Market Share and Product Performance - The company holds a 64.6% market share in the treatment of thrombocytopenia in mainland China for its product Tevazo, according to IQVIA data for the first half of 2023[5]. - The company has a 42.9% market share in the rhEPO market in mainland China, maintaining its leadership for the past 20 years[5]. - The company’s product Mandi has a dominant market share of 70.3% in the minoxidil solution market in mainland China as of the first half of 2023[5]. - The company’s TNFα inhibitor product Yisai has captured 23.7% of the TNFα market in mainland China during the same period[5]. - Tebentafusp holds a 33.1% market share by volume and 64.6% by sales in the treatment of thrombocytopenia in mainland China as of the first half of 2023[13]. - Yibiao has maintained a dominant position in the rhEPO market in mainland China since 2002, with a significant market share alongside Cybor[14]. - Yisaipu's market share in the TNFα inhibitor market in mainland China was 23.7% in the first half of 2023, reflecting a decline due to increased competition and price adjustments[15]. - Mandi holds a 70.3% market share in mainland China with a sales growth of 35.3% year-on-year in the first half of 2023[18]. Financial Performance - Revenue increased by RMB 689.3 million or 22.3% to RMB 3,783.8 million for the six months ended June 30, 2022[10]. - Gross profit rose by RMB 636.4 million or 24.8% to RMB 3,201.6 million, with gross margin increasing from 82.9% to 84.6%[10]. - Net profit attributable to equity holders increased by RMB 13.7 million or 1.4% to RMB 980.6 million, while normalized net profit rose by RMB 199.3 million or 20.1% to RMB 1,191.5 million[10]. - EBITDA grew by RMB 37.5 million or 2.9% to RMB 1,330.5 million, with normalized EBITDA increasing by RMB 228.4 million or 17.7% to RMB 1,518.1 million[10]. - The company's revenue for the reporting period was approximately RMB 3,783.8 million, an increase of about RMB 689.3 million or 22.3% compared to RMB 3,094.5 million for the same period last year[36]. - The gross profit increased to approximately RMB 3,201.6 million, up by about RMB 636.4 million or 24.8%, with a gross margin rising from approximately 82.9% to 84.6%[40]. - The company reported a total comprehensive income of RMB 933,638 thousand for the first half of 2023, compared to RMB 892,185 thousand in 2022[92]. Research and Development - As of June 30, 2023, the company is actively developing 30 pipeline products, with 25 being innovative drugs in mainland China[6]. - The company is focusing on expanding its CDMO business to increase revenue scale, which has been operational since December 2021[5]. - The company is advancing multiple innovative biopharmaceuticals and small molecule drugs, including SSS06 (NuPIAO) for anemia and 608 for autoimmune diseases[26]. - The R&D team consists of nearly 600 experienced scientists focused on accelerating clinical development and seeking breakthrough therapies[26]. - The company is actively promoting the long-term efficacy and safety of Yisaipu through post-marketing clinical studies[15]. Clinical Trials and Approvals - The first patient has been enrolled in the Phase III clinical study of Tebentafusp for chronic liver disease-related thrombocytopenia[12]. - The NDA for Remitch® has been approved for treating pruritus in hemodialysis patients, marking it as the first selective opioid κ receptor agonist approved for this indication in China[12]. - Yibiao has been approved for three indications: anemia due to chronic kidney disease (CKD), chemotherapy-induced anemia (CIA), and perioperative red blood cell mobilization[14]. - The pre-filled Yisaipu injection has been approved by the National Medical Products Administration in March 2023, expected to enhance patient convenience and drive further growth[15]. - The company has initiated a Phase III clinical trial for anti-IL-17A monoclonal antibody (608) for plaque psoriasis, with primary endpoint data expected in the second half of 2023[30]. Distribution and Market Presence - The company has established a national distribution network selling products to approximately 8,700 hospitals and medical institutions across mainland China[6]. - The sales and marketing network consists of approximately 2,704 sales and marketing personnel, 1,144 distributors, and 1,889 third-party promoters[33]. - The company’s products are sold in nearly 2,700 tertiary hospitals and over 6,000 secondary or lower-level hospitals across all provinces in mainland China[33]. Employee and Operational Metrics - The company employs 5,311 staff across its operational facilities in Shenyang, Shanghai, Hangzhou, Shenzhen, and Como, Italy[6]. - The group employed a total of 5,311 employees as of June 30, 2023, compared to 5,213 employees as of December 31, 2022, with employee costs amounting to approximately RMB 604.4 million during the reporting period[59]. Debt and Financing - As of June 30, 2023, the total interest-bearing bank borrowings of the group amounted to approximately RMB 3,725.7 million, an increase from RMB 2,315.0 million as of December 31, 2022, reflecting new bank borrowings of approximately RMB 1,640.9 million during the reporting period[54]. - The group’s leverage ratio increased from approximately 29.2% as of December 31, 2022, to approximately 30.9% as of June 30, 2023[54]. - The financing costs increased to approximately RMB 88.9 million, an increase of about RMB 52.4 million or approximately 143.6% compared to RMB 36.5 million for the six months ended June 30, 2022[47]. Shareholder Information and Stock Options - The company has authorized the issuance of up to 242,439,857 shares under the stock option plan, representing approximately 9.94% of the issued shares as of the report date[67]. - The stock option plan is designed to provide selected participants with an opportunity to acquire ownership interests in the company, encouraging efforts to enhance the company's value[67]. - The stock options granted to employees (excluding directors) as of June 30, 2023, included 15,656,000 options, with 50,000 options exercised during the period[70]. - The company adopted the 2019 Share Award Scheme on July 16, 2019, allowing a maximum of 10% of the total issued shares at the adoption date for awards, which amounted to 253,500,255 shares[72]. Regulatory and Compliance - The independent review report concluded that no matters were found that would lead to a belief that the interim financial information was not prepared in accordance with International Accounting Standard 34[88]. - The company has applied new and revised International Financial Reporting Standards from January 1, 2023, with no impact on the interim consolidated financial information[106].
三生制药(01530) - 2023 - 中期财报