Takeda Announces First-Quarter FY2025 Results With Significant Late-Stage Pipeline Progression

(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.”

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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Financial information and Non-IFRS Measures
Takeda’s financial statements are prepared in accordance with International Financial Reporting Standards (“IFRS”).

This press release and materials distributed in connection with this press release include certain financial measures not presented in accordance with IFRS, such as Core Revenue, Core Operating Profit, Core Net Profit for the year attributable to owners of the Company, Core EPS, Constant Exchange Rate (“CER”) change, Net Debt, Adjusted Net Debt, EBITDA, Adjusted EBITDA, Free Cash Flow and Adjusted Free Cash Flow. Takeda’s management evaluates results and makes operating and investment decisions using both IFRS and non-IFRS measures included in this press release. These non-IFRS measures exclude certain income, cost and cash flow items which are included in, or are calculated differently from, the most closely comparable measures presented in accordance with IFRS. Takeda’s non-IFRS measures are not prepared in accordance with IFRS and such non-IFRS measures should be considered a supplement to, and not a substitute for, measures prepared in accordance with IFRS (which we sometimes refer to as “reported” measures). Investors are encouraged to review the definitions and reconciliations of non-IFRS measures to their most directly comparable IFRS measures, which are in the Financial Appendix appearing at the end of our FY2025 Q1 investor presentation (available at www.takeda.com/investors).

Peak Sales and PTRS Estimates
References in this press release to peak revenue potential ranges are estimates that have not been adjusted for probability of technical and regulatory success (PTRS) and should not be considered a forecast or target. These peak revenue potential ranges represent Takeda’s assessments of various possible future commercial scenarios that may or may not occur.

References in this press release to PTRS are to internal estimates of Takeda regarding the likelihood of obtaining regulatory approval for a particular product in a particular indication. These estimates reflect the subjective judgment of responsible Takeda personnel and have been approved by Takeda’s Portfolio Review Committee for use in internal planning.

Medical information
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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.

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