Takeda Announces FY2026 First-Half Results Highlighting Launch Momentum and Pipeline Milestones

Currency benefits lifted the full-year forecast, while first-half operating cash flow fell 27.2%.

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• ORZEYFUL^TM approved in the U.S., Japan and China for narcolepsy type 1 (NT1), MIMRYLO^TM launched in the U.S. for erythrocytosis in polycythemia vera (PV)
• Zasocitinib advances to U.S. Food & Drug Administration (FDA) Priority Review and European Medicines Agency (EMA) review
• Late-stage pipeline continues to advance
• FY2026 full-year outlook upgraded to reflect foreign exchange (FX) benefit
• Takeda will host a Capital Markets Day on Dec. 11, 2026, in Tokyo, Japan

OSAKA, Japan--(BUSINESS WIRE)-- Takeda (TOKYO:4502/NYSE:TAK) announced financial results for the first half of fiscal year 2026 (April 1, 2026, to Sept. 30, 2026). The period included the approval of ORZEYFUL (oveporexton) in the U.S., Japan and China, the U.S. launch of MIMRYLO (rusfertide), progress in the regulatory review of zasocitinib, and additional clinical evidence across the late-stage pipeline. Takeda’s focus remains on execution against the first horizon of its growth strategy: successfully launching three new medicines, advancing its late-stage pipeline, ensuring resilience of core in-line brands and executing its transformation program.

FY2026 First-Half Highlights

• Revenue increased by 8.4% versus the prior period on an actual exchange rates (AER) basis and decreased by 1.0% at constant exchange rates (CER).
• Core Operating Profit increased by 11.2% on an AER basis, and increased by 0.7% on a CER basis, supported by enterprise-wide transformation, which is helping fund growth investments.
• Reported Operating Profit increased by 60.4% on an AER basis reflecting the end of the amortization period for VYVANSE® intangible assets and lower impairment charges.
• Core EPS was 308 JPY, an increase of 10.5% at AER and decrease of 1.2% at CER. Reported EPS was 193 JPY, an increase of 169.0% at AER.
• Adjusted Free Cash Flow was JPY 325.7 billion.
• ORZEYFUL’s approvals in the U.S., Japan and China, together with the U.S. launch of MIMRYLO, mark significant progress toward Takeda’s near-term commercial priorities. ORZEYFUL is now available in Japan and China; its U.S. launch remains subject to Drug Enforcement Administration (DEA) scheduling.
• MIMRYLO launched in the U.S. in August 2026 and is now available to patients.
• The FDA accepted the New Drug Application (NDA) under Priority Review for zasocitinib; the EMA is also reviewing the application. Phase 3 head-to-head data in plaque psoriasis further strengthened the clinical evidence for zasocitinib.
• FY2026 full-year outlook upgraded to reflect FX benefit.

Takeda President and Chief Executive Officer, Julie Kim, commented:
“The launches of ORZEYFUL and MIMRYLO, combined with the acceptance of zasocitinib under Priority Review and its positive head-to-head Phase 3 data, represent a significant moment for Takeda and reflect strong execution against our two-horizon growth strategy.”

“Our focus now is to translate these milestones into strong commercial execution, while continuing to advance our late-stage pipeline, ensuring resilience of our core in-line brands and unlocking capabilities through transformation. Progress against our priorities in Horizon One of our strategy is building the foundation for Takeda’s next phase of growth. We look forward to sharing more details on our growth strategy and how we will build sustainable leadership in our core therapeutic areas at our Capital Markets Day in December.”

Takeda Chief Financial Officer, Milano Furuta, commented:
“We are reinvesting transformation savings to support new product launches and advance our pipeline. Our first-half results demonstrate that we are on track in advancing our Horizon One priorities and we will continue our disciplined execution to deliver on our revised full-year forecast and management guidance.”

FINANCIAL HIGHLIGHTS for First-Half Results ended September 30, 2026

(Billion yen, except percentages and per share amounts)
Item	FY2026 H1 (Billion JPY)	FY2025 H1 (Billion JPY)	YoY (AER)
Revenue	2,407.0	2,219.5	+8.4%
Operating Profit	406.7	253.6	+60.4%
Margin	16.9%	11.4%	+5.5pp
Net Profit	305.6	112.4	+171.8%
EPS (Yen)	193	72	+169.0%
Operating Cash Flow	431.9	593.7	-27.2%
Adjusted Free Cash Flow (Non-IFRS)	325.7	525.4	-38.0%

Core (Non-IFRS)
(Billion yen, except percentages and per share amounts)
Item	FY2026 H1	FY2025 H1	YoY (AER)	YoY (CER)
Revenue	2,407.0	2,219.5	+8.4%	-1.0%
Operating Profit	710.6	639.2	+11.2%	+0.7%
Margin	29.5%	28.8%	+0.7pp
Net Profit	489.6	438.6	+11.6%	-0.2%
EPS (Yen)	308	279	+10.5%	-1.2%

FY2026 Full-year Forecast and Guidance
Takeda raised its FY2026 outlook mainly due to FX benefit.
(Billion yen, except percentages and per share amounts)
Item	FY2026 ORIGINAL MANAGEMENT GUIDANCE AT CER (MAY 2026)	FY2026 REVISED MANAGEMENT GUIDANCE AT CER (OCT 2026)
Core Revenue	Low-single digit % decline	Low-single digit % decline
Core Operating Profit	5% to 8% decline	Mid-single digit % decline
Core EPS (Yen)	Mid-teens % decline	Low-teens % decline

Item	FY2026 ORIGINAL FORECAST (MAY 2026)	FY2026 REVISED FORECAST (OCT 2026)
Revenue	4,640.0	4,700.0
Core Revenue (Non-IFRS)	4,640.0	4,700.0
Operating Profit	420.0	453.0
Core Operating Profit (Non-IFRS)	1,160.0	1,190.0
Net Profit	166.0	209.0
EPS (Yen)	104	131
Core EPS (Yen) (Non-IFRS)	472	482
Adjusted Free Cash Flow (Non-IFRS)	650.0 – 750.0	700.0-800.0
Annual dividend per share (Yen)	204	204

New Medicines and Late-Stage Pipeline Progress
New medicine approvals and late-stage pipeline progress during the first half of FY2026 reinforce progress against Takeda’s strategic priorities. The following updates highlight key milestones.

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).
• Launched in Japan and China for adults with NT1 on October 15; U.S. commercial launch remains subject to DEA scheduling, expected in early November 2026.
• Phase 3 results were published in the New England Journal of Medicine, demonstrating significant improvements across key symptoms and quality-of-life measures.

MIMRYLO

• First-in-class hepcidin mimetic approved in the U.S. for the treatment of erythrocytosis in adults with polycythemia vera (PV); launched in August.
• MIMRYLO has been shown to maintain hematocrit control, the primary treatment goal in PV, as well as reduce phlebotomy burden and alleviate symptoms including fatigue.
• Approval supported by Phase 3 VERIFY results showing 76.9% of patients achieved clinical response during weeks 20-32.
• MIMRYLO is the only treatment to be recommended as a Category 1 option across low- and high-risk PV in the National Comprehensive Cancer Network® (NCCN®) clinical practice guidelines in oncology for myeloproliferative neoplasms.

Zasocitinib

• The FDA accepted the NDA under Priority Review for adults with moderate-to-severe plaque psoriasis; the EMA also accepted the Marketing Authorization Application for review.
• Phase 3 demonstrated superiority to deucravacitinib on the primary and all key secondary efficacy endpoints; more than 2.5 times as many patients achieved complete skin clearance.
• Zasocitinib remains investigational, with commercial launch planning underway, subject to regulatory approval.

Broader Oncology Pipeline

• At the European Society for Medical Oncology (ESMO), Takeda presented positive Phase 3 results showing that arcotatug tavatecan (TAK-921) delivered statistically significant and clinically meaningful improvements in overall survival and progression-free survival in patients with advanced gastric cancer.
• The findings support a regulatory filing in Japan in FY2027 and continued global development of arcotatug tavatecan in CLDN18.2-positive cancers.
• Development of TAK-928 continues, including through a global Phase 3 study in patients with immunotherapy-resistant squamous NSCLC. Takeda also recently announced that it will expand this study to include a new sub-trial for patients with non-squamous NSCLC.
• ELAHERE® (mirvetuximab soravtansine) was approved in Japan for folate receptor alpha-positive, platinum-resistant recurrent ovarian cancer.

Transformation, Capital Allocation and Shareholder Returns
Takeda continues to make solid progress on its enterprise transformation, a key FY2026 priority alongside the launch of new medicines and the advancement of its R&D pipeline. These efforts are designed to enhance operational efficiency, strengthen capabilities and optimize resource allocation, and support near-term execution under Horizon One of Takeda’s two-horizon growth strategy, while laying the foundation for sustainable growth under Horizon Two. Takeda maintains a disciplined capital allocation framework that prioritizes investment in new product launches and innovation, while maintaining its commitment to shareholder returns through its progressive dividend policy.

Additional Information Regarding FY2026 First Half Results
Takeda will host a conference call for investors and analysts on Thursday, Oct. 29, 2026, at 19:00 Japan Time / 6:00 U.S. Eastern Time to discuss its FY2026 first half 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 half 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.

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 drug pricing, 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 FY2026 H1 investor presentation (available at www.takeda.com/investors).

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20261026300481/en/

Investor Relations
Christopher O’Reilly
Takeda.ir.contact@takeda.com

Media Relations
Corporate Communications
toiawase_kouhou@takeda.co.jp (Tokyo)
media_relations@takeda.com (Boston)

Source: Takeda Pharmaceutical Company Limited

Key Terms

new drug application regulatory

A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.

priority review regulatory

Priority review is a regulatory fast-track that shortens the time an agency spends evaluating a drug, vaccine or medical device application so a decision comes sooner than normal. For investors, it matters because a faster review is like an express lane to market: it can speed revenue potential and reduce regulatory uncertainty, but it does not guarantee approval and still requires the product to meet safety and effectiveness standards.

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.

constant exchange rate financial

Constant exchange rate is a way of reporting financial results using the same set of currency conversion rates for each period so foreign-exchange swings don't change the comparison. Think of it like comparing prices after converting everything to the same fixed currency rate — it helps investors see whether revenue or profit moved because the business actually changed, not because currency values moved up or down.

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.