- First regimen approved in advanced urothelial cancer to demonstrate superiority to platinum-containing chemotherapy, the standard of care for nearly 40 years1 - European Marketing Authorization based on positive overall survival and progression-free survival results from the global Phase 3 EV-302 trial1 TOKYO, Aug. 28, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the European Commission has granted Marketing Authorization for PADC ...

Financial Performance - Revenue increased by 262% YoY, reaching 4731 billion yen, with a foreign exchange impact of +454 billion yen[4] - Core operating profit increased by 205% YoY to 883 billion yen, with a foreign exchange impact of +116 billion yen[4] - Strategic Brands expanded to 750 billion yen, representing a threefold increase YoY of approximately +500 billion yen[4, 5] Key Products - XTANDI contributed significantly to overall revenue growth, particularly in the US, with sales of 2242 billion yen, a 29% increase YoY (+502 billion yen)[4, 5] - PADCEV global sales reached 384 billion yen, a 152% increase YoY (+232 billion yen)[6] US sales were $174 million (+128%), and EST sales were €45 million (+178%)[7] - IZERVAY US sales were $82 million, with a market share of approximately 35% in Q1/FY2024, representing a QoQ growth of +73%[10, 11] - VEOZAH global sales were 66 billion yen, a 972% increase YoY (+60 billion yen)[6] US sales were $39 million (+778%), and EST sales were €3 million (+3)[9] Cost Items - SG&A expenses increased by 230% YoY to 2069 billion yen, with a foreign exchange impact of +208 billion yen[4] Excluding US XTANDI co-pro fee, SG&A expenses increased by 175% YoY (+217 billion yen)[4] - R&D expenses increased by 344% YoY to 868 billion yen, with a foreign exchange impact of +69 billion yen[4] Pipeline and Strategy - The company is pursuing product value maximization for ZOLBETUXIMAB / VYLOY as a first-in-class anti-CLDN182 treatment, with a regulatory decision anticipated for Q4/FY2024[15] - A new Phase 3 study for ZOLBETUXIMAB / VYLOY in combination with CPI and chemotherapy is planned to start in 1H/CY2025[15] - The company is investing in business growth, aiming for higher dividend increases aligned with robust profit growth forecasts[27]

- 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]

Financial 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]

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 ...