Thank very much for joining our fiscal year 2021 Third Quarter Earnings announcement. I am the moderator and I’m Chris O'Reilly, the head of Global IR. And we have the interpretation button at the bottom of that Zoom. And if you'd like to listen to Japanese, please select the Japanese language and if you'd like to listen to English, please select the English Channel. And if you'd like to listen to the original audio, please turn the interpretation function off. Before starting, I'd like to remind everyone that we will be discussing forward-looking statement within the meeting 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. This also refer to the important notice on page two of the presentation material for today. Today, our presenters, as well as the people to answer the questions we have Christophe Weber, President and CEO, and Andy Plump, R&D President and Costa Saroukos, Chief Financial Officer, and Masato Iwasaki, Representative, Director of Japan General Affairs, and Ramona Sequeira, President, U.S. Business Unit and Global Portfolio Commercialization and Julie Kim, President of Plasma-Derived Therapies Business Unit. And first we will have the presentation from Christophe and Andy and Costa and we'll have some time to taking questions from all of you. Let's get started.

Thank you, Chris, and thank you everyone on the phone for joining us today. If you could look at the Slide 4. At Takeda, our vision is to discover and deliver life transforming treatments, guided by our commitment to patients, our people on the planet. And our growth strategy reflects that vision. And I'm pleased to discuss with you another quarter of growth and progress. In the context of Omicron, I'm so proud of the dedicated and patient focus colleagues that live our values and work tirelessly to support our mission. This is an incredibly exciting time at Takeda. We are growing faster than ever, with competitive scale, and a diverse pipeline with approximately 14 molecules in clinical development. Our portfolio is growing as demonstrated by two new products approved in the past six months. As you will see today, our performance in the third quarter of fiscal year 2021 reinforce that we remain well positioned for long-term business growth. We are in a position of strength. We have solid margins, strong cash generation and top-line growth driven by our 14 global brand. We have consistently delivered on the fundamentals and this quarter is no exception, with year-to-date underlying revenue growth at plus 7.1% and reported revenue growth at 11%. This growth continued to be driven by Takeda's 14 global brands with underlying growth of 12% year-to-date, which we expect to rise to the mid-teens for full year results. Our diverse portfolio of 14 global brands represents an impressive 42% of our core revenue and should continue to grow. We expect significant revenue growth from our global brands over the near to medium term, particularly as we expand into new markets. Based on the strong third quarter result, we are upgrading our full fiscal year 2021 forecast for revenue, reported…

Thank you very much Christophe. If we can please move to the next Slide nine. We've had a number of significant pipeline events since October starting with the U.S. approval for LIVTENCITY in resistant or refractory post-transplant CMV infection as Christophe has mentioned. This is our second FDA approval this fiscal year and notably the most FDA approvals Takeda has had since 2014. Additionally, we are proactively submitting our final 4.5 year Dengue vaccine data to the CHMP as part of the EU medicines for all procedure designed to enable approval of high priority medicines in markets across the globe. These 4.5 year data continued to support the overall benefit risk profile and reinforce our regulatory package. Now this will lead to a short pause in our review, as we gather and submit in the coming months. We are very confident in the profile and public health benefits of our vaccine and continue to believe we will see an approval in fiscal year 2022. As previously disclosed, we received a CRL from the FDA for Eohilia in eosinophilic, esophagitis or EOE. Now we have judged the overall benefit risk profile for Eohilia to be positive. And we are very keen to bring this therapeutic option to patience. After an extended set of interactions and analyses, FDA ultimately did not agree that our pivotal data supported registration. We have thus decided to discontinue Takeda’s development of Eohilia. Now, please let me provide a brief summary of events that have led to this decision in full transparency. In 2016, FDA granted a breakthrough designation for this program. In 2019, Eohilia completed and met the Phase 3 induction study co-primary endpoint with statistical significance. In October 2020, we completed our rolling submission of the new drug application. And in December 2020, FDA granted…

Thank you, Andy and hello everyone this Costa Saroukos speaking. I'm pleased to report that in the first three quarters of fiscal 2021, we have continued to make excellent progress in terms of top-line growth, margins and cash flow. Our top-line growth continues to accelerate with underlying revenue growth of 7.1% driven by our 14 global brands, which grew at 12%. This truly demonstrates the resilience of our portfolio through the COVID-19 pandemic, including the recent wave of Omicron. We remain focused on maintaining competitive margins and delivered an underlying core operating profit margin of 29.4% in quarter three year-to-date with underlying core operating profit growth of 5.4%. We also continue to generate robust free cash flow with ¥671.3 billion year-to-date, and opportunities in unlocking working capital have enabled us to raise our full year target to ¥700 billion to ¥800 billion. We saw steady progress with deleveraging, reaching 3.0x net debt to adjusted EBITDA and our abundant cash has allowed us to recently call an additional U.S.$1.5 billion of fiscal 2023 debt for prepayment. With regard to the full year outlook, we are upgrading our forecast across the reported and core P&L, reflecting business momentum, OpEx discipline and also some foreign exchange favorability. We are also working on track towards our management guidance and trending towards the high end of mid-single digit growth for underlying revenue, underlying core operating profit and underlying core EPS. Let me go into more detail on the year-to-date performance in Slide 16. Q3 year-to-date reported revenue was almost ¥2.7 trillion up 11% versus the prior year, benefiting from ¥133 billion booked as revenue from the sale of our Japan diabetes portfolio in quarter one. Core revenue which adjusted out this one-time impact grew at plus 5.6% as business momentum and favorable foreign exchange more…

Now we'd like to open the floor for taking questions. Please use the raise hand button, if you are listening to Japanese please ask questions in Japanese. If you are selecting the English Channel, please speak in English and if you are listening to the original audio, you can ask questions in either of the languages and please limit the number of your questions to two. First question is from Hidemaru Yamaguchi from Citi.

Thank you. This is Yamaguchi from Citi. Congratulations on the good numbers. Two questions please. The first one is, you changed your full year guidance and you gave me some numbers. Just given the reason why the sales up by ¥140 billion and with the cost control, our operating profit, core earnings, core Op goes up by billion, which sounds like of course is a higher than expected which you mentioned. Can you elaborate what kind of the reason behind it including PDT and other things? That’s the first question. The second question is that, full year number chart shows that the you raised the global sales range from 5% to 10% to 10% to 20%. Can you give me the reason behind it and also can give me the pricing and the collection which is the usual kind of questions on the PDT front? Thank you.

Thank you, Yamaguchi. What I understood from your first part of the question was the reason for the upgrade in a revenue of ¥140 billion. So what we're seeing is strong business momentum overall. And in particular, the 14 global brands are driving that momentum. In addition to the 14 global brands, we're also adding additional doses of Spikevax in Japan. So we're seeing as we mentioned, we including approximately anywhere between 40% to 50% of the incremental 93 million doses of the Spikevax vaccine. And then we also have some portion of favorability in FX. So I didn't get the other question that you had was it? What was the other question you had?

Given the sales was up by ¥140 billion as in a delta but OP delta is ¥40 billion, which sounds like a little bit low. So you hinted the cost is higher than expected on a cost range, can you give me the reason why cost is higher on your new guidance compared to old guidance?

So we have seen some cost of goods headwinds, as we alluded to in the first half of the fiscal year driven by some -- the donor fee and the dynamics in the U.S. for PDT. We have also seen on the cost of goods, an increase due to FX and mainly because a lot of our operations in Europe on the manufacturing and it's in euros. So that's really the key message. And remember, in Q4, we typically have more phasing on acceleration of expenses and we do expect an uptick in R&D investment to accelerate in Q4.

So it's a common space, it's more donor fee and FX that the two big reason rather than pretty good, okay, further commitment will should be good, right?

That's correct. Christopher O’Reilly: Maybe I'll jump in. This is Chris O’Reilly speaking. On your second question around the PDT guidance. So yes, we have upgraded the reported forecasts for immunoglobulin. But this essentially reflects FX, you'll see the underlying growth forecast is unchanged at 5% to 10% growth.

Okay, it's currency. Christopher O’Reilly: It's currency, yes.

Okay. Can you elaborate quickly on the pricing environment currently on the collection trend in the U.S. if you have any words? Christopher O’Reilly: Julie, are you on the line and able to answer that one?

Yes, this is Julie Kim. Thank you for the question. In terms of the pricing dynamics in the U.S., the continued impact of the pandemic is prolonging the ability to return to more normal levels. So at this point, what we do see is continued fluctuation in the pricing in terms of donor fees. We continue to moderate and push towards normal levels, leveraging our transformation efforts throughout the Biolife organization, which is our plasma infrastructure. So, as you've heard from both Costa and Chris, we continue to try to mitigate the impact of that, but the prolongation of the pandemic does make it a bit harder to completely offset those costs.

With that, we want to move on to the next is Stacy Ku from Cowen.

Hi, Stacy Ku from Cowen. Thanks for taking our questions and congratulations on the progress. My two questions. First, given your updated commentary on ENTYVIO LOE. Can you remind us your thoughts on the ENTYVIO market share in Crohn's disease, as we approach the loss of excessivities for Humira and Stelara in 2023, can you expect differentiation to protect to be protective in Crohn's disease as we expect it to be in ulcerative colitis? That's the first question. And then the second question is, could you narrow the timing for when we would expect investor disclosure of the Phase 1 data for orexin 861 program and the healthy volunteers and Type 1 narcolepsy patients. Thanks so much.

Yes, absolutely. Hi, Stacy. Thanks for your question. So yes, if you look at first of all, what we see in the biosimilar market in the U.S. right now, we don't see an impact outside of molecule for the biosimilar. So we're not seeing an impact on ENTYVIO either on our payer access or on our uptake or prescribing as a result of biosimilars. As you start looking at the Crohn's situation, we would expect much the same to continue. So what's happening with Crohn's now is that as physicians start to treat earlier, ENTYVIO actually becomes a better and better choice. So people might prefer some of those other products when they've got a crisis patient with Crohn's, but as we're starting to see more earlier use of biologics in Crohn's people actually are preferring ENTYVIO because it's safe and it's effective and got really, really good long term data available and so we don't expect any impact outside of molecule to ENTYVIO from the other biosimilars. Thank you.

And Stacy, this is Andy. We'll spend some time at 4Q mapping out timelines for the vaccine program. But I'll remind you, there are four ongoing relevant activities. The first is our evaluation of the 994 Phase 2b data setting, there are some very important information in that data set, including chronic dosing in the effects of orexin agonist and chronic dosing. The second, as you mentioned, we are accelerating our TAK-861 one next generation molecule. So we'll have data from our Phase 1 studies and plans to move forward into later development. Thirdly, we're bringing back TAK-925 our oral TAK-925 program. And then lastly, as we've mentioned, we'll have next generation molecules that will be coming into the clinic. And so we'll have at least a timeline for each of those four events to share in 4Q.

Now, let's move on to the next question. From Jeffries and .

Hello, thanks for taking my question. I'd like to ask about TAK-003, your Dengue vaccine candidate, you're pushing back guidance for a possible CHMP advisory decision from the second half of the current fiscal year to sometime next fiscal year. And at the same time, the head of your vaccine business is leaving the company what's going on there? I can think of a couple of different reasons either the European authorities have a problem with the data, or is it something else? You did say that you're in discussions with the governments of the countries where you actually hope to sell the vaccine? Are there some reservations coming from that side? Any color would be appreciated?

Thank you for the question. First there is, we have submitted the data. And the data is complex. That's why remember that we had to fast track process first. But then when the EMEA saw the data and they do that in many cases. They decided that they would go back to the normal review because of the complexity of the data, we are submitting more long-term data as well. So we shouldn't see this new timeline as you sign that there is problem with the data, it’s just the complexity of the data, the fact that we are submitting long-term data. And as Andy mentioned, we are fully convinced of the value on the public health impact that these vaccines will have in the countries where the Dengue’s endemic. Don't read anything between that and the departure of Rajeev. Rajeev has been leading the vaccines business unit for 10 years. He's going for a new step in his career. We have a very strong leader with Gary to lead the vaccines business unit. We are very committed to it. So there is really no connection between the two And regarding other countries, at the same times we file in Europe, we file it on any countries and the process is that they are actually reviewing the dossier. And in parallel, they can use the expertise of the EMEA, if they want. So that's the current regulatory process. So again, we are very excited about the vaccines. It's complex Dengue, because you have four serotypes, you have seropositive, seronegative. Of course, there is increased scrutiny because of what happened with a previous vaccines. So that's also probably why there is also a lot of debate, but we are very convinced about the value of the vaccines.

Next is JPMorgan, Seiji Wakao.

This is Wakao, JPMorgan. I have two questions. The first is about SG&A cost. And as a percentage of sales, I think your management is now the lower level than the previous year but at an absolute level, I think it exceeded the previous year. Do you think in the absolute term it will be further increasing? Core Op margins 30% is the target of UI management we understand that but how do you view the absolute amount of SG&A? And the second is Velcade. Last time, genetic the range was expected to be in the middle of FY 2021. But now, it is expected to be at the end of FY '2021. If you have any information and if you can disclose what is the latest situation? And is there any possibility that it won't come within 2021 fiscal?

Thank you very much Wakao. And to answer your question. In the appendix Slide 39, you can see the SG&A expenses on a reported basis for Q3 year-to-date. They have gone up versus last year by 3.4%. However, the excluding FX impact were flat. So I think the organization is a laser focused on cost optimization and management in particular in SG&A when leveraging a lot more data digital and technology here. Our TBS organization is ramping up. So SG&A, very well managed. The only incremental is FX driven. Thanks for your question.

Thank you. And regarding Velcade, we still believe that there will be 505(b)(2) sub-Q launch in Q4 fiscal year '21. So that's our current estimate. And that's our guidance. Now, when it comes to Velcade and , their growth rate does not necessarily reflect the long-term dynamic of the product because there has been some pandemic effect last year, especially. So Velcade and were impacted depending on the cycle of the pandemic, if you like. So, one needs to be careful when reading the growth rate of the product.

Next question from Credit Suisse, Fumiyoshi Sakai.

Few questions, I have a follow up for . We've been hearing about the shortage of blood supply in the U.S. because of the Omicron situation. Can you just give us the overall observation how the business is running? And this situation persist, assuming it is going to be upside or downside anymore your business but targeted business for FY '2022? So that's my first question. The second question is for Costa Saroukos as always. Your cash flow, I'm not going to ask the hard guidance for FY '2022. But given that you having more flexibility and maneuverability, in your cash management, are you expecting same rate of the cash flow generation for FY '2022? If so, you could say just yes. But if not, can you just give me some variables that you're thinking about going forward? Thank you.

So in regards to your first question around the dynamics in the U.S. market. Clearly because of the impact of Omicron and the ongoing pandemic, it is still challenging for the entire industry to collect at levels that are equivalent to or better than pre-pandemic. For Takeda as we've shared previously, we did surpass our pre-pandemic levels back in April of 2021. And we continue to be able to grow our collection. So while we can't give specifics going into FY '22, at this point, what I can confirm is that we are going to be in that 15% to 25% range for growth of our plasma collections this year, which is where we wanted to land and that will support our ongoing growth of our IG portfolio and albumin across the globe. So while I cannot comment specifically on what is happening from a competitor standpoint, we are monitoring the situation quite closely and we will continue to do what we can to make sure that patients will have continued access to therapy.

We're not giving guidance on cash flow now in Q3, but in principle, we're seeing acceleration of our revenue. We're also seeing acceleration on our core operating profit margins as we move forward. And as a result that will reflect in our overall free cash flow as well. So we there's no reason why we will be going, we will differ from that strategy.

Okay. I mean, just a brief follow up question. I mean, it's nice to hear that 98% of your debt is fixed rate. What about currencies? I could see, US dollar has dominated, Euro dominated. What about Japan? I mean, Japanese yen dominated, how much you exposure the foreign currencies out to be our total ¥4 trillion debt.

So it's a great question and the way we've financed our debt was really to match our currencies of our business, so very much equal to the currencies that we receive on U.S., Euros and also Japanese yen, so it's very well matched. Therefore we do that much exposure there.

All right, so that's a neutral. You're saying.

That's great.

Next is a Morgan Stanley, Shinichiro Muraoka.

Novavax vaccine, I have a question. ¥140 billion revenue was up. But Novavax vaccine sales was not included. Is that right? And according to Japanese media report, PMDAs review, pointed out rhabdovirus impact and which may delay the program. Is it true, the fact? And if that's the case, what is the progress going forward? That's about Novavax vaccine related question. Another question I'd like to ask you is page 58 of your Slide ENTYVIO needleless syringe, injector I think is discussed. And however, there are some technical issues and as a result, pivotal study is delayed to be in FY 2023. Could you elaborate? What is this a technical issue? How it will be solved? That's my second question.

This is Iwasaki. Thank you for your question. Concerning rhabdovirus virus I'd like to answer and then regarding the financial aspect, I think Costa can supplement. Concerning rhabdovirus during -- in the manufacturing process because of our contract with Novavax I cannot disclose the details of manufacturing process. However, rhabdovirus issue, we exchange information with PMDA and we are discussing it and of course properly we will address this issue and the EU authority i.e., EMA there is assessment report and full clear answer rhabdovirus is a proven, therefore, it is not a concern. That's the conclusion the report says. That's all for me. Thank you.

Yes, excellent. Sorry. So there is no risk of a delay.

At the moment, we don't see any delay due to that particular reason.

Understood. Thank you.

And it's Costa here. Thanks Muraoka for your question. Just to confirm in our guidance or updated guidance, there's no revenue factored in for Novavax for this fiscal year 2021.

And Christophe, I can step in and take the question around ENTYVIO and the device strategy. So maybe I'll just comment on both devices that are part of our LCM program, we've got our sub-q that we've been talking about. And I will mention that has been launched in Europe and the launch uptake is going really well. So we're very pleased with what we're seeing, particularly in markets like the U.K. and Germany, which are some of our early launch markets. And we're definitely seeing the subq driving incremental growth for ENTYVIO. In the U.S., based on our discussions with the FDA, we have now more clarity on the actual path forward for the subq in the U.S. And so we've disclosed that we expect to be able to launch that in FY 23 in the U.S. And then the other program we have for ENTYVIO is the needle free device. And that's one that's a little bit earlier in the process through development, but we're continuing to look at that there's a great opportunity there for patients who don't like needles or a needle phobic to be able to bring that needle free device forward into the future. Thank you.

And the next question is going to be the last question. The last question is from .

Thank you akana from Nikkei Newspaper, I have two questions first, about Novavax. Around the beginning of 2022, you will start the supply but then we are already in to February. So when you talk about early 2022, what is exactly the timing? Are you talking about January to March or up to June maybe? And a booster vaccination has started in Japan and another vaccine? Could it be also used for booster vaccination? So that's my first question. The second question, and this is to Mr. Weber. And this is a very broad question. For instance, in France or in Europe. I think economic activities have been returning even with the spread of the Omicron variant and no more restrictions on economic activities or lifting of those restrictions. But here in Japan, we are still continuing to see it's not so much as an emergency declaration. But then the government has not really relaxed those restrictions. And in terms of vaccination and Omicron variant spread and there are kind of differing responses among different countries. How do you see that Mr. Weber?

As announced already. We have already submitted a letter which is under review right now. So we can't really mention a particular month for the launch of Novavax. But regardless of the timing of the launch, we have had tech transfer, and manufacturing. So as early as possible during this calendar year 2022. We'd like to get an approval and right after the approval, we'd like to launch the product. That is a schedule. As for the booster of Novavax. The data package submitted for application, a part of that data include the booster vaccination, as this is under review right now. It is really up to the Japanese authorities to determine. Thank you very much.

Thank you very much for your question. First I would say that the Omicron pandemic wave is not synchronized. So in Europe, this pandemic wave of Omicron started before the wave in Japan's right so, in many European countries, they are seeing declining number of Omicron case which is -- we're not in this phase in Japan. So of course countries. Every country is managing that situation, while at the same time managing the economic impact. One thing I can say, on the other hand is that, it's pretty clear that the Omicron wave is unstoppable because the Omicron is very transmissible. And therefore, I don't believe in two zero COVID strategy, which is not a strategy of Japan. So I think that when there will be signs of declining number, it will be time to restimulate the economy because the Omicron will be with us for a long time. And so this is I think the new reality that many governments are facing is that the pandemic is still with us might still be with us for a long time. And therefore, we need to find a way to manage that while keeping the economy going because we cannot, stop the economy forever. I think this is really the new reality that governments are facing. Thank you for your question.

Thank you very much. Thank you. With this, we conclude the webinar. Thank you for your attendance out of your very busy schedule. Thank you all and I look forward to working with you. Thank you.