Financial Data and Key Metrics Changes - Revenue for the nine-month period was just over JPY 3.4 trillion, a decrease of 3.3% or -2.8% at constant exchange rate (CER) [10] - Core Operating Profit (Core OP) was JPY 971.6 billion, a year-on-year decrease of 3.4% at both actual effects and CER [10] - Reported operating profit was JPY 422.4 billion, an increase of 1.2% [11] - Core EPS was JPY 428, and reported EPS was JPY 137 [11] - Adjusted free cash flow was JPY 625.9 billion, even after a $1.2 billion upfront payment to Innovent Biologics [11] Business Line Data and Key Metrics Changes - Growth and launch products represented over 50% of total revenue and grew 6.7% at CER, an improvement from the 5% growth rate in Q1 and Q2 [11] - In Gastroenterology (GI), Entyvio grew 7.4% at CER, with strong growth in Q3 due to a one-time gross-to-net drop [12] - In rare diseases, Takhzyro slowed to 2.4% growth at CER, impacted by new competing products in the US [12] - Immunoglobulin (IG) growth was 4.3% year to date, driven by subcutaneous IG products, while IVIG sales were impacted by Medicare Part D redesign [13] - In oncology, Perzaca continues to expand with global launches, and vaccine Qdenga growth accelerated to 22.1%, driven primarily by Brazil [14] Market Data and Key Metrics Changes - Entyvio Pen is now on the formulary with all three large pharmacy benefit managers, achieving commercial coverage of more than 80% [12] - The decline in Vyvanse was heavily weighted to the first half of the year, with growth and launch products performing better in the second half [15] - The overall market for Takhzyro has matured, with high diagnosis rates and penetration of prophylaxis treatment [68] Company Strategy and Development Direction - The company is preparing for significant new product launches, focusing on Oveporexin, rusfertide, and zasocitinib, expected to launch over the next 18 months [6][24] - The company aims to maintain operational efficiency while investing in R&D and new product launches [16] - A strategic partnership with Innovent Biologics has added new assets to the pipeline, enhancing growth potential [8] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the significant impact of Vyvanse generic erosion but noted strong cost discipline to limit its impact on profit [10] - The company is revising revenue guidance to a low single-digit decline at CER due to stronger than anticipated Vyvanse generic erosion [17] - Management remains committed to operational efficiency while investing in necessary launches for long-term growth [16] Other Important Information - The transition of leadership to Julie Kim, CEO-elect, is underway, with a focus on maintaining momentum and preparing for upcoming launches [30][32] - The company is implementing organizational changes to enhance competitiveness and speed in the market [32] Q&A Session Summary Question: Thoughts on next fiscal year and dividend policy - Management indicated it is too early to provide guidance for the next fiscal year, with the budget being finalized [41] - The company aims to maintain a progressive dividend policy, considering core EPS and cash flow [44] Question: Zasocitinib phase 2 outcomes and safety data - Data from UC and Crohn's disease phase 2 studies are expected this year, with ongoing studies assessing dosing [46] - The safety profile for psoriasis is consistent with previous studies, with further data to be presented at an upcoming medical conference [47] Question: Impact of MFN and organizational changes - Management does not support MFN due to its potential impact on innovation and is evaluating its effects on the company [54] - Organizational changes are focused on enhancing marketing and sales excellence, particularly in the US market [56] Question: Entyvio sales performance and IRA impact - Entyvio's Q3 performance was strong, with improved coverage in the US, and management is optimistic about sustaining growth [61] - The impact of IRA price negotiations on Entyvio is being assessed, with uncertainty regarding potential price cuts [65] Question: Takhzyro growth and competitive impact - Takhzyro's growth has slowed due to competition and Medicare Part D redesign, but it remains the gold standard for HAE patients [68] - Long-term efficacy data supports Takhzyro's position in the market despite recent competitive entrants [69] Question: PDT clinical progress and Zasocitinib data presentation - Demand for PDT has slowed, particularly in albumin due to regulatory changes in China, but growth is expected to return [86] - Zasocitinib phase III data may be presented at AAD, focusing on its fast onset of action and strong safety profile [90]

Financial Data and Key Metrics Changes - Revenue for the nine-month period was just over JPY 3.4 trillion, a decrease of 3.3% or -2.8% at constant exchange rate [10] - Core Operating Profit was JPY 971.6 billion, a year-on-year decrease of 3.4% at both actual effects and constant exchange rate [10] - Reported operating profit was JPY 422.4 billion, an increase of 1.2% [11] - Core EPS was JPY 428, and reported EPS was JPY 137 [11] - Adjusted free cash flow was JPY 625.9 billion, even after a $1.2 billion upfront payment to Innovent Biologics [11] Business Line Data and Key Metrics Changes - Growth and launch products represented over 50% of total revenue and grew 6.7% at constant exchange rate [11] - In GI, Entyvio grew 7.4% at constant exchange rate, with strong growth in Q3 due to a one-time gross-to-net drop [12] - Rare diseases product Takhzyro slowed to 2.4% growth at constant exchange rate, impacted by new competing products in the US [12] - Immunoglobulin growth was 4.3% year to date, driven by subcutaneous IG products [13] - Qdenga growth accelerated to 22.1%, primarily driven by Brazil [13] Market Data and Key Metrics Changes - Entyvio Pen is now on formulary with all three large pharmacy benefit managers, achieving commercial coverage of more than 80% [12] - Takhzyro's growth is being offset by new competitors and the impact of Medicare Part D redesign in the U.S. [13] - Albumin has returned to growth of 1.3%, but slower than expected due to softening demand in China [13] Company Strategy and Development Direction - The company is preparing for significant new product launches, focusing on Oveporexin, rusfertide, and zasocitinib, expected to launch over the next 18 months [5][6] - The late-stage pipeline includes eight programs with potential to transform the standard of care [8] - The company is committed to maintaining operational efficiency while investing in R&D for future growth [15] Management's Comments on Operating Environment and Future Outlook - Management revised revenue guidance to low single-digit decline at constant exchange rate due to stronger than anticipated Vyvanse generic erosion [16] - The company maintains full-year guidance for core operating profit and core EPS [16] - Management emphasized the importance of cost discipline while preparing for new product launches [15] Other Important Information - The transition of leadership to Julie Kim, CEO-elect, is underway, with operational responsibilities being handed over [28][30] - The company is focusing on simplifying processes and adopting advanced technologies [31] Q&A Session Summary Question: Thoughts on next fiscal year and dividend policy - Management indicated it is too early to provide guidance for the next fiscal year, with the budget being finalized [39] - Emphasis on maintaining a progressive dividend policy, with decisions based on core EPS and cash flow [43] Question: Zasocitinib phase 2 outcomes and safety data - Data from UC and Crohn's disease phase 2 studies expected this year, with ongoing studies on dosing [45] - Safety profile consistent with previous studies, with more data to be presented at an upcoming medical conference [46] Question: Impact of MFN on U.S. policy - Management does not support MFN, emphasizing that price controls could impact future innovation [52] - Organizational changes aim to enhance competitiveness and speed in U.S. marketing [54] Question: Entyvio sales performance and IRA impact - Q3 sales were robust, with improved coverage in the U.S. [59] - Anticipation of price negotiations under IRA, with uncertainty on the extent of potential price cuts [61] Question: Takhzyro growth trends and competitive impact - Takhzyro remains the gold standard, but growth is impacted by new competitors and Medicare Part D redesign [66] - Long-term efficacy data supports Takhzyro's position in the market [66] Question: PDT clinical progress and outlook - Demand slowdown noted, particularly in albumin due to regulatory changes in China [81] - Overall outlook for PDT remains mid-single-digit growth for the year [81] Question: Zasocitinib phase III data presentation - Presentation at AAD is a possibility, with focus on fast onset of action and clear skin [87] - Competitive advantages include ease of administration and strong safety profile [88]