Financial Performance - Revenue for the year ended December 31, 2023, was RMB 73.2 million, a decrease of 12.4% compared to RMB 83.6 million in 2022[2] - Gross profit was RMB 48.6 million with a gross margin of 66.3%, down from RMB 69.8 million and 83.5% in the previous year, representing a decline of 30.4%[2] - Loss attributable to shareholders was RMB 115.8 million, significantly improved from a loss of RMB 1,346.0 million in 2022, marking a 91.4% reduction[2] - Adjusted loss attributable to shareholders under non-Hong Kong Financial Reporting Standards was RMB 108.3 million, compared to RMB 100.9 million in 2022, an increase of 7.4%[2] - Basic and diluted loss per share was RMB (0.10), a substantial improvement from RMB (1.50) in the previous year, reflecting a 93.3% decrease in loss per share[2] - Total revenue for the year ended December 31, 2023, was RMB 73,219,000, a decrease of 12.4% from RMB 83,604,000 in 2022[36] - Revenue from product sales was RMB 72,684,000, down from RMB 82,634,000, representing a decline of 12.1%[36] - Revenue from installation and training services decreased to RMB 535,000 from RMB 970,000, a drop of 44.8%[36] - The company recorded a loss of RMB 1,171.0 million for the year ended December 31, 2023, compared to a loss of RMB 1,346.0 million for the year ended December 31, 2022[120] Assets and Liabilities - Total assets as of December 31, 2023, were RMB 573.3 million, down from RMB 690.3 million in 2022[27] - Cash and cash equivalents totaled RMB 134.1 million, with bank deposits maturing in over three months amounting to RMB 65.6 million[24] - Trade receivables increased to RMB 3,691,000 for the year ended December 31, 2023, up from RMB 148,000 in 2022, indicating improved collection efficiency[74] - The net amount of trade and other receivables rose to RMB 10,350,000 in 2023 from RMB 6,534,000 in 2022, showing a growth of approximately 58%[74] - Trade and other payables decreased to RMB 29,029,000 in 2023 from RMB 39,229,000 in 2022, indicating improved cash flow management[88] - The company has unutilized bank financing of RMB 490.0 million as of December 31, 2023[124] - Capital commitments amounted to RMB 356.0 million as of December 31, 2023, related to the purchase of construction and equipment services for the group's production facilities[125] Research and Development - Research and development expenses for the year were RMB 41.3 million, slightly down from RMB 44.2 million in 2022[5] - The company has developed 173 approved patents and 137 pending patents, with a dedicated R&D team of over 100 members[94] - The company aims to enhance its competitive advantage in the FFR and IMR fields and expand its IVD product coverage and market presence in 2024[105] - The company is committed to adhering to the Good Manufacturing Practice (GMP) standards for its medical products[158] - The company emphasizes the importance of clinical trials to validate the efficacy and safety of its medical devices[180] Product Development and Market Strategy - The company is engaged in the research, development, manufacturing, and commercialization of medical devices related to caFFR systems, caIMR systems, and IVD products in China, Europe, and other regions[33] - The company’s caFFR system has achieved over 95% accuracy and a convenient operation process of less than five minutes, establishing itself as a leading FFR measurement product in China[90] - The caIMR system received approval from the National Medical Products Administration in April 2023, marking it as the world's first minimally invasive IMR measurement product to complete confirmatory clinical trials[90] - The company plans to expand the indications for the caFFR system to include acute STEMI, acute NSTEMI, and HFpEF patients, enhancing its market reach[90] - The company aims to automate the entire PCI process through the integration of its vascular intervention robot with its existing clinical applications[90] - The company has halted clinical trials for the Flash RDN system, indicating a strategic shift in product development[96] Governance and Corporate Structure - The company has established an audit committee consisting of three independent non-executive directors to oversee financial reporting and internal controls[148] - The board of directors consists of executive directors including Mr. Huo Yunfei, Mr. Lv Yonghui, Mr. Zhang Liang, and Ms. Gu Yang, along with non-executive directors and independent non-executive directors[200] - The company is focused on enhancing corporate governance in accordance with the Corporate Governance Code[161] - The presence of multiple executive and independent directors suggests a robust governance framework[200] - The company is committed to transparency and accountability in its operations as reflected in the board's composition[200] Future Outlook - The company plans to continue expanding in both the Chinese and global markets, focusing on product development and potential mergers and acquisitions[137] - The company aims for healthy growth and high-quality development in 2024 despite a challenging industry landscape[105] - Future communications may include detailed financial performance and strategic initiatives as the company progresses[200]

Revenue and Profitability - Revenue for the six months ended June 30, 2023, decreased by approximately 2.9% to RMB 50.4 million from RMB 51.9 million for the same period in 2022[8]. - Gross profit for the same period decreased by approximately 16.7% to RMB 37.3 million, with a gross margin decline from 86.4% to 74.0%[9]. - The overall decrease in revenue is attributed to reduced sales of the FlashPressure caFFR sensor and caFFR system[8]. - The company recorded a loss of RMB 480.0 million for the six months ended June 30, 2023, compared to a loss of RMB 1,210.2 million in the same period of 2022[20]. - The company reported a loss of RMB 48,015 thousand for the six months ended June 30, 2023, significantly improved from a loss of RMB 1,210,222 thousand in the same period of 2022, representing a reduction of approximately 96%[102]. - Total comprehensive loss for the period was RMB 39,570 thousand, compared to RMB 1,286,552 thousand in the previous year, indicating a substantial decrease of about 97%[102]. - Basic loss per share improved to RMB 0.04 in 2023 from RMB 1.88 in 2022, demonstrating a positive trend in financial performance[153]. Expenses and Cost Management - Research and development expenses decreased by approximately 19.1% to RMB 22.6 million from RMB 28.0 million in the prior year, primarily due to capitalized R&D expenditures[11]. - Sales expenses increased by approximately 18.3% to RMB 38.4 million from RMB 32.5 million in the previous year, driven by increased employee benefits and marketing development expenses[13]. - General and administrative expenses decreased from RMB 471.5 million in the six months ended June 30, 2022, to RMB 373.2 million in the same period of 2023, a year-on-year decline of approximately 20.9%[16]. - Employee benefit expenses rose to RMB 65,347 thousand from RMB 62,727 thousand, while total expenses decreased to RMB 111,464 thousand from RMB 114,630 thousand[145]. Cash Flow and Financial Position - Cash used in operating activities was RMB 602.0 million, significantly impacted by high R&D, administrative, and sales expenses[21]. - Cash and cash equivalents increased to RMB 1,229.0 million as of June 30, 2023, up RMB 318.0 million from RMB 911.0 million on December 31, 2022[22]. - The company incurred cash outflows from operating activities of RMB 60,236 thousand, compared to RMB 48,456 thousand in the previous year, representing an increase of about 24%[114]. - The company reported a net cash inflow from investing activities of RMB 84,410 thousand, a significant improvement from a cash outflow of RMB 12,186 thousand in the same period of 2022[114]. - The company has unutilized bank financing of RMB 185,000,000 as of June 30, 2023, compared to RMB 191,000,000 in the previous year[179]. Shareholder Structure and Equity - The largest shareholder, Opera Rose Limited, holds 214,749,000 shares, representing 18.40% of the company[74]. - The total number of issued shares as of June 30, 2023, is 1,167,799,000[78]. - The company has granted a total of 707,628 share options, adjusted to 35,381,400 shares, representing 3.03% of the current issued share capital, with an exercise price of HKD 3.90 per share[92]. - The weighted average number of ordinary shares issued increased to 1,167,799,000 shares in 2023 from 644,500,000 shares in 2022, reflecting a substantial increase in share capital[153]. Product Development and Market Expansion - The company is focusing on expanding its product offerings, including the introduction of the FlashAngio caIMR system and IVD products, which generated sales of RMB 2.9 million and RMB 2.6 million, respectively[8]. - The company plans to continue investing in R&D and expanding its market presence to drive future growth[11]. - The company plans to launch its vascular interventional surgical robot by 2026, aiming to automate the entire PCI process through integrated clinical applications[42]. - The company aims for positive growth and high-quality development in 2023, focusing on strengthening its competitive advantages in the FFR and IMR sectors while actively pursuing overseas market opportunities[58]. Acquisitions and Investments - The company acquired a 57% equity stake in Tianjin Yuehekang Biotechnology Co., Ltd. for RMB 15.96 million and subscribed to an increase in registered capital for RMB 10.0 million[27]. - The acquisition of Tianjin Yuehekang Biotechnology Co., Ltd. is part of the company's strategy to expand into the in vitro diagnostics field[58]. - The company completed the acquisition of Tianjin Yuehe Kang Biotechnology Co., Ltd. for a total consideration of RMB 25,960,000, acquiring 68.32% of its registered capital[183]. Research and Development - The R&D team consists of over 100 members, accounting for approximately one-third of the total workforce, focusing on innovative products in the field of interventional precision therapy[47]. - The company capitalized development costs of approximately RMB 12,238,000 for the six months ended June 30, 2023, compared to zero in the same period of 2022, indicating increased investment in R&D[158]. - The company holds 128 approved patents and has 159 patents pending, including 120 in China and 45 overseas[47]. Regulatory and Compliance - The caIMR system received approval from the National Medical Products Administration in April 2023, becoming the world's first minimally invasive IMR measurement product approved for commercialization[42]. - The company’s subsidiary in Suzhou enjoys a preferential tax rate of 15% on estimated taxable profits due to its certification as a high-tech enterprise[150]. - The company has not made any provisions for Hong Kong profits tax as there were no estimated taxable profits generated in Hong Kong for the periods ended June 30, 2023, and 2022[149].

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性或完整性亦不發表 任何聲明，並明確表示，概不就因本公告全部或任何部分內容而產生或因依賴該等內容而引致的任何損失承擔任 何責任。 Rainmed Medical Limited 潤 邁 德 醫 療 有 限 公 司 （於開曼群島註冊成立的有限公司） （股份代號：2297） 截 至 2023 年 6 月 30 日 止 六 個 月 之 中 期 業 績 公 告 財務摘要 未經審核 截至6月30日止六個月 2023年 2022年 變化 人民幣百萬元 人民幣百萬元 （百分比除外）（百分比除外） 收入 50.4 51.9 (2.9%) 毛利 37.3 44.8 (16.7%) 毛利率 74.0% 86.4% 本公司股東之應佔虧損 (47.5) (1,210.2) (96.1%) 經調整非香港財務報告準則之 本公司股東之應佔虧損附註 (42.1) (22.2) 89.6% ...

Financial Performance - Revenue for the year ended December 31, 2022, was RMB 83.6 million, representing a 3.0% increase from RMB 81.2 million in 2021[11] - Gross profit for 2022 was RMB 69.8 million, with a gross margin of 83.5%, down from 85.0% in 2021[11] - The company reported a loss attributable to shareholders of RMB 1,346.0 million, a 112.4% increase compared to a loss of RMB 633.6 million in 2021[11] - The adjusted loss per share for 2022 was RMB 0.11, an increase of 37.5% from RMB 0.08 in 2021[11] - Total revenue for the year ended December 31, 2022, was RMB 83.6 million, a slight increase from RMB 81.2 million in 2021, driven primarily by sales of the FlashPressure caFFR pressure sensor[46] - Gross profit increased from RMB 69.0 million in 2021 to RMB 69.8 million in 2022, with a gross margin of 83.5% in 2022 compared to 85.0% in 2021[47] - Research and development expenses surged by approximately 63.8% from RMB 27.0 million in 2021 to RMB 44.2 million in 2022, mainly due to increased employee benefits and professional service costs[49] - Sales expenses decreased by about 4.8% from RMB 70.1 million in 2021 to RMB 66.8 million in 2022, primarily due to a reduction in one-time share-based payment expenses[52] - General and administrative expenses decreased from RMB 115.2 million in 2021 to RMB 109.3 million in 2022, a year-on-year decline of approximately 5.1%[55] - Other income rose from RMB 0.4 million in 2021 to RMB 5.3 million in 2022, primarily due to an increase in government subsidies[56] - The net cash used in operating activities was RMB 111.2 million, mainly due to significant R&D, administrative, and sales expenses[60] - Cash and cash equivalents decreased from RMB 559.1 million in 2021 to RMB 91.1 million in 2022, a reduction of RMB 468.0 million[61] - The company recorded a loss of RMB 1,346.0 million for the year ended December 31, 2022, compared to a loss of RMB 633.6 million for the year ended December 31, 2021[59] - The fair value loss of financial liabilities increased significantly from RMB 493.9 million in 2021 to RMB 1,210.9 million in 2022 due to the rise in the company's valuation[58] Assets and Liabilities - Non-current assets increased by 34.6% to RMB 86,897,000 in 2022 from RMB 64,547,000 in 2021[13] - Total assets rose by 7.8% to RMB 690,330,000 in 2022 compared to RMB 640,192,000 in 2021[13] - Total liabilities decreased by 94.9% to RMB 71,694,000 in 2022 from RMB 1,414,676,000 in 2021[13] - Total equity improved significantly to RMB 618,636,000 in 2022 from a loss of RMB 774,484,000 in 2021, marking a change of 179.9%[13] Product Development and Market Position - The caFFR system achieved over 95% accuracy and a convenient operation time of less than five minutes, establishing a leading position in the domestic FFR measurement market[5] - The company plans to expand the indications for the caFFR system to include acute STEMI, acute NSTEMI, and HFpEF patients[5] - The caIMR system is expected to become the world's first commercially approved minimally invasive IMR measurement system in 2023[5] - The company aims to launch its vascular interventional surgical robot by 2024, integrating all clinical applications for automated PCI processes[5] - The caFFR system achieved a clinical accuracy rate of 93.81% in 2022, with over 1,000 hospitals using the system by year-end[17][19] - The caIMR system entered the special approval pathway of the National Medical Products Administration in April 2022, with commercialization expected in Q2 2023[17] - By the end of 2022, the caFFR system was commercialized in 30 provinces and regions in China, with 21 provinces covered by medical insurance[19] - The company is actively seeking investment and acquisition targets to enhance its product lineup and expand its precision diagnosis and treatment product lines[22] - The global FFR measurement market is projected to grow from approximately USD 504.1 million in 2020 to about USD 1,200.0 million by 2025, with a compound annual growth rate (CAGR) of 18.9%[26] - The Chinese FFR measurement market is expected to rise from RMB 78.6 million in 2020 to approximately RMB 2,385.7 million by 2025, reflecting a CAGR of 97.9%[26] Research and Development - The R&D team consists of over 100 members, accounting for approximately one-third of the total workforce, focusing on innovative products in the field of interventional precision therapy[34] - As of December 31, 2022, the company holds 102 approved patents and has 178 patents pending, including 129 in China and 49 overseas[34] - The company is considering investments and acquisitions within the industry to expand its product pipeline and introduce innovative products[23] - The IMR measurement market is still in its early stages, and the company plans to focus on training for doctors, patients, and hospital managers regarding the caIMR system[27] Corporate Governance and Management - The company has a management team with over 16 years of experience in compliance, investment, and financing, enhancing its strategic capabilities[83] - The company’s Vice President, Ms. Gu Yang, has been with the group since March 2021, focusing on human resources management[87] - The company’s independent non-executive director, Mr. Liao Chuanjiang, has over 20 years of experience in accounting, auditing, and management, providing independent oversight[94] - The company has a strong governance structure with a diverse board, including members with extensive backgrounds in finance and investment management[89][92] - The company is focused on compliance and regulatory communication, ensuring adherence to market standards[84] - The company’s strategic direction is supported by a board that provides investment strategies and governance guidance[89][92] Shareholder Information - As of December 31, 2022, Mr. Huo Yunfei holds 214,749,000 shares, representing 18.39% of the company[155] - Mr. Lü Yonghui holds 30,937,000 shares, accounting for 2.65% of the company[155] - The company has a total of 1,167,799,000 shares issued as of December 31, 2022[174] - The company has significant ownership concentration, with several shareholders holding around 5.05% each[171] - The ownership structure includes various partnerships and trusts, indicating a complex ownership arrangement[172] - The company is indirectly controlled by Ping An Group, which holds significant stakes in related investment entities[176] Future Outlook and Challenges - The company remains optimistic about the market outlook in mainland China and Hong Kong for 2023 despite recent challenges[45] - The group has faced significant operational losses since its inception, which may continue in the foreseeable future as it expands product development and seeks regulatory approvals[127] - Regulatory approval processes are lengthy, costly, and inherently unpredictable, which could severely impair the group's ability to commercialize its research products[137] - The group may face additional costs or delays in product development if clinical trials do not demonstrate satisfactory safety and efficacy to regulatory authorities[127] - The group’s future growth largely depends on the successful development and commercialization of its research products[127]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性或完整性亦不發表 任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產生或因倚賴該等內容而引致的任何損失承擔任 何責任。 Rainmed Medical Limited 潤 邁 德 醫 療 有 限 公 司 （於開曼群島註冊成立的有限公司） （股份代號：2297） 截 至 2022 年 12 月 31 日 止 年 度 之 年 度 業 績 公 告 財務摘要 截至12月31日止年度 2022年 2021年 變動 人民幣百萬元 人民幣百萬元 （百分比除外）（百分比除外） （經審核） （經審核） 收入 83.6 81.2 3.0% 毛利 69.8 69.0 1.2% 毛利率 83.5% 85.0% 本公司股東之應佔虧損 (1,346.0) (633.6) 112.4% 經調整非香港財務報告準則之 本公司股東之應佔虧損附註 (100.9) (51.7) 95.2% ...

Financial Performance - Revenue increased by approximately 17.7% from RMB 440.84 million for the six months ended June 30, 2021, to RMB 518.99 million for the six months ended June 30, 2022, primarily due to increased sales of FlashPressure caFFR pressure sensors[8]. - Gross profit rose from RMB 383 million for the six months ended June 30, 2021, to RMB 448 million for the six months ended June 30, 2022, an increase of about 16.9%[9]. - The net loss for the six months ended June 30, 2022, was RMB 1,210.2 million, compared to a loss of RMB 253.7 million for the six months ended June 30, 2021[23]. - Basic and diluted loss per share was RMB 1.88, compared to RMB 0.40 in the previous year, indicating a deterioration in per-share performance[110]. - The company reported a total comprehensive loss of RMB (1,286,552) thousand[120]. Expenses and Costs - Research and development expenses surged by approximately 254.1%, from RMB 78.93 million for the six months ended June 30, 2021, to RMB 279.51 million for the six months ended June 30, 2022, mainly due to increased employee benefits and R&D material costs[12]. - Sales expenses decreased significantly from RMB 458.6 million for the six months ended June 30, 2021, to RMB 324.5 million for the six months ended June 30, 2022, representing a year-on-year decline of approximately 29.2%[14]. - General and administrative expenses decreased from RMB 601.1 million for the six months ended June 30, 2021, to RMB 471.5 million for the six months ended June 30, 2022, a year-on-year decline of approximately 21.5%[18]. - Employee benefits expenses decreased to RMB 62,727 thousand in H1 2022 from RMB 91,415 thousand in H1 2021, a reduction of approximately 31.4%[172]. - Total expenses for H1 2022 were RMB 114,630 thousand, slightly down from RMB 119,616 thousand in H1 2021, representing a decrease of about 4.1%[172]. Assets and Liabilities - As of June 30, 2022, total assets amounted to RMB 617,952 thousand, a decrease from RMB 640,192 thousand as of December 31, 2021, representing a decline of approximately 3.8%[115]. - Total liabilities reached RMB 2,671,599 thousand as of June 30, 2022, compared to RMB 1,414,676 thousand as of December 31, 2021, marking an increase of approximately 88.7%[117]. - Non-current liabilities increased significantly to RMB 2,630,541 thousand as of June 30, 2022, up from RMB 1,370,609 thousand as of December 31, 2021, reflecting an increase of approximately 92%[117]. - The company has a total equity of RMB (2,053,647) thousand as of June 30, 2022, compared to RMB (774,484) thousand as of December 31, 2021, indicating a significant deterioration in equity position[120]. Cash Flow - Cash and cash equivalents amounted to RMB 518.5 million, a decrease of RMB 40.6 million from RMB 559.1 million as of December 31, 2021[25]. - Operating cash flow for the six months ended June 30, 2022, was RMB (48,456) thousand, compared to RMB (19,110) thousand for the same period in 2021, indicating a worsening cash flow situation[126]. - The company incurred a net cash outflow from investing activities of RMB (12,186) thousand for the six months ended June 30, 2022, compared to RMB (23,672) thousand in the prior year, showing a decrease in cash used for investments[126]. Market and Product Development - The company plans to continue expanding in the Chinese and global markets, focusing on product development through internal growth, mergers, and acquisitions, supported by sufficient bank credit facilities[33]. - The caFFR system has achieved over 95% accuracy and a convenient operation process of less than five minutes, becoming a leading FFR measurement product in China[41]. - The company aims to launch its vascular interventional surgical robot by 2024, integrating all clinical applications for automated PCI processes[41]. - The company is developing the caIMR system, which is the only minimally invasive IMR measurement product that has completed confirmatory clinical trials globally[41]. - The company plans to expand the indications for the caFFR system to include acute STEMI, acute NSTEMI, and HFpEF patients[41]. Corporate Governance - The board of directors consists of two non-executive directors, three independent non-executive directors, and four executive directors, ensuring a balanced distribution of power and authority[61]. - The audit committee, comprising three independent non-executive directors, has reviewed the unaudited interim financial information for the six months ending June 30, 2022[65]. - The company is committed to maintaining high standards of corporate governance to enhance shareholder value and accountability[59]. Shareholder Information - Major shareholders include Opera Rose Limited and Dawning Sky Limited, each holding 214,749,000 shares, representing 18.40% of the company[81]. - The company has multiple shareholders with significant stakes, including Zhou Bin with 82,720,000 shares (7.09%) and Hebei Dongtuo Investment Co., Ltd. with 59,801,000 shares (5.12%)[86]. - The report indicates a diverse ownership structure with various entities holding substantial shares[86]. Regulatory and Compliance - The company was listed on the Hong Kong Stock Exchange on July 8, 2022[129]. - The financial data for the six months ending June 30, 2022, was prepared in accordance with Hong Kong Accounting Standards, specifically HKAS 34[129]. - The company has not recognized any tax provision in mainland China for H1 2022 due to no estimated taxable profits[182].