Financial Performance - For the year ended December 31, 2022, the company reported a loss before tax of RMB 440,914,000, a decrease of 11.9% compared to RMB 500,673,000 in the previous year[2]. - The net loss for the year was RMB 440,914,000, reflecting a reduction of 11.9% from RMB 500,673,000 in 2021[2]. - The loss attributable to equity holders of the parent company was RMB 439,311,000, down 12.2% from RMB 500,517,000 in the prior year[2]. - Basic and diluted loss per share for the year was RMB 1.20, a decrease of 18.9% compared to RMB 1.48 in 2021[2]. - The total comprehensive loss for the year was RMB 432,629,000, compared to RMB 500,673,000 in the previous year[6]. - The net loss for the years 2021 and 2022 was RMB 500.7 million and RMB 440.9 million, respectively[48]. - The net cash used in operating activities for 2022 was RMB 158.5 million, primarily due to significant R&D and administrative expenses[49]. - Cash and cash equivalents as of December 31, 2022, were RMB 727.4 million, a decrease of 9.2% from RMB 800.6 million as of December 31, 2021[49]. - The company has no declared dividends for the year ending December 31, 2022, consistent with the previous year[21]. - The board of directors does not recommend the payment of a final dividend for the year ended December 31, 2022[61]. Research and Development - The company focuses on the research and development of interventional products for treating structural heart diseases, indicating a strategic emphasis on medical innovation[10]. - Research and development expenses increased to RMB 291,580,000 from RMB 265,336,000 in the previous year[5]. - The company has a total of 12 products in various stages of development, focusing on interventional products for structural heart disease[27]. - The company aims to enhance its product development capabilities and seek strategic partnerships to expand its product portfolio[39]. - The company is committed to research and development (R&D) initiatives[71]. Clinical Trials and Product Development - The company completed the feasibility clinical trial for LuX-Valve Plus and is expected to submit registration to the National Medical Products Administration in Q3 2023[3]. - The company has initiated early feasibility clinical trials for LuX-Valve in Europe and is also starting trials in the US and Canada[3]. - The company completed the confirmatory clinical trial for Ken-Valve and is analyzing data, with plans to submit for registration in Q2 2023[4]. - LuX-Valve received approval from the National Medical Products Administration (NMPA) and is expected to achieve commercialization approval in Q3 2023[29]. - LuX-Valve Plus is currently undergoing confirmatory clinical trials, with enrollment expected to be completed in Q2 2023 and registration submission to NMPA anticipated in Q3 2023[30]. - Ken-Valve has completed confirmatory clinical trials and submitted for NMPA approval, with commercialization expected in H1 2024[29]. - JensClip is in confirmatory clinical trials, with enrollment completion expected in Q4 2023 and commercialization projected for H2 2025[29]. - MicroFlux is in feasibility clinical trials, with confirmatory trials expected to start in H2 2023 and commercialization anticipated in H2 2025[29]. - SimuLock is preparing for feasibility clinical trials, expected to start in H1 2023, with commercialization projected for H2 2025[29]. - JensFlag and JensRelive are in early feasibility clinical trials, with expected commercialization in H1 2026 and H2 2026 respectively[29]. - KenFlex, a next-generation transcatheter aortic valve replacement system, is currently preparing for feasibility clinical trials, aiming to enhance accuracy and stability during valve placement[31]. - JensClip, a transcatheter mitral valve repair system, completed feasibility clinical trials in December 2022, with confirmatory trials ongoing and patient enrollment expected to finish in Q4 2023[32]. - MicroFlux, a first-generation transcatheter device for treating heart failure with preserved ejection fraction (HFpEF), is currently in feasibility clinical trials in China[34]. - AlginSys, a biocompatible injectable polymer product for preventing late-stage heart failure, is undergoing animal testing as of the announcement date[34]. - SimuLock, a left atrial appendage occluder system, is expected to initiate feasibility clinical trials in H1 2023 after obtaining ethical approval[35]. - OmniSeal, a biodegradable patent foramen ovale (PFO) occluder system, is currently in animal testing[35]. Financial Position and Assets - Total non-current assets increased to RMB 575,970 thousand in 2022 from RMB 512,554 thousand in 2021, representing a growth of 12.35%[8]. - Current assets rose to RMB 855,359 thousand in 2022, up from RMB 828,805 thousand in 2021, reflecting a 3.14% increase[8]. - Total liabilities increased to RMB 56,736 thousand in 2022, compared to RMB 49,700 thousand in 2021, marking a rise of 14.09%[8]. - Net assets reached RMB 1,373,027 thousand in 2022, up from RMB 1,290,591 thousand in 2021, indicating a growth of 6.38%[8]. - The current ratio as of December 31, 2022, was 15.1, down from 16.7 in 2021, while the debt-to-asset ratio increased to 4.1% from 3.8%[52]. - The company has no outstanding borrowings or unused bank financing as of December 31, 2022[53]. - The net cash from financing activities for 2022 was RMB 188.9 million, primarily from global sales proceeds[49]. - The company has not engaged in any significant investments or acquisitions as of December 31, 2022[55]. Corporate Governance and Compliance - The company has adopted new and revised International Financial Reporting Standards, ensuring compliance with updated accounting practices[12]. - The company has adopted the corporate governance code as its own governance guidelines and has complied with all applicable provisions during the period from listing to December 31, 2022, with some deviations noted[63]. - The audit committee, consisting of three independent non-executive directors, has reviewed the annual performance and financial reporting procedures, ensuring compliance with applicable accounting standards[66]. - The preliminary announcement of the consolidated financial statements for the year ended December 31, 2022, has been confirmed by the auditors, ensuring consistency with the draft financial statements[67]. - The company is recognized for compliance with health, safety, and environmental standards in the European Economic Area[69]. - The National Medical Products Administration oversees the company's regulatory compliance in China[71]. Market Presence and Strategic Initiatives - The company was listed on the Hong Kong Stock Exchange on October 10, 2022, enhancing its market presence[10]. - The company aims to expand its market presence by developing solutions for various types of structural heart diseases, including tricuspid valve disease and heart failure[26]. - The company entered into a strategic cooperation agreement with Xianjian Technology on February 6, 2023, focusing on potential collaboration in business development, project investment, and financing in both mainland China and overseas[60]. - The company successfully completed its initial public offering on the Hong Kong Stock Exchange, issuing 8,076,400 shares at a price of HKD 27.80 per share[25]. - The company aims to accelerate the commercialization of its core products to capture opportunities in the growing market for transcatheter trileaflet valve replacements[39].
健世科技-B(09877) - 2022 - 年度业绩