공고 • Jul 28
Otsuka Holdings Co., Ltd. Revises Consolidated Earnings Guidance for the First Half Ending June 30, 2026 Otsuka Holdings Co., Ltd. revised consolidated earnings guidance for the first half ending June 30, 2026. For the period, the company now expects revenue of JPY 1,332,000 million, operating profit of JPY 278,000 million, profit for the period of the company of JPY 218,000 million, and basic earnings per share of JPY 407.90 compared to previous forecast for revenue of JPY 1,218,000 million, operating profit of JPY 175,000 million, profit for the period of JPY 131,000 million, and basic earnings per share of JPY 243.07. Reasons for the revision: Due to the favorable performance of its businesses during the interim consolidated accounting period, the Company has revised upward its consolidated earnings forecast announced on February 13, 2026. During the interim consolidated accounting period, revenue exceeded the previous forecast primarily due to the later-than- expected entry of generic versions of JYNARQUE in the United States and ABILIFY MAINTENA in Europe, strong performance of VOYXACT, REXULTI, and LONSURF, as well as the positive impact of foreign exchange rates, mainly reflecting the depreciation of the Japanese yen against the U.S. dollar and the euro. In addition, research and development expenses are expected to be lower than previously anticipated, mainly due to the discontinuation of development for certain indications of ulotaront and differences in the timing of expense recognition for development projects. As a result, revenue, business profit, operating profit, profit for the period, and profit attributable to owners of the Company are all expected to exceed the previous forecast. 공고 • Apr 29
Otsuka Holdings Co., Ltd. to Report Q2, 2026 Results on Jul 31, 2026 Otsuka Holdings Co., Ltd. announced that they will report Q2, 2026 results at 1:30 PM, Tokyo Standard Time on Jul 31, 2026 공고 • Feb 14
Otsuka Holdings Co., Ltd. to Report Q1, 2026 Results on Apr 28, 2026 Otsuka Holdings Co., Ltd. announced that they will report Q1, 2026 results at 1:30 PM, Tokyo Standard Time on Apr 28, 2026 공고 • Nov 10
Otsuka Pharmaceutical, Co. Ltd. Announces Findings from 12-Month Interim Analysis of Sibeprenlimab for the Treatment of Immunoglobulin A Nephropathy (IgAN) in Adults Otsuka Pharmaceutical Co. Ltd. (Otsuka) announced that findings from a 12-month interim analysis of sibeprenlimab for the treatment of immunoglobulin A nephropathy (IgAN) in adults were presented in a late-breaking presentation session at the 2025 American Society of Nephrology (ASN) annual Kidney Week meeting in Houston, Texas. Summary data was simultaneously published in the online version of The New England Journal of Medicine. 12-month interim analysis outcomes for the novel APRIL antibody drug candidate sibeprenlimab, targeting IgA nephropathy, as part of the Phase 3 VISIONARY trial. Study outcome on proteinuria measured at 12 months demonstrated that sibeprenlimab achieved a 54.3% (95% confidence interval [CI, 46.4% to 60.9%) placebo-adjusted reduction. Trial outcomes presented at a late-breaking presentation session of the American Society of Nephrology (asN) Kidney Week, November 6 to 9, 2025. Proteinuria reduction is a recognized surrogate marker correlating with delaying progression to kidney failure. Otsuka filed a Biologics License Application (BLA) for sibeprenlimab with the U.S. FDA and received a Priority Review designation from the agency, with a target action date (PDUFA date) of November 28, 2025. Twelve-month data on proteinuria levels, measured as urine-protein-to-creatinine ratio in 24-hour urine collections (uPCR-24), as well as on safety, from the Phase 3 VISIONARY study (NCT05248646) of Sibeprenlimab were submitted as part of the BLA (Biologics License Application) submission to the U.S. FDA. The VISIONARY study, the largest Phase 3 IgAN trial conducted to date, also showed that patients taking sibeprenlimab experienced substantially reduced serum immunoglobulins (IgA, IgG, IgM), A PRol proliferation-Inducing Ligand (APRIL), galactose-deficient IgA1 (Gd-IgA1) and rates of hematuria, and delivered higher proteinuric remission versus placebo, which is consistent with APRIL inhibition. Consistent treatment effects with Sibeprenlimab at nine-month effects were seen across prespecified subgroups, including those patients prescribed or not prescribed SGLT2 inhibitors, varying baseline proteinuria and estimated glomerular filtration rate (eGFR), demographics, and prior immunosuppression. Sibeprenlimab works by blocking APRIL, which plays a key role in the process of IgAN pathogenesis and is an important initiating and sustaining factor in IgAN progression by promoting the production of pathogenic galactose-deficiency IgA1 (Gd -IgA1). In inhibition of APRIL results in reduced levels of galactose-deficient IgA1 (Gd- IgA1), which is implicated in the pathogenesis of IgAN.2 Sibeprenlimab is administered in a single-dose prefilled syringe for subcutaneous injection every four weeks intended for self-administration. Otsuka filed a biologics License Application (BL a Biologics License Application ("BLA") for sibepren Limab with the U.S., and the U.S. FDA, and received a priority Review designation from the agencies, with a target action date ("PDUFA date") of November 28, 2025. 12-month data on proteinuria level, measured as urine-protein -to-creatinine ratios in 24-hour urine collections ("uPCR-24"), as well as on safety. 
