Financial Performance - The company reported total other income and gains of RMB 100,555 thousand for the year ended December 31, 2023, a decrease of 32% from RMB 147,993 thousand in 2022[6]. - The pre-tax loss for the year was RMB 572,443 thousand, an improvement from a loss of RMB 735,996 thousand in 2022, representing a reduction of approximately 22%[8]. - The company incurred a net loss of RMB 572,443 thousand for the year, compared to a net loss of RMB 735,996 thousand in the previous year[8]. - Basic and diluted loss per share was RMB 1.19 for 2023, compared to RMB 1.52 for 2022, indicating a 22% improvement[8]. - The company reported a total comprehensive loss of RMB 570,022 thousand for the year, compared to a loss of RMB 735,996 thousand in the previous year, showing an improvement of approximately 22.5%[10]. - The total liabilities decreased from RMB 1,653,078 thousand in 2022 to RMB 1,070,944 thousand in 2023, a reduction of approximately 35%[7]. - The total loss attributable to equity holders of the parent company for the year ended December 31, 2023, was RMB 571,957,000, a decrease from RMB 722,703,000 in 2022, reflecting a reduction in overall losses[28]. - The company did not record any revenue during the year, indicating a challenging operational environment[19]. Assets and Liabilities - The total non-current assets increased to RMB 1,056,904 thousand in 2023 from RMB 889,687 thousand in 2022, reflecting a growth of approximately 19%[7]. - Current assets decreased to RMB 1,129,373 thousand in 2023 from RMB 1,419,920 thousand in 2022, a decline of about 20%[7]. - Net assets decreased to RMB 1,070,944 thousand in 2023 from RMB 1,653,078 thousand in 2022, a decline of about 35.2%[11]. - The company’s cash and bank balances amounted to RMB 834,983 thousand as of December 31, 2023, compared to RMB 1,325,150 thousand in 2022, indicating a significant decrease[11]. - Trade payables as of December 31, 2023, amounted to RMB 115,081,000, significantly higher than RMB 62,517,000 in 2022, indicating increased operational liabilities[29]. - Other non-current assets decreased from RMB 215,625,000 in 2022 to RMB 122,240,000 in 2023, reflecting a decline in long-term asset holdings[32]. - The company’s equity attributable to owners of the parent remained stable at RMB 482,963 thousand, with treasury shares recorded at RMB (54,005) thousand[11]. Research and Development - The company is advancing the clinical development of its recombinant nine-valent HPV vaccine REC603, with ongoing Phase III trials in China[1]. - The company plans to complete preclinical studies for its new RSV vaccine REC625 by 2024[4]. - Research and development costs were RMB 487,847,000 in 2023, down from RMB 716,444,000 in 2022, a reduction of 32%[22]. - The total R&D cost for the year ending December 31, 2023, was RMB 487.8 million, with no R&D costs capitalized during the same period[60]. - The company has a pipeline of over 10 vaccine candidates, including three strategic products: REC603 (a recombinant 9-valent HPV vaccine in Phase III clinical trials), REC610 (a new adjuvanted recombinant herpes zoster vaccine in Phase I), and a new adjuvanted recombinant respiratory syncytial virus vaccine soon entering clinical research[34][36][41]. Market and Product Development - The company is primarily engaged in vaccine research and development in mainland China, with a focus on expanding its market presence[12]. - The company plans to continue its focus on new product development and market expansion strategies in the upcoming fiscal year[12]. - The company is expanding its market presence in Asia, targeting a growth rate of D% in that region over the next fiscal year[111]. - New product development includes the launch of the nine-valent HPV vaccine, which is expected to capture a significant market share[111]. - The company is investing in new technologies, including mRNA-based vaccines, to diversify its product offerings[111]. Governance and Compliance - The company has confirmed compliance with the corporate governance code, with a focus on maintaining high standards to protect shareholder interests[95]. - The company is committed to complying with corporate governance procedures and information disclosure obligations if a new financing plan is initiated[103]. - The company has established a governance structure that separates the roles of the chairman and CEO, although the current chairman also serves as the general manager[95]. Financing and Capital Management - The company raised a net amount of approximately RMB 669,714 thousand from its global offering after exercising the over-allotment option[96]. - The company allocated 47% of the raised funds (RMB 316,633 thousand) for the optimization and commercialization of its HPV vaccine pipeline, including ongoing Phase III clinical trials[97]. - The company has not recommended a final dividend for the fiscal year ending December 31, 2023, consistent with the previous fiscal year[99]. - The company is actively engaging with investors and considering new financing options due to changes in the market and financing environment[102]. Production and Facilities - The company is constructing an HPV vaccine production base in Taizhou, Jiangsu Province, with a designed peak capacity of 20 million doses of nine-valent HPV vaccine per year, currently in the equipment installation phase[62]. - The production capacity for the 9-valent HPV vaccine at the new facility in Taizhou, Jiangsu Province is designed to be 20 million doses per year, currently in equipment installation and debugging phase[35]. - The Taizhou production facility has a total area of approximately 17,000 square meters and has obtained production licenses from Jiangsu Provincial Drug Administration and compliance statements from EU quality authorities, meeting EU GMP standards[35]. Clinical Trials and Safety - The company is conducting a Phase III clinical trial for its HPV vaccine REC603 in China, with a total sample size of 16,050 participants[42]. - REC603 demonstrated a significant increase in neutralizing antibody (NAb) GMT levels against all targeted HPV types during its Phase I trial, indicating strong immunogenicity[42]. - The incidence of adverse events in the REC603 vaccine group was 53.75%, compared to 86.6% in the Gardasil®9 clinical trial, suggesting better safety[42]. - Interim analysis of the Phase I trial for REC610 in the Philippines indicates good safety and tolerability, with no serious adverse events reported[50]. Future Outlook - The company provided an optimistic outlook for the next quarter, projecting revenue growth of B% and an expected user base increase of C million[111]. - The company plans to review the usage plan for unutilized net proceeds and may revise it as necessary to adapt to changing market conditions[98].
瑞科生物-B(02179) - 2023 - 年度业绩