Takeda Announces FY2026 First Quarter Results, Near-Term Launch Preparations and Pipeline Progress on Track

Takeda (TOKYO:4502/NYSE:TAK) announced financial results for the first quarter of fiscal year 2026 (April 1, 2026 to June 30, 2026), marking a period of disciplined execution and operational momentum. Takeda leveraged the resilient performance of its core in-line portfolio to support its long-term strategy, advancing commercial launch preparations and driving critical R&D pipeline milestones. With a clear operational trajectory established in the first quarter and under a new operating model, Takeda remains on track to deliver its strategic and financial commitments for the fiscal year.

FY2026 First Quarter Highlights

• Revenue increased by +10.2% versus the prior-year period on an actual exchange rate (AER) basis and decreased by -0.5% on a Constant Exchange Rate (CER) basis as the negative impact of the loss of exclusivity of VYVANSE® was largely offset by growth from core in-line brands.
• Core Operating Profit increased by +11.5% on an AER basis and decreased by -0.5% on a CER basis, reflecting continued growth investments supported by the transformation program.
• Reported Operating Profit increased by +9.1% on an AER basis.
• Core EPS increased by +1.5% at AER and decreased by -11.8% at CER, while Reported EPS decreased by -9.8% YoY.
• Adjusted Free Cash Flow amounted to JPY 68.6 billion.
• Launch preparations for key late-stage pipeline assets (ORZEYFUL, rusfertide and zasocitinib) are progressing on schedule, with the first approval for ORZEYFUL achieved in China.
• FY2026 full-year outlook remains unchanged.
• A Capital Markets Day will be held on December 11, 2026, in Tokyo, Japan.

Takeda President and Chief Executive Officer, Julie Kim, commented:
“Our solid performance this quarter marks a good start to the fiscal year and keeps us on track to achieve our full-year targets.

“This quarter’s results reflect our unwavering commitment to financial discipline and the progressing execution of our enterprise transformation. The efficiencies unlocked by this ongoing program are directly fueling our highest priorities in Horizon One in our two-horizon growth strategy: the successful launch of three medicines that have the potential to be blockbuster brands, the advancement of our late-stage pipeline, the enduring resilience of our core in-line portfolio and new capabilities and efficiencies gained through transformation. We look forward to sharing the detailed strategic roadmap for these two growth horizons at our Capital Markets Day in December.”

Takeda Chief Financial Officer, Milano Furuta, commented:
“Our first-quarter performance is tracking consistently with management guidance, with the resilience of our core in-line brands largely offsetting our mature portfolio decline, and OPEX savings through the transformation program being strategically reinvested to fund future growth opportunities. Our full-year forecast and guidance remain unchanged.”

FINANCIAL HIGHLIGHTS for First Quarter Results ended June 30, 2026

Pipeline Progress Building the Foundation for Future Growth
Takeda’s next-generation growth engine is anchored by three, high-potential, late-stage pipeline assets expected to obtain regulatory approvals in the U.S. and other key regions in the coming year. While this represents a pivotal period of strategic investment and commercial launch execution, Takeda is positioned to deliver tangible milestones over the next 12 to 24 months. By establishing a track record of launch excellence today, Takeda is securing the foundation that will underpin the Company’s sustained, long-term growth and meaningful impact for patients globally.

ORZEYFUL

• An orexin receptor agonist with a first-in-class mechanism of action, designed to address the orexin deficiency that causes narcolepsy type 1 (NT1).
• The first approval of oveporexton was recently granted in China under the brand name ORZEYFUL.
• New drug applications are currently under review in the United States and Japan.
• Preparations for the expected launches in the U.S., Japan and China in the second half of the year are well underway.
• At SLEEP 2026, Takeda presented Phase 3 clinical trial results for ORZEYFUL demonstrating improvements in daily functioning, cognition and nighttime sleep in patients with narcolepsy type 1.

Rusfertide

• A potential first-in-class hepcidin mimetic for the treatment of adults with the blood cancer polycythemia vera (PV).
• Demonstrated significant improvements in hematocrit control and phlebotomy reduction for patients with PV in a Phase 3 clinical trial.
• Granted Priority Review by the U.S. FDA, Takeda is prepared for a commercial U.S. launch expected in the second half of 2026.

Zasocitinib

• A next generation, highly selective and potent TYK2 inhibitor that has demonstrated rapid, durable skin clearance in a convenient once-daily oral pill with no fasting restrictions.
• Achieved positive topline results across the primary endpoint and all key secondary endpoints in a head-to-head Phase 3 clinical trial against deucravacitinib.
• Achieved consistent, high rates of skin clearance across the body, including hard-to-treat and high-impact sites in Phase 3 psoriasis studies.
• Takeda is making the necessary investments with a view toward regulatory submissions in 2026 and a commercial launch anticipated in the first half of 2027.

Capital Allocation and Shareholder Returns
Takeda maintains a disciplined capital allocation framework that prioritizes investments in new launches and R&D innovation with the goal of driving growth and enabling the company to deliver returns to shareholders under its progressive dividend policy. The annual dividend forecast for FY2026 is JPY 204 per share.

Additional Information Regarding FY2026 First Quarter Results
Takeda will host a conference call for investors and analysts on Thursday, July 30, 2026, at 19:00 Japan Time / 6:00 U.S. Eastern Time to discuss its FY2026 first quarter results.

A live webcast of the conference call and the presentation materials will be available in the Investor Relations section of Takeda’s website (www.takeda.com/investors). The presentation materials include details on Takeda’s FY2026 first quarter results, business progress and pipeline updates, as well as definitions of non-IFRS measures.

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 https://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 FY2026 Q1 investor presentation (available at www.takeda.com/investors).

Medical Information

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