- If approved by the European Commission, zolbetuximab would become the first and only CLDN18.2- targeted therapy approved in the European Union TOKYO, July 26, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that on July 26, 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of zolbetuximab in the European Union. Zolbetuximab, a first-i ...

- If approved, enfortumab vedotin in combination with pembrolizumab will be the first and only treatment to offer an alternative to platinum-containing chemotherapy, the current standard of care for those with unresectable or metastatic urothelial cancer - Positive opinion is based on Phase 3 EV-302 clinical trial results which showed enfortumab vedotin in combination with pembrolizumab nearly doubled median overall survival compared to platinum-containing chemotherapy1 TOKYO, July 26, 2024 /PRNewswire/ -- ...

If approved, the investigational therapy would offer a new treatment option for patients with advanced gastric and gastroesophageal junction cancers as the first and only CLDN18.2-targeted therapy in the U.S. TOKYO, May 30, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the company's resubmission of the Biologics License Application (BLA) for zolbetuximab, a first-in-class i ...

Financial Data and Key Metrics Changes - Revenue increased to JPY1,603.7 billion, up 5.6% year-on-year, achieving 102.7% of the full year forecast [10] - Core operating profit was JPY184.6 billion, down by 35.6% year-on-year, but exceeded the full year forecast at 112.6% [10] - Operating profit decreased to JPY25.5 billion, down by 80.8% year-on-year, and profit decreased to JPY17 billion, down 82.7% year-on-year [11] Business Line Data and Key Metrics Changes - XTANDI sales increased to JPY750.5 billion, up by about JPY90 billion or 14% year-on-year [12] - PADCEV global sales increased to JPY85.4 billion, up 92% year-on-year, realizing nearly twofold growth [13] - XOSPATA global sales increased to JPY55.1 billion, up 18% year-on-year [16] - VEOZAH sales reached JPY7.3 billion, progressing in line with the forecast [16] - IZERVAY sales reached JPY12.1 billion, exceeding the full year forecast [18] Market Data and Key Metrics Changes - Commercial lives covered for VEOZAH expanded to 50% as planned by the end of March [17] - The number of launched countries for PADCEV increased to 36 in total [15] Company Strategy and Development Direction - The company aims to maximize product value through active life cycle management and indication expansion [41] - The focus is on sustainable growth through strategic product launches and pipeline development [22][44] - The company plans to review management resource allocation and implement stringent cost control while securing investment for future growth [46][79] Management's Comments on Operating Environment and Future Outlook - Management acknowledged challenges due to the entry of generics and the impact of the Inflation Reduction Act on XTANDI sales [40][49] - The company is optimistic about the growth of strategic products like PADCEV and IZERVAY, despite some setbacks [41][62] - Future sales growth is expected to significantly outpace expenses, contributing to profits [66] Other Important Information - The company has revised its peak sales forecast for IZERVAY from JPY300 billion - JPY500 billion to JPY150 billion - JPY250 billion [61] - The definition of core basis has been updated to better reflect profitability [74] Q&A Session Summary Question: Review of CSP assumptions for FY 2025 - Management confirmed that the performance goals in CSP 2021 will remain unchanged, but they will continue to analyze the numbers and scenarios [90][91] Question: Impact of J-Code approval on IZERVAY sales - Management highlighted that the permanent J-Code will simplify reimbursement procedures, expanding the customer base, and emphasized the importance of launching IZERVAY in additional markets [92][93] Question: Concerns regarding mirabegron generics - Management acknowledged the ongoing legal situation but noted that the injunction by the appeals court is temporary and its duration is unclear [95] Question: Journey towards improving core OP margin - Management indicated that growth in products like PADCEV and IZERVAY is expected to positively impact the OP margin [97][99] Question: Dividend strategy and future increases - Management expressed a commitment to stable dividend increases while being cautious about future profitability, especially with XTANDI's patent expiration approaching [102][103]

Astellas Pharma Inc. (OTCPK:ALPMF) Q3 2023 Results Earnings Conference Call February 5, 2024 2:00 AM ET Company Participants Hiromitsu Ikeda - Corporate Head, Advocacy & Relations Atsushi Kitamura - Chief Financial Officer Tadaaki Taniguchi - Chief Medical Officer Claus Zieler - Chief Commercial Officer Conference Call Participants Hidemaru Yamaguchi - Citigroup Securities Kazuaki Hashiguchi - Daiwa Securities Shinichiro Muraoka - Morgan Stanley MUFJ Securities Akinori Ueda - Goldman Sachs Securities Seiji ...

Q2/FY2023 FINANCIAL RESULTS ENDED SEPTEMBER 30, 2023 Naoki Okamura President and CEO Astellas Pharma Inc. November 1, 2023 CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION In this material, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas Pharma. These statements are based on management's current assumptions and beliefs in light of the informati ...

Astellas Pharma Inc. (OTCPK:ALPMF) Q2 2023 Earnings Conference Call August 1, 2023 4:00 AM ET Company Participants Hiromitsu Ikeda - Corporate Head, Advocacy and Relations Naoki Okamura - Representative Director, President and CEO Yoshitsugu Shitaka - Chief Scientific Officer Tadaaki Taniguchi - Chief Medical Officer Claus Zieler - Chief Commercial Officer Conference Call Participants Hidemaru Yamaguchi - Citigroup Securities Kazuaki Hashiguchi - Daiwa Securities Naomi Kumagai - Mitsubishi UFJ Morgan Stanle ...

Q3/FY2022 FINANCIAL RESULTS ENDED DECEMBER 31, 2022 Minoru Kikuoka Chief Financial Officer (CFO) Astellas Pharma Inc. February 6, 2023 CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION In this material, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas Pharma. These statements are based on management's current assumptions and beliefs in light of t ...

Astellas Pharma Inc. (OTCPK:ALPMF) Q3 2022 Earnings Conference Call October 31, 2022 4:00 AM ET Company Representatives Kenji Yasukawa - Chief Executive Officer Yoshitsugu Shitaka - CScO, Chief Scientific Officer Minoru Kikuoka - Chief Financial Officer Tadaaki Taniguchi - Chief Medical Officer Bernie Zeiher - Chief Medical Officer Hiromitsu Ikeda - Corporate Head, Advocacy and Relations Conference Call Participants Hidemaru Yamaguchi - Citigroup Securities Motoya Koutani - Nomura Securities Fumiyoshi Sakai ...

Q1/FY2022 FINANCIAL RESULTS ENDED JUNE 30, 2022 Minoru Kikuoka Chief Financial Officer (CFO) Astellas Pharma Inc. August 1, 2022 CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION In this material, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas Pharma. These statements are based on management's current assumptions and beliefs in light of the inf ...