Financial Performance - For the year ended December 31, 2024, the net loss of the group was approximately RMB 93.3 million, a decrease of 50.6% compared to RMB 188.8 million in 2023[4] - The basic and diluted loss per share for 2024 was RMB 0.36, compared to RMB 0.72 in 2023[5] - Total comprehensive loss for the year was RMB 93.3 million, consistent with the net loss[5] - The company reported a pre-tax loss of RMB 93,324,000 for 2024, compared to RMB 188,820,000 for 2023, indicating a significant improvement in performance[23] - Net loss for 2024 was RMB 93.3 million, compared to RMB 188.8 million in 2023[52] Cash and Assets - As of December 31, 2024, cash and cash equivalents were approximately RMB 202.4 million, a decrease of 45.2% from RMB 369.4 million as of December 31, 2023[4] - The total assets less current liabilities amounted to RMB 714.1 million in 2024, down from RMB 797.8 million in 2023[7] - The total equity of the group was RMB 680.5 million in 2024, a decrease from RMB 773.9 million in 2023[7] - The debt-to-asset ratio increased from 5.4% in 2023 to 7.3% in 2024, primarily due to a decrease in cash and cash equivalents[58] Research and Development - Research and development expenses for the year ended December 31, 2024, were approximately RMB 41.3 million, a reduction of 63.0% from RMB 111.7 million in 2023[4] - The company is focused on two main therapies: Bioresorbable Scaffolds (BRS) for coronary artery disease and Renal Denervation (RDN) for hypertension, addressing unmet medical needs in China[31] - The company has three products in different stages of development, with the core product, the DCB, expected to be commercialized by 2026[33] - Research and development expenses increased to RMB 69,058,000 in 2024 from RMB 25,830,000 in 2023, indicating a strong commitment to innovation[30] Regulatory Approvals and Product Development - The Iberis® RDN system received approval from the National Medical Products Administration on February 26, 2025, for assisting in the treatment of resistant hypertension and drug-intolerant hypertension patients[4] - The first commercial procedure using the Iberis® RDN system was completed in Europe in February 2025[4] - Bioheart® has received regulatory approval in China as an "Innovative Medical Device" and is expected to obtain approval from the National Medical Products Administration by Q3 2026[34] - The RDN system is currently in the registration phase in China, with expected approval from the National Medical Products Administration by February 2025[33] Income and Expenses - Other income decreased to RMB 2,679 thousand in 2024 from RMB 8,567 thousand in 2023, representing a decline of approximately 68.8%[18] - Bank interest income fell to RMB 1,106 thousand in 2024 from RMB 4,000 thousand in 2023, a decrease of approximately 72.3%[18] - Administrative expenses decreased from RMB 52.9 million in 2023 to RMB 19.7 million in 2024, primarily due to a reduction in share-based compensation expenses of RMB 22.2 million[44] - Total other income and gains amounted to RMB 948 thousand in 2024, down from RMB 3,619 thousand in 2023, reflecting a decrease of approximately 73.8%[18] Corporate Governance - The company has complied with all applicable corporate governance code provisions during the reporting period, except for the separation of the roles of Chairman and CEO[81] - The board consists of three executive directors and three independent non-executive directors, ensuring strong independence[83] - The audit committee, composed of three independent non-executive directors, is responsible for reviewing financial reports and internal controls[85] - The company is evaluating the effectiveness of its corporate governance structure, including the potential separation of the roles of chairman and CEO[83] Future Plans and Investments - The company plans to actively seek external collaborations, strategic investments, and acquisition opportunities to facilitate future growth[41] - A new manufacturing facility in Jiaxing, Zhejiang Province, is under construction and expected to be operational by 2026, expanding production capacity[39] - The company plans to allocate HKD 134.37 million for the commercialization of its core product Bioheart® by December 31, 2024, with HKD 115.02 million already utilized[72] Employee and Operational Information - The total employee benefit expenses during the reporting period amounted to approximately RMB 16.7 million[64] - The company has employed 63 full-time employees, all based in China, as of December 31, 2024[64]
百心安(02185) - 2024 - 年度业绩