Astellas(US:ALPMY)2024-02-05 18:08Financial Data and Key Metrics Changes - Revenue for Q3 FY 2023 increased to ¥1.1891 trillion, up 2.1% year-on-year, but was behind the full-year forecast revised in Q2 [8] - Core operating profit decreased to ¥149.6 billion, down 36% year-on-year, primarily due to the impact of the acquisition of Iveric Bio and LEXISCAN generics [9] - Operating profit was ¥74.1 billion, down 59.1% year-on-year, with profit decreasing to ¥50.3 billion, down 65.3% year-on-year [10] Business Line Data and Key Metrics Changes - XTANDI global sales increased to ¥460 billion, up 9% year-on-year, in line with the revised full-year forecast [11] - XOSPATA global sales increased to ¥41.3 billion, up 14% year-on-year, also in line with the revised full-year forecast [14] - PADCEV global sales increased substantially to ¥55.6 billion, up 68% year-on-year, in line with the revised full-year forecast [15] - VEOZAH year-to-date sales were ¥3.6 billion, with full-year forecast revised downward to $50 million due to lower-than-expected demand [20][24] Market Data and Key Metrics Changes - In the U.S., XTANDI received an additional indication approval based on EMBARK study results, expected to contribute to future sales [12] - PADCEV's approval for additional indications in the U.S. and Europe is anticipated to drive significant sales contributions in FY 2024 and beyond [16][44] - VEOZAH's market access expanded to about 35% lives covered as of December, with expectations to exceed 50% by the end of FY 2023 [25] Company Strategy and Development Direction - The company aims to maximize the product value of VEOZAH while carefully examining the timing for investments to ensure the greatest return [40] - Astellas is focusing on sustainable growth, with expectations for revenue and profit increases in FY 2024, setting FY 2023 as a turning point [64] - The company is enhancing its DTC activities to increase awareness and drive demand for VEOZAH and IZERVAY [29][35] Management's Comments on Operating Environment and Future Outlook - Management acknowledged that VEOZAH's demand is trailing internal expectations due to HCPs' perceptions of payer coverage [21][24] - The company is optimistic about the future growth of IZERVAY, driven by upcoming milestones such as the permanent J-code and label update [35] - Management expects to achieve sustainable growth from FY 2024 onward, with a focus on key strategic products [64] Other Important Information - The company has made significant progress in the development of key strategic products, including the launch of VEOZAH and IZERVAY [62] - Astellas is actively working on open innovation initiatives to enhance R&D capabilities and collaborations with academic institutions [60] Q&A Session Summary Question: What is the biggest reason behind the lack of progress in payer coverage for VEOZAH? - Management clarified that payer coverage has progressed to 35% and is on track to exceed 50% by the end of FY 2023, but HCPs' perceptions lag behind this progress [68][70] Question: Why is there a delay in patients visiting HCPs despite increased awareness from DTC activities? - Management noted that the time for women to get appointments with HCPs is longer than anticipated, now estimated at three to four months [73] Question: What percentage of physicians consider the coverage sufficient? - Management is currently researching this question and will provide details in the next quarterly call [75] Question: Will the payer coverage conditions be simplified? - Management indicated that they are not changing their approach to payers at this time and are confident in achieving the planned coverage [81] Question: What is the update on the label for IZERVAY? - Management confirmed that a submission for a label update was made in January, aiming to lift the restriction on administration duration and extend the administration schedule [82][85]