AKESO(HK:09926)2024-08-28 13:56Financial Performance - Total revenue for the six months ended June 30, 2024, was RMB 1,024.7 million, a significant decrease from RMB 3,676.9 million for the same period in 2023[1]. - Gross profit for the six months ended June 30, 2024, was RMB 943.2 million, down from RMB 3,599.7 million in the same period last year[2]. - The company recorded a loss of RMB 249.3 million for the six months ended June 30, 2024, compared to a profit of RMB 2,489.5 million in the previous year[3]. - Other income and net gains for the six months ended June 30, 2024, were RMB 211.8 million, down from RMB 380.1 million in the same period in 2023[42]. - The company reported a loss before tax of RMB 249,348 thousand for the six months ended June 30, 2024, compared to a profit of RMB 2,489,544 thousand in the same period of 2023[72]. - The basic loss per share for the current period was RMB (0.28), compared to earnings of RMB 3.01 per share in the previous year[74]. - The company did not declare or pay any dividends for the six months ended June 30, 2024, consistent with the previous year[97]. Revenue Sources - Product revenue increased by 23.96% to RMB 939.4 million compared to RMB 757.9 million in the previous year[1]. - Sales of the product Akeso® (Cadonilimab) reached approximately RMB 705.7 million, a 16.50% increase from RMB 605.8 million in the same period last year[7]. - The main revenue source was from Kadtunili® (Cardunili, PD-1/CTLA-4), generating RMB 705.7 million, up 16.50% from RMB 605.8 million in the previous year[39]. - Revenue from licensed fees for the six months ended June 30, 2024, was RMB 85,318,000, a substantial drop from RMB 2,918,988,000 in the same period of 2023[86]. - Revenue from customers in mainland China for the six months ended June 30, 2024, was RMB 938,131,000, up from RMB 756,189,000 in 2023, reflecting an increase of approximately 24.0%[89]. Research and Development - The company has over 50 innovative projects in development, with 10 products in commercialization or Phase III clinical trials[5]. - The company is actively pursuing clinical development for Ivosidenib in various indications, including a Phase III trial for biliary cancer and another for pancreatic cancer[16]. - The company is advancing multiple clinical trials, including AK111 (IL-17) for psoriasis and ankylosing spondylitis, and AK120 (IL-4Rα) for moderate to severe atopic dermatitis[21]. - The company is focusing on expanding its ADC platform, with IND applications submitted for AK138D1 (HER3 ADC) for late-stage malignancies[37]. - The company is committed to advancing its clinical development and exploration of various therapeutic areas, ensuring efficient progress across its pipeline[22]. Clinical Trials and Approvals - The sNDA for Cadonilimab as a first-line treatment for gastric cancer was accepted by NMPA in January 2024, with positive Phase III trial results presented at the AACR annual meeting[8]. - Cardinili has entered the third phase of clinical trials for its combination therapy with chemotherapy for advanced gastric and gastroesophageal junction cancer, with the first patient enrolled[11]. - The company received approval for the new drug Yida Fang® (Ivosidenib) for treating locally advanced or metastatic non-squamous NSCLC after progression on EGFR-TKI therapy, marking its second core dual antibody entering commercialization[12][13]. - The company has initiated a Phase III clinical trial for the combination therapy of AK117 (CD47) and other agents in head and neck squamous cell carcinoma[20]. - The company is currently enrolling patients for a study involving AK117 combined with chemotherapy for first-line gastric cancer[26]. Market Expansion and Strategy - The company expects to become a global leader in biopharmaceuticals through innovative R&D and commercialization platforms[5]. - The company is preparing for commercialization of its products by developing comprehensive business plans considering patient affordability, market accessibility, and competitive landscape[20]. - The company is actively pursuing market expansion and new product development strategies, focusing on immunotherapy and metabolic disease treatments[29]. - The company aims to enhance its market presence globally, leveraging innovative therapies to benefit patients worldwide[38]. - The company is expanding its commercialization team to enhance hospital and commercial insurance access, aiming to explore more clinical opportunities with its core bispecific products[38]. Financial Position - As of June 30, 2024, the group's current assets totaled RMB 6,746.5 million, with cash and cash equivalents, time deposits, and financial products amounting to RMB 5,693.6 million, an increase of RMB 799.2 million from RMB 4,894.4 million as of December 31, 2023[49]. - The group has pledged assets and land use rights totaling RMB 1,301.2 million to secure its loans and bank credit facilities as of June 30, 2024[51]. - The group's capital commitments as of June 30, 2024, were RMB 778.5 million, up from RMB 770.0 million as of December 31, 2023, primarily for the construction of world-class production facilities[57]. - The company's total assets minus current liabilities reached RMB 9,049,598 thousand, compared to RMB 7,976,508 thousand in 2023, indicating an increase of approximately 13.46%[75]. - The company’s total current liabilities rose to RMB 1,409,717 thousand, up from RMB 1,204,582 thousand, reflecting an increase of about 17.03%[75]. Employee and Operational Metrics - As of June 30, 2024, the total number of employees is 2,815, with 642 in clinical roles and 575 in production and quality control[30]. - The total employee compensation cost was RMB 539.2 million, an increase from RMB 408.0 million as of June 30, 2023, primarily due to an increase in employee numbers[59]. - The company operates a total production capacity of 54,000 liters, with plans for continuous expansion to meet future clinical and commercialization needs[31]. - The Zhongshan Cuixing Kangfang Bay Technology Park has a planned production capacity exceeding 100,000 liters, equipped with advanced biopharmaceutical facilities[31]. - The company has established production facilities compliant with GMP requirements, supporting the entire drug development process from discovery to commercial production[31].