Upcoming Dividend • Jun 25
Upcoming dividend of JP¥70.00 per share Eligible shareholders must have bought the stock before 29 June 2026. Payment date: 01 September 2026. Payout ratio is a comfortable 15% and this is well supported by cash flows. Trailing yield: 1.3%. Lower than top quartile of German dividend payers (4.8%). Lower than average of industry peers (2.6%). Declared Dividend • May 20
Dividend of JP¥70.00 announced Shareholders will receive a dividend of JP¥70.00. Ex-date: 29th June 2026 Payment date: 1st September 2026 Dividend yield will be 114%, which is higher than the industry average of 2.4%. Sustainability & Growth Dividend is well covered by both earnings (20% earnings payout ratio) and cash flows (27% cash payout ratio). The dividend has increased by an average of 3.4% per year over the past 10 years and has been stable with no material reductions to payments, indicating a long track record of dividend growth and stability. EPS is expected to grow by 14% over the next 3 years, which should provide support to the dividend and adequate earnings cover. Announcement • 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 Announcement • 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 Announcement • 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. Announcement • 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 Announcement • 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. Announcement • 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. Announcement • 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 Announcement • 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. Announcement • 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 Announcement • 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. Announcement • 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. Announcement • 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. Announcement • 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 Announcement • Feb 14
Otsuka Holdings Co., Ltd., Annual General Meeting, Mar 28, 2025 Otsuka Holdings Co., Ltd., Annual General Meeting, Mar 28, 2025. Announcement • 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. Reported Earnings • Nov 01
Third quarter 2024 earnings released: EPS: JP¥155 (vs JP¥109 in 3Q 2023) Third quarter 2024 results: EPS: JP¥155 (up from JP¥109 in 3Q 2023). Revenue: JP¥621.1b (up 17% from 3Q 2023). Net income: JP¥83.9b (up 42% from 3Q 2023). Profit margin: 14% (up from 11% in 3Q 2023). Revenue is forecast to stay flat during the next 3 years compared to a 3.4% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 6% per year but the company’s share price has increased by 18% per year, which means it is tracking significantly ahead of earnings growth. Announcement • 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 Buy Or Sell Opportunity • Sep 18
Now 23% undervalued Over the last 90 days, the stock has risen 35% to €49.40. The fair value is estimated to be €64.35, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 14% over the last 3 years. Earnings per share has grown by 3.4%. For the next 3 years, revenue is forecast to grow by 1.0% per annum. Earnings are also forecast to grow by 12% per annum over the same time period. Declared Dividend • Aug 04
First half dividend of JP¥60.00 announced Shareholders will receive a dividend of JP¥60.00. Ex-date: 27th December 2024 Payment date: 31st March 2025 Dividend yield will be 138%, which is higher than the industry average of 2.4%. Sustainability & Growth The dividend has increased by an average of 5.5% per year over the past 10 years and has been stable with no material reductions to payments, indicating a long track record of dividend growth and stability. EPS is expected to grow by 36% over the next 3 years, which should provide support to the dividend and adequate earnings cover. Reported Earnings • Aug 02
Second quarter 2024 earnings released: EPS: JP¥56.04 (vs JP¥75.85 in 2Q 2023) Second quarter 2024 results: EPS: JP¥56.04 (down from JP¥75.85 in 2Q 2023). Revenue: JP¥589.4b (up 18% from 2Q 2023). Net income: JP¥30.4b (down 26% from 2Q 2023). Profit margin: 5.2% (down from 8.2% in 2Q 2023). Revenue is forecast to stay flat during the next 3 years compared to a 3.6% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 3% per year but the company’s share price has increased by 11% per year, which means it is tracking significantly ahead of earnings growth. Announcement • 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. Announcement • 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 Announcement • 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. Reported Earnings • Apr 30
First quarter 2024 earnings released: EPS: JP¥143 (vs JP¥113 in 1Q 2023) First quarter 2024 results: EPS: JP¥143 (up from JP¥113 in 1Q 2023). Revenue: JP¥519.5b (up 16% from 1Q 2023). Net income: JP¥77.4b (up 26% from 1Q 2023). Profit margin: 15% (up from 14% in 1Q 2023). Revenue is forecast to stay flat during the next 3 years compared to a 3.4% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 3% per year but the company’s share price has increased by 9% per year, which means it is tracking significantly ahead of earnings growth. Buy Or Sell Opportunity • Apr 16
Now 21% undervalued Over the last 90 days, the stock has risen 6.7% to €38.20. The fair value is estimated to be €48.33, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 13% over the last 3 years, while earnings per share has been flat. For the next 3 years, revenue is forecast to grow by 0.7% per annum. Earnings are also forecast to grow by 6.9% per annum over the same time period. Declared Dividend • Apr 11
Final dividend of JP¥60.00 announced Shareholders will receive a dividend of JP¥60.00. Ex-date: 27th June 2024 Payment date: 4th September 2024 Dividend yield will be 159%, which is higher than the industry average of 2.4%. Sustainability & Growth Dividend is well covered by both earnings (49% earnings payout ratio) and cash flows (48% cash payout ratio). The dividend has increased by an average of 6.3% per year over the past 10 years and has been stable with no material reductions to payments, indicating a long track record of dividend growth and stability. EPS is expected to grow by 23% over the next 3 years, which should provide support to the dividend and adequate earnings cover. Buy Or Sell Opportunity • Mar 26
Now 21% undervalued Over the last 90 days, the stock has risen 14% to €38.00. The fair value is estimated to be €48.29, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 13% over the last 3 years, while earnings per share has been flat. For the next 3 years, revenue is forecast to grow by 0.6% per annum. Earnings are also forecast to grow by 6.7% per annum over the same time period. Announcement • 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 Announcement • Feb 16
Otsuka Holdings Co., Ltd., Annual General Meeting, Mar 28, 2024 Otsuka Holdings Co., Ltd., Annual General Meeting, Mar 28, 2024. Reported Earnings • Feb 16
Full year 2023 earnings released: EPS: JP¥224 (vs JP¥247 in FY 2022) Full year 2023 results: EPS: JP¥224 (down from JP¥247 in FY 2022). Revenue: JP¥2.02t (up 16% from FY 2022). Net income: JP¥121.6b (down 9.3% from FY 2022). Profit margin: 6.0% (down from 7.7% in FY 2022). Revenue is forecast to stay flat during the next 3 years compared to a 3.1% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 2% per year whereas the company’s share price has fallen by 3% per year. New Risk • Feb 14
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 0.03% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. This is currently the only risk that has been identified for the company. Announcement • 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. Upcoming Dividend • Dec 21
Upcoming dividend of JP¥50.00 per share at 1.9% yield Eligible shareholders must have bought the stock before 28 December 2023. Payment date: 01 April 2024. Payout ratio is a comfortable 15% and this is well supported by cash flows. Trailing yield: 1.9%. Lower than top quartile of German dividend payers (5.1%). Lower than average of industry peers (2.6%). Announcement • 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. Reported Earnings • Oct 31
Third quarter 2023 earnings released: EPS: JP¥109 (vs JP¥76.07 in 3Q 2022) Third quarter 2023 results: EPS: JP¥109 (up from JP¥76.07 in 3Q 2022). Revenue: JP¥531.5b (up 18% from 3Q 2022). Net income: JP¥59.1b (up 43% from 3Q 2022). Profit margin: 11% (up from 9.1% in 3Q 2022). The increase in margin was driven by higher revenue. Revenue is forecast to stay flat during the next 3 years compared to a 3.2% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 4% per year whereas the company’s share price has remained flat. Announcement • 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 New Risk • Sep 19
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 0.1% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. This is currently the only risk that has been identified for the company. New Risk • Sep 04
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 0.3% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. This is currently the only risk that has been identified for the company. Buying Opportunity • Aug 18
Now 20% undervalued Over the last 90 days, the stock is up 3.7%. The fair value is estimated to be €42.13, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 9.7% over the last 3 years, while earnings per share has been flat. For the next 3 years, revenue is forecast to grow by 0.3% per annum. Earnings is also forecast to grow by 1.6% per annum over the same time period. Reported Earnings • Aug 01
Second quarter 2023 earnings released: EPS: JP¥75.86 (vs JP¥85.70 in 2Q 2022) Second quarter 2023 results: EPS: JP¥75.86 (down from JP¥85.70 in 2Q 2022). Revenue: JP¥499.2b (up 15% from 2Q 2022). Net income: JP¥41.2b (down 12% from 2Q 2022). Profit margin: 8.2% (down from 11% in 2Q 2022). The decrease in margin was driven by higher expenses. Revenue is forecast to stay flat during the next 3 years compared to a 2.7% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has fallen by 1% per year whereas the company’s share price has fallen by 3% per year. Announcement • 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 Announcement • 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. Announcement • 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. Upcoming Dividend • Jun 22
Upcoming dividend of JP¥50.00 per share at 1.8% yield Eligible shareholders must have bought the stock before 29 June 2023. Payment date: 05 September 2023. Payout ratio is a comfortable 32% and this is well supported by cash flows. Trailing yield: 1.8%. Lower than top quartile of German dividend payers (4.7%). Lower than average of industry peers (2.6%). Announcement • 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 Reported Earnings • May 15
First quarter 2023 earnings released: EPS: JP¥113 (vs JP¥42.88 in 1Q 2022) First quarter 2023 results: EPS: JP¥113 (up from JP¥42.88 in 1Q 2022). Revenue: JP¥448.3b (up 18% from 1Q 2022). Net income: JP¥61.4b (up 164% from 1Q 2022). Profit margin: 14% (up from 6.1% in 1Q 2022). The increase in margin was driven by higher revenue. Revenue is forecast to stay flat during the next 3 years compared to a 3.9% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has fallen by 5% per year whereas the company’s share price has fallen by 3% per year. Buying Opportunity • Mar 31
Now 20% undervalued after recent price drop Over the last 90 days, the stock is down 4.0%. The fair value is estimated to be €36.21, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 6.5% over the last 3 years. Earnings per share has declined by 7.9%. For the next 3 years, revenue is forecast to grow by 1.0% per annum. Earnings is also forecast to grow by 0.6% per annum over the same time period. Announcement • Feb 16
Otsuka Holdings Co., Ltd., Annual General Meeting, Mar 30, 2023 Otsuka Holdings Co., Ltd., Annual General Meeting, Mar 30, 2023. Reported Earnings • Feb 15
Full year 2022 earnings released: EPS: JP¥247 (vs JP¥231 in FY 2021) Full year 2022 results: EPS: JP¥247 (up from JP¥231 in FY 2021). Revenue: JP¥1.74t (up 16% from FY 2021). Net income: JP¥134.0b (up 6.8% from FY 2021). Profit margin: 7.7% (down from 8.4% in FY 2021). The decrease in margin was driven by higher expenses. Revenue is forecast to grow 1.4% p.a. on average during the next 3 years, compared to a 3.5% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has fallen by 8% per year and the company’s share price has also fallen by 8% per year. Announcement • 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. Buying Opportunity • Jan 05
Now 23% undervalued after recent price drop Over the last 90 days, the stock is down 10.0%. The fair value is estimated to be €37.39, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 5.2% over the last 3 years. Earnings per share has declined by 6.2%. For the next 3 years, revenue is forecast to grow by 1.7% per annum. Earnings is also forecast to grow by 4.0% per annum over the same time period. Announcement • 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 Upcoming Dividend • Dec 22
Upcoming dividend of JP¥50.00 per share Eligible shareholders must have bought the stock before 29 December 2022. Payment date: 31 March 2023. Trailing yield: 2.3%. Lower than top quartile of German dividend payers (5.1%). Lower than average of industry peers (2.7%). Buying Opportunity • Dec 20
Now 21% undervalued after recent price drop Over the last 90 days, the stock is down 2.0%. The fair value is estimated to be €37.77, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 5.2% over the last 3 years. Earnings per share has declined by 6.2%. For the next 3 years, revenue is forecast to grow by 2.2% per annum. Earnings is also forecast to grow by 5.4% per annum over the same time period. Announcement • Nov 30
Otsuka Medical Devices Co., Ltd. and Recor Medical, Inc. Announce Submission of Application for Pre-Market Approval of the Paradise uRDN to the U.S. FDA Otsuka Medical Devices Co., Ltd. and ReCor Medical, Inc. announced the filing of the pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the ParadiseTM uRDN System in the treatment of uncontrolled hypertension. The Paradise uRDN System is designed to reduce sympathetic nerve activity by denervating nerves which surround the renal arteries with the goal of reducing blood pressure. Paradise uRDN uses a combination of ultrasound energy to denervate the renal nerves and a water-filled balloon to protect the renal artery. The Paradise uRDN System employs an interventional procedure in which the Paradise catheter is placed in each of the main renal arteries, following which two to three seven-second ultrasound emissions are delivered to denervate the surrounding renal nerves, thereby reducing blood pressure. Since 2009, ReCor has been focused on developing and testing the Paradise uRDN System to treat hypertension safely and effectively. ReCor has three global, independently powered, sham-controlled randomized clinical trials of the Paradise uRDN System in more than 500 patients with uncontrolled hypertension: RADIANCE-HTN SOLO, RADIANCE-HTN TRIO and RADIANCE II. Each RADIANCE trial met its prespecified primary efficacy endpoint of blood pressure reduction, with positive safety. RADIANCE II is the U.S. FDA IDE pivotal trial. In September of this year, ReCor and Otsuka Medical Devices announced that the trial successfully reached its primary efficacy endpoint. Results showed a reduction in daytime systolic ambulatory blood pressure of -7.9 mmHg in those treated with uRDN and a difference between uRDN and sham of -6.3 mmHg (p <0.0001). The results from the all three RADIANCE clinical trials have been included in the submission for approval to the U.S. FDA. Hypertension is the leading contributor to disease burden worldwide, resulting in increased cardiovascular morbidity and mortality, poorer quality of life, and higher costs to health systems. The Paradise uRDN System bears the CE mark for the treatment of hypertension in Europe and is an investigational device in the United States and Japan. Reported Earnings • Nov 01
Third quarter 2022 earnings released: EPS: JP¥76.07 (vs JP¥64.97 in 3Q 2021) Third quarter 2022 results: EPS: JP¥76.07 (up from JP¥64.97 in 3Q 2021). Revenue: JP¥451.8b (up 16% from 3Q 2021). Net income: JP¥41.3b (up 17% from 3Q 2021). Profit margin: 9.1% (in line with 3Q 2021). Revenue is forecast to grow 2.6% p.a. on average during the next 3 years, compared to a 4.0% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has fallen by 6% per year whereas the company’s share price has fallen by 4% per year. Announcement • Nov 01
Otsuka Holdings Co., Ltd. Revises Consolidated earnings Guidance for the Fiscal Year Ending December 31, 2022 Otsuka Holdings Co., Ltd. revised consolidated earnings guidance for the fiscal year ending December 31, 2022. For the year, the company expects revenue to be JPY 1,710,000 million against previous guidance of JPY 1,670,000 million. Operating profit to be JPY 142,000 million against previous guidance of JPY 152,000 million. Profit for the year to be JPY 134,000 million against previous guidance of JPY 138,000 million. Profit attributable to owners of the Company to be JPY 131,000 million against previous guidance of JPY 135,000 million. Basic earnings per share to be JPY 241.46 against previous guidance of JPY 248.82. Announcement • Oct 31
Otsuka Holdings Co., Ltd. Provides Dividend Guidance for the Fiscal Year Ending December 31, 2022 Otsuka Holdings Co., Ltd. provided dividend guidance for the fiscal year ending December 31, 2022. For the year-end, the company expects to pay dividend of JPY 50.00 per share against JPY 50.00 per share paid a year ago. Announcement • Sep 18
Otsuka Holdings Co., Ltd. to Report Q2, 2023 Results on Oct 31, 2022 Otsuka Holdings Co., Ltd. announced that they will report Q2, 2023 results on Oct 31, 2022 Announcement • Sep 14
U.S. FDA Acceptance of New Drug Application for Aripiprazole 2-Month by Otsuka America Pharmaceutical, Inc On September 13, 2022, Otsuka America Pharmaceutical Inc., and H. Lundbeck A/S (Lundbeck) announce the U.S. Food and Drug Administration (FDA) acceptance of their New Drug Application (NDA) for aripiprazole 2-month, ready-to-use, long-acting injectable, a medication administered for the treatment of schizophrenia in adults and for maintenance monotherapy treatment of bipolar I disorder in adults. Aripiprazole 2-month, ready-to-use, long-acting injectable is provided in a single-chamber-type, prefilled syringe. It is intended for dosing every two months via intramuscular injection in the gluteal muscle. The 2-month, ready-to-use, long-acting injectable of aripiprazole in 960 mg and 720 mg prefilled syringes will deliver sustained plasma concentrations similar to that demonstrated in studies with aripiprazole once-monthly long-acting injectable, resulting in consistent efficacy. Regulatory approval would be based on a multiple-dose,randomized,parallel-arm, clinical trial to assess safety, tolerability, and pharmacokinetics in adults with schizophrenia or bipolar I disorder. Reported Earnings • Jul 31
Second quarter 2022 earnings released: EPS: JP¥85.70 (vs JP¥86.15 in 2Q 2021) Second quarter 2022 results: EPS: JP¥85.70 (down from JP¥86.15 in 2Q 2021). Revenue: JP¥434.0b (up 14% from 2Q 2021). Net income: JP¥46.5b (flat on 2Q 2021). Profit margin: 11% (down from 12% in 2Q 2021). The decrease in margin was driven by higher expenses. Over the next year, revenue is forecast to grow 3.4%, compared to a 8.2% growth forecast for the industry in Germany. Over the last 3 years on average, earnings per share has increased by 1% per year whereas the company’s share price has increased by 3% per year. Announcement • Jun 23
Otsuka Holdings Co., Ltd. to Report Q2, 2022 Results on Jul 29, 2022 Otsuka Holdings Co., Ltd. announced that they will report Q2, 2022 results on Jul 29, 2022 Upcoming Dividend • Jun 22
Upcoming dividend of JP¥50.00 per share Eligible shareholders must have bought the stock before 29 June 2022. Payment date: 06 September 2022. Payout ratio is a comfortable 52% and this is well supported by cash flows. Trailing yield: 2.3%. Lower than top quartile of German dividend payers (4.4%). Lower than average of industry peers (2.7%). Reported Earnings • May 14
First quarter 2022 earnings released: EPS: JP¥42.88 (vs JP¥82.39 in 1Q 2021) First quarter 2022 results: EPS: JP¥42.88 (down from JP¥82.39 in 1Q 2021). Revenue: JP¥380.3b (up 13% from 1Q 2021). Net income: JP¥23.3b (down 48% from 1Q 2021). Profit margin: 6.1% (down from 13% in 1Q 2021). The decrease in margin was driven by higher expenses. Over the next year, revenue is forecast to grow 2.3%, compared to a 7.1% growth forecast for the industry in Germany. Over the last 3 years on average, earnings per share has increased by 10% per year but the company’s share price has fallen by 1% per year, which means it is significantly lagging earnings. Announcement • Apr 08
Otsuka Holdings Co., Ltd. to Report Q1, 2022 Results on May 13, 2022 Otsuka Holdings Co., Ltd. announced that they will report Q1, 2022 results on May 13, 2022 Reported Earnings • Feb 11
Full year 2021 earnings: EPS in line with analyst expectations despite revenue beat Full year 2021 results: EPS: JP¥231 (down from JP¥273 in FY 2020). Revenue: JP¥1.50t (up 5.3% from FY 2020). Net income: JP¥125.5b (down 15% from FY 2020). Profit margin: 8.4% (down from 10% in FY 2020). The decrease in margin was driven by higher expenses. Revenue exceeded analyst estimates by 1.0%. Over the next year, revenue is forecast to grow 2.1%, compared to a 7.4% growth forecast for the pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 18% per year but the company’s share price has fallen by 5% per year, which means it is significantly lagging earnings. Announcement • Jan 28
Otsuka Holdings Co., Ltd. Revises Earnings Guidance for the Fiscal Year 2021 Otsuka Holdings Co., Ltd. revised earnings guidance for the fiscal year 2021. For the year, the company expects revenue of JPY 1,498,000 million compared to previous forecast of JPY 1,480,000 million, operating profit of JPY 154,000 million compared to previous forecast of JPY 203,000 million, Profit for the year of JPY 129,000 million compared to previous forecast of JPY 165,000 million and basic earnings per share of JPY 230.46 compared to previous forecast of JPY 296.84. Upcoming Dividend • Dec 23
Upcoming dividend of JP¥50.00 per share Eligible shareholders must have bought the stock before 29 December 2021. Payment date: 31 March 2022. Payout ratio is a comfortable 37% but the company is not cash flow positive. Trailing yield: 2.3%. Lower than top quartile of German dividend payers (3.3%). Lower than average of industry peers (2.6%). Reported Earnings • Nov 13
Third quarter 2021 earnings released: EPS JP¥64.97 (vs JP¥75.52 in 3Q 2020) The company reported a soft third quarter result with weaker earnings and profit margins, although revenues improved. Third quarter 2021 results: Revenue: JP¥388.6b (up 4.6% from 3Q 2020). Net income: JP¥35.2b (down 14% from 3Q 2020). Profit margin: 9.1% (down from 11% in 3Q 2020). The decrease in margin was driven by higher expenses. Over the last 3 years on average, earnings per share has increased by 19% per year but the company’s share price has fallen by 7% per year, which means it is significantly lagging earnings. Reported Earnings • Aug 09
Second quarter 2021 earnings released: EPS JP¥86.15 (vs JP¥90.54 in 2Q 2020) The company reported a soft second quarter result with weaker earnings and profit margins, although revenues improved. Second quarter 2021 results: Revenue: JP¥382.0b (up 7.3% from 2Q 2020). Net income: JP¥46.7b (down 4.8% from 2Q 2020). Profit margin: 12% (down from 14% in 2Q 2020). The decrease in margin was driven by higher expenses. Over the last 3 years on average, earnings per share has increased by 16% per year but the company’s share price has fallen by 5% per year, which means it is significantly lagging earnings. Upcoming Dividend • Jun 22
Upcoming dividend of JP¥50.00 per share Eligible shareholders must have bought the stock before 29 June 2021. Payment date: 07 September 2021. Trailing yield: 2.2%. Lower than top quartile of German dividend payers (3.1%). Lower than average of industry peers (2.8%). Reported Earnings • May 16
First quarter 2021 earnings released: EPS JP¥82.39 (vs JP¥69.54 in 1Q 2020) The company reported a decent first quarter result with improved earnings and profit margins, although revenues were flat. First quarter 2021 results: Revenue: JP¥336.8b (flat on 1Q 2020). Net income: JP¥44.7b (up 19% from 1Q 2020). Profit margin: 13% (up from 11% in 1Q 2020). Over the last 3 years on average, earnings per share has increased by 14% per year but the company’s share price has fallen by 7% per year, which means it is significantly lagging earnings. Analyst Estimate Surprise Post Earnings • Mar 06
Revenue misses expectations Revenue missed analyst estimates by 0.2%. Over the next year, revenue is forecast to stay flat compared to a 2.4% growth forecast for the Pharmaceuticals industry in Germany. Reported Earnings • Mar 06
Full year 2020 earnings released: EPS JP¥273 (vs JP¥235 in FY 2019) The company reported a strong full year result with improved earnings, revenues and profit margins. Full year 2020 results: Revenue: JP¥1.42t (up 1.9% from FY 2019). Net income: JP¥148.1b (up 17% from FY 2019). Profit margin: 10% (up from 9.1% in FY 2019). Over the last 3 years on average, earnings per share has increased by 11% per year but the company’s share price has fallen by 6% per year, which means it is significantly lagging earnings. Is New 90 Day High Low • Mar 02
New 90-day low: €32.60 The company is down 4.0% from its price of €34.00 on 02 December 2020. The German market is up 8.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is up 4.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €48.17 per share. Reported Earnings • Feb 14
Full year 2020 earnings released: EPS JP¥273 (vs JP¥235 in FY 2019) The company reported a strong full year result with improved earnings, revenues and profit margins. Full year 2020 results: Revenue: JP¥1.42t (up 1.9% from FY 2019). Net income: JP¥148.1b (up 17% from FY 2019). Profit margin: 10% (up from 9.1% in FY 2019). Over the last 3 years on average, earnings per share has increased by 11% per year but the company’s share price has fallen by 2% per year, which means it is significantly lagging earnings. Analyst Estimate Surprise Post Earnings • Feb 14
Revenue misses expectations Revenue missed analyst estimates by 0.2%. Over the next year, revenue is forecast to stay flat compared to a 2.5% growth forecast for the Pharmaceuticals industry in Germany. Announcement • Feb 13
Otsuka Holdings Co., Ltd., Annual General Meeting, Mar 30, 2021 Otsuka Holdings Co., Ltd., Annual General Meeting, Mar 30, 2021.