Financial Performance - Total revenue for the six months ended June 30, 2023, was RMB 5,339,000, a decrease of 16.1% compared to RMB 6,363,000 in the same period of 2022[2]. - The net loss for the period was RMB 79,352,000, representing an 87.8% reduction from a loss of RMB 652,080,000 in the prior year[2]. - The company recorded no revenue for the six months ended June 30, 2023, consistent with the same period in 2022[11]. - The company reported a net loss attributable to owners of RMB (79,352,000) for the six months ended June 30, 2023, compared to a net loss of RMB (652,080,000) in the same period of 2022, indicating a significant improvement[16]. - The company’s basic and diluted loss per share improved to RMB 0.41 from RMB 6.64 in the same period last year[4]. - The pre-tax loss decreased by approximately 87.8% from RMB 652.1 million in the six months ended June 30, 2022, to RMB 79.4 million in the six months ended June 30, 2023[47]. - The adjusted loss for the period decreased by approximately 39.9% from RMB 880 million in the six months ended June 30, 2022, to RMB 529 million in the six months ended June 30, 2023[50]. Research and Development - Research and development expenses decreased by 39.9% to RMB 33,157,000 from RMB 55,186,000 in the previous period[2]. - The company successfully completed Phase II clinical trials for its core product LZ901 in China, with statistically significant results and good safety profiles[3]. - The company plans to initiate Phase III clinical trials for LZ901 in China in Q3 2023, based on the Phase II trial data[3]. - The company has established an innovative precision protein engineering platform for drug development, supporting the development of human vaccines and monoclonal antibodies[28]. - LZ901, the company's recombinant herpes zoster vaccine, has shown high immunogenicity and safety in Phase II clinical trials, with significant antibody geometric mean concentrations compared to placebo[30]. - The company plans to initiate a Phase III clinical trial for LZ901 in China in Q3 2023 and submit a Biologics License Application (BLA) to the National Medical Products Administration in H2 2024[30]. - The company aims to expand the participant age range for the Phase III trial of LZ901 to adults aged 40 and above in China[30]. - The company has received IND approval from the FDA for LZ901 and plans to complete Phase I trials in the U.S. by Q1 2024[30]. - K3, a biosimilar to Humira®, is expected to enter Phase III clinical trials in Q1 2024 and aims for commercialization by Q4 2025 in China[31]. - K193, a bispecific antibody for B-cell leukemia and lymphoma, is projected to complete Phase I trials by Q1 2024 and enter Phase II trials in Q2 2024[32]. - Other pipeline products include recombinant varicella vaccine and rabies vaccine, with the latter submitting a Pre-IND application in Q4 2023[33]. Expenses and Costs - Administrative expenses decreased by 7.5% to RMB 41,239,000 from RMB 44,603,000 year-on-year[2]. - The company incurred listing expenses of RMB 26,459,000, an increase of 111.5% compared to RMB 12,513,000 in the previous period[2]. - The cost of sales for the immune reagent testing kits was RMB 280,000, down from RMB 348,000 in the previous year, reflecting a 19.5% decrease[13]. - Other expenses significantly decreased by approximately 90.3% from RMB 2.9 million to RMB 0.3 million for the same period, mainly due to the absence of costs related to financial liabilities from a previous financing round[40]. - Financing costs increased by 12.5% from RMB 3 million in the six months ended June 30, 2022, to RMB 4 million in the six months ended June 30, 2023[45]. - Listing expenses increased by approximately 111.5% from RMB 125 million in the six months ended June 30, 2022, to RMB 265 million in the six months ended June 30, 2023[46]. Assets and Liabilities - The total assets as of June 30, 2023, were RMB 1,250,495,000, compared to RMB 1,070,170,000 as of December 31, 2022[5]. - The company’s net asset value increased to RMB 1,151,773,000 from RMB 937,466,000 year-on-year[5]. - The estimated unused tax losses as of June 30, 2023, were approximately RMB 242,129,000, up from RMB 170,512,000 as of December 31, 2022[15]. - Right-of-use assets increased by RMB 46,622,000 during the reporting period, reflecting investments in R&D and commercial production facilities in Beijing[18]. - The construction in progress for commercial production facilities in Zhuhai and Beijing increased by RMB 42,846,000 and RMB 77,277,000, respectively, during the reporting period[19]. - Total prepayments and other receivables decreased significantly to RMB 42,311,000 as of June 30, 2023, from RMB 190,469,000 as of December 31, 2022[20]. - The company obtained a new bank loan of RMB 10,000,000 at an annual interest rate of 2.35%, due within one year[22]. - As of June 30, 2023, the total deferred government grants amounted to RMB 34,186,000, a decrease from RMB 36,771,000 as of December 31, 2022[23]. - The company reported a capital expenditure commitment of RMB 25,701,000 for equipment and construction projects as of June 30, 2023, compared to RMB 13,498,000 as of December 31, 2022[27]. - The debt-to-asset ratio decreased to 7.9% as of June 30, 2023, compared to 12.4% as of December 31, 2022[52]. Corporate Governance and Compliance - The company has complied with all applicable corporate governance codes since the listing date[60]. - The company emphasizes the importance of regulatory compliance with the National Medical Products Administration in China[67]. - The company aims to comply with Good Manufacturing Practices (GMP) to ensure quality assurance in its production processes[66]. - The company is committed to reducing risks of contamination and errors in drug production through adherence to regulatory guidelines[66]. - The board of directors includes key figures such as Mr. Kong Jian, who serves as the executive director and chairman[68]. Employee and Organizational Structure - The company employed 129 full-time employees as of June 30, 2023, and has established a performance evaluation system for employee assessments[58]. - The employee incentive plan adopted prior to the listing does not involve the issuance of new shares or options[59]. - The production team consists of 29 members, and the quality control team has 28 members, both trained in regulatory and GMP standards[36]. Capital and Funding - The net proceeds from the global offering amounted to approximately HKD 241.6 million, after deducting underwriting commissions and other expenses[55]. - As of June 30, 2023, the allocation of net proceeds from the global offering includes HKD 140.7 million (58.2%) for clinical development, manufacturing, and commercialization of core product LZ901[56]. - Funding for ongoing and planned clinical trials of LZ901 in China and the U.S. is allocated HKD 97.0 million (40.2%)[56]. - The company expects to fully utilize the net proceeds from the global offering by 2026[58]. Stock and Listing Information - The company’s H-shares were listed on the Hong Kong Stock Exchange on May 8, 2023[67]. - The company’s shares have a par value of RMB 1.00 each, with both domestic and H-shares included in its capital structure[68]. - The board did not recommend an interim dividend for the six months ended June 30, 2023, consistent with the previous year[54].
绿竹生物(02480) - 2023 - 中期业绩