Financial Data and Key Metrics Changes - Revenue in Q1 2025 was just over JPY 1,100 billion, a decrease of 8.4% or 3.7% at constant exchange rates [11] - Core operating profit decreased by 15.8% at actual FX or 11.9% at constant exchange rates, amounting to JPY 321.8 billion [11] - Reported operating profit increased by 11% to JPY 184.6 billion, mainly due to lower impairments and restructuring expenses [11][17] - Adjusted free cash flow was strong at JPY 190.1 billion [11] Business Line Data and Key Metrics Changes - Launch products, which represent 50% of revenue, grew by 5% at constant exchange rates [12] - In the GI segment, Entyvio grew by 4.9% at constant rates, with a 30% increase in active EntyvioPen patients in the U.S. [12][13] - TAKHZYRO continues to grow as a market leader in HAE prophylaxis, while the PDT portfolio experienced fluctuations typical of quarterly results [13] - QDenga was impacted by shipment timing and currency effects, but volume is increasing with expectations for strong growth [14] Market Data and Key Metrics Changes - The U.S. market saw a significant impact from Vyvanse's generic erosion, which was a main driver of the revenue decline [15][16] - The generic supply situation in the U.S. improved, leading to expectations of less headwind from Vyvanse in future quarters [15] - The appreciation of the Japanese yen against major currencies also posed a headwind this quarter [16] Company Strategy and Development Direction - The company views FY 2025 as pivotal due to a rapidly progressing late-stage pipeline, with positive results from pivotal Phase III studies of oviporexant [8][20] - The focus remains on late-stage development activities, with ambitions to file for up to five additional indications through FY 2029 [36] - The company is committed to maintaining a strong manufacturing presence in the U.S. and is exploring direct-to-consumer models for certain products [59][63] Management's Comments on Operating Environment and Future Outlook - Management anticipates that FY 2025 will be the last year of significant impact from Vyvanse erosion, with expectations for revenue growth to moderate in subsequent quarters [7][20] - The company is well-positioned to manage potential impacts from tariffs and is actively preparing for price negotiations related to Medicare [20][110] - Management remains confident in achieving full-year guidance despite the challenges faced in Q1 [42][46] Other Important Information - The company executed two leverage-neutral bond issuances to streamline its maturity profile [18] - The company plans to file for U.S. approval of oviporexant later this year, with regional filings to follow [27] - The company is exploring the potential of orexin agonists in various disorders beyond narcolepsy, including sleep-wake cycle disruptions and metabolism [77] Q&A Session Summary Question: Expectations for recovery in sales of specific products - Management acknowledged that Q1 was soft but does not reflect the underlying dynamics, expecting recovery as market access improves [42][44] Question: Additional benefits of new molecules in the pipeline - Management indicated that the new orexin agonist has potential for broader applications beyond narcolepsy, with ongoing development in various disorders [47][49] Question: Competitive landscape for narcolepsy treatments - Management expressed confidence in the competitive positioning of oviporexant, highlighting significant improvements in key symptoms [57][58] Question: Investment strategies in the U.S. market - Management confirmed ongoing investments in U.S. manufacturing and R&D, emphasizing the importance of the U.S. market for future growth [59][60] Question: Dynamics affecting Entyvio's market performance - Management noted challenges in transitioning patients to the pen formulation but expects improvements as access issues are addressed [86][88] Question: R&D spending outlook - Management clarified that Q1 spending was in line with plans, with expectations for increased R&D activities as new trials commence [72][106] Question: Most Favored Nation drug pricing policy discussions - Management is preparing for potential negotiations related to the MFN policy but has not yet been contacted for direct discussions [109][110] Question: Preparations for the launch of oviporexant - Management is focusing on building a sales team and utilizing digital technology for diagnostics leading up to the launch [113]

Financial Data and Key Metrics Changes - Revenue for Q1 2025 was just over JPY 1,100 billion, a decrease of 8.4% or 3.7% at constant exchange rates [9] - Core operating profit decreased by 15.8% at actual FX or 11.9% at constant exchange rates, amounting to JPY 321.8 billion [9] - Reported operating profit increased by 11% to JPY 184.6 billion [9] - Adjusted free cash flow was strong at JPY 190.1 billion [9] Business Line Data and Key Metrics Changes - Launch products, which represent 50% of revenue, grew by 5% at constant exchange rates [10] - In the GI segment, Entyvio grew by 4.9% at constant rates, with a 30% increase in active patients [10][11] - TAKHZYRO continues to grow as a market leader in HAE prophylaxis [11] - In oncology, prazacla is expanding with global launches [12] - QDenga was impacted by shipment timing and currency effects but is expected to deliver strong growth for the full year [12] Market Data and Key Metrics Changes - The U.S. market saw a significant impact from Vyvanse's generic erosion, which was a main driver of the revenue decline [13][14] - The generic supply situation in the U.S. improved, leading to expectations of less headwind from Vyvanse in future quarters [14] - The appreciation of the Japanese yen against major currencies also posed a headwind this quarter [14] Company Strategy and Development Direction - The company views FY 2025 as pivotal due to its rapidly progressing late-stage pipeline, including positive results from pivotal studies of oviporexton [6][7] - The focus remains on expanding the orexin franchise and exploring additional indications for orexin agonists [29][35] - The company plans to file for U.S. approval of oviporexton later this year, with regional filings to follow [25] Management's Comments on Operating Environment and Future Outlook - Management anticipates that the impact from Vyvanse's generic erosion will moderate in future quarters, with no change to the full-year outlook [6][18] - The company is well-positioned to manage potential tariff impacts and is actively preparing for future negotiations regarding drug pricing policies in the U.S. [18][110] Other Important Information - The company executed two leverage-neutral bond issuances to streamline its maturity profile [16] - The average annual maturity over the next three years is approximately JPY 220 billion, which is considered manageable [17] Q&A Session Summary Question: Expectations for recovery in sales of Entyvio, IG, Vyvanse, and QDenga - Management believes Q1 performance does not reflect underlying product dynamics and expects recovery as market access improves [43][45] Question: Additional benefits of new molecules in the pipeline - The company is exploring multiple indications for orexin agonists, with ongoing Phase IIb programs and plans for new molecules [48][49] Question: Competitive landscape for narcolepsy treatments - Management believes oviporexton is potentially best in class, with significant benefits across all symptoms of narcolepsy type one [57] Question: Investment strategy in the U.S. market - The company is highly invested in U.S. manufacturing and R&D, with plans to continue this trend [59][60] Question: Dynamics affecting Entyvio's market access - Management is addressing local access issues and expects improvements to drive growth for the Entyvio pen [86] Question: R&D spending outlook - R&D spending is expected to ramp up as new trials begin, with management maintaining full-year guidance [72][107] Question: Most favored nation drug pricing policy discussions - The company is preparing for potential negotiations related to the IRA Medicare price negotiations but has not been contacted directly yet [110]

Financial Performance - FY2025 Q1 revenue was JPY 1,1067 billion, a decrease of 84% compared to FY2024 Q1[16] - FY2025 Q1 core operating profit was JPY 3218 billion, a decrease of 158% compared to FY2024 Q1[16] - FY2025 Q1 reported operating profit increased by 110% to JPY 1846 billion, primarily due to lower impairment and restructuring expenses[16, 28] - Adjusted free cash flow for FY2025 Q1 was JPY 1901 billion, a significant increase of 7036% compared to FY2024 Q1[16] - Takeda maintains its FY2025 forecast with revenue of JPY 4,5300 billion, a decrease of 11%[34] Portfolio Performance - Growth & Launch Products increased by 50% at CER in Q1[18] - Growth & Launch Products accounted for JPY 5581 billion (USD 39 billion), representing 50% of total revenue[19] - VYVANSE revenue is expected to decline by JPY 1096 billion (-30% at CER) in FY2025[34] Pipeline and Milestones - Oveporexton (TAK-861) Phase 3 met all primary and secondary endpoints, showing transformative potential in NT1[40] - Zasocitinib is in Phase 3 for Psoriasis with a head-to-head start vs deucravacitinib[46, 49] - Rusfertide is targeting US filing for Polycythemia Vera in H1 FY25[49]

Financial Data and Key Metrics Changes - The company reported quarterly revenue of $145.5 million, with $134 million attributed to Orlodayo, marking a significant increase from the previous year [6][28] - Annual revenue guidance for Orlodayo has been raised to between $580 million and $600 million, reflecting a growth of 33% to 37% over last year [6][29] - Operating profit for Q1 2025 was $21.2 million, with net income reported as slightly positive [29] - Cash at the end of the quarter stood at $317 million, and the company reduced its outstanding debt by $75 million, bringing it down to $249 million [28][30] Business Line Data and Key Metrics Changes - The U.S. commercial team successfully transitioned patients from free drug to paid status, achieving a 10 percentage point increase in the paid patient rate, now at 84% [10][12] - The paid rate among Medicare patients improved significantly, with 89% now receiving paid therapy [93] - The gross to net ratio improved, with expectations to maintain it around 15% for the full year [14][51] Market Data and Key Metrics Changes - The company noted a strong demand for Orlodayo, with new prescriptions slightly exceeding the best quarter from the previous year [8][10] - The percentage of U.S. patients who strongly prefer oral prophylaxis increased to 70%, up from 51% in 2023 [10] - The company anticipates reaching $1 billion in global revenue by 2029, with a more profitable path than previously expected [13][64] Company Strategy and Development Direction - The company is focusing on expanding its pipeline, with significant milestones achieved, including the submission of a pediatric NDA for Orlodayo [16] - The company aims to capture more revenue from Orlodayo as the patient base continues to grow, with a long-term goal of 85% paid therapy [12][13] - The company is committed to disciplined capital allocation to create sustainable long-term revenue growth while reducing debt [30][31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the sustainability of the paid rate improvement, viewing 84% as a new floor for future performance [118] - The company is optimistic about the impact of the Inflation Reduction Act on patient affordability and access to Orlodayo [11][57] - Management highlighted the importance of real-world evidence in convincing payers of the drug's efficacy, which has improved payer conversations [94] Other Important Information - The company is preparing for the launch of a pediatric formulation of Orlodayo, with expectations for rapid deployment following approval [106] - The company is also advancing its clinical pipeline, with a focus on rare diseases and the potential for transformative treatments [16][18] Q&A Session Summary Question: What is the potential impact of the pediatric launch on Orlodayo? - Management expects the pediatric launch to be a significant tailwind, with around 500 pediatric patients in the U.S. potentially appropriate for prophylactic therapy [35][36] Question: Can you elaborate on the improvements in getting patients onto paid drug? - The team made investments in the reauthorization process and improved their execution, leading to a higher paid rate [46][47] Question: What benchmarks are being set for the DME program? - The company is looking for a clear reduction in retinal edema as a benchmark for moving forward with the DME program [41][97] Question: How sustainable is the paid rate improvement? - Management believes the paid rate improvement is sustainable, with 84% being a new baseline for future performance [118] Question: What is the expected timeline for the pediatric formulation launch? - The company aims to minimize the lag time between approval and market availability, similar to previous launches [106][107]