TSE: 4502 Committed to Growth & Shareholder Returns FY2025 Q3 Earnings Announcement The companies in which Takeda directly and indirectly owns investments are separate entities. In this presentation, "Takeda" is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words "we", "us" and "our" are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifyi ...

Takeda Pharmaceutical Company FY Conference Summary Company Overview - **Company**: Takeda Pharmaceutical Company (NYSE: TAK) - **Revenue**: $30 billion, with over 50% from the U.S. market, up from less than 20% a decade ago [2][3] - **R&D Investment**: Approximately $5 billion annually [3] - **Global Presence**: Operations in 80 countries, with headquarters in Tokyo and a significant hub in Boston [2][3] Core Focus Areas - **Innovation and Digital Transformation**: Takeda has shifted focus towards innovation and digital technology since 2014, moving all data to the cloud in 2018 [1][2] - **Therapy Areas**: Focus on gastroenterology, neuroscience, and oncology [3] Financial Performance and Strategy - **Generic Exposure**: Experienced a 20% revenue loss from 2021 over the past five years due to generic competition, but expects lower exposure moving forward [3] - **Product Portfolio**: Transitioned away from branded generics and OTC businesses to concentrate on innovative medicines [2][3] Upcoming Product Launches - **Pipeline**: Eight late-stage assets expected to launch before the end of the decade, with significant potential for revenue generation [5][19] - **Key Products**: - **Oveporexton**: First orexin agonist, expected launch in H2 2026, with peak revenue potential of $2-$3 billion [12][19] - **Rusfertide**: For polycythemia vera, also launching in H2 2026, with potential to transform standard care [13][19] - **Zasocitinib**: TYK2 inhibitor for psoriasis and psoriatic arthritis, with peak revenue potential of $3-$6 billion [18][19] Market Dynamics - **Oveporexton**: Addresses unmet needs in narcolepsy type 1, with a patient population of approximately 100,000 in the U.S. [11][12] - **Rusfertide**: Aims to replace phlebotomy in treatment, with 78% of patients currently uncontrolled [14][19] - **Zasocitinib**: Competes in a mature market, with a focus on creating a new oral treatment option [17][28] Oncology Pipeline - **TAC-928 and TAC-921**: New immuno-oncology assets with promising data, focusing on non-small cell lung cancer and gastric cancer respectively [6][7] - **Market Positioning**: Takeda aims to differentiate its oncology products through unique mechanisms and partnerships, particularly with Innovent in China [44] Leadership Transition - **CEO Transition**: Christophe will retire in June 2026, with Julie Kim set to succeed him, marking a significant leadership change [4][21] Challenges and Future Outlook - **Patent Cliffs**: Anticipated decline in revenue from Entyvio starting in 2030, necessitating successful launches of new products to offset losses [19][20] - **Investment Strategy**: Balancing investment in new product launches with margin commitments, while managing the transition from recent losses [45][46] Conclusion - Takeda is positioned for significant growth through its innovative pipeline and strategic focus on high-potential therapy areas, while navigating challenges related to market competition and patent expirations. The upcoming product launches are critical for sustaining revenue growth and maintaining market leadership.

Core Insights - The development of the biopharmaceutical industry in China and the U.S. appears to have a "time difference," with China experiencing a surge in activity while the U.S. market faces macroeconomic challenges [1][74]. Group 1: Market Trends - In the first three quarters of this year, particularly in the first half, the Chinese biopharmaceutical sector rapidly restored valuations due to a surge in business development (BD) activities, leading to a wave of IPOs in Hong Kong [2][74]. - The Chinese biopharmaceutical sector has seen a year-to-date increase of over 90%, with significant IPOs, including the successful listing of Heng Rui Medicine on the Hong Kong Stock Exchange [33][74]. - In contrast, the U.S. biopharmaceutical sector faced a downturn due to macroeconomic fluctuations, with a rebound occurring only in the fourth quarter as macro risks dissipated and strong earnings from pharmaceutical companies emerged [2][74]. Group 2: Key Issues in the Industry - The core issues affecting the global biopharmaceutical industry include the rise of China as a key player, the obesity epidemic, advancements in AI, the clustering of drug targets, and the emergence of new therapies [36][41][46]. - China has become a significant contributor to global clinical trials, with the proportion of trials initiated in China rising from 5% a decade ago to 30% today, matching the U.S. [37][74]. - The cost advantages in talent acquisition in China are notable, with CEO salaries in Chinese biopharmaceutical companies being significantly lower than their U.S. counterparts, leading to substantial cost savings for companies [39][74]. Group 3: Regulatory and Manufacturing Challenges - The U.S. faces challenges in drug pricing and manufacturing, with a historical trade deficit in pharmaceuticals reaching $140 billion this year and a commitment from the industry to invest $360 billion in domestic manufacturing [4][77]. - The FDA has experienced significant staff turnover, leading to instability and uncertainty in the regulatory environment, although recent statements from the new FDA director indicate a commitment to maintaining high standards for efficacy and safety [4][77]. - Concerns about the NIH budget cuts could adversely affect long-term industry development, particularly in terms of pipeline, talent, and foundational scientific progress [5][78]. Group 4: Financial Performance and Investment Trends - The biopharmaceutical sector's earnings remain robust, with a potential expansion in price-to-earnings ratios as the sector is currently at a 30-year low in valuation multiples [9][82]. - The industry has seen a significant milestone with 3.6 trillion defined daily doses (DDD) administered globally in 2024, indicating unprecedented coverage [12][74]. - The trend of increasing collaboration and partnerships in the industry is evident, with 63% of revenue coming from externally sourced assets, highlighting the importance of business development [16][58].