百心安(02185) - 2024 - 中期业绩

Financial Summary The company significantly narrowed its loss in the first half of 2024, with a notable decrease in R&D and administrative expenses, though cash and cash equivalents declined, indicating active cost control despite continued losses Key Financial Indicators for H1 2024 (RMB million) | Indicator | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | Year-over-Year Change | | :--- | :--- | :--- | :--- | | Loss for the Period | RMB 28.3 | RMB 95.1 | Decreased 70.2% | | R&D Expenses | RMB 21.8 | RMB 68.4 | Decreased 68.2% | | Administrative Expenses | RMB 7.1 | RMB 30.9 | Decreased 77.0% | | Basic and Diluted Loss Per Share (RMB) | RMB 0.11 | RMB 0.35 | Improved 68.6% | Key Balance Sheet Indicators (RMB million) | Indicator | June 30, 2024 | December 31, 2023 | Period Change | | :--- | :--- | :--- | :--- | | Cash and Cash Equivalents | RMB 273 | RMB 369 | Decreased 26.1% | | Net Debt-to-Equity Ratio | 4.9% | 5.4% | Decreased 0.5 percentage points | Interim Condensed Consolidated Financial Statements Interim Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Income For the six months ended June 30, 2024, the company reported no revenue, with a loss for the period of RMB 28.325 million, a significant reduction from RMB 95.117 million in the prior year, primarily due to substantial decreases in R&D and administrative expenses Summary Statement of Profit or Loss (Unit: RMB Thousand) | Item | Six Months Ended June 30, 2024 (Unaudited) | Six Months Ended June 30, 2023 (Unaudited) | | :--- | :--- | :--- | | Other Income and Gains | 1,415 | 5,764 | | R&D Expenses | (21,791) | (68,497) | | Administrative Expenses | (7,084) | (30,908) | | Loss Before Tax | (28,325) | (95,117) | | Loss for the Period | (28,325) | (95,117) | | Loss Per Share Attributable to Ordinary Equity Holders of the Parent (RMB) | (0.11) | (0.35) | Interim Condensed Consolidated Statement of Financial Position As of June 30, 2024, the company's total assets were RMB 784 million, total liabilities RMB 38 million, and net assets RMB 746 million, with slight decreases in total assets and net assets from year-end 2023 primarily due to reduced cash and cash equivalents Summary Statement of Financial Position (Unit: RMB Thousand) | Item | June 30, 2024 (Unaudited) | December 31, 2023 (Audited) | | :--- | :--- | :--- | | Total Non-current Assets | 426,470 | 409,426 | | Total Current Assets | 357,345 | 408,473 | | Total Assets | 783,815 | 817,899 | | Total Current Liabilities | 14,513 | 20,069 | | Total Non-current Liabilities | 23,770 | 23,973 | | Total Liabilities | 38,283 | 44,042 | | Net Assets | 745,532 | 773,857 | Notes to the Interim Condensed Consolidated Financial Statements Notes explain the company's basic information, basis of preparation, and accounting policies, highlighting its focus on BRS and RDN product R&D with no sales revenue, a single reportable operating segment, no dividends declared, and investment details in associate Heart Medical - The company primarily engages in the research and development of BRS (fully biodegradable stent) products and second-generation Renal Denervation (RDN)[7] - The company operates with a single reportable segment, all non-current assets are located in China, and no revenue was recorded during the reporting period[11] - The company neither paid nor declared any dividends during the reporting period[17] - The company holds a 22.18% equity interest in Heart Medical, primarily engaged in DEB (drug-eluting balloon) R&D, and exercises significant influence, with the investment accounted for using the equity method[19][20] Management Discussion and Analysis I. Business Review Positioned as a leading innovative interventional cardiovascular device company in China, the company focuses on BRS and RDN therapies, with core products Bioheart® BRS and second-generation Iberis® RDN systems in registration, expected approvals in Q2 2025 and Q4 2024 respectively, while actively advancing DCB product R&D and optimizing production strategies to enhance operational efficiency, aiming to accelerate commercialization, boost R&D capabilities, and pursue strategic collaborations to become a globally recognized chronic disease management medical device platform Pipeline Products and Estimated Commercialization Timeline | Pipeline Product | Therapy | Key Progress | Estimated Commercialization Time (China) | | :--- | :--- | :--- | :--- | | Bioheart® BRS System (Core Product) | BRS | In Registration Phase | Q2 2025 | | Second-generation Iberis® RDN System | RDN | Clinical Study Report (CSR) received, in registration phase | Q4 2024 | | Sirolimus Drug-Eluting Balloon (DCB) | DCB | Pre-clinical | 2027 | - Core products Bioheart® and second-generation Iberis® have both been designated as 'Innovative Medical Devices' by the NMPA, qualifying for expedited approval[23][24] - To reduce costs and enhance efficiency, the company terminated a production facility lease in 2023 and plans to establish a new production facility before product commercialization[28] - Future strategic priorities include accelerating product commercialization to capture market opportunities, intensifying sales efforts, expanding the product portfolio, and actively seeking external collaborations and investment opportunities[29][30] II. Financial Review In H1 2024, the company's financial performance significantly improved, with net loss narrowing from RMB 95.1 million to RMB 28.3 million, primarily due to substantial reductions in R&D and administrative expenses, notably equity-settled share-based payment expenses; cash flow was mainly used for R&D and administrative expenses, ending cash and cash equivalents at RMB 273 million, maintaining a robust capital structure with no outstanding borrowings - Administrative expenses decreased by 77.0% year-over-year to RMB 7.1 million, primarily due to a RMB 15.7 million reduction in equity-settled share-based payment expenses, alongside lower professional service and depreciation expenses[32][33] - R&D expenses decreased by 68.2% year-over-year to RMB 21.8 million, mainly due to a RMB 17.3 million reduction in share-based payment expenses and a RMB 16.7 million decrease in third-party contractor costs as RDN product clinical trials entered later stages[34][35] - Net loss for the period was RMB 28.3 million, a significant reduction from RMB 95.1 million in the prior year[38] - As of June 30, 2024, cash and cash equivalents totaled RMB 273 million, a 26.1% decrease from year-end 2023, with net cash used in operating activities amounting to RMB 76.9 million[39][40] - The debt-to-asset ratio decreased from 5.4% at year-end 2023 to 4.9%, and the company had no outstanding borrowings at period-end[42][43] Human Resources As of June 30, 2024, the Group employed 54 full-time staff, with total employee benefit expenses of approximately RMB 7.2 million for the first half, utilizing the 2020 Restricted Share Scheme and 2022 H Share Award Scheme to incentivize and retain key talent - As of June 30, 2024, the Group had 54 full-time employees, with total employee benefit expenses of approximately RMB 7.2 million during the reporting period[49] - The company has established a 2020 Restricted Share Scheme and a 2022 H Share Award Scheme to attract, incentivize, and retain highly skilled talent[50] Use of Proceeds The company reallocated the net proceeds from its 2021 Global Offering, diverting funds originally for Bioheart® and RDN product R&D to acquire production facility properties and fund DCB R&D; as of June 30, 2024, approximately HKD 317 million of the HKD 442 million net proceeds had been utilized, with HKD 125 million remaining - The Board approved revisions to the use of proceeds in February 2024, reallocating approximately HKD 26.37 million for property acquisition and approximately HKD 70 million for DCB R&D[51][52] Summary of Use of Global Offering Proceeds (As of June 30, 2024) (HKD million) | Use (As Revised) | Revised Allocation | Amount Utilized | Unutilized Amount | | :--- | :--- | :--- | :--- | | Bioheart® R&D and Commercialization | 203.85 | 107.57 | 96.28 | | Second-generation Iberis® R&D | 67.71 | 48.21 | 19.50 | | Acquisition of Production Facilities | 26.37 | 26.37 | – | | DCB R&D | 87.25 | 82.79 | 4.46 | | General Corporate and Working Capital, etc. | 56.51 | 52.10 | 4.41 | | Total | 441.69 | 317.04 | 124.65 | Other Disclosures The company did not purchase, sell, or redeem any listed securities during the reporting period, and the Board does not recommend an interim dividend; regarding corporate governance, the company largely complied with the Corporate Governance Code, with a deviation where Mr. Wang Li serves as both Chairman and CEO, which the Board believes enhances management efficiency, and the Audit Committee has reviewed the interim results - The Board does not recommend the payment of an interim dividend for the six months ended June 30, 2024[56] - The company deviates from the Corporate Governance Code's provision requiring separation of Chairman and Chief Executive Officer roles, with Mr. Wang Li serving concurrently as Chairman of the Board and General Manager; the Board believes this arrangement benefits the Group's management and strategic execution efficiency[60] - The Audit Committee has reviewed and scrutinized the Group's interim results and considers them to be properly prepared and disclosed in accordance with applicable accounting standards[61]