Rusfertide acetate

OSAKA, Japan--(BUSINESS WIRE)--Takeda (TOKYO:4502/NYSE:TAK) today announced earnings results for the first quarter of fiscal year 2025 (three months ended June 30, 2025), with generic erosion of VYVANSE significantly impacting revenue and Core Operating Profit in line with company expectations for the quarter. The company expects these impacts to moderate in future quarters. Takeda also achieved several important milestones in its R&D pipeline, reinforcing its long-term growth trajectory and underscoring its commitment to delivering sustainable value through innovation. Most notably, both Phase 3 studies of oveporexton successfully met all primary and secondary endpoints, demonstrating statistically significant improvements across doses. These results reinforce the potential of oveporexton to transform the standard of care in narcolepsy type 1. In addition, Takeda received U.S. FDA approval for GAMMAGARD® LIQUID ERC and European Commission (EC) approval for ADCETRIS® in new indications and presented promising clinical data for rusfertide at the 61st American Society of Clinical Oncology (ASCO) Annual Meeting Plenary Session. These developments underscore the strength of Takeda’s late-stage pipeline and its potential to drive future growth. Takeda chief financial officer, Milano Furuta, commented: “The impact of VYVANSE generic erosion on Takeda’s FY2025 Q1 results was very significant, but consistent with our expectations, and there is no change to our full-year outlook announced in May. “Our late-stage pipeline continues to advance with the announcement in July of positive results from two pivotal Phase 3 studies for oveporexton in narcolepsy type 1, with both studies meeting all primary and secondary endpoints. These results represent a significant scientific milestone, and we are very excited about the potential for our late-stage pipeline to deliver value to the patients we serve and to position Takeda for sustainable growth.” FINANCIAL HIGHLIGHTS for FY2025 Q1 Ended June 30, 2025 (Billion yen, except percentages and per share amounts) FY2025 Q1 FY2024 Q1 vs. PRIOR YEAR (Actual % change) Revenue 1,106.7 1,208.0 -8.4% Operating Profit 184.6 166.3 +11.0% Net Profit 124.2 95.2 +30.4% EPS (Yen) 79 61 +30.8% Operating Cash Flow 215.4 170.3 +26.5% Adjusted Free Cash Flow (Non-IFRS) 190.1 23.7 +703.6% Core (Non-IFRS) (Billion yen, except percentages and per share amounts) FY2025 Q1 FY2024 Q1 vs. PRIOR YEAR (Actual % change) vs. PRIOR YEAR (CER % change) Revenue 1,106.7 1,208.0 -8.4% -3.7% Operating Profit 321.8 382.3 -15.8 % -11.9% Margin 29.1% 31.6% -2.6 pp ― Net Profit 237.0 276.8 -14.4% -10.3% EPS (Yen) 151 176 -14.1% -10.0% FY2025 Outlook (unchanged from May 2025) (Billion yen, except percentages and per share amounts) FY2025 FORECAST FY2025 MANAGEMENT GUIDANCE Core Change at CER (Non-IFRS) Revenue 4,530.0 --- Core Revenue (Non-IFRS) 4,530.0 Broadly flat Operating Profit 475.0 --- Core Operating Profit (Non-IFRS) 1,140.0 Broadly flat Net Profit 228.0 --- EPS (Yen) 145 --- Core EPS (Yen) (Non-IFRS) 485 Broadly flat Adjusted Free Cash Flow (Non-IFRS) 750.0-850.0 --- Annual Dividend per Share (Yen) 200 --- Additional Information About Takeda’s FY2025 Q1 Results For more details about Takeda’s FY2025 Q1 results, commercial progress, pipeline updates and other financial information, including key assumptions in the FY2025 forecast and management guidance as well as definitions of non-IFRS measures, please refer to Takeda’s FY2025 Q1 investor presentation (available at https://www.takeda.com/investors/financial-results/quarterly-results/). About Takeda Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com. 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Please refer to slide 6 of Takeda’s FY2025 Q1 investor presentation (available at https://www.takeda.com/investors/financial-results/quarterly-results/) for the definition of Growth & Launch Products.