Takeda Pharmaceutical Company Limited (4502) Earnings Call Transcript & Summary

Hello, everyone, and thank you for joining Takeda's investor call focusing on our growth and emerging markets business unit. My name is Christopher O'Reilly, Global Head of Investor Relations. Before we start, I'd like to remind everyone that we will be discussing forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those discussed today. The factors that could cause our actual results to differ materially are discussed in our most recent Form 20-F and in our other SEC filings. Please also refer to the important notice on Page 2 of today's presentation. Turning to Slide 3. I would like to introduce our main speakers today: Ricardo Marek, President of Takeda's Growth and Emerging Markets business unit, and Costa Saroukos, Chief Financial Officer. Moving next to the agenda on Slide 4. First, Costa will give a brief introduction to today's event. Following that, Ricardo will present our growth and emerging market strategy, driving sustainable investments in innovation-led growth and patient access. Finally, we will close with a panel Q&A session. In addition to Ricardo and Costa, several other representatives of the GEM BU and R&D team will participate in the Q&A session. Sean Shan, Head of Takeda China; Dave Pearce, Head of Portfolio Management for the GEM BU; Choo Beng Goh, Head of Medical Affairs for Asia Pacific; and Taran Bae, Senior Director, R&D, Investor Relations and Strategy. With that, please turn to Page 5, and I will hand over to Costa.

Thanks, Chris. Hello, everyone. This is Costa speaking. It's my great pleasure to welcome you to today's investor call focusing on Takeda's growth and emerging markets business unit. Our emerging markets business currently represents approximately 13% of total Takeda's revenue. And in fiscal year 2020, year-to-date, the region has delivered solid underlying revenue growth of 6%, and that's off the backdrop of a very challenging COVID environment. Going forward, we aim to accelerate this growth rate with a strategic focus that is fully aligned to Takeda's global strategy as a value-based, R&D-driven biopharmaceutical company. The GEM portfolio has undergone a transformation in recent years. And many of our recent divestitures of noncore products have been in the GEM region. Simultaneously, we have shifted resources to focus on key markets where we have the scale to be competitive. And we've also shifted our focus on our growing portfolio of innovative products within our key business areas. In particular, we have strategies in place to maximize the potential of our 14 global brands. And already, we have seen great progress with strong launches of ENTYVIO in Brazil and NINLARO in China, 2 examples, which we'll share with you in today's presentation. Furthermore, we are preparing for global launches of our highly innovative Wave 1 pipeline. Today, we'll spend some time on TAK-003, our late-stage dengue vaccine candidate that could have a significant impact on public health in the GEM region. Of course, all of our strategies will be executed in line with Takeda's values and patient-centric approach, and patient access will be another key topic in today's presentation. At our Wave 1 pipeline event in December last year, Christophe introduced Takeda's company-wide goal to achieve JPY 5 trillion revenue by fiscal year 2030. A critical driver of that ambition will be our GEM business unit, and we are very excited for the opportunity today to take a deeper dive into our activities in this important region. Thank you again, and it's my pleasure to now hand over to Ricardo Marek, President of Takeda's Growth and Emerging Market Business Unit. Thank you.

Thank you, Costa. Hello, everyone. I'm Ricardo Marek, President of Takeda's Growth and Emerging Markets Business Unit. Thank you for dialing in today. Over the next hour, I'm going to take you through 3 sections for our presentation, and then we will open the lines to answer your questions. So first of all, let me take you through our differentiated strategy for GEM, our leadership team and key aspects of our revenue growth ambition. So moving to Slide 7. So to ensure GEM contributes towards achieving Takeda's primary drivers to deliver value that Costa showed you on Slide 5, we have put in place a differentiated GEM strategy that is aligned with our overarching corporate strategy. It is simultaneously geared up to never lose sight of our commitment to wider patient access to medicine, deliver strong revenue growth that fast tracks innovation to patients. We will do both these things in sustainable ways. During the presentation today, I will demonstrate how we will achieve that most notably across the 2 critical dimensions that we have highlighted here: investments and focus on portfolio and our geographic presence. Starting with the portfolio here on Slide 8. Over the course of the past 6 years or so, we have taken bold steps to increasingly sharpen our therapeutical focus. We started on our transformation journey across Takeda in 2014, and this transformation covered all aspects of our business, including portfolio. At the time, we commenced with the preparation for the globalization of our approach to this critical aspects of our business and the innovative assets that we had or we are developing to be growth drivers of the future. In fiscal year '14, our global brands contributed less than 1% of total GEM revenues. In 2017, we further enhanced our innovation focus via strategic divestments. For example, exiting our JV in China and selling Multilab in Latin America. These moves further sharpened the profile of our portfolio to be truly innovative to drive towards a globally aligned innovative portfolio. In parallel, these moves were complemented by the strong momentum gained from our launch engine with around 20 innovative launches taking place across GEM during 2017 to 2019. To accelerate growth and increase patient impact, we continued along the path of divesting noncore assets. The Shire acquisition, which accelerated Takeda's and GEM strategies, was a catalyst for 5 noncore divestments that generated approximately $2 billion in cash, pending the final deal close in China, while importantly, delivering further refinement and focus across GEM's portfolio. Simultaneously, we increased the GEM investments in our global brands and 5 key business areas. These moves have served to further boost our corporate and regional strategies. Our portfolio has evolved from 1% fiscal year '14 revenue from a single global brand to 95% alignment with Takeda's 5 key business areas as of fiscal year '19. As of the last quarter Q3 fiscal year '20 across GEM, revenue growth for our 14 global brands was 18% versus previous year. Top line GEM revenues have grown 63% from fiscal year '14 to fiscal year '19. Critically, as we look out to the long-term horizon to fully capture the innovation opportunity, GEM BU's ambition is to reach JPY 1 trillion revenue by fiscal year 2030. This will be driven off our 14 global brands and Wave 1 assets across our 5 key business areas. From a geographic perspective, on Slide 9, you can gain a very quick sense of the scale and complexity of GEM and the operational challenges that such abroad and diverse region presents to Takeda. From our Singapore headquarter, we currently address over 80 countries and territories that are home to 6.5 billion people across 15 time zones. GEM BU employs around 6,500 people organized in 6 geographic areas that are very close to the patients we serve and the partners we collaborate with. All in all, this is a vast and complex region. So next slide. In order to manage such a complex and diverse region, we have strong, experienced and diverse leadership team to navigate the operational landscape of the region and its multiple challenges. So this is Slide 10. You can see that we are organized with 3 country leaders for Brazil, Russia and China, having specific single country responsibilities due to market complexities and scale. We then have 3 leaders managing, Asia Pacific, APAC, co-located here in Singapore, South Cone, Andean and Mexico, SAM, which is Latin America countries and Central America, excluding Brazil, out of Buenos Aires. ICMEA, as we refer to it at Takeda, here, we have group it together, India, CIS countries, the Middle East, including Turkey and Africa, which we manage out of Dubai, UAE. In addition, we also have key leaders sitting in emerging markets headquarter, managing business operations, portfolio management, finance, HR, access to medicines as well as other important functions like medical affairs, market access, regulatory affairs, public affairs, communications and so on. We are a very diverse organization. So I'm proud to say that 44% of GEM executive roles across the extended GEM leadership team are held by women. 50% of the 6 geographic areas have women leading these organizations. Our extended GEM leadership of 25 people that includes the roles with the profile, photographs and flags on this slide and the 13 functions underneath includes people from 15 nationalities. With this -- with those functions across GEM BU, we have in place the right capability to adapt and deliver strong business performance in critical areas that will help drive our ambition for the region. So on Slide 11, you can see 4 examples: regulatory affairs, medical affairs, market access, launch expertise and commercialization. So this slide illustrates the proven track record we have in product registration with around 150 individual filings being secured in key GEM countries across our 5 key business areas since 2019. A great example is our successful approach to registration is Takeda securing more product registrations than any other multinational companies in China in 2020. Also, as the external environment evolves, we are seeing our 14 global brands being launched and made available to China's patients much sooner after they become available in the U.S. and the Europe. Delivering scientific meetings with over 150 related events conducted in 2020, so the majority of which were via agile digital platforms that we put in place last year. Leveraging Takeda's pricing principle that is centered around optimal patient access, such as value-based agreements and tiered pricing. Another strong related expertise we have is addressing patient access to medicines through affordability-based assistance programs. We currently have 27 in place across GEM supporting around 2,000 patients. More on that later. Commercialization and launch excellence with over 90 successful commercial launches taking place for our 14 global brands across our 5 key business areas since 2019. Our capabilities in this arena are deeply embedded in the business, so we ensure we generate value with local and above country expertise, focus on both extensive planning to drive flawless execution. A great example on Slide 12 of how leadership team can execute on this strategy, generated value and also helped Takeda achieve an ever sharper portfolio focus. We have the 5 recent divestments of noncore assets undertaken across GEM following the acquisition of Shire. So these moves have accelerated us further down the path to providing a truly innovative portfolio to patients, and we have generated close to $2 billion in value when the last agreement signed in China closes. So with 95% of GEM revenues now coming from products that are aligned with the Takeda's 5 key business areas, GEM has the strong strategic foundations in place. So over on Slide 13, you can see that those strong foundations in innovative brands are already delivering strong revenue growth, 18% as of Q3 fiscal year '20 on an underlying basis. What also demonstrates the strength of those foundations is the balance of the revenues contributions across the 5 key business areas. This indicates GEM is not over-reliant on 1 or 2 aspects of our portfolio. So the relative revenue contributions for each therapy area in the top half of this slide do not change dramatically over the coming years with the exception of the addition of vaccines that will help us diversify and derisk the portfolio further, while also delivering healthy revenue growth. So in the bottom half of the slide shows current rapid revenue growth coming from highly innovative brands, such as HYQVIA, TAKHZYRO and NINLARO that are delivering revenue growth of over 50%. It's also hugely encouraging to see ENTYVIO is still delivering such great revenue growth. So on Slide 14, shows that success with ENTYVIO has been a hallmark of growth from GEM and a great example of how the delivery of high innovation to patients is transforming our region. So here, you can see, from a geographic perspective in Brazil, one of our largest countries by revenue in GEM, ENTYVIO has evolved into a leader within the private market with an excellent 38% peak market share position as of Q3 2020. Critically, as we continue to strive to meet unmet patient needs, our holistic approach to patient access to medicines via a combination of tiered pricing, patient support programs and Takeda patient assistance programs have paved the way for public reimbursement for ENTYVIO, which we are anticipating in fiscal year 2021. We are confident that this will translate into a threefold increase in the forecasted number of patients of ENTYVIO treatment during the period of fiscal year '20 to fiscal year '22. That increase is set to move from 2,600 patients to around 8,000 people. Wider patient access via public reimbursement listing is also a driver of revenue growth. So in line with our GEM and corporate strategy, we are delivering sustainable growth via high innovation with ENTYVIO, while staying true to our patient-centric purpose. So in the next slide, coming to the next session, I want to talk a little bit more about the environment for significant growth in GEM. So in line with Takeda's purpose, we address unmet patient needs in our therapeutic areas of focus and simultaneously, appropriately drive sustainable growth. So on Slide 16, here, we are -- we have 3 examples of opportunities to expand in GEM around underused medical innovation biologics, low diagnostic rates in HAE and low testing rates in ALK. Across our therapeutic areas, we have a fantastic range of opportunities to bring innovation to address unmet patient needs and increase access. At the same time, GEM can grow and maximize our business and portfolio in comparison to more mature and developed health care systems. When you look at examples like penetration of biologics in emerging markets vis-à-vis U.S. or diagnosis rates in HAE in emerging markets vis-à-vis U.K., you can see strong opportunities to maximize growth and market penetration in some of our 5 key business areas. However, as challenging as these current examples may be for patients and pharma companies, they do indicate increasingly favorable opportunities for greater patient access to innovation and sustainable growth for Takeda's portfolio in future. So beyond specific therapeutic opportunities are also growth prospects presented by the evolution of health care systems across GEM and macroeconomic developments. So first of all, let's look at the macroeconomic and political environments as potential drivers of long-term sustainable growth across GEM on Slide 17. During the 20-year period up to -- and including 2019, the index of political stability and absence of violence and terrorism on the left of this slide reflects a strong evolution of GEM countries. We can see them moving closer to having more predictable and stable environments as seen in more mature economies. This is reflected in green in the bottom half of the table on the extreme left. While I'm not a political scientist, this increasing stability indicate operating environments where investments are derisked to an extent and that the likelihood of investments in health care by government plus the ability of people to access health care and/or pay for it is increasingly more likely. So moving to the middle of this table we can see that some macroeconomic measures in some GEM countries may drive currency fluctuations versus hard currencies, such as U.S dollars. While volatility remains to some extent within selected GEM FX rates, we see GDP for emerging markets economies on the right side has far [ outperformed ] others, more mature economies with continued growth and sharp favorable rise over the past 20 years. All in all, against this backdrop, we see clear opportunity to maximize and grow the Takeda GEM business unit. So when we look at Slide 18 and a specific health care environment for GEM and compare it to other key geographies, such as Japan, the U.S. and Europe, there is also a clear upward trend around total health care expenditure that is more favorable than those parts of the world. Tellingly, that trend at 10% CAGR is far more favorable than the low and mid-single digits seen elsewhere. In fact, over the same period of 2010-2018, emerging markets contributed 40% of the total growth in global health care expenditure. When coupled with the massive unmet patient needs across the region, illustrated here bottom right as the total population of 6.5 billion people needing access to health care, that rapid evolution and increasing maturity of the region's health care ecosystems, driven by those investments underpin the opportunity for revenue growth. And those opportunities for revenue growth and attractive are represented at scale. As you can see in the table on the left of the Slide 19, 9 GEM countries are currently in the global top 20 countries by pharma spend, with that number moving to 10 countries by 2025. This and around 5 more will be the focus of GEM's commercial activities to drive sustainable growth, but I will talk more about those and access to medicines a bit later. I will also go into a little more detail on China, which is ranked second by pharma spend worldwide. What is important to note on the right is that the worldwide pharma market grew 4% during the period of 2016 up to 2020, while the CAGR for emerging markets was 6%, further illustrating the current positive underlying strong growth trajectory for the region. On the next slide, as GEM countries evolve and mature via increased financial investments, attractive revenue growth opportunities will present themselves for Takeda's portfolio. There are 4 favorable health care trends captured here in this Slide 20 that will help provide GEM BU with sustainable growth over time. So let's start one by one. So the first is health care ecosystems. We've evolved across important GEM countries as capacity and infrastructure strengthened. The second one is higher GDP per capita is a solid indicator of increased standards of living and greater spending power. The third, there are increasingly favorable government reimbursement environments that are indicated by lower levels of out-of-pocket expenditure for specialty care medicines and highly innovative treatments. And fourth, health care policy environments continue to mature and evolve with an increasing number of policies and legislation that widens access to innovation. For example, here we have called out improvements in access to treatments for rare diseases. We've seen a solid positive trend for large GEM countries for Takeda's rare diseases portfolio. On the far right are those 9 important GEM countries that I alluded to the previous slide that GEM is focusing on and investing in, all of which are in the top 20 countries worldwide by pharmaceutical spend. They have benefited from a combination of some of these trends that drive and strengthen GEM's growth platform. So next slide. Not only is Takeda's GEM BU set to grow its current revenue platform, it is also set to outpace the market even within the segments for treatments focused on delivering high innovation to patients. In the middle of this slide, we can see nonspecialized treatments growing at steady 5% in selected GEM countries. Importantly, for Takeda's portfolio, CAGR for specialized, highly innovative treatments will deliver stronger 8% CAGR for the period of 2025. Takeda's GEM BU is extremely well positioned to capture that opportunity over the next 5 years and beyond. We are estimated to deliver impressive double-digit growth by 2025 compared to 8% for the total market for innovative medicines. We will continue along that double-digit growth trajectory to fiscal year 2030, delivering projected top line revenues of JPY 1 trillion. So in the next session, I will focus on GEM BU's strategic imperatives for future growth, so then we can move to Slide 23. So right at the beginning of the presentation, I mentioned 3 principles that we have used to develop our GEM BU strategy across the 2 critical dimensions of portfolio and geographical footprint. So adopting an access-first mindset in line with our values. So patients get the treatments they need wherever they are in GEM. Simultaneously making sure we fast-track the delivery of our truly innovative medicines to drive revenue growth. We also need to approach both patient access to medicines and our commercial growth ambitions in holistic, sustainable ways. So to do so, we have 3 regional imperatives in place that are consistent with Takeda's global strategy. So they are: one, first, invest in key markets and portfolio growth drivers; two, successfully launch Takeda's global brands and prepare Wave 1 launch assets; and three, drive sustainable access to Takeda's innovative treatments across our 5 key business areas. So next slide. I will now walk you through each of those imperatives one by one. We will start with the GEM's investments in growth drivers in key countries and our portfolio. So now we can move to Slide 25. So from an investment perspective, here, we have captured both GEM geographic archetypes on the left and the innovative brands on the right. The immediate focus is on 15 core countries and around 10 others, which represents 70% of GEM's population. This represents a high proportion of GEM's current and future revenue. In fiscal year '19, almost 95% of our revenues were generated from these countries. As you can see on the right, there are portfolio investments that we need to make that will drive revenue growth, primarily for our 14 global brands that Takeda makes available to patients globally, along with some others that are outside of that criteria. One example is ADCETRIS in our oncology portfolio, which is not marketed by Takeda in the U.S. but has GEM annual revenues of around [ JPY 220 million ]. Incidentally, that's more than the revenues generated in the highly developed pharma market as Japan. These brands across our 5 key business areas will drive around 20% CAGR in GEM over the next 2 years. So on Slide 26. We've highlighted 3 countries that appear towards the top of the list of 20 countries ranked by pharma revenue, which I mentioned on the Slide 18, China, Brazil and India. These individual countries offer significant opportunities for growth that's very closely aligned to Takeda's portfolio. For example, in Brazil, in the middle of this slide, we anticipate high single-digit CAGR between now and fiscal year '25. Here, our efforts are tightly focused on Takeda's global therapeutic areas of choice, and the exception in this regard in Brazil and India on the extreme right is that we do see strong growth opportunities for our dengue vaccine candidate, TAK-003, one of our Wave 1 pipeline assets. For India, when this candidate is coupled with our PDT portfolio, we will double the size of the local business in the next 5 years. As you can see on the left, in China, the second-largest pharma market in the world, we have aspiration for our portfolio to grow 20% over the next 5 years, which will be driven off our gastroenterology, oncology, PDT and rare diseases franchises. Takeda China is an important driver of revenue growth for GEM and Takeda globally. It is an investment priority as the local operating environment continues to reward innovation. So on Slide 27, you can see that our investments have and will continue to transform Takeda China, especially as the local operating environment continues to reward innovation. We believe the underlying fundamentals for the industry are strong in this country. The Chinese government's health care reforms are helping sustain our business growth by accelerating and rewarding innovation, which is an opportunity for Takeda. As you can see in the middle of this slide, our investments in the second-largest pharma market worldwide is spent manufacturing, R&D as well as our commercial operations. All Takeda global functions are aligned to capture the opportunities presented and address the unmet needs of the large patient populations across our 5 key business areas. As you can see on the right, we aspire to market leadership positions for Takeda China in GI, PDT and the treatment of the rare diseases, our portfolio addresses. So in the next slide. So in fact, Takeda China will be a driver of revenue growth for both GEM and Takeda globally. We feel that the local operating environment is favorable to rewarding innovation and also to the reimbursement of Takeda's current portfolio and future Wave 1 assets. In the top right of the slide, you can see a significant jump in approvals of multinational registration in 2017 over '16 due to China health care reforms taking hold at reward innovation. That positive trend for innovation and multinationals products has continued and looks set to continue. Our 14 global brands and Wave 1 pipeline ideally position Takeda for sustained growth in China. We are quite proud that this year, Takeda had 2 more products listed on NRDL, stands for National Reimbursement Drug List with ENTYVIO and Vocinti. Takeda China has also secured more product approvals than any other multinational in fiscal year '20. Over time, we plan to -- we plan for 15 innovative launches over the next 5 years, which will make a significant contribution to both Takeda China's revenue growth ambitions and indeed, those of Takeda worldwide. So this positive commercial momentum also means more of China's patients gain access to our innovative treatments. So on Slide 29. So it's a great example of a Takeda innovation from within our 14 global brands, delivering sustainable growth in China via NINLARO. With the right innovation, local strategy and conducive operating and regulatory environments, patient access can be increased, strong revenue growth achieved and market share delivered. This may be contrary to some misconceptions around the opportunities for high innovation in China and across GEM. Critically, on the left, you can see that when compared to the EU-5 and Canada, uptake of NINLARO 2 years post launch in China exceeded this highly developed pharma markets. Changes to the local regulatory policy and reimbursement environments for the brands saw accelerated patient access to the brand via 600 hospital listing, resulting in over 16,000 patients benefiting since launch. Our holistic approach to access means that not only did patient benefit, Takeda China secured a healthy 23% market share, helping us drive ever more sustainable growth by NINLARO as a global brand. So let's now highlight successful launches for Takeda global brands and Wave 1 across GEM in the next slide. From a GEM launch perspective, NINLARO and oncology, bottom left of the Slide 31, will also provide GEM with around 10 launches in the coming years as we continue to roll out of NINLARO and ALUNBRIG gains further momentum in the short to medium term. Other parts of Takeda's 5 key business areas also have a raft of launches planned over the next 5 years, all of which will be strong drivers of revenue growth. We've captured here rare diseases, PDT and GI, in addition to oncology. Laser-sharp investments across these 4 areas will result in 70 innovative brand launches in our 20 of our most important GEM countries taking place by 2025. Some highlights to note are in the rare diseases space where we have 36 launches planned, primarily from 5 brands and around 15 launches in PDT centered in CUVITRU and HYQVIA. Within gastroenterology, ALOFISEL and Revestive will continue to gain traction, along with the launch of ENTYVIO in some countries, where it isn't currently available. So moving to the next slide. Takeda's key business areas are also reflected in our R&D efforts that are focused on 4 therapeutic areas. Once again, oncology, rare genetic and hematology, neuroscience and gastroenterology, GI, as well as targeted R&D investments in PDT and vaccines. I know that many of you may be familiar with this slide, #32, in front of us here, that Andy Plump has presented in the past around our exciting pipelines of Wave 1 and 2 pipeline assets. So moving to Slide 33. We wanted to take a moment to show you all how GEM BU is advancing the registration time line for potential approvals and ultimately, their future Wave 1 launches in GEM that will be significant drivers of revenue growth and expanded patient access to innovation. We see potential over the period of 2021 to 2026 as reflected here with 11 Wave 1 assets being rolled out and registered in GEM across 5 therapeutic areas. There is a nice balance across our therapeutic areas of focus with 4 rare genetic hematology assets, 2 in neuroscience, 1 within gastro and 3 from within oncology being rolled out across GEM. So notably, in the top row, you can see the addition of vaccines and reference to TAK-003, which is our dengue vaccine candidates. We believe TAK-003 is set to play a critical role in driving revenue growth, both for GEM BU and Takeda globally. So next slide. Unfortunately, some of the heaviest disease burdens for dengue are within our region, with the highest incidences of the disease predominantly in Southeast Asia and Latin America. Within the 390 million annual infections worldwide, this will be an arena where Takeda's GEM strategy will be at its most nimble, so that we can, a, honor our commitments to get this highly innovative intervention to the people who need it as quickly as possible; two, deliver in a manner that reflects responsible pricing; and finally, drive appropriate access and sustainability. The opportunity for Takeda and GEM to have a positive impact on patients' lives in this space is enormous. From a perspective of revenue growth, based on current assumptions, we estimate peak global sales potential of $700 million up to $1.6 billion with a healthy 55% CAGR from launch based on non-PTS adjusted figure. The overwhelming majority of projected global revenues from TAK-003 will come from GEM BU. Once again, another strong example of our access commitments and ability to capture innovative growth opportunities for the region. On the Slide 35. When we take a look at the time lines for TAK-003, we can see an exciting degree of immediacy. We are looking at regulatory filings in our first Wave endemic countries in GEM, such as Argentina, Brazil, Colombia, Indonesia, Malaysia, Mexico, Singapore, Sri Lanka and Thailand in fiscal year '21. This will follow our 36-month data readout in the coming quarter. In fiscal year '22, we will start to capture innovative growth opportunities that TAK-003 promises for the region and beyond and also taking the first steps in having a positive impact on the lives of 50% of the world's population, who live under the threat of dengue, the world's fastest spreading mosquito-borne viral disease. Our efforts in this space will also embrace elements of Takeda's holistic approach to patient access to health and medicines. So now let's move to the next slide #37, and our sustainable approaches to drive in access to Takeda's highly innovative treatment. So Slide 37 outlines our holistic, sustainable approach to access to medicines that is in line with Takeda's purpose and our growth agenda. Our access mindset is a constant at GEM. From a geographic perspective, it has been instrumental in guiding our commitments to ensuring patients access to innovation, while at the same time, balancing the need for sustainable growth. As you can see on this slide, there are a raft of access to medicines initiatives which we take to the patients. These are not all simply philanthropic in nature but are embedded in the way Takeda's GEM BU operates. These are captured in the wheel-like graphic slightly to the left. Commercial activities like launches drive revenue growth, but they also drive access as patients get treated with our highly innovative portfolio. We also have mechanisms like tiered pricing, where we look at actable price points to make sure that local market conditions and both peoples' and governments' ability to pay is reflected in those prices. We also have Takeda's patient access programs where individuals in out-of-pocket countries, who face challenges around their ability to pay for our medicines can through a -- special mechanisms get some of our medicines based on the amounts they can pay. These innovative and collaborative financing models are tailored to individual patients and to current socioeconomic context and local legal health frameworks. They build on collaborative models between patients, Takeda and at times, local authorities, plus other parties to share treatment costs. Almost 2,000 patients have been treated in this way to date. We also have our more regular approaches to playing our part in strengthening the policy environments in these countries as well as philanthropic donations type of mechanisms, such as via compassionate access programs. This holistic approach to access to medicines has resulted in recent news that some of you may have seen, Takeda received external recognition in the 2021 Access to Medicines index, where we ranked 6th overall and first in one of the 3 technical areas measured, which is governance of access. Takeda has above-the-average scores in the other 2 areas of research and development, and product delivery. These are outstanding results for the company from an external benchmarking perspective. We are simultaneously very proud and also humbled. What's clear is adopting a holistic, sustainable set of approaches to patient access, this means we are living our values and delivering value via revenue growth. Going to Slide 38, and our region will grow. These are exciting times for GEM. The region is set to be a major contributor of Takeda's global revenue growth over the next 10 years. Our goals are to deliver above-market, double-digit growth and reach JPY 1 trillion in revenue by fiscal year 2030. This represents doubling our fiscal year '19 revenues. The drivers of growth are harnessed in our differentiated regional strategy with sustainable targeted investments that: one, fast track our highly innovative portfolio to patients, 14 global brands and 12 Wave 1 pipeline, including dengue vaccine candidate TAK-003; and two, focus on our geographic presence. We have the right degree of scale to be competitive in key markets. Notably, China is expected to be the second largest market at Takeda in the second half of the decade. Last but not least, our holistic access-first mindset means patients get continued access to medicines as we fast track innovation by prioritizing sustainable approach to both commercial operations and initiatives that aim to drive greater patient access to our 14 global brands and Wave 1 assets. Thank you so much. So Chris, back to you.

Great. Thank you, Ricardo. So we will now open up for Q&A. And as a reminder, in addition to Ricardo and Costa, we also have some other members of the GEM business unit and R&D team on the call for the Q&A session. So we have Sean Chan, Head of Takeda China; Dave Pearce, Head of Portfolio Management for the GEM Business Unit; Choo Beng Goh, Head of Medical Affairs for Asia Pacific; and Taran Bae, Senior Director, R&D, Investor Relations and Strategy. So operator, if you'd like to open up the call for Q&A, please.

[Operator Instructions]

[Interpreted] I'm Yamaguchi with Citigroup. And I have 3 questions. First of all, with your country strategy, Russia and Brazil, specifically, Brazil growth rate seems to be quite low. And you didn't say anything about Russia, but anyway, what about the growth rate in these 2 countries? Why are they -- is the growth rate low in these 2 countries? What is the reason? That's my first question. Second question is about strategy for 003. Peak sales, I think there's a huge range. This is $700 million to $1.6 billion. Why is this such a big range? What are the factors behind this? That's my second question. And the third question is about profitability. You have not disclosed the information, but by 2030, you want to achieve the same profitability as the whole group of Takeda. And currently, in 5 years' time, how does the GEM profitability compare against the whole Takeda group? Those are my questions.

Thank you, Yamaguchi-san. Ricardo speaking here. So I'd like to address the question #1 and 3. Perhaps I can also hand over to Costa with regards to the peak sales of dengue vaccines and the range. So regards to Brazil and Russia, I think you rightly said, I think I didn't brought here Russia in this presentation. My idea was to allude to some of the importance of some of these markets. I could, of course, present for our next session about Russia and many others. But in terms of growth expectations, these markets, in fact, they represent a high single-digit growth. This is exactly in line to the pharma environment of these 2 markets. And I can tell you that Takeda with the portfolio that we have and mainly the launches that we have ahead of us, mainly driven by rare diseases, hematology products, oncology products and GI, those are the markets, Brazil, Russia, respectively, very strong to continue to accelerate our growth potential for these 2 markets. So regards to the third question about profitability, emerging markets is nondilutive. I can tell you that we have amazing profitability, a great profitability delivering to the organization. And what I can tell you is nondilutive to the Takeda globally. So Costa, perhaps you can comment on the peak sales of dengue.

Yes. Firstly, thank you so much, Yamaguchi-san for the question. You may recall that during the R&D Day, we provided the peak revenue for our Wave 1 assets. And what we did at that stage was we used an average PTS across the portfolio. And it was -- what we used was a lower range in the PTS-adjusted number. Of course, we continue to monitor the situation. We're continuing to see how the pricing will be impacting the overall launch and peak sales of the product in different countries. So we're continuing to monitor that. And we're still very confident that we will be within those ranges, $700 million to the top peak revenue range. And of course, as we start to get further readouts and launches, we can update that number. But for now, you should assume that the average PTS that we addressed was more towards the lower range.

[Interpreted] This is Muraoka from Morgan Stanley. I'd like to state my questions first. The first question, maybe related to the previous question about the margin. The accretive margin, if you look at that margin, now and 2030, if we compare the 2, currently, in GEM, they are high-margin countries and low-margin countries. In 2030, how do you think the landscape will change? And the second question about the dengue vaccine 003. You're talking about $700 million to $1.6 billion, I believe. When you accomplish these numbers, what will be the number of patients? What will be the dose needed to accomplish the numbers that you had stated? And the third question about China, CAGR, 20% 5-year growth. If you are able to accomplish that, what would be the top product? ENTYVIO, plasma, NINLARO? What will the product that would make sure that you achieve that in China?

So Costa, perhaps you can take the first question in regards to margin, then I can pass to Choo Beng about the vaccines. And then we can also complement the third question. So perhaps you, Costa, start.

Sure. Thanks, Ricardo. Thank you very much for the question. As you can well appreciate, we don't disclose the core operating profit by regions, divisions or functions. But Muraoka-san, I can tell you that year-to-date, the GEM core operating profit margin is not dilutive to the overall Takeda margin. So the team has done an amazing job restructuring, managing the cost base. But I think for 2030, that margin will only continue to improve given the innovation and the overall cost base that we're seeing with the infrastructure that's already been set. The foundation that the team set now has allowed for a very competitive and accretive margin profile for the region.

Thank you, Muraoka-san, for the question. About the doses, it is difficult to estimate that at this moment, but it's important to recognize from the presentation about the extensive burden of dengue in GEM, which is 390 million. So with this estimate, we can also look at the dosing of our vaccine, which is a 2-dose vaccine. We have also invested in the manufacturing facility in Europe already to address the needs of this entity when we launch this vaccine.

In regards to the last question about the key products, So I will start and perhaps Sean you can complement. But in the horizon of the next 10 years, we see part of our Wave 1 pipeline, as an example, Orexin driving a fantastic growth in the Chinese market. Mainly the incidence, it seems very high for the population in China. Then we continue to see a fantastic growth uptake of albumin FLEXBUMIN in China. And those key products will really continue to accelerate in the coming years. So Sean, if you want to comment further on these 2 or more products. I know that we have also ENTYVIO. ENTYVIO is one of the fantastic product moving forward mainly in view of the high incidence curve that we have found out in the Chinese market. And as you can see, all these products is, in fact, innovation, bringing to the pharmaceutical market in China. So Sean, please, I think you can complement further.

Thank you, Ricardo, and thank you, Muraoka-san, for your questions. Yes, exactly, like Ricardo mentioned, the Chinese government health care reform already started and will be very helpful for the sustainable business growth by accelerating and rewarding innovation. So -- which is a great opportunity for Takeda, as we are set to launch more than 15 innovative medicines and the future, we won assets over the next 5 years. Actually, just in 2020, we already got 4 new innovative products approval by China and MPA authority, including ENTYVIO, ADCETRIS, TAKHZYRO and REPLAGAL. And also at the same year, we have 2 products listed on the latest NRDL, National Reimbursement Drug List. So you can understand we will have very strong pipeline in oncology, in GI and as well as we have the albumin FLEXBUMIN in China. In the meantime, those strong rare disease products also can contribute those -- more than 20% CAGR for the next 5 years. I hope I answered your question.

[Interpreted] JPMorgan, Wakao. I have 3 questions. My first question is you aim at JPY 1 trillion revenue and you mentioned which one will be mainly contributing. And from the patent expiry viewpoint, are there any differences of those contributions in terms of the timing of expiration or generics market penetration, I think may be different in GEM vis-à-vis the western countries? And talking about the Chinese market, I think Chinese market is going to be more important. And are there any changes in manufacturing? Well so far, the system was not matured. Therefore, it was difficult. However, now it's getting better and matured, so what is your view on the health care system currently in China? And also, are there any risks that we have to pay attention to talking about the Chinese market? Those are my questions.

Thank you, Wakao-san. I would like -- first question, I would like to have Dave Pearce who's our Head of Portfolio Management. And then I pass to Sean to comment on China further.

Thank you for the question, Wakao-san. I think as Ricardo alluded to in his initial presentation, we had strong contribution across our 5 core business areas as we continue to invest in innovative products and this will continue over the period of LRF. So I think it is well balanced in terms of that contribution. In terms of the landscape of individual patent expiries, as you well mentioned, it does look somewhat different to GEM. And we expect if there are patent expiries, those to occur somewhat later, and we obviously monitor that and have built those into our forecast looking forward.

I'd just like to start talking about a bit on China's investments, manufacturing, how do you see the market and landscape. I think it's also important to mention that in the past years, for example, Takeda's investments extends from the new drug development, manufacturing, supply chain and commercialization and expanding quickly. So we've been investing in China and not only but also in other specific markets, around $215 million in the past 5 years, and we continue to do so. So as an example, we had also additional investments around RMB 110 million, which is close to $15 million, $16 million in the Tianjin plant manufacturing site that we have also in China. And currently, the site today produces medicines for 2 of the 4 Takeda core therapeutic areas, oncology and gastroenterology. And then from R&D perspective, China is now by default a part of our global development program for all new pipeline assets, and we aim for filing in China for all new pipeline assets concurrently as U.S., Europe and Japan. So Sean, perhaps you can give more nuances about the landscape in China, please.

Yes. Thank you, Wakao, for your question. Yes, China -- Chinese government actually initiated a very brave and encouraged the health care reform. And we know also the health care expenditure growth is expected to outpace the GDP growth in China and any potential effects and economic slowdown are not expected to fundamentally impact the extension of health care spending. The government's Healthy China 2030 program also targets tripling total health care expenditure from 2017 to 2030 to USD 2.5 trillion. So -- which provide a great opportunity for Takeda. Because just like I already mentioned, in the next 5 years, we will have more than 15 innovative medicine and the future Wave 1 assets launched in China market. So yes, we are quite -- I believe now with the points just mentioned by Ricardo, we extend our manufacturing site in Tianjin and also establish Takeda Development Center Asia in Shanghai. So we will have the full ecosystem investment for Takeda growth and developing in China market. And the last question you mentioned and risk, actually, we're also aware of some downside price pressure. But the way we see the situation is that we recognize that the increasing numbers of the branded generics will create a downward price pressure within this segment. But simultaneously, the Chinese government have made a very strong commitment to improving availability and access to innovative, high-quality drugs. This included accelerated registration pathways and a strong support for innovative drugs with high clinical value. So with our 15 new launch and the future Wave 1 assets, this move presents opportunities for our innovative portfolio, and a wider and faster patient access to them will drive sustainable growth.

Moving on to the next question.

[Interpreted] Sakai with Crédit Suisse. I have 3 questions. Ricardo, you're in charge of many countries and some of these countries suffered really extensively because of COVID-19, Brazil, India, Argentina, these are the countries and also in the South Asian region, many countries suffered a lot from COVID-19. And the governments need to reduce their budget. And that could potentially negatively impact your business in the next 5 years. Are the numbers in this presentation representative of that situation? That's the first thing I want to check. And the second question is about ENTYVIO in China. I think the approval is given maybe last year or the year before. And now it's going to be part of the reimbursement list. And we have expectations for the revenue. Compared to the free pricing in the past, how much momentum -- additional momentum do you expect in China? ENTYVIO sales in emerging markets up to the third quarter was about JPY 4 billion, not so large. And maybe not everything is from China, but what is the outlook? I would like to know this as a reference. And the third question? Maybe this question is not really fair to you. But when Nycomed was acquired, Takeda had a very ambitious emerging market strategy. But afterwards, most of the launch plans failed. With Shire acquisition -- it's not that you're reentering the emerging markets because of Shire acquisition, I think it's more about the Takeda portfolio. You have a sufficient portfolio to be able to do business in the emerging markets. That's my take on that. But the question really is, today, you explained the plan. What do you think is the probability of success? How confident are you that you can be successful with this strategy considering what happened in the past? What do you think about this? So these are the 3 questions.

Thank you, Mr. Sakai. Ricardo speaking. I think the first one was related to COVID situation. The second one is much more about China, and then I can revert to Sean again. And the third one, I think, raise that -- a question about the emerging markets when Takeda acquired Nycomed and my level of confidence. So perhaps I can start with COVID situation. I think for all of us, it doesn't matter if this is coming from Ricardo from Takeda or any other colleague from any other multinational company, pharmaceutical business or any other type of business, I think all of us were very concerned about COVID back in 2020. I think all of us, perhaps also you, working in a bank, I think you were also concerned about COVID situation. So I think 1 year had passed. And what I can tell you is that our concerns about our people, our employees, we took care of them. In case of our patients, we continued to support all the needs of the patients wherever they are. And we continue to connect with our key opinion leaders and HCPs throughout digital platforms and capabilities that we developed online real-time last year. So back to your point about how do we see this year, the situations in countries like Brazil or Argentina, I can see and can extend the concerns of many others -- in many other countries. The good thing about COVID is that there is, in a common sense, a group of leaders, global leaders trying to find out innovative vaccines to the populations across the globe. And good to say and to see is that many countries that you alluded before, as an example, Brazil and Argentina, they have already started the vaccination, I think, beginning of January. As an example, Brazil has already vaccinated around 4% of population, close to 10 million, 12 million people around that or more than that today. Argentina is the same, but we have also seen countries that is also part of our GEM organization, like Chile, that today has around 15% up to 20% of the population already received their first jab, which makes me believe that in terms of COVID, this year, we will see much better situation than what we faced last year. Because last year, we didn't have any visibility about the damage, the problem and the solution. Today, we know the impact, and we have seen the solution already. So it makes me feel much more relieved that we are on the right track. And with regards to our business, I think we are pretty much confident that our plan, not only for fiscal year '21, but moving forward, is strong and sustainable because we are launching innovative medicines, innovative therapies for the patients, where most of these markets under GEM, they are really rewarding innovation. As Sean mentioned in China, I can also bring examples of many other markets as an example, Argentina, Chile, Brazil, Singapore, Australia, Korea, Turkey and many others. So it makes me believe that we are on the right track. I would like to jump to your last question. And then, of course, Sean, you respond to the second one around China. So in terms of emerging markets, I think your comparison vis-à-vis the acquisition of Nycomed back 2011, 2012, I think we are living in a different environment, mainly in terms of health care investments from the country's perspective, from the government's perspective, from the Ministry of Health perspectives. Today, we see countries rewarding innovation. So -- and I think Takeda today, with the current global brands plus the Wave 1 pipeline that we are aiming to launch in all markets, not only in GEM but also in Japan, U.K. and U.S., all these markets, we will succeed because we are bringing innovation, where it will be very difficult to governments not reward such innovation. And why then Nycomed was a bit different? Because we were competing with purely generics and brand generics. We are competing with the local players with the different environment, different criterias and different price consideration. So back to your question to me about how confident I am, I am 110% confident that with our strategy, we will succeed in emerging markets with a portfolio that we have in our Wave 1 pipeline, with the global brands that we are still launching in emerging markets, we will succeed. And then I think as I could allude to you with the examples of ENTYVIO in Brazil, reaching more than 8,000 patients with a high number of incidence and prevalence of Crohn's disease, it's amazing opportunity for the patients in that country. Same applies to China. And then, of course, I'd like to pass to Sean to comment specifically about the success that we may see in China because of the reforms that the health care in China put in place in the past years and will continue, in my view, to put in place for the future. So Sean, perhaps you can complement.

Thank you, Ricardo. And also thank you, Sakai-san, for your question. Yes, just like ENTYVIO is one of Takeda's 14 global brands, approved in China in March 2020 and successfully commercial launched in November 2020, within the same year. Meanwhile, also got the -- successfully enlisted into the National Reimbursement Drug List last December. This actually already implemented starting from March 1, so which allowed us to provide the optimal patient access for ENTYVIO, which covers the whole country at the fastest speed. And now there are about 60,000 patients diagnosed with CD and more than 300,000 patients diagnosed with UC in China. The diagnosis rate and the biologic penetration rate, which has significant room to grow, which continue to rise in China and will continue to increase the IBD market significantly. Our strategy is to develop the biologic markets and to make the golden standard treatment of ENTYVIO for IBD disease in China. And we also plan to partner with local societies to drive certification of our IBD centers and FCP education for optimal IBD diagnosis and treatment, including CD and UC. So including ENTYVIO, I'm quite confident with those 15 new launch and Wave 1 assets, we are well placed to become Takeda number -- second number -- second biggest market worldwide by 2030.

So we'd like to move on to the next question.

[Interpreted] This is Ueda from Goldman Sachs. I'd like to ask 3 questions as well. The first question, Takeda is an emerging country business. Their strength is with the innovative products. What are the other strengths that you can allude to? And the next question, JPY 1 trillion by 2030, that is a target you announced today. What will be the main drivers? And what will be the certainty of success? CAGR 8%, you mentioned, but is it going to be stable growth? Or is it going to be sharp growth around 2030? Can you talk about the tendency of growth going forward? And third, about the vaccine for dengue fever, the peak sales, when do you think this peak sales will come? And the third question, access to medicine was explained today during the presentation. The access and economic value, how would you be balancing the 2? Can you talk about that perspective? For each of the drugs, the net present value, how are you going to perceive them? What are the criterias? If you could share them with us, it will be appreciated.

Thank you, Ueda-san. Ricardo speaking here. So I've got here 4 questions instead of 3, but that's fine. So we would like to start with your first question about emerging market strength, and you'd like to know our strength. I would like to say that we can start with people. I think the culture that we have already put in place, the understanding of the market dynamics, the strategy that we decided to have our GEM's general managers in the countries managing key responsibilities, as an example, finance, HR, market access, portfolio management. So they know best what are the needs of the countries. At the same time, they are much well prepared to correspond to the expectations of health care authorities in the countries. As an example, we have shown here in China that has plenty of knowledge about the dynamics that's happening in China. I have many other general managers spread across all this vast region that are able to navigate according to the circumstances that may occur in the emerging markets. So the second point about strength is our geographic region. As an example, if something happens in one country, as an example, in terms of macro-political or economic situation, I have many other countries that can make counterbalance situations, as an example of FX exposure. So we have plenty of other that are very strong in terms of macroeconomics. As an example, China. So we have many others as Australia. We have Korea. So if something happens in other non -- strong country in terms of macroeconomic, I have a very strong strength in terms of counterbalance measures. So your second question is about the JPY 1 trillion, our CAGR of 8% and how can we achieve there. So our plan is really to launch, firstly, our global brands that we are still launching in emerging market countries. As an example, that you could see in my presentation, we are still launching products like ENTYVIO and ADCETRIS in China, but we have many other countries doing the same. And we started to prepare the launch engine to prepare the organizations in the countries to launch Wave 1 pipeline. Let me again -- bring again the dengue vaccine. So as I mentioned before, majority of the revenue will happen in emerging markets, mainly because most of these countries in Latin America and Southeast Asia are the so-called endemic countries. So for these specific regions, we have already put in place strong people, a strong organization to prepare the launch or prelaunch of dengue vaccines. One of the key measures is to prepare the right doses for the countries. The second one, we will prepare the regulatory affairs, prepare the market access for all these specific markets. We are mapping out private market, public market. So I think we have a very strong organization, ready to start, ready to launch dengue vaccine. So consequently, our growth uptake will be very strong in many, many products. And you may see our CAGR most probably in the first years of these launches being more than 10%, 11% and some other years will be 8%, 7%, 9% because we need to understand that we may have peak sales in some of these markets faster than others. So I think I covered also the vaccine's point. And the last one is much more about ATM, so about the economics, et cetera. I think we need to look at access to medicines in a very holistic view. We need to take into consideration our values as a company, always following, as you may know, that Christophe used to allude in his presentations, the so-called PTRB, patient, trust, reputation and business in that order. So taking PTRB into consideration and our values, as I mentioned before, one of the key programs to help us to sustain our launches, mainly in the low-income countries, we will have the PAP programs that I also presented in some of my slides, and PAP stands for Takeda Patient Assistance Programs. So we want to support patients in a very low income to have access to our products, to our medicines. And even if you need to donate partially of number of vials to these patients, we'll do so. Because at the end, the governments in these specific countries will recognize the need for the society. And consequently, there is a high tendency that this market will reimburse our products, our medicines. The second one is to continue to expand the patients across emerging markets. Once you expand patients, you are also expanding revenue growth. This is a correlation that we need to understand for emerging markets, which is very critical and vital for the success of our strategy in some of these key markets. As an example, let me bring here Philippines, South Africa, Egypt, that we are still considering access to medicine countries. Big population, affordability is still critical, but the governments in these markets are still working in public affair policies to allow us to have our products reimbursed in these markets. Differently than China or Brazil or Mexico, that we have a very nice reimbursement system in place already, where we can see the listing of our products. In less than 1 or 2 years, there've been reimbursement of our products in such markets. So all in all, we should not see ATM as a donation mechanism, but more a sort of holistic view having number of patients and consequently, the revenue growth of our products.

We'd like to take the next question.

It's Steve Barker from Jefferies Securities. I want to ask about the TAK-003, your dengue vaccine candidate. Looking at Slide 35, the plan appears to be to apply for approval in the U.S. followed by the EU. And then sometime down the track, apply for approval in markets, the emerging markets where the majority of demand is going to be. I was wondering if you could explain a little bit more about the thinking behind the order in which you're making applications for approval. And then second question is about the data package. It's almost exactly a year ago that you published, I think, it was 18-month data from the Phase III TIDES trial. I imagine, well, you've got another 12 months of data in hand. And I imagine that must be part of the data package. Could you comment on what it looks like compared to the 18 months data? And specifically, do you still see the same differential in the efficacy between the different serotypes? And is that a problem?

Thank you, Stephen. I'll invite Choo Beng here. So he can, of course, go into details around your questions.

Yes. Thanks, Stephen, for the question. So the first question is around the sequencing of our submission of our dossier. So you asked about why the U.S. followed by the endemic countries. So the approach that we have adopted really is to consider a global view on how we register this vaccine, considering that this is a problem that isn't just restricted to the emerging markets because we are looking at a global dengue problem. So when we look at the strategy around the submission of the dossiers, we have also looked at the EU as a benchmark. So the EU has this Article 58 approach, which is otherwise now called the EU-M4all. So several of our countries are part of this agreement, whereby once this approval has been given in the EU, it will simultaneously trigger reviews and approvals in these countries. So we have adopted this approach in order to expedite the review of the dossier across these countries. And these countries in the Wave 1 select group apply to the GEM geography, as you've heard. So that explains the launch sequence in these endemic countries. The second question is around the data package. So yes, we have the month 18 data that you saw in today's presentation. We also have the month 24 data, and we also expect the month 36 data. The month 36 data will be part of the regulatory dossier that will be submitted as of this month in many of these countries. We continue to see the effectiveness of this vaccine, the overall efficacy of the vaccine as well as the behavior of this vaccine in the seronegative and seropositive populations in the trial. What is very important is how this vaccine has started to show its differentiation with a previous vaccine in terms of the sero status of the subjects. So this will be -- we believe is an important consideration when the regulatory authorities look at this vaccine. Now safety is paramount, when we look at the Phase III data, and I'm pleased to say that safety continues to be acceptable based on our review committees and, at the same time, the overarching concern around ADE continues to be minimal when we look at the cohort. Across the different subtypes, and now we are going into the exploratory endpoints, I will leave that to the publication, that will eventually be released in time with the submission of the dossiers for further elucidation of the data within the secondary endpoints. But what I've highlighted really are the primary endpoints of the trial, and that's really the very important endpoints that the regulators will look at in terms of the global burden of dengue, which is really vaccine-controllable disease and at the same time, the hospitalization burden that many of the populations around the emerging markets continue to grapple with.

Just a follow-up question. So you mentioned ADE. So that is a real thing, a real concern. And would you, therefore, concede that some people who get the vaccine will actually wind up with a worse outcome, even though the overall outcome on a population level is likely to be very positive?

So this is definitely top most on many of our key opinion leaders when we organize advisory boards. So as I mentioned, in this Phase III trial, the pivotal trial, we've looked at the safety database extensively. We do not see that the febrile episodes have been attributed to any ADE phenomenon.

Okay. It seems like there are no further questions. So I think we can bring this conference call to a close. Thank you, everyone, for participating today, and we appreciate your interest in Takeda. Thank you very much.

Thank you all. Thank you. [Portions of this transcript that are marked [Interpreted] were spoken by an interpreter present on the live call.]