Takeda Pharmaceutical Company Limited

Good evening, everybody, or good morning, everybody. Thank you very much for joining Takeda's earnings conference call webinar for the first quarter FY 2022. I will serve as MC today. My name is Ayako Iwamuro, in charge of global IR. First, I will explain language setup. At the bottom of the Zoom screen, you find language selection. If you want to listen in Japanese, please select the Japanese audio. If you want English audio, then select English. Or if you want original audio, please turn off this language function. Before starting I'd like to remind everyone that we will be discussing forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those discussed today. The factors that could cause our actual results to differ materially are discussed in our most recent Form 20F and in other SEC filings of Takeda. Please also refer to the important notice on page 2 of the presentation. Let's move to the presentation today. We have with us Christophe Weber, President and CEO, R&D President Andrew Plump, and Chief Financial Officer Costa Salocas. They will be presenting. After the presentation, we will have a Q&A session. Please, let's start.

Thank you, Ayako, and thank you everyone for joining us today. Our purpose is to create better health for people, brighter future for the world by discovering and delivering life-transforming treatments. with a commitment to patients across the world, to our people, and to the planet. Needless to say that this purpose is more relevant than ever. It's not only a moral imperative to create shareholder and societal value, but it's also a way to make the company stronger. Our performance in the first quarter of this fiscal year reinforce our ability to drive long-term business growth. In the first quarter, core revenue was 972.5 billion yen, with growth at a constant exchange rate of 8.3%, driven by our growth on launch products. Core betting profit for the quarter was 319.1 billion yen, growing at an impressive 17% on a constant exchange rate basis, and core earning per share grew 15.8% to 145 yen. These put us well on track towards our full year guidance for fiscal year 2022 of low single-digit core revenue growth and high single-digit core operating profit and core EPS growth at constant exchange rate. On a reported basis, our strong business performance coupled with favorable foreign exchange enabled us to deliver reported revenue growth of 2.4%. And this is despite the large gain of 133 billion yen we booked as revenue in the first quarter of the last year related to the sale of a diabetes portfolio in Japan. On reported profit basis, this one-time transaction had an impact on the first quarter growth rate, but our full year outlook still anticipates double-digit reported operating profit and EPS growth. We continue to see progress in our commercial execution. Our diverse portfolio of growth and launch product grew at an impressive 26% at constant exchange rate, driven by Antivio, Taxaro, and our Immunoglobulin franchise. At the same time, we have very much focused on our launch excellence, as I will detail in a few minutes. Andy will detail our pipeline progress shortly, so I would like to now give you an update on our most recent launches in the U.S. Let's start with Liftensity, which is redefining the way cytomegalovirus or CMV infection is treated. Patients now have access to a therapy that can enable sustained and effective treatment against post-transplant CMV infection, which could save an organ or a life. that might otherwise be lost. As CMV is one of the most common and serious post-transplant infection, recent data support the meaningful impact we are seeing. At the recent medical meetings, we presented data on a new exploratory analysis showing that patients treated with lift density had reduction in hospitalization and length of hospital stay compared to those treated with conventional antiviral therapies. We are also seeing promising momentum since the launch in December 2021. 56% of the 314 US transplant centers have initiated therapy with at least one patient and demand is continuing to grow. Our global expansion plan is underway with an EU approval decision expected in second half of fiscal year 2022. We also anticipate phase three data for lift density, which could expand use in first line. We expect the readout at some point later this fiscal year. We are very proud of the impact of these transformative treatments. Patients who would otherwise be vulnerable to CMV now have hope and a better quality of life. I'd like to talk about another launch product, Excivity. Excivity is an important new treatment for adult patients with locally advanced or metastatic non-small cell lung cancer. It is the first and only approved oral therapy designed to target EGFR exon 20 insertion mutation for patients whose disease has progressed on or after platinum-based chemotherapy. The very unique and distinct value of this important treatment combined with our launch capability is driving its success. We see it in the continued progress following the launch in the U.S. We are continuing to see better than expected new patient starts and have now reached 50% Exxon 20 market share in U.S. Following approval in the U.S. and the U.K., we continue to receive approval from health authorities around the world, most recently in Switzerland, Australia and South Korea. However, in the EU, we decided to withdraw the EU marketing authorization application filing in second line non-small cell lung cancer, following discussion with the CHMP, where the committee indicated that additional clinical data would be needed to confirm benefit for mobocytinib in the second line. Pending outcome from the phase 3 trial in first-line EGFR exon 20 insertion, non-small cell lung cancer, we plan to pursue approval in the EU. This first-line trial is event-driven and is targeted for submission in fiscal year 2024. We remain confident that Xtivity offers an effective treatment option for patients suffering from this difficult to treat cancer and are hopeful that we will continue to make important progress on bringing this treatment to patients in need. In closing, this quarter is yet another example of our ability to deliver on our mission to transform the life of patients while driving long-term financial growth. This result reinforces that our strategy is working, specifically the launch of our new innovative products, our deliberate investment in data and digital, and also commitment to sustainability. We have an incredibly exciting time ahead, patient by patient. We see the impact of our mission to transform life. I now would like to hand over to Andy to introduce our pipeline updates in more detail. Thank you.

Thank you very much, Christophe, and hello to everyone on the call today. As Christophe mentioned, the impact we are seeing on the lives of patients is the key factor to our success. We see this impact so clearly as we make progress in our pipeline. The opportunity to bring transformative medicines to patients is an inspiring and motivating force for all of our scientists. I think you'll see this today as I walk through a few highlights from the first quarter. Next slide, please. There's a lot of enthusiasm here about our dengue vaccine. We recently presented the final data for TAC-003 and are very pleased with the long-term efficacy against hospitalizations as well as protection against dengue disease, which was maintained Thank you for joining us today. This convenient dosing and ability to self-administer at home has the potential to reduce the burden of chronic immunoglobulin treatment. Patients with Alpha-1 antitrypsin-associated liver disease were treated with Fazirceram, our first-in-class RNAi therapy, in an open-label Phase II trial. The strong results were published in the New England Journal of Medicine. and highlights include the regression of fibrosis in 7 out of 12 patients and a median 83% reduction in accumulated ZAAT protein in the liver. This is the key pathologic aggregate that causes inflammation and can lead to fibrosis and eventual liver transplant. These early results demonstrate the potential for Vazisaran to one day help these patients avoid liver transplant. Completing our clinical updates, TAC-280, a conditional B7H3 targeted bispecific T-cell engager designed to treat solid tumors, entered the clinic this quarter. This is the second program that we have entered into the clinic from Maverick Therapeutics, our build-to-buy acquisition completed last year. And as Christophe highlighted earlier, we have in-licensed an exciting hypercylated immunoglobulin candidate from Momenta Pharmaceuticals. This therapy has the potential to increase potency, allowing for significantly lower doses. If you go to the next slide, 10, please. Here are our 10 late-stage development programs. Nevaxavid was approved early this fiscal year and is now available in Japan, adding to the armament against COVID-19. Modaclifos balsa is our first-in-class immunocytokine that delivers an attenuated interferon to tumor and immune cells in a highly targeted manner. UPDATED RESULTS PRESENTED AT THE EUROPEAN HEMATOLOGY ASSOCIATION FOR SINGLE AGENT MEDACOFUS BALFA SHOW AN OVERALL RESPONSE RATE OF 43% WITH MULTIPLE COMPLETE RESPONSES IN HEAVILY PRE-TREATED PATIENTS, IMPORTANTLY INCLUDING THOSE REFRACTORY TO ANTI-CD38 THERAPIES. This quarter, we started the first of a series of Phase II trials for Modocovus balfa, our lead innate immune program, which will define its path forward in relapsed or refractory multiple myeloma. Next slide, 11, please. We continue to be excited about our proof-of-concept readouts to come over the course of the next two years. These are the first of many new molecular entities that could emerge from our rich and transformative early stage pipeline and add to our growing list of late stage development programs. Next slide, 12, please. Here are select expansion opportunities we have for our major brands. We expect to file TaxIRO for the prevention of hereditary angioedema in children ages 2 to 12 in the near future. This filing is based upon the outstanding data presented at the European Academy of Allergy and Clinical Immunology in July. TaxIRO demonstrated an approximately 95% reduction in HAE attacks when compared to baselines. Most of these children averaged nearly two attacks per month before entering the trial, and a majority of them remained attack free during the full 52-week treatment period, a result not seen with any other agent. and as mentioned, we also expect to file Hycuvia in the US and EU as maintenance therapy for patients with CIDP based upon the positive results announced just this past month. So next slide 13. We have some key regulatory approvals and phase three readouts underway. Before we discuss our exciting data for TAC-003 and Hycuvia, we wanted to highlight upcoming data in Q2 for Liptensity. As Christophe mentioned, we expect the top-line Phase III live-tensity data in first-line post-transplant CMV infection to read out in the second quarter. This trial compares live-tensity against the current standard of care, valgancyclovir, in patients with first CMV infections following hematopoietic stem cell transplants. In Phase 2, the intensity showed a numerically higher rate of CMV viremia clearance versus valgancyclovir with a significantly lower rate of neutropenia at 5% versus 18%. Neutropenia is an independent predictor of mortality in stem cell transplant patients. Liftensity's favorable safety profile, especially its lack of neutropenia, represents a potentially significant therapeutic advance for these patients. The late stage data readout shown here will allow for global filing in these indications with future label expansion opportunities to come. So now let's look at some of our data. If we can go to slide 14, please. As Christophe noted, Thank you very much. While mortality from dengue is relatively low, severe dengue infection can be devastating for patients, sometimes leading to hospitalization. For regions that experience a dengue epidemic, hospitals can become overrun with patients requiring supportive care. And so the secondary consequences for patients with other diseases can be substantial, not unlike what we have seen with COVID. There is an incredible unmet medical need and we are ready to meet that need with a really good vaccine. Our four and a half year data continue to support sustained efficacy. What we show here with patients at baseline who are seropositive or seronegative is an incredible 84% reduction in hospitalization. Hospitalization is an indicator of severe forms of dengue. As we have seen with COVID, It's not just if you can prevent infection, but if you can prevent severe infection, it's clear that we can do both with our vaccine. Now, the efficacy does vary by serotype. We have strong efficacy in serotypes one and two, which are the most common. We have strong efficacy in serotype three patients with previous dengue infections. However, we have no efficacy in serotype three patients and to date, we do not have enough data in serotype 4 to draw conclusions. Now, allow me to highlight the hospitalization data from the last 18 months of the trial in the lower right. We are most reassured by the zero hospitalizations seen in the zero negative arm for patients on TAC003 versus placebo. We believe these data will be reassuring to physicians and importantly regulators. We are currently under review in the EU. We believe these data continue to support a favorable benefit-risk profile and are hopeful for a positive decision in the next few months. If we can go to the next slide, 15, please. CIDP is a rare autoimmune and inflammatory disorder that causes demyelination and damage to peripheral nerves. Thank you for joining us. So a facilitated subcutaneous immunoglobulin like Hycuvia should help address an important need for patients with CIDP. We are very excited by the positive results in this Phase 3 study. In the ADVANCE-1 trial, the Hycuvia arm showed a significant difference in relapse rate compared with the placebo arm when used as maintenance therapy in CID patients with a favorable safety profile. Importantly, most of the patients achieve these results with a once-every-four-week dosing regimen using Hycuvia, which is less frequent than any conventional subcutaneous immunoglobulin on the market. These data will be presented at an upcoming medical meeting and be used to file for approval in both the EUS and EU later this fiscal year. So we conclude with two exciting data sets that in the near future could bring new therapies and indications to benefit our patients. Thank you. And I will now turn it over to Kosta. Kosta.