Financial Performance - For the six months ended June 30, 2023, the net cash used in operating activities was RMB 381 million, primarily due to significant R&D and administrative expenses incurred during the reporting period [15]. - The net loss for the six months ended June 30, 2023, was RMB 95.1 million, compared to a net loss of RMB 115.6 million for the same period in 2022 [43]. - Other income and gains decreased from RMB 10.2 million to RMB 5.8 million, primarily due to a reduction in foreign exchange gains of RMB 4.3 million [37]. - Employee benefit expenses decreased from RMB 43.2 million to RMB 18.6 million, including share-based payment expenses which fell from RMB 40.3 million to RMB 15.7 million [38]. - R&D expenses decreased from RMB 71.4 million to RMB 68.5 million, mainly due to reduced share-based payment expenses for R&D employees [41]. - The company's cash outflow from investing activities was RMB 23.9 million, mainly due to property, plant, and equipment purchases, and payments for investments in an associate [63]. - Current assets decreased from RMB 512.7 million as of December 31, 2022, to RMB 436.2 million as of June 30, 2023, primarily due to a reduction in cash and cash equivalents [64]. - Capital expenditures decreased from RMB 17.7 million for the six months ended June 30, 2022, to RMB 10.5 million for the same period in 2023, mainly due to reduced machinery procurement [65]. - The company reported a loss attributable to ordinary equity holders of RMB 86,186 thousand, compared to a loss of RMB 101,439 thousand in the same period of 2022, indicating an improvement of approximately 15% [137]. - The basic loss per share for the period was RMB 0.35, an improvement from RMB 0.42 in the prior year [137]. - The company’s major shareholders include Mr. Wang, who holds 40.59% of H shares and 3.16% of non-listed foreign shares [123]. - No dividends were declared or paid during the six months ended June 30, 2023, consistent with the same period in 2022 [146]. Research and Development - The company is actively preparing for clinical research of the drug-coated balloon product in collaboration with PMDA [55]. - The IBERIS-HTN study achieved its primary clinical endpoint, with detailed data presented at the 2023 China Interventional Cardiology Conference [28]. - The second-generation Iberis® has achieved its primary clinical endpoint in the randomized controlled trial for primary hypertension patients, with results presented at the 2023 China Interventional Cardiology Conference [53]. - The company aims to enhance R&D capabilities and expand its product portfolio to capture the unmet needs in the biodegradable stent and renal denervation markets in China [58]. - The company has one core product, one RDN product in development, and one rapamycin DCB product in different stages of development [34]. - The company is focused on expanding its market presence and enhancing its product offerings through ongoing research and development initiatives [138]. Product Development and Market Strategy - The company invested RMB 15 million in Xinzhiyuan Medical Technology Co., Ltd., acquiring approximately 22.18% equity, enhancing its cardiovascular device product portfolio [12]. - The company anticipates obtaining approval from the National Medical Products Administration for the Bioheart® product in the third to fourth quarter of 2024 [29]. - The DCB product is positioned as a complementary product to fully biodegradable stents, promoting the concept of "intervention without implantation" [12]. - The company has contracted with the European Cardiovascular Research Center to evaluate the second-generation Iberis® RDN system in a European clinical trial, with the first patient enrolled on March 27, 2023 [31]. - The RADIUS-HTN trial will compare the efficacy of renal denervation via transradial access (TRA) and transfemoral access (TFA), with TRA preferred due to lower complication rates and shorter hospital stays [31]. - The company aims to increase its market share in the Chinese interventional cardiovascular device market and expand production capacity [37]. - A new factory with a total construction area of over 7,000 square meters has been established in Zhangjiang Hi-Tech Park, Shanghai, to meet growing market demand [57]. - The company plans to commercialize its core product Bioheart® by December 2027, with an initial allocation of HKD 273.85 million for clinical trials [1]. - The company is also developing its second-generation product Iberis® with an allocation of HKD 94.08 million, expected to be completed by December 2027 [1]. Corporate Governance and Compliance - The independent auditor, Ernst & Young, reviewed the interim financial data for the six months ending June 30, 2023 [118]. - The board of directors has undergone changes, with Mr. Lin Jie Cheng resigning as an independent non-executive director effective June 26, 2023 [119]. - The chairman and CEO roles are held by the same individual, Mr. Wang, which the board believes enhances strategic initiative execution [115]. - The company has adopted the standard code of conduct for securities trading, confirming compliance by all directors and supervisors during the reporting period [114]. - The company did not purchase, sell, or redeem any of its listed securities during the reporting period [116]. - There were no other disclosures required under the listing rules beyond those mentioned in the interim report [122]. - The company has not reported any changes in the interests of directors, supervisors, or senior management in the company's shares or related securities as of June 30, 2023 [107]. Shareholder Information and Incentive Plans - As of June 30, 2023, Winning Powerful Limited holds a beneficial interest of 45,645,584 shares, representing 18.71% of the total shares [108]. - Shanghai Bai Xin An Tong holds a beneficial interest of 27,962,081 shares, accounting for 11.46% of the total shares [108]. - TPG Asia VII SF PTE. LTD. has a beneficial interest of 20,753,025 shares, which is 8.51% of the total shares [113]. - The 2020 employee incentive plan allows participants to acquire shares at RMB 1.0 per share, based on the company's par value at the relevant date [164]. - The 2020 plan is designed to incentivize employees and consultants for their contributions to the company's success [179]. - The equity vesting schedule for participants includes 50% vesting in the first and second anniversaries, with full vesting within 24 months [180]. - A total of 13,514,629 shares remain unexercised, with 457,386 shares already exercised [195]. - The company has a structured employee incentive plan established prior to its listing, which includes two employee incentive platforms [200]. - The company has a total of 13,057,243 shares that are yet to be vested [195].
百心安-B(02185) - 2023 - 中期财报