Financial Performance - The company's total revenue for the year ended December 31, 2024, was RMB 38.4 million, a slight decrease from RMB 39.3 million for the year ended December 31, 2023[3]. - Other income and gains decreased significantly from RMB 2,571.4 million in 2023 to RMB 97.2 million in 2024, primarily due to the recognition of most funds received from CEPI in 2023[5]. - The company reported a net loss of RMB 903.4 million for the year ended December 31, 2024, an increase of RMB 764.9 million compared to a net loss of RMB 138.5 million in 2023[7]. - Adjusted net loss, excluding the impact of share-based compensation, was RMB 887.2 million for 2024, compared to RMB 85.0 million in 2023[8]. - Cash and bank balances decreased from RMB 1,095.5 million as of December 31, 2023, to RMB 556.5 million as of December 31, 2024, mainly due to loan repayments and ongoing R&D investments[4]. - The cost of sales increased to RMB 16.8 million in 2024 from RMB 15.0 million in 2023, resulting in a gross profit of RMB 21.6 million, down from RMB 24.2 million, indicating a gross margin contraction[39]. - The adjusted loss for the year was RMB 887.2 million in 2024, compared to RMB 85.0 million in 2023, indicating a significant deterioration in financial performance[40]. - The group reported a pre-tax loss of RMB 903,428 thousand for the year 2024, compared to a loss of RMB 138,539 thousand in 2023[71]. - The total expenses for 2024 were RMB 738,201,000, down from RMB 1,811,944,000 in 2023, showing a decrease of about 59.3%[90]. Research and Development - Research and development expenses were reduced by approximately 72% from RMB 649.9 million in 2023 to RMB 183.4 million in 2024, reflecting the completion of certain clinical and regulatory activities[6]. - The company has made significant progress in expanding its product portfolio, including the RSV vaccine (SCB-1019), which has entered clinical trials and demonstrated positive immunogenicity and safety data[9]. - The company is prioritizing resources to advance the clinical development of SCB-1019, aiming to establish its potential as a globally best and highly differentiated product in the RSV vaccine market[16]. - The company initiated an additional Phase I clinical trial for SCB-1019 in elderly participants in mid-June 2024, comparing it head-to-head with GSK's RSV vaccine Arexvy[21]. - The company plans to launch the SCB-219M candidate, a fusion protein for treating chemotherapy-induced thrombocytopenia (CIT), with Phase Ib clinical trials starting in November 2024[15]. - The company continues to focus on technological innovation and expanding its product pipeline to ensure long-term sustainable development[33]. Product Development and Market Strategy - The company has established a leading respiratory vaccine product portfolio to meet unmet needs in preventing severe respiratory infections[19]. - The company is focused on capturing significant cross-promotion, combination therapy, and long-term lifecycle management opportunities in the respiratory vaccine market[19]. - The company received approval for the importation of the only quadrivalent seasonal influenza vaccine AdimFlu-S for individuals aged three and above in mainland China, facilitating faster market entry and distribution before the autumn-winter vaccination season[15]. - The company aims to strengthen its domestic commercialization capabilities through optimized team construction and smooth execution, following the approval of the quadrivalent influenza vaccine[16]. - The company plans to initiate clinical trials for SCB-1019 in 2025 to evaluate its application in RSV vaccine booster shots and respiratory combined vaccines[25]. Operational Efficiency and Cost Management - Administrative expenses decreased by approximately 62% from RMB 198.8 million in 2023 to RMB 75.2 million in 2024, reflecting cost-saving measures and improved operational efficiency[6]. - Sales and distribution expenses decreased from RMB 54.8 million in 2023 to RMB 19.7 million in 2024, a decline of approximately 64% due to a more mature commercialization system[46]. - The company has successfully implemented various strategies for cost control and capital raising, which are crucial for future operations[81]. Regulatory and Compliance - The company continues to hold an emergency use authorization (EUA) for its COVID-19 vaccine obtained in December 2022[12]. - The company has not declared a final dividend for the year ended December 31, 2024[113]. - The company continues to adhere to high standards of corporate governance and has implemented relevant policies to ensure compliance[114]. Risks and Challenges - The company faces significant risks including the inability to successfully complete clinical development and obtain regulatory approvals for candidate products, which could severely impact business operations[128]. - The regulatory approval process for vaccines is highly dynamic and may lead to unforeseen delays or challenges[128]. - The company acknowledges that it cannot guarantee the successful development and commercialization of its candidate drugs and vaccines[131]. Legal and Disputes - The company is currently in a dispute with GAVI regarding contract liabilities amounting to USD 224 million (approximately RMB 1,612,450,000)[76]. - GAVI has claimed a total of USD 224 million in prepayments, which the company disputes as unfounded[110]. - The company received a notice from GAVI on March 21, 2025, unilaterally terminating the pre-purchase agreement and demanding immediate repayment of USD 224 million[111].
三叶草生物-B(02197) - 2024 - 年度业绩