Takeda Pharmaceutical Company Limited American Depositary Shares (each representing 1/2 of a share of - TAK STOCK NEWS

Takeda reported strong Q1 FY2024 results, with revenue growth of 14.1% at AER and 2.1% at CER. Growth & Launch Products drove performance, increasing 17.8% at CER and representing 46% of total revenue. Core Operating Profit rose 4.5% at CER, with a margin of 31.6%. The company maintained its full-year forecast and management guidance.

Key highlights include:

• Geographic expansion with approvals of LIVTENCITY in Japan and FRUZAQLA in EU
• Positive Phase 2b data for TAK-861 in narcolepsy type 1 and mezagitamab for ITP
• Q1 revenue of 1,208.0 billion yen and Core Operating Profit of 382.3 billion yen
• Core EPS of 176 yen, up 17.5% year-over-year

Takeda has announced new director assignments, decided at the Board of Directors and Audit and Supervisory Committee meetings following the 148th Ordinary Meeting of Shareholders. The Board is composed of 11 external directors out of 14 total members, ensuring transparency and objectivity.

An external director will continue to chair the Board. The Audit and Supervisory Committee, Nomination Committee, and Compensation Committee will be composed solely of external directors.

The new assignments include Christophe Weber as Representative Director and CEO, Milano Furuta as Director and CFO, and Andrew Plump as Director of R&D. External directors such as Masami Iijima, Ian Clark, and Steven Gillis hold various roles, ensuring robust governance.

These changes are effective from June 26, 2024, and emphasize Takeda's commitment to strong, independent governance.

Takeda announced the Japanese Ministry of Health, Labour and Welfare's approval of LIVTENCITY® (maribavir) for post-transplant cytomegalovirus (CMV) infection/disease resistant to existing anti-CMV therapies. LIVTENCITY is the first and only post-transplant treatment in Japan that targets pUL97 kinase. The approval is based on Phase 3 SOLSTICE trial results, which demonstrated significant improvement with maribavir over alternative treatments in clearing CMV viremia by Week 8. The trial included 235 maribavir patients and 117 on alternative treatments, with adverse reactions in 60.3% of maribavir patients. An additional Japanese Phase 3 study showed 33.3% efficacy at clearing CMV viremia by Week 8, with adverse reactions in 36.6% of patients.

Takeda unveiled positive results from its Phase 2b study of mezagitamab (TAK-079) in treating persistent or chronic primary immune thrombocytopenia (ITP). The study showed rapid and sustained platelet increases among patients receiving mezagitamab, with effects persisting for eight weeks post-treatment.

Among patients treated with the 600mg dose, 81.8% achieved complete platelet response, 90.9% achieved clinically meaningful platelet response, and 100% achieved hemostatic platelet response. Adverse events (AEs) were lower in the mezagitamab group compared to placebo. Takeda plans to initiate a Phase 3 trial in the second half of FY2024.

Takeda has received European Commission (EC) approval for FRUZAQLA (fruquintinib) as a treatment for adult patients with metastatic colorectal cancer (mCRC) who have exhausted other standard therapies. This approval follows the Phase 3 FRESCO-2 trial, which demonstrated significant efficacy and a manageable safety profile for FRUZAQLA. The EC decision was preceded by a positive opinion from the CHMP on April 25, 2024, and an FDA approval on November 8, 2023. FRUZAQLA is now the first new targeted therapy for mCRC in the EU in over a decade, providing a new option for patients regardless of their biomarker status.

Takeda has shared long-term data from the Phase 3 ADVANCE-CIDP 3 clinical trial, evaluating HYQVIA for treating chronic inflammatory demyelinating polyneuropathy (CIDP). The study, the longest of its kind, demonstrated HYQVIA's safety, tolerability, and low relapse rate, supporting its use as maintenance therapy. Presented at the PNS Annual Meeting, HYQVIA is the first facilitated subcutaneous immunoglobulin for CIDP, approved by the FDA and European Commission. The trial involved 85 patients over 33 months, reporting consistent safety profiles with no new concerns. Adverse events were mostly mild or moderate, with serious events in three patients. Results indicated stable disease maintenance with a low annualized relapse rate of 4.5%.

Takeda has released topline results from two Phase 3 studies for its drug soticlestat (TAK-935) targeting Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS). The SKYLINE study for DS narrowly missed its primary endpoint of reducing convulsive seizure frequency but showed significant effects in multiple secondary endpoints. The SKYWAY study for LGS missed its primary endpoint of reducing Major Motor Drop seizures. Despite the mixed results, soticlestat was well tolerated in both studies. Takeda plans to discuss the data with regulatory authorities and assess the financial impacts, including potential impairment losses.

Takeda has signed an option agreement with Ascentage Pharma for an exclusive global license to olverembatinib, a third-generation BCR-ABL tyrosine kinase inhibitor (TKI) for treating chronic myeloid leukemia (CML) and other hematological cancers.

The agreement gives Takeda the option to license and commercialize olverembatinib outside of mainland China, Hong Kong, Macau, Taiwan, and Russia. Ascentage Pharma will continue late-stage clinical development before Takeda exercises the option.

Ascentage Pharma will receive a $100 million option payment, a potential option exercise fee, and additional milestone and royalty payments. Takeda will also make a minority equity investment in Ascentage Pharma. Olverembatinib has shown promising clinical results, addressing a significant unmet need for CML patients resistant to current TKIs.

Takeda has announced an expanded partnership with Partners In Health (PIH) to support a new initiative aimed at addressing social determinants of health and improving access to care in Massachusetts. This initiative builds on Takeda's global partnership with PIH, which began in 2017 and has provided screening and diagnostic services to over 8 million people. The expanded collaboration will focus on establishing Health Equity Communities of Practice, expanding local health departments' capacity, and increasing opportunities for community health workers. This effort aims to dismantle systemic barriers to health equity and strengthen the health workforce in diverse communities across Massachusetts.