Roche Holding AG (ROG) Earnings Call Transcript & Summary

[Operator Instructions] One last remark, if you would like to follow the presented slides on your end as well, please feel free to go to roche.com/investors to download the presentation. At this time, it's my pleasure to introduce you to Bruno Eschli, Head of Investor Relations. Bruno, the stage is yours.

Thanks a lot, Henrik, and welcome to our first ESG event focusing on access to health care. From our perspective, the most relevant ESG topic for a health care company, we really believe we can make the biggest impact in the contribution to society. We hope we have -- we hope that together with our subject matter experts, we have put together an interesting event today covering many different aspects. Regarding the agenda, we will have a quick overview on ESG at Roche, which will be done by Pascale Schmidt, our Chief Compliance and Sustainability Officer before we will divide into the access topic. The access topic, we have split 50-50 between dia and pharma. And dia is yet to come first, represented by Thomas Schinecker, our CEO, Diagnostics; and by Stefan Seliger, our Head Global Access and Policy for diagnostics. When it comes to diagnostics, I think -- when it comes to broadening the global access to health care, I think the role of diagnostics cannot really be overestimated, especially when you consider the health economy, the investments you have to do versus the benefits you can generate for a broad patient population around the globe. The second part then will be covered by Michael Oberreiter, our Head of Global Access for the Pharmaceuticals Division. He will talk about our overall access strategy, including pricing and take you through the challenges and opportunities when bringing highly innovative medicines as they are in our portfolio, also including many rare and orphan diseases to patients around the world. I think it's also important to keep in mind, there are several takeaways which are true for both divisions. We strongly believe that innovation is a major part of our Global Access Solution. And also that access is not a topic specific to just 1 geography, but rather to every country, whether it's a low, mid-income country or a high-income country faces its own very special challenges. Next slide, please. This slide summarizes our ambitions for both divisions, and I wanted to highlight again some of the underlying building blocks on how we want to deliver. So if we look on the left side, on the pharma side, you see we have 2 ambitions here. We have the 2030 ambition, which is double medical advances at less costs to society by 2030. This ambition initially presented by our Former CEO, Bill Anderson in 2020. And the underlying building blocks are here to double medical advances, we have already done some work on this one by reallocating resources into R&D. The second part is improve other patient benefits. This is by innovating more holistic solutions around our medicines, for example, disease management through digital tools. And then the third part is here focusing on earlier, more targeted and shorter interventions, which should also put some relief -- bring some relief on the overall cost of the treatments. And then if you look here today, we highlight a second ambition on the pharma side, which is basically double patient excellence in the low, mid-income countries for our innovative medicines. This we want to achieve by 2026. And this is the topic, I think, which will be covered by Michael later in more detail in his section. And then if you look on the right side, this is the dia side. Here, we also have a 2030 access goal out, which says double patient access to novel, high medical value diagnostics by 2030. There are 2 elements contributing and I think Thomas will cover this in more detail. The 1 element coming to place again to accelerate innovation and the other 1 is reduced time to reimbursement. And with that, I would like to hand over to Pascale Schmidt, our Chief Compliance and Sustainability Officer, just to give you a quick intro on ESG at Roche. Pascale, please?

Thank you, Bruno. Good morning, good afternoon, good evening, all. Delighted to be with you here today. Bruno, you alluded to it, and next slide, please. The divisional ambitions you just mentioned and which will be presented in more detail by Thomas, Stefan and Michael directly linked to our approach to sustainability, starting with the reason why sustainability specifically matters to Roche. Our purpose is doing now what patients need next and how we identify and meet those needs, what we do every day must be sustainable if we are to succeed. It's why sustainability is built into our business strategy and is part of everyone's Roche job -- job at Roche. We drive the execution of the company's sustainability agenda and strong alignment with the business strategy, and our approach is holistic and integrates the 3 dimensions of sustainability, the environment, how we minimize our impact on nature, the economy, how we invest in medical advances, create jobs and insure livelihoods and the society, how we contribute to a better tomorrow for all. We want to deliver value to all stakeholders, and our approach reflects the topics that are of high relevance to our stakeholders, as assessed by an integrated and exclusive materiality assessments we conducted in 2018, 2019 with more than 600 external and internal stakeholders and 30 experts. It has been enhanced since then by a continuous stakeholder dialogue confirming the most important contribution where Roche can make a difference. So what is our unique contribution? Well, on the left side, you see that on the environmental dimension, which is on the high scrutiny also by the investors' community. We have had great achievements so far, but we've set ourselves an ambition goal and want to reduce greenhouse gas emissions for Scope 1 and 2 to real 0 by 2050, and not net zero in contrast to other corporations. It means that we don't want to revert that to CO2 reduction certificates, but effectively emit less and less CO2. But if you go to the right-hand side, even though environmental sustainability is a must for cooperation, however, as a global health care company, our greatest contribution to the United Nations Sustainable Development Goals is goal 3, which promotes healthy lives and well-being for everyone, everywhere. Roche's work to provide better global access to quality essential medicines and diagnostics support the school. And our real differentiator lies in innovation to achieve more medical progress at lower cost, notably through digitalization. Our investment in R&D exceeds that of any other health care company worldwide, also in 2021, and this results in 14 new molecular entities in late-stage and significant launches in diagnostics. If you go to the next slide, you see that the embeddedness of sustainability into our business strategy is also reflected by a strong involvement from all business areas and senior management in the sustainability governance structure. So sustainability is connected to the highest executive and nonexecutive committees with a corporate governance and sustainability committee being responsible and accountable for governing sustainability at the Board of Directors level and the corporate executive committee being responsible and accountable for the strategy and appointing the members of the Corporate Sustainability Steering Committee to whom it has delegated the responsibility for establishing, managing and coordinating the implementation of the sustainability strategy. The Sustainability Operations Committee implements the sustainability agenda, monitors and reports progress towards the goals. It works in agile ways in cross-functional working groups and throughout the global sustainability network, made of affiliates, global functions, external experts and advisers, but also our communities of interest of grassroots organizations. If you go to the next slide, please. We are committed to transparency, to improve our business and provide accurate information to our stakeholders. On improving our business side, Roche's nonfinancial reporting is directed by the Corporate Sustainability Committee and is assured by PricewaterhouseCoopers. The data and information collected serves as a guide for reviewing and adjusting the sustainability strategy. And because we firmly believe that transparent reporting helps us improve our business, we have had a centralized repository for nonfinancial data since 2014. This allows us to provide accurate information to our stakeholders, notably through our annual report or on our roche.com site but also adhering to a number of different standards and frameworks such as GRI and the UN Global Compact Report enabled us to provide clear and balanced information to our stakeholders. In 2022, we will also join the Science Based Targets initiative, whereas we have always been confident in our Scope 1 and 2 activities and had Science Based Targets in place for many years. Joining the Science Based Targets initiative allows us to simplify our message to our stakeholders as well as integrate our Scope 3 reduction plans into the business strategy. Last but not least, we also proactively contribute to the assessment by 2 rating agencies, mainly to serve us to benchmark ourselves and continuously improve our sustainability agenda. DJSI helps us to assess our general sustainability framework and Access to Medicine Index our access strategy. Furthermore, if you go to the next slide, you see that we actively shape the corporate sustainability landscape through our contribution in biopharma and cross-industry initiatives and coalitions. If I may just highlight 1 that started recently, we are -- and that's the 1 in black, we are a member of the Health Systems Task Force from the sustainability market initiative. This 1 was launched in 2021 after COP26. The task force is composed of leaders in the health care industry, institutions, academia, NGOs, et cetera, who work together to accelerate the delivery of sustainable health care to improve individual societal and planetary health. Let's now look at what we have achieved already on the next slide. Our performance in 2021 across our 3 pillars illustrate our strong commitment to sustainability. But let me just, though, highlight some figures on the social dimension, which is the focus of today's presentation. 16.4 million patients treated with Roche medicines in 2021. 27 billion tests conducted with Roche Diagnostics products and 80 new molecular entities in clinical development. So to conclude, we have all ESG dimensions covered in our sustainability framework. But today, we want to focus on the access component of Roche's pillar, as highlighted in the introduction, it is our greatest contribution to society. With this, I thank you for your attention and pass the word to Thomas. Thomas, the floor is yours.

Thank you very much, Pascale, and welcome also from my side. As Pascale mentioned, sustainability is strongly ingrained in our culture and our history also through the founders of Roche. And I truly believe that it is a competitive advantage of our organization. And one, the mentioned sustainability is the impact that we're having on patients worldwide and access is really the foundation of our strategy and to achieve this. Improving outcomes and reduce cost of care is only able -- we are only able to do that if patients actually have access to our products. Now let me start on the next slide to give you a bit more of an external market perspective. The needs from the health care systems and patients are changing. Health care systems across the globe are facing significant challenges to meet the needs of an aging population. They're challenged by the fragmentation and inefficiencies in the system. And when you need to scale -- if you scale something that's inefficient, that makes things oftentimes even worse. So how can they counter that and still improve outcomes to patients while at same time reduce cost of care. At the same time, we see that data exists in many different pockets of the system, but they cannot be linked to each other and therefore, cannot be used for better decision-making. We see the patient engagement is increasing and there's a trend towards decentralization with home testing, telehealth solutions, et cetera. But we also see a strong trend towards centralization to decrease the cost in the system. There's also an increasing role of public, private partnerships to deliver better health care. We consider this collaboration and the role of the private sector is crucial to increase access worldwide and especially for those that the most immediate. With increased expectations on outcomes and strained budgets across the system, we also see an opportunity to shape health technology assessments to inform investment decisions. And I particularly think that diagnostics, again, can play an important role through earlier diagnosis to patient stratification, we can actually use diagnostics also to reduce the cost in other parts of the health care system. Digitalization also has the potential to change health care dramatically. Yet what we see is that the regulatory environment around data protection is evolving and vary across markets. This impacts the availability and adoption of digital solutions across the world. Lastly, I would say that pandemic acted really as a catalyst for many of trends. It really accelerated some of the changes in how we deliver health care to patients, also with more focus on preventive measures in remote care. Now let's quickly look at our strategy on the next slide. To address those needs of the health care system, we have built our strategy really around 3 pillars. The first is to deliver medical value on integrated testing solutions. This actually means bringing new markers on our fully automated platforms, thereby improving outcomes and reduce cost of care. So basically, full automation and digitalization of the lab, helping more cost-efficient solutions, but also better quality and decision-making through that. At the same time, introducing new markers with which you can stratify patients earlier, and you can detect diseases earlier and with that have better treatment options as well. The second pillar is really enabling better and more confident health care decisions. And this becomes more important as it is more difficult to have decisions navigate through their wealth of all this medical knowledge. So combining all the data is already a big advantage because today, the medical doctors don't even have access to all of the data when they need to make decisions but then leveraging AI to then support them in decision-making is the next step. Lastly, we want to improve care along the patient journey and provide true disease management solutions. And these are important to tackle the fragmentation and inefficiencies of health care. We believe that there is a lot of opportunity to reduce all the waste in the system and so that you can actually invest into the patient. And in fact, we are investing very heavily into these priorities. Over the last 3 years, we've increased our R&D investment by $500 million. And with that, we are, by far, the company spends the most money in innovation. And we have a lot of exciting innovation coming to the market in the next couple of years to exactly address the pain points in the system. Beyond that, the basis is -- our areas like access. And these are important to accelerate innovation and make sure that diagnostics is available to more people worldwide. And why is it important? It's important because science without access, it's just science fiction and it doesn't really help. So access is at the core of our strategy and of our 10-year ambition in diagnostics, which is then to double patient access to novel high medical value solutions. And we measure the ambition in 2 dimensions: one is accelerating innovation, we bring novel solutions to market, 75 novel solutions by 2030. Now we differentiated in our innovative pipeline really, the products that are just a development opportunity versus true innovation. And here, we're talking about true innovation, bringing something to market that no one else has in the industry. The second piece is to reduce time from launch of the product to a time of the reimbursement by half, which is critical so that people have faster access to this innovation. And we have a couple of examples in Stefan's section around that. Now on the next slide, you see that our strategy really covers the entire patient journey. And really, in order to improve outcomes and reduce cost of care, health care systems need to develop more patient-centric approaches. They need to try to optimize interventions along the patient journey and get rid of fragmentation and inefficiencies. And here, the interplay between diagnostics, pharma and also our investments into digitalization insights. With that, we are really uniquely positioned in the industry because the interplay of these 3 disciplines will merge over time and with that, provide better patient care for people around the world. And in fact, this is what we see from our customers more and more in the future where they would like us to help them solve their issues they have in the system, and you can only do that when you have actually the 3 pillars under 1 roof. Now whether it's cancer, heart disease, infectious diseases or other health threats, prevention and early detection are actually really key and every treatment always starts with a diagnosis. So they really all depend on high-quality diagnostics. And again, the earlier you do it, the earlier you recognize the disease, the higher the chances are for the patients. So overall, diagnostic tests and medicines will continue to increase in use, also given the significant unmet need in several disease areas. And in fact, there are some where it's still a situation that you cannot detect the disease yet or it's too late or [ it's an ] invasive method. And with diagnostics, we can really change the game here. I think Alzheimer's is one, but also areas in women's health like endometriosis is another great example for that. And we believe that with our strategy, we're really best positioned to address those challenges. And where we have gaps, and we cannot pull it in-house, we also will create strategic partnerships. Now on the next slide, you see that with our strategy, we also target the major disease areas to reduce impact on patients and the economy. Now the ones that I just mentioned, cardiovascular disease, infectious disease, cancer and neurologic disorders together account for approximately 50 million deaths every year. Now there's approximately a $2 trillion impact on the economy through these diseases. Now this is very, very conservative, likely the impact is insignificantly higher. And in fact, throughout the pandemic, it is likely that alone infectious diseases contributed to more than $2 trillion economic impact in this time period. Now let me shift, on the next slide, to those disease burdens and really look at the impacts that we're having around the world. First, and that's honestly shocking is that almost half of the world's population have little or no access to diagnostics. So there is huge opportunity to improve health care around the world. More than 300,000 women every year die of cervical cancer. This disease is highly preventable. And in fact, the majority of these 300,000 deaths a year have been in low and middle-income countries. So by screening these women earlier, every one of these women can survive. The same applies for tuberculosis related deaths. About 2 billion, so 1 in 3 to 1 in 4 people in the world have latent tuberculosis and 95% of these deaths are actually in the LMICs. Then there are people living with HIV, 2/3 of those people are in Africa and majority of those are actually being tested and monitored on our solutions. Now at Roche Diagnostics, we're addressing those challenges with very dedicated solutions. Now to give you a couple of insights. Over 90 of our tests fall into the categories of the WHO list of essential diagnostics. We've sold 240,000 plasma separation cards in 2021, which helps detect or get samples in the most rural areas in Africa to a centralized machine where they can be then tested at a very -- on a very deep level. And we see that the demand for these cards are very high because to have point-of-care systems everywhere is not always the most cost-effective solution and there are times also from a temperature perspective more problematic. More than 8 million people in Africa are using Roche tests to manage their HIV viral loads. Now we believe these are some impressive numbers really highlighting our efforts. And I would say also a recent example that I can add is our partnership with the global fund to support low, middle income countries in strengthening the diagnostics infrastructure. And Stefan will actually give you more examples later. Now let me also talk about COVID-19 and our contribution against the fight for this pandemic because I think it's also a story of access. Since the pandemic until end of Q1, we've had more than 1.5 billion COVID tests done on our systems. And this was only possible because we were very quick to market, and we provide very high-quality solutions. And let me just give you a couple of examples. We were the first company to have a SARS-CoV-2 detection test only days after the sequence was known back in January 2020. The PCR tests running on the high-throughput solutions was the first fully IVD an FDA-approved test, which was launched days before WHO actually recognized this pandemic. Also, when you look at our antibody tests, they are now widely recognized in all the studies as being best in class, the nucleocapsid and spike antibody test. When it comes to rapid antigen, looking at the corporate studies and other matter analysis, we show that our performance is also best in class here. So we were not only fast, but the quality is also there. And 1 of the ways you can see that is that also we didn't have to change the sequence or anything during this time. What's also important is being responsible and ethical player in the market. We said we will have a responsible pricing strategy from the beginning, basically, pricing similar to pre-pandemic times. And this was important because we said costs should not be a barrier to access. And when it comes to pandemic, Roche needs to do their part to help the world. And since the pandemic, we've also more and more extended our platforms into all kinds of different markets. And we've also launched a lower throughput solution in the molecular side. So really enabling access to parts of the world that before didn't have that much access. Now let me give you an example of the impact of COVID-19 testing, and you see that on the next slide regarding Germany. And studies conducted in Germany showed that PCR rapid antigen testing reduced the negative impact of the pandemic on the economy and also the health care system. In the study it was shown that this meant about 3 million fewer infections and 62,000 fewer deaths. On the economic side, this reduced the cost in the health care system by about EUR 3 billion and prevented a EUR 36 billion decrease in German GDP. Now this is a real good example to show that investing into diagnostics in the pandemic was the right thing to do and actually helped reduce the burden in the system. Let me finalize with 1 slide around global emerging and reemerging infectious diseases. This is just a selection of viruses that are existing around the world and that could emerge also more globally. Now most of these infections occur in low- to middle-income countries, really with limited access to diagnostics. And it is clear to us that we need to be even better prepared for the next pandemic. And the next pandemic may not even come from a virus, but may come from bacteria. This is why we're also working with [ Foreign Health Institute ], where we establish an epidemic preparedness program. And we've been actively working on being prepared for pandemics even prior to this pandemic, and this is also why we were able to react solidly. Now we'll continue with this approach, and we'll closely monitor all the pathogens listed here and many more, and we'll be ready to step up in our role as a global corporation when we are needed also in the future. With that, I thank you, and I would like to hand over to Stefan Seliger, our Head of Global -- Global Head of Access and Policy.

Thank you, Thomas, and a warm welcome also from my side. I'm very excited to share with you some more details how we think about our ambition to create more access to the diagnostic solutions that we have so more patients can benefit from it. Let me jump straight to the first slide, which I want to use mainly to ground ourselves in the reality that affects whether and how fast that the novel diagnostic tests will actually be reimbursed by local health care systems. With the health care landscape and the trends that Thomas had laid out earlier, we see clear opportunities, but also some barriers that we want to address when we think about accelerating patient access down the line. This slide shows a few of them that we're addressing in our product development, in our commercialization strategies, but also in our policy work and that also extends down to the country level. Despite the impact that in-vitro diagnostics have had on clinical decision making, there's oftentimes no structure when timely reimbursement mechanism and pathway in place, that ensures that reimbursement comes straight after the market authorization of a novel diagnostic test. And this is a key difference that we see compared to pharmaceuticals, for instance. Our ambition is to ensure that our solutions can reach as many patients as soon as possible after market authorization. That means coordinating all the efforts early on to accelerate coverage decisions and adoption right after the product obtains marketing authorization in the countries. On the next slide, please. As Thomas mentioned, Roche is an integrated health care company. And with that we're in a unique position to really ensure that patients and health care systems can benefit from our innovative diagnostic solutions along the entire patient journey, and we have the therapeutics in some instances as well to support that. Our broad diagnostics portfolio allows us to provide solutions in all disease areas along the patient journey from screening all the way down to monitoring of disease progression. And over the years, we have gained broad experience in ensuring access to our diagnostic solutions around the globe. COVID was just 1 example that Thomas just highlighted. Although the product development process is centralized to guarantee quality and safety standards at the global level, access is by nature the local issue. And we should always consider in our global strategies, the needs in the local markets in order to succeed. Therefore, we have many access activities going on at any given time between global, regional and local teams to ensure we're addressing these hurdles that exist at the market level. Today, I want to highlight 4 examples, which serves to illustrate that our experience in this space and the learnings that we have gained in addressing some of the barriers and opportunities that exist. So we start on the patient journey on the left-hand side of your slide with an example of cervical cancer screening before we move down the journey to a preeclampsia example, then a biomarker-driven lung cancer management example. And lastly, I want to touch on our Global Access Program a bit more, and it was mentioned before, for instance, the plasma separation card in HIV monitoring. So this is -- these are 4 distinct areas that highlight how we are thinking about access along the patient journey. On the next slide, please. Let's start with cervical cancer. This is really 1 of our priority areas. And as you know, the WHO has a goal that by 2030, we are trying to eradicate cervical cancer. And we are very much behind this goal, and it is a priority for us as well. The majority of the cases of cervical cancer are actually caused by infection with a human papillomavirus. In fact, in 2020 alone, there were over 600,000 new diagnosed cases of cervical cancer around the globe. That is more than 1 per minute. Despite the fact, as Thomas said, that this disease is really preventable through early screening, more than half of the women still die unnecessarily of this disease. Well, the conventional Pap smear and the pathology that follows have been the primary method of choice for clinicians, so 1/3 of those women presenting with locally advanced cervical cancer did, in fact, have appropriate Pap screening prior to diagnosis showing the low accuracy of this exam. At the same time, many women are lost to follow up after Pap smears. And with this, the mortality is expected to continue to grow. While the incidence is disproportionately high in low and middle-income countries, 10% to 16% of cases are still affecting women in high income countries. So it's really important, and we are very passionate about bringing new and effective molecular screening solutions to patients around the globe to help detect the disease early and allow initiation of curative treatments. We have all tools needed to support the WHO goal of eliminating cervical cancer. The question is just how do we partner with governments, with associations, NGOs and in-patient organizations to implement women's screening programs using HPV molecular testing and increase awareness and capacity for those that are diagnosed to find the right treatment, no matter where they may live. Next slide, please. Our contribution to the elimination of cervical cancer in the world goes beyond primary molecular testing. Roche is the only company that offers the entire spectrum of self sampling, screening, triage and digital solutions that provide biological insights to guide conditions as well as women along each step. So I would like to zoom into HPV viral DNA screening and talk a little bit about the Australian team and what they have done to enable access to this very critical first step in the patient journey. On the next slide. So Roche in Australia has supported an ongoing trial -- the COMPASS trial, that is generating clinical evidence as well as local health economic evidence and this data was used to engage local thought leaders on the benefit of a confirmatory early diagnosis of molecular testing programs, which resulted in the implementation of a comprehensive national cervical cancer program by the end of 2017. And with this, Australia is on track to be the first country in the world to eliminate cervical cancer in this population. Commercially, what did it mean for us? It meant that we established ourselves as a leader in HPV molecular testing, and we managed to increase our sales 14 fold in the subsequent years. So the timely evidence generation, including the analytical, clinical and local health economic evidence were really the key drivers to ensure access and then subsequently the adoption locally. On the next slide, I would love to touch on 1 element that is also very important in this context. When we think about evidence generation, it is increasingly important to think about evidence generation strategies across diverse populations. Addressing barriers to clinical trial participation, for instance, is key in ensuring broad patient benefit as well as access [indiscernible]. Across Roche, whether on the dia side or on the pharma side, we are innovating to bring studies to traditionally underserved patient populations to broaden clinical trial access, to diversify clinical data and accelerate scientific discovery. Being able to demonstrate the value for diverse populations for enrollment across geographies and populations is more important than ever to inform local payor and coverage decisions. And both pharma and dia demonstrate this commitment as shown in some of the examples shown here on the right. As an example, today, 51% of our patients in infectious disease clinical trials are recruited from populations that have traditionally been understudied. Next slide, please. I would like to stay, in women's health, for 1 more example, and let's talk about preeclampsia, where appropriate use of in-vitro diagnostics can really make a significant difference for both the patient as well as health care systems. A confirmed preeclampsia diagnosis is critical because the disease itself comes with severe complications that affect about 3% to 5% of all pregnancies. It's, in fact, the #2 leading cause of maternal deaths representing about 14% of our maternal deaths. And this condition is associated typically with high blood pressure and the presence of increased levels of protein in the urine and poses severe health issues for both mother and baby and is associated with extensive hospitalization costs. Diagnosis for many patients presenting the suspected preeclampsia fails because many pregnancy care programs don't even cover routine testing for known biomarkers in women at risk of developing the disease. And clinical management of the condition is very difficult and a very quick decision needs to be taken and, therefore, oftentimes immediate hospitalization and close monitoring is the first choice for a clinician now being presented with a suspected case of preeclampsia. And this can translate into unnecessary hospitalization without confirmatory diagnosis. Roche has a test the sFlt-1/PIGF ratio test, which can actually rule out preeclampsia with a very high negative predictive value of nearly 100% for the following 7 days, and you can imagine what that means. You can immediately separate a suspected preeclampsia patient that needs to be hospitalized and monitored versus someone that is a very low risk of developing actual preeclampsia. On the next slide, I want to show what this looks like in the U.K. So in the U.K., Roche funded and partnered with local providers on the INSPIRE trial, that yielded published health economics data and risk stratification data to support wider adoption of preeclampsia routine testing. And just last month, based on the cost-effectiveness data, NICE formerly recommended routine preeclampsia testing for better patient outcomes, reduce cost of care and optimize resourcing at NHS. Cost effectiveness data have shown, on average, the health care system saves around GBP 344 per patient, which translates to a net savings of GBP 24 million per year in U.K. So this impact is not limited just to the U.K. On the next slide, you see that similar health economics studies have shown that the medical and economic potential for routine biomarker testing to rule out preeclampsia can be universally realized in different health care systems. Of course, dependent on their local costs for typical hospitalization, the amount that can be realized differs. But the estimated impact, if you can just imagine this being implemented worldwide is well above $1 billion a year. On the next slide, I would like to move into lung cancer. And we all know that much progress has been made in the development of targeted treatment for lung cancer with Roche contributing several therapeutic products to today's treatment. Molecular-targeted therapies all rely on the use of testing, computations on the target gene to inform which therapy may yield the best outcome for the patients while avoiding less effective therapies and associated cost in time. Next slide. Adoption of these targeted therapies requires the inclusion of mutation testing in guidelines and the reimbursement by the system. In Chile, the existing reimbursement for IHC test -- for a regular IHC test did not fully capture the value of the information that this test will give. So by generating local health economic models and the partnership with local therapeutic experts, testing guidelines incorporated a new evidence and a dedicated higher reimbursement rate was created. Creating access more to companion diagnostics is often unfold from the availability of the therapeutic option. So in this case, it took 5 years to actually achieve the value-based reimbursement for the combination of the 2. Sinking up the timing of the marketing authorization and reimbursement of the diagnostic solution on the 1 hand with that of the therapeutic requires alignment between diagnostics and pharma strategies early on. And with a growing portfolio of the integrated solutions, Roche really takes advantage of having both diagnostics and pharma capabilities under 1 roof. I want to switch gears now to the monitoring side of the patient journey on the next slide, and I want to talk about -- quickly about the Global Access Program. This program started in 2014 to provide affordable access solutions for HIV viral load testing in Africa and has since expanded to other infectious diseases such as Hepatitis B and C, tuberculosis, cervical cancer and most recently COVID. This program now includes 89 low and middle income countries today. Thomas already mentioned the plasma separation card, which allows self-testing in remote areas, which has been a great success to ensure access in rural areas and the addition of iThemba app allowed patients to receive their results remotely on their mobile phones and manage their disease also locally. Critical to the success of the Global Access Program have been these sustainable public-private partnerships with NGOs because we also need to think about increasing capabilities and capacities locally to ensure that we ultimately have access. Thomas mentioned the global funds, I will not go into that any further and instead go to the next slide. And this is another aspect of creating access, the capability building that needs to happen in order to create access to a broad portfolio. On the left-hand side, you see the typical basic laboratory and then a laboratory, for example, actually take last one that was invested into modern technology like cobas 6800. And you can visualize already the difference that this machine could make in providing a whole portfolio of different testing solutions to the communities that they serve. In order to reach in more emerging markets, we're also tailoring our instrument development to meet the needs of the low and middle income countries like on the right-hand side, you see the emerging markets analyzer that provides a compact desktop capability for emerging markets in China with an expected launch in 2025. And one of the aspects of this is that there will be significantly lower manufacturing costs associated with it, making it more [ affordable ] for low and middle income countries. Let me switch to the next slide and just highlight an aspect of the importance of good sustainable partnerships in order to get to equitable access. We have a number of partnerships that allow us to co-create the solutions that we need on the ground in order to have a sustained impact and ensure funding as capability building on the ground. On the next slide, I would like to shift in gears and look into the future. So while we had meaningful impact on the availability of diagnostic tests across the globe today, lot more needs to be done to achieve truly equitable access. Remember the 47% that Thomas mentioned in the beginning, we have a long way to go. Our ambition is to double patient access, and we want to do by embedding prospectively the access requirements into our product and then commercialization strategies to achieve rapid, broad and sustainable access for patients around the globe. In doing so, our ambition is to accelerate reimbursement coverage decisions to go rapid. But we also want to make sure that take into account the needs of up to 23 different markets to ensure that our global strategies address any different markets possible and lay the foundation for scaling up in even more countries after that. And lastly, we want to make sure that the value of our solutions is recognized by health care systems and our customers so we can fuel a sustainable pipeline of future innovation. On my last slide, I just want to sort of give you, after a lot of information, such as the key takeaways that access is central to our strategy here at Roche Diagnostics, and we're building on our experience and the impact we have had across the globe and continue to invest in our growing internal capabilities as well as our external network. And even more so, we are going to focus on integrating these access requirements into development and commercialization for our solutions portfolio. And with that, I say thank you for your attention, and I will hand it over to my colleague from Pharma, Michael Oberreiter.

Thank you, Stefan. And also thank all your great work and your diagnostics' colleagues are doing because the pharma strategies are really building on the successes of our diagnostics' colleagues. So what I would like to join me now is on a little bit of [indiscernible] over the next couple of minutes about the Roche principal philosophies when we approach in pharma, access and how we want to broadening the access, also how we actually translated the learnings from the past 2.5 years of the pandemic and the very concrete actions in the ground. I want to share with you some very practical examples on behalf of the colleagues that are working in countries with the local stakeholders on the ground and also briefly touch on the way we look at pricing and affordability in general. The next slide, please. So the access philosophies and strategies we're developing in pharma actually grounded in the SDG goals, and they're particularly grounded in 2 of the so-called SDG targets. In target 3.4, which has the aim to reduce the number of premature deaths due to NCDs by 1/3 by 2030 and in SDG target 3.8, which is achieving universal health coverage, including financial protection. And universal health coverage basically means everyone should get the treatment, he or she needs, without suffering financial option. About 2 years and a couple of months ago, this historical UHC declaration was signed at the UN General Assembly. And if you look where they're standing now, we have to acknowledge that a lot of those countries signed the declaration has the suffering. And some of the achievements we have on the progress we made in the past 2.5 years is really at risk because the current situation looks like that, Thomas said, half of the world population does not have access to diagnostics, and this is really true but the situation is even more severe because half of the population do not have access to any quality basic health care solutions. We also do know without timely intervention, we are falling short of 18 million health care workers, frontline health care workers, doctors, GPs, oncologists, name it by 2030. Majority of these health care workers will be missed out in their mix, and we also know that every year, still by now, over 100 million people are driven into poverty because they cannot afford their health care cost. Next slide, please. So what we also have seen that actually COVID has something that has brought new challenges we thought or we had -- the experience [indiscernible] actually COVID has amplified and [indiscernible] with the already existing ones. I will not repeat what Thomas already laid out beautifully, just highlight a couple of aspects, which are very specific really to pharma. Number 1 is we are facing in upper middle and high-income countries an increasing competition between budgets. There is a budget in the health care, which is not going to be expanded in many of those countries. And there's almost the type of competition between disease areas, also [ between ] the investment. And the digital health offers a lot of opportunities. This is also [indiscernible] to build infrastructure, which will not be spent to treatment and medicines. We also noted due to COVID actually, we are facing an unliquidated backlog of medical procedures, yes, even in developed countries. Most of the countries either stopped screening programs for cancer or patients were too afraid to get a COVID infection when they would come to the hospital. So they did not show up at the hospital at all. And on the more technical side, what we are facing, particularly in those health care systems that are more established, we are facing a situation that current HTA systems [indiscernible] way the value of innovation [indiscernible] does not keep up with scientific progress. If we would switch to the side of the low- and low-income (sic) [ low-middle ] countries, the already existing lack of health care infrastructure and health care professionals has been clearly amplified. We're still facing a lot of low disease awareness and diagnosis, some cultural challenges, lack of regulatory processes there, general economic pressure. But 1 of the big barriers is also inadequate funding and basically a lack of even basic insurance system in those countries. The next slide, please. But I really don't want to paint a picture which is too dark. We also have seen a lot of progress and positive [ stickiness ] in the past 2.5 years. And I think it's going to be our joint challenge that we need to keep those things that were really good and helped well and to further translate it into concrete actions. What we're seeing in upper-middle income countries is there are positive signals for a fairly economic growth. We see this a rapidly growing middle class, and we also see really, really a more adoption of technology in those countries, which also interestingly see an increasing adoption of telemedicine and telehealth among physicians, but [indiscernible] in low and middle income countries. What we also do see, particularly in the middle income countries, there's an increased country collaboration. The countries are more willing to share health care facilities, to share the experience and thinking about creating joint data space to exchange health care information. And what is also happening, particularly in low and middle income countries is that the aging population is really driving the development of new health care services. The next one, please. So the way we, as Roche, thought about it. And when we thought about it, [indiscernible] that we do know that Roche is really standing on 3 pillars. And those pillars are population coverage, its health system coverage and its financial protection. So we work together with local stakeholders in the ground to identify what we call our 6 prioritized drivers of UHC, which are those 6 areas where we think with our expertise, with our knowledge, but also with our product-solutions can make the biggest impact towards UHC. Number 1 is clearly in the access space around expanding access to standard of care. Clear example would be that I'm happy to share that we have currently over 3 million people on patient support programs and also the LMICs goal for access, which I will highlight a little bit more in detail later on. Second area where we think we could play a very important role is really in the innovation. As Pascale mentioned, we are the #1 investor in pharmaceutical research and development. One example would be the investments we are taking in expanding our portfolio around the COVID-19 pandemic, but we did not only expand our investment into research and development of treatment, we also expanded our investment really in creating new knowledge transfer systems to be better prepared. The third area where we're focusing on is on making an investment case for non-communicable diseases and rare diseases because, as Thomas mentioned, for a lot of countries, infectious diseases are still a major problem. But there's no way you can achieve universal coverage when we continuously neglect, which is happening in a lot of those countries, entities and the rising number of rare diseases. Very practical examples I'm going to say later would be what the work that we have done with external stakeholders around our both drugs, Hemlibra in hemophilia and Evrysdi for SMA. Next one, please. Also an area where we think we have a lot of expertise and can contribute is system capacity, and system capacity is really referring to the ability of systems to provide health services in the most efficient way. It aims to strengthen health resilience. So we're working together with external partners and our key projects here are the Project ECHO, which is a telementoring program or our long-standing partnership with City Cancer Challenge, which aims at implementing low cancer care ecosystem at the city level. Projects that we have done work that we have done on the product side to support system capacity and free up, let me just highlight 1, that would be Phesgo. Phesgo is a fixed combination of 2 cancer drugs and this fixed combination will be delivered in a vial and this vial is so easy to administer the patient but the preparation and administration lasts only 5 minutes and will be done in the hospital. Before we had fixed dose combination, what we have seen is that patients have to spend 2.5 hours. So what Phesgo is actually doing on the 1 hand, it's more convenient for patients because they don't have to spend 2.5 hours in infusion chair. On the other hand, it really helps to free up to [ such new, ] needed capacities, particularly in the chemotherapy units of a lot of hospitals. The fifth area or the fifth key driver of our prioritized drivers is really around digital and personalized health care. We think the pipeline technology, we can help to close the target. We are also very aware that digital has the power to either be the great unifier or being a great divider. So our approach when we develop digital tools, also if you try to really collaborate with people in the natural settings where they would then apply the technology. One example would be the Floodlight App, which helps patients with MS to monitor the progress of the disease and they will share the data with the doctor and make together informed decisions. And finally, the #6 area that we're focusing on, the key driver would be really the element of sustainable funding and financing solutions. And if you look at our actual strategies, you don't find always all 6 of those key drivers addressed because it highly depends on what is locally and what is in the local ecosystem needed, but you will always sign from combination of the 6 drivers. And next one, please. So we decided to battle out particularly for having an ambitious yet achievable goal. And as I mentioned, this call is really directed towards improving access to our innovative core products in the areas of oncology, neuroscience, rare diseases and immunology, but it is also really directed towards supporting SDG target of reducing the number of premature deaths in NCDs. And the goal is double the number of patients in LMICs by the end of 2026, and the way we want to approach this, next one, please, is that we look really at the LMICs, and we speak about LMICs, we are talking, we're using development classification, which is generally accepted. We're talking about 85 countries where 50% of the world's population does reside, but they have also 45% of the world's poor in those countries and they generate 30% of the global GDP. Roche is not present in all of these 85 countries, but we do believe that we are present in those countries who present archetypes. So our clear ambition here is also to define solutions that are scalable and transferable from 1 setting into another setting into another country. Next one, please. The way how we approach this call to double the number of patients with access to our core therapy is that we really apply a very systematic approach around the patient pathway and around the value chain. We're going to start with more inclusive clinical trial designs. So where we want to find a way to support the equity and diversity and also we're placing more clinical trials into those countries because when we do that, number 1, that is not only accelerate access for patients, it also really helps with local upskilling and scaling up of those initiatives. We're also working together with local stakeholders on -- in those countries where there is a regulatory and reimbursement system, accelerating those processes because the gaps are really dramatic. If you would compare the time for access in filing and reimbursement between a low income country and between Europe, there is a gap that's very quite [indiscernible] and we really want to also, of course, work in the area of affordability. But we do believe that particularly in LMICs, there is an opportunity that those systems can [indiscernible] because most of the high developed countries are either financed by the Bismarck or the Beveridge system and we do think that for those LMICs countries that they can find alternative way of funding and financing sources for their population health needs. We're also working in the space of capacity enablement, which is something that Stefan also touched upon, which is really about supporting local infrastructure with external partners, supporting knowledge transfer, supporting the culture transfer. And then finally, underlying all of this is really this huge element of partnerships, finding the right partners, either on global, national or regional level to take also ownership of these access projects because our fundamental belief is sustainability from an access perspective would mean that we, at Roche, act as a catalyst for those access projects. But then there comes a point in time where Roche will be no longer needed because [indiscernible] it will be implemented by the system. What I really personally like very much about this is those -- this whole access is [ virtually ] focused on expanding local capabilities and creating solutions on the ground that fit locally, but it also will force us and that versus actually at Roche accelerate and adapt [indiscernible] internal processes. Next one, please. A key element because it's on the LMICs and we do know 2 facts. #1, we do know that currently in LMICs out-of-pocket financing is the #1 source for health care financing. And the #2 [indiscernible] the only way to achieve sustainable universal health coverage is by the increased governmental investment and governmental funding. So the way we want to approach the big topic of funding/financing is that we gradually want to help systems that want to create solutions together with people from the system to move from the bottom left corner from those countries who are predominantly out of pocket and out-of-pocket payments, which drives people into poverty but particularly in the disease areas where we are in more towards hybrid private banking schemes with the goal in the end that we will end at government and compulsory health insurance schemes. And we have some examples from previous project where we can demonstrate that we can do it. But the challenge we were facing here is addressing sustainable health care financing LMICs is that we really -- there's no one with all approach. We need a variety of multiple complementary funding solutions. The next one, please. And this is just a snapshot of the geographical and cultural overview on a variety of the access challenges that we are facing. Allow me just to point out one because we also believe when we develop these access solutions, we need to put way more focus on the cultural context for redevelopment solutions than we did in the past. And 1 example we really like is about New Zealand. So when we see that indigenous population is roughly about 15% of New Zealand population, we've had outcomes that fall way behind rest of the population. So -- and we basically started the dialogue and found out that the problem or a challenge is here that there's a fundamental [indiscernible] culture believe in the Maori population. So they are highly interested in innovation. They want to get genomic testing, but their belief is that no part of the body should or can leave New Zealand. So our solution was then that we hired actually a public health leader from the Maori community who does help us now engaging with the community and will help us to shape our local programs. And we already had the first round of a genomic sequencing high stakeholder table to develop jointly with the community, a solution that would work. Next one, please. And this is not an area where I do a little deep dive into 3 projects for above brand or product agnostic solutions. As I mentioned in the beginning, we are falling short of 50 million health care workers, particularly in LMICs there is a huge gap into trained health care workers and also particularly in the areas that Roche is operating, where we need highly trained and skilled people. Project ECHO is a possible solution to addressing the health care gap. It is a telementoring program, which works on a Zoom-like platform and thus connect health care workers from all around the world or within the country. It is a collaborative model of medical education on the 1 hand plus developing patient pathways and care management on the other hand. What it actually does is it can help to increase access the specialty treatment, particularly in rural and remote settings. And it really engages clinicians and local partners on the ground in kind of a learning ecosystem around that. We have started the partnership in October 2020 in a couple of countries. We are currently at 8 countries where we do have some pilot with ECHO. And I just want to share 1 very concrete. In Indonesia, we -- after collecting or after testing the pilot [indiscernible] Indonesia, we set together with the government of Indonesia and the National Institute for Cancer Care [indiscernible]. What we're also doing around [indiscernible] we are collecting data about the impact of the program and the government likes the program, finds it's highly applicable because in Indonesia, we are talking about 5 main islands in more than 6,000 islands that people are living. So health care capacity in the absence of public transport and getting patients to witness a huge issue. So the Indonesian government has now taken on ECHO as a core element, how they want to build up the health care infrastructure and committed to create a telementoring network across all of Indonesia with 10 so-called hubs, which will be diversity clinics and they work with over 100 so-called spokes, which are like satellites in very remote areas in Indonesia. And this is all with the aim to improve, on the 1 hand, the quality of the treatment that is available, but also to raise medical application and close the gap of health care workers. Next one, please. If you look at the funding and financing challenges that we are facing, 1 example is the Cancer Health Fund in Nigeria. Nigeria is a country of 211 million people roughly and 84% of the population in Nigeria were in the category of highly, highly vulnerable. Medical insurance is almost not available. And if it's available, it does not cover treatment for cancer care. So what we did is, again, like Stefan said, the initial approach is engaging with the local system going into Nigeria, connect with local stakeholders. We create and led a private sector coalition and led a cooperation with the World Bank, which resulted in establishment of the Nigerian Cancer Health Fund. What this fund is doing is that this Cancer Health Fund provides basic funding of up to $5,000 for treatment in the 3 most known type of cancers in Nigeria, which is breast, cervical and prostate. Roche also signed a memorandum of understanding with this Cancer Health Fund to ensure we established a cost-sharing model between the Cancer Health Fund and Roche and the aim of this cost-sharing model is to reduce the percentage of out-of-pocket payment for the patient. And another very, very important element of this collaboration is that we could convince the government to establish quality criteria and quality management of existing providers to harmonize the quality standard for cancer care gap. And the impact is that since the creation of this fund, about 4 million has been already allocated and about 400 people have received their care and looking at 400 people receiving care versus there is a population of 200 million people sounds very tiny and small, but this is quite often how is local access project work. But the cancer fund, again, it's scalable, it's transferable, it's replicable and we [indiscernible]. The next one, please. EMPOWER clinics in Kenya. What EMPOWER clinics in Kenya are doing is they are addressing local infrastructure and capacity building needs through community centers. Kenya, 40 million people, 30 oncologists, very few specialized hospitals. People mostly tend to go to so-called medical community centers, which you would also find in those rural areas. So we set together, and this is a coalition of Roche. It's a coalition of the County First Ladies of Kenya and of the Kenyan Cancer Association, and we [indiscernible] what instead of creating specific treatment centers, we would embed low accessible screening centers into already existing medical centers, and this was really sort of like [indiscernible] of the EMPOWER clinics. So since we started this project with EMPOWER clinics, we have already established 6 clinics all over the country. In that time period -- and the good thing is those clinics are established within the local infrastructure where people would go anyway. Since the establishment of the EMPOWER clinics, over 25,000 people were screened. Over 10,000 women were screened for breast and cervical cancer and 950 patients did receive treatment in those centers. But the impacts of this EMPOWER clinic, which is run and owned and hosted by local [indiscernible] goes beyond cancer care. In addition to cancer screenings, the doctor [indiscernible] around anywhere, why not screening for diabetes and hypertension. So the screening process and the screening portfolio that is offered will be continually expanded. And also what those clinics do is, those clinics scale up and train up [indiscernible] women with disabilities as community health care workers, and they help and run those clinics. The next one, please. And now I would also switch a little bit here from like all the solutions or all the solutions I shared with you now, we're really not at all product related, where we are really also proud of is all the solutions, any other company that wanted to join, it's completely open. We do not own EMPOWER clinics. We do not run EMPOWER clinics. We do not own the cancer health center so everyone can join there. Let me focus a little bit briefly on some more product-specific solutions. So 1 solution, what we did to enable and accelerate global access to innovative medicines during health emergency [indiscernible]. So what we actually did, we signed up quite early on research and development partnerships to accelerate [ track ] development. We also signed up manufacturing deals and made knowledge transfer to other manufacturers to scale up production capabilities. We had, within a short period of time, almost 1 million people treated with severe COVID treatments, really treated with Actemra. And in addition, we committed that we will deliver 2,050 (sic) [ 250,000 ] doses to WHO and ACT-A partners to distribute, particularly in LMICs and applied for the WHO list of prequalified medicines. And we also dedicated all our largest manufacturing facilities working with industry partners to maximize the production and overcome the global supply challenge because Actemra was originally not a COVID medicine. It was a medicine for rheumatoid arthritis. So the challenge we faced here was also that there's a lot of people out there, which were already in existing treatments. Next one, please. Hemlibra in hemophilia is where I think good examples for what is possible to enable global access to new standard of care, if you collaborate at the right time with the right people early on. #1, so the benefit of Hemlibra actually, it gives more freedom to patients. It's a treatment for hemophilia. It requires a loading dose -- initial loading dose around it and then you can decide to the maintenance dose to give it once a week, every 2 weeks or every 4 weeks, which actually gives way a very more freedom to us and also Hemlibra can be test administered which frees up resources. So what we did try to do earlier on is, #1, link back to what Stefan said is together with patients and patient groups, we designed 1 of the largest clinical programs where we really looked at endpoints in the trial population that we select the patients that really get the treatment. We started early on developing an integrated access strategy with a focus on access for all, specifically for the LMICs to let us to collaborate with World Federation of Hemophilia. We made partnerships around diagnosis, patient, education and training of HCPs and did -- made a collaboration with the world [indiscernible] explanation program from the Hemophilia Consortium and achieved that we could reach 1,000 patients across 30 countries who have now access. And what is really important here is it's the first time ever the patient in LMICs get prophylactic treatment for hemophilia. And we're going to [ base it ]. We're going to continue this partnership. Next one, please. I think this is the last product with example. It's about the Evrysdi in spinal muscular atrophy, where we use similar principles in Hemlibra, which is focusing on how can you achieve broad and rapid access. #1 is early partnerships with patient advocacy groups, particularly with the SMA Foundation that helped us to deliver the broadest clinical development program for SMA. Again, very important early on generating the data that would allow to make conclusions about the applicability [indiscernible]. We work where it was possible with accelerated regulatory pathways to ensure that we have rapid submissions for pricing and for reinvestment. We put a lot of focus on 2 key access pillars, which were awareness and diagnosis and offered also value-based pricing solutions. And we also still continue to partner with the SMA community to reach the rest of the patients. The next one. What we are doing is across all those initiatives and there is just 2 sentences here is, and this is sort of like a new discipline since 2019, we're working with Boston University to establish an evaluation framework, which means basically we do not want to start any new access program where we have not exactly clarity about what are the outcomes we want to achieve, of course, clarity experimenting how we're going to achieve them, but how do we measure what we achieve. You're going to look at what are the most cost-effective [indiscernible] that can be taken, what would be the right partners and also what data is needed to convince the policymakers to take those programs on. Next one. And with that, I'm in the space of affordability and pricing and how we look at. For all our new product launches, we do not only launch a product price. We've always launch a product with affordability and financing solutions. And we usually have those solutions in like 4 categories. It doesn't again mean that we use all the 4 categories in each and every country, it highly depends on the local situation. But those most common 4 solutions in the offering are either finance-based solutions, which are really aimed to address either budget uncertainty or just like lack of ability to bear. One example would be what we did in average cost that we made instead of negotiating product per product, where we made innovative portfolio of basket deal in combination with public, private partnership to reduce the cost of care. We're increasingly experimenting performance-based solution or you could say, paper outcomes, which is a novel approach, but that only works in very sophisticated health care systems with a robust data generation model around it. But 1 example here would be really what directive we did for Polivy in Spain. We also work a lot with patient [indiscernible] programs who are always designed and codesigned and cocreated with the patients on the ground and is an underlying core element of all the pricing [indiscernible] approach towards international differential pricing. There is not 1 country that is sort of like exactly the same price in the other country. So we are factoring in GDP per capita, purchasing power, public health expenditure and the Human Development Index with the aim to really develop an international differentiated pricing model that meets the need of the system. The next one, please. And our pricing approach is really rooted in the WHO definition of the pricing. The WHO definition of the pricing is that the price should be affordable for health care system of patients and at the same time generate incentives for the industry to invest in research and development. So the dimension that we are really looking is when we're defining our prices is that we look, first and foremost, what is the health impact and the societal impact that [indiscernible] bringing patients in the system. We also have to look at the system context, which is a country's ability to pay plus we have to look at other already alternative treatments available. In fact, we also have to look at the future innovation. And so this is our way how we want to try to combine on [indiscernible] innovation, affordability and health impact. And the last one, please. And what we're actually quite aware of is that the value really lies in the [ R&D build ]. We do not claim and we do know that we do not only definition of value but what we think what we do on and what we need to do is our accountability is that we need to raise the advantage for the different dimensions of value, the societal value, population health value and the patient and caregiver value and have a robust dialogue with all the stakeholders because we do believe it is critically important if we want to achieve universal health coverage. And if you want to achieve access to innovation brought around the world, there needs to be a mutual understanding of the definitions of value and what needs to be done to realize the value in the individual context of the countries we're operating in. Thank you. And with that, I'm giving it back to Bruno.

Thanks, Michael, for these many insights, and thanks to all the speakers. I think there's a lot of topics we could touch about on, and we have several questions here. I will soon open the Q&A. I would also want to make you aware that we have a call starting now, which is 10 questions. We would very much appreciate if you could provide us here some feedback, which then will be helpful for our future planning on also communicating our goals.

I will take the first question from the -- here from the chat and this goes maybe to Thomas. It's about diagnostics, and there is a target for the number of -- is there a target for the number of instruments in low-mid income countries by 2030, [indiscernible] insights with a broader 2030 target of doubling the access? And there is also the mentioning here, overall, how should we judge the success of Roche? Where would you like to be in 2030 on the access to medicines index? Ninth place is okay, but a long way behind Novartis, maybe just a quick commentary from my side. I think when you judge Roche, I think you always have to take into account our special portfolio. So if you have a portfolio which has a lot of rare disease medicines in there, like Michael pointed out, Hemlibra, Evrysdi in SMA. I think you have a special situation. You have very, very small patient populations. There's a global patient populations of only 30,000 people. So I think this you have to take into account when you want to benchmark. So benchmarking is not so straight forward. And on the machine placements, Thomas, over to you.

Thank you very much for the question. So first, let me say, as Roche, we're very committed to being present early in many of these markets. So in fact, it's probably the only diagnostic company we are oftentimes present locally in these affiliates, in these countries when many others are still present there as the distributor. And that really gives us an advantage to build the infrastructure and also the network in the systems to help shape the health care system. Regarding the targets, we do have targets specifically even by region and every country, so including also low and middle income countries. We do expect that these markets will continuously outperform in the developed markets as there is a lot of catch-up that needs to be done. And lastly, let me say that we are also -- when we look at product development, we're starting to develop also products that are more specifically suitable for some of these markets. For example, the emerging market analyzer that Stefan mentioned that exactly fits into the segment. But also like on the [indiscernible] is an example, a bit lower throughput solution that fits in these markets. So you also have to understand those areas. So yes, we do have these targets for these markets, and we do believe that the share will continue to increase.

Thanks, Thomas. I would just pick another question from the chat which come from Charles Pitman from Redburn. And this one is about, looking back, so given access to medicines has long been a key focus for large pharma, could each panelist, I think we need 1 for the pharma and 1 for the dia side, outline what previously implemented policies that -- what previously implemented policy, they believe has been the most effective in improving access over the past decade? And what future pieces of innovation do you believe would be the greatest contribution to improving access going forward? Maybe we can start again with Thomas or maybe Stefan as well.

I can jump in and maybe others can build on it. So first of all, thank you for the question, Charles. I think it's a very good one because we have learned over the years that policies can actually drive access and adoption in different markets. And it's a combination of global policies as well as local policies that may be needed. So if we just think back, I think there's a number of global policies around disease eradication whether it was cervical cancer, as mentioned earlier, whether it's tuberculosis programs, malaria programs, you can even go all the way back to polio eradication that can have a profound impact on access to health care and make us a great impact on society. I mentioned a couple of local ones for our local eradication programs, for instance, that make a big difference as well. There was an angle to the future, but maybe we want to stay first on the past ones and fight either way. Let me take... Well, I have the microphone, I think that what Michael was touching on the universal health coverage commitment that the nations have signed has tremendous potential in terms of really building resilient health care systems, but also ensuring that health care is available to patients no matter where they are. So this increase in commitment to invest in health care, I think, will be very critical in the next 10, 15 years to come.

Maybe let me chime in to what Stefan said. I agree that a lot of the WHO initiatives like the 90-90-90 initiative on HIV, eradication of cervical cancer, the T initiatives et cetera, those are helpful initiatives. And at the same time, with support of global funds, a lot of investments have gone into this part of the world. And I think we've made huge progress. Now with the pandemic, I think there have been some setbacks because a lot of people have not been tested. But at the end, there is a lot of opportunity to improve health care in these parts of the world. And at the same time, given the fact that the world is not much more globalized than in the past, a problem in emerging market is in the future also a problem for the global world, right? Because especially you saw the list of all the infectious diseases and most of them are appearing in more of the developing world. These are also the problems of the developed world. And so funding needs to shift from developed -- into developing world to help control these diseases.

Okay. Then I would pick now a question from the line. The next one would be Peter Welford from Jefferies.

I've got a question. You mentioned a comment that for your low-middle income country, pharma goal, where you said that Roche was not present in all of the low-middle income countries. I think you defined as 85. I guess I'd be curious, how many of those 85 is Roche not present in, perhaps either as a number or as a percentage of the population? But then just in those countries, would -- do you consider or have you already in the past some examples where you've either perhaps licensed out the manufacturing to a local player of your drugs or equally would you consider licensing out the IP as well to local players perhaps for a royalty-free or low royalty to enable access of those drugs to those regions? [indiscernible] what could potentially be done to reduce the volumes that are needed at a low capacity for some of these therapies in those areas?

So thank you, Peter. Allow me to come back to answer the question to you in writing because for sure, I would give you the wrong number. What I can tell you is, we are not present in all of those countries, but we're actually almost in a majority because even if we are not present, we usually work with local companies together or we work with [indiscernible] suppliers. When it comes to what are we considering what we can do particularly in those countries, as I try to point out is we are really looking across the value chain. What you mentioned about would we consider out-licensing? It would sort of like consider to developing volume, I have to go back to what we are currently in network we're doing with local partners is really focusing on the root cause of not on the systems. So that's just delivering and sort of like some arrangement, that even transferring of a key in the majority of cases would not solve the problem because the key problem is referring to what Thomas said is, there's basically no access to diagnostics. You have no infrastructure. There's no data infrastructure around that. But we are looking at all those options together with the local stakeholders in those countries where we want to achieve the goal.

So I think, Michael, if I get your question -- your answer right, basically, I think it's a bit simplified. If you just think of it as an excess goal in terms of there -- it's a supply issue. I think also for some of our medicines, for example, we would need a cool chain, which needs to be in place and all these hurdles, which exist so...

Correct. Yeah.

Okay. I don't know, Peter, did this answer your question? Or do you have a follow-on question, maybe?

No. That's great. Thank you.

Thanks. Next one would be Harry Sephton. Harry, please?

Jo Walton here. Harry is on holiday. Can you hear me?

Yes, we can hear you.

Two questions, please. Firstly, on -- just a broader 1 on diagnostics. One of the issues always seems to be the silo nature of the diagnostics budget and therapeutics budget. Have you been able to break that down? And has the COVID situation really helped that and particularly in the lower and middle income countries. And then my second question goes to the access to medicines and just looking at your assessment here and perhaps it follows on from Peter's, but the area where you seem not to be rated highly is in long-term supply chain capacity aims. And I just wonder whether there's more local investment that you could do in terms of, I don't know, local training, local employment. Just how -- which helps sustain the health care ecosystem rather than doing it more remotely. I wonder if there's anything you could talk to on that.

Yes. So maybe let me take the first part on the Diagnostics side. I think cervical cancer is a perfect example for that. As you rightly mentioned that there are separate budgets in the system and people don't really -- not really good in ecosystem to shift budgets from one place to next. I think this is where the health technology assessments are really critical to show the benefit in the system and then work with the system in making sure these budgets are -- be allocated. Now one of the parts of the goals is to shorten the time to reimbursement and one way we can do that is actually that we shape policy. So it's not only having a data but really shaping laws and policy in the countries that once they have all the data that they have to make faster decisions. And I think that's something where -- in some countries, we've been faster and then in other countries, in Germany, for example, we've been able to shape loss that accelerate the reimbursement time significantly. And that's the role of the countries together with Stefan to do that. The second part to your question was around developing countries and how we see that there. And actually, sometimes it helps when a system doesn't have any health care development because before you establish something new, you don't have to tear down the walls of something that existed. And so -- and sometimes with innovation and cervical cancer was a great example, for example, in Central America, where they were faster than other parts of the world, simply because they didn't have an infrastructure and they didn't have kind of the different parts of the system that we're finding for the budget, but they didn't have to take walls down before they actually were able to do about something new.

Jo, did this answer your questions? Or do you also looking for a question on the pharma side, I assume?

Well, on the pharma side as well, but just generally in terms of the level of local investment because one of the ways to grow a system is to invest in it and have more people involved. I don't know -- and some countries like to see local manufacturing. And I just wondered whether particularly given the supply chain capacity issues that access to medicine raised, whether you were looking to do more local manufacturing and local investment, people on the ground?

I think maybe Michael can join in. I think on the manufacturing side, actually, even in this crisis situation, which we faced with the pandemic, I think we have been able to deliver to the world so there was a lot of pressure in the system to align our resources and also to seek collaborations. I think on the manufacturing side, it's probably tricky to -- or I'm not that straight forward that we would branch out now in many countries and set up individual manufacturing capacity. But I think on all the other parts of the value chain, and I think Michael had several examples here. I think there, we actually strive for doing these investments and building local capacity and maybe, Michael, you could here again elaborate on the examples on where we believe it makes most sense to invest in some of these low-mid income countries.

So what we are doing is around this -- also this corporate [ code ] of business activities that started years before with our colleagues on supply chain management. We need in order to realize this goal and objective, what we need is local expertise. We need local experience, and we need local capabilities to implement. Where we have countries, where we have the expertise and we have to experience [indiscernible] to implement, we are looking currently what would be options, what can we do also with the colleagues on supply chain. And what would be the credit type of knowledge transfer. Realistic challenges, there needs to be some sort of like groundwork already done because we are not in small molecules business. We are -- like what we are doing also like our supply chain, so like, I have a lot of, like, very specific capabilities you need to build around it. So we're really looking into it. What I can also [indiscernible] you is like there will be investment, but it's not sort of like going to materialize and happen overnight just because of the complexity of the area in which we operate in.

And maybe I can just add to him, if you look at our current portfolio, then you see it's dominated, for example, by biologics or by antibody drugs. And you see where we presently produce, for example, in the United States, at the East Coast, we have hubs. We have then Germany, Switzerland and Singapore and Japan. And I think you just have to also think about the investments which are needed. So normally, such a biologics manufacturing facility, this is an investment of $0.5 billion, and it takes like 5 years to build it up and you need several hundred people to run it. You need a certain skilled workforce, you need a certain stable environment and you need many suppliers, which you need reliability in terms of electricity, all these things. So I think it's not that easy basically to set up a biologics manufacturing, for example, on -- in every spot around the world. And I don't know, Jo, any additional questions?

No, that's absolutely fine. I don't think any of us expect you to make monoclonal antibodies in Nigeria, but thank you very much. I'll let other people get in.

We would have 1 question in the line from [indiscernible]. Okay. I think it seems he has left. Then maybe we can take 1 more question on the chat. So there's 1 question here from [indiscernible] who is focusing on infectious diseases. And his question is, why is Roche not developing more drugs on infectious diseases as this seems a very important area for diagnostics division and synergies could be significant with pharma? I don't know maybe, Thomas, Stefan, you quickly want to summarize our efforts in -- on the dia side and then I can maybe jump in on what we recently started on the pharma side.

Yes, sure. So I think we already talked about SARS-CoV-2, as mentioned in the last call. We do have our investor call for Q1. We do have the launch plans pretty much the next days or maybe weeks. We're still waiting for FDA approval for SARS-CoV-2 to do test, which is a true qualitative SARS-CoV-2 test. All the tests on market beyond -- before were not truly quantitative. We'll be launching a T-cell test for SARS-CoV-2 as well. So we are continuously building out that menu. But there are other infectious diseases; dengue, tuberculosis, et cetera. So there is a huge opportunity for us to support the world in managing those patients. And at the same time, it's a big market in diagnostics. So it's actually critical. And looking at the Diagnostics business, we need to have a full portfolio of tests because one of the reasons for customers deciding to work with Roche is the high level of automation and the level of consolidation, meaning that you don't need many instruments, you just need Roche to run all of your assays. And this is why we continue to build out the menu on infectious diseases and it's a really key pillar for us in that.

And I think on the pharma side, [indiscernible], actually, we have a lot of activities ongoing. There are some projects which are preclinical. So in terms of antibiotics, we have signed collaborations with external biotech companies, but we also have an in-house development program. I think we last updated at our digitization event last November, where we basically showed that we use artificial intelligence and to basically screen existing libraries with known structures, which work where we create de novo [indiscernible] candidates, which then we test in screenings. And there are several independent initiatives ongoing. And the other thing is also, I think we have a project in hepatitis, which we portrayed before at the Pharma Day where we have several compounds in Phase I, Phase II development, and we are currently in the testing of various combinations. So infectious diseases are definitely an area where we are active in, and we also try to deploy new technologies here to tackle the upcoming issues of resistances. So I think this is a growing part of our early pipeline.

And let me just add, in both those programs, we're actually working together between diagnostics and pharma.

Yes. I don't know. I think with that, we are -- would be at the end of our session. I wanted to use the occasion again also to thank several people who have made this event possible. So thanks again to all the speakers for their time and dedication and also to some of the people in the back who supported them and made the event happen. Especially, I would like to thank [indiscernible]. She is covering -- is in the IR team. I think many of you know her already, and she had the overall lead and was also leading on Pascale's and Michael's presentations, together with Andy Walker and [indiscernible]. And then on the dia side, we have [indiscernible] who was covering as an IR officer, our diagnostics business. And together with [indiscernible] and Christian Huston, they were responsible for developing the decks of Thomas and Stefan. And last but not least, I would thank [indiscernible] who just made the event possible on the organizational side. And I hope this event was helpful in outlining our access strategy and also our ambitions and provided examples. And I'm looking forward to a future dialogue. And if there are remaining questions, but also any suggestions, please feel free to reach out to us. Have a good day, and talk to you soon. Bye.

Thank you.

Bye.