Financial Performance - The company reported a net loss of RMB 379,096, a decrease of 14.0% compared to the previous year's loss of RMB 440,914[2] - The loss attributable to equity holders of the parent company was RMB 371,736, down 15.4% from RMB 439,311 in the previous year[2] - The basic and diluted loss per share was RMB 0.89, a decrease of 25.8% from RMB 1.20 in the previous year[2] - Total revenue for the year ended December 31, 2023, was RMB 43,828,000, a decrease of 19.5% compared to RMB 54,424,000 in 2022[8] - Research and development expenses for 2023 were RMB 288,151,000, slightly down from RMB 291,580,000 in 2022[8] - The company reported a loss before tax of RMB 379,096,000 for 2023, an improvement from a loss of RMB 440,914,000 in 2022, indicating a reduction of approximately 13.9%[8] - Basic and diluted loss per share for the year was RMB 0.89, compared to RMB 1.20 in the previous year, reflecting a 25.8% improvement[10] - The company’s net asset value decreased to RMB 1,226,254,000 in 2023 from RMB 1,373,027,000 in 2022, a decline of about 10.7%[11] - The company’s other income and gains decreased from RMB 544 million in 2022 to RMB 438 million in 2023, primarily due to a reduction in foreign exchange gains[45] - The company has not declared or paid any dividends during the year[24] Product Development and Clinical Trials - The company announced the completion of confirmatory clinical trials for LuX-Valve Plus, with plans to submit for registration approval to the National Medical Products Administration soon[3] - LuX-Valve's registration application has been formally accepted by the National Medical Products Administration, entering the priority review process[3] - LuX-Valve Plus has received positive feedback from clinical centers in Europe, with ongoing clinical trials aimed at obtaining CE certification[3] - The company plans to conduct commercialization activities globally to meet the urgent treatment needs of patients with tricuspid regurgitation[4] - The company has established a professional commercialization team to enhance market expansion and marketing capabilities for its core products[4] - The company has been developing a series of interventional products for treating structural heart diseases since its establishment in November 2011[29] - The core product, LuX-Valve, is designed for patients with severe tricuspid regurgitation and high surgical risk, with 16 related patents and 20 patent applications filed[32] - LuX-Valve has entered the registration review stage, but the company may not obtain registration approval on schedule due to the need for additional clinical evidence[32] - LuX-Valve Plus, the second-generation product, is expected to simplify the procedure and reduce surgical time, with clinical trials ongoing in multiple European countries[33] - The company anticipates that LuX-Valve Plus will complete patient enrollment for CE certification clinical trials in Europe by the end of 2023[33] - The company is actively working on the commercialization foundation for its product series through various means, including clinical trials and approvals[30] - The company has received positive feedback from clinical centers participating in the LuX-Valve Plus trials, indicating strong support for the product[33] - LuX-Valve Plus has received formal acceptance for EFS pre-submission by the FDA and is expected to complete EFS clinical research by Q4 2024[34] - The company has completed several clinical implants of LuX-Valve Plus in North America and is advancing commercialization efforts in the region[34] - Ken-Valve has received acceptance from the National Medical Products Administration (NMPA) in October 2023, with commercialization expected in H2 2024[35] - JensClip has completed feasibility clinical trials in December 2022, with all subjects enrolled and one-month follow-up completed as of the announcement date[36] - MicroFlux is currently undergoing confirmatory clinical trials in China, aimed at treating heart failure with preserved ejection fraction[37] - SimuLock initiated feasibility clinical trials in Q3 2023, with the first confirmatory clinical trial and subject enrollment completed in November 2023[37] Market Expansion and Commercialization - The company has trained over 50 independent doctors and instructors for the LuX-Valve series products domestically, and 24 independent doctors abroad[5] - The company has expanded its coverage to over 220 influential hospitals in China for the LuX-Valve series products, covering more than 30 provinces and municipalities[6] - The company aims to establish strategic collaborations and expand regional business development for the LuX-Valve product line[30] - The company is collaborating with Xianjian Technology in the Asia-Pacific region for pre-commercialization activities[34] - The company has established a commercialization team of over 60 members, focusing on market introduction and education for core products, and has expanded its reach to over 220 influential hospitals across more than 30 provinces and municipalities in China[42] - The company plans to accelerate the commercialization of its core products in the rapidly growing transcatheter valve replacement market[44] Financial Position and Assets - Total assets as of December 31, 2023, amounted to RMB 1,445,092,000, a decrease from RMB 1,431,339,000 in 2022[11] - Current assets increased to RMB 1,154,913,000 in 2023 from RMB 855,359,000 in 2022, representing a growth of approximately 35.1%[11] - The company’s non-current assets totaled RMB 172,179,000 in 2023, significantly down from RMB 575,970,000 in 2022, a decrease of approximately 70.1%[11] - Cash and cash equivalents increased by 27.6% from RMB 727.4 million as of December 31, 2022, to RMB 927.8 million as of December 31, 2023[54] - Capital expenditures rose from RMB 49.6 million in 2022 to RMB 78.6 million in 2023, attributed mainly to the purchase of properties, plants, and equipment[55] - The company's current ratio improved to 19.7 in 2023 from 15.1 in 2022, indicating better short-term financial health[56] - Total bank borrowings amounted to RMB 40.7 million as of December 31, 2023, with RMB 15.8 million secured by collateral[57] - The company generated net cash from investing activities of RMB 358.1 million, primarily from the sale of equity in a joint venture[53] Governance and Compliance - The board of directors consists of two executive directors, four non-executive directors, and three independent non-executive directors, ensuring strong independence[69] - The audit committee, composed of three independent non-executive directors, oversees financial reporting and internal controls[72] - The company has adopted the corporate governance code as per the listing rules and has complied with all applicable provisions during the reporting period, except for a deviation regarding the roles of the chairman and CEO[69] - The company has confirmed that all directors and supervisors adhered to the standards for securities trading during the reporting period[70] - The company has no significant litigation or arbitration pending as of December 31, 2023[61] - The board of directors does not recommend a final dividend for the year ended December 31, 2023[66] - The company emphasizes adherence to International Financial Reporting Standards, ensuring transparency and compliance in financial reporting[77] Employee and Operational Metrics - The company has a total of 376 employees as of December 31, 2023, an increase from 292 employees as of December 31, 2022[62] - The company has expanded its annual production capacity from 3,500 units to approximately 4,000 to 5,000 units, with a target to reach about 10,000 units by the end of 2024[41] - The company’s manufacturing facility in Ningbo, Zhejiang, spans approximately 7,000 square meters and is designed to meet GMP requirements for large-scale production[41] Future Plans and Strategic Initiatives - The company plans to hold a special general meeting on December 15, 2023, to approve the H-share incentive and trust plan[76] - The expected timeline for utilizing the net proceeds includes completion by December 31, 2026, for core product development and by December 31, 2024, for working capital[65] - The company is focused on expanding its market presence, particularly in the Hong Kong region, to enhance shareholder value[76] - The company is actively engaging with stakeholders to align its strategic objectives with market expectations and regulatory requirements[76]
健世科技-B(09877) - 2023 - 年度业绩