Financial Performance - Total revenue for the year ended December 31, 2024, was RMB 21,387,000, representing a 6.5% increase from RMB 20,085,000 in 2023[9] - The net loss before tax decreased by 32.5% to RMB 168,235,000 in 2024 from RMB 249,350,000 in 2023[9] - Basic and diluted loss per share improved by 33.6% to RMB 0.83 in 2024 from RMB 1.25 in 2023[9] - The company's other income increased by approximately 6.5% from RMB 20.1 million in 2023 to RMB 21.4 million in 2024, primarily due to government subsidies related to R&D activities amounting to RMB 6.4 million[40] - The net other income decreased by approximately 34.9% from RMB 18.2 million in 2023 to RMB 11.8 million in 2024, mainly due to a reduction in foreign exchange gains of about RMB 5.7 million[43] - Administrative expenses were reduced by 25.5% to RMB 64,795,000 in 2024 from RMB 87,011,000 in 2023[9] - R&D expenses decreased by approximately 21.7% from RMB 172.7 million in 2023 to RMB 135.1 million in 2024, mainly due to reduced depreciation and amortization related to LZ901[46] - The company reported a pre-tax loss of RMB 168.2 million in 2024, a decrease of approximately 32.5% from RMB 249.4 million in 2023[38] Clinical Development and Product Pipeline - The company completed the enrollment of 26,000 healthy participants in the Phase III clinical trial for its core product, LZ901, in January 2024[14] - LZ901's Biologics License Application (BLA) has been accepted by the National Medical Products Administration in China, with commercialization efforts ongoing[14] - The company initiated two new clinical-stage vaccine products targeting HSV-1 and HSV-2, addressing unmet medical needs globally[15] - The company has six clinical-stage products in its pipeline, including LZ901, and additional preclinical products under development[12] - The core product LZ901 is expected to progress in its listing application in China and clinical trials in the US, with commercialization anticipated in the first half of 2026[18][24] - K3, a biosimilar to Humira®, is under evaluation for a Phase III trial in China, expected to start as early as the first half of 2026[26] - K193, a bispecific antibody for treating B-cell leukemia and lymphoma, is in Phase I trials, with completion expected in the second half of 2025[27] - The company plans to advance more products into clinical research stages in 2025, aiming to meet growing market demand[18] Assets and Liabilities - Non-current assets increased to RMB 577,587,000 in 2024 from RMB 545,722,000 in 2023, reflecting a growth of 5.9%[11] - Current assets decreased to RMB 472,876,000 in 2024 from RMB 620,972,000 in 2023, a decline of 23.8%[11] - The group's property, plant, and equipment increased by approximately 19.2% from about RMB 383.9 million as of December 31, 2023, to about RMB 457.6 million as of December 31, 2024, mainly due to the construction of a new R&D and production base in Beijing[52] - The group's prepaid expenses, deposits, and other receivables decreased by approximately 58.8% from about RMB 62.3 million as of December 31, 2023, to about RMB 25.6 million as of December 31, 2024, primarily due to a reduction in recoverable VAT[53] - The group's bank balance decreased by approximately RMB 124.9 million from about RMB 265.0 million as of December 31, 2023, to about RMB 140.1 million as of December 31, 2024, mainly due to share buybacks and capital expenditures[54] - The group's total bank borrowings increased to approximately RMB 54.9 million as of December 31, 2024, compared to about RMB 7.0 million as of December 31, 2023[54] - The group's debt-to-asset ratio increased to 18.7% as of December 31, 2024, from 12.5% as of December 31, 2023[59] - The group's net current assets decreased from about RMB 524.7 million as of December 31, 2023, to about RMB 374.0 million as of December 31, 2024[60] Corporate Governance and Management - The company has established a comprehensive internal product discovery capability, with a research and development team consisting of 17 personnel as of December 31, 2024[34] - The company is constructing a new R&D and production facility in Beijing with a total area of approximately 45,072.87 square meters[36] - The company’s production team includes 43 personnel, while the quality control team consists of 44 personnel, all trained in regulatory and quality control standards[36] - The company has a strong emphasis on quality control and assurance in its vaccine production processes[87] - The company has a strategic focus on expanding its product pipeline and enhancing clinical trial management[87] - The company’s board includes members with extensive experience in drug development and biopharmaceutical research[89] - The company is committed to providing independent oversight and strategic advice through its independent non-executive directors[92] Shareholder Information - The company did not declare any final dividends for the reporting period[147] - The company has no distributable reserves as of December 31, 2024[157] - The company may face challenges in managing its growth and business expansion[146] - The total issued share capital of the company as of December 31, 2024, includes 202,449,032 H-shares, which encompasses 1,460,000 shares held in treasury[173] - The total percentage of shareholding for Mr. Kong, Ms. Zhang, and Mr. Ma combined is significant, indicating a concentrated ownership structure within the company[170] Risks and Challenges - The group faced significant risks related to the success of its clinical-stage and preclinical-stage products, which may not receive regulatory approval or may experience delays[131] - The group may encounter difficulties in recruiting clinical trial participants, potentially delaying clinical development activities[131] - The group generated a net loss and negative operating cash flow during the reporting period, with expectations of continued losses[140] - The group may require additional financing for research and operational expansion, which may not be secured[140] - The group is exposed to supply chain risks, including price increases or supply disruptions that could adversely affect its business[136] Compliance and Regulations - The group has complied with all relevant laws and regulations without any serious violations during the reporting period[145] - The pharmaceutical industry in China is highly regulated, and changes in regulations may affect the approval and commercialization of the company's research products[146]
绿竹生物-B(02480) - 2024 - 年度财报