Financial Performance - In 2022, the company reported a net loss of RMB 230.87 million, a decrease from a loss of RMB 409.83 million in 2021, representing a 43.7% improvement year-over-year[34]. - The company reported a net loss of RMB 230.9 million for 2022, compared to RMB 409.8 million in 2021, due to ongoing investments in product development[63]. - Other income increased from RMB 7.2 million in 2021 to RMB 23.8 million in 2022, primarily due to favorable foreign exchange gains and increased interest income[64]. - Cash and cash equivalents decreased by 36.3% from RMB 708.5 million as of December 31, 2021, to RMB 451.3 million as of December 31, 2022[11]. - Current assets totaled RMB 541.53 million, down from RMB 756.53 million in 2021, reflecting a 28.5% decrease[34]. - The company’s total equity as of December 31, 2022, was RMB 915.05 million, a decrease from RMB 1,034.88 million in 2021[34]. Research and Development - R&D expenses decreased from RMB 214.2 million in 2021 to RMB 157.8 million in 2022, primarily due to a reduction in equity-settled share-based payment expenses related to R&D employees[1]. - Employee benefit expenses under R&D decreased from RMB 173.9 million in 2021 to RMB 84.8 million in 2022, with equity-settled share-based payment expenses dropping from RMB 163.6 million to RMB 73.1 million[2]. - Research and development expenses for 2022 were RMB 157.83 million, down from RMB 214.23 million in 2021, indicating a 26.3% reduction[34]. - The company has developed a new drug-eluting balloon with high technical barriers and is advancing preclinical studies in Japan[24]. - The company is focused on developing drug-eluting stent products, with a strong emphasis on research and development in the cardiovascular medical device sector[73]. - The company has prioritized its product pipeline based on market size, promotion difficulty, and technological barriers, leading to the termination of less promising projects[45]. Product Development and Commercialization - The company revised the expected timeline for commercialization of BRS and RDN products due to delays in clinical enrollment and follow-up[24]. - The company plans to commercialize the second-generation Bioheart® BRS system, with expected approval in Q3 to Q4 2024[44]. - The second-generation Iberis® RDN system is anticipated to receive approval in Q2 to Q3 2024, following successful clinical trials[44]. - The company achieved significant milestones in 2022, including the completion of patient enrollment for the second-generation renal denervation system Iberis® and the Bioheart® temporary stent clinical trials[36]. - The second-generation Iberis® is the only renal denervation product globally that allows both femoral and radial access, having received CE approval[36]. - The second-generation Iberis® multi-electrode renal artery radiofrequency ablation catheter system achieved its primary clinical endpoint in a randomized controlled trial for patients with primary hypertension, as reported on April 11, 2023[85]. Corporate Governance - The company is committed to maintaining high standards of corporate governance through independent oversight by its board members[90]. - The board consists of three executive directors, two non-executive directors, and three independent non-executive directors, ensuring strong independence[144]. - The company has established an audit committee, a remuneration committee, and a nomination committee to oversee specific aspects of its affairs, ensuring compliance with corporate governance standards[162]. - Independent non-executive directors' independence is confirmed annually, ensuring compliance with listing rules[147]. - The company has adopted a standard code of conduct for securities trading by directors and senior management to prevent insider trading[143]. Strategic Partnerships and Market Expansion - The company is actively expanding its business globally, including clinical trials for the second-generation Iberis® in Europe and Japan[36]. - The company has established a partnership with the European Cardiovascular Research Center for clinical trials of the second-generation Iberis® in Europe[49]. - The company aims to expand its production capacity and establish an internal sales and marketing team to enhance its market presence in China and globally[61]. - The company acquired a 15.42% stake in Shanghai Xinzhi Medical Technology Co., which has four DCB products in clinical stages, enhancing the company's cardiovascular device portfolio[55]. - The company invested RMB 50 million for a 9.09% stake in Kandi Tech, which is developing a balloon-expandable TAVR product, expected to begin clinical trials in 2023[57]. Financial Management and Investments - Financial costs increased from RMB 0.7 million in 2021 to RMB 1.0 million in 2022, attributed to new lease liabilities incurred in the second half of 2022[4]. - The company has not reported any significant post-reporting period events up to the date of the annual report[79]. - The board will continue to evaluate the use of net proceeds and may modify plans as market conditions change[196]. - The anticipated commercialization of the products may face potential delays, leading to a revised timeline for utilizing the unutilized proceeds[196]. - The company has established a remuneration committee consisting of three independent non-executive directors to review and recommend remuneration policies[176]. Employee and Management Structure - As of December 31, 2022, the group employed 54 full-time employees, all based in China, with total employee benefit expenses amounting to approximately RMB 157.8 million[180]. - The company has a total of 6 senior management members, with one earning between RMB 86,000,001 and RMB 86,500,000, and two earning between RMB 10,000,001 and RMB 10,500,000[171]. - The company encourages all directors to participate in relevant training courses, with costs covered by the company[161]. - The company has established a framework for continuous professional development for all directors to enhance their knowledge and skills[161].
百心安-B(02185) - 2022 - 年度财报