim to go in the future with value-based health care, et cetera. And for that, we can bring together a couple of different modalities. We can bring together our diagnostics capabilities, our digital capabilities, but also working with pharma, we can bring together diagnostics therapy and clinical decision support. And this is what we are doing in the third axis, and you will see some examples there as well. And with those priorities, we also address our 10-year ambitions from our group as well. Now going to the next slide. As a consequence of our strategy, we also looked at how we set ourselves up for the future for 2 reasons. One is for the customer, so that it's easier to do business with us. So they don't have to interface with too many different business areas. But really get more holistic solutions, solutions that touch different modalities of technologies and disease areas that otherwise would be too fragmented. So we can really think about that more holistically. And -- but also in terms of when we looked at ourselves internally, we can reduce complexity by not having duplications for different functions across too many different business areas. So what we've done is we've combined 3 business areas into 1 which is called the Roche Diagnostics Solutions. And we've actually combined 4 different organizations that were dealing with digital products to 1 solution, also being able to serve from 1 hand with a common look and feel. Now going to the next slide, please. Now this will also mean that from a reporting perspective, we will also change a little bit from the reporting side. So first, on the top side, what we have included now is the 4 different customers area heads -- customer areas: core lab; molecular lab; point-of-care; and pathology. And diabetes care, which is the stand-alone business unit, as we had communicated a couple of years in the past. But with those, we really focus on those customer segments. And at the same time, in the past, we had Japan reported separately. Now already for a couple of years, Japan is actually part of Asia Pacific. So in terms of reporting, we said then it only makes sense to also include that in Asia Pacific. Going to the next slide, please. Now it was clear that if we want to further invest into research and development, we also need to take it from somewhere. And by simplifying our organization, we can free up resources due to these increased efficiencies, and we'll reinvest that into the strategic focus areas. We are already investing more than anyone else in research and development. But really, if we want to fund more of the incredible opportunities that we have around medical value solutions, which includes new biomarkers, digital solutions and insight generation, clinic decision support, but also disease management capabilities and access capabilities, we also wanted to make sure that we take the money from areas where it doesn't create value for patients and for the system, to really put that in that direction where it does actually create the value, and we can then benefit as a return of that, from that value that we generate. Now going to the next slide, please. Now let me just take you through the 3 different levers of our strategy. First, the one around delivering medical value and integrated testing solutions. As mentioned, we have 4 customer areas that we serve here: core labs; molecular labs; pathology; and point of care. We have different products that we offer: systems, assays, digital and IT solutions, but also services. And there are 4 areas on how we strongly differentiate also versus our competition. The first one is around medical value. We have, by far, the biggest and broadest menu of tests. But not only that, we have the most differentiated menu. So we have really highly innovative markers, and we have a full pipeline of additional markers to come that we are really excited about. And I believe this is differentiating us from many of the other players who have maybe not as much expertise on the medical side as we have given our combination also with pharma and the folks that we've had over many years. The second part is around efficiency. These labs, and you've seen a picture in the beginning, need to be highly, highly efficient because the majority of the costs in a lab is personnel. And if they can do more of the testing at the same amount of people or even less people, this is what the labs are really looking forward to, and we have really a new generation of different platforms that really truly enables that. And so we are also extremely well positioned here. Another great example, I think, is on the molecular side, where we have the most automated solutions in the market. The third piece is around digitalization. And here, we've done an acquisition, for example, also around UX, where it helps labs really optimize the lab in a very good way, also helps labs work with the clinicians to make sure that clinicians order the right tests. And this is something that we have seen in the past when we've done installations of UX that actually people presenting the same symptoms don't always get the same amount of testing and not always according to the guidelines. And with that, we can really influence the clinical decision-making to digitalization. And the fourth piece is around access, where we've done a lot around preeclampsia and HPV, which Ann will talk about as well. Going to the next. Here, this part is around enabling of confident health care decisions. Next slide, please. Here, we have solutions for labs. We have solutions for providers and for patients. Products that we have in here are platforms, applications, also marketplace. We can guide lab and clinical workflows, support clinical decisions and also disease management. What's critical here is to have a good running platform that helps build different applications on top of that. Also, this platform will need to enable an efficient operation in the different hospitals. You can imagine when sometimes maybe the wrong kind of testing is done, guiding the right testing through clinical efficient support solutions will make it more efficient. There will be less stays in hospital. There will be more correct procedures and also better treatments. And then really guiding through clinical decision support solutions, we can also improve the outcomes for patients. So again, this is an area where we can improve outcomes and reduce cost of care. And using that data, we can then also support hospitals but also providers to generate insights to really understand, okay, how can we better treat chronic diseases in the future so that we can reduce the amount of hospital stays. Going to next slide, please. This is the part about improving care along patient journeys. Now today, it's really about understanding, from a patient perspective, where is the gap in the health care system. And how can we improve the care for the patient and the outcomes for the patient by filling that gap in the patient journey, really looking at it from a patient perspective. But also in the future, as value-based care will be more prominent, hospitals, but also health care systems, will look more at companies to help them really provide solutions, combine solutions between digital, medicines and diagnostics to improve, for example, the care of chronic patients, to really bring down the cost in the health care system. And the health care systems need to partner with companies such as ours to really do that effectively. And we'll have some examples for atrial fibrillation and also diabetes care. Next slide. Yes, so at the end, this is the 3 areas that we're really focused on. Clearly, this we can only do with the best talent in the industry. We will shift money to invest into our strategic priorities to even spend more in research and development, but taking it from areas that don't create value. And with that, we want to continue to grow our market share. Next slide, please. With that, thank you for now, and I hand over to Ann.

Ann Costello

executive
#4

Thanks a lot, Thomas. Hello, everybody, and a warm welcome from my side. My name is Ann Costello, and I head up the newly formed Roche Diagnostics Solutions business area. And I'm very excited to give you an overview of our strategic priorities and share some examples of how we're actually driving medical innovation on our integrated systems. So with that, let's move to the next slide. We can have a look at our overall structure. As you heard, Diagnostics Solutions is a key contributor and will remain a key contributor of our revenues over the next 10 years. But it's important we continue to drive the business for it. And to do that, we want to do that really by understanding sort of the demands that are put on the labs to do more testing with less. And really, we believe customer centricity or intimacy is the key to success here. And from our side, we have decided to evolve our structure from a focus on technology to a focus on customers and ultimately, as Thomas said, on patient outcomes. Now we are organized into 4 different customer segments, core lab. Core lab is really the workhorse of diagnostic testing. It's covering immunology, clinical chemistry, hematology and so on. In the molecular lab, of course, big areas like virology, microbiology and more and more clinical genomics. The pathology lab covering the histology and cytology testing. And then point of care, which really spans everything from the satellite lab to patient self-testing. Now with the health care budgets coming under pressure, our customers are looking to companies like us to help really solve their pain points. They don't want just another supplier of instruments and assays. They're looking for much more. They expect comprehensive solutions and really a unique experience that's personalized for them. And when we talk about a comprehensive solution, we're talking about solutions that cover everything, all the nuts and bolts, full automation, digital tools like clinical decision support tools, IT connectivity and value-added services such as consulting or remote servicing. These are really important components. But what's really important from our side is that the solution works seamlessly. Everything is integrated together and that we can provide that customized solutions to meet our customer needs and to provide them with meaningful value. Now if we go to the next slide, we can have a look at some of these solutions. We strongly believe that differentiation comes from developing better and more innovative products and solutions much faster than competitors. And we've defined 4 pillars of differentiation here: medical value; diagnostics efficiency; digitization; and market access. And let me talk you through some examples here. So if we look at the area of medical value, we're really focused on those top disease areas with the biggest burden, cardiometabolic disease, oncology, infectious diseases and of course, up and coming CNS. And as you can see here, we have 9 breakthrough devices under our belt. And that shows really that the FDA recognizes the potential benefit of these assays. And Palani will talk more in detail about those individual assays. Now in the area of lab automation, and as you know, this is an area where we have been at the forefront for many, many years, and we continue to innovate in this space. And just to give you an example, we recently launched the cobas prime, a fully automated pre-analytical system that streamlines the workflow molecular labs. This is really the first of its kind. We're bringing a complete end-to-end solution for molecular testing here. Then jumping on to the digital side of the house here, digital technology has basically transformed our lives and the way we work. And it's, quite frankly, no different in the lab where digital solutions can really help drive quality and speed and allowing better interpretation of testing results. And let me give you a couple of examples here. One is in the area of digital pathology. For example, here, we have the uPath workflow software, which allows pathologists to move seamlessly between multiple slides in a single view, something that you can't do with a normal microscope. Another area is what we call the v-TAC, and this is in the area of blood gas analyzers. We recently launched a digital algorithm that calculates arterial blood gas values from venous blood which, of course, is much more convenient and much less painful and invasive for the patient. Looking at the fourth pillar is market access. I mean what's clear is one side of the coin is innovation, but we need to make sure that innovation is reimbursed and it's getting to the patients that need it. Again, here, I think we can be very proud of some of the great progress that we have made in getting adoption of new technologies and biomarkers. An example of this, of course, is cervical cancer, where we have generated both clinical as well as health economic evidence to really drive the uptake of HPV in primary screening. Another great example is preeclampsia. Preeclampsia is a pregnancy complication and it's characterized by high blood pressure. And it can occur in about 1 in 20 pregnancies. If it's left untreated, it leads to very serious complications for the mother and baby. And it is already associated with significant health care cost. With our test, we are able to reduce those unnecessary hospitalization of the mothers by having a look at are the mothers at risk of developing preeclampsia and of course, identifying those actually who are high risk and that need to have the appropriate care. Now speaking of that innovation, I want to talk about our SARS-CoV-2 portfolio. And if we move to the next slide, we can talk again about all of the areas that we were quickly able to innovate in SARS-CoV-2 and our contribution to the pandemic. Now it's almost 1 year to the day, right, that we brought the very first PCR assay to the market in absolutely record time. And since then, we've continued to rapidly develop a portfolio of solutions that help to detect and diagnose the infection as well as providing digital support for health care systems. The depth and breadth of our technology was a huge asset, allowing us to really develop different assays very quickly to address the clinical questions that were coming up as well as providing solutions for the different settings, from the clinical labs and all the way to the point-of-care setting. And just last week, actually, we were very proud. We were able to bring the first PCR variant test to the market. Again, really responding to those customer needs. Developing tests is just one part of that story. And once you've developed the test, you need to be able to manufacture and deliver at scale. And that's what you're going to see on the next slide, that we've made some very significant investments here. As the demand for COVID testing just came sort of unprecedented, we needed to ramp up and we needed to respond very quickly to meet that demand. And we invested heavily across the entire portfolio and the value chain. Everything from raw materials, manufacturing lines for reagents, consumables as well as investments in the instrumentation side, all in all, we have invested about CHF 600 million and put on about 1,200 people to be able to do this ramp up so fast. Again, I think this really speaks to the idea of the capabilities of Roche Diagnostics and our ability to quickly respond by bringing together that expertise as well as the innovation that's needed to really maximize that capacity and bring the tests that are needed. If we go to the next slide, please. Now during the days of the pandemic, I think we're all aware of how governments and health care providers found themselves on the back foot when it came to testing infrastructure. They simply didn't have the testing capacity, the instruments in place to be able to respond quickly. And that's what they had to do. They had to really step up that capacity. And certainly, we were a strong partner for them to do that. Again, it speaks to the strong position we had. We were able to respond very quickly. And as you can see on this slide here, we were able to increase -- we saw an increase of about 42% in our installed base of the 6800, 8800 full automated instruments compared to the end of 2019. And we actually see this continuing as hospitals and labs continue to invest in molecular systems. We're aiming at an installed base of 1,600 to 1,700 instruments by the end of 2021, which means we would have doubled our installed base. So if you could just move to the next slide, please. The ongoing pandemic has really underpinned the central role that diagnostic plays. And I think something that has always sort of been in the background has come to the forefront. As you heard from Thomas, all good diagnoses are done by diagnostic testing. And it's really important that labs continue to be able to generate that. And that's where we're looking to the future. We're expecting more consolidation of labs and we're expecting a shift to full automation, which is really in our wheelhouse because that's the important part, is to be able to increase the efficiency as well. And we're seeing that in a number of areas. You probably have seen from the media as well. The U.K. are creating these 2 mega labs with testing capacity of greater than 600 tests per day. And that's to add diagnostic capacity, not only for COVID, but of course, beyond COVID for critical diseases, including cancer. And I think with our growing installed base, we find ourselves in a really strong position to be able to leverage our portfolio of assays and future pipeline. If you go to the next slide, please. So let me just say a final word on GenMark. As you have seen last week, we made -- we signed a definitive merger agreement with GenMark Diagnostics to get access to their novel technology and broad range of pathogens that they can test for with a single patient sample. The GenMark syndromic panel testing will absolutely broaden and complement our current molecular diagnostics portfolio. And we're very excited about that prospect. We also believe that our commercial network, which is very broad and global, will certainly open up new opportunities in new markets. So with that, let me hand over to Palani to talk us through our R&D activities.

Palani Kumaresan

executive
#5

Many thanks, Ann. A warm welcome from my side as well. I hope you're doing well and staying safe. My name is Palani Kumaresan. I'm the Global Head of Research and Development for Roche Diagnostics Solutions. And in the next few slides, I would like to walk you through our approach to medical value innovation. But before I do that, first, I would like to show you a number around what Thomas mentioned, which is our investment in R&D. As you can clearly see from this chart, we are clearly out-investing our nearest competitors when it comes to R&D because we truly believe that this is what will really usher us into the future with the innovative solutions that Thomas also highlighted across both medical value but also the insights business. The additional point that I would like to make is in the next slide, you'll see by bringing R&D for the first time under 1 umbrella for Roche Diagnostics Solutions, we can also drive some important efficiencies. We are looking at increasing organizational effectiveness as well as improving project delivery. And what do I mean by these? By bringing R&D under 1 umbrella, we can clearly look at areas where we can improve standardization and also cross-pollination of best practices across our organization. And we are also very carefully looking to shift funds to those medical value projects and those digital projects versus nonproject activities. When it comes to improving project delivery, we are also looking very holistically at prioritization and going through a very rigorous portfolio prioritization process. And we clearly are looking very closely at that unprecedented grade at which we were able to develop solutions for COVID-19 that Ann showed to you. And we are looking at what are the elements of that we can truly internalize and take it to other parts of our portfolio and development work. With that said, in the next slide, you'll see our approach to -- or rather, our strategy around medical value innovation. Quite simply put, there are 2 elements to this. Looking at a broad menu of our tests and biomarkers that run -- that can run on our broad installed base, that Thomas and Ann highlighted, and especially in the molecular space with the doubling of our installed base, we clearly see having that broad menu will allow for that consolidation on our platforms at their customer sites. And on top of that, the differentiation, the important part is around the medical value solutions. And here, we are focusing on those high disease burden areas: cardiometabolic diseases, infectious diseases, oncology and central nervous system. So in the next slide, I'll show you the approach that we take for these high medical value solutions. So if you follow me, in the top, you see those disease areas that I mentioned and this is illustrative. Now if you take, for example, cardiometabolic diseases, we take a step in and say, okay, what are the key indications with high disease burden within cardiometabolic diseases? And I show you here a subset, atrial fibrillation, coronary artery disease, chronic heart failure, acute coronary syndrome, some of these indications. And in each of these indications, then as Thomas also highlighted, we look at that patient journey. We look at the patient management in different health care systems, all the way from screening, diagnosis, risk stratification and therapy selection/monitoring. And having that broad offering, the breadth and the depth in our portfolio, which is quite unique to Roche, we can then come in and say, where are the key unmet needs? Where can we improve the outcomes of reduced cost? And then we go into a toolbox of our broad menu and say, okay, what do we want to then bring to the market to appropriately address that? So it could be biomarkers. It could be digital solutions. It could be other kinds of innovation. And to make it more concrete, in the next slide, I show you an example of the kind of solutions we have in the market and what we are looking at. To just to orient you to this slide, on the left-hand side, you see the disease areas. Next to them, you see some of the indications, this is again not comprehensive, but some key examples. And the coloring for the indications, as you can see, we are picking from different parts of our toolbox. So there are solutions coming from core lab, molecular lab, pathology lab and point of care. And that's how the coloring shows on the indication. And then you see from the dots, our on-market solutions in development and under evaluation across that continuum of care. And in the second half of our presentation, our experts in infectious diseases, oncology, cardiometabolic, they will give you some examples, walk you in a little bit more detail of some of these innovative solutions that we are working on. Now this is our view. I wanted to show you also the recognition that we have received from the FDA in the U.S. in terms of Breakthrough Device Designations and briefly highlight the number of Breakthrough Device Designations we have had in the recent years. Here, you can see across the key disease areas the different Breakthrough Device Designations we have had since 2018. I won't go through all of them, but for example, to just highlight, say, infectious diseases, in 2018, we received a Breakthrough Device Designation from the FDA for our Epstein-Barr virus quantitative tests as well as the BK virus. Now these are quite omnipresent, but they can -- and they're generally quite fine for healthy individuals, they're in the latent phase or in the dormant phase. But if for transplant patients, this can be an extremely important risk factor. And here, the testing of these patients for these tests is very critical. And based on that Breakthrough Device Designation, we were able to speed up our launch of these tests. And last year, in Q3, we came out -- we launched these tests in the U.S. as well as in the rest of the world. If you have questions around any of the others, I'll be happy to answer during the Q&A session. I wanted to close out my section by showing you what is our delivery agenda for 2021. As you can see, it's quite a busy slide, and we like to keep it that way, this slide. You can see our delivery agenda across instruments, tests and digital solutions and across the different customer areas. And some of these will get highlighted in the second half of our presentation. So I would spare you the details here. But as you can see, it's a very busy agenda, and we are tracking to this as the year is progressing. Thank you very much, and I will hand it back to Birgit to open up the Q&A session.

Birgit Masjost

executive
#6

Hello, everybody, and a very, very warm welcome from my side as well. My name is Birgit Masjost. I'm the Investor Relations Officer for our Diagnostics division, and I will run you through the Q&A. [Operator Instructions] The first question I will take is from Jack Meehan from Nephron Research, and he has 2 questions. First one, I think, is for Thomas: "How are you feeling about supply/demand dynamics in the PCR and antigen markets for COVID-19?" And the second question is for Ann: "What indicators do you have around how the additional cobas 6800, 8800 systems you placed during the pandemic could be used longer term?"

Thomas Schinecker

executive
#7

Yes. Thank you very much, Birgit, for the question. And let me first answer the question around PCR. So looking at current demand on PCR testing, I still believe that the demand is still higher than what at least we can supply at this point in time despite the fact that we are increasing our capacities. And compared to like 3 months ago, where 3 months ago I would have said, well, the entire market has that situation, now I would not necessarily say that anymore. And the reason why I'm saying that is, specifically in the U.S., you do see a drop in terms of the amount of PCR that's being done or, in general, the amount of testing that's being done, I believe that is public information. In Europe, you don't see that. And I think we benefit from a couple of things here. First, we don't have such a strong U.S. exposure. So we are not exactly the first company to feel that. Second, what we have seen is actually that -- is that people hold on to our platforms because our platforms are the most automated, and they would rather -- if they go down in testing, they would rather not do some of the more manual systems. And since our system are automated, we are in a very good situation. So from our perspective, we still see the demand higher than supply, but this may be a Roche view right now given that there's some dynamics that are changing specifically in the markets with high vaccination rates. Regarding antigen testing, here, I would say that there have been some news from some companies that they've also seen a drop in demand, specifically in the U.S. When we look at the different regions around the world, specifically Europe, which is a big market, at the moment, I would say, definitely, there is a lot more supply still than there is demand. But this could change as some of the countries want to open up their economies, and they want to do much more frequent testing. Example, I think, is Germany. Another example is Switzerland or the U.K. We'll see how that develops. But on the other hand, if you look in this market, there are probably more than 100 companies right now and a lot of Chinese companies, for example, on this market. So there is a lot of supply on the market. In the U.S., it's a little bit different because there are only very few companies right now that have been approved by the FDA, but there are hundreds that have applied for this approval. So I think this will, on the one hand, change with the amount of vaccination. But also if there are more of these companies getting the FDA approval, then there will be also more dynamics there. So that's my view on this part for now.

Birgit Masjost

executive
#8

Ann, your turn.

Ann Costello

executive
#9

Yes. Thank you, Birgit. Yes. So actually, on the idea about the additional capacity in the market, I think the first remark that I would make is that COVID will be with us for quite some time. It will go from a pandemic to endemic. So there will be still demand in the marketplace, not as it is today, but I think we will see it settling into something like the flu business or even a little bit bigger. I think the other important point, though, for us is that we expect to see consolidation in the market. And by that, that is a big advantage for us because of the strong position we have in automation. Our systems of the 6800, 8800 and the upcoming 5800, they bring more automation than other systems. And there are very few companies that are able to meet those demands for efficiency and consolidation that our customers are looking for. I think the other thing, and Palani alluded to this, is that we have a huge focus on medical value and building out our pipeline. And we are active in all of the disease areas, and there is still a lot of areas where we can bring new biomarkers that will add value here in the area of sexually transmitted diseases, in the area of virology, in the area of respiratory disease as well. So I think that is an advantage for us. I think the other remark that I would make, though, is about the pricing situation. We made a very conscious decision at the beginning of the pandemic to really look at pricing in a way that it was fair and that it was compatible with the current portfolio that we have. And I think as -- if price erosion will come in, other companies will be hit before we are because they have priced much higher. This sort of global pricing that we took on is something that will protect us. So we're not going to feel as much impact as some of our competitors might feel. So I think we are very well positioned going forward once the pandemic starts to recede.

Birgit Masjost

executive
#10

Thanks, Ann. So the next question, I will take from Richard Vosser, JPMorgan.

Richard Vosser

analyst
#11

A couple of a follow-up questions here. Just you mentioned the size of the flu business. Could you quantify the size of the flu business for your -- for the Diagnostics every year to give us some sort of framework of what the future could like? And then just on the change in terms of the installed base in terms of the growth, is that in concrete orders or can government still change their minds? And is that still more direct investment rather than the more traditional, I suppose, paying-over-time model? And then finally, Thomas, you spoke about conversations with governments to increase testing of other diseases, maybe just how are those conversations going? What should we think about the increased demand to fill up post-COVID?

Birgit Masjost

executive
#12

Okay. Great. I think the first question is one for Thomas. The second one, maybe for Ann. And then the third one, maybe you can answer them together, Thomas, because I think it's for you again.

Thomas Schinecker

executive
#13

Yes. Yes, maybe let me just take those questions. Yes, so if you look at the flu business, I think it's a good number to guide ourselves in terms of what the markets could look like from one aspect because it's a respiratory disease. However, the reason why I believe it's a bit bigger than the flu testing business is because the majority of that market was actually in the U.S. in the past. And if you look at Europe, people really didn't take the flu as seriously, I would say. And you can also see that with Tamiflu sales. In the past, we had a lot of Tamiflu sales in the U.S., but actually in Europe, not so much, but there was also not so much testing. But yet, a lot of people die every year of influenza as well. So we believe that actually that business will likely look a bit bigger than that because the rest of the world will test much more also for flu because they're taking this much more seriously. So it's in the low single-digit billions in terms of global markets. So I would say, once we get through this, and the question is when, right, because I wouldn't declare victory yet on this pandemic because there are a lot of variants around, et cetera, then it could recede into that kind of more of a midterm, long-term size. Now you had a question about can the governments give systems back? Well, I would say most of the time, the governments were not the ones buying the instruments; it was actually customers under contract. And as you mentioned, the majority of these instruments were sold and they were not done in a reagent rental contract because exactly for the reason that we didn't know, I mean, how long is this pandemic going to last. And for sure, we didn't want to be the ones then sitting on a lot of instruments. We want customers to actually put them to use and really help diagnose more patients for other diseases. And this is where we come to the third point, where I would say one of the governments that actually is really looking at this very seriously right now is actually the U.K. government, where we are in close exchange, versus most of the other governments are still trying to figure out how to deal best with this pandemic and they're not so really focused on other diseases yet. But it's clearly -- there's a huge opportunity if we can shift diagnosis to much earlier into the disease. There are many diseases where either the survival rate is much higher where people literally can survive and don't have to die at all, right? And I think cervical cancer is a great example. Lung cancer, hepatocellular carcinoma, these are all great examples where you can actually use screening specifically for viruses, but also liquid biopsy to detect diseases much earlier. And with that, you cannot only improve outcomes, but you can actually significantly reduce cost of care because most of the time, it's really those patients, when they're detected so late that there's a huge cost to the system.

Birgit Masjost

executive
#14

Okay. Thanks, Thomas. So the next question, I will take from Michael Leuchten, UBS.

Michael Leuchten

analyst
#15

Sorry, can you hear me?

Birgit Masjost

executive
#16

Yes.

Michael Leuchten

analyst
#17

Sorry. Two questions, please. One is just going back to your answer just now, Thomas, is it the governments that will drive these programs to incremental testing for other diseases? Or do you need to get to decision-makers like physicians that really have to change the behavior? And if you do, how do you to do [indiscernible] like that increased installed base? And then my second question is about the sort of increase in capacity that the pandemic has driven into the market. Is there a risk that more testing is going to be done in-house in large hospitals and away from the centralized labs? And as a result of that, you have to slightly change your business model and your approach to where the volume is done?

Birgit Masjost

executive
#18

Thomas, do you want to take those?

Thomas Schinecker

executive
#19

Yes.

Birgit Masjost

executive
#20

Yes.

Thomas Schinecker

executive
#21

Yes, I can. And I hope I did understand the first question. I think given the fact that we have a very broad menu on our systems and they're so automated, I think those are the 2 key decision criteria for hospitals and labs to decide which platforms they're going to focus on because simply, they need to reduce the amount of manual labor. I can tell you, there are a lot of people that I've spoken to that are using more research-like platforms. They're saying, as soon as you deliver more, we really need your help because people are burning out doing these -- all these manual steps. So I believe from that perspective, we are, I think, very well positioned. Now then you had another question around, will it be more decentralized? I think there is a great opportunity because there are actually hospitals that didn't have PCR capacity. Now they do have PCR capacity, so they can run these tests. And I believe these are tested otherwise would not have been run, right? And when you look at these big reference labs, I think those will also still exist significantly in the future because they're getting a lot of the samples also from the primary care segment. So I think those are elements that will continue to exist, and there will be a place for point of care. But clearly, it will balance itself out a little bit more. I mean the fact is that antigen testing is not as accurate as PCR testing, and one of the reasons for antigen testing that it played a role, actually, are 2 main reasons. One is there was not enough capacity. And with that, also turnaround times were too long. But also with this virus because the viral load is so high, you can at least detect infectious people or people that have above a certain amount of viral load. And by the way, sometimes I see some accuracy data of rapid antigen test of high 90s, that's just impossible, right? It's simply from a biology perspective, you will never be able to get to that level with detecting proteins. But this will also change a little bit because if you look at flu, actually, rapid antigen testing is not a preferred method because the viral load is not so high. And then you actually have an issue detecting -- you get a lot of false negatives. And as people get vaccinated, rapid antigen testing will become less relevant simply because of the same reason. And I've talked to a number of key opinion leaders because if people that get infected, their viral load will not be as high as it was in the past with infections. And so they will need to resort more to, I think, the PCR side. But there may have been one more question that I didn't answer, can you just repeat that?

Michael Leuchten

analyst
#22

Yes. Just sorry, the line might have been bad. But the question was, you said how the U.K. government is maybe a little bit more constructive on how to think about the screening for the diseases. But is it the government that will drive it or it's the decision-makers?

Thomas Schinecker

executive
#23

Yes. Yes. Yes, you're right. So I think it's really dependent on the health care system. So you have health care systems like the U.K., which is very centralized, one payer system. So they have a more -- an easier time to drive those kinds of things. And what we've seen in the past, for example, with cervical cancer or other diseases, actually, it gets into the guidelines quite quickly, but it's still not done. And the reason why it's not done is because there's no reimbursement. So I think where the governments need to play a big role in countries like Germany, Switzerland, or other countries, if they want to incentivize certain screening programs, they need to put reimbursements in place. Because as long as there's no reimbursement in place, people don't do it. That's the role of the government, to put the incentives in place.

Birgit Masjost

executive
#24

Okay. Thanks. The next question is from Keyur Parekh, Goldman Sachs.

Keyur Parekh

analyst
#25

Two big picture questions for you, Thomas, if I can. The first one is from the last 10 years, Roche Diagnostics on an underlying basis delivered about 6.5% kind of revenue growth. As you look at the various pushes and pulls kind of over the next 5 years, what do you think is the base case kind of top line growth we should be modeling? Clearly, there will be a COVID impact in kind of second half '21 or '22. But as you look at the installed base, as you look at new test dynamics that you were talking about, what should be our kind of base case for that growth? And then separately, as you think about delivering that growth and in the context of kind of the drivers of that growth, how should we think about the potential for margin expansion, kind of, off your diagnostics business over the next 3 to 5 years?

Thomas Schinecker

executive
#26

Yes. So thanks for that question. So first, regarding the underlying growth. What I have mentioned in the full year reporting is that I believe we'll have strong underlying growth in '21. And I can confirm that. So overall, the base business is doing extremely well. And if we then look at the COVID sales, you should see that a bit like Tamiflu in the past, right? It comes, and it may go to a certain degree, maybe not completely. But if there are more waves in the future, there may be another wave in Q4 this year, and we'll see how that plays out. But there may be other waves coming in the future, maybe not only of this disease -- of this virus but other viruses. So we should look at it with and without COVID effect. And without the COVID effect, we do believe that we'll outpace the market continuously over the next 5 to 10 years. So growing ahead and in line with what you have said approximately in terms of sales growth that you have mentioned on your side. And with that, our aim is to continuously improve our margins. We had a huge jump in terms of margin improvement last year with 50% growth on the operating profit. It's clear that some of that is COVID related. But also looking at what we have modeled, we're going to come out of this much stronger in terms of margin than how we went into it -- into this COVID crisis. And so -- and from then on, we will continue to build and improve our margins.

Birgit Masjost

executive
#27

Thank you very much, Thomas. The next question I have is from Jo Walton, Credit Suisse.

Jo Walton

analyst
#28

Can you hear me?

Birgit Masjost

executive
#29

Yes, we can, Jo. Go ahead.

Jo Walton

analyst
#30

I have a couple of questions. The first one is relating to point of care. So with the -- and you already explained why you think some of that will move back towards more centralized testing. But I wonder if you feel that there are any technology advances, which will allow sufficiently accurate for at least first blush diagnostics to move more of diagnostics away from the centralized reference system to the point of care. I've got used to going and having a COVID test and getting my answer within 30 minutes. That's way better than having to wait 2 or 3 days for it to go through a reference lab. So I wonder where -- what proportion of the market you think point of care might be going forwards? And my second question would be going back to the really big installed basis that you have. You have emphasized that breadth of menu and level of automation are 2 key aspects. If I was sitting in a hospital somewhere, and I had a relatively limited amount of floor space to add another test and I was already an installed base with Abbott or whatever, what would be your sales pitch to me? Would it be that you've got 10 tests that I would want to do routinely that you can only get on my machine? I just don't understand what is unique about your machine versus one of your competitors and imagine I'm sitting in the U.S. as a new customer.

Birgit Masjost

executive
#31

Thomas, do you want to take that? Thomas, are you on mute?

Thomas Schinecker

executive
#32

Sorry about that, I was on mute. Your first question was around point of care and the role of point of care. Now the main reason why point of care is done is really a sense of urgency, right, if you need to have a decision immediately. And with COVID, clearly, if you wait a couple of days until you know whether or not you're positive, it's important to know that immediately because then you know I need to isolate the person or not, right? If the person sits at home and basically can't go anywhere because they're still waiting for the results, it's not effective. So there's a sense of urgency. Now if you look at other diseases, I would say, cardiac, there's a certain urgency. Do I have a heart attack, I need to know immediately. Sepsis, et cetera. So there are certain diseases where it is absolutely critical that you have a result immediately. And in many of the examples that I've just mentioned, the accuracy is really critical. So PCR in the point-of-care segment or really high-sensitive troponin levels in the point-of-care setting, those are key criticalities. And so you have to have technologies that are able to do that. And what we call that in the past is lab-like performance. Now during COVID, this lab-like performance, because there was such a big need, maybe was not so big in the focus, and we had to look at what's good enough to at least get some sort of kind of -- yes, filter in place so that people don't infect others. But there are other diseases like sepsis or cardiac, I don't -- you don't want to have a false negative, I can tell you because then you really have an issue, right? So it really depends on the disease and it depends on why you need to have the quick answer. So -- and in the past years, there was actually really a bifurcation of the market. There was a shift for really urgent things in point of care, but low volume. In the high volume that's not so urgent was done more in a central lab, just simply because of cost reasons because you could bring down the costs much more. Now I think, overall, the trend will continue. I think that there could be certain technologies that could be interesting in the point-of-care setting, but costs will become more of an issue again than maybe it is today, right? I mean right now, cost seems to be not a big issue, but that will change. But then again, what I can also say, there are certain market differences. Certain markets have always been more prone to point of care than others, right? So that's on that end with point of care. I think we'll see more of a normalization to what we've seen in the past, really focusing on those diseases and those indications that are really, really urgent. Then the second question, you said rightly, we have a huge installed base. By the way, this is only our automated platforms. We have with MagNA Pure LightCycler, thousands and thousands of placements as well and with cobas 4800, but these are only on the higher automated ones. And with 5800, we're actually introducing the same kind of automation for lower throughput labs. So we have solutions for every size of the lab. And I think that's one of the key selling arguments. If you said, yes, throughput place -- space is critical, we actually have a solution that fits in your space. That's one. The second is the level of automation. And I've spoken to a number of customers. What they can actually do is, in the evening before they go home, they put samples on the machine and they can go home. And the next day when they come, the samples are done. You cannot do that with systems where you have constant manual intervention. So the amount of man and woman labor that it needs is so much less that actually the total cost of care is so much less. And the last point beyond the menu is, we are actually able to also connect our systems to preanalytics so that every step in the way, also before the sample ever hits the system, it's completely automated. No one needs to touch it, no mistakes happen. This is the age of digitalization. And with cobas prime, we actually have a solution that can handle all kinds of tube and sample types, which is the only one of its kind. So this level of automation is unprecedented. And with that, a clear advantage for our customers who need to do it at reduced costs and at the high quality.

Birgit Masjost

executive
#33

Thank you very much, Thomas. I think with this, we need to close the Q&A in order to stay within the time lines. I would like to make you aware that we will have a second Q&A where you can ask your questions again, and we will have all the speakers from the first session in the second Q&A as well. So please stay with us. We have a really short break now of just 2 minutes in order to stay with the time line -- within the time lines. And then we will meet back here for the second part of the presentation session. So please enjoy the platform in the meantime, walk around, take a look and hope to see you here again in about 2 minutes. Thank you. [Break]

Birgit Masjost

executive
#34

Hello, and welcome back to the second part of the presentations for our Diagnostics Investor Day. I have the pleasure now to introduce Benjamin Lilienfeld to you, our life cycle leader of our systems, and he will be presenting live from our showroom in Rotkreuz. So Benjamin, the stage is yours.

Benjamin Lilienfeld

executive
#35

Thank you very much, Birgit. It's a great pleasure. Welcome, everyone. Please go to the next slide. In the year 2020, we further increased our large global installed base especially in the area of molecular diagnostics with our cobas 6800 and 8800 platforms in order to support the fight against the COVID-19 pandemic. Next slide. We now look at an installed instrument base of over 1,200 systems, 400 of which have been placed last year alone. Together with a broad and growing reagent menu, this secures a constant revenue stream for the years to come. Next slide. Also in the area of serum work area with our clinical chemistry and immunochemistry business, we continuously grew our installed base last year. And together with over 230 immunochemistry and clinical chemistry assays, many of which are unique, high medical value assays, we guarantee a revenue stream for the coming years also in this important business. Next slide. The year 2021 is a particularly exciting year for us. Just last week, we launched cobas pure integrated solutions, our integrated clinical chemistry and immunochemistry analyzer optimized for lower-volume labs. And today, actually, we announced the launch of the new and extended configurations for cobas pro integrated solutions in markets accepting the CE mark. Later this year, we will then launch cobas 5800, which is a molecular solution, and is actually the most compact, fully automated molecular diagnostic solutions for the lower volume labs, lower volume compared to the cobas 6800 and 8800 offering. However, if you look at the competitive instruments, most of them do actually not even reach the throughput level of the cobas 5800. And I'm now thrilled to present to you live from the showroom, our headquarter in Rotkreuz, Switzerland, these instruments. Let me start with cobas pure integrated solutions that you can see here, our integrated immunochemistry as well as clinical chemistry analyzer. Again, this has been just brought to the markets accepting the CE mark last week. You can see it occupies a very small footprint of 2 square meters or 21.5 square feet only. In the middle, you can see the loading area with a dedicated port for so-called emergency samples. cobas pure integrated solutions offers industry's broadest serum work area assay menu, with over 230 different assays, many more to come and many of these assays, unique, high medical value. cobas pure is packed with innovations. All of these innovations helping to deliver excellent results, while at the same time, simplifying the work in the lab. We do this with significantly reduced system preparation and overall hands-on time for the user. Many things are completely automated in the background. For example, many of the maintenance procedures are running in the background by the instrument without the need for any operator intervention. This and other innovations are clearly setting us apart from competition. Over here, you can see cobas pro integrated solutions. cobas pro integrated solutions is basically the bigger brother or sister of cobas pure. The version you can see here is optimized for labs with a medium throughput. But as I mentioned, just today, we announced that we now offer new and additional configurations for cobas pro integrated solutions, basically doubling the number of test results it can deliver every hour by adding up to 2 additional of these analytical units. Now together, cobas pure and cobas pro offer a seamless experience and the highest level of standardization. They use the same technologies. They have the same assay menu and deliver consistent results and operation. This allows for flexible staff assignment and minimal training needs. cobas pure and cobas pro are therefore ideal candidates for so-called integrated health networks or big laboratory chains with main labs and smaller satellite labs. Both cobas pure and cobas pro can be remotely controlled using this tablet, which we call cobas mobile solution. This greatly increases efficiency and convenience by giving the user access to a number of unique apps. Now let's move over to the molecular lab. This is cobas 5800. cobas 5800 will be launched towards the end of this year in markets accepting the CE mark. It is the most compact fully automated polymerase chain reaction, for short, PCR system, with continuous loading and improved workflow flexibility. As you can see, it is very compact and offers truly consolidated flexible and efficient testing without any trade-offs. It also allows for prioritization of specific samples or assays, which is important in an emergency setup. Overall, this offers a huge benefit for clinicians expecting to receive results fast and expecting to be able to choose from a broad variety of assays giving answers to many of their questions. Together with cobas 6800 that you can see over here, as well as the even higher throughput instrument, cobas 8800, which is not on display today, they form a so-called system family, just like cobas pure and cobas pro. They share an identical user experience, reagent concept, performance and quality, allowing for standardization and full scalability, and they benefit from a broad and expanding menu of high medical value assays. Now both molecular diagnostic as well as serum work area labs are constantly looking to further increase their workflows by automating as many steps as possible. This includes also the so-called pre-analytical steps, which are done before the samples will be brought to this analysis. And one of these instruments I would like to introduce to you now. This is cobas prime. cobas prime has been launched last year, and it is the first and only solution capable of automatically preparing both the variety and volume of samples received for molecular diagnostic testing. This fully automated system consolidates, integrates and standardizes the pre-analytical process to streamline lab operations. It therefore allows lab technicians to focus on the more value-added tasks. Overall, the system families I introduced to you, both in the area of molecular diagnosis as well as clinical chemistry and immunochemistry, help labs to improve outcomes by addressing the needs of labs of all sizes and thereby help to increase patient access to these important diagnostic technologies. For us, they help to greatly increase overall profitability because they help us to reduce standard manufacturing costs of our reagents as well as service costs of our systems. Last but not least, these new generation of instruments are more sustainable, and they, for example, help to significantly reduce the plastic waste generated per test result. Now let's look into the future a bit further, and please show the slides again. So also in the outer years, we will continue to bring new innovations to the market. Today, I would like to focus on 2 new solutions that will enable us to expand into new areas and thereby increasing patient access to new technologies. Firstly, let's focus on the left side. With the integration of mass spectrometry into cobas pro integrated solutions, the instrument I have shown you before, we will bring this great technology into the core lab and equip the lab with a fully automated mass spectrometry solution that will work as simple as clinical chemistry and immunochemistry today; sample in, result out. This is completely different to the way it is done today, where you need highly specialized and skilled labor that use lab-developed tests in a very manual procedure. Now automating all of these steps will greatly increase the access for patients to this exciting technology that offers promising new high medical value biomarkers. It also helps Roche Diagnostics to tap into a great and growing market of CHF 2.1 billion. Now on the right side, I would like to draw your attention on a compact and easy-to-operate benchtop analyzer we are designing right now. It is designed for the specific needs of emerging markets and combines immunochemistry and clinical chemistry into 1 single box, thereby greatly increasing the access for patients to diagnostics. It also allows us to tap into a CHF 2 billion accessible highly growth market, further fueling our revenue streams for the future. And with this, I would like to thank you very much for your attention and hand over to my colleague, Michael.

Michael Hombach

executive
#36

Hello, everybody. My name is Michael Hombach. I'm heading clinical science infectious diseases. I'm a physician by training, having treated infected patients myself. And I've been heading the diagnostic microbiology lab at the University of Zurich. As you'll see, infectious diseases have always been close to my professional heart in a way. And from that perspective, I want to take you through the strategic importance of infectious diseases as an area. On the first slide, let's start from the immense disease burden that infectious diseases pose to the public. Infectious diseases kill 13 million patients a year and that total was then increased by an additional 2 million last year by COVID. And altogether, that translates also into a massive economic burden, at the baseline, at least CHF 2 trillion a year, and again, at least doubled by COVID. So how can we improve that situation from a diagnostic perspective? I want to start you in the next slide from the biological background. Every comprehensive diagnostic solution in infectious diseases has to take care of 3 aspects: there's a pathogen, bacteria, viruses; there is the immune response, antibodies and T cells; and there is the general host response of our body, for example, the inflammatory response. And a comprehensive solution in the disease area needs to take care of all those aspects. To make that a bit more tangible for you, I want to show you some clinical utility cases from the patient journey in the next slide. The question on the pathogen end that physicians and patients have are, am I actively infected? And even more, can I transmit the virus to my friends, my family, my coworkers? Those medical need questions are best answered by our PCR assays or the antigen assays, either on point of care or centralized, depending on where the answer and in what speed the answer is needed. And then later in the patient journey, on the immunity side, the question is, have I been exposed? And now most important, am I immune? Am I now protected? A significant part of the answer is provided by our antibody assays, again, point of care or centralized. That's an example from COVID, again, but what about other infectious diseases beyond COVID? On the next slide, you see just a selection of emerging and reemerging infectious diseases of the last decades. And from a scientific perspective, I'm absolutely convinced that during the next 5, maybe 10 years, we will see the next big epidemic and some when, unfortunately, also another pandemic. Meaning, we need to be prepared. And the best preparation is a comprehensive menu and a strong pipeline. On the next slide, you will see in blue our existing broad infectious diseases menu spreading about a wide range of infectious diseases already and being expanded by the in-development assays that are shown in green here. And I want to highlight that those are covering the 3 important aspects that I mentioned before, pathogen detection, immune response, host response. That's all contained here. And from a -- for a scientist part, the most exciting part is hidden in the gray boxes, actually. That's the areas of high medical value innovation and research. And I want to just highlight the big 5 areas in which we are active in the next slide, starting with tuberculosis, the deadliest and largest infectious disease in the world, also a silent pandemic that never stopped; sepsis still killing 20% of all patients that get it; dengue fever or Lyme disease that are rapidly spreading, together with the mosquitoes and the ticks that transmit them due to climate change and global warming, also through the U.S. and Europe; and then also the massively growing problem of antimicrobial resistance. Those 5 together only account for more than CHF 100 billion of direct health care costs per year, and there are projections that at least this will triple or more during the next 2 to 3 decades. So there is obviously a lot to do and a lot to gain here in those areas. And I wanted to show you a concrete example of what we are doing here for the post-COVID era in the next slide, when the medical question, is it SARS-CoV-2, yes or no, that is causing the coughing of the patient in a doctor's office turns into the differential diagnosis, which of many viruses is causing that symptoms. And here, the medical need is now differential diagnosis and can be merged and matched with our in-development, multiplexed respiratory panel that will run on the PCR cobas family that was just introduced by Benjamin. So we bring here together the efficiency of the large and enlarged installed base with an unmet medical need that's now in focus. With that, I hope I was able during the last 5 minutes to give you an impression about the strategic medical importance of infectious diseases. And I would like to close with a quote from Peter Doherty, a Nobel Prize Laureate in immunology, with whom I very much concur that working on infectious diseases, having a strong pipeline and solutions here is really according to Roche's mission of doing now what patients need next. Thanks a lot for your attention, and I will pass over to my colleague, André, and cardiology.

André Ziegler

executive
#37

Thank you, Michael. Hello, and good day, ladies and gentlemen. My name is André Ziegler, and I'm the clinical leader in Roche Diagnostics for cardiovascular disease. With more than 18 million deaths per year, as shown on the first slide, the various cardiac diseases are yet another big burden to our society. And based on the deaths, it's actually the leading cause of death for noncommunicable disease. More importantly, the WHO estimates that 30% of these cardiac deaths are premature and cause a considerable economic impact of CHF 1 trillion per year by the various life years lost due to premature mortality and the years lived with the disability. And yet behind such impressive numbers, there are individual fates. Probably every of us has a case in the family where a relative like a grandma died too early because of 1 of the 4 major cardiac disease, such as coronary artery disease, strokes, heart failure and atrial fibrillation that altogether affect currently more than 400 million patients. In Roche cardiac, we are therefore committed to develop new solutions to help these 400 million patients who have the disease, but also to a much larger population who are at a high risk to develop this disease. So we have a strong ambition to prevent these diseases and help also help saving health care costs by early and more differentiated diagnosis. In the next slide, I will show you that the global cardiovascular societies, in particular, ask for very strong clinical evidence and clinical impact data like in pharma, where the Class Ia recommendation is the highest grade that one can achieve, considered as the gold standard. And by respecting these fundamental principles of a evidence-based medicine, we succeeded to become the market leader for IVDs for our major cardiac products with a Class Ia recommendation for several of these intended uses and products. In the next 3 slides, I will present 1 example per major cardiac disease, where Roche will grow further and will launch new solutions within the next few weeks and months. Next slide, please. On the left side, you see the example of heart attack, also called myocardial infraction where Roche helped the hospitals to make faster and safer decisions and thus save considerable costs in the emergency departments. In particular, this disease is acute and very life-threatening, where the emergency rooms of the hospitals are confronted with the situations where only 20% need rapid help, but 80% will have another disease. Because every hour in the ED is expensive, Roche has helped to provide solutions with global experts into pioneering these fast protocols, improving our test performances and providing sufficient clinical evidence for these Class Ia recommendations. On the right side, you see a different clinical situation, where up to 5% of noncardiac surgeries can be complicated by silent heart attack, where Roche now provides new solution to identify these patients much earlier and we here speak about 300 million patients. This is important because 80% of these MIs are asymptomatic because of the concomitant anesthesia. And from a business perspective, this expands the potential market from 100 million suspected MIs to an additional 300 million patients at high risk for these myocardial infarctions. On the next slide, I show an example from heart failure, where the disease has a 5 years mortality of up to 70%, 80%, and this does worse than many cancer types. Through many clinical studies supported, we can offer a Class Ia solution for these 64 million patients. But in the next months, we will provide a new solution for more than 450 million patients at a very high risk for heart failure. Where, on the right side, you can see the latest clinical data from the PONTIAC trial, which is an interventional study where the basis for therapy is based on a biomarker from Roche. And the identification of the patients at high risk and early treatment with standard of tracks help to prevent the cardiac disease events by more than 65%, which is considerable when compared to usual track trials. With the next slide, I show an example of atrial fibrillation where Roche is pioneering another disease of 60 million patients globally with IVDs, where the stroke risk is a permanent guest and threat to disability, paralysis and death. And with new solutions to be launched soon, Roche will innovate many aspects of this patient journey, such as a cost-effective screening solution on the left-hand combined with ECG and other devices; also innovation with new diagnostic biomarkers, shown here in the diagnostic and the risk stratification area, as well as optimizing therapy by providing better risk stratification for bleeding risk, which is one of the major threats of concurrent treatments; and ultimately, therapy selection, where we, at current, run 2 outcome trials. So in the summary slide, next slide, please. I hope I can give you a short overview that Roche is innovating and launching cardiac solutions in the 3 major cardiac diseases with 4 launches this year. And overall, we have the strong ambition to recognize and cure these diseases much earlier in the patient journey, thus also helping to reduce costs by providing clinical outcome data, which leads in parallel to a larger patient population, as shown on the right. With that, I want to thank you very much for your attention. I now hand over to my colleague, Jill.

Jill German

executive
#38

Thank you, André. I really appreciate it, and good day to everyone. I'm Jill German, Head of the Pathology Customer Area. Much like you saw from André in cardiovascular, on the next slide, what you'll see is that the disease burden in oncology is also forecast to rise significantly. And you can see this across all cancer types, and specifically in areas such as lung, breast, colorectal and prostate. What you can also see is that the statistics really show that across not only incidences and mortality, but the cancer burden on overall cost of care and then, of course, the personal burden that many of us perhaps have even encountered is expected to rise. If we dig into it a bit further on the next page, coincident to this increasing burden, what we also see is that the oncology market itself is rapidly evolving. New therapies, new therapy combinations are being put in clinical trials every day, with the intent to really improve patient survival rates. One example, demonstrating this trend is cancer immunotherapy. Dramatic progress has really been seen, but there's still so much more that can be done to really improve survival rates and really utilizing insights and new biomarkers. And as you see, as we go across the page here, what's going to be required to really improve, continue improving survival rates is not only new biomarkers, but digital tools. These combined are going to be critically important in what we really expect is that multimodal approaches are going to be required across all categories of in vitro diagnostics, not only sequencing, PCR, as you've heard about, immunohistochemistry and many other areas, tissue multiplexing. So all these will come together with clinical decision support to really help improve the patient experience. So where does Roche play in this? And where do we differentiate? Let's take a look at the next slide where you can see the Roche portfolio. We lead the industry, spanning all of the in vitro diagnostic modalities that I just mentioned. And we play across the entire patient journey that Thomas originally illustrated in his discussion. Digital pathology algorithms also play a really important role in the portfolio, aiding and really identifying the interpretation of key companion assays. This slide summarizes the number of diagnostic solutions in each patient journey segment, broken down by the diagnostic technology area. As you can see illustrated across the bottom, clinical decision support tools, such as NAVIFY Mutation Profiler and the Tumor Board, are really an important part of this as they bring together then integration of multiple diverse streams of input about the patient so that the clinician can really have clarity into optimal clinical decision-making. On the next slide, I share with you the future of the oncology portfolio. And you can see that we are focused on further expanding the patient journey solutions that we already provide. A unique advantage that we really have here is the extensive partnerships that we have with multiple internal and external pharma partners. This really enables us to embed novel diagnostics into pharma registrational trials, ultimately resulting in co-development and approval of multiple novel companion diagnostics. As you can see, a growing number of decision support tools, including clinical and digital pathology algorithms and NAVIFY applications will be part of this integrated solution across the patient journey. This is part of an overall decision support strategy and vision, which is visualized then on the next slide. So let me -- much like André, let me walk you through how a patient journey solution really comes together for lung cancer patients. With 1.8 million newly diagnosed cases every year, it's the most common cause of cancer death. And it remains a very high burden. Our solution provides vital information along that entire journey. If you start with the diagnosis on the left, with the diagnosis and classification assays such as Napsin A, p40 and ProGRP aiding the differential diagnosis and subclassification of lung cancer, and that ensures that the right diagnosis is made. In the therapy selection area, a multimodal approach has really become the standard of care. And this is really important to choose the right therapy. This also helps get patient on the right therapy faster and eliminate some of the waste in the system that Thomas mentioned earlier as well. This includes EGFR, KRAS, BRAF and the PCR. And then you can see for the other modalities, what is offered there as well. And then in monitoring and surveillance, you can see CYFRA 21-1, ProGRP, EGFR and PCR all come together to give the clinicians insight throughout the entire patient journey. And then pulling it all together, as you look at across the bottom, you can see the decision support tools. I want to take that a little bit further in the next slide, where we really pull together the decision support tools that exist. We've got NAVIFY -- the digital pathology algorithms, which really solidify the interpretation of a biomarker. The NAVIFY Mutation Profiler, which really helps identify therapy options and clinical trials that might really fit that particular patient. And then the NAVIFY Tumor Board, which pulls together all the data that exists around a patient that come from other areas such as radiology and pulls that together so that the Tumor Board can make a really meaningful decision for that patient. And as we look at future oncology decision support tools, access to longitudinal oncology data is critical. And so we really leverage the vast oncology data that exists to us through our colleagues at Flatiron and Foundation Medicine. We really believe that the workflows and insights along this kind of solution will help us reduce the overall cost of care and, more importantly, to really improve the quality of care for patients. So with that, I turn it back over to Birgit. Thank you.

Birgit Masjost

executive
#39

Great. Great. Thanks, Jill. So we will start the second session, the second Q&A session now. [Operator Instructions] The first question I have here is from Lisa Clive from Bernstein. And I think it's a question for Palani actually. "What is the potential threat from digital PCR? Could this be a big disruptor in the molecular market?"

Palani Kumaresan

executive
#40

No, thank you for the question. So it's important to start with what are the capabilities of digital PCR? I mean one of the key things that enables those extremely high sensitivity. And how do we leverage that? And when we look at it closely, we see that there are specific applications like genetic screening, prenatal genetic screening, or in select areas of oncology, we are looking at very rare variants. In those cases, that level of single molecule accuracy provides that additional benefit that you would otherwise may not have from quantitative PCR. And in those cases, we do see digital PCR playing an important role but we see it more as being a complementary solution to both our efforts in our quantitative and otherwise qualitative PCR, the solutions that we shared with you today, and also the sequencing work that we are doing. So it's more as a complementary to the other areas that we are looking at. And of course, digital PCR is also part of our pipeline as we look to the future.

Birgit Masjost

executive
#41

Thanks, Palani. The next question, I think, is Emmanuel Papadakis from Deutsche. Emmanuel, so you can speak now.

Emmanuel Papadakis

analyst
#42

Emmanuel Papadakis from DB. A couple, if I may. Thomas, a question for you on the COVID side. We had, obviously, the big uplift in molecular from the PCR testing. You didn't talk much about how you're doing in immunology. So particularly with regard to both the rapid antigen and the antibody testing offerings, pricing's obviously a lot lower. You have talked about capacity for both of those in the tens of millions per month previously. Perhaps you could just give us an update on how that's proceeding commercially. Question on the oncology side. Number one, -- couple actually. How penetrated is NAVIFY software now into the addressable U.S. market? And is it profitable yet? Secondly, are you not missing out on significant synergies by the lack of integration for FMI and Flatiron? I believe they're both sitting still within the pharma business rather than diagnostics. Please correct me if that's wrong. I'll leave it there and come back if there's space at the end.

Birgit Masjost

executive
#43

Okay. Great, Emmanuel. I think the first one is for Thomas. Maybe the second one about the NAVIFY, Jill would like to answer? Yes. Okay.

Thomas Schinecker

executive
#44

And then I can -- I close it out on FMI and Flatiron. So when I gave some information in January for our full year results, I would say all that information that I gave is still valid. We saw a very strong Q4. I said we will see even stronger Q1. And we will see also very strong Q2. I would say the one thing that has changed in my assessment is that we will see more -- probably more sales in Q3, in Q4 than I had originally thought still back in January. And that is simply because in some parts of the world, the vaccination takes a bit longer, and there will be more testing being done. Regarding PCR, clearly, demand is still extremely high. And that will be the technology that will probably stick around the longest. And when it comes to the immunology side, specifically on the antibody side, we do see a bit stronger demand now than probably as the last year. And I think one of the reasons is that certain countries have said, either you need to have a test or you need to show that you've had antibodies that you can cross borders. And so in certain countries, there's actually some more antibody testing because people, instead of being swabbed for an active infection, they want to show this -- be able to show this antibody testing. But clearly, we're still talking about low double-digit million and not huge amounts yet. But this can still change as we also have cooperation with some of the vaccine companies to really look at what level of antibodies are necessary in order to be protected. And so we are following cohorts where we want to then also demonstrate from which level people need to get revaccinated, and that could trigger more of a demand in terms of antibody testing in the future. Now then the question around rapid antigen testing. Yes, I would say rapid antigen testing is an area that has seen a lot of competitive pressure. And also the prices have gone down, specifically in Europe, where there are more than 100 companies likely on the markets. And here, I would say that we're doing similarly as in the past, maybe a slight pickup, but we are not at the max of what we can supply at this point in time. Again, this could change if more governments go to more frequent testing, like we have seen in Germany or Austria or U.K., that if some more of these governments go in that direction, there could be even more pickup there. But it's a very competitive market, I would say, from a pricing perspective.

Birgit Masjost

executive
#45

Next up, Jill?

Jill German

executive
#46

Yes, I'll pick up on the second part of the question. Emmanuel, you asked about the NAVIFY platform. I would say that it's still early days for all digital insight products and still early days for NAVIFY, although we see good market traction. And we've also seen an increase in adoption with customers who have -- using it with their Tumor Boards. I think recent numbers show over 30,000 lives being discussed around Tumor Board. So that's a -- it's a good pickup for that particular application. What will really drive it, of course, is we are absolutely committed to this. And the more meaningful applications we continue to put on it, the more value we'll have across the health care systems. Recently, just in 2020, we launched our digital pathology uPath workflow that Ann mentioned earlier on to the NAVIFY platform for cloud-based use. And these are the kinds of tools that really help integrate everything together for our customers who are working with oncology patients. So hopefully, that helps. Thomas, I don't know what you might want to add about FMI and Flatiron, but I can tell you from my personal experience, we certainly work closely with them as an organization.

Thomas Schinecker

executive
#47

Yes. I agree. I think you don't necessarily have to integrate it from an organizational perspective. We work very closely with both FMI and Flatiron to leverage all of those synergies. And with regards to NAVIFY Tumor Board, I believe we have now more than 100 installations of that, again, more than 30,000 patients being really treated based on decisions that are being made on that digital solution. So we are progressing there as well. And let me just add to the previous question 1 or 2 more points. The other point that I did not mention is that we do see a stronger pickup than expected in our underlying base business. So that's actually doing very well. And I think that's an important piece to also understand, that there's a certain level of recovery that from what we've seen last year.

Birgit Masjost

executive
#48

Perfect. Thanks, Emmanuel. So the next question I would like to take from Vijay Kumar from Evercore.

Vijay Kumar

analyst
#49

Appreciate the effort in putting up the presentation. I have enjoyed 360-degree view, the web view. So thanks for that. I guess, Thomas, I had a couple of questions for you. One, on your comments around the base business and the antigen comments, a couple of clarifications. What did you guys assume for the base business recovery heading into the guidance? And where are we now? And on the antigen side, and I appreciate all the comments, but I guess, when you look at the question of a fast pass dose for PCRs, right, with high Ct values, perhaps you're getting high false positives, perhaps there is a use case for rapid antigen. Can you flesh that out in terms of -- on the preopening side, could we perhaps see a little bit more demand? Is that being priced in? Or how do you think that should play out? When we all get back to work, are we going to be using rapid antigen tests, I guess, is the question. And one on the tech side, I saw the mass spec -- integrated mass spec product. Is that a new market area for Roche? Who plays in that market? And how should we think about market adoption for those kinds of products?

Birgit Masjost

executive
#50

Thanks, Vijay. Yes, I think as indicated, the first 2 questions to Thomas and then maybe the one on mass back to Benjamin.

Thomas Schinecker

executive
#51

Yes. So on the base business, we did expect kind of a recovery from last year. But for certain, the recovery is higher than what we would have expected. So the base business is doing very well. And I don't want to go into more details than that because we don't usually guide on that level. But what I still can say is that all that I have communicated in the full year results still holds true with things dragging on in terms of vaccination. So we will see probably more of the COVID testing than we had expected, and the base business is doing better. So those are the 2 comments that I would like to add to what I said at full year. Now with the rapid antigen testing and PCR testing, I think you can define it as PCR is, am I infected? And rapid antigen is, am I infectious? So with the PCR test, you can detect down to 25, 30 copies per ml with the best technologies. Some other technologies maybe go in the thousands or maybe even a bit higher than that. With rapid antigen tests, you can detect about approximately 0.5 million to 1 million copies per ml. Below that, you cannot detect it. And that's why the sensitivity is lower than when you compare it to PCR. And that's why when I see some statements about high 90s sensitivity, that's just not true. There is no possibility that a rapid antigen can do that. And with our test, this was externally validated by surety in the University of Heidelberg, so really independent studies also for self-testing. So we have a complete independent evaluation of that. And I just want to say that because if you really want to detect someone who is infected, you will have to go with the PCR test. That being said, knowing if someone is infectious, if you do it multiple times, you will catch the person eventually because the amount of virus, the viral load goes up significantly, very quickly, right? So you really have to repeat the testing very frequently. But it's more like a safety net. There are some holes. But if you throw it often enough, you're going to catch wherever you want to catch, right? So yes, you could see there is a certain time period until people -- a lot of people have been vaccinated, where people may do the screening tests like in schools and back to work, et cetera. That's kind of the application that we see for rapid antigen tests. I think once you get to a certain level of vaccination and closer to herd immunity, they will not do this kind of testing. And it will be more important to detect who's infected. And specifically, when people actually have been vaccinated, they can still exhibit disease. They can still have a virus. They can still be getting sick. But usually, they don't get as sick, and the viral load is lower. So with that, similar to influenza, where the viral load is also not high, you will need to detect it with more sensitive methods. And so PCR will definitely continue to play a role there in a decentralized setting and in a centralized setting. And I think for the months to come, there will still be an interesting spot for rapid antigen. But just as with influenza, where this rapid antigen test was -- market was declining and the PCR is actually -- has been overtaking, you will see a shift there, specifically because you will want to know who is infected, and people will not exhibit such high viral loads anymore, so. And then there was a question to mass spec. Who wants to take that one, or should I take it?

Birgit Masjost

executive
#52

Yes. Benjamin maybe, do you want to give it a try?

Benjamin Lilienfeld

executive
#53

Sure. Well, thanks a lot for the question. I think for us, mass spec is a new and very exciting technology that we will bring to the market. And what is really differentiating is the way that we will bring it to the market. And it's bringing it into the core lab, integrating it into cobas pro integrated solutions, one of these routine instruments that you have seen in my tour before. So it will be fully automated and very easy to use just as the other diagnostic technologies in the core lab today, which is completely different than the way it is done today, very manual somewhere in the dungeon by highly specialized and highly skilled labor.

Birgit Masjost

executive
#54

Thank you, Vijay. Thanks, Benjamin. So time is running fast, but I think we'll make time for a few more questions. The next one that I have is from Richard Parkes from Exane. You can talk now.

Richard Parkes

analyst
#55

Firstly, it's more of a clarification. You discussed a potential single-digit billion COVID testing market post the pandemic. Just wondered if you could clarify what your current COVID testing market share is and how you'd expect that to develop post easing of the pandemic. The second question is on the diabetes division. Diabetes Care is the only segment not included in the new structure. Obviously, it's been dragging on growth in recent years. I'm just wondering, does that signal plans to exit that business longer term? Or is there some other reason for that being carved out separately? And then thirdly, on oncology. Could you just talk about where we are in terms of market penetration of next-generation sequencing overall in the oncology market? And Roche's position there and whether you're comfortable with that and potential longer-term impact on the business?

Birgit Masjost

executive
#56

Great. Thanks, Richard. I think the first one, again, for Thomas. And the last one, maybe for Jill or for Palani.

Thomas Schinecker

executive
#57

Yes. So with regards to rapid antigen testing, I think that market is quite difficult to really assess because I can tell you, there are so many Chinese companies that are on the market that it's really hard to say. But I would say, probably from a volume perspective, one of the main suppliers and also from a financial perspective. And on the PCR side, it's clear that there may be 2 or 3 suppliers that provide the majority of the testing, and there are a lot of minor players, and we are definitely in that category. And I would say, from a volume perspective, very much on the front here. And Diabetes Care, your question. We believe in this market because there are a lot of diabetics around the world, and so the amount of people with diabetes is going to increase simply because it's also a lifestyle. This is, to a certain degree, but also with type 1, it's also something that sometimes people are born with. And so from a disease burden perspective, it's one of the main diseases and that's a good opportunity. And we are investing into research and development to make sure that we set up for the future.

Birgit Masjost

executive
#58

Thanks, Thomas. Palani, for the sequencing one?

Palani Kumaresan

executive
#59

Absolutely. On the sequencing side, a couple of comments I would make. First of all, we are looking at the sequencing market very much from a clinical sequencing standpoint, which is what we have also communicated in the past that is looking at an end-to-end solution, all the way from the nucleic acid extraction to that tertiary analysis, the NAVIFY Mutation Profiler that Jill shared earlier. We are making good progress here in that end-to-end solution. We obviously have some of the solutions on the reagent side for sample preparation, library preparation and so on in the market through our recent side of our business. But that end-to-end solution is obviously still a very high-risk proposition. We are working on it actively. We stay committed. But beyond that, I wouldn't be able to comment at this point in time.

Birgit Masjost

executive
#60

Thanks, Palani. The next question will be from Scott Bardo, Berenberg.

Scott Bardo

analyst
#61

One question to Michael, please. Thank you very much for taking us through the infectious disease portfolio. It seems now that Roche has a strong offering in both low-plex testing for molecular diagnostic, multiplexing for decentralized settings with GenMark and now you comment on multiplexing in a more high-volume setup. Can you give us some sense as to how you think the market for multianalyte PCR testing is going to shake out between these various different buckets of low-plex, decentralized and high volume? And second quick question, please, if possible, for Benjamin. Thanks for showing us the integrated immunoassay clinical chemistry analyzer. Can you help us understand whether Roche has particular market strengths in one of these modalities? You're strong in immunoassay or clinical chemistry? How can you use this combined solution to increase your positioning? And last question, if I can, Birgit, to Thomas. There's been a lot of focus on the molecular diagnostic PCR testing for COVID and the pricing environment that may unfold. Thomas, can you share any thoughts as to pricing for molecular diagnostics for the post-pandemic portfolio? Do you think levels would be now sustainably higher given government activity here? Or could there be indeed more longer-term pressure due to a rapid entrance of multiple players?

Thomas Schinecker

executive
#62

Yes. So, Birgit, should I take the last one?

Birgit Masjost

executive
#63

Yes. Yes. Yes, exactly.

Thomas Schinecker

executive
#64

And maybe also the first one around GenMark?

Birgit Masjost

executive
#65

Yes. Yes.

Thomas Schinecker

executive
#66

So let me take the first one around the molecular PCR and pricing. I think we are extremely well positioned from multiple aspects. First is the level of automation. And when customers look at the costs, they always do a total cost of ownership calculation, meaning, what do they need in terms of personnel to run that and other potential equipment they may need to run systems, right? Since our system is so automated, the total cost of ownership is very low. And with that, we have protection on our price because they don't have to add so much on manual labor on top. And I think I gave some examples before on more research-like platforms, where, literally, the people are burned out because they've been working so much to really do all these manual steps. Now furthermore, we actually -- what we've done in terms of pricing is, from the get-go of this pandemic, we said to be very clear that we want to have a contribution to society and in this pandemic, to fighting this pandemic, we are not going to be a company that increases prices in a pandemic, right? So what we've done is we took, from all of our tests, we did take the average price we have in our portfolio, and we applied the price. And with that, we priced it lower than many other companies that have gone out with COVID tests. So if we see an erosion in terms of pricing, it's going to hit others much harder than us given that, a, we are coming out with huge volumes now in Q2 and Q3; and b, because, I mean, others would have to move to our price level, which is significant difference before we have to move on our price. So it will hurt them definitely much more. Now then you asked, do I believe that we will have higher or lower pricing in other parts of the portfolio after the pandemic? First, let me say, I don't believe it's necessarily going to be higher pricing. But I could see that maybe we'll see faster reimbursement for new tests, for screening, for things like sort of cancer or screening for hepatitis C, which also causes cancer. So I would see we see more of a volume effect. That's one element. And then the second element goes back to what I said earlier. With the high level of automation and the lower cost of ownership, people do a total cost of ownership calculation, and we do fairly well compared to that. And there are really 2, 3 players, I would say, in the market that can somewhat compete on that. And compared to rapid antigen, which is a rather, I would say, is easier technology to manufacture and also to develop, and that's why you have so many different companies. I can tell you the amount of money that we spent on developing 6800, 8800 goes in the hundreds of million and many years, right? So it's -- from a copy perspective, it's much, much more difficult to copy than you would see on the rapid antigen side, where there was definitely more price erosion. Then you had the question around multiplex and how GenMark fits into the overall concept. I think the special part about the GenMark technology is that they can multiplex 40 different respiratory samples, and it provides results in 90 minutes. So if you have severely ill patients where you need to be treating these patients quickly, you need a result very quickly, and with screening all of the different pathogens, this is where this technology fits. And this is not a space that we have actually played in, in the past. And it has been dominated really by 1 player and -- in the past. And we believe that bringing in our global footprint where GenMark has been largely only present in the U.S., we can expand to other markets in the world. We can support in automation of manufacturing, in raw materials, et cetera. We can bring in certain expertise with which this technology can fully blossom. And this is where we see the big opportunity. And after all, I mean, if you look at the molecular space, this high multiplexing market in a stat way, stat, meaning you load the sample any time, which you can do with GenMark and you get results in 90 minutes, this is a market that's growing 20% and more every year. So it's a really attractive market.

Birgit Masjost

executive
#67

Thanks Thomas. Benjamin, do you want to take the one on immuno analyzers and breadth of menu?

Benjamin Lilienfeld

executive
#68

Sure. Thank you very much. First of all, let me stress that we were the inventors of the integrated clinical chemistry and immunochemistry analyzers back in 2002. Only in the last few years, competitors started to copy this successful concept. And you have seen we have consequently pursued new innovations using this concept now with cobas pure integrated solutions for the lower-volume customers as well as cobas pro integrated solutions for the medium- to high-throughput customers. So we integrated this business to bring this together and sell it together. To answer your question, if we have particular strengths in one or the other, we're strong, and we are the market leader in both businesses.

Birgit Masjost

executive
#69

Thanks, Benjamin. Great. So I think with this, we actually need to close the second Q&A sessions. I would very much encourage you for your remaining questions, just send them to us by e-mail, and we will certainly get back to you and answer them. And I need -- I would like to hand it over now to Thomas for the closing words. Thomas?

Thomas Schinecker

executive
#70

Thank you very much, Birgit. And I believe we have 2 slides left, and I'll make it very short. First, around point of departure. And it's clear that -- and I think we have demonstrated that health care is shifting to reward more improved patient outcomes and reduce cost of care. And we really need to tackle both in order to meet the needs of the health care system. And only if you meet the needs of health care systems, you can be really successful. We also believe that we are very well positioned to address these evolving health care needs because we have the broadest -- many of different markers, but we also have access to the broadest different modalities of technologies. And with that, we can really support in finding the solutions that governments and the hospitals are looking for to improve patient outcomes. Now in our strategy, we want to expand from our diagnostic solutions to really go and also support in taking this data and making better clinical decision support decisions. Based on all of the data, and we also believe that in the future, there will be more of an ask of us to help manage diseases more proactively, specifically chronic diseases. And in order to do that, we will continue our strong investment in innovation, and we'll even invest more by really improving on the efficiency and effectiveness of our organization and also invest more also in market access and partnering activities. Overall, the implications are that we will contribute with that to the Roche ambitions. And it also means that we'll shift investments, as I mentioned, and realign the operating model to implement strategy. If you go to the last slides. And here, just like I say, we will continue to drive our focus on growing our market share organically and inorganically. And really shifting our investments into our strategic priorities, really looking at where can we create most value with the money we have, really taking things that maybe don't have such a big impact on customers and patients and shifting it to areas where we can have a higher impact. And with that, really looking at which part of our company actually has direct impact on customer value and really focusing our investments there. With that, I would like to thank you for your attendance today, and I hand over to Karl for the last remaining words.

Karl Mahler

executive
#71

Yes. Thanks a lot, Thomas. I think what we saw today is that diagnostics is not a nice to-have, but a must-to-have in a business. I mean, we've got that fantastic overview of the world's leading IVD business. The demonstration in the 360 was really live. I was really impressed, I mean, really well done. So I wanted to thank all the speakers in explaining their business so easily, so clearly, so that everybody, even myself, could understand it. So thanks for that. Birgit, I wanted to thank you. I know how much work went into this event. That was very well done. And I also wanted to thank [ Jeff ], Gian Luca, Bruno for giving input into the presentations, also helping with the formatting. And last but not least, to Eva and Janet for helping with the organizational setup here. And I wish everybody a nice day. Thanks for your interest in Roche. Stay healthy, and all the best to you. Bye-bye.

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