Thank you for joining us for the Takeda Plasma-Derived Therapies Investor event. This is Elizabeth Borgeson from the Takeda Investor Relations team. Before we start today, a few housekeeping things to keep in mind. First off, please draw your attention to the interpretation button or globe that's at the bottom right-hand of your screen. Choose the language that you'd like to listen and speak in, so English, Japanese. If you are to choose off, you will hear the original language and be able to speak in either language. If you haven't already done so, please change your name in Zoom to your first and last name, as well as your company name. That is what we will use to call on you during the Q&A session. Now, moving to slide one. I'd like to remind everyone that we'll 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 refer to the additional information on page one of today's presentation. Joining us today for our call is Julie, President of the PDT business unit, and several members of her leadership team, including Kristina Allikmets, Head of PDT R&D. Dana Mendenhall, Head of PDT Strategy and Marketing. Adrian Murphy, Head of PDT Global Manufacturing and Supply. Ramy Riad, CFO of PDT, and Hema Tallman, Global Head of BioLife. With that, I'll hand it over to Julie. Thank you, Elizabeth. Hello, and thanks for joining us today. I'd like to welcome everyone to our PDT IR event, and especially those of you who joined us for our first PDT investor event in 2019 and have been with us along our journey from the start. In 2019, Takeda introduced Plasma-Derived Therapies, a new business unit. At the time, many questioned the value of PDT and what Takeda could do with this business. In November of that year, we shared three things. Our strategy to accelerate growth and create long-term value. Our transformation effort across the value chain, which was reflected in our ambition to reimagine the industry to best serve patients. Our growth commitment, with a target of greater than 65% increase in our plasma donations and capacity by the end of FY 2023. We also embraced Takeda's values, which have guided us in every aspect of our work as we focus on transforming lives of patients who rely on our medicines. So how are we doing? Well, overall, we are very much on track, and I'm excited to share with you what we've been doing since then. In terms of our strategy execution, we have delivered growth of 16% across our IG portfolio and 6% across our total PDT portfolio in FY 2020. Ramy will go through further performance parameters in his section. Our transformation efforts have exceeded our expectations and are a significant contributor to our performance during the pandemic. Both Hema and Adrian will provide details in their sections. We have also reinvigorated R&D, which Kristina will go through later as well. We are on track to deliver our greater than 65% growth commitment, even with the impact of the pandemic. Earlier this month, we reconfirmed our revenue guidance for FY 2021. As we execute, we continue to learn and to push ourselves to do more, including reframing our ambition to be more patient-centric. Dana will walk you through that in a moment. Before I hand off to the team, let me take a few moments to set context. I have two context-setting slides, and I'll start with why plasma is different from pharma. Let me take you through some of the nuances. We are dependent on human plasma, which is donated by healthy individuals like you and I. There isn't a scientific advancement in the foreseeable future that will replace it entirely. From plasma collection through to manufacturing, it's very complex and capital-intensive. It is also more heavily regulated than pharma due to the nature of blood products, and this has resulted in a relatively small number of successful companies in this space. We also have to consider plasma economics. There's an interdependency between the products as the starting point is the same unit of plasma. This single ingredient results in multiple products, whereas in pharma, each product is made from different ingredients. Financial sustainability results from more products being made from each unit of plasma and high demand across multiple products. From an innovation standpoint, the technology platforms have remained fundamentally the same, with incremental improvements over the years, but nothing that has really transformed the industry. Beyond these differences, there is a significant runway for growth. The life cycles are relatively long because in general, the challenges with loss of exclusivity does not exist with plasma as they do with pharma. I love saying that albumin, which was launched commercially right after World War II, still hasn't reached peak sales. When you look at indication expansion, particularly for immune globulins, this is where again, there is significant runway for growth and the opportunity for geographic expansion for all plasma products. While pharma tends to have relatively low R&D productivity, it tends to be relatively higher for plasma R&D because the majority of the focus is on protein replacement with the natural protein, as well as supporting lifecycle management, again, because the product life cycles have a very, very long timeframe. Finally, from a market growth perspective, this is driven by under-diagnosis in the major uses, particularly of IG, as well as the need for optimal treatment levels and standard of care across the plasma product portfolio. These factors all contribute to an attractive growth profile for plasma. The next context I want to discuss is the environment. In terms of our headwinds, the first two pandemic-related ones we're handling quite well. Again, you'll hear from both Hema and Adrian on how we're managing this. In terms of supply chain, we do have to still work on addressing some of the vulnerabilities that were exposed during the pandemic. The last one, particularly in regards to anti-FcRns, this has been known for a while, and we believe this is manageable, and I'll tell you why on the next slide. When we look at the opportunities, our digital efforts have been accelerated like it has for many during the pandemic. Although the COVID-19 hyperimmune didn't turn out how we had hoped, it has led to silver linings in higher awareness of plasma in general, as well as an interest in engaging on policy and regulatory changes that can be positive drivers for the industry. In addition, there has been a willingness to collaborate on other opportunities, one of which Dana will also cover in her section. Now let me address the anti-FcRn question. Again, as I said, we believe this is manageable, and I'm going to walk you through the indications on the right-hand side, and then Kristina will talk to you about the science behind this. When you look at the overall uses for IG, you will see that the single largest use is in the immunodeficiency, both primary and secondary immune deficiencies. Because of the mechanism of action, this is not going to be impacted by anti-FcRns. When you look at the two indications that are being pursued first for anti-FcRns, both ITP and IG, we would expect to see a decline in IG use if anti-FcRns demonstrate safety and efficacy, and again, very manageable. The other piece that I want to highlight in terms of the autoimmune area is CIDP. Here, because of the heterogeneity of the patient population, we don't expect anti-FcRns to entirely replace IGs, which are today the gold standard for treatment, because of the nature of the patient population. We believe that there will be continued use for IGs in the treatment protocols. When you look at this holistically, this is why we think the potential challenge from anti-FcRn is manageable. You'll see on the left-hand side a growth chart looking at the overall plasma market, which is in the mid-single digits, as you've seen before, I'm sure. This is being driven by high growth of the IGs in particular. This runway for growth is supported by the opportunity for better diagnosis in primary immune deficiency, optimizing therapy levels, and improving standard of care across multiple indications, strong growth in secondary immune deficiency, pursuit of new indications for IG, as well as geographic expansion. All of these factors are the basis for why we believe there will be continued growth over the long term. Since the inception, and despite the pandemic, PDT has been meeting or exceeding performance goals across the entire value chain. Our donations declined only 11% in FY 2020, and we have been consistently surpassing pre-pandemic collection levels since earlier this year. We've been delivering efficiencies through our transformation efforts in BioLife and in manufacturing in order to maintain a reliable supply for our patients. We have been accelerating growth, as seen by our IG portfolio, particularly our subcutaneous IG portfolio, and we have seen strong progress in our R&D pipeline. At this point, I will hand it over to Dana Mendenhall, who is elevating our marketing capabilities and making sure we stay on strategy. Dana, over to you. Thank you, Julie. Hello, I am Dana Mendenhall, and I serve as Head of Strategy and Marketing for our Plasma-Derived Therapies business, and I will share a strategy for growth with you today. However, first, I'd like to introduce you to a very important person to Takeda, a patient, Hannah. Although only 50, Hannah has experienced a lifetime of health challenges that have aged her beyond her years. Repeated and progressively worse bronchitis and sinusitis infections led to repeated doctor's visits, misdiagnosis, and hospitalization after hospitalization. Hannah built her life around a health condition she could neither articulate nor explain. An answer came in the form of an accurate diagnosis when she was 43, primary immunodeficiency. The only effective treatment today for primary immunodeficiency is immunoglobulin therapy. We have spoken to many patients around the world, just like Hannah, who live with a variety of rare and chronic complex diseases that are treated with life-sustaining plasma-derived therapies, and many of which have no medical alternatives. They are grateful for their therapies, but desire and deserve more. While their therapies are life-saving, they are also accompanied by challenges such as too many needle sticks per treatment and worry about consistent and reliable on-time deliveries for their monthly therapies. At Takeda, our commitment is to deliver an improved experience for Hannah and other patients worldwide, and I am excited to share with you how we bring to life this commitment. As Julie mentioned, much of our recent growth is due to our ability to execute on the ambitious strategy we set forth when the PDT business unit at Takeda was formed. While it has evolved, as have we, the core of our strategy is about simultaneously making what we have work smarter and reimagining decades of established thinking and application. Our strategy is rooted in optimizing our core business and making calculated investments to serve more patients. It is built upon six strategic pillars, all geared towards addressing the challenges faced by patients like Hannah and the important nuances unique to the plasma market that Julie just spoke of. These pillars are supported by purposeful investments in our people, patients, processes, and our planet. Let's dive deeper into our strategy. To optimize our business, we are, A, driving last liter product growth through innovative plasma collection, R&D, and commercial initiatives, which I will talk about in just a moment on the next slide. We are, B, accelerating first liter product growth and maximizing the use of each liter of donated plasma, thereby unlocking greater access for patients with a variety of rare diseases. C, we remain committed to the continuity, excuse me, of care for patients through end-to-end enhancements to infrastructure, capabilities, processes, and systems. Next, we will not stop investing in the future. As you can see at the bottom of the slide, we are implementing disruptive manufacturing technologies, processes, and innovative business models that yield new standards for the plasma industry. We are pursuing growth opportunities and partnerships worldwide, building upon our robust network of strategic collaborations. F, we are innovating across our end-to-end value chain to further support established and new patient populations through transformative R&D. As we move through today's presentations, my colleagues will demonstrate how we are bringing this strategy to life. Before they do, I'd like to share with you the last liter growth example I promised you. Now, this is where the rubber meets the road. These are our inline portfolio drivers that create a competitive advantage and position us to grow and improve access for patients like Hannah. Takeda offers the broadest and most differentiated IG portfolio to support patient needs across multiple therapy areas. Featured on the left side of this slide are our IG brands. There are significant growth opportunities across the portfolio, fueled by targeted indication and geographic expansion, and focus on integrated care solutions that improve the standard of care. Kristina will share more about this focus later in today's presentation. Our IG products feature unique attributes that continue to position them as best in class. For example, CUVITRU, our 20% subcutaneous IG, provides more reliable protection from infection, is well-tolerated in adults and children, and is an easy-to-use treatment. We continue to work to expand its benefits to pediatric and young adult populations. Ultimately, our commitment is to deliver a seamless IG treatment experience for individuals who live with rare and complex chronic diseases. We are bolstering our efforts to do this by merging our IG portfolio with digital, device, and diagnostic technologies. My next slide will highlight the fact that while we continue to make strides toward fulfilling our strategic commitments, we are also acting on our responsibility to shape the external environment and to partner with key stakeholders to transform as many patient lives as possible. After all, more plasma equals more therapies, and more therapies means treating more patients. We are leading the charge in three key focus areas. Number one, policy and regulatory change, which will enable us to bring more therapies to patients. For example, we co-founded the CoVIg Plasma Alliance to develop a potential plasma-derived medicine to treat those at risk of serious complications resulting from COVID-19. Despite not meeting our clinical endpoints, this alliance united plasma manufacturers and regulators enforced new ways of approaching innovation. The end result placed laser focus on the importance of improved access to essential plasma-derived therapies for patients just like Hannah with no medical alternatives. Number two, evidence-based advocacy that enables us to drive change through education. For instance, we commissioned the Copenhagen Economics Report, a first of its kind publication designed to increase plasma awareness and education and influence the policy debate within Europe. The findings reinforce the value of plasma to patients, as well as the significant economic and healthcare benefits that result from having donation infrastructure and a science-based policy and regulatory framework for collection and fractionation of plasma. Third, proactive sustainability actions. For example, we are forging an initiative with the Plasma Protein Therapeutics Association (PPTA), to take a multi-stakeholder approach to reduce plastic waste generated through plasma collection. As I close, I invite you to return to our starting point. It is our strategy. Our strategy is grounded, improving the lives of and offering greater access to plasma-derived therapies for patients like Hannah, and this in turn translates into good business. I will now pass today's presentation to my colleague and my friend, Hema Tallman, who will walk us through the critical first step in this strategy, our plasma donation process. Thank you. Thank you, Dana. My name is Hema Tallman, and I lead the Global BioLife organization, Takeda's Plasma Donation Network. Good day, everyone. BioLife might be at the very front end of the value chain, but as Dana said, it's our focus on our ultimate objective, how we best meet the growing patient need for plasma medicines that drives and defines how we're expanding and enhancing our operations. Transforming patient lives informs how we engage with donors and drives every decision we make to deliver an exceptional donation experience. We want to provide more people with the opportunity to help save or change a life and to keep doing so. It's why it's vital we delight the donor at every step of the journey. What does that mean? Fundamentally, while we believe it's important for us to get bigger, and I'll show you how we have and will continue to do so next. Getting better at what we do is how we distinguish ourselves. It's about setting new industry standards by transforming plasma donation that attracts more people to donate and to keep donating. This is what best enables us to have a sustainable supply and continuity of care for the growing number of patients worldwide who rely on us every day. Let me start with how and where we are expanding our network and why. While expansion in recent years includes acquisition, notably in Europe, where we now have greater than 30 centers, most new centers on our plan to be internally developed, the best and most efficiently support meeting the increased patient demand. Here's what we're doing. We're rapidly expanding the global footprint. Since 2018 we've added over 100 centers globally. We manage our expansion strategy and plan by making carefully modeled data-driven decisions about where we expand. Our intent is for each BioLife center to become an integral part of that community while we broaden our reach and diversify our donor base. How do we do this? One of the ways is to unlock new states, giving more donors across diverse markets the opportunity to make an impact to patients. For example, in FY 2019, we started with a footprint of 27 states, and we're now at 35. Tapping into new markets allows us to tap into new segments of donors, an important part of our differentiation strategy. In parallel, we're working directly with industry partners and governments at the state level to modernize state plasma collection legislation and make it easier for us to reach our donors. While all this is a primary focus, we are keeping our eye on approaching growth responsibly through Takeda's commitment to the planet. BioLife has dedicated programs in place to continue to reduce our environmental footprint and innovate to create and support sustainable solutions. For example, we're now building all new U.S. donation centers as all electric centers. Importantly, we have plans to deliver this while continuing to improve our overall margins year-over-year, because many of these will actually save costs. That's how we've grown our infrastructure and operations. Now, I'd like to bring your attention to our transformation efforts, the true differentiator. What does distinguishing ourselves by being better look like? By transforming the donation experience across the entire donor journey, from awareness all the way to the returning donor, we are attracting and retaining new donors within our local communities in a revolutionized way. Let me share a few examples. In September, we completed the migration of all U.S. donation centers to the cloud. That improved our scalability and overall performance. We now have an uptime of over 99.5% and added capabilities in turn to bring digital enhancements to the market even more rapidly. It's provided us better visibility into the data that, when turned into actionable insights, enables us to confidently improve that overall donation experience even faster. Every donor is unique, and the effectiveness lies in how we personalize the use of these insights. We know loyalty is built from the first interaction someone has with us. Companies with extremely strong omni-channel engagement retain on average 89% of their customers, compared to 33% where they don't. By combining our cloud-based, data-driven insights with best-in-class omni-channel engagement, we're providing an unparalleled personalized experience, delivering the right message at the right time through the preferred channel. To give you an idea, we sent almost 8 million emails and 1.5 million text messages just the last six months. We've learned that new donors, as they embark on a journey to donate, have a lot of questions. Part of the personalized experience is achieved by offering digital tools like our virtual assistant chatbot technology, which provides answers that ensure a positive and lasting experience. Once that donor has engaged with us, one of our most key differentiators is avoiding long waits, making the experience as quick and convenient as possible through the highly utilized appointment application. By example, our donors have scheduled over 16 million appointments since March. The outcome of all of this data and digital capabilities effectively enabling us to attract and retain donors, a strong contributor to increasing our donor base across the network by 21% since 2019. This brings me neatly to operational excellence and how not only are we getting bigger and better, but we're getting faster. This saves time and cost, and most importantly, it brings therapies to Hannah even faster. Before the pandemic, we assessed and improved our supply chain end to end. It enabled multiple efficiency improvements, contributing to improving the speed at which Takeda moves plasma from a donation center to fractionation, as we pass that baton to our manufacturing partners and ultimately to the patient. For BioLife, this included acceleration of plasma inventory to the plant through advanced inventory management systems and optimized logistics routing, reducing shipping lead times, utilizing the plasma more quickly, thereby getting it to the patients faster. This work has been one of the biggest contributors to our ability to maintain performance and enable a steady supply for patients during this pandemic. Bigger, better, and faster. What impact did this have for us as we take a closer look at the results in terms of plasma donation volumes? We started to consistently surpass pre-pandemic collection volumes from as early as Q1 2021. We have been fast to recover, and our total volumes have been impacted to a much lesser extent versus 2019 and 2020. Our ability to act quickly as new obstacles have emerged, coupled by our differentiation strategy I spoke about today, means we expect the last two quarters of FY 2021 will contribute to the full year growth of 15%-25% versus overall fiscal 2020. Importantly, this means we can meet our commitments to patients on Takeda therapies. Next slide. It's important to note that the 27% growth in donation volume throughout these past six months has come from both established and new centers because all of our transformation work that I described has been applied across the entire global network. We've not relied solely on expansion, and no stone has been left unturned to improve performance. Let me get into some more specifics on this last slide. Our strategy was clearly adaptable to any environment. It is serving us well, even during this global pandemic. I already covered with you the last two columns you see on this slide, so my remaining focus as I conclude will focus on the first two. Business continuity and an investment in our people have been pivotal to our success. In spite of COVID and severe weather, the centers remained open with just a few closures. We put in place a dedicated critical response team to facilitate the dynamic changes, quickly implemented safety measures, providing the donors and the employees the protection and the confidence they needed to continue to donate. Our recruitment and retention efforts allowed us to sustain our historically low turnover rate and optimize labor productivity. Our turnover continues to be significantly lower than the industry. This, plus the transformation and the optimization initiatives listed on the right, have been the basis for our success and why patients like Hannah have continued to have access to treatment. With that, it gives me great pleasure in once again passing the baton in this end-to-end chain to my teammate, Adrian Murphy. Thank you, Hema. I need to thank you for your continued terrific partnership. Hello, everyone. I'm Adrian Murphy, Head of the Plasma Operating Unit, and delighted to be here to represent the over 7,000 team members who come to work each and every day with one purpose, to help transform patient lives. Over the next few minutes, I will share with you how we are really focused on executing our strategy and leave you with three takeaways. The first, always staying really focused on the patient need. The second, building a high-performing organization with a culture of continuous improvement and transformation. The third, delivering on our goal to sustainably increase capacity by 65% by end of fiscal year 2023 within our existing network. First, I would like to give you a quick overview of the major manufacturing steps and how manufacturing plasma-derived therapies is different to other modalities of manufacturing. The biggest differences are complexity and scale. In terms of complexity, what is different is each liter of plasma or raw material can make one or indeed 20 distinct products, depending on patient demand. Our drug substance manufacturing processes are designed to deal with this complexity. The second difference is scale. In volume terms, we measure drug substance quantities in tons, whereas other biologic manufacturing processes, drug substance quantities are often measured in kilos or indeed grams. Our batch sizes are therefore very large, and the number of batches we produce annually is significant. The final steps of the process, filling and packaging, are similar steps to how other sterile products are manufactured. Throughout the process, the teams are always aware that plasma is a scarce and finite resource, and we work closely together to minimize any losses, ensuring we optimize the performance of each and every step of the value chain. The mantra at our field sites is, "Every vial has a name." This ensures that patients like Hannah are always at the forefront of everything we do. This slide captures how we are organized globally and how we continuously strive to improve. We have a very strong heritage and have been developing and producing plasma-derived therapies for over 70 years to serve patients around the world. Our strategic network of 8 manufacturing locations and 4 strategic partners has set us up really well to ensure we reliably supply our patients. Patients like Hannah are always on our mind, and during those tough days when things go wrong, they are our source of inspiration to overcome those challenges. In addition, our strategy of dual sourcing our strategic products ensures we have the capability to respond to unplanned events. Our organization has a curious mindset and has really embraced the power of data and digital, looking for ways it can help accelerate our transformation to supply more patients. In addition to our internal capabilities, we have several active external collaborations who are focused on working with us to really learn how to leverage new technologies and expertise to improve our manufacturing processes. This in turn guides our investment strategy and ensures we continually invest to maintain our facilities as best in class and operationally state-of-the-art, while ensuring we continuously expand our capacity to serve more patients to meet the growing demands of our therapies. To give you more insight into our network, you will see on the top left-hand side of this slide, each of the major manufacturing steps in the process. Below it shows what steps performed at each of our manufacturing locations. Some sites like Los Angeles are drug substance sites. Others like Round Lake are drug product sites, while others like Vienna are fully integrated and complete all manufacturing steps. Our mantra of stronger together ensures we work seamlessly together to optimize product flow across the network. To the right-hand side, we have highlighted some of the major projects our teams have completed over the last two years to serve more patients. Those of you who attended the 2019 investor event would have seen firsthand our fully integrated and newest facility at Covington in Georgia. This facility has outperformed capacity targets year on year since coming online in 2018, and continues to expand capacity through process optimization. The site reached 90% of its original design capacity in FY 2020, well ahead of plan, and has a goal of achieving 150% of design capacity by 2024. In addition to our expansion at Covington, it's important you understand that our expansion plans are advancing across all our manufacturing locations. As Julie shared earlier, we are ahead of plan to increase plasma supply by at least 65% by end of FY 2023, with 40% installed capacity already realized. Now, a picture paints 1,000 words, so we have prepared this short video to give you a feel for how we are achieving all of this. Takeda's Factories of the Future program provides an umbrella organization for our strategic investments in disruptive manufacturing and digital technologies. It's radically transforming how we make plasma-derived therapies. By unleashing the power of data and digital, we're pulling through the full value of our investments and delivering on our commitment to increase capacity across our existing network by more than 65% without adding new sites. We're exploring how analytics, disruptive technologies, data-driven processes, and partnerships can bring more of our vital medicines to patients faster. We're making big changes. Increased automation and use of robotics and drones, as well as the integration of augmented and virtual reality, is enhancing our employee safety and experience. We're harnessing disparate sources of data to gain real-time insights in the production floor, improving quality control, reducing downtime, preventing failures, creating efficiency, and reducing cost. We're doing all this while protecting our planet. It's vital we grow and transform our operations responsibly with respect for the people and communities we serve. Our Factories of the Future program is setting new industry standards to increase supply sustainably and enabling Takeda to transform the lives of more and more patients around the world. You will have seen in the video lots of great examples of how we are harnessing digital and technology to transform our operations. As we increase our capacity, we are very focused we do so in a sustainable way. This slide captures our sustainability goals and how through the implementation of our Factories of the Future program, we're delivering on these very ambitious targets. To the right-hand side, you will see how we are designing sustainability into our sites. On the left-hand side are some specific examples of successes already achieved. We are always looking at how we can reduce our operating costs at the same time. A great example of this is the Water Consumption Reduction project in Belgium, where we're using new technology to reuse our water and at the same time reduce our city water charges by EUR 1 million per annum. Finally, none of this is possible without a great team, and it's important to recognize all we have achieved while navigating a global pandemic. The last 20 months has brought unprecedented challenges to many operations, including ours. The resilience and resolve of our teams at each of our sites has ensured uninterrupted patient supply and enabled us meet all our commitments to patients on Takeda therapies. During the same period, we produced an unplanned investigational therapy to potentially treat patients with COVID-19 in record time. Our dedicated manufacturing teams continue to successfully navigate supply chain challenges, such as shortages of single-use technology components, which are used in the manufacture of all our therapies. Having to deal with this adversity has accelerated our transformation and capability building. It's meant we have exceeded many of our targets and energized our teams to do even more for patients like Hannah, who are especially vulnerable right now, and produce even more innovative, life-changing medicines. Finally, I hope we have demonstrated how we are delivering our three takeaways. First, always staying really focused on the patient need. Second, building a high-performing organization with a culture of continuous improvement and transformation. Third, delivering on our goal to sustainably increase capacity by 65% by end of fiscal year 2023 within our existing network. On that note, I'd like to hand it over to Kristina, who will tell you more about how her team is driving innovation and patient care. Thank you. Thanks, Adrian. Hello, everyone. My name is Kristina Allikmets. I lead PDT's R&D organization, and I'm excited to have the opportunity to share with you some of the progress that we are making to advance and grow our portfolio and pipeline. Since establishing our dedicated Plasma R&D organization 2.5 years ago, we have been working to maximize the therapeutic value of our plasma-derived therapies. To do this, we have a two-pronged R&D strategy. On one hand, we want to continually improve life for patients who already rely on our therapies, like Hannah, who you've already met. We want to do this by focusing on the whole patient experience, empowered by the latest technological advances and digital transformation. On the other hand, for patients with complex chronic conditions who don't have effective therapy options today, like Edward here, we want to uncover novel proteins within plasma that might have therapeutic potential. Research and development for plasma products truly is unique. Therefore, having a dedicated R&D organization is key to enable us to innovate across our entire vein- to- vein value chain, as shown in this illustration. It starts with our donors. Earlier, Hema shared with you that BioLife strives to deliver an exceptional donor experience. Our device engineering team is supporting this goal, driving forward innovative device projects. Our pharmaceutical sciences team is deeply invested in improving our manufacturing processes and developing novel formulations. To build our portfolio, innovation certainly means identifying novel plasma proteins, but it also means that we are working to develop novel biomarkers that would allow for patient stratification and for more personalized therapy. Lastly, we see significant value in our current portfolio to better serve patients. Today, we do this through responsible expansion of indications and geographic reach of our therapies. Tomorrow, we aspire to reduce the burden of therapy for all our patients by offering complete care solutions to integrate treatment into their lives more seamlessly than is possible today. That's why innovation in PDT really is a journey. The cornerstone is our portfolio of therapies that we continually expand, which you can see on the left-hand side of this slide. For example, as Dana highlighted earlier in her presentation, we offer the broadest and most differentiated IG portfolio in the industry. This includes the only facilitated subcutaneous IG, HYQVIA, and the lowest IgA content IVIG, GAMMAGARD S/D. However, we know from our patients and caregivers how important delivery methodology is for them. It can take hours and dozens of steps to prepare, administer, and then clean up after a single IG infusion. Innovation in that area is needed. That's why we've developed our proprietary delivery device, HyHub, to simplify the process of administering HYQVIA. This advanced vial access device reduces the number of administration steps significantly. We've recently submitted for FDA clearance, and we hope to bring this innovation to patients soon. This is just a starting point for us. We want to do more. Our ultimate vision for the future is to offer fully integrated solutions to better manage the unique and complex needs of our patients from diagnosis and therapy initiation to delivery and ongoing care. We have programs underway exploring novel devices and companion apps that leverage the latest advances in data, digital, and technology. The goal is to simplify care, to help our patients live a life that feels like their own. Our pipeline reflects the different innovations across our portfolio and our efforts to maximize the therapeutic value of plasma across our value chain. We are committing about a third of our R&D investment to development of novel proteins, early research activities, and innovative technology programs. While about 70% of our budget is dedicated to enhancing our current in-line portfolio. Our work is broadly anchored in 4 key platforms shown on the right-hand side. We're focusing on proteomics to enable more personalized therapies and to identify novel proteins. I've already talked about the importance of pharmaceutical sciences and also about the aspirations that we have for our integrated care solutions platform. As for the last bucket, plasma drug combinations, here we're leveraging our close relationship with Takeda's global R&D powerhouse to explore combining plasma-derived therapies with other therapeutic modalities for some rare disease indications. We made significant advances on our pipeline in recent months, and there are several value-driving near-term milestones that I would like to highlight here. For our last- liter portfolio, we made considerable progress with TAK-771, our HYQVIA product. After obtaining a broad label in Europe for secondary immunodeficiencies, SID, we're now focused on the CIDP indication. The recruitment for the pivotal ADVANCE-1 trial in this indication was recently finalized, and we expect the readout early next year. We also anticipate expanding HYQVIA label to the pediatric population in the U.S. next year and launching the HyHub device, which I had mentioned earlier. Our Japan program for the IGs is on track. The pivotal study for TAK-664, CUVITRU, is underway, and studies for TAK-771 HYQVIA, will be initiated later this fiscal year. For our first- liter portfolio, we see a valuable growth opportunity. As you know, there are fewer supply constraints on first liters, yet there is a significant unmet need in indications that are or can be addressed by these therapies in geographies around the world. As part of our Japan program, we recently started a PK study for TAK-662, Ceprotin. For TAK-330, Prothromplex, our four-factor PCC, we're exploring a new indication, reversal of direct oral anticoagulant therapy before surgical procedures. The pivotal trial in the U.S. for this indication will start later this fiscal year. We recently completed recruitment to our FEIBA STAR study, which will bring valuable evidence about lower volume faster rate infusion to update the product label. As to our early programs, I talked about our broad and differentiated IG portfolio. To continue to further expand this, we are working on TAK-881, a facilitated 20% subcutaneous IG formulation. I'm excited to share that we've recently initiated the first-in-human clinical study for that program. We're making good progress with TAK-880, our new liquid, low- IgA product for patients with IgA hypersensitivity. As to TAK-882, we're moving forward with the non-clinical program, and this is our novel inter-alpha inhibitor protein project that we are developing with our partner, ProThera. In the past years, there's been a lot of innovation happening in the rare autoimmune disease space. As Julie mentioned earlier, novel modalities like the anti-FcRns are poised to enter the therapeutic treatment paradigm for certain rare diseases that are also addressed by IGs. CIDP is one of these indications. It's a heterogeneous disease where treatment is guided primarily by clinical presentation, given the lack of clear markers to guide therapy choices. That's why IG therapy brings unique benefits. It has a broad, multifaceted, anti-inflammatory, and immunomodulatory effect. It's known to be effective in a broad subset of CIDP patients and has a well-established safety profile. Anti-FcRns are a targeted therapy that focuses on a specific pathway, leading to a reduction of circulating IgG levels, and thereby also a reduction in the levels of IgG-type autoantibodies. These autoantibodies are present in a subset of CIDP patients and may play a role in the disease, among several other mechanisms that are involved in the aberrant immune response that characterizes this disease. Innovation is always good for patients. However, it's unlikely that the anti-FcRn compounds would substantially displace the unique benefits of IG therapy in this indication, given the heterogeneity of the disease. Now, the heterogeneity of many rare diseases really highlights the need for more personalized therapies for our patients. Understanding the role of plasma proteins in different disease states will enable us to better define responder populations and patient stratification, as well as potentially identify biomarkers for improving therapeutic value or monitoring disease progression. To pursue this goal, we've decided to focus on proteomics as one of our key research platforms. We're collaborating with several academic partners and technology companies, such as Biognosys, to leverage their capabilities in state-of-the-art proteomics technology to carry out this research. When it comes to partnerships, we are keenly aware of the power of collaborations to accelerate innovation. Since our inception, we've been building our network and currently have more than 30 strategic collaborations with academia, industry, and technology organizations, while continuing to collaborate with professional and patient organizations to drive our innovative programs forward. We have also about 70 clinical research collaborations ongoing, which are supported by our dedicated medical affairs organization. Finally, internal partners are equally important. By partnering within Takeda, we have the unique opportunity to collaborate on a range of research projects, sharing in-house expertise, capabilities, and resources. In conclusion, we are making significant progress on our work to support the growth of Takeda plasma-derived therapies through innovation across our end-to-end value chain. Our progress is enabled by several unique differentiators, including a dedicated and specialized plasma R&D organization, which is driven by a clear and well-defined research and development strategy and dedicated budget. Supported by our strong partnership and collaboration with Takeda's global R&D organization. With that, I would like to pass it to Ramy, who will give you more details about our progress. Thank you, and over to you, Ramy. Thank you, Kristina. Hello, everyone. I am Ramy Riad, the CFO for Plasma-Derived Therapies business unit. In the next 10 minutes, I will share with you how our strategy, focused on patients like Hannah, has allowed us to create a sustainable business with strong growth for Takeda. As you heard from Julie, we have transformed the PDT business unit since its inception in January 2019. I want to highlight for you in this slide a few key indicators that lay a strong foundation for us to drive from. Our first row focuses on our capacity expansion. As you heard today from Hema and Adrian, our BioLife and plasma operations are more than halfway to our goal of increasing supply capacity by 65%. BioLife grew its network by 56% since FY 2018 to increase our plasma collections. At the same time, plasma manufacturing operations has invested to drive growth, increasing our installed capacity by 40%. The next row highlights activities focused on improving our operational efficiency and donor's experience, which translate to margin improvement across the value chain over time. Two key metrics to highlight in this area. Number one, the migration of 100% of U.S. donor information system to the cloud. Number two is the improvement of IG process efficiency to increase by 3% since FY 2018. These investments in digital capabilities and process efficiencies continue to deliver for patients and performance. In the last row, you can see the other end of the value chain. We have invested to provide more access to our products for patients. Our R&D continues to lead the way with geographic and indication expansion, which lead to more than 40 commercial launches in both last and first liter, and these expansions allow us to expand our reach to patients globally. The focused effort of the value chain have also provided strong growth in the U.S. market, which is our largest market for IG, with CAGR volume growth of 12% since fiscal year 2018. The foundation I shared with you in the prior slides has set the basis for our underlying growth across the PDT products portfolio and continue to fuel our growth and performance. In this slide, I will show you our underlying revenue growth during the last two fiscal years, 2019 and 2020. The left-hand side shows the sources of our revenue in fiscal year 2020, where 66% is driven by IG, 11% is driven by albumin, and 22% is driven by first liter, including other immunology and other hematology products. As you know, fiscal year 2020 was the year of the pandemic, but our foundation and strong coordination across the full end-to-end value chain helped us to have quick and agile response, and this resulted in strong underlying IG growth of 16% despite all the market challenges. This drove the overall PDT revenue to grow by a healthy 6% in year 2020. As you can see, our IG portfolio double-digit growth last year was fueled by our strategy to focus on growing our subcutaneous IG portfolio, which grew by 21%. Albumin demand continued its strong growth, fueled by emerging markets and China. The underlying growth for fiscal year 2020 reflects the impact of the pause in albumin shipment to China, but was significantly offset by strong growth of FLEXBUMIN, which reached 37% last year. As a reminder, from total Takeda perspective, we focus on 14 global brands, where four of these global brands are in Plasma-Derived Therapies business unit and shown in this slide. These products are CUVITRU, HYQVIA, GAMMAGARD LIQUID or KIOVIG, and albumin portfolio. As we have shown you today, we are working closely across our end-to-end value chain to build a sustainable plasma business. This strategy and our end-to-end value chain performance has resulted in two metrics that together illustrate how the beginning of our value chain efforts translate to top-line growth. Driven by patient demand, our value chain works together to ensure our patients on therapy, on Takeda therapy, continue to receive treatment through reliable supply and with new patients confidently being served. Starting with the plasma collection growth. Hannah shared what we do differently in BioLife to create a donor experience that drives our collections. We are very proud of the successful response to the pandemic in fiscal year 2020, which resulted in only 11% decline, which is much less than the overall industry impact. As Hannah said, we have reached our pre-pandemic level and starting fiscal year 2021, we consistently surpass it, which allow our guidance of growth in collection to be confirmed. The revenue growth you saw on the previous slide in our IG portfolio is also shown here again, and this is to demonstrate the results of our approach to serving patients and delivering our commitments. You can see the cumulative revenue growth is faster than the cumulative collection growth, which reflects the process efficiencies improvement and the strong inventory management across the network. Before I hand over back to Julie for closing, I want to remind you of our first half of the year results and guidance for fiscal year 2021, which was shared a few weeks ago during our quarter two earnings call. The Plasma-Derived Therapies business closed the first half of fiscal year 2021 with very strong results. Our total PDT underlying revenue grew by 7%, driven by PDT Immunology, which grew by 11%. Also, note here, albumin had a strong 35% growth in the first half, demonstrating the regularity of supply back to China. This strong performance allow us to confirm our guidance given at the start of the fiscal year and shown here in the middle part of the page. As you heard from my colleagues, our strategy of innovation across the value chain will require us to prioritize our investments. We are doing so by prioritizing both the revenue growth activities and margin improvement activities through new products development and process efficiencies. This investment strategy will continue to drive us toward the PDT ambition to transform the lives of patients through innovation and sustainability. With that, I hand it back to Julie for our closing remarks. Thank you. Thank you, Ramy. As you've heard throughout our presentation today, we have made significant progress toward our ambition of transforming the lives of patients through innovation and sustainability by executing our strategy, driven by our focus on developing deep understanding of patients, donors, and the entire ecosystem. We have been leveraging data, digital, and technology across our entire value chain. We've been focused on delighting our donors, delivering on our increasing supply of plasma through our capacity expansion. We've also been transforming our operations to deliver efficiencies and transforming our R&D to reinvigorate innovation in plasma. All of this to create more sustainable access for our patients worldwide. Now, this is made possible by a fantastic and diverse team, some of whom you've had the opportunity to meet today. As a team, we've laid out a strong strategy. We've delivered strong execution thus far. Without this strong team, we wouldn't have been able to deliver results like the ones we have. This team possesses the capabilities and experience to achieve our ambition and our goals while also serving as role models for leading through purpose and values. This is a clear point of differentiation for us. As you've seen since our inception, we have transformed from a potential liability to a key growth driver for Takeda. PDT represents 16% of Takeda in FY 2020, and we anticipate this number to grow. For fiscal year 2021, we are on target to deliver our revenue guidance. We are also grounded in Takeda's values, which leads to our ethical decision-making framework as reflected in how we operate, which you've seen throughout the presentation. This is another point of differentiation. Finally, we are aligned on shared goals. Our growth of greater than 65% is contributing to Takeda's overall growth profile. Our year-over-year improvement in core operating profit and our aim to be non-dilutive, reaching the mid-30s in the midterm. We are also R&D-driven with an innovation focus on transforming both patient and donor experiences. We have a multitude of initiatives to drive to carbon neutrality and zero waste to landfill. We are also leading Takeda in terms of leveraging data and digital platforms like cloud computing and blockchain. To wrap it up, we've come a long way since we set out with our strategy in 2019. We are executing well and delivering results that are meeting or exceeding expectations, and we expect to continue to do so. At this point, we have demonstrated that PDT can be a growth engine for Takeda as we continue to strive to set new standards for patients and donors while delivering value for Takeda and our stakeholders. Thank you again for joining us today. Now I will turn it back to Elizabeth to take your questions. Thank you, Julie, and thanks to the whole Plasma team for walking us through this excellent presentation and doing a deeper dive into Takeda's plasma business. Before we start the Q&A today, a couple reminders. First, please make sure that your displayed name is your first name, last name, and company name, as that's how we will call on you during the Q&A session. To ask a question, you'll use the Raise Hand function that's located at the bottom of your screen. When it's your turn to ask a question, we'll call on you by name, invite you to unmute your line, and then we'd like you to introduce yourself before asking the question. Also, as a reminder, if you are on the English line, please ask your question in English. The same applies for the Japanese line, and if you have your translation set to off, you can ask your question in either language. With that, I think we can go to our first question. Yamaguchi-san from Citi, you are welcome to unmute your line and go ahead and ask your question. Can you hear me? Yes. Yes, we can hear you. Great. Yeah. Good morning from Tokyo. Thank you very much for the comprehensive conference. It was very useful. A couple of questions from me, Yamaguchi, Citi. First one, an obvious one, which I need to ask is that, because of the pandemic, average liters collected per center has gone down. Should have gone down. Is it returned to the pandemic level? What is the implication for the donor fee per liter this year and next year going forward? Is it going up or down for next year, given the things that settle down? That's the first question. Can we go through the question first or one by one? It's okay. I'm taking notes, Yamaguchi-san. If you want to ask all of your questions, please feel free to do so. Yes. Yes. Thank you. Second question is regarding U.S. supply and demand plasma situations. Because of this situation, our plasma collection center like you and the industry have to access more donors in the United States to fuel the industry growth in the future. I'm wondering that is there enough donors in the United States? How much percentage you have to take to have an access to the eligible donor in the U.S.? Is this situation okay to have enough donors you have in the U.S. for going forward? That's the two major questions. Thank you. Okay. Thank you. Let me provide some context upfront, and then I'm going to ask Hema to add further details. In terms of your first question, and again, Hema will give you some specifics here. When we look at how we manage overall, we have multiple levers that we are using to look at our total plasma supply through our donation network. Here we moderate, for example, donor fees. They go up and down depending on what we are trying to achieve. In general, we are moving to a more normalized state from a donor fee perspective, as well as the average collections per center. You will have seen from our overall data that we've surpassed pre-pandemic levels. Now, that doesn't necessarily mean that every single center is at the same place. On the whole, we are in a very good recovery mode. Again, Hema will add some details there, as well as addressing your second question around attracting more donors. Is there still room for growth in the U.S., which the simple answer is yes, but again, Hema will give you more detail. Yeah. Thank you. Absolutely. Thank you so much. I will say that just to rapidly iterate that while the decline in the donations during the pandemic did drive higher than normal fees across the industry, BioLife's approach was to make very sensible and well-timed investment decisions. I would say that the donor fees varied across the past many months, depending on market dynamics and seasonality. As Julie put it, most importantly, it is only one lever. We are not only looking at multiple levers, but looking at them in a coordinated fashion. In the short term, the increases in donor compensation in the U.S. They've contributed to growth, but they are not our strategic long-term focus. Our continued expansion, optimization and transformation activities will continue to be central to our efforts to increase plasma volumes. As far as the opportunity, the opportunity is there and it's good. We have a very data-driven model for our location strategy that allows us to select where our centers will go in this growth trajectory, where we will have the most volume and the most volume potential that we can gain across the globe. The potential certainly is there, and we believe through our transformation activities, we will reach more donors that are in a more diversified category as well as in a broadened reach. Okay. Thank you. Thank you. Next we'll go to Muraoka-san from Morgan Stanley. You can unmute your line and ask your question. Morgan Stanley. Muraoka. [Non-English content] Arigato, Muraoka-san, for the questions. I'm gonna ask both Ramy and Hema to comment on this in a minute. Let me just say that overall, from our transformation efforts, as we've described during the presentation, have offset a significant portion of our increase in costs that have come through during the pandemic. While your calculations, and Ramy can comment on this, whether they would be correct or not, but you cannot look at it in isolation because we do look at this holistically. As I said, a number of our transformation efforts have contributed to further efficiencies that offset those increase in costs. In comparison to our competition, again, I think you will see from our performance numbers that we have shared thus far, that we are faring relatively well. Ramy, if you want to add some further comments about the questions on the deterioration due to the fees, and then Hema, I'm gonna ask you to talk about the importance of the plasmapheresis technology. Thank you, Julie, and thanks for the question. Basically, I would like to highlight donor fees is one component of the total cost structure for plasma-derived therapies. Today you heard from Dana how our strategy is based upon building a sustainable business, which includes improving our margins year-over-year. Our commercial strategy, for example, is focused on growth by maximizing the value of plasma through first liter strategy and accelerating innovative products such as subcutaneous IG and FLEXBUMIN. Our operational strategy from the other end is focused on driving efficiencies and more yields across our donation and manufacturing network. Also, from the other end of the value chain, we are managing our OpEx very, very carefully by investing in advancing the strategy you heard today from my colleagues. All in all these activities that I have mentioned just right now continue to improve our margins and have enabled us to offset higher donor fees, which has been witnessed by the whole industry across the first half of the year. We continue to improve as this is part of the strategy and transformation. All in all, we are on track of offsetting that and moving our margins improvement from year to another. Hema, from the other. Sure. Thank you. There are major three players in the market, Haemonetics, Terumo, and Fresenius Kabi. They all have new apheresis machines, which are an improvement, and they have continued to do well in improving those machines, but not really a fundamental shift in technology. We continue to evaluate the landscape and the potential partnerships out there to be able to identify opportunities whereby we can improve our operations. As it relates to our own internal capabilities, we also continue to explore and invest in ways to make the donor experience more efficient and effective. Through both incremental and disruptive approaches. As far as the work goes with Terumo, we explore innovations from Fresenius Kabi and others doing pilots and changes, where we see the potential for significant improvements to both the donation experience and the efficiency of our operations versus what we are doing. Thank you. Our next question will be from Stacy from Cowen. Stacy, you can go ahead and unmute yourself and ask your questions. Stacy, we can't hear you. How about now? Yes. Okay. Hi, team. Stacy from Cowen. Thanks for a very insightful presentation. We had a few questions. First, a broad question. You've commented on a 21% underlying subcutaneous IG revenue growth. One of your competitors has highlighted increased adoption of sub-Q and at-home administration. Looking forward, what do you expect will be the split between IV and sub-Q in a few years? That's the first question. The second question is gonna be about CIDP. As we further understand FcRn developments, how should we be thinking about how IVIG and FcRns might coexist? If you had to comment on a potential erosion in CIDP, what would be the potential splits? Any commentary would be appreciated. As we think about IVIG and CIDP and your development on HYQVIA and the other IVIG brands, what will be the strategy to potentially take share from some of the other competitors, potentially, for instance, CSL's 20% sub-Q product? Then one last question for Kristina, on TAK-881, 20% facilitated immunoglobulin. In what potential patient population would you pursue as a potential first indication? How should we be thinking about timing? Thanks. Hi, Stacy. Thanks for all of those questions. In terms of your first one with the subcutaneous growth, you know, we do expect, especially when you look at primary immune deficiency, that in the future, a significant portion, if not the majority, will move to subcutaneous use. We see that already in Europe. The U.S. is not split in the same manner, but we do expect that trend to continue. Now, for the other therapies, as you have seen with some of the competitive products that have entered in the autoimmune indications, it is quite difficult for patients with the standard sub-Q. This goes to your, I'm going to skip your second question and address your third one in terms of HYQVIA. This is where the differentiated positioning of HYQVIA has advantage in autoimmune over the standard subcutaneous treatments. When you think about it, just to make it very concrete, if I were a patient that had an autoimmune disease like CIDP and needed to use standard subcutaneous treatment, I would have to insert multiple needles multiple times per week. It could be up to 16 needles per week for someone of my size. Now, that is quite burdensome. Whereas with a product like HYQVIA, if you look into our protocol for CIDP, you will see that it would be for someone like me, one needle stick once every two weeks in terms of maintenance. That is a significant difference, and that will allow more of a shift to subcutaneous treatment than the current standard sub-Q. Now, for your other two questions in terms of how CIDP, in CIDP IG treatment may coexist with anti-FcRn, I'm gonna ask Kristina to take that from a clinical practice perspective, and then she can also address the TAK-881 question. Before I pass it off to her, I want to see if Dana has any comments that she wants to add about the patient experience. You're on mute, Dana. Can you hear me now? Yes. Okay, great. Thank you so much for sharing that. I think as we think about the patient experience and we think about the burden that they have on a day-to-day basis, all of our strategies, all of our business decisions are really focused around them and how we alleviate that burden and really help them get to where they live lives on their terms. I think about one of the larger concerns that we as an organization are concerned about and focused on is really around undiagnosed patients. When we think about PID, for example, and we think about even though treatment exists and these patients are not tapping into this therapy, it's life-threatening, it's life-altering. When we look at the globe and 80% of these patients are undiagnosed, hospitalization after hospitalization, infection after infection, our calling is very clear, our commitment is very clear in this space, and it's really to create greater access to the many IG therapies, to the many products that we've talked about today to ensure again that they're able to live lives as they determine normal. As they define normal and really take advantage of therapies that exist today. It is very clear what we are committed to do in this place, and that's create greater access for patients to plasma-derived therapies. Thank you. Kristina? Yes. Thank you, Julie. Stacy, thank you for the question. To your question about how would the FcRn compounds and plasma products coexist in the therapy paradigm for CIDP, and what would be the potential split. Well, at the moment, it's difficult to say what the split would be because we don't really have yet the data about the efficacy of FcRn compounds in the CIDP. We can look at it from the point of mode of action. As I mentioned earlier, the FcRn compounds are a targeted therapy, which means they work specifically on a mechanism that controls the levels of IG in plasma, in particular IgG type of immunoglobulins. Their effect is to reduce the autoantibodies that are also of IgG type, so part of the overall spread of autoantibodies that could be in plasma. Clearly, it would be anticipated that patients in whom the disease is driven by these autoantibodies should derive benefit. Again, I'm speculating based on the mode of action. It's known in CIDP that up to 30% of the CIDP patients exhibit autoantibodies. Science is not very precise about what exactly the impact on the disease pathology the types of antibodies have, and clearly not all 30% are equally important. It's hard for me to say what the therapeutic split would be. I would just say it's very good for patients to have additional options for therapy. Majority of patients have a good effect of CIDP, but not all do. We know that, and therefore we are excited about this new innovation. As to your next question about TAK-881, thank you for asking. It's our facilitated 20% subcutaneous IG formulation. We're really excited getting this program started in humans. We started, as I mentioned, a first-in-human study where we look at the tolerability and safety of this formulation. The benefit of having this approach, as you know, HYQVIA, our 10% facilitated subcutaneous IG gives us already an advancement in terms of the volumes that we're able to offer the patients for subcutaneous administration. Now, having a 20% IG solution would of course enable patients to administer more and would be, in particular, beneficial in autoimmune indications where the doses of IGs have to be higher for treatment effect. Your question was about the indication. We are in planning for the regulatory approach as well as the indication approach. I'm really looking forward to telling you more about it when we talk next time. Thank you. Thank you. Thanks. Next question is from Wakao-san from JP Morgan, excuse me. Wakao-san, you can unmute yourself and go ahead and ask your questions. Thank you for taking my question. Can you hear me? Yes. Okay, thank you. This is Wakao from JP Morgan. I have two questions. First, about digitalization of plasma collection. You introduced your digitalization of plasma collection today, and you also have explained that digitalization has helped to limit the negative impact of COVID-19 before. Could you tell us the advantages of your company's digitalization for plasma collection in comparison with other companies in this industry? Second, about countermeasures of donation fee rising. When the donation fee go up again in the future, please let us know if reducing the amount of collection as you did this time will be a countermeasure, or do you also have other countermeasures for rising donation fees in the future? Could you comment on this point? Thank you. Sure. Thank you for those questions, Wakao-san. Let me just make a couple of comments up front, and then I'm gonna ask a number of people to add further comments. When we look at the digitalization efforts that we have done, it's difficult for us to really comment on what competition is doing. We only have visibility to what is in the public domain. You know, we have not shared with you everything that we are doing because it is competitively sensitive, but we have shared with you a high level of our efforts. I'm gonna ask Hema to comment a little bit in terms of the donation side, how that digitalization has helped and to reinforce some of the messages from the presentation, and then ask Adrian to talk about it. I know you didn't ask about this, Wakao-san, but it's an important piece of the overall value chain, and our digitalization efforts have also been significant in the manufacturing area, and this is also part of the reason why, to your second question, we are able to decrease our overall growth projections for plasma collection for the year. As I've said in previous settings, the plasma collection level is not a standalone measure that we use. Our primary driver is our ability to meet our growth commitments for IG. Plasma collections is one input into that. Given that we can meet our commitments for IG, we then look at all of the other variables that are inputs into that and determine where we need to end up for each of those parameters. That's why we've lowered our plasma collection parameter, because the other areas have compensated, and we don't need to collect greater than 30%, which we had initially said at the beginning of the fiscal year. Hema, some comments about the digitalization in BioLife, then Adrian in the operation side, and then if Ramy can round it out with our other countermeasures for the donor fees in terms of the impact to our overall costs. Thank you, Julie. You know, what we know, and it's publicly known, is what Takeda's performance has been relative to the impact of the pandemic both in 2020 and 2021, which has been, you know, significantly less impacted than the rest of the industry. Our focus on data and digital advancements starts with embedding that into the mindsets of all of our employees. It is foundationally now become the platform from where we grow and succeed. It's enabling us to increase our capabilities to be more future-ready for new technologies. It is stabilizing our systems where we have a lot less downtime, 99.5%, as I mentioned earlier, increasing the reliability of those systems. More importantly, allowing us, in this revolutionized way, to deliver this unparalleled personalized donor experience where we can reach the right donors at the right time through the right channels. That ability to do that automatically increases your reach and allows you to get to a broader donor base than what is usual. In this recent pandemic, our use of data and digital was critical to our success. What it allowed us to do is it helped us have data that turned into insights that we were able to use in a very agile way to make decisions in a dynamic environment, looking at the donor trends and behaviors, managing capacity and forecasting, and maintaining business continuity at the same time, so that we could deliver therapies to our patients efficiently. Adrian. Thank you. Thanks, Hema. Thanks, Julie, and thanks indeed for the question. I guess as Julie said, when we think about our patients, we think about what's needed across the whole value chain. One of the things that we've really put a lot of emphasis on is the partnership between BioLife and the plasma and manufacturing operations. That's really seamless. We really look at that as being hand in glove. When we think about our operations, we really, again, going back to maybe what I shared earlier, really focus again on the patient. I think, you know, the 7,000 colleagues that work across the plasma OPU really do have the patient in mind. When we think about what we need to achieve, we talked about, you know, our growing our capacity. There are many levers we pull, and data and digital is a very key enabler for us to be able to grow our capacity, really understand each of our processes, how we understand variation and variability in our processes. As Julie said, there are many levers that we really look at. We look at our capacity at each step. We look at our efficiencies at each step. We look at optimizing the process, improving the right first time of each of our steps. We look at the overall cycle times of each of our processes and really looking at how we optimize those. That data and digital mindset and approach in our organization has really helped us to understand how we can use more data on our processes to really improve them and optimize and ultimately give us multiple levers on how we can serve patients in a more cost-conscious and optimized way. That's been our approach. It is a journey. We... While we have a very strong heritage, as mentioned earlier of 70 years in manufacturing Plasma-Derived Therapies, I can tell you that the pandemic has certainly brought us to a different level of transformation as we think about how we optimize our processes and how we engage our organization with the mindset and the curiosity and the capabilities that they have to really help us achieve the goal of making sure, and that's what we achieved, that no patient went unserved. That was something that we really focused on and were successful in achieving at that time. Ramy. Thank you, Adrian. Yeah, thank you, Julie. Maybe just to confirm what Julie started in the beginning. The donor fees or the donation fees are not the key driver for our plasma collection. The driver are meeting the patient demands. Now, if we want to have it from financial perspective, donor fees is one component of the total cost, and the total cost is one component of the total margin, and the total gross margin, and the gross margin is part of the core operating cost. The key success part is to make sure that we are managing the full end-to-end value chain financially. Donor fees, as Hema said, we are not expanding donor fees in all months. We are very targeted in investing the donor fees. With that, we make sure in the total value chain, other components are moving with the transformation and the strategy that Dana said that can compensate the total sustainability of the business from end-to-end value chain. To reconfirm, again, efficiencies are that I showed you in the slides, efficiencies are moving, are improving year over year. We are also improving our marketing strategy. We are very focused on our OpEx discipline and from commercial drivers. We are actually improving our subcutaneous and our subcutaneous IG, FLEXBUMIN and first liter, which all have a huge impact to the core operating profit. I just want to confirm, donor fees, yes, it is more than last year's due to the pandemic, but it is one component of the total value chain. The most important part is to financially manage the total value chain end to end. Thank you. Thank you. Thanks. We will take our next question from Ueda from Goldman Sachs. Ueda, you can go ahead and unmute your line and ask your questions. Hi. Can you hear me? Yes. Thank you for taking my questions. I'm Akino Ueda from Goldman Sachs, Tokyo. I also have two questions. First of all, we'd like you to share your view on Takeda's IG volume growth in the last and the next several years. You explained that, you know, IG volume CAGR is at 12% on slide 44, and indicated the company's IG, you know, portfolio trends on page 46. So, do those numbers mean that the sales trends of Takeda's IG business are almost same as the market trends? Also the company mentioned the, you know, aggressive, you know, investment stance. Could you share your thoughts on whether you think that Takeda can grow ahead of the industry from now? My second question is also about, you know, margins outlook. You mentioned that, you know, donor fee is now normalizing, but, you know, it would be appreciated if you can share your thoughts on any other factors which could have impact on the margins of Takeda's PDT plasma therapy business, both in positive and negative side, including, you know, macro conditions or, you know, when expanding the capacity in Covington site. Or, you know, can we think the margin will be stable from now? Thank you. Thank you, Ueda-san, for those questions. Again, I'll make some comments up front, and then I'll ask a few individuals to add additional commentary. When we look at the trajectory for IGs, when you see our numbers, what Takeda provides from a guidance perspective is our underlying revenue growth. You have that for the current fiscal year. We've also shared with you in this presentation our volume growth. And in terms of your question about being ahead or behind the market. Last year, as you know, the growth in FY 2020 for the industry was not very strong. Prior to FY 2020, IG revenue growth was in the mid- to high teens for a few years in a row. In FY 2020, it was not that case for the industry. Based on public statements, you will see that a significant part of the growth in 2020 for some of the competition was not driven by volume, but driven by price. This is why we chose to share with you our volume growth numbers in this presentation, because we wanted to emphasize that our growth is come from volume growth. Yes, we had some benefit of price, but the majority of our growth is coming from volume, not price. When you look at that, yes, last year we did grow faster than the market, and this year we'll have to see where the market ends up. It's, you know, my crystal ball is probably the same as your crystal ball in terms of being able to predict market demand growth in any given year. We'll have to wait and see at the end of the year to see how we fared. In general, you've seen from our plasma collection performance, and the overall value chain efficiencies that we've been able to achieve, we feel pretty confident that we can continue to grow as needed to support the demands from our patients. In terms of the factors that impact margins, again, I'm gonna ask Ramy to comment here about the different factors that are incorporated into the margin beyond the cost components that he went through for the last question. Ramy. Thank you, Julie. Again, for the margins improvement, a lot of things impact the overall margins. One of them is the efficiencies that we have shared. For example, the yield that we get, and Adrian spoke about it in his presentation, the yield that we get from each liter of plasma is important, very important indicator for us. The IG content and the grams of protein we get from each liter of plasma is very important for us. How we are utilizing our CapEx in our manufacturing sites are very important for us. And overall, the cost of materials and in general running our factories is very important. All of these are on track. We are moving and transforming year-over-year as planned. The other aspect of it is how we can maximize the value or the revenue that's coming from each liter of plasma, and this is very important, and this is what Dana spoke about in the beginning, of how we are concentrating on each liter of plasma to make sure that we are maximizing the value from it, meaning selling the last liter, improving our first liter. The other part of it is how we are very selectively and targeting investing in R&D to make sure that we are improving hand in hand the first liter that Kristina is speaking about. Margins is not only cost. Margins, because of the plasma economics, it is cost, which is including a lot of things, but also how the commercial and the R&D is impacting the overall top line of it. If you want to look at it from end to end. Now, if you look at the PDT from end to end, we need to make sure that we are efficiently managing our resources. Here it comes our OpEx part. OpEx, I spoke about R&D, but what kind of resources we need at even the commercial levels in the countries that we need to manage it, and this is actually part of total value chain. Again, if you want to look at the margins and the core operating profit from end to end, there are a lot of items that you cannot manage one item by itself because it's all offsetting each other. When one item is not meeting in one year, the others offset it. This is how we make sure that we have our growth and sustainable growth, let's say, and margins improvement year over year. Thank you. Thank you so much for your detailed answer. Thank you. Okay, our next question is from Haruta-san from Credit Suisse. Go ahead and unmute your line and you can ask your questions. Sorry, this is Sakai from Credit Suisse. Probably you misread or we misread our name, registration. Anyway, I guess most of the question being exhausted, but I have a couple of questions. Now, I just wanna go back, slide 39. This is the example of the future of the IG therapy and new modalities. Now, probably near term, there might not be a new huge impact from this FcRn and CIDP. But near-term future or midterm future, they may coexist. Long-term future, we don't know. I agree with that. With these new modalities coming anyway, how do you see the breakdown of plasma use in the future? I mean, this going to be a bottleneck given that demand of the plasma going forward. With that, how do you impact your CapEx? Do you need better and bigger collection and processing facilities in the future? Is it, you know, how do you see this opportunity and risks coming going forward? That's my first question. Second question is for Ramy-san, and this is very simple question. Now, CFO Costa, he doesn't wanna talk about the margin or breakdown of the profit coming from the PDT business. In your last presentation page, you said margin improvement. If you could give us at least minimum guidance where the margin came from and margin is going next five years, let's say, you know, couple of percentage point, that could be very, very helpful for us to build in your business, I mean, your profit into a model. That's the two questions. Ramy-san, thank you. Thank you, Sakai-san. I was wondering when we would get your question. In terms of your first one, let's look at it from two aspects. One, in terms of the clinical landscape, you asked about how there might be coexistence between IGs and anti-FcRn. I'm gonna ask Kristina to again give her perspective on that. From a CapEx standpoint, actually, I'm gonna ask Adrian to talk about how we are using CapEx to support the investment in our capacity growth. I think we have done it in a very efficient way, and we will continue to do so. Then ask Hema to talk about CapEx expense from the BioLife perspective, and then Ramy to round it out with how CapEx in terms of our overall investment, how that looks as we continue to support growth. From a margin improvement standpoint, unfortunately, yes, Costa is not sharing details and neither can we. We cannot give you any specifics. As Ramy shared in his presentation, we are committing to year-over-year improvements in our core operating profit margin. We expect to be non-dilutive to Takeda's target, which is mid-thirties in a few years' time. We are not there today, but that is what we are driving towards with year-over-year improvement. To your first part, Kristina, to confirm the split and then the CapEx question for Adrian, Hema, and Ramy. Thank you, Julie. Yes, thank you very much for the question. With regard to the FcRns and their place in the treatment paradigm, as you are aware, the first indications where we see the entry and we will learn more than about those compounds will be in MG, myasthenia gravis, and in ITP indications, as the second one potentially if the trials read out there. That will give us an insight as to what the effects will be, what the safety of the compounds will be, and what the uptake in the patient population as well might be. As you know, these two indications amount to about 10%, a bit less than 10% of IG use if we look at the current usage of IGs across therapeutic landscape. Now, with regard to CIDP, again, it's hard for me to say what exactly will be the percentage of patients who eventually have a significant positive effect of the FcRn therapy. It's the link with the autoantibodies is not that clear in literature, so it's hard to really put a stake in the ground here. I guess we just need to wait and see when the trials read out. We only have one interim analysis readout that we base our own kind of understanding on at this moment. But with that being said, as I said earlier, we know that the IG therapy is effective in a very broad population among CIDP patients. That is clearly shown with several of the IGs that are used in that indication. I would just say that if there is less need for CIDP patients, I guess that means good news for the PID as well as SID patients, where we see a growth in those both indications based on better diagnosis and more therapy going to these indications. Adrian. Thanks, Julie. So I guess for those that had the opportunity to attend our 2019 investor conference, you saw what we can do in terms of building a very new and modern and vertically integrated facility in Covington in Georgia. When we set about our journey to improve capacity, what we really wanted to do and as I mentioned in the presentation, we really wanted to leverage the value of our existing network. That's what we've been really focusing on. We didn't build an additional facility. We're really looking at how do we really understand our networks? How do we value engineer the processes and each step of the process? How do we reimagine how we think about how we manufacture the product? We've been partnering very closely with R&D and really looking at, again, how do we look at our process and how do we improve it. We have very, very deep technical knowledge within the operating unit with over 70 years of experience. We've garnered quite a bit of experience, but we also know we still have lots to learn. Those external partnerships have really helped us. We have several external partnerships with companies that can really help us think differently and work differently, and then think about the use of data and digital to really optimize our process. I can really say that, you know, when we think about value engineering, how we grow capacity, we've been really, really effective. I can say it's been very, very modest increases and really looking at our value chain and optimizing steps that not only increase capacity, but also increase the process efficiencies that Ramy made reference to earlier. It is a multitude of projects and initiatives that are really laser-focused on that objective to get to that goal of 65% capacity improvement. But at the same time, we've demonstrated significant improvement already by really realizing over 40% capacity improvement already. Thanks, Adrian. Hema, how we use CapEx efficiently in our BioLife network. Absolutely. Just to tag on to my friend Adrian, the aspect of using CapEx in BioLife, for us, it really is in the similar vein as Adrian described. It is a few areas. One of those is expanding at the very rapid rate that we have been in terms of our new centers. We opened 26 centers last year. That is, you know, from our normal trajectory of opening 5 to 6, and we'll continue on that path over the next few years as well. Furthermore, it is also an investment that we're making in disruptive technologies. Technologies, as we mentioned earlier, there's not been a whole lot of change with devices, for example, but looking at disruptive technologies that we can bring to the collection part of our business to where we can improve that donor experience and continue in the vein of our strategy of being able to make the donation process more comfortable, more safe, and certainly something that people are more attracted to. Lastly, we have a tremendous amount of investment in transformation initiatives through our data and digital channels. I covered a vast amount of them, of course, today. We are also looking at a lot of different modeling exercises across BioLife that make it much easier for us to improve our capacity in the centers to be able to collect more. Ramy, just to round it out, how CapEx looks overall for us? Maybe in the beginning, as you probably all know, CapEx for plasma-derived therapies normally are much higher than the normal pharma business. What we do is that, as Adrian said, we optimize, we make sure that we optimize our existing capacity, our existing CapEx, and make sure that we apply efficiencies within the existing CapEx. As I shared in general, our investments are targeted into revenue growth projects and margins improvement projects, and more importantly, across the value chain. When we invest, we make sure that we don't have idle capacity across the board. When we invest in BioLife plasma collection, it has to go hand in hand with what we are doing in the plasma manufacturing side, and it has to go with what we are sourcing in our commercial. Most importantly, how we first of all optimize existing. Second, when we invest and add more capacity, we make sure that we are moving very targeted and on timely basis. Timely investment is the key to optimizing our products. Thank you. Well, thank you very much. Hope to visit Covington sometime in the future. Yes. We hope this next one will be at one of our facilities as well. Thank you. Thanks. Next question comes from Andrew Goodsall from MST Marquee. Andrew, go ahead and open your line and ask your question. Thank you very much. I'm hoping you can all hear me now. Yes. Terrific. Really appreciate you taking the time to give us this update. Again, also hope to join the next briefing on site. I know you might have touched on this a little bit, but just interested in your thoughts on whether access to care, or the lower supply in some markets have created some demand suppression, particularly for products like IVIG or immunoglobulins. Just your thoughts on how quickly that'll bounce back, particularly as supply comes back on and with yourselves having more supply than others, where that conveys an advantage to you, being sort of earlier to market as such. Sure. Thanks for the question, Andrew. When we look at what's been happening across the globe, I think it is fair to say that there has been some suppression of demand. As many of you know, the diagnostic journey that Dana was referring to, particularly for primary immune deficiency patients, is a very long one. Because of the pandemic, people stayed at home. They weren't getting sick. You know, it's typically multiple pneumonias or bronchitis, ear infections, et cetera that trigger the thought of, hmm, maybe there might be a primary immune deficiency behind this. The diagnosis that has been happening is at a lower level than what it typically is at. We have seen that suppression, particularly when you look at, let's just say the more developed markets. What we have also seen is that, from a competitor standpoint, they have been moving out of some of the markets that typically have challenges to access due to their pricing. While Takeda has remained committed to our patient base, as you have heard, that wasn't necessarily the same across the board. We have seen challenges with patients not receiving treatment in other geographies. We have heard anecdotally that patients are having to space out their treatments in order to manage with the supply levels that are available. These are all contributing to a lower level of demand that is somewhat driven by diagnosis, but also driven by the supply that's available in that given country. How quickly will it bounce back? I think it depends on what is the driver. In terms of the suppressed diagnosis, for example, I think if we continue to see things like Delta variant and other variants, making it very concerning for individuals who tend to get sick to stay protected, that suppression is going to take a while to revert back to a normal level. If the suppression is being driven more by the fact that supply is not available or that patients are spacing out their treatments, I think as the supply returns, you will see that demand returning step-by-step with the supply. I think we really need to look at what is driving the suppression, and that will tell us how quickly the demand will bounce back. But we do expect it to return overall. How quickly is part of the larger question. It's a terrific answer. Thank you. Thanks. Next question is from Stephen Barker from Jefferies. Stephen y ou can go ahead and unmute yourself and ask your questions. Okay. Hopefully you can hear me now. Firstly, I wanted to ask about HAE and the outlook for plasma-derived products, FIRAZYR and CINRYZE. I'm trying to understand the sales trends and see if they are being beaten by TAKHZYRO. I think your strategy has been to find new markets for these plasma-derived HAE treatments, as they're displaced in some markets by TAKHZYRO. I was wondering, is that strategy working? Can you maintain sales of those PDP HAE treatments? That's my first question. Second question is about your R&D. I think you said 70% is dedicated to improving existing products and 30% is dedicated to finding new products. How, c an you talk a little bit about how you measure the return on that investment and, you know, what sort of results can we see from your R&D efforts? Thanks so much. Thanks for the question, Stephen. Look, in terms of HAE, first let me clarify, FIRAZYR is not a plasma-derived product. It is a product that has gone off of patent. At this point, it is not a clear focus from a PDT perspective, nor from our colleagues in the rare disease organization. We still have FIRAZYR to supplement in particular situations for acute attacks. Our primary focus for HAE is TAKHZYRO because of the fantastic data that we have and the lowest frequency of attacks that occur with TAKHZYRO. For CINRYZE, which is our plasma-derived product here, there are two areas that we are focused on in terms of supporting CINRYZE, from an ongoing standpoint. First is that there are some specific patient populations that still benefit from CINRYZE that are not on label for TAKHZYRO, and so that is an area where CINRYZE is still used. For example, if you look at pregnant women and very young children. The second is in terms of the geographic expansion that you have already identified. In some of our geographies, TAKHZYRO may or may not be launching, or if it is launching, it might take a while before it is able to be commercialized. In those markets, we are providing CINRYZE to have a therapeutic option, because CINRYZE is still a very good therapy for HAE. That is our approach until TAKHZYRO is able to enter those markets. Now, in terms of your question for R&D and how we look at the return. From a split perspective, what I would say is that 70% is focused on the in market portfolio and supporting the ongoing growth. That return is demonstrated by the continued growth in my simplistic terms. Ramy can add his comments on that. As you heard from both Dana and Kristina, there is still unmet need. Part of it is not just about what financial return we can receive from these investments, but it's also the impact that we are having on patients. Ramy, if you want to add some comments about how we look at that, and then I don't know if Kristina or Dana want to add any comments about the patient impact. Thank you, Julie. Maybe I will share something, and I will refer to the slides I shared. As Kristina said, 70% of our investment is in our existing portfolio. If you look at my slide, in my first slide, we are saying that we have launched more than 40 last and first liter products in the last two years. This is all driven by our R&D investments in our existing portfolio, including our first liter, our registrations and our geographic expansion, if you will. This was important. If you want to measure, like quickly and roughly our return on our 70%, it came with the launches and with the existing portfolio that keeps going. This is clear. For the other part, which is the 30% of our investment, this is a continuation, and this is where we are always investing to for our midterm, so we can actually make sure that we have sustainable portfolio overall within the plasma derivatives and to maximize our revenue from each liter. This is maybe the quick way to look at it from how we measure our success from the 70% investment in R&D. If Kristina want to add more details about the R&D itself. Well, actually, I'm going to at this point. I understand we have one more question, and I know that we are over time already. Let's just take that last question and try to wrap things up. Great. Our last question is from Hashiguchi-san from Daiwa. Please unmute your line and go ahead and ask your question. [Non-English content] Thank you for the question, Hashiguchi -san. -san. Yes, we do believe that we benefit from being a part of Takeda, especially when you look at our R&D approach. I would say first and foremost, part of what you see now has been driven by our switch to an external focus. Previous to joining Takeda, it was very much an internally driven approach to R&D. As part of Takeda, we have adopted the same externally facing view. You will have seen from Kristina the number of partnerships that we have done has changed dramatically since we've become part of Takeda. That is one concrete aspect that I can point you towards. Now, unfortunately, most of these partnerships are for very early assets, and so you will not see the fruits of those partnerships for a number of years. In terms of the other benefits of having the scientific expertise and the different modalities within our global R&D organization, I'm gonna ask Kristina to talk to that. Yeah. Thank you Julie for the question. Hashiguchi-san, thank you for asking. The benefit that we have with the specialized R&D organization within the Plasma-Derived Therapies business unit is really that we can focus solely on the plasma products. To your point about there are other modalities addressing the needs of patients with certain conditions like HAE, for example, or for hemophilia patients, that's very true, but this is not where we focus. We know also that plasma therapies still carry a lot of value in those indications, and it is our duty to maximize that value for our patients. We do that by working on, for example, FEIBA, which is a product a long time on the market and still very much valued for certain hemophilia patients with inhibitors, has a clear place in treatment paradigm. I would also say the way we try to improve the value for patients here is that we have a lot of clinical activities ongoing with our first-line products, bringing new knowledge to treating physicians and opening up new indications that enable more patients to benefit from these products. We can do that because we have that unique plasma-dedicated R&D organization within Takeda's global R&D organization focusing on other modalities and the therapy areas that are the focus areas for broader Takeda's global R&D organization. I hope I answered your question. Great. Well, in closing, we just wanna thank everyone for joining us and taking the time to learn more about Takeda's Plasma business. If there are any questions that come up that we weren't able to answer tonight, please feel free to reach out to the investor relations team, and we look forward to seeing you at future events. Take care. Bye.