Takeda Pharmaceutical Co Ltd SEC Filings

Takeda Pharmaceutical’s Chief Medical Officer, Farajallah Awny Samaan Botros, reported his initial shareholdings in the company. He holds 112,629 American Depositary Shares directly, including 73,220 restricted stock units that convert into ADSs as they vest on scheduled dates from July 1, 2026 through July 1, 2028.

Takeda Pharmaceutical executive Ibrahim Ramy Riad Ahmed filed an initial statement of ownership, reporting 84,787 American Depositary Shares of the company. This total includes 48,928 restricted stock units (RSUs), each convertible into one ADS. The RSUs vest in stages on July 1, 2026 (24,022 shares), July 1, 2027 (16,554 shares) and July 1, 2028 (8,352 shares), showing a multi‑year equity-based compensation structure tied to his role as President of the PDT business unit.

Takeda reported strong Phase 3 results for its investigational oral TYK2 inhibitor zasocitinib (TAK-279) in adults with moderate‑to‑severe plaque psoriasis. In two large global LATITUDE PsO studies, about 70% of patients on zasocitinib achieved clear or almost clear skin (sPGA 0/1) at week 16, far exceeding placebo and apremilast.

Zasocitinib also drove high rates of deeper responses: over half of treated patients reached PASI 90 at week 16, and roughly one‑third achieved complete skin clearance (PASI 100 and sPGA 0), with responses improving through week 24. More than 90% of responders who stayed on drug at week 40 maintained sPGA 0/1, PASI 75 and PASI 90 through week 60, indicating durable control.

The once‑daily pill showed a safety profile consistent with earlier trials, with treatment‑emergent adverse events in 62.1% of zasocitinib patients versus 46.9% on placebo and 50.5% on apremilast; the most common were upper respiratory infection, nasopharyngitis and acne, and no new safety signals were seen. Takeda plans to begin New Drug Application filings in fiscal 2026, targets a first psoriasis launch in the first half of 2027, and cites combined psoriasis and psoriatic arthritis peak revenue potential of $3‑6B, though these results do not change its full‑year forecast to March 31, 2026.

Takeda Pharmaceutical Company Limited is advancing its leadership transition and Board renewal. The Board will propose CEO-elect Julie Kim as a new internal director at the 150th Ordinary General Meeting of Shareholders on June 24, 2026. If elected, she will be appointed representative director, president & CEO immediately after the meeting, while current representative director, president & CEO Christophe Weber plans to retire from Takeda and its Board on the same day.

Takeda is also reshaping its Board with three new external candidates – Bruce Broussard, Koichiro Kimura and Paul Stoffels – and the planned retirement of six current external directors. All other current Board members are expected to be proposed for re-election. An attachment notes that Julie Kim holds 173,773 ADSs and outlines her prior leadership roles at Shire and Takeda, reinforcing her experience ahead of assuming the top role.

Takeda Pharmaceutical Company Limited is launching the next phase of its global transformation program to boost competitiveness and support multiple upcoming drug launches. The company targets annualized gross savings of more than JPY 200 billion by FY2028, mainly through streamlined corporate functions, simpler processes and better use of technology.

These efficiencies are expected to largely offset investments in launch preparations for medicines such as oveporexton, rusfertide and zasocitinib, as well as late-stage pipeline and technology spending. Takeda currently estimates restructuring expenses of about JPY 150 billion in FY2026, with smaller charges in FY2027 and FY2028. The initiatives are not expected to have a significant impact on the full-year consolidated financial forecast for FY2025.

Takeda Pharmaceutical Company reported that the U.S. FDA has accepted the New Drug Application and granted Priority Review for rusfertide, an investigational first-in-class hepcidin mimetic peptide for adults with polycythemia vera. The agency set a Prescription Drug User Fee Act target action date in the third quarter of this calendar year.

The NDA is primarily supported by the Phase 3 VERIFY study, where rusfertide plus standard of care more than doubled clinical response rates versus standard care alone, as well as four-year efficacy and safety data from Phase 2 REVIVE/THRIVE studies. Rusfertide met its primary and all four key secondary endpoints and was generally well-tolerated, with injection site reactions, anemia and fatigue as the most common adverse events.

Rusfertide has also received Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA. Takeda states that the impact of the NDA acceptance on its financial results for the fiscal year ending March 31, 2026 is immaterial.

Takeda Pharmaceutical Company Limited filed a Form 6-K highlighting that the U.S. Food and Drug Administration has accepted its New Drug Application and granted Priority Review for oveporexton (TAK-861) to treat narcolepsy type 1, a rare neurological disease driven by orexin loss. Oveporexton is an investigational oral orexin receptor 2-selective agonist designed to restore orexin signaling and address the underlying orexin deficiency that causes narcolepsy type 1.

The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date in the third quarter of this calendar year, positioning oveporexton as a potential first-in-class orexin agonist therapy. The application is supported by global Phase 3 FirstLight and RadiantLight studies that showed statistically significant, clinically meaningful improvements across key symptoms and quality-of-life measures, with a generally well-tolerated safety profile. Takeda states that this NDA filing has no significant impact on its full year consolidated forecast for the fiscal year ending March 31, 2026.

Takeda Pharmaceutical Company Limited reported mixed results for the nine months ended December 31, 2025. Revenue fell to JPY 3,411.2 billion, down 3.3% year over year, mainly because its ADHD drug VYVANSE in the U.S. faced heavy generic competition, sharply reducing Neuroscience revenue.

Despite lower sales, cost controls and fewer restructuring charges helped operating profit edge up 1.2% to JPY 422.4 billion, while net profit rose 2.4% to JPY 216.3 billion. Core operating profit and Core EPS declined about 3–4% as Takeda absorbed lower Neuroscience revenue and higher impairments on certain R&D assets.

The balance sheet strengthened, with total assets at JPY 15.4 trillion and the equity ratio improving to 49.6%. Operating cash flow increased to JPY 966.9 billion, supporting ongoing dividends; the company projects a full-year dividend of JPY 200 per share. Management slightly raised FY2025 revenue, operating profit and EPS forecasts, mainly from foreign-exchange tailwinds, but revised Core Revenue guidance to a low-single-digit decline at constant exchange rates.

Takeda reported strong Phase 3 results for its investigational oral psoriasis drug zasocitinib (TAK-279) in adults with moderate-to-severe plaque psoriasis. Two large, randomized, double-blind studies showed zasocitinib was superior to placebo at week 16 on both co-primary goals: static Physician Global Assessment (sPGA 0/1) and Psoriasis Area and Severity Index (PASI 75). All 44 ranked secondary endpoints, including higher bars of PASI 90 and PASI 100 against both placebo and apremilast, were also met.

More than half of treated patients achieved clear or almost clear skin (PASI 90), and on average about 30 percent reached completely clear skin (PASI 100) by week 16, with responses continuing to improve through week 24. Zasocitinib was generally well-tolerated, with common side effects such as upper respiratory infections, nasopharyngitis and acne, and no new safety signals. Takeda plans to submit a New Drug Application to the U.S. Food and Drug Administration and other regulators starting in fiscal year 2026, and currently expects these results to have no significant impact on its full-year forecast for the fiscal year ending March 31, 2026.