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].

Core Insights - Takeda Pharmaceutical revised its full-year revenue guidance downward to JPY 4.53 trillion, reflecting a low single-digit decline at constant exchange rates due to stronger-than-anticipated erosion of Vyvanse generics in the U.S. [1][7] - The company maintained its full-year guidance for core operating profit at JPY 1.15 trillion and core EPS at JPY 486, supported by disciplined cost management [1][7] - Takeda reported adjusted free cash flow of JPY 625.9 billion for the period, indicating strong cash generation despite a $1.2 billion upfront payment to Innovent Biologics [2][7] Financial Performance - For the nine-month period, Takeda's revenue was just over JPY 3.4 trillion, down 3.3% year over year (down 2.8% at constant exchange rates) [3] - Core operating profit decreased by 3.4% year over year to JPY 971.6 billion, while reported operating profit rose by 1.2% to JPY 422.4 billion [3] - Core EPS was reported at JPY 428, with reported EPS at JPY 137 [3] Growth Drivers - Growth-and-launch products accounted for over 50% of total revenue, growing 6.7% year to date, driven by Entyvio and vaccines [5][8] - Entyvio experienced a growth of 7.4% at constant exchange rates, attributed to strong third-quarter performance and formulary wins [9] - Qdenga vaccine growth accelerated to 22.1%, primarily driven by demand in Brazil [10] Pipeline Developments - Takeda is preparing for several late-stage product launches, with three key pipeline assets—oveporexton, rusfertide, and zasocitinib—expected to shape future growth [4][11] - Positive phase III readouts for oveporexton and rusfertide have led to NDA filings, with launches planned within the current calendar year [6][11] - Zasocitinib showed significant efficacy in psoriasis treatment, with a summer submission target and a potential launch in 2027 [14] Leadership Transition - CEO Christophe Weber announced his transition from the main presenter role, with Julie Kim set to take over leadership in June [17]

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 [11] - Core Operating Profit was JPY 971.6 billion, a year-on-year decrease of 3.4% at both actual effects and constant exchange rate [11] - Reported operating profit was JPY 422.4 billion, an increase of 1.2% [12] - Core EPS was JPY 428, and reported EPS was JPY 137 [12] - Adjusted free cash flow was JPY 625.9 billion, even after a $1.2 billion upfront payment to Innovent Biologics [12] 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 [12] - 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][13] - Takhzyro in rare diseases slowed to 2.4% growth at constant exchange rate, impacted by new competing products in the U.S. [13] - Immunoglobulin growth was 4.3% year to date, driven by subcutaneous IG products [14] - Qdenga growth accelerated to 22.1%, primarily driven by Brazil [14] Market Data and Key Metrics Changes - Entyvio Pen is now on the formulary with all three large pharmacy benefit managers, achieving commercial coverage of more than 80% [13] - The impact of Medicare Part D redesign in the U.S. has affected IVIG sales, which are expected to normalize in Q4 [14] - Albumin growth returned to 1.3%, slower than expected due to softening demand in China [14] Company Strategy and Development Direction - The company is preparing for significant new product launches, focusing on oveporexton, rusfertide, and zasocitinib, expected to launch over the next 18 months [6][9] - The late-stage pipeline includes eight programs with the potential to transform the standard of care [10] - The company is committed to maintaining operational efficiency while investing in R&D for future growth [17] 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 [18] - The company maintains full-year guidance for core operating profit and core EPS, emphasizing cost discipline [18] - Management expressed confidence in the potential of new product launches to drive future growth despite current challenges [20][41] Other Important Information - This earnings call marked Christophe Weber's last as a main presenter, with Julie Kim set to take over as CEO [29] - The company is undergoing organizational changes to enhance competitiveness and speed in preparation for multiple launches [31][55] 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] - The company aims to maintain a progressive dividend policy, evaluating core EPS and cash flow to decide on potential increases [42] Question: Zasocitinib phase II outcomes and safety data - Data from UC and Crohn's disease phase II studies are expected this year, with ongoing studies assessing higher doses for efficacy [44][46] Question: Impact of MFN and organizational changes - Management does not support MFN, emphasizing that price controls could hinder future innovation [53] - Organizational changes focus on enhancing U.S. marketing and maintaining a strong oncology business unit [55] Question: Entyvio sales trends and IRA impact - Q3 sales performance was strong, with improved coverage in the U.S. [60] - The company is preparing for potential price negotiations under the IRA, with uncertainty regarding the extent of price cuts [62][63] Question: Takhzyro growth and competitive impact - Takhzyro continues to be the gold standard for HAE patients, but recent competitive entrants have impacted new starts [67] - Long-term efficacy data supports Takhzyro's market position despite current challenges [68]

Core Insights - Alkermes is set to acquire Avadel Pharmaceuticals for $18.50 per share, totaling approximately $2.1 billion, which includes a potential additional payment of $1.50 per share contingent on FDA approval for Lumryz by 2028 [2][3] - The acquisition aims to enhance Alkermes' position in the sleep medicine market, particularly with the launch of its own drug, alixorexton, which targets narcolepsy [4][5] - Analysts view Alkermes as the second player in the narcolepsy drug market, following Takeda Pharmaceutical, which is advancing its own drug, oveporexton, with projected annual sales of $3 billion [6] Company Strategy - The acquisition of Avadel is seen as a strategic move to accelerate Alkermes' entry into the sleep medicine market at a critical time [4] - Avadel's existing commercial infrastructure is expected to support the launch of alixorexton, providing operational efficiencies and potential cost synergies [7] Market Context - Lumryz, Avadel's main asset, is approved for treating excessive daytime sleepiness and cataplexy, with a market potential similar to Xyrem, which peaked at nearly $2 billion in annual sales [2][3] - The U.S. narcolepsy patient population is estimated to be between 100,000 and 200,000, indicating a significant market opportunity for sleep-related medications [5]