Takeda Pharmaceutical Company Limited

Good day, everyone, and welcome to the conference call of Takeda Pharmaceutical Company Limited. During the presentation from the company, all the telephone lines are placed for listening mode only, and a question and answer session will be held after the presentation. Now we start the conference. Mr. O'Reilly, please go ahead.

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 the most recent Form 20F and our other SEC filings. Please also refer to the important notice on page two of the presentation. Now, please let me introduce today's presenters and panel. Christophe Weber, President and CEO, Costa Sorokas, Chief Financial Officer, Andrew Plump, President of R&D, Masato Iwasaki, President of the Japan Pharma Business Unit, and Julie Kim, President of the PDT Business Unit. First, we would like to start with a presentation by Christophe followed by Andy and Costa. After that, we'll have a question and answer session. Now, we'll start the presentation. Please have the presentation materials to hand.

Thank you very much, Chris. Hello, everyone. Thank you for taking the time to review our first semester result and outlook for the year. I have to say I'm missing the face-to-face interaction with all of you, and I hope we'll be able to resume that soon or later. I'll go on to slide number four, just to say that Overall, we are managing the present. We are managing the exceptional circumstances of this year. We are managing it well. Our organization is resilient. Our portfolio is resilient. And so we are able to commit to our full year management guidance. We are raising our forecast of profit EPS and free cash flow. We have a strong financial position. So we are managing well the present, and I'm sure we'll come back to that. At the same time, we don't forget the future, and the future is our pipeline, the progression of our pipeline, because that will drive our long-term revenue growth. And we have a very exciting pipeline, the Wave 1 assets, the 12 Wave 1 assets in our pipeline, the 30 in Wave 2. We are planning to file seven new molecular entity in the next 12 months. So we are very much focusing on that as well. So overall, the year is progressing well. It's not without challenge, of course. Every week is a new week. You have seen, for example, how the pandemic is evolving in Europe. So we are adapting to that. We have been very agile to adapt to the situation. But so far, so good, we have been able to really maintain our operation and manage our business well. I'll go to the next slide, which gives a little bit more granularity about the situation, slide number five. I'll start with the bottom to say first that the remediation of our e-carry situation is progressing well. We do intend to be inspection-ready by end of this year, which means that we believe that our remediation will have been sufficiently progressed to be inspection-ready by end of this year. We don't know if there will be an inspection because we don't know if the FDA will do inspection at that time, but we will be ready. We have minimized the supply disruption of lupraline as much as possible. There is a supply disruption. but we were able to resume the manufacturing for Japan in July, for other countries in August, so we are catching up, but there is supply disruption in some region. It's not financially impactful, but our goal here is to really make sure that the patient have a solution and alternatives, and this is very much our focus. You would have seen that we have sign a partnership with Amazon Web Services and Accenture to move, accelerate our transformation towards data and digital. We will move 80% of our application to the cloud. It will really unlock our ability to leverage data, digital, AI. And so this is a very exciting time. And we are very pleased that we were able to do this quite unique partnership because it's a It's really a strategic partnership, and not many companies have done that, but this is, we believe, the way to go in order to accelerate our digital transformation. You will see later in the COSAT presentation that our first semester performance is good. We have a 15% revenue growth of our 15 global brands. Our overall underlying revenue growth is plus 0.5%. It's enough to maintain our management guidance of low single-digit growth because we expect an acceleration of that growth in the second semester. We are increasing our profit and cash flow forecast. Costa will explain that. On the R&D side, We have made good progress. We have added one, we believe, very exciting component in our pipeline, TAC999. Andy will cover that. And we are progressing our cell therapy pipeline, and we have now a cell therapy manufacturing facility, which is very important for the future. So again, we are confirming our full year management guidelines, and we are raising our forecast for cash flow and EPS. I'll spend the next two slides to zoom on our COVID, the way we are managing COVID. We have been very proactive to keep our employees safe, but at the same time, maintaining our operation. And this is still what we do in many parts of the world. We are working in a remote way, like this evening meetings. We have defined that... our future in the future in a postcovid environment we will work at takeda in an hybrid way in person so on site and virtual we believe that this is the best way for what for us for what we have to do and for the problem the type of problems we have to solve so takeda will embrace an hybrid working model in person and virtual and we are now really working the detail of what it will look like because we want to be a very attractive company as well for people to join take it down for our employees we have maintained our business as i explained at the same time we are developing uh solutions again the kobe 19 so if you go on the next slide slide 7 We are working in three areas, vaccines, and we have partners now with Novavax and Moderna, two promising vaccines, two different scientific platforms, and we believe that these are promising vaccines, and we are very pleased to be a partner with these two companies to bring these vaccines to Japan. We are working on the hyperamine globulin product, and the trial now is ongoing. and hopefully we'll get the results by the end of this year. And we are developing this. This trial is happening in 16 countries, including Japan. And we are testing existing therapies for their potential impact on COVID-19. And we are part of a different R&D coalition And we believe that these two, Firazi and Taxaro, could have a potential positive impact against COVID-19. So we are testing these two products in clinical trials. That's what I wanted to share with you in the introduction. And I'm now very happy to pass the floor to Andy to update us on our R&D situation. Thank you very much.