What Takeda Pharmaceutical (TAK) Said on Its Q2 Earnings Call

Key Points

• First-half results were broadly on track: Core revenue fell 1% year over year at constant exchange rates to just over ¥2.4 trillion, while core operating profit increased 0.7% to ¥710.6 billion. Takeda maintained its outlook for a low-single-digit revenue decline but raised full-year core operating profit guidance to ¥1.19 trillion, helped by foreign-exchange assumptions.
• New launches are central to Takeda’s growth plans: ORZEYFUL launched in Japan and China and is expected to launch in the U.S. in early November, while MIMRYLO is now available in the U.S. Zasocitinib is under priority review in the U.S. for psoriasis, with a potential launch expected in fiscal 2026.
• Pipeline progress remains significant: The investigational cancer drug TAK-921 met overall- and progression-free-survival endpoints in advanced gastric cancer, supporting a planned Japan filing in fiscal 2027. Takeda also reported promising but dose-dependent ulcerative-colitis data for zasocitinib and plans to assess additional Crohn’s disease data before deciding on phase III development.

Takeda Pharmaceutical NYSE: TAK reported first-half fiscal 2026 results that management said were in line with expectations as the company invested in new product launches and its late-stage pipeline while using savings from a transformation program to support profitability.

Core revenue totaled just over ¥2.4 trillion in the first half, declining 1% at constant exchange rates, while core operating profit rose 0.7% to ¥710.6 billion. Core earnings per share declined 1.2% at constant exchange rates. On a reported basis, revenue increased 8.4% to ¥2.407 trillion, aided by a weaker yen, and reported EPS rose 169% to ¥193.

President and CEO Julie Kim said the company is managing headwinds from mature and off-patent products that have not yet been fully offset by recent launches. “Our first-half results demonstrate that we are on track against our FY 2026 priorities,” Kim said.

New Launches Take Center Stage

Takeda highlighted three medicines it expects to support future growth: ORZEYFUL for narcolepsy type one, MIMRYLO for polycythemia vera, and the psoriasis candidate zasocitinib.

ORZEYFUL, an oral orexin receptor 2 agonist designed to address orexin deficiency in narcolepsy type one, launched in Japan and China on Oct. 15. Takeda expects a U.S. launch in early November after completion of Drug Enforcement Administration scheduling. Kim said the company has prepared its specialty-pharmacy network, patient-support programs and medical outreach in the U.S. ahead of launch.

Rhonda Pacheco, president of Takeda’s U.S. Business Unit, said physicians have responded positively to prelaunch education efforts and that the company is also working to improve diagnosis of narcolepsy type one. Kim said the initial response following the Japan and China launches had been encouraging, though the products had only been on the market for two weeks.

MIMRYLO, a once-weekly subcutaneous hepcidin mimetic for erythrocytosis in adults with polycythemia vera, received U.S. Food and Drug Administration approval on Aug. 28 and became commercially available shortly afterward. The treatment is listed as a category one option in National Comprehensive Cancer Network guidelines for both low- and high-risk patients, according to Takeda.

Teresa Bitetti, president of Takeda’s Oncology Business Unit, said it remains early in the launch and the company did not provide quantitative prescription or coverage figures. She said feedback from healthcare providers and patients has been positive, while Takeda focuses on physician education, awareness and payer access.

Meanwhile, the FDA accepted Takeda’s application for zasocitinib in psoriasis under priority review, and the European Medicines Agency accepted the company’s marketing authorization application. Takeda is preparing for a potential U.S. launch following an FDA decision expected in the fourth quarter of fiscal 2026.

Pipeline Updates Include Gastric Cancer Data

Research and Development President Andy Plump highlighted phase III data for TAK-921, an investigational Claudin 18.2-targeted antibody-drug conjugate in previously treated advanced gastric cancer. The study met dual primary endpoints of overall survival and progression-free survival, Takeda said.

In a population that had received at least three prior lines of therapy, including 30% who were in fourth- or fifth-line treatment, TAK-921 produced a statistically significant and clinically meaningful overall-survival result with a hazard ratio of 0.57, Plump said. Takeda plans to file for approval in Japan for previously treated advanced gastric cancer during fiscal 2027.

The company is also conducting proof-of-concept studies in first-line gastric and pancreatic cancer, with results expected over the next 18 months. Plump said Takeda sees the product’s gastrointestinal tolerability profile as potentially supportive of combinations with current and future standards of care.

Takeda initiated a phase III study of elritercept in myelofibrosis and submitted TAK-881, a hyaluronidase-facilitated subcutaneous immunoglobulin program, in the U.S. for primary immunodeficiency.

ENTYVIO Data and Zasocitinib IBD Questions

The company also presented findings from the VERDICT study of ENTYVIO in moderate to severe ulcerative colitis. Plump said treatment to more stringent endpoints reduced the risk of ulcerative-colitis-related complications by approximately 70%, with benefits extending as long as 80 weeks after target achievement. In the trial, 52.1% of patients assigned to the most stringent treatment-target group achieved disease clearance.

Takeda disclosed a directional summary from a phase II ulcerative colitis study of zasocitinib. Plump said the company observed a robust efficacy effect and a strong nominal p-value at the 50-milligram dose, but did not see the same result at the 75-milligram dose. The company said safety at both doses was consistent with previous psoriasis and psoriatic arthritis studies.

Takeda plans to evaluate the ulcerative colitis findings alongside data from a phase II-B Crohn’s disease study expected near the end of fiscal 2026 before deciding whether and how to proceed into phase III trials for inflammatory bowel disease.

Transformation Savings Fund Investment

CFO Milano Furuta said Takeda’s transformation program is progressing, with approximately 3,000 impacted roles communicated as of Sept. 30. The company has also implemented procurement initiatives generating about ¥30 billion in annualized savings.

Takeda remains on track to achieve ¥100 billion in gross savings from the program during fiscal 2026, with restructuring costs now expected to total ¥160 billion, ¥10 billion below its earlier forecast. Furuta said savings are being redirected toward launch preparations, research and development, and other growth priorities.

The company maintained its full-year outlook for a low-single-digit percentage decline in revenue at constant exchange rates. It raised absolute revenue guidance by ¥60 billion and core operating profit guidance by ¥30 billion, primarily reflecting foreign-exchange assumptions. Takeda’s revised core operating profit forecast is ¥1.19 trillion, up from ¥1.16 trillion previously.

Kim said Takeda plans to provide additional detail on its longer-term growth strategy at its Capital Markets Day on Dec. 11.

About Takeda Pharmaceutical (NYSE:TAK)

Takeda Pharmaceutical Company Limited is a global biopharmaceutical company headquartered in Tokyo, Japan. The company researches, develops, manufactures and commercializes medicines for patients worldwide, with a focus on areas of significant unmet medical need. Its principal therapeutic areas include gastroenterology, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines.

Takeda's portfolio includes treatments such as Entyvio for inflammatory bowel disease, Takhzyro for hereditary angioedema, and medicines for certain blood cancers and rare conditions.

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