百心安(02185) - 2023 - 中期业绩

Performance Highlights Financial Summary For the six months ended June 30, 2023, the company recorded a loss for the period of RMB 95.1 million, narrowing from RMB 115.6 million in the prior period, with basic loss per share of RMB 0.35, primarily due to a significant decrease in administrative expenses Financial Summary (For the six months ended June 30) | Metric | 2023 (RMB '000) | 2022 (RMB '000) | | :--- | :--- | :--- | | Research and Development Expenses | (68,497) | (71,391) | | Administrative Expenses | (30,908) | (53,853) | | Loss for the Period | (95,117) | (115,576) | | Loss per Share Attributable to Ordinary Equity Holders of the Parent (RMB) | (0.35) | (0.42) | Business Highlights During the reporting period, the company achieved key progress in core product R&D, with the IBERIS-HTN study reaching its primary clinical endpoint, BRS and RDN products completing patient follow-ups, and the first patient enrolled in the RADIUS-HTN trial in Europe - The IBERIS-HTN study has reached its primary clinical endpoint, with detailed data presented at the China Interventional Cardiology Conference[1] - The company's BRS (bio-resorbable scaffold) and RDN (renal denervation) products completed patient follow-ups in February and January 2023, respectively[105] - On March 27, 2023, the company announced the enrollment of the first patient in the RADIUS-HTN trial conducted in Europe[131] Interim Condensed Consolidated Financial Statements Interim Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Income For the six months ended June 30, 2023, the company reported a pre-tax loss of RMB 95.1 million, a 17.7% reduction from RMB 115.6 million in the prior period, with no income tax expense and a loss attributable to owners of the parent of RMB 86.2 million Summary of Statement of Profit or Loss (For the six months ended June 30) | Item | 2023 (RMB '000) | 2022 (RMB '000) | | :--- | :--- | :--- | | Other income and gains | 5,764 | 10,178 | | Research and development expenses | (68,497) | (71,391) | | Administrative expenses | (30,908) | (53,853) | | Finance costs | (391) | (510) | | Share of loss of an associate | (1,085) | – | | Loss before tax | (95,117) | (115,576) | | Loss for the period | (95,117) | (115,576) | Interim Condensed Consolidated Statement of Financial Position As of June 30, 2023, the company's total assets were RMB 911.2 million, total liabilities RMB 58.3 million, and net assets RMB 852.9 million, with net current assets decreasing from RMB 512.7 million to RMB 436.2 million compared to year-end 2022, primarily due to reduced cash and cash equivalents Summary of Statement of Financial Position (As of June 30) | Item | 2023 (RMB '000) | December 31, 2022 (RMB '000) | | :--- | :--- | :--- | | Non-current assets | 449,030 | 439,991 | | Current assets | 462,178 | 541,528 | | Of which: Cash and cash equivalents | 389,334 | 451,318 | | Current liabilities | 25,990 | 28,846 | | Non-current liabilities | 32,311 | 37,623 | | Net assets | 852,907 | 915,050 | | Total equity | 852,907 | 915,050 | Notes to Interim Condensed Consolidated Financial Statements The financial statements are prepared in accordance with IAS 34, adopting new IFRS amendments with no significant impact on financial position, and the company, primarily engaged in R&D of bio-resorbable scaffolds and renal denervation systems, operates as a single segment, with no dividends declared during the period and an additional investment made in associate XinZhi Medical in April 2023 - The Group is primarily engaged in the research and development of bio-resorbable scaffolds (BRS) and second-generation renal denervation (RDN) systems[113] - As the Group's non-current assets are all located in China and no revenue has been recorded, no geographical segment analysis is presented, resulting in only one reportable segment[116][138] - In April 2023, the company made an additional capital contribution of RMB 15,000,000 to its associate, Shanghai XinZhi Medical Technology Co., Ltd., increasing its equity interest to 22.18%[148][156] - For the six months ended June 30, 2023, the company did not pay or declare any dividends[15] Management Discussion and Analysis I. Business Review The company is a leading innovative interventional cardiovascular device company in China, focusing on bio-resorbable scaffolds (BRS) and renal denervation (RDN) therapies, with core products Bioheart® (BRS system) and second-generation Iberis® (RDN system) achieving significant clinical progress and expected approval in 2024, while also developing drug-coated balloon (DCB) products and expanding its portfolio through strategic investment in XinZhi Medical, and has completed a new plant exceeding 7,000 square meters for commercialization preparation - The core product Bioheart® (BRS system) has completed patient enrollment in clinical trials and is expected to receive NMPA approval in Q3-Q4 2024[127] - The second-generation Iberis® (RDN system) randomized controlled clinical trial has reached its primary clinical endpoint and is expected to receive NMPA approval in Q2-Q3 2024[128] - The company is developing a Rapamycin drug-coated balloon (DCB) as an ideal complement to BRS products for treating in-stent restenosis[130][154] - The company made a strategic investment in Shanghai XinZhi Medical Technology Co., Ltd., increasing its equity interest to approximately 22.18% after the capital increase, to enrich its cardiovascular device product portfolio[156] - To prepare for product launch, the company has completed a new plant with a total construction area exceeding 7,000 square meters in Shanghai Zhangjiang Hi-Tech Park, which commenced operations in December 2021[157] II. Financial Review During the reporting period, the company's net loss narrowed from RMB 115.6 million to RMB 95.1 million, with administrative expenses significantly decreasing by RMB 23.0 million due to reduced equity-settled share-based payment expenses, and R&D expenses slightly decreasing by RMB 2.9 million; cash and cash equivalents decreased by 13.7% to RMB 389.3 million, with liquidity primarily relying on existing bank balances and IPO proceeds, and the asset-liability ratio decreased from 6.8% to 6.4% Administrative Expenses Breakdown (For the six months ended June 30) | Item | 2023 (RMB '000) | 2022 (RMB '000) | | :--- | :--- | :--- | | Employee benefit expenses | 18,554 | 43,210 | | Of which: Equity-settled share-based payment expenses | 15,652 | 40,322 | | Depreciation expenses | 5,588 | 3,399 | | Professional service expenses | 3,577 | 5,019 | | Total | 30,908 | 53,853 | Research and Development Expenses Breakdown (For the six months ended June 30) | Item | 2023 (RMB '000) | 2022 (RMB '000) | | :--- | :--- | :--- | | Third-party contract research organization costs | 25,028 | 11,956 | | Employee benefit expenses | 23,692 | 49,044 | | Of which: Equity-settled share-based payment expenses | 17,322 | 43,299 | | Total | 68,497 | 71,391 | - As of June 30, 2023, cash and cash equivalents amounted to RMB 389.3 million, a 13.7% decrease from RMB 451.3 million at the end of 2022[60] - Net cash used in operating activities was RMB 38.1 million, in investing activities RMB 23.9 million, and in financing activities RMB 3.7 million[36][59][37] - The asset-liability ratio (total liabilities/total assets) decreased from 6.8% at the end of 2022 to 6.4% as of June 30, 2023[63] Future Outlook The company aims to become a globally renowned medical device platform for chronic disease management, planning to rapidly advance clinical development and commercialization of pipeline products, especially Bioheart® and second-generation Iberis®, to gain first-mover advantage, while expanding production capacity, building an internal sales and marketing team, increasing sales efforts, and actively seeking external collaborations, strategic investments, and acquisition opportunities to expand its business footprint in China and globally - Rapidly advance the clinical development and commercialization of Bioheart® and second-generation Iberis®, striving for "first-mover" advantage in the bio-resorbable scaffold and renal denervation markets[27] - Further expand production capacity and establish an internal sales and marketing team[27] - Intensify sales efforts to increase market share in China's interventional cardiovascular device market and expand global operations[23] - Actively seek external collaborations, strategic investments, and acquisition opportunities to facilitate future expansion[27] Human Resources As of June 30, 2023, the Group employed 58 full-time staff, all based in China, with total employee benefit expenses of approximately RMB 42.2 million during the reporting period, and utilizes the 2020 Plan and 2022 H Share Award Scheme to attract, incentivize, and retain highly skilled talent to support future Group development - As of June 30, 2023, the Group had 58 full-time employees, with total employee benefit expenses of approximately RMB 42.2 million during the reporting period[70] - The company has a 2020 Restricted Share Scheme and a 2022 H Share Award Scheme, designed to attract, incentivize, and retain key personnel[71][46] Other Information Use of Proceeds The company listed on December 23, 2021, with net proceeds from global offering of approximately HKD 441.69 million; the Board reallocated some unutilized funds originally designated for other pipeline products to DCB R&D, with total utilized funds of approximately HKD 151 million as of June 30, 2023 (HKD 35.5 million utilized during the reporting period), leaving HKD 290.68 million unutilized, expected to be fully utilized by December 2027 - Net proceeds from the global offering amounted to approximately HKD 441.69 million, with some funds reallocated from other pipeline products to DCB R&D[47] Summary of Use of Proceeds (As of June 30, 2023) | Item | Revised Allocation (HKD Million) | Unutilized Amount (HKD Million) | Expected Full Utilization Time | | :--- | :--- | :--- | :--- | | Core Product Bioheart® | 273.85 | 182.30 | December 2027 | | RDN Pipeline Product Second-Generation Iberis® | 94.08 | 74.70 | December 2027 | | DCB R&D | 17.25 | 15.45 | December 2027 | | General Corporate and Working Capital | 44.17 | 18.23 | December 2027 | | Total | 441.69 | 290.68 | | Corporate Governance and Other Disclosures During the reporting period, the company complied with most provisions of the Corporate Governance Code, though the roles of Chairman and General Manager (CEO) are held by the same individual (Mr. Wang Li), which the Board believes facilitates efficient management and strategic execution; no interim dividends were declared, nor were any listed securities purchased, sold, or redeemed, and subsequent to the period, a new wholly-owned subsidiary was established in Singapore for overseas R&D and sales activities, with interim results reviewed by the Audit Committee and independent auditor Ernst & Young - The company complied with the Corporate Governance Code, with a deviation where the roles of Chairman and General Manager (CEO) are held by the same person, which the Board believes facilitates efficient management[95][78] - The Board does not recommend the payment of an interim dividend for the six months ended June 30, 2023[75] - Subsequent to the reporting period, on July 10, 2023, the company established a wholly-owned subsidiary, BIO-HEART BIOLOGICAL PTE. LTD., in Singapore, expected to engage in overseas R&D and sales activities[50] - The Audit Committee has reviewed the interim results, and independent auditor Ernst & Young has reviewed the interim financial information in accordance with Hong Kong Standard on Review Engagements 2410[97][81]