Takeda Pharm SEC Filings

Takeda Pharmaceutical Company Limited filed a Form 6-K highlighting new longer-term clinical data for rusfertide, a Phase 3 investigational treatment for polycythemia vera developed with Protagonist Therapeutics. At 52 weeks in the pivotal VERIFY study, 61.9% of patients continuously treated with rusfertide plus standard care maintained a durable clinical response, defined by absence of phlebotomy eligibility, and mean hematocrit stayed below 43%, supporting sustained blood count control. Patients who switched from placebo to rusfertide at Week 32 also showed strong responses, with 77.9% achieving absence of phlebotomy eligibility between Weeks 40 and 52. Long-term THRIVE extension data in 46 patients showed a more than 13-fold reduction in annual therapeutic phlebotomy rate, from 9.2 to 0.7 phlebotomies per year, with a safety profile generally consistent with earlier studies and no new signals. Takeda states that the impact of these study results on its financial performance for the fiscal year ending March 31, 2026 is immaterial.

Takeda Pharmaceutical Company Limited has an affiliated holder filing a notice to sell American Depositary Shares (ADSs) under Rule 144. The planned sale covers 87,023 ADSs with an aggregate market value of $1,242,688.44, to be executed through Interactive Brokers LLC on the NYSE, with an approximate sale date of 12/05/2025. The table notes that 123,490,548 ADSs are outstanding.

The securities to be sold were acquired as compensation through vested restricted stock unit (RSU) awards from Takeda on three dates: 99,692 ADSs on 07/01/2023, 31,896 ADSs on 07/01/2022, and 17,200 ADSs on 07/01/2021. By signing the notice, the selling person represents that they are not aware of any material adverse, nonpublic information about Takeda’s current or prospective operations.

Takeda Pharmaceutical Company Limited (TAK) insider has filed a notice to sell American Depositary Shares. The filing covers the planned sale of 58,421 ADSs through Interactive Brokers LLC on the NYSE, with an indicated aggregate market value of $836,004.51. The filing notes that 123,490,548 ADSs were outstanding at the time of the notice, providing context for the size of the intended sale.

The seller previously acquired 81,862 ADSs on 07/01/2023 through vested restricted stock unit awards from Takeda Pharmaceutical Company Limited, characterized as compensation. The individual also represents that they are not aware of any undisclosed material adverse information about the issuer’s current or prospective operations.

Takeda Pharmaceutical Company (TAK) reported softer first-half FY2025 results as generics and currency weighed on performance. Revenue was JPY 2,219.5 billion (down 6.9% AER), led by a steep decline in Neuroscience from U.S. generic erosion of VYVANSE. Operating profit fell to JPY 253.6 billion (down 27.7%), and net profit to JPY 112.5 billion (down 39.9%). Core metrics were more resilient: core operating profit was JPY 639.2 billion (down 11.2%) and core EPS JPY 279.

ENTYVIO, TAKHZYRO, LIVTENCITY, ADCETRIS and FRUZAQLA helped offset U.S. pressure and FX in GI, Rare Diseases, PDT and Oncology. The company recorded JPY 336.8 billion in amortization and impairment on product intangibles, including JPY 58.2 billion tied to discontinuing a gamma delta T‑cell therapy program. Cash generation remained strong with JPY 593.7 billion from operating activities; cash ended at JPY 681.5 billion. Total equity was JPY 7,131.7 billion and bonds and loans totaled JPY 4,645.3 billion. R&D advanced with positive Phase 3 results for oveporexton in narcolepsy and a collaboration with Innovent in late‑stage oncology.

Takeda Pharmaceutical Company Limited reported six-month results to September 30, 2025 showing lower earnings amid U.S. generic pressure and FX headwinds. Revenue was JPY 2,219.5 billion (-6.9%), operating profit JPY 253.6 billion (-27.7%), and net profit JPY 112.5 billion (-39.9%). Core operating profit was JPY 639.2 billion (-11.2%) with Core EPS of JPY 279.

Performance reflected continued generic erosion of VYVANSE in the U.S., partly offset by growth in ENTYVIO, LIVTENCITY, and TAKHZYRO. Intangible-related charges rose to JPY 336.8 billion, including JPY 58.2 billion tied to discontinuing a gamma delta T‑cell therapy platform. Operating cash flow strengthened to JPY 593.7 billion.

The company revised FY2025 guidance: revenue JPY 4,500.0 billion, operating profit JPY 400.0 billion, net profit JPY 153.0 billion, and EPS JPY 97.14. Core operating profit is JPY 1,130.0 billion and Core EPS JPY 479; management now expects core operating profit and Core EPS to decline by a low single-digit percentage at CER. An interim dividend of JPY 100 per share is set for payment from December 1, 2025, maintaining the annual projection of JPY 200.

Takeda revised its FY2025 outlook (year ending March 31, 2026), cutting reported guidance across key metrics after Q2 pipeline decisions and transactional FX.

Revenue is now JPY 4,500.0 billion, down JPY 30.0 billion (0.7%) from the prior forecast. Operating profit is reduced to JPY 400.0 billion, a decline of JPY 75.0 billion (15.8%), reflecting an unfavorable product mix from lower high-margin products, FX headwinds, and higher intangible asset impairments, partially offset by additional R&D and enterprise cost savings. Net profit attributable to owners is lowered to JPY 153.0 billion (down 32.9%), and reported EPS to JPY 97.14.

Core measures are trimmed modestly: Core revenue JPY 4,500.0 billion (−0.7%), Core operating profit JPY 1,130.0 billion (−0.9%), and Core EPS JPY 479. Management guidance at constant exchange rates shifts to “low-single-digit % decline” for Core operating profit and Core EPS, with Core revenue remaining “broadly flat.” Drivers include a revised ENTYVIO outlook and a steeper-than-anticipated VYVANSE decline in the U.S. due to generic erosion.

Takeda Pharmaceutical Company Limited filed a Form 6-K as a foreign private issuer and indicates it files annual reports on Form 20-F. The company describes its R&D-driven, values-based strategy focused on life-transforming treatments across core therapeutic areas including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Takeda states it operates globally with employees in approximately 80 countries and regions and emphasizes commitments to patients, employees and the planet.

The filing contains a detailed forward-looking statements disclaimer listing risks that could cause actual results to differ from expectations, including economic conditions, competitive and regulatory developments, clinical and manufacturing uncertainties, currency fluctuations, safety concerns, pandemic impacts, post-merger integration and divestiture timing, and greenhouse gas reduction uncertainties. Takeda notes no undertaking to update forward-looking statements except as required by law.