Takeda Reports Third-Quarter FY2025 Results: Updates Full Year Outlook to Reflect VYVANSE® Generics Impact, OPEX Discipline and FX Tailwind; Progressing Toward Three Transformative Launches Ahead

Key Terms

new drug applications (ndas) regulatory

A New Drug Application (NDA) is a formal request submitted to a drug regulator asking for permission to market a new medicine after clinical testing, including data on safety, effectiveness, manufacturing, and labeling. Investors watch NDAs like a building permit because approval clears the way for sales and revenue growth, while rejection or delays can sharply affect a company’s future earnings and stock value.

non-ifrs financial

Non-IFRS refers to financial measures that companies report outside the standard accounting rules set by the International Financial Reporting Standards; these figures exclude or adjust certain items such as one-time costs, stock-based pay, or restructuring charges. Investors care because non-IFRS numbers try to show the business’s underlying performance — like a chef presenting a dish with optional toppings removed to highlight the core flavor — but they can be shaped to look more favorable, so compare them with the official IFRS statements.

phase 3 medical

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

core operating profit financial

Core operating profit is the company's profit from its normal day-to-day business activities after removing one-time items, unusual gains or losses, and financing or tax effects. Investors use it like a household budget that strips out unexpected windfalls or repairs: it shows the steady earnings power of the business and helps compare performance across periods or with peers without distortion from rare or non‑operational events.

• Year-to-Date Revenue Declined by 2.8% at Constant Exchange Rate (CER), 3.3% at Actual Exchange Rates (AER); Impact of VYVANSE^® Generics is Tapering Off
• Core Operating Profit Declined by 3.4% at both CER and AER Year to Date
• Reported Operating Profit Increased by 1.2% at AER Year to Date, Lower Restructuring Expenses More Than Offset Impairment

 

OSAKA, Japan--(BUSINESS WIRE)-- Takeda (TOKYO:4502/NYSE:TAK) today announced earnings results for the third quarter of fiscal year 2025 (nine months ended December 31, 2025). The gap between incremental Growth & Launch Products revenue and VYVANSE erosion is narrowing, and operational efficiencies drove year-on-year reductions in operating expenses, including R&D. The company raised its full-year forecasts based on cost discipline and FX tailwind, while its Revenue Management Guidance has been updated primarily due to the impact of VYVANSE generics.

Takeda is positioned for long-term growth and has multiple late-stage programs with multibillion-dollar peak revenue potential. Following the positive readouts from Phase 3 studies in 2025, the company has submitted New Drug Applications (NDAs) for oveporexton and rusfertide and is on track to file an NDA for zasocitinib. Each of these programs, which Takeda expects to launch within the next 18 months, has the potential to redefine standards of care, transform patient lives and contribute to Takeda's new growth trajectory.

Takeda chief financial officer, Milano Furuta, commented:
“While we manage the impact of VYVANSE generics, we are implementing disciplined cost management and improving operational efficiency and therefore expect to achieve the previously disclosed Management Guidance for Core Operating Profit.

“FY2025 remains a truly pivotal year for Takeda as we are in a phase of preparing for significant new product launches. Looking ahead, with multiple innovative launches and a robust late-stage pipeline, Takeda is positioned to bring life-transforming medicines that improve patient lives and deliver long-term shareholder value.”

FINANCIAL HIGHLIGHTS for FY2025 Q3 YTD Ended December 31, 2025

(Billion yen, except percentages and per share amounts)
Item	FY2025 Q3 YTD	FY2024 Q3 YTD	vs. PRIOR YEAR (Actual % change)
Revenue	3,411.2	3,528.2	-3.3%
Operating Profit	422.4	417.5	+1.2%
Net Profit	216.1	211.1	+2.4%
EPS (Yen)	137	134	+2.7%
Operating Cash Flow	966.9	835.0	+15.8%
Adjusted Free Cash Flow (Non-IFRS)	625.9	568.3	+10.1%

Core (Non-IFRS)
(Billion yen, except percentages and per share amounts)
Item	FY2025 Q3 YTD	FY2024 Q3 YTD	vs. PRIOR YEAR (Actual % change)	vs. PRIOR YEAR (CER % change)
Revenue	3,411.2	3,528.2	-3.3%	-2.8%
Operating Profit	971.6	1,006.3	-3.4%	-3.4%
Margin	28.5%	28.5%	-0.0 pp	―
Net Profit	673.6	698.9	-3.6%	-3.4%
EPS (Yen)	428	443	-3.3%	-3.1%

FY2025 Outlook
Updating Full Year Management Guidance for Revenue and Forecasts
Takeda has updated its full year Management Guidance for Revenue primarily due to VYVANSE and raised full year forecasts to reflect cost discipline and FX tailwind.
FY2025 Management Guidance Core Change at CER (Non-IFRS)
Item	FY2025 PREVIOUS MANAGEMENT GUIDANCE (October 2025)	FY2025 REVISED MANAGEMENT GUIDANCE (January 2026)
Core Revenue	Broadly flat	Low-single-digit % decline
Core Operating Profit	Low-single-digit % decline	Low-single-digit % decline
Core EPS	Low-single-digit % decline	Low-single-digit % decline

FY2025 Reported and Core Forecasts
(Billion yen, except percentages and per share amounts)
Item	FY2025 PREVIOUS FORECAST (October 2025)	FY2025 REVISED FORECAST (January 2026)
Revenue	4,500.0	4,530.0
Core Revenue (Non-IFRS)	4,500.0	4,530.0
Operating Profit	400.0	410.0
Core Operating Profit (Non-IFRS)	1,130.0	1,150.0
Net Profit	153.0	154.0
EPS (Yen)	97	98
Core EPS (Yen) (Non-IFRS)	479	486
Adjusted Free Cash Flow (Non-IFRS)	600.0-700.0	650.0-750.0
Annual Dividend per Share (Yen)	200	200

Additional Information About Takeda’s FY2025 Q3 Results
For more details about Takeda’s FY2025 Q3 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 Q3 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 Q3 investor presentation (available at www.takeda.com/investors).

Peak Revenue Potential and PTRS Estimates
References in this press release to peak revenue 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 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.

U.S. Dollar Convenience Translations
In this press release, certain amounts presented in Japanese yen have been translated to U.S. dollars solely for the convenience of the reader. Except where otherwise noted, these convenience translations have been made at an exchange rate of 1USD = 156.80 JPY, the Noon Buying Rate certified by the Federal Reserve Bank of New York on December 31, 2025. The rate and methodologies used for these convenience translations differ from the currency exchange rates and translation methodologies under IFRS used for the preparation of Takeda’s consolidated financial statements. These translations should not be construed as a representation that the Japanese yen amounts could be converted into U.S. dollars at this or any other rate.

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 7 of Takeda’s FY2025 Q3 investor presentation (available at https://www.takeda.com/investors/financial-results/quarterly-results/) for the definition of Growth & Launch Products.

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Source: Takeda Pharmaceutical Company Limited