Takeda Pharm SEC Filings

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.

Takeda Pharmaceutical Company Limited and its subsidiary Takeda Vaccines, Inc. reported disposal of all their HilleVax, Inc. (HLVX) common stock held through Takeda Vaccines. On 09/17/2025, 6,724,000 shares were sold pursuant to a cash tender offer by XOMA Royalty Corporation and XRA 4 Corp. at a price of $1.95 per share, with closing announced on 09/17/2025.

The filing states that following the transaction the reporting persons hold 0 shares beneficially. The shares were held directly by Takeda Vaccines, Inc., an indirect wholly owned subsidiary of Takeda Pharmaceutical Company Limited, and the filing explains the ownership chain among Takeda entities.

HilleVax, Inc. (HLVX) agreed to be acquired and taken private by XOMA Royalty Corporation through a cash tender offer and subsequent merger. Shareholders received $1.95 per share plus one non-transferable contractual contingent value right (CVR) for each share. The tender offer expired and was completed on September 15, 2025, and the merger became effective September 17, 2025, with Merger Sub merging into HilleVax and HilleVax continuing as the surviving corporation and a wholly owned subsidiary of Parent. As a result, HilleVax common stock ceased to be publicly traded, Nasdaq delisting and deregistration steps were requested, and the company plans to suspend Exchange Act reporting by filing Form 15.

Takeda reported positive Phase 3 results for oveporexton (TAK-861), an oral OX2R-selective agonist for narcolepsy type 1 (NT1). Two global, double-blind, placebo-controlled studies (FirstLight and RadiantLight) met all primary and secondary endpoints at week 12 with p-values <0.001 across doses (twice-daily 1mg and 2mg), showing statistically significant improvement in wakefulness, excessive daytime sleepiness, cataplexy frequency, symptom severity and quality of life.

The 12-week program enrolled 273 patients across 19 countries; more than 95% of completers entered the ongoing long-term extension. Oveporexton was generally well tolerated with no treatment-related serious adverse events reported; the most common adverse events were insomnia and urinary urgency/frequency. Takeda said these Phase 3 results do not have a significant impact on its consolidated forecast for the fiscal year ending March 31, 2026.