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

Revenue Decline of 3.7% at Constant Exchange Rate (CER); 8.4% Decline at Actual Exchange Rates (AER) as VYVANSE Generic Erosion Impacts Revenue in Line With Company Expectations
Core Operating Profit Decline of 11.9% at CER, Primarily Reflecting Generic Erosion
Reported Operating Profit Increase of 11.0% at AER, Reflecting Lower YoY Impairment and Restructuring Expenses
Positive Results from Two Pivotal Phase 3 Studies of Oveporexton in Narcolepsy Type 1 Reinforce Continued Momentum in Late-Stage Pipeline
No Change to Full-Year Outlook Announced in May

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.”

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.

Important Notice
For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this press release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “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 identifying the particular company or companies.

The product names appearing in this document are trademarks or registered trademarks owned by Takeda, or their respective owners.

Forward-Looking Statements
This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects”, “forecasts”, “outlook” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States and with respect to international trade relations; competitive pressures and developments; changes to applicable laws and regulations, including tax, tariff and other trade-related rules; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic; the success of our environmental sustainability efforts, in enabling us to reduce our greenhouse gas emissions or meet our other environmental goals; the extent to which our efforts to increase efficiency, productivity or cost-savings, such as the integration of digital technologies, including artificial intelligence, in our business or other initiatives to restructure our operations will lead to the expected benefits; and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings-and-security-reports/or at www.sec.gov.Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

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
This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

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.

Contacts

Investor Relations
Christopher O’Reilly
Christopher.oreilly@takeda.com
+81 (0) 90-6481-3412

Media Relations
Brendan Jennings
Brendan.jennings@takeda.com
+81 (0) 80-2705-8259
(Outside Japan business hours)
Media_Relations@takeda.com