Upcoming Dividend • Jun 25
Upcoming dividend of JP¥66.00 per share Eligible shareholders must have bought the stock before 29 June 2026. Payment date: 28 August 2026. Payout ratio is a comfortable 44% and this is well supported by cash flows. Trailing yield: 1.8%. 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¥66.00 announced Shareholders will receive a dividend of JP¥66.00. Ex-date: 29th June 2026 Payment date: 28th August 2026 Dividend yield will be 155%, which is higher than the industry average of 2.4%. Sustainability & Growth Dividend is covered by both earnings (44% earnings payout ratio) and cash flows (65% cash payout ratio). The dividend has increased by an average of 23% per year over the past 10 years. However, payments have been volatile during that time. EPS is expected to grow by 42% over the next 3 years, which should provide support to the dividend and adequate earnings cover. Duyuru • Mar 23
Chugai Pharmaceutical Co., Ltd. Announces Discontinuation Of Development Of GYM329 (Emugrobart) In Spinal Muscular Atrophy And Facioscapulohumeral Muscular Dystrophy Chugai Pharmaceutical Co., Ltd. announced that Roche has decided to discontinue the clinical development of GYM329 (emugrobart), an investigational anti-latent myostatin sweeping antibody, for spinal muscular atrophy (SMA) and facioscapulohumeral muscular dystrophy (FSHD). This decision follows a rigorous assessment of data from the Phase II/III MANATEE study (Part 1) in SMA and the Phase II MANOEUVRE study in FSHD. While emugrobart showed a favorable safety profile and target engagement by reducing mature myostatin, it did not translate into the intended functional outcomes. Specifically, muscle growth and exploratory functional efficacy were neither consistent nor robust enough across study participants to provide sufficient confidence for Phase III development in SMA and FSHD. Emugrobart was well tolerated across both studies, with no serious adverse events or treatment withdrawals. The discontinuation of these studies was not due to safety concerns. As the scientific rationale for continuing to investigate emugrobart in obesity remains strong, this decision does not impact the development of emugrobart in obesity. Obesity is a chronic metabolic disease with symptoms and underlying causes being fundamentally different from neuromuscular conditions like SMA and FSHD. In obesity, muscle quality is not primarily affected by a neurodegenerative (nerve-wasting) or myopathic (muscle-wasting) process and there is generally more myostatin for an anti-myostatin antibody to act on. Consequently, the Phase II development of emugrobart in obesity will continue as planned. Duyuru • Feb 24
Sarepta Therapeutics, Inc. Announces Commercial Launch of ELEVIDYS in Japan Sarepta Therapeutics, Inc. announced the commercial launch of ELEVIDYS (delandistrogene moxeparvovec) in Japan by Chugai Pharmaceutical Co. Ltd., following its reimbursement listing on Japan's National Health Insurance (NHI) price list. ELEVIDYS is the first gene therapy to be launched in Japan for Duchenne muscular dystrophy (DMD). In Japan, ELEVIDYS is available for ambulatory individuals with Duchenne ages 3-to less than 8-years-old, a deletion of any portion or the entirety of exon 8 and/or exon 9 in the DMD gene, and who are negative for anti-AAVrh74 antibodies. Chugai announced that ELEVIDYS has been launched in Japan following reimbursement listing, enabling access for eligible patients under the conditional and time limited approval granted by Japan's Ministry of Health, Labour and Welfare (MHLW) in May 2025. Chugai will be responsible for postmarketing clinical studies and all case postmarketing surveillance in Japan as part of the Roche Group collaboration to further evaluate long-term efficacy and safety. The approval in Japan was based on efficacy and safety data from the ELEVIDYS clinical development program, including results from the global Phase 3 EMBARK study. EMBARK evaluated ELEVIDYS in ambulatory boys with DMD and demonstrated clinically meaningful improvements in key motor function measures. ADVERSE REACTIONS: The most common adverse reactions (incidence 5%) reported in clinical studies were vomiting, nausea, liver injury, pyrexia, thrombocytopenia, and troponin-I increased. Report negative side effects of prescription drugs to the FDA. Duyuru • Oct 25
Chugai Pharmaceutical Co., Ltd. (TSE:4519) agreed to acquire Renalys Pharma for ¥31 billion. Chugai Pharmaceutical Co., Ltd. (TSE:4519) agreed to acquire Renalys Pharma for ¥31 billion on October 24, 2025. A cash consideration of ¥15 billion will be paid by Chugai Pharmaceutical Co., Ltd. Chugai Pharmaceutical Co., Ltd. will pay an earnout/contingent payment of ¥16 billion cash. As part of consideration, ¥31 billion is paid towards common equity of Renalys Pharma. The expected completion of the transaction is November 30, 2025. Duyuru • Feb 01
Chugai Pharmaceutical Co., Ltd. Provides Guidance for the Financial Year Ending December 31, 2025 Chugai Pharmaceutical Co., Ltd. provided consolidated non-audited earnings guidance for the financial year ending December 31, 2025. For the year, company expects revenues of JPY 1,190,000 million, Core operating profit of JPY 570,000 million, Core net income of JPY 410,000 million and Core earnings per share of JPY 250.00. Duyuru • Jan 31
Chugai Pharmaceutical Co., Ltd., Annual General Meeting, Mar 27, 2025 Chugai Pharmaceutical Co., Ltd., Annual General Meeting, Mar 27, 2025. Duyuru • Jan 16
CHEPLAPHARM K.K. agreed to acquire the Japan business concerning the anti-cancer agent Tarceva® Tablets 25, 100, and 150 from Chugai Pharmaceutical Co., Ltd. (TSE:4519). CHEPLAPHARM K.K. agreed to acquire the Japan business concerning the anti-cancer agent Tarceva® Tablets 25, 100, and 150 from Chugai Pharmaceutical Co., Ltd. (TSE:4519) on January 14, 2025. Upon completion, CHEPLAPHARM group will solely market Tarceva after transferring assets related to Tarceva that are owned by Roche Group and Chugai Pharmaceutical Co., Ltd. (TSE:4519), including the marketing authorization and intellectual property rights (patents and trademarks, etc.).
The transfer of the marketing authorization is scheduled to take place on April 1, 2025, and the sales transfer is scheduled to take place in June 2025. Reported Earnings • Oct 27
Third quarter 2024 earnings released: EPS: JP¥66.54 (vs JP¥47.15 in 3Q 2023) Third quarter 2024 results: EPS: JP¥66.54 (up from JP¥47.15 in 3Q 2023). Revenue: JP¥315.7b (up 22% from 3Q 2023). Net income: JP¥109.5b (up 41% from 3Q 2023). Profit margin: 35% (up from 30% in 3Q 2023). The increase in margin was driven by higher revenue. Revenue is forecast to grow 3.8% p.a. on average during the next 3 years, compared to a 3.7% 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 15% per year, which means it is tracking significantly ahead of earnings growth. Buy Or Sell Opportunity • Jul 30
Now 23% overvalued after recent price rise Over the last 90 days, the stock has risen 25% to €38.44. The fair value is estimated to be €31.28, however this is not to be taken as a sell recommendation but rather should be used as a guide only. Revenue has grown by 6.4% over the last 3 years. Earnings per share has grown by 5.7%. For the next 3 years, revenue is forecast to grow by 3.4% per annum. Earnings are also forecast to grow by 3.9% per annum over the same time period. Reported Earnings • Jul 28
Second quarter 2024 earnings released: EPS: JP¥67.98 (vs JP¥50.57 in 2Q 2023) Second quarter 2024 results: EPS: JP¥67.98 (up from JP¥50.57 in 2Q 2023). Revenue: JP¥315.9b (up 18% from 2Q 2023). Net income: JP¥111.9b (up 35% from 2Q 2023). Profit margin: 35% (up from 31% in 2Q 2023). The increase in margin was driven by higher revenue. Revenue is forecast to grow 3.5% 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 increased by 6% per year whereas the company’s share price has increased by 7% per year. Reported Earnings • Apr 25
First quarter 2024 earnings released: EPS: JP¥45.22 (vs JP¥44.68 in 1Q 2023) First quarter 2024 results: EPS: JP¥45.22 (up from JP¥44.68 in 1Q 2023). Revenue: JP¥236.9b (down 24% from 1Q 2023). Net income: JP¥74.4b (up 1.2% from 1Q 2023). Profit margin: 31% (up from 24% in 1Q 2023). The increase in margin was driven by lower expenses. Revenue is forecast to grow 3.9% p.a. on average 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 10% per year but the company’s share price has remained flat, which means it is significantly lagging earnings. Declared Dividend • Apr 11
Final dividend of JP¥41.00 announced Shareholders will receive a dividend of JP¥41.00. Ex-date: 27th June 2024 Payment date: 30th August 2024 Dividend yield will be 132%, which is higher than the industry average of 2.4%. Sustainability & Growth Dividend is well covered by both earnings (40% earnings payout ratio) and cash flows (38% cash payout ratio). The dividend has increased by an average of 19% per year over the past 10 years. However, payments have been volatile during that time. EPS is expected to grow by 18% over the next 3 years, which should provide support to the dividend and adequate earnings cover. Buy Or Sell Opportunity • Mar 09
Now 20% overvalued after recent price rise Over the last 90 days, the stock has risen 15% to €39.60. The fair value is estimated to be €32.98, however this is not to be taken as a sell recommendation but rather should be used as a guide only. Revenue has grown by 16% over the last 3 years. Earnings per share has grown by 14%. For the next 3 years, revenue is forecast to grow by 3.0% per annum. Earnings are also forecast to grow by 5.6% per annum over the same time period. Buy Or Sell Opportunity • Feb 17
Now 20% overvalued after recent price rise Over the last 90 days, the stock has risen 22% to €35.80. The fair value is estimated to be €29.79, however this is not to be taken as a sell recommendation but rather should be used as a guide only. Revenue has grown by 16% over the last 3 years. Earnings per share has grown by 14%. For the next 3 years, revenue is forecast to grow by 2.5% per annum. Earnings are also forecast to grow by 4.2% per annum over the same time period. Reported Earnings • Feb 03
Full year 2023 earnings released: EPS: JP¥198 (vs JP¥228 in FY 2022) Full year 2023 results: EPS: JP¥198 (down from JP¥228 in FY 2022). Revenue: JP¥1.11t (down 12% from FY 2022). Net income: JP¥325.5b (down 13% from FY 2022). Profit margin: 29% (in line with FY 2022). Revenue is forecast to grow 2.3% p.a. on average 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 14% per year but the company’s share price has fallen by 8% per year, which means it is significantly lagging earnings. Upcoming Dividend • Dec 21
Upcoming dividend of JP¥40.00 per share at 1.5% yield Eligible shareholders must have bought the stock before 28 December 2023. Payment date: 01 April 2024. Payout ratio is a comfortable 20% and this is well supported by cash flows. Trailing yield: 1.5%. Lower than top quartile of German dividend payers (5.1%). Lower than average of industry peers (2.6%). Duyuru • Dec 06
Chugai Pharmaceutical Co., Ltd. to Report Fiscal Year 2023 Results on Feb 01, 2024 Chugai Pharmaceutical Co., Ltd. announced that they will report fiscal year 2023 results at 5:00 PM, Tokyo Standard Time on Feb 01, 2024 Reported Earnings • Oct 26
Third quarter 2023 earnings released: EPS: JP¥47.15 (vs JP¥41.21 in 3Q 2022) Third quarter 2023 results: EPS: JP¥47.15 (up from JP¥41.21 in 3Q 2022). Revenue: JP¥257.9b (up 14% from 3Q 2022). Net income: JP¥77.6b (up 14% from 3Q 2022). Profit margin: 30% (in line with 3Q 2022). 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 18% per year but the company’s share price has fallen by 8% per year, which means it is significantly lagging earnings. Reported Earnings • Jul 28
Second quarter 2023 earnings released: EPS: JP¥50.57 (vs JP¥44.00 in 2Q 2022) Second quarter 2023 results: EPS: JP¥50.57 (up from JP¥44.00 in 2Q 2022). Revenue: JP¥267.4b (up 14% from 2Q 2022). Net income: JP¥83.2b (up 15% from 2Q 2022). Profit margin: 31% (in line with 2Q 2022). Revenue is expected to decline by 1.0% p.a. on average during the next 3 years, while revenues in the Pharmaceuticals industry in Germany are expected to grow by 2.7%. Over the last 3 years on average, earnings per share has increased by 22% per year but the company’s share price has fallen by 10% per year, which means it is significantly lagging earnings. Upcoming Dividend • Jun 22
Upcoming dividend of JP¥40.00 per share at 1.9% yield Eligible shareholders must have bought the stock before 29 June 2023. Payment date: 30 August 2023. Payout ratio is a comfortable 41% and this is well supported by cash flows. Trailing yield: 1.9%. Lower than top quartile of German dividend payers (4.7%). Lower than average of industry peers (2.6%). Reported Earnings • Apr 30
First quarter 2023 earnings released: EPS: JP¥44.68 (vs JP¥80.14 in 1Q 2022) First quarter 2023 results: EPS: JP¥44.68 (down from JP¥80.14 in 1Q 2022). Revenue: JP¥312.2b (down 13% from 1Q 2022). Net income: JP¥73.5b (down 44% from 1Q 2022). Profit margin: 24% (down from 37% in 1Q 2022). The decrease in margin was primarily driven by lower revenue. Revenue is forecast to grow 1.1% p.a. on average during the next 3 years, compared to a 3.3% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 27% per year but the company’s share price has fallen by 14% per year, which means it is significantly lagging earnings. Duyuru • Feb 04
Chugai Pharmaceutical Co., Ltd., Annual General Meeting, Mar 30, 2023 Chugai Pharmaceutical Co., Ltd., Annual General Meeting, Mar 30, 2023. Reported Earnings • Feb 03
Full year 2022 earnings released: EPS: JP¥228 (vs JP¥184 in FY 2021) Full year 2022 results: EPS: JP¥228 (up from JP¥184 in FY 2021). Revenue: JP¥1.26t (up 26% from FY 2021). Net income: JP¥374.4b (up 24% from FY 2021). Profit margin: 30% (in line with FY 2021). Revenue is expected to decline by 2.8% p.a. on average during the next 3 years, while revenues in the Pharmaceuticals industry in Germany are expected to grow by 3.6%. Over the last 3 years on average, earnings per share has increased by 32% per year but the company’s share price has fallen by 12% per year, which means it is significantly lagging earnings. Duyuru • Feb 03
Chugai Pharmaceutical Co., Ltd. Provides Consolidated Earnings Guidance for the Financial Year 2023 Chugai Pharmaceutical Co., Ltd. provided consolidated earnings guidance for the financial year 2023. For the year, company expects revenues of ¥1,070,000 million, Core operating profit of ¥415,000 million, Core net income of ¥306,000 million and Core earnings per share of ¥186.00. Buying Opportunity • Jan 24
Now 20% undervalued Over the last 90 days, the stock is up 1.7%. The fair value is estimated to be €29.25, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 21% over the last 3 years. Earnings per share has grown by 34%. For the next 3 years, revenue is forecast to decline by 1.0% per annum. Earnings is forecast to grow by 1.0% per annum over the same time period. Upcoming Dividend • Dec 22
Upcoming dividend of JP¥38.00 per share Eligible shareholders must have bought the stock before 29 December 2022. Payment date: 30 March 2023. Payout ratio is a comfortable 37% and this is well supported by cash flows. Trailing yield: 2.2%. Lower than top quartile of German dividend payers (5.1%). Lower than average of industry peers (2.7%). Buying Opportunity • Dec 03
Now 21% undervalued after recent price drop Over the last 90 days, the stock is down 1.9%. The fair value is estimated to be €31.03, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 21% over the last 3 years. Earnings per share has grown by 34%. For the next 3 years, revenue is forecast to decline by 1.5% per annum. Earnings is forecast to grow by 1.6% per annum over the same time period. Board Change • Nov 17
Less than half of directors are independent There are 5 new directors who have joined the board in the last 3 years. Of these new board members, none were independent directors. The company's board is composed of: 3 independent directors. 6 non-independent directors. Outside Independent Director Masayuki Oku was the last independent director to join the board, commencing their role in 2015. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity. Duyuru • Nov 01
Chugai Pharmaceutical Co., Ltd. to Report Fiscal Year 2022 Results on Feb 02, 2023 Chugai Pharmaceutical Co., Ltd. announced that they will report fiscal year 2022 results at 5:00 PM, Tokyo Standard Time on Feb 02, 2023 Reported Earnings • Oct 25
Third quarter 2022 earnings released: EPS: JP¥41.23 (vs JP¥52.32 in 3Q 2021) Third quarter 2022 results: EPS: JP¥41.23 (down from JP¥52.32 in 3Q 2021). Revenue: JP¥225.3b (down 22% from 3Q 2021). Net income: JP¥67.8b (down 21% from 3Q 2021). Profit margin: 30% (in line with 3Q 2021). Revenue is expected to decline by 2.4% p.a. on average during the next 3 years, while revenues in the Pharmaceuticals industry in Germany are expected to grow by 4.0%. Over the last 3 years on average, earnings per share has increased by 34% per year but the company’s share price has fallen by 2% per year, which means it is significantly lagging earnings. Buying Opportunity • Aug 03
Now 26% undervalued after recent price drop Over the last 90 days, the stock is down 4.4%. The fair value is estimated to be €35.54, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 22% over the last 3 years. Earnings per share has grown by 37%. For the next 3 years, revenue is forecast to decline by 1.8% per annum. Earnings is forecast to grow by 0.6% per annum over the same time period. Duyuru • Aug 02
Chugai Pharmaceutical Co., Ltd. to Report Q2, 2022 Results on Aug 21, 2022 Chugai Pharmaceutical Co., Ltd. announced that they will report Q2, 2022 results on Aug 21, 2022 Reported Earnings • Jul 22
Second quarter 2022 earnings released: EPS: JP¥44.00 (vs JP¥43.02 in 2Q 2021) Second quarter 2022 results: EPS: JP¥44.00 (up from JP¥43.02 in 2Q 2021). Revenue: JP¥235.6b (up 6.4% from 2Q 2021). Net income: JP¥72.4b (up 2.3% from 2Q 2021). Profit margin: 31% (down from 32% in 2Q 2021). The decrease in margin was driven by higher expenses. Over the next year, revenue is expected to shrink by 7.2% compared to a 8.0% growth forecast for the industry in Germany. Over the last 3 years on average, earnings per share has increased by 37% per year but the company’s share price has only increased by 8% per year, which means it is significantly lagging earnings growth. Duyuru • Jun 29
Chugai Pharmaceutical Co., Ltd. to Report Nine Months, 2022 Results on Oct 24, 2022 Chugai Pharmaceutical Co., Ltd. announced that they will report nine months, 2022 results on Oct 24, 2022 Upcoming Dividend • Jun 22
Upcoming dividend of JP¥38.00 per share Eligible shareholders must have bought the stock before 29 June 2022. Payment date: 30 August 2022. Payout ratio is a comfortable 32% 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%). Duyuru • May 29
Chugai Pharmaceutical Co., Ltd. to Report Q2, 2022 Results on Jul 21, 2022 Chugai Pharmaceutical Co., Ltd. announced that they will report Q2, 2022 results on Jul 21, 2022 Board Change • Apr 29
Less than half of directors are independent There are 5 new directors who have joined the board in the last 3 years. Of these new board members, none were independent directors. The company's board is composed of: 3 independent directors. 6 non-independent directors. Outside Independent Director Masayuki Oku was the last independent director to join the board, commencing their role in 2015. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity. Duyuru • Apr 08
Chugai Pharmaceutical Co., Ltd. to Report Q1, 2022 Results on Apr 25, 2022 Chugai Pharmaceutical Co., Ltd. announced that they will report Q1, 2022 results on Apr 25, 2022 Buying Opportunity • Feb 15
Now 22% undervalued after recent price drop Over the last 90 days, the stock is down 7.1%. The fair value is estimated to be JP¥36.99, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 16% per annum over the last 3 years. Earnings per share has grown by 34% per annum over the last 3 years. Duyuru • Feb 06
Chugai Pharmaceutical Co., Ltd., Annual General Meeting, Mar 29, 2022 Chugai Pharmaceutical Co., Ltd., Annual General Meeting, Mar 29, 2022. Reported Earnings • Feb 04
Full year 2021 earnings: EPS in line with analyst expectations despite revenue beat Full year 2021 results: EPS: JP¥184 (up from JP¥131 in FY 2020). Revenue: JP¥999.8b (up 27% from FY 2020). Net income: JP¥303.0b (up 41% from FY 2020). Profit margin: 30% (up from 27% in FY 2020). The increase in margin was driven by higher revenue. Revenue exceeded analyst estimates by 2.5%. Over the next year, revenue is forecast to grow 4.0%, compared to a 7.1% growth forecast for the pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 34% per year but the company’s share price has only increased by 19% per year, which means it is significantly lagging earnings growth. Upcoming Dividend • Dec 22
Upcoming dividend of JP¥30.00 per share Eligible shareholders must have bought the stock before 29 December 2021. Payment date: 24 March 2022. Payout ratio is a comfortable 38% and this is well supported by cash flows. Trailing yield: 1.6%. Lower than top quartile of German dividend payers (3.3%). Lower than average of industry peers (2.6%). Board Change • Nov 05
Less than half of directors are independent There are 5 new directors who have joined the board in the last 3 years. Of these new board members, none were independent directors. The company's board is composed of: 3 independent directors. 6 non-independent directors. Outside Independent Director Masayuki Oku was the last independent director to join the board, commencing their role in 2015. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity. Reported Earnings • Oct 23
Third quarter 2021 earnings released: EPS JP¥52.32 (vs JP¥36.58 in 3Q 2020) The company reported a strong third quarter result with improved earnings, revenues and profit margins. Third quarter 2021 results: Revenue: JP¥287.3b (up 38% from 3Q 2020). Net income: JP¥86.0b (up 43% from 3Q 2020). Profit margin: 30% (up from 29% in 3Q 2020). The increase in margin was driven by higher revenue. Over the last 3 years on average, earnings per share has increased by 34% per year but the company’s share price has only increased by 19% per year, which means it is significantly lagging earnings growth. Reported Earnings • Jul 27
Second quarter 2021 earnings released: EPS JP¥43.02 (vs JP¥30.89 in 2Q 2020) The company reported a strong second quarter result with improved earnings, revenues and profit margins. Second quarter 2021 results: Revenue: JP¥221.4b (up 17% from 2Q 2020). Net income: JP¥70.7b (up 39% from 2Q 2020). Profit margin: 32% (up from 27% in 2Q 2020). The increase in margin was driven by higher revenue. Over the last 3 years on average, earnings per share has increased by 35% per year but the company’s share price has only increased by 29% per year, which means it is significantly lagging earnings growth. Duyuru • Jul 20
Chugai Pharmaceutical Co., Ltd. Obtains Regulatory Approval from the Ministry of Health, Labour and Welfare for the Anti-SARS-CoV-2 Monoclonal Antibody RONAPREVE Chugai Pharmaceutical Co., Ltd. announced that it obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for the anti-SARS-CoV-2 monoclonal antibody RONAPREVE for Intravenous Infusion Set 300 and Set 1332 [generic name: Casirivimab (genetical recombination) /Imdevimab (genetical recombination)] for the indication of SARS-CoV-2 infection on July 19. The Special Approval for Emergency under article 14-3 of the Pharmaceuticals and Medical Devices Act was applied to this approval. This approval is based on the results from the global phase III clinical study (REGN-COV 2067 study) in patients with COVID-19 and a phase I clinical study to examine the safety, tolerability, and pharmacokinetics in Japanese. Under the agreement with the Japanese government, the domestic supply of Ronapreve is secured for use in 2021. The company will continue to collaborate with the Japanese government to ensure an appropriate and timely supply of the antibody cocktail. Combining two virus-neutralizing antibodies, casirivimab and imdevimab, Ronapreve has been created by Regeneron (U.S.) for the potential treatment and prevention of COVID-19. In August 2020, Regeneron and Roche announced a collaboration to manufacture, develop and distribute the antibody cocktail. In December of the same year, Chugai obtained development and exclusive commercialization rights in Japan from Roche. Ronapreve has not been approved in countries other than Japan at the moment. Product name: RONAPREVE for Intravenous Infusion Set 300RONAPREVE for Intravenous Infusion Set 1332 Generic name: casirivimab (genetical recombination) imdevimab (genetical recombination) Indications: SARS-CoV-2 infection Dosage and The usual dose for adults and children aged 12 years and older and weighing 40 kg or administration: more is 600 mg casirivimab (genetical recombination) and 600 mg imdevimab (genetical recombination) given as a single intravenous dose. Duyuru • Jun 30
Chugai Pharmaceutical Co., Ltd. Announces That Roche Has Been Granted Marketing Authorization from the European Commission Chugai Pharmaceutical Co., Ltd. announced that Roche has been granted Marketing Authorization from the European Commission for the pH-dependent binding humanized anti-IL-6 receptor monoclonal antibody Enspryng® (satralizumab), created by Chugai, as the first subcutaneous treatment option for adults and adolescents from 12 years of age living with anti-aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD), as a monotherapy or in combination with immunosuppressive therapy (IST). Enspryng is the first treatment approved in the EU for adolescents from 12 years of age with NMOSD. The efficacy and safety of Enspryng has been evaluated in large clinical trials representative of the real-world population of people with NMOSD, including those who have only experienced a single NMOSD attack and adolescents. The approval by the European Commission is based on the results from two global phase III clinical studies in people with NMOSD: SAkuraSky Study (NCT02028884) and SAkuraStar Study (NCT02073279). SAkuraSky evaluated Enspryng in combination with baseline immunosuppressive treatment, and SAkuraStar assessed monotherapy. Enspryng is designed to prevent NMOSD relapses by inhibiting IL-6 signal signaling, which is a key driver in NMOSD. Enspryng is currently approved in 54 countries including Japan, the United States and EU countries. The impact on the consolidated financials for the fiscal year ending December 2021 of Chugai is expected to be negligible. Self-administration is not covered in Japan at this time. Subcutaneous administration at 2-week intervals up to the fourth week of treatment and at 4-week intervals thereafter. New Data of Chugai’s Enspryng (Satralizumab) on Risk and Severity of Relapse in Neuromyelitis Optica Spectrum Disorder (NMOSD) (September 10, 2020). SAkuraSky study Results from Phase III SAkuraSky Study for Chugai’s Satralizumab in Neuromyelitis Optica Spectrum Disorder Published in The New England Journal of Medicine Online (November 29, 2019). SAkuraStar study Positive Results from the Second Phase III SAkuraStar Study for Chugai’s Satralizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD) Published in The Lancet Neurology (April 24, 2020). Upcoming Dividend • Jun 22
Upcoming dividend of JP¥30.00 per share Eligible shareholders must have bought the stock before 29 June 2021. Payment date: 28 August 2021. Trailing yield: 1.5%. Lower than top quartile of German dividend payers (3.1%). Lower than average of industry peers (2.8%). Duyuru • Apr 27
CHMP Recommends EU Approval of Chugai's Enspryng (Satralizumab) for Neuromyelitis Optica Spectrum Disorder Chugai Pharmaceutical Co., Ltd. announced that Roche has received notification that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the approval of the pH-dependent binding humanized anti-IL-6 receptor monoclonal antibody Enspryng® (satralizumab), created by the company, as the first subcutaneous treatment option for adults and adolescents from 12 years of age living with anti-aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD), as a monotherapy or in combination with immunosuppressive therapy. Enspryng has been evaluated for efficacy and safety in clinical trials in NMOSD including people who have only experienced a single NMOSD attack and adolescents, and is expected to be approved in the EU. The positive recommendation is based on the results from two global phase III clinical studies in people with NMOSD: SAkuraSky Study (NCT02028884) and SAkuraStar Study (NCT02073279). SAkuraSky evaluated Enspryng in combination with baseline immunosuppressive treatment, and SAkuraStar assessed monotherapy. Enspryng is designed to prevent NMOSD relapses by inhibiting IL-6 signal signaling which is a key driver in NMOSD. Enspryng is currently approved in 20 countries including Japan and the United States. About neuromyelitis optica spectrum disorder (NMOSD): NMOSD is an autoimmune disease of the central nervous system characterized by inflammatory lesions in the optic nerves and spinal cord, and causes a continual and significant decrease in quality of life due to permanent neurological disability. Patients with NMOSD frequently experience a relapsing disease course with repeated attacks leading to accumulating neurological damage and disability. Symptoms may include visual impairment, motor disability, pain leading to decreased quality of life. In some cases, attacks of NMOSD result in death. Aquaporin-4 antibodies (AQP4-IgG), pathogenic antibodies, are detected in around 70-80% of NMOSD people. AQP4-IgG is known to target and damage a specific central nervous cell type called astrocytes, resulting in inflammatory demyelinating lesions of the optic nerve(s), spinal cord and brain 2-5. The inflammatory cytokine IL-6 is now emerging as an important factor in NMOSD pathogenesis 6-10. Diagnostic criteria introduced in 2006 for NMO were characterized by inflammation of the optic nerve (optic neuritis) and the spinal cord (myelitis). These were revised in 2007 with the definition of NMOSD, proposed for diseases with either optic neuritis or myelitis. In 2015, the definition of NMOSD further revised to include a broader spectrum of diseases. The diagnostic term NMOSD is now accepted 11. Duyuru • Apr 24
Chugai Pharmaceutical Co., Ltd. Provides Earnings Guidance for the Full Year Ending December 31, 2021 Chugai Pharmaceutical Co., Ltd. provided earnings guidance for the full year ending December 31, 2021. On consolidated basis, the company expects revenues of ¥168,817 million, core operating profit of ¥65,353 million, core net income of ¥48,396 million and core earnings per share of ¥29.42. Duyuru • Feb 20
Atea Pharmaceuticals Announces Chugai In-License of AT-527 from Roche for the Treatment of COVID-19 in Japan Atea Pharmaceuticals Inc. announced that Chugai Pharmaceutical Co., Ltd. has in-licensed the rights for AT-527 for the treatment of COVID-19 in Japan from Roche. Under a strategic collaboration, Roche and Atea are jointly developing AT-527 for the treatment of COVID-19 and Roche has the right to commercialize AT-527 outside of the United States. AT-527 is an orally administered, direct-acting antiviral developmental agent derived from Atea’s purine nucleotide prodrug platform and is in Phase 2 development for the treatment of COVID-19. Atea and Roche announced a strategic collaboration on October 22, 2020. The collaboration aims to accelerate the clinical development and manufacturing of AT-527, to investigate its safety and efficacy, and to provide this potential treatment option to patients around the world as quickly as possible. Duyuru • Feb 04
Chugai Pharmaceutical Co., Ltd Announces Executive Changes Chugai Pharmaceutical Co., Ltd. announced that, based on the recommendation of the Appointment Committee, the Company resolved at the Board of Directors Meeting held to appoint Osamu Okuda, currently Representative Director, President and Chief Operating Officer (COO), as Chief Executive Officer (CEO) as of March 23, 2021. Under the new management structure, Tatsuro Kosaka will continue to chair the board in his capacity as Representative Director and Chairman. Dr. Osamu Okuda will bear the role and responsibilities for decision- making over company-wide strategies and the execution of operations in his capacity as Representative Director, President and CEO. Is New 90 Day High Low • Jan 09
New 90-day high: €47.00 The company is up 31% from its price of €36.00 on 09 October 2020. The German market is up 8.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is up 11% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €34.62 per share. Is New 90 Day High Low • Dec 24
New 90-day high: €42.20 The company is up 12% from its price of €37.80 on 25 September 2020. The German market is up 9.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is flat over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €30.51 per share. Upcoming Dividend • Dec 22
Upcoming Dividend of JP¥25.00 Per Share Will be paid on the 31st of March to those who are registered shareholders by the 29th of December. The trailing yield of 1.0% is below the top quartile of German dividend payers (3.5%), and is lower than industry peers (3.1%). 
