Investment Rating - The report maintains a positive outlook on Takeda Pharmaceutical, indicating that there is more potential to be unlocked in the future [3][4]. Core Insights - Takeda reported a 4.2% year-on-year revenue growth for Q3 FY2026, aligning with market expectations. Net profit surged by 335.7% due to improved profit margins and reduced non-operating costs, exceeding market forecasts [4]. - The company anticipates multiple late-stage pipeline products to be launched starting in FY2026, including Zasocitinib, which has shown competitive results in clinical trials for moderate to severe plaque psoriasis [5][6]. - The strong performance of Entyvio, with an 18% increase in sales to 265 billion yen, was noted, although the decline in Vyvanse sales by 42% partially offset this growth [4]. Summary by Sections Financial Performance - For Q3 FY2026, Takeda's revenue reached 1.192 trillion yen, a 4.2% increase year-on-year, with net profit rising to 104 billion yen, a 335.7% increase [4]. - The company maintained its full-year guidance for FY2026 despite fluctuations in product sales [4]. Pipeline Developments - Takeda's late-stage assets, including Zasocitinib and Dacomitinib, are expected to be submitted for new drug applications in FY2027, with promising clinical trial results reported [5][6]. - The company has also submitted a new drug application for rusfertide and plans to enter the application phase for oveporexton shortly [5]. Market Position - Takeda operates in various therapeutic areas, including gastroenterology, rare diseases, plasma-derived therapies, oncology, and neuroscience [8]. - The company’s revenue distribution shows that 29.6% comes from gastroenterology, 22.5% from plasma-derived therapies, and 16.4% from rare blood diseases, with significant contributions from the Americas [10].

Financial Data and Key Metrics Changes - Revenue for the nine-month period was just over JPY 3.4 trillion, a decrease of 3.3% or -2.8% at constant exchange rate [10] - Core Operating Profit was JPY 971.6 billion, a year-on-year decrease of 3.4% at both actual effects and constant exchange rate [10] - Reported operating profit was JPY 422.4 billion, an increase of 1.2% [11] - Core EPS was JPY 428, and reported EPS was JPY 137 [11] - Adjusted free cash flow was JPY 625.9 billion, even after a $1.2 billion upfront payment to Innovent Biologics [11] Business Line Data and Key Metrics Changes - Growth and launch products represented over 50% of total revenue and grew 6.7% at constant exchange rate [11] - In GI, Entyvio grew 7.4% at constant exchange rate, with strong growth in Q3 due to a one-time gross-to-net drop [12] - Rare diseases product Takhzyro slowed to 2.4% growth at constant exchange rate, impacted by new competing products in the US [12] - Immunoglobulin growth was 4.3% year to date, driven by subcutaneous IG products [13] - Qdenga growth accelerated to 22.1%, primarily driven by Brazil [13] Market Data and Key Metrics Changes - Entyvio Pen is now on formulary with all three large pharmacy benefit managers, achieving commercial coverage of more than 80% [12] - Takhzyro's growth is being offset by new competitors and the impact of Medicare Part D redesign in the U.S. [13] - Albumin has returned to growth of 1.3%, but slower than expected due to softening demand in China [13] Company Strategy and Development Direction - The company is preparing for significant new product launches, focusing on Oveporexin, rusfertide, and zasocitinib, expected to launch over the next 18 months [5][6] - The late-stage pipeline includes eight programs with potential to transform the standard of care [8] - The company is committed to maintaining operational efficiency while investing in R&D for future growth [15] Management's Comments on Operating Environment and Future Outlook - Management revised revenue guidance to low single-digit decline at constant exchange rate due to stronger than anticipated Vyvanse generic erosion [16] - The company maintains full-year guidance for core operating profit and core EPS [16] - Management emphasized the importance of cost discipline while preparing for new product launches [15] Other Important Information - The transition of leadership to Julie Kim, CEO-elect, is underway, with operational responsibilities being handed over [28][30] - The company is focusing on simplifying processes and adopting advanced technologies [31] Q&A Session Summary Question: Thoughts on next fiscal year and dividend policy - Management indicated it is too early to provide guidance for the next fiscal year, with the budget being finalized [39] - Emphasis on maintaining a progressive dividend policy, with decisions based on core EPS and cash flow [43] Question: Zasocitinib phase 2 outcomes and safety data - Data from UC and Crohn's disease phase 2 studies expected this year, with ongoing studies on dosing [45] - Safety profile consistent with previous studies, with more data to be presented at an upcoming medical conference [46] Question: Impact of MFN on U.S. policy - Management does not support MFN, emphasizing that price controls could impact future innovation [52] - Organizational changes aim to enhance competitiveness and speed in U.S. marketing [54] Question: Entyvio sales performance and IRA impact - Q3 sales were robust, with improved coverage in the U.S. [59] - Anticipation of price negotiations under IRA, with uncertainty on the extent of potential price cuts [61] Question: Takhzyro growth trends and competitive impact - Takhzyro remains the gold standard, but growth is impacted by new competitors and Medicare Part D redesign [66] - Long-term efficacy data supports Takhzyro's position in the market [66] Question: PDT clinical progress and outlook - Demand slowdown noted, particularly in albumin due to regulatory changes in China [81] - Overall outlook for PDT remains mid-single-digit growth for the year [81] Question: Zasocitinib phase III data presentation - Presentation at AAD is a possibility, with focus on fast onset of action and clear skin [87] - Competitive advantages include ease of administration and strong safety profile [88]

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 ...

Investment Rating - The report maintains a "Buy" rating for the pharmaceutical and biotechnology sector [1] Core Insights - The oral treatment landscape for psoriasis has established a dual leadership pattern with TYK2 and IL23 inhibitors, highlighting the potential of companies like Yifang Biopharma, Nocankang, and Haishike [1][16] - The A-share pharmaceutical index has shown a year-to-date increase of 14.49%, while the Hang Seng Healthcare Index has surged by 65.28% [4][9] - The report emphasizes the importance of innovative drugs, with a ranking of preferred sub-industries: innovative drugs > research services > CXO > traditional Chinese medicine > medical devices > pharmacies [10][12] Industry Trends - The report notes that the A-share pharmaceutical index has underperformed relative to the CSI 300 index, with a slight decrease of 0.14% this week [4][9] - The report highlights the strong performance of the medical commercial sector (+4.94%) and medical devices (+1.16%) this week, while the chemical pharmaceuticals sector saw a decline of -1.74% [4][9] - The report identifies key companies to watch in the TYK2 space, including Yifang Biopharma and Nocankang, as well as those involved in oral IL23 treatments like Haishike [16][12] Company-Specific Recommendations - Recommended companies in the innovative drug sector include: - Yifang Biopharma - Nocankang - Haishike - Heng Rui Medicine - Bai Jie Shen Zhou - Shi Yao Group - Zai Jian Medicine - Di Zhe Medicine [12][16] - In the CXO and research services sector, recommended companies include: - WuXi AppTec - Hao Yuan Medicine - Aopumai - Kingsray Biotech [12] - For traditional Chinese medicine, companies to focus on include: - Zuo Li Pharmaceutical - Fang Sheng Pharmaceutical - Dong E E Jiao [12] Market Performance - The report indicates that the A-share pharmaceutical index has shown a year-to-date increase of 14.49%, while the Hang Seng Healthcare Index has increased by 65.28% [4][9] - The report also notes that the medical commercial sector has performed well this week, with a gain of 4.94% [4][9]

Investment Rating - The report suggests a positive investment outlook for the innovative drug sector and anticipates a reversal of challenges in the left-side sectors, identifying them as the biggest investment opportunities in the pharmaceutical sector for 2025 [4]. Core Insights - The launch of the Ant Group's AI health application "Antifufu" has significantly increased attention on the medical AI theme, addressing previous issues in internet healthcare such as low user engagement and limited access to quality medical resources [1][12]. - Takeda's TYK2 inhibitor Zasocitinib has successfully met all primary and secondary endpoints in its Phase III clinical trials for moderate to severe plaque psoriasis, with over 50% of patients achieving PASI 90 and approximately 30% achieving PASI 100 by week 16 [2][44]. - The report highlights the successful results of Eli Lilly's orforglipron in maintaining weight loss over 52 weeks, indicating its potential to extend the usage cycle of GLP-1 medications [2][46]. Summary by Sections AI Medical Applications - The Antifufu app has upgraded its features to include health companionship, health Q&A, and health services, effectively increasing user engagement and linking patients with medications and services [1][12]. - The platform connects with 5,000 hospitals and 300,000 real doctors, democratizing access to quality medical resources [1][12]. Pharmaceutical Sector - Takeda's Zasocitinib has shown promising results in clinical trials, with plans to submit a new drug application to the FDA and other regulatory bodies by the 2026 fiscal year [2][44]. - The report emphasizes the potential of innovative drugs, particularly dual/multi-antibody drugs and those addressing unmet clinical needs in chronic diseases, as key investment opportunities [4]. Biologics - Eli Lilly's orforglipron has demonstrated superior weight maintenance compared to placebo, suggesting a promising future for GLP-1 drugs [2][46][48]. Medical Devices - The domestic continuous glucose monitoring (CGM) market is expected to expand, driven by rapid product iterations and improvements in quality and patient acceptance [3]. Retail Pharmacy - The report notes that leading companies in the pharmacy sector are likely to increase market share through mergers and acquisitions during the industry consolidation phase [3]. Medical Services and Consumer Healthcare - The AI medical market is being validated as a scalable business model, with ongoing developments in AI healthcare applications [3][4]. Key Investment Targets - The report identifies several key companies for investment consideration, including Innovent Biologics, Kintor Pharmaceutical, and others in the pharmaceutical and healthcare sectors [5].

Market Overview - The A-share market showed a high-level fluctuation with the Shanghai Composite Index rising by 0.36%, the Shenzhen Component Index increasing by 0.66%, and the ChiNext Index up by 0.49% [1][13] - The total trading volume in the Shanghai and Shenzhen markets reached 1.73 trillion yuan, an increase of 704 billion yuan compared to the previous trading day, with over 4,400 stocks rising [1][13] - The Hong Kong market also saw gains, with the Hang Seng Index up by 0.75% and the Hang Seng Technology Index rising by 1.12% [1][13] Sector Performance - Main capital inflows were observed in sectors such as general equipment, automotive, and retail, while there were outflows from semiconductor, aerospace, and electronics sectors [2][14] - The consumer sector experienced a surge, particularly in retail and duty-free shops, while sectors like Hainan Free Trade Zone, nuclear fusion, rare earth permanent magnets, cross-strait integration, and intelligent driving concepts were active [2][14] Economic Data and Policy Impact - The U.S. inflation data for November showed a significant drop, with the overall CPI year-on-year falling to 2.74%, below the expected 3.06%, which has raised questions about data accuracy due to the government shutdown affecting previous data [3][15] - The Bank of Japan raised its target interest rate by 25 basis points to 0.75%, marking a 30-year high, which aligns with market expectations for ongoing monetary policy normalization [3][15] Innovation Drug Sector - The innovation drug sector is rebounding due to several catalysts, including a recovery in valuation after months of correction and upcoming key clinical data disclosures at the ASCO annual meeting in May 2026 [4][17] - The sector is entering a commercialization phase, with policy support extending from process optimization to full-chain empowerment, enhancing competitiveness [4][17] Hong Kong Technology Sector - The Hong Kong technology market has faced short-term pressure but is expected to rebound, with potential for capital inflows post-Christmas [6][18] - The market anticipates a recovery in January, although the extent of the rebound may be limited [6][18] Commodity Sector - The commodity sector, particularly non-ferrous metals, is performing well due to multiple factors, including a slowdown in U.S. CPI data, which has raised expectations for liquidity easing and supported metal prices [8][20] - The easing of rare earth export controls and a balanced supply-demand situation in industrial metals are also contributing to the sector's strength [8][20] Investment Opportunities - Investors are encouraged to consider ETFs focused on innovation drugs, Hong Kong technology, and commodities, as these sectors show potential for growth and recovery [4][21][22]

Core Insights - Takeda's Zasocitinib shows promising results in Phase 3 trials for treating plaque psoriasis, indicating potential for a new treatment era with a once-daily pill format [1] Group 1: Clinical Data - The Phase 3 trial data for Zasocitinib demonstrates significant efficacy in achieving clear skin for patients with plaque psoriasis [1] - The treatment is designed to be taken once daily, enhancing patient compliance and convenience [1] Group 2: Market Implications - The successful results from the trial could position Takeda as a leader in the psoriasis treatment market, potentially increasing market share [1] - The introduction of Zasocitinib may catalyze a shift in treatment paradigms for plaque psoriasis, influencing future drug development strategies [1]

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].

Investment Rating - The industry investment rating is "Outperform" [1] Core Viewpoints - The global market for Inflammatory Bowel Disease (IBD) drugs is expected to reach $37 billion by 2030, with major pharmaceutical companies investing in this area [4][26] - There is a significant unmet clinical need for new therapies due to the complexity of IBD mechanisms and the high percentage of patients who do not respond to initial treatments [4][18] - The report emphasizes the importance of new targets and mechanisms in drug development, particularly focusing on TL1A, which has garnered interest from multiple multinational corporations (MNCs) [4][32] Summary by Sections IBD Treatment Overview - IBD includes Ulcerative Colitis (UC) and Crohn's Disease (CD), affecting over 3 million patients in the US and Europe, with no current cure available [4][10] - The market for IBD drugs is projected to grow at a compound annual growth rate (CAGR) of 5.88% from $23.26 billion in 2022 to $37 billion by 2030 [26][29] Market Dynamics - The sales proportion of TNF inhibitors is declining, while IL-23 inhibitors and JAK inhibitors are increasing in sales [4][29] - Ustekinumab is expected to contribute approximately $7.8 billion to the market by 2024, while Vedolizumab is projected to reach $6.107 billion [4][29] Clinical Needs and Drug Development - There is a pressing need for new therapies as up to 30% of patients do not respond to initial treatments, and 40% lose response over time [4][18] - The report suggests focusing on new targets and mechanisms, including companies like Abivax, Chenxin Pharmaceutical, and others for potential investment opportunities [4][32] Long-term Investment Strategy - The report recommends a strategic focus on leading innovative drug companies and those involved in the development of new therapies for IBD, highlighting companies such as Innovent Biologics, BeiGene, and others [4][32] - The report also notes the potential for significant market transactions in the IBD space, with several deals exceeding $5 billion in value [4][30]

Core Insights - The article highlights the long-term value of Yifang Biotech, a leading domestic small molecule drug development company, focusing on high-barrier targeted therapies in oncology, autoimmune diseases, and metabolism [1][2]. Group 1: Product Pipeline and Approvals - As of March 2025, the company has two drugs approved for market: the third-generation EGFR-TKI, Befotnib, and the KRAS G12C inhibitor, Gsorese [1]. - Befotnib is the fourth approved third-generation EGFR-TKI in China, indicated for EGFR mutation-positive NSCLC in 1st and 2nd line treatments, with mPFS of 22.1 months, significantly extending the duration compared to the control group [1][2]. - Gsorese is the second KRAS G12C inhibitor in China, expected to be approved in November 2024 for treating KRAS G12C mutation NSCLC patients, with an ORR of 52% and DCR of 88.6% in Phase II trials [2]. Group 2: Strategic Collaborations - The company has partnered with Betta Pharmaceuticals for the commercialization of Befotnib, leveraging Betta's established operational and sales capabilities to enhance market penetration [1]. - An exclusive licensing agreement was signed with Zhengda Tianqing for Gsorese, which may accelerate its growth potential in the market [2]. Group 3: Research and Development Potential - The company is advancing several promising candidates, including the oral TYK2 inhibitor D-2570, which has shown strong efficacy in treating moderate to severe plaque psoriasis with a PASI75 response rate of 85.0%-90.0% [2][3]. - The oral SERD D-0502 for HR+/HER2- breast cancer is in critical Phase III clinical trials, indicating its potential to be a best-in-class (BIC) therapy [3]. - The URAT1 inhibitor D-0120 for hyperuricemia and gout has completed Phase IIb clinical trials, showcasing its promising drug development potential [3]. Group 4: Financial Projections - The company forecasts revenues of 191 million yuan, 255 million yuan, and 399 million yuan for the years 2025, 2026, and 2027, respectively, indicating a positive growth trajectory [3].