Tillkännagivande • 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. Tillkännagivande • 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 Tillkännagivande • 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 Tillkännagivande • 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. Tillkännagivande • Nov 01
Otsuka Holdings Co., Ltd. to Report Fiscal Year 2025 Results on Feb 13, 2026 Otsuka Holdings Co., Ltd. announced that they will report fiscal year 2025 results at 1:30 PM, Tokyo Standard Time on Feb 13, 2026 Tillkännagivande • Oct 31
Otsuka Holdings Co., Ltd. Provides Consolidated Financial Forecast for the Fiscal Year Ending December 31, 2025 Otsuka Holdings Co., Ltd. provided consolidated financial forecast for the Fiscal Year Ending December 31, 2025. For the year, the company expects revenue of ¥2,420,000 million, operating profit of ¥452,000 million, Profit for the year of ¥334,000 million and Basic earnings per share of ¥622.52. Tillkännagivande • Sep 22
Otsuka Pharmaceutical Co., Ltd. Receives Complete Response Letter from U.S. FDA for sNDA of REXULTI (Brexpiprazole) in Combination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S (Lundbeck) announce that Otsuka has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the supplemental New Drug Application (sNDA) for use of REXULTI®? (brexpiprazole) in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD). The CRL states that the FDA has completed their review but cannot approve the application in the current form, further stating that the application does not provide substantial evidence of effectiveness to support the approval. Tillkännagivande • Aug 01
Otsuka Holdings Co., Ltd. to Report Q3, 2025 Results on Oct 31, 2025 Otsuka Holdings Co., Ltd. announced that they will report Q3, 2025 results at 1:30 PM, Tokyo Standard Time on Oct 31, 2025 Tillkännagivande • Jun 06
Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical, Co. Ltd. Present Results from a Pre-specified Interim Analysis of the Phase 3 Vision Study Evaluating Sibeprenlimab, for the Treatment of Immunoglobulin A Nephropathy (IgAN) Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co. Ltd. (Otsuka) presented results from a pre-specified interim analysis of the Phase 3 VISIONARY study (NCT05248646) evaluating sibeprenlimab, for the treatment of immunoglobulin A nephropathy (IgAN) in adults. Patients treated with sibeprenlimab achieved a 51.2% (P<0.0001) reduction in proteinuria (as measured by 24-hour uPCR [urine protein-to-creatinine ratio) at nine months of treatment when compared to placebo. The data were presented during a late-breaking clinical trials session at the European Renal Association (ERA) Congress in Vienna, Austria. The study, the Phase 3 IgAN trial conducted to date, also showed the safety profile of sibeprenlimab was favorable and consistent with previously reported data. Specifically, 76.3% of patients treated with sibepren Limab experienced any Treatment Emergent Adverse Event (TEAE) versus 84.5% in the placebo group.1 Patients who experienced a serious TEAE were 3.9% treated with sibeprenab compared to 5.4% treated with placebo. Sibeprenlimab received Priority Review designation from the FDA last month following its BLA filing in March. Proteinuria reduction is a recognized surrogate marker correlating with delaying progression to kidney failure and has been used as an endpoint in IgAN clinical trials to support accelerated. regulatory approvals. Sibeprenlimib is an investigational monoclonal antibody that selectively inhibits the activity of APRIL (A PRol proliferation-Inducing Ligand) in adults with IgAN. APRIL plays a key role in the 4-hit process of IgAN pathogenesis and is an important initiating and sustaining factor in IgAN progression by promoting the production of pathogenic Gd-IgA1 and immune complex formation. By selectively binding and inhibiting APRIL, sibeprenlimab reduces the amount of immunoglobulin A (IgA) and Gd-IgA 1 levels1. Lower levels of Gd-IgA2 in people with IgAN provide less substrate for immune complex formation7. Sibeprenlim AB is administered in a single-dose prefilled syringe for subcutaneous injection every four weeks intended for self-administration or administration by caregiver, providing patients the option of convenience at home. The VISIONARY study continues in a blinded manner to evaluate the change in kidney function over 24 months as measured by estimated glomerular filtration rate (eGFR) and is expected to be an effective and safe approach for this progressive and irreversible kidney disease. The VISIONARY study continue in a blinded manner to evaluate The change in kidney function over 24 weeks as measured by estimated glomerultration rate (eGR) and is expected to be in the U.S. Food and Drug Administration (FDA) with a target action date of November 28th, 2025. Tillkännagivande • May 02
Otsuka Holdings Co., Ltd. to Report Q2, 2025 Results on Jul 31, 2025 Otsuka Holdings Co., Ltd. announced that they will report Q2, 2025 results at 1:30 PM, Tokyo Standard Time on Jul 31, 2025 Tillkännagivande • Apr 30
Shanghai Fund Is Said to Weigh Buying Otsuka’s Stake in MicroPort A fund backed by Shanghai Industrial Investment (Holding) Co., Ltd. is in talks to buy Otsuka Holdings Co., Ltd. (TSE:4578)’s stake in Chinese medical device maker MicroPort Scientific Corporation (SEHK:853), according to people familiar with the situation. Otsuka has been considering options for its holding in Hong Kong-listed MicroPort, including selling it, Bloomberg News reported in October. The Japanese drugmaker’s stake was about 20.9% as of the end of June. Tillkännagivande • Mar 31
Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and Otsuka Pharmaceutical Development & Commercialization, Inc. Files Biologics License Application (BLA) for Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy Otsuka Pharmaceutical Co. Ltd. (Otsuka) and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) announced the filing of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for sibeprenlimab, an investigational monoclonal antibody that selectively inhibits the activity of APRIL (A PRoliferation-Inducing Ligand) in adults with immunoglobulin A nephropathy (IgAN). APRIL plays a key role in the 4-hit process of IgAN pathogenesis and is an important initiating and sustaining factor in IgAN progression by promoting the production of pathogenic Gd-IgA1 and immune complex formation. Sibeprenlimab is a single-dose prefilled syringe for subcutaneous injection every four weeks intended for self-administration or administration by caregiver, providing patients the option of convenience at home. IgAN is a progressive, autoimmune, chronic kidney disease that is associated with a high risk for progression to end-stage kidney disease (ESKD) over the lifetime of many patients. In 2024, the FDA granted a Breakthrough Therapy designation for sibeprenlimab following favorable results of the Phase 2 ENVISION clinical trial. This designation accelerates the development and regulatory review of potential new medicines intended to treat a serious condition and address a significant unmet medical need. If approved, sibeprenlimab would be administered via injection every four weeks, which would allow patients the convenience and option of self-administration in the home setting. The BLA submission, Otsuka's first, is supported by results from the Phase 2 ENVISION clinical trial (NCT04287985) and the Phase 3 VISIONARY clinical trial (NCT05248646), which met its primary endpoint by demonstrating that sibeprenlimab produced a statistically significant and clinically meaningful reduction in 24-hour uPCR (urine protein-to-creatine ratio) compared to placebo after nine months of treatment.4 In the trial, the safety profile of sibeprenlimab was favorable and consistent with previously reported data. The VISIONARY study is a multicenter, randomized, double-blind, placebo-controlled trial consisting of approximately 530 adult patients (largest trial to date) with IgA nephropathy who were receiving standard-of-care therapy (defined as maximally tolerated ACE inhibitor or ARB +/- SGLT2 inhibitor), designed to evaluate the efficacy and safety of sibeprenlimab 400 mg administered subcutaneously every four weeks, compared to placebo. The primary efficacy endpoint is to evaluate the change in 24-hour uPCR at 9 months compared with baseline. The secondary endpoint is to evaluate the annualized slope of eGFR estimated over 24 months. Tillkännagivande • Mar 18
Otsuka Holdings Co., Ltd. (TSE:4578) announces an Equity Buyback for 12,000,000 shares, representing 2.23% for ¥70,000 million. Otsuka Holdings Co., Ltd. (TSE:4578) announces a share repurchase program. Under the program, the company will repurchase up to 12,000,000 shares, representing 2.23% of its share capital, for ¥70,000 million. The purpose of the program is to improve capital efficiency and return profits to shareholders. The program will expire on April 30, 2025. As of February 28, 2025, the company had 537,092,696 shares in issue (excluding treasury stock) and 14,932,021 shares in treasury. Tillkännagivande • Feb 15
Otsuka Holdings Co., Ltd. to Report Q1, 2025 Results on Apr 30, 2025 Otsuka Holdings Co., Ltd. announced that they will report Q1, 2025 results at 1:30 PM, Tokyo Standard Time on Apr 30, 2025 Tillkännagivande • Feb 14
Otsuka Holdings Co., Ltd., Annual General Meeting, Mar 28, 2025 Otsuka Holdings Co., Ltd., Annual General Meeting, Mar 28, 2025. Tillkännagivande • Feb 08
Otsuka Holdings Co., Ltd. Revises Consolidated Earnings Guidance for the Fiscal Year 2024 Otsuka Holdings Co., Ltd. revised consolidated earnings guidance for the Fiscal Year 2024. For the year, the company expects revenue to be JPY 2,320,000 million, operating profit to be JPY 323,000 million, profit to be JPY 347,000 million, Profit attributable to owners of the Company to be JPY 343,000 and basic EPS to be JPY 633.54 against previous forecast of revenue to be JPY 2,310,000 million, operating profit to be JPY 320,000 million, profit to be JPY 244,000 million, Profit attributable to owners of the Company to be JPY 240,000 and basic EPS to be JPY 443.24. Reasons for the revision: Due to the impact of temporary tax adjustment in the U.S. for the consolidated fiscal year, profit for the period is expected to be JPY 347.0 billion and profit attributable to owners of the company is expected to be JPY 343.0 billion, significantly exceeding the earnings forecast announced on October 31, 2024. Tillkännagivande • Nov 01
Otsuka Holdings Co., Ltd. to Report Fiscal Year 2024 Results on Feb 14, 2025 Otsuka Holdings Co., Ltd. announced that they will report fiscal year 2024 results at 1:30 PM, Tokyo Standard Time on Feb 14, 2025 Tillkännagivande • Aug 02
Otsuka Holdings Co., Ltd. (TSE:4578) announces an Equity Buyback for 10,000,000 shares, representing 1.84% for ¥50,000 million. Otsuka Holdings Co., Ltd. (TSE:4578) announces a share repurchase program. Under the program, the company will repurchase up to 10,000,000 shares, representing 1.84% of its share capital, for ¥50,000 million. The purpose of the program is to improve capital efficiency and return profits to shareholders. The program will expire on December 20, 2024. As of June 30, 2024, the company had 542,903,744 shares in issue (excluding treasury stock) and 14,931,873 shares in treasury. Tillkännagivande • Aug 01
Otsuka Holdings Co., Ltd. to Report Q3, 2024 Results on Oct 31, 2024 Otsuka Holdings Co., Ltd. announced that they will report Q3, 2024 results at 1:30 PM, Tokyo Standard Time on Oct 31, 2024 Tillkännagivande • Jun 08
Otsuka Holdings Co., Ltd. Provides Earnings Guidance for the Year 2026 Otsuka Holdings Co., Ltd. provided earnings guidance for the year 2026. For the year, the company expects Revenue of JPY 22,000 million, EPS of JPY 380 and Business profit of JPY 2,700 million. Tillkännagivande • Feb 17
Otsuka Holdings Co., Ltd. to Report Q1, 2024 Results on Apr 30, 2024 Otsuka Holdings Co., Ltd. announced that they will report Q1, 2024 results at 1:30 PM, Tokyo Standard Time on Apr 30, 2024 Tillkännagivande • Feb 13
Otsuka Holdings Co., Ltd. Revises Consolidated Earnings Guidance for the Fiscal Year Ended December 31, 2023 Otsuka Holdings Co., Ltd. revised consolidated earnings guidance for the Fiscal Year Ended December 31, 2023. For the year, company expects Revenue of JPY 2,018,000 million, Operating profit of JPY 139,000 million, Profit for the period of JPY 125,000 million, Profit attributable to owners of the Company of JPY 121,000 million and Basic earnings per share of JPY 222.97 previously forecasted as follows: Revenue of JPY 1,985,000 million, Operating profit of JPY 245,000 million, Profit for the period of JPY 192,000 million, Profit attributable to owners of the Company of JPY 188,000 million and Basic earnings per share of JPY 346.44. Tillkännagivande • Nov 01
Otsuka Holdings Co., Ltd. Revises Consolidated Earnings Guidance for the Fiscal Year Ending December 31, 2023 Otsuka Holdings Co., Ltd. revised consolidated earnings guidance for the fiscal year ending December 31, 2023. For the year, the company expected revenue to be JPY 1,985,000 million, Operating profit to be JPY 245,000 million, Profit attributable to owners of the company to be JPY 188,000 million or Basic EPS to be JPY 346.44. Tillkännagivande • Oct 31
Otsuka Holdings Co., Ltd. to Report Fiscal Year 2023 Results on Feb 14, 2024 Otsuka Holdings Co., Ltd. announced that they will report fiscal year 2023 results on Feb 14, 2024 Tillkännagivande • Jul 31
Otsuka Holdings Co., Ltd. to Report Q3, 2023 Results on Oct 31, 2023 Otsuka Holdings Co., Ltd. announced that they will report Q3, 2023 results at 1:30 PM, Tokyo Standard Time on Oct 31, 2023 Tillkännagivande • Jul 26
Otsuka Holdings Co., Ltd. Revises Consolidated Earnings Guidance for the First Half of Fiscal Year 2023 Otsuka Holdings Co., Ltd. revised consolidated earnings guidance for the first half of Fiscal year 2023. For the year, the company expects revenue to be JPY 947,500 million against previous guidance of JPY 867,000 million. Operating profit to be JPY 130,500 million against previous guidance of JPY 91,500 million. Profit for the period to be JPY 105,000 million against previous guidance of JPY 70,000 million. Profit attributable to owners of the Company to be JPY 102,500 million against previous guidance of JPY 68,000 million. Basic earnings per share to be JPY 189.00 against previous guidance of JPY 125.31. Tillkännagivande • Jun 29
Otsuka Pharmaceutical Co., Ltd. Announces Positive Results of Phase III Trial in Japan Showing Reduced Agitation in Patients with Alzheimer's Dia Treated with Brexpiprazole Otsuka Pharmaceutical Co., Ltd. announced positive results from a phase III clinical trial in Japan for brexpiprazole in the treatment of agitation associated with Alzheimer's dementia. The trial (ClinicalTrials.gov Identifier NCT03620981) was designed to assess the efficacy, safety and tolerability of one daily fixed dose (1mg/day or 2mg/day) of brexpiprazole in The treatment of patients with agitation associated with Alzheimer's dementia". It was a 10-week, multicenter, randomized, double-blind, placebo-controlled trial that comprised 410 patients, aged 55 to 90 years, with agitation associated with Alzheimer's Alzheimer's dementia. The primary endpoint was mean change from the baseline in the Cohen-Mansfield Agitation Inventory (CMAI) total score at week 10. The study's primary endpoint was attained, demonstrating a statistically significant improvement in the CMAI total score of the groups administered brexpiprazole 1mg/day (p value=0.0175) or 2mg/day (p value<0.0001) compared with the placebo group. Improvement was also observed in secondary endpoints such as Clinical Global Impression-Severity Illness (CGI-S) score in the 1 mg/day and 2 mg/day brexpiprazole groups compared with the placebo group. Brexpiprazole was generally well tolerated, and no new safety signals were observed. Additional analysis of the trial results is planned to further interpret the efficacy and safety of brexpiprazole for the treatment indication. Based on this study outcome Otsuka is planning a regulatory filing in Japan later in 2023 for an additional treatment indication for brexpiprazole. If approved, brexpiprazole would be the first pharmacological treatment indicated for agitation in patients with Alzheimer's dementia in Japan. Tillkännagivande • Jun 21
Otsuka Holdings Co., Ltd. to Report Q2, 2023 Results on Jul 31, 2023 Otsuka Holdings Co., Ltd. announced that they will report Q2, 2023 results on Jul 31, 2023 Tillkännagivande • Feb 16
Otsuka Holdings Co., Ltd., Annual General Meeting, Mar 30, 2023 Otsuka Holdings Co., Ltd., Annual General Meeting, Mar 30, 2023. Tillkännagivande • Jan 30
Otsuka Pharmaceutical Co., Ltd. (Otsuka) Files an Application in Japan for an Additional Indication for Rexulti Otsuka Pharmaceutical Co., Ltd. (Otsuka) filed an application in Japan for an additional indication for Rexulti® (generic name: brexpiprazole) for the treatment of depression/depressive state (Administration should be limited to patients who showed an inadequate response to existing antidepressant therapy). The phase 3 clinical trial evaluated the efficacy and safety of brexpiprazole as adjunctive therapy in 740 adult patients aged 20 to 64 in Japan, with MDD. Brexpiprazole was administered once daily for six weeks, in 1 mg or 2 mg doses, as an adjunctive therapy to SSRI or SNRI antidepressants, for patients who previously had inadequate responses to antidepressant monotherapy. In the study, improvements from baseline on the primary endpoint of the Montgomery-Asberg Depression Rating Scale for patients receiving 1mg and 2mg of brexpiprazole for six weeks as adjunctive therapy were statistically greater than for those receiving adjunctive placebo. Brexpiprazole was generally well tolerated by trial participants, and no new safety concerns were identified. Brexpiprazole is expected to become a new treatment option for patients whose depressive symptoms are not adequately relieved by existing antidepressants. Otsuka will continue to deliver innovative products to meet unmet medical needs around the world. Tillkännagivande • Dec 26
Otsuka Holdings Co., Ltd. to Report Fiscal Year 2022 Results on Feb 14, 2023 Otsuka Holdings Co., Ltd. announced that they will report fiscal year 2022 results on Feb 14, 2023 Tillkännagivande • Sep 23
Otsuka Holdings Co., Ltd. to Report Q3, 2020 Results on Nov 13, 2020 Otsuka Holdings Co., Ltd. announced that they will report Q3, 2020 results on Nov 13, 2020 Tillkännagivande • Jun 29
Otsuka Holdings Co., Ltd. to Report Q2, 2020 Results on Aug 07, 2020 Otsuka Holdings Co., Ltd. announced that they will report Q2, 2020 results on Aug 07, 2020