Takeda Pharmaceutical Company Limited

Thank you very much for your participation in the conference call for the financial results for Q1 Fiscal Year 2021. My name is Christopher O'Reilly, Global Head of Investor Relations. First, I'd like to explain the language setting. At the bottom of the Zoom webinar window, there is a language button. If you want to listen to Japanese, please select Japanese. If you want to listen to English, please select English. Or if you want to listen to the original language, please turn it off. Before starting, I'd like to remind everyone that we'll be discussing forward-looking statements within the meaning of the Private Securities Litigation 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 the most recent Form 20F and in our other SEC filings. Please also refer to the important notice on page 2 of the presentation. Now, please let me introduce today's presenters and panel. Christophe Weber, President and CEO, R&D President Andy Plump, Costa Sarucos, Chief Financial Officer, Masato Iwasaki, Japan General Affairs, Ramona Seguela, President, U.S. Business Unit and Global Portfolio Commercialization, Julie Kim, President, Plasma Derived Therapies Business Unit. First, I would like to start with a presentation by Christophe, followed by Andy and Costa. After that, we will have a question and answer session. Now we start the presentations.

Thank you, Chris. It's Christophe Weber here. Thank you very much for attending our Q1 results. If we can go to the first slide, please. In a nutshell, as you know, this year is an inflection year for Takeda, an inflection year in terms of revenue, dynamic and momentum. Our growth will accelerate in 2021. It's also an inflection year with our pipeline. And this is exactly what we are seeing during the Q1. which is a great start of the year our revenue grew 3.8 percent driven by our 14 global brand and we are really looking forward to continue to accelerate our growth in 2021 we also are very active to facilitate to help with the vaccination Again, the COVID-19 vaccines in Japan, and you will have seen that we have extended our partnership with Moderna to bring 100 million doses of the Moderna vaccines in Japan. So, good start of the year in terms of top-line momentum. In spite of some variability, product by product, overall, we are starting with an acceleration of our top-line growth. An infection year also with the pipeline. It's a very important year in terms of submission and approval. You saw that in the last two weeks, two of our products got a breakthrough status designation in the US. It's a demonstration that we are also aiming for a very innovative pipeline. So the TAC994 got a breakthrough designation status as well as TAC999. We are also continuing with the development of the Novavax vaccines in Japan with a potential approval in the second part of the year. On the vaccines, we are focusing on dengue as well as the COVID-19 and Zika, but the dengue and COVID-19 is very much our focus and you will have seen that we just did a partnership to continue the development of our norovirus vaccines, but with a partner instead of fully doing it by ourselves with a capital investment which is required. So in a nutshell, very good momentum for the Q1, both on the top line and on the pipeline. And now Andy will explain further our situation regarding our pipeline. Thank you very much.

Great. Thank you very much, Christophe. I'm trying to turn my video on. Great. If someone centrally could turn my video on. Well, good morning, good evening, everybody, and thank you very much, Christophe. Three themes to my presentation this morning. The first is we have a very exciting and very dynamic pipeline, and we are 100% focused on delivering and sharpening our ability to deliver on that pipeline predictably. Secondly, we follow the science. whether that's for our pipeline or for our global brands and you'll see a great example of a success story for Intivio. And then thirdly, this is, as Christophe just said, a year of significant R&D pipeline inflection. We expect major milestones coming up over the rest of this year and into early next year. So if we can go to the next slide, please. Just showing you here a chronology of the major inflections and the momentum that we started late last year and many more. In the middle bucket, you see the progress that we're making with our orexin franchise, which includes all three of our development candidates, all three with the potential to become medicines for patients in the marketed setting. In particular, the major events for our lead molecule, for which we're quite excited, TAC994. and then very importantly, you see on the bottom row across oncology, GI and rare genetic hematology are other three therapeutic areas of focus and very significant, very meaningful proof of concept inflections that we're expecting to see over the course of this year that will set us up for the future. We can go to the next slide, please. I'm not going to dive into this slide in any detail. This is a list of the major milestones for our pipeline that we put out in front of you in May at our Q4 2020 earnings announcement. There's a similar visual for our market brands in the appendix. In a sense, it's our report card, how we judge ourselves for our success over the course of the year. And if we go to the next slide, what I will do, though, is dive into the accomplishments that and the major events that we've had up to date in this fiscal year. So let's just start with very significant regulatory interactions and Christophe has already alluded to some of these and I'll just do a deeper dive. Firstly, very excited about the approval of the Moderna mRNA COVID vaccine in Japan. In addition, as you know, we're very focused on expanding our global Thank you very much. With respect to our wave one pipeline, both Moribivir and Mobocertinib have been filed globally and the United States both have priority review and we're looking forward, we're engaged in discussions with FDA. Currently, we're looking forward to potential approvals for both of these agents in the not too distant future. As you know, we've submitted our dengue vaccine. The dengue vaccine was initially accepted as an accelerated approval. That's actually been conferred, Thank you very much. We're still expecting a CHMP opinion in this fiscal year. And then lastly, with our wave one pipeline, we had, as Christophe mentioned, two big events just this week with TAC 994 and TAC 999, both designated with breakthrough designations. And we're also making decisions on our pipeline. We've made decisions To prioritize our investments and to focus our attention and energy on those programs in our wave one and wave two pipeline and our research pipeline that are most aligned strategically and drive the greatest value for Takeda. And so we found partnerships for three of our very exciting programs. There's still very significant potential in these programs. And there are two points that I'd like to highlight. One is that by finding partners, we remove ourselves not just from financial obligations and costs for these programs, but from the operational burden so we can redirect our attention on our priorities. And secondly, we maintain very significant economic upsides with these programs. If we go to the next slide, please. Let me just walk you through a new indication that we're pursuing in Europe for intibio. So this is a very interesting story. It's a condition known as antibiotic refractory pouchitis, a very high unmet medical need. and just the brief backstory is that in 2016, we initiated a randomized double-blind placebo-controlled multicenter trial. The trial was known as ERNEST. It was a Takeda-sponsored trial and it was a trial that was conducted with the highest quality standards, but it was a phase four study in antibiotic refractory pouchitis. What is that? Well, 10 to 15% of ulcerative colitis patients will undergo colectomy. About 50% of patients patients who have undergone colectomy with the formation of what's known as an anatomical pouch will develop an inflammatory condition known as pouchitis. and then a very high percentage, as much as 15% of these individuals become refractory to existing standards of care, which is predominantly antibiotics. So this can be quite worrisome for patients and even in some cases fatal. So we ran this study, it was a high quality study and we saw striking results. In fact, you can see in the lower right, clinical remission of over 30% within tibia and under 10% with standard of Thank you very much. Given the high medical need and the robustness of these data, we made the decision to submit this dossier to the EMA. That submission has been validated and accepted and is under review. We think that there's a good shot at getting a labeled indication. There are some risks. It was a phase four study, which means we didn't have agreement. with the EMA on what those endpoints for registration would look like. And it's a single study, but that's now under review. So if we just go to the next slide, please, Chris. And the last slide, I'll just end before I hand it over to Costa, just emphasizing that it's a really exciting time for our pipeline. Our pipeline is dynamic, it's moving, and it's really starting to deliver value. With that, Costa, I will hand it over to you.