Financial Performance - In 2024, the company achieved a revenue of RMB 53.531 million, representing a year-on-year growth of 30.7%[9] - The gross profit for 2024 was RMB 38.410 million, compared to RMB 31.052 million in 2023[8] - The company reported a net loss of RMB 111.277 million for 2024, slightly higher than the loss of RMB 105.746 million in 2023[8] - Revenue increased from RMB 41.0 million for the year ended December 31, 2023, to RMB 53.5 million for the year ended December 31, 2024, representing a growth of RMB 12.5 million or 30.7%[39] - Overall gross profit increased from RMB 31.1 million for the year ended December 31, 2023, to RMB 38.4 million for the year ended December 31, 2024, while gross profit margin decreased from 75.8% to 71.8%[41] - Other income and gains rose from RMB 15.0 million for the year ended December 31, 2023, to RMB 20.7 million for the year ended December 31, 2024, primarily due to increased government subsidies[42] Assets and Liabilities - As of December 31, 2024, the total current assets were RMB 98.159 million, down from RMB 149.915 million in 2023[8] - The total non-current assets decreased to RMB 51.088 million in 2024 from RMB 62.906 million in 2023[8] - Total debt increased from RMB 11.0 million as of December 31, 2023, to RMB 13.3 million as of December 31, 2024[56] - Current ratio decreased from 4.9 to 1.6, and quick ratio decreased from 4.1 to 1.1 from December 31, 2023, to December 31, 2024[57] - Net cash used in operating activities was RMB 82.9 million for the year ended December 31, 2024, primarily due to significant R&D and administrative expenses[53] Product Development and Commercialization - The company received NMPA approval for multiple products, including the cardiac cryoablation system and the cryoadhesion treatment system in January 2024[10] - A significant milestone was achieved with the commercialization of the cardiac cryoablation system and cryoadhesion treatment system in September 2024[10] - The product portfolio includes 14 cryo-treatment products and 9 non-cryo treatment products, with 10 already commercialized as of the report date[13] - The company aims to accelerate product commercialization and improve profitability to create greater value for shareholders[11] - The company is focused on expanding its product pipeline in the vascular intervention and respiratory intervention sectors[15] Research and Development - The company has established a product development team of 70 internal R&D staff and 24 clinical operation staff, focusing on understanding clinical needs and developing new products[36] - The company is actively pursuing innovation in medical technology, with a focus on international product introduction[94] - The company has a strong focus on research and development, with a CTO overseeing R&D activities since 2019[92] - The company is committed to developing new technologies and applications in the medical field, leveraging the expertise of its board members[78] Management and Governance - The management team includes experienced professionals with over 21 years in the medical industry and over 10 years in auditing[68][70] - The company has a structured governance framework with representatives from various departments, ensuring comprehensive oversight[89] - The board consists of three executive directors, two non-executive directors, and four independent non-executive directors, ensuring a balance of power[109] - The company has implemented a comprehensive risk management policy to identify, assess, and monitor key risks related to its strategic objectives[147] Corporate Culture and Employee Relations - The company emphasizes the importance of corporate culture for long-term business development and sustainable growth[101] - The company has a focus on employee training and development, providing regular feedback and internal and external training on various aspects[64] - The company is committed to compliance with Chinese labor laws, including individual employment contracts and contributions to social insurance funds[64] - The employee gender ratio is approximately 42% male to 58% female as of December 31, 2024[144] Compliance and Risk Management - The company has implemented strict internal controls to comply with regulations regarding sensitive data handling and anti-corruption measures[151] - The company conducts regular training for management and employees on compliance with applicable laws and regulations, including anti-corruption policies[152] - The company has adopted a whistleblowing policy to encourage employees and stakeholders to report suspicious activities confidentially[154] - The audit committee oversees the implementation of necessary measures to ensure compliance with relevant laws and regulations governing business operations[155] Environmental, Social, and Governance (ESG) - The report is the third Environmental, Social, and Governance (ESG) report issued by the company, adhering to principles of objectivity, transparency, and comprehensiveness[176] - The company identified 6 highly important ESG issues, 10 moderately important issues, and 2 generally important issues during the reporting period[197] - The company emphasizes the importance of sustainable development in its operations[198] - The company has committed to optimizing its corporate governance structure and ESG management system for sustainable development[186]

Financial Performance - For the fiscal year ending December 31, 2024, the company reported revenue of RMB 53,531,000, an increase of 30.7% compared to RMB 40,950,000 in 2023[2] - The gross profit for the same period was RMB 38,410,000, reflecting a growth of 23.7% from RMB 31,052,000 in the previous year[2] - The net loss for the year was RMB 111,277,000, which is a 5.2% increase from the loss of RMB 105,746,000 in 2023[2] - Revenue from the sale of medical devices and consumables increased to RMB 53,531,000 in 2024 from RMB 40,950,000 in 2023, representing a growth of approximately 30.6%[27] - Government grants received rose to RMB 19,271,000 in 2024 compared to RMB 12,025,000 in 2023, marking an increase of about 60.5%[30] - The total income for 2024 was RMB 20,733,000, up from RMB 14,959,000 in 2023, reflecting an increase of around 38.5%[30] - The company reported a pre-tax loss of RMB 111,143,000 for 2024, compared to a loss of RMB 105,746,000 in 2023, reflecting an increase in losses of approximately 3.9%[33] - The effective tax expense calculated at the group's actual tax rate for 2024 was RMB 134, while the statutory tax expense at a rate of 25% amounted to RMB 27,786,000 for 2024[33] - The basic loss per share attributable to ordinary equity holders of the parent was calculated based on a weighted average of 239,110,000 shares for both 2024 and 2023, with no adjustments for dilution due to unexercised options[35] - The company’s revenue from a single major customer amounted to RMB 2,784,000 in 2024, down from RMB 5,752,000 in 2023, showing a decline of approximately 51.5%[26] - The company’s contract liabilities recognized as revenue from medical consumables were RMB 964,000 in 2024, down from RMB 3,160,000 in 2023, indicating a decrease of about 69.5%[28] Regulatory Approvals and Product Development - The company achieved several regulatory approvals, including the market approval for the cryo-adhesion treatment system in January 2024[3] - The benign stricture cryoablation system entered the confirmatory clinical trial phase in January 2024[3] - The company submitted a registration application for its anti-reflux system in May 2024[3] - The cardiac cryoablation system is expected to receive approval from the National Medical Products Administration (NMPA) in December 2023, following its registration application submitted in July 2022[46] - The Cryofocus cryoablation system, designed for resistant hypertension, is anticipated to gain NMPA approval in the second half of 2027[47] - The pulmonary hypertension cryoablation system is currently in preclinical research and is expected to receive NMPA approval in the second half of 2029[48] - The COPD cryo-spray treatment system is entering confirmatory clinical trials, with registration documents expected to be submitted to the NMPA in the second half of 2025 and approval anticipated in the second half of 2026[49] - The asthma cryoablation system is also in confirmatory clinical trials, with plans to submit registration documents to the NMPA in the second half of 2025 and approval expected in the second half of 2026[50] - The malignant stenosis cryoablation system is designed for ablating malignant airway tumors and reducing the frequency of airway restenosis, with clinical trials initiated in April 2021 and regulatory submission expected in May 2024[51] - The benign stenosis cryoablation system, based on liquid nitrogen, entered the confirmatory clinical trial phase in January 2024, with regulatory submission anticipated in the first half of 2027[52] - The lung peripheral nodule cryoablation system is currently in the feasibility clinical trial phase, with expected regulatory submission in the second half of 2026[53] - The cough cryo-spray treatment system is in the feasibility clinical trial phase, with regulatory submission expected in the first half of 2025[54] - The tuberculosis cryo-spray treatment system is also in the feasibility clinical trial phase, with anticipated regulatory submission in the second half of 2025[55] - The frozen adhesion treatment system received regulatory approval in January 2024 and was commercialized in September 2024[56] - The bladder cryoablation system was approved by the National Medical Products Administration in June 2022 and commercialized in December 2022[57] - The gastric cryoablation system is currently in the feasibility clinical trial phase, with expected regulatory submission in the second half of 2025[58] - The esophageal cryo-spray treatment system is in the feasibility clinical trial phase, with anticipated regulatory submission in the second half of 2025[59] - The lung nodule localization needle was commercialized in May 2019 after receiving regulatory approval in March 2019[60] - The atrial fibrillation pulsed field ablation (PFA) system is currently in feasibility clinical trials, with expectations for regulatory approval in the first half of 2027[63] - The anti-reflux system is expected to submit a registration application in May 2024, with anticipated regulatory approval in the first half of 2025[64] Financial Position and Assets - The total assets decreased from RMB 182,039,000 in 2023 to RMB 89,432,000 in 2024, indicating a significant reduction in asset value[7] - The company’s cash and cash equivalents dropped from RMB 103,402,000 in 2023 to RMB 45,458,000 in 2024[7] - Trade receivables remained unchanged at RMB 74,000 for both 2024 and 2023, with a full impairment provision reflecting a 100% expected credit loss rate[39] - Other receivables decreased from RMB 22,088,000 in 2023 to RMB 22,828,000 in 2024, with impairment losses increasing from RMB 620,000 to RMB 901,000[40] - Trade payables increased from RMB 906,000 in 2023 to RMB 1,205,000 in 2024, indicating a rise in short-term liabilities[41] - Total debt increased from RMB 1,101 million in 2023 to RMB 1,332 million in 2024[85] - Current ratio decreased from 4.9 in 2023 to 1.6 in 2024, indicating reduced liquidity[86] Corporate Governance and Compliance - The company has adopted corporate governance principles and has complied with all applicable provisions of the corporate governance code during the reporting period[101] - The audit committee, consisting of one non-executive director and two independent non-executive directors, has reviewed the financial performance for the year ended December 31, 2024, ensuring compliance with relevant accounting standards[104] - Ernst & Young has agreed with the financial figures reported for the year ended December 31, 2024, confirming consistency with the group's consolidated financial statements[105] - The company did not purchase, sell, or redeem any of its listed securities during the reporting period[103] - The board will continue to monitor and review its corporate governance practices to maintain high standards[102] Employee and Operational Metrics - As of December 31, 2024, the group employed 276 full-time employees, a decrease from 392 in 2023, with total employee benefits expenses amounting to approximately RMB 100.7 million[95] - The company aims to maintain strict control over outstanding receivables to minimize credit risk, with management regularly reviewing overdue balances[37] - The company has a comprehensive product portfolio with 14 cryotherapy products and nine non-cryotherapy products in development, with ten products already commercialized[44] - The company focuses on minimally invasive cryotherapy, utilizing unique liquid nitrogen ablation technology and advanced flexible catheter technology[43] - The company aims to expand its product portfolio based on its cryoablation technology and plans to selectively expand its global business[69] Expenses and Financial Management - R&D expenses decreased from RMB 761.3 million in 2023 to RMB 734.55 million in 2024, a reduction of RMB 26 million or 3.5%[74] - Administrative expenses increased from RMB 690 million in 2023 to RMB 812 million in 2024, an increase of RMB 122 million or 17.6%[75] - Sales and distribution expenses surged from RMB 57 million in 2023 to RMB 141 million in 2024, an increase of RMB 84 million or 148.2%[76] - Financing costs rose from RMB 7 million in 2023 to RMB 11 million in 2024, an increase of RMB 4 million or 67.3%[78] - Net cash used in operating activities was RMB 829 million for the year ending December 31, 2024, primarily due to significant R&D and administrative expenses[82] - Cash and cash equivalents decreased from RMB 1,034 million in 2023 to RMB 455 million in 2024, a reduction of RMB 579 million or 56.0%[82] - The company reported a net loss increase from RMB 1,058 million in 2023 to RMB 1,113 million in 2024[81] Shareholder and Meeting Information - The board does not recommend the distribution of a final dividend for the reporting period, consistent with 2023[96] - On March 7, 2024, the China Securities Regulatory Commission approved the conversion and listing of 29,341,981 non-listed shares into H-shares, which commenced trading on September 6, 2024[97] - The board proposed amendments to the company's articles of association and changes to the use of net proceeds from the global offering, which were approved at the annual general meeting on June 14, 2024[98] - A total lease agreement was renewed with Ningbo Linrong for a period of three years starting January 1, 2025, with the transaction constituting a continuing connected transaction[99] - The annual general meeting is scheduled for June 20, 2025, with a suspension of H-share transfer registration from June 17 to June 20, 2025, to determine eligibility for voting[112][113] - The company maintains the required public float as per listing rules as of the announcement date[111] - The company plans to submit a special resolution for amendments to the articles of association at the annual general meeting[107] - The annual report for the fiscal year ending December 31, 2024, will be published in accordance with listing rules[114]

SHA 康澧生物科技(上海)股份有限公司 Cryofocus Medtech (Shanghai) Co., Ltd. (於中華人民共和國註冊成立的股份有限公司) 股份代號: 6922 GINN 中期報告 2024 目錄 2 公司資料 4 財務摘要 5 管理層討論及分析 17 其他資料 27 中期簡明綜合損益表 28 中期簡明綜合全面收益表 29 中期簡明綜合財務狀況表 30 中期簡明綜合權益變動表 31 中期簡明綜合現金流量表 33 中期簡明綜合財務資料附註 44 釋義 l l D magamm 公司資料 | --- | --- | |---------------------------------------------------|------------------------------------| | | | | 董事會 | 聯席公司秘書 | | 執行董事 | 劉偉先生 | | 李克儉先生 （主席） | 梁慧欣女士 （ ACG、HKACG ） | | 朱軍先生 （總經理） | | | 劉偉先 生（首席財務官、董事會秘書兼聯席公司秘書） | 授權代表 | | 非執行董事 | 朱軍先生 梁慧欣女士 ...

Financial Performance - Revenue for the six months ended June 30, 2024, was RMB 19,475,000, an increase of 3% from RMB 18,914,000 in the same period of 2023[2] - Gross profit for the same period was RMB 15,281,000, up from RMB 14,638,000, reflecting a gross margin improvement[2] - The net loss for the six months ended June 30, 2024, was RMB (55,953,000), compared to a loss of RMB (47,428,000) in the prior year, representing a 18% increase in losses[2] - Revenue from the sale of medical devices and consumables reached RMB 19,475,000 in the six months ended June 30, 2024, compared to RMB 18,914,000 in the same period of 2023, representing an increase of approximately 2.96%[19] - Other income decreased to RMB 2,122,000 for the six months ended June 30, 2024, down from RMB 3,750,000 in the same period of 2023, reflecting a decline of approximately 43.5%[21] - The group reported a pre-tax loss of RMB 34,330,000 attributed to research and development expenses during the six months ended June 30, 2024[22] - The group recognized a net foreign exchange loss of RMB 3,179,000 for the six months ended June 30, 2023[22] - The company reported a loss attributable to ordinary equity holders of RMB 52,171,000 for the six months ended June 30, 2024, compared to a loss of RMB 43,402,000 for the same period in 2023, representing an increase in loss of approximately 20%[28] - Basic and diluted loss per share for the six months ended June 30, 2024, was RMB (0.22), compared to RMB (0.18) for the same period in 2023, indicating a deterioration in earnings per share[28] - The company has not declared or paid any dividends for the six months ended June 30, 2024, consistent with the previous year[26] Research and Development - Research and development expenses increased to RMB (37,222,000) from RMB (34,330,000), indicating a focus on innovation[2] - The group’s employee benefits expenses, including salaries and wages, amounted to RMB 29,414,000 for the six months ended June 30, 2023[22] - The company has established a product development team consisting of 90 internal R&D staff and 36 clinical operation staff[53] - The company holds 152 patents and has 53 patent applications as of June 30, 2024, to protect its core technologies[54] - The company aims to become a global platform for minimally invasive cryo-interventional medical devices, focusing on rapid clinical development and commercialization of its pipeline products[56] Product Development and Approvals - The company received market approval for its cryo-adhesion treatment system in January 2024, following previous approvals for related products[2][3] - The benign stricture cryoablation system entered the confirmatory clinical trial phase in January 2024[3] - The company submitted registration applications for its malignant stricture cryoablation system and gastroesophageal reflux system[4] - The Cryofocus cryoablation system is designed for hypertension treatment and is expected to receive regulatory approval from the National Medical Products Administration (NMPA) in the second half of 2025[35] - The cardiac cryoablation system received NMPA approval in December 2023, following clinical trials initiated in October 2019[34] - The chronic obstructive pulmonary disease (COPD) cryo-spray treatment system entered confirmatory clinical trials in March 2023, with expected NMPA submission in the second half of 2025 and approval anticipated in the second half of 2026[36] - The asthma cryoablation system is currently in confirmatory clinical trials, with NMPA submission expected in the second half of 2025 and approval anticipated in the second half of 2026[37] - The pulmonary hypertension cryoablation system is in preclinical research, with expected NMPA approval in the second half of 2027[35] - The anti-reflux system is expected to be commercialized in the first half of 2025[34] - The malignant stenosis cryoablation system is designed to treat malignant airway tumors and reduce the frequency of airway re-stenosis[37] - The company has submitted registration applications for several products, indicating a strong pipeline for future growth and market expansion[34] Financial Position - As of June 30, 2024, total non-current assets were valued at RMB 67,944,000, an increase from RMB 62,906,000 at the end of 2023[9] - Current assets decreased to RMB 116,701,000 from RMB 149,915,000, primarily due to a reduction in cash and cash equivalents[9] - Total equity as of June 30, 2024, was RMB 126,028,000, down from RMB 173,460,000 at the end of 2023[12] - Cash and cash equivalents decreased from RMB 1,035 million as of December 31, 2023, to RMB 696 million as of June 30, 2024, a reduction of RMB 339 million or 32.8%[70] - Total debt as of June 30, 2024, was RMB 17,697,000, up from RMB 11,011,000 as of December 31, 2023, representing an increase of approximately 60.5%[73] - The current ratio decreased to 2.5 as of June 30, 2024, from 4.9 as of December 31, 2023, while the debt-to-asset ratio increased to 31.7% from 18.5%[74] Governance and Corporate Structure - The board of directors includes executive directors Mr. Li Kejian, Mr. Zhu Jun, and Mr. Liu Wei, along with non-executive directors Mr. Lv Shiwen and Mr. Zhao Chunsheng, and independent non-executive directors Dr. Gao Dayong, Mr. Liang Xianzhi, Dr. Qin Zheng, and Dr. Hu Henan[93] - The audit committee, consisting of one non-executive director and two independent non-executive directors, has reviewed and confirmed that the interim financial results for the six months ending June 30, 2024, comply with relevant accounting standards and regulations[87] - The board composition reflects a mix of executive and independent directors, which may enhance governance and strategic decision-making[93] - The presence of multiple independent directors may indicate a commitment to transparency and accountability in corporate governance[93] - The emphasis on board diversity may contribute to a broader range of insights and strategies for market expansion[93] Market and Strategic Outlook - The company is focused on biotechnology, suggesting potential developments in health-related products and technologies[93] - The company believes its competitive advantages and product pipeline create high barriers to entry for competitors in the market[31] - The company is likely to discuss future outlook and performance guidance in upcoming communications[93] - The announcement suggests ongoing engagement with stakeholders regarding company performance and strategic direction[93] - The date of the announcement indicates that the company is actively communicating with investors and the market[93]

| --- | --- | --- | --- | |--------------------------------------------------------------------------------------------------------------------------------------|-------|-------|-------| | | | | | | | | | | | GBXb 康澧生物科技(上海)股份有限公司 Cryofocus Medtech (Shanghai) Co., Ltd. (於中華人民共和國註冊成立的股份有限公司) 股份代號 : 6922 | | | | | | | | | 目錄 2 公司資料 104 獨立核數師報告 4 財務概要 109 綜合損益表 5 主席報告 110 綜合全面收益表 6 管理層討論及分析 111 綜合財務狀況表 19 董事、監事及高級管理層 112 綜合權益變動表 28 企業管治報告 113 綜合現金流量表 45 環境、社會及管治報告 115 財務報表附註 79 董事會報告 166 釋義 102 監事會報告 公司資料 | -- ...

Financial Performance - Revenue for the year ended December 31, 2023, was RMB 40,950,000, an increase of 50.8% compared to RMB 27,149,000 in 2022[2] - Gross profit for the same period was RMB 31,052,000, representing a 60.4% increase from RMB 19,362,000 in 2022[2] - The net loss for the year narrowed to RMB (105,746,000), a 10.6% improvement from RMB (118,316,000) in the previous year[2] - Revenue from customer contracts for medical devices and consumables reached RMB 40,950,000 in 2023, up from RMB 27,149,000 in 2022, representing a growth of approximately 50.5%[24] - Other income increased to RMB 13,259,000 in 2023 from RMB 8,750,000 in 2022, marking a rise of about 51.4%[28] - Government grants accounted for RMB 12,025,000 in 2023, compared to RMB 7,542,000 in 2022, reflecting an increase of approximately 59.5%[28] - The group recorded a pre-tax loss of RMB 105,746,000 for 2023, an improvement from a loss of RMB 118,316,000 in 2022, representing a reduction of approximately 10.5%[33] - The company reported a net loss reduction from RMB 118.3 million for the year ended December 31, 2022, to RMB 105.8 million for the year ended December 31, 2023[90] Assets and Liabilities - Non-current assets increased to RMB 62,906,000 in 2023 from RMB 49,655,000 in 2022[9] - Current assets decreased to RMB 149,915,000 in 2023 from RMB 264,208,000 in 2022, reflecting a significant reduction in cash and cash equivalents[9] - Total equity decreased to RMB 173,460,000 in 2023 from RMB 259,389,000 in 2022, indicating a decline in the company's net worth[10] - Trade receivables remained unchanged at RMB 74,000 for both 2023 and 2022, with a full impairment provision applied[36][40] - Other receivables increased to RMB 22,088,000 in 2023 from RMB 17,858,000 in 2022, marking an increase of approximately 23%[42] - Trade payables decreased to RMB 906,000 in 2023 from RMB 1,763,000 in 2022, a decline of about 48.7%[44] - Other payables and accrued expenses totaled RMB 25,637,000 in 2023, down from RMB 37,275,000 in 2022, representing a decrease of approximately 31.3%[45] - Cash and cash equivalents decreased from RMB 226.4 million as of December 31, 2022, to RMB 103.4 million as of December 31, 2023, a reduction of RMB 123.0 million or 54.3%[91] - Total liabilities as of December 31, 2023, were RMB 11.0 million, slightly down from RMB 11.4 million as of December 31, 2022[93] Research and Development - R&D expenses increased from RMB 59.9 million for the year ended December 31, 2022, to RMB 76.1 million for the year ended December 31, 2023, a rise of 27.0% primarily due to increased personnel costs and materials used in ongoing R&D projects[83] - The company has developed a comprehensive product portfolio, including 14 cryoablation products and 9 non-cryoablation products, with 8 products already commercialized[47] - The company plans to accelerate clinical development and commercialization of its pipeline products, focusing on minimally invasive cryoablation therapy and expanding its product portfolio[76] - The company aims to continue developing various underlying technologies and selectively expand its global business[76] Regulatory Approvals and Clinical Trials - The company received approval from the National Medical Products Administration for its cardiac cryoablation system in December 2023[3] - The cardiac cryoablation system passed GMP review in January 2024, indicating readiness for market introduction[3] - The company completed patient recruitment for the confirmatory clinical trial of the malignant stenosis cryoablation system[3] - The asthma cryoablation system and COPD cryo-spray treatment system entered the confirmatory clinical trial phase in March 2023[3] - The Cryofocus cryoablation system, designed for hypertension treatment, is expected to receive approval from the National Medical Products Administration in the second half of 2025[51] - The pulmonary hypertension cryoablation system is currently in preclinical research, with expected approval in the second half of 2027[52] - The COPD cryo-spray treatment system entered confirmatory clinical trials in March 2023, with registration documents expected to be submitted in the second half of 2025[53] - The asthma cryoablation system also entered confirmatory clinical trials in March 2023, with anticipated registration submission in the second half of 2025[54] - The malignant stenosis cryoablation system is in confirmatory clinical trials, with patient recruitment completed and expected registration submission in Q2 2024[55] - The benign stricture cryoablation system is expected to enter confirmatory clinical trials in January 2024, with product registration submission anticipated in Q4 2024 and approval expected in H1 2026[56] - The lung nodule cryoablation system entered feasibility clinical trials in August 2023, with product registration submission expected in H2 2026 and approval anticipated in H2 2027[57] - The cough cryo-spray therapy system is currently in feasibility clinical trials, with product registration submission expected in H1 2025 and approval anticipated in H2 2026[58] - The tuberculosis cryo-spray therapy system is also in feasibility clinical trials, with product registration submission expected in H2 2025 and approval anticipated in H2 2026[60] - The frozen adhesion treatment system received approval for supporting cryotherapy equipment in December 2023 and is expected to receive approval for single-use cryo-probes in January 2024, with market approval anticipated in January 2024[61] Corporate Governance and Compliance - The group has adopted new and revised Hong Kong Financial Reporting Standards for the current financial year, with no impact on the measurement, recognition, or presentation of any items in the financial statements[14] - The group has not recognized deferred tax assets or liabilities for temporary differences, and the revisions have no effect on the financial statements[16] - The group operates primarily in the medical consumables and devices sector, with nearly all revenue generated from sales in mainland China[22] - The company has adopted corporate governance principles and has complied with all applicable provisions of the corporate governance code throughout the reporting period[100] - The audit committee, consisting of one non-executive director and two independent non-executive directors, has provided independent opinions on financial reporting procedures and internal controls[103] - The audit committee reviewed and confirmed that the annual financial performance for the year ending December 31, 2023, complies with relevant accounting standards and regulations[104] - The company is committed to compliance with corporate governance standards as outlined in the listing rules[114] Employee and Operational Insights - The company employed 392 full-time employees as of December 31, 2023, an increase from 375 employees in 2022, with total employee benefit expenses amounting to approximately RMB 116.9 million[98] - The company maintains the required public float as per listing rules[110] - The company is focused on maintaining transparency and communication with stakeholders[113] - The company will provide necessary information to shareholders regarding the annual report and general meeting in a timely manner[112] - The company emphasizes the importance of shareholder participation in the annual general meeting[111]

Financial Performance - Revenue for the six months ended June 30, 2023, was RMB 18,914,000, an increase of 83.5% compared to RMB 10,306,000 for the same period in 2022[5] - Gross profit for the same period was RMB 14,638,000, up from RMB 7,088,000, reflecting a gross margin improvement[5] - The net loss for the period was RMB (47,428,000), slightly higher than the loss of RMB (44,850,000) in the previous year[5] - Revenue increased from RMB 10.3 million for the six months ended June 30, 2022, to RMB 18.9 million for the six months ended June 30, 2023, representing an increase of RMB 8.6 million or 83.5%[33] - Gross profit rose from RMB 7.1 million for the six months ended June 30, 2022, to RMB 14.6 million for the six months ended June 30, 2023, with a gross margin increase from 68.8% to 77.4%[35] - The company incurred a loss before tax of RMB 47,428 thousand, slightly higher than the loss of RMB 44,850 thousand reported in the previous year[81] - The company reported a total comprehensive loss of RMB 47,674 thousand for the period, compared to RMB 44,762 thousand in the previous year[82] - The company recorded a loss attributable to ordinary equity holders of RMB 43,402,000 for the six months ended June 30, 2023, compared to a loss of RMB 42,698,000 in the same period of 2022[107] Research and Development - Research and development expenses increased to RMB (34,330,000) from RMB (22,807,000), indicating a focus on innovation and product development[5] - Research and development expenses increased significantly to RMB 34,330,000 for the six months ended June 30, 2023, up from RMB 22,807,000 in the same period of 2022, reflecting a growth of 50.6%[102] - The company has established a comprehensive intellectual property portfolio with 131 patents and 52 patent applications as of June 30, 2023[30] - The company aims to expand its product portfolio based on its cryoablation technology platform and selectively expand its global business[32] Product Development and Clinical Trials - The company has entered the confirmatory clinical trial phase for its asthma cryoablation system and COPD cryospray treatment system as of March 2023[6] - Patient recruitment for the confirmatory clinical trial of the malignant stenosis cryoablation system is over 75% complete[6] - A registration application has been submitted for the cryoadhesion treatment system, indicating progress in product pipeline[6] - The company has commercialized eight products as of June 30, 2023, with a comprehensive product portfolio targeting vascular intervention and NOTES[8] - The Cryofocus cryoablation system is designed for hypertension treatment and is expected to receive regulatory approval from the National Medical Products Administration (NMPA) in the second half of 2025[11] - The company's cardiac cryoablation system for treating paroxysmal atrial fibrillation is anticipated to gain NMPA approval in the fourth quarter of 2023[10] - The pulmonary hypertension cryoablation system is currently in preclinical research, with expected NMPA approval in the second half of 2027[12] - The chronic obstructive pulmonary disease (COPD) cryo-spray treatment system entered confirmatory clinical trials in March 2023, with NMPA submission expected in the second half of 2025 and approval in the second half of 2026[13] - The asthma cryoablation system is also in confirmatory clinical trials, with NMPA submission expected in the second half of 2025 and approval in the second half of 2026[14] - The malignant stenosis cryoablation system is in confirmatory clinical trials, with NMPA submission expected in the third quarter of 2023 and approval anticipated in the fourth quarter of 2024[15] - The benign stenosis cryoablation system is in feasibility clinical trials, with NMPA submission expected in the fourth quarter of 2024 and approval in the first half of 2026[16] - The lung nodule cryoablation system is currently in preclinical research and is expected to submit registration documents to the National Medical Products Administration (NMPA) in the second half of 2026, with approval anticipated in the second half of 2027[17] - The cough cryo-spray treatment system is in feasibility clinical trials, with plans to submit registration documents to the NMPA in the first half of 2025 and expected approval in the second half of 2026[18] - The tuberculosis cryo-spray treatment system is also in feasibility clinical trials, with registration submission planned for the second half of 2025 and approval expected in the second half of 2026[19] - The frozen adhesion treatment system has submitted a registration application and is expected to receive NMPA approval in the first quarter of 2024[20] - The bladder cryoablation system was approved by the NMPA in June 2022 and was commercialized in China in December 2022[21] - The gastric cryoablation system is in feasibility clinical trials, with registration submission expected in the second half of 2025 and approval anticipated in the second half of 2026[22] - The esophageal cryo-spray treatment system is in feasibility clinical trials, with plans to submit registration documents in the second half of 2025 and expected approval in the first half of 2027[23] - The atrial fibrillation pulsed field ablation (PFA) system is in preclinical research, with expected NMPA approval in the first half of 2027[27] Market and Industry Trends - The Chinese interventional cryotherapy device market is experiencing strong growth, driven by factors such as an aging population and increasing chronic disease prevalence[7] - The company aims to leverage its unique liquid nitrogen cryoablation technology and advanced flexible catheter technology to establish high entry barriers in the market[7] Financial Position and Cash Flow - Cash and cash equivalents decreased from RMB 2,264 million as of December 31, 2022, to RMB 1,590 million as of June 30, 2023, a reduction of RMB 674 million or 29.8%[46] - Net cash used in operating activities for the six months ended June 30, 2023, was RMB 582 million, primarily due to significant R&D expenditures[46] - Total debt as of June 30, 2023, was RMB 10,033 million, down from RMB 11,371 million as of December 31, 2022[49] - The current ratio improved to 8.0 as of June 30, 2023, compared to 5.8 as of December 31, 2022[50] - The asset-to-liability ratio decreased to 13.6% as of June 30, 2023, from 17.4% as of December 31, 2022[50] - Capital expenditures for the six months ended June 30, 2023, were RMB 1,812 million, down from RMB 2,236 million for the same period in 2022[48] - The company has no significant investments or acquisitions during the reporting period[53] - The company employed 384 full-time employees as of June 30, 2023, with total employee benefit expenses of approximately RMB 480 million for the six months ended June 30, 2023[55] - The company has utilized HKD 41.70 million of the net proceeds, leaving HKD 98.20 million unutilized[60] - 58.20% of the net proceeds are allocated for the R&D and commercialization of the bladder cryoablation system, with expected full utilization by 2024[60] - 15.70% of the net proceeds are designated for the R&D and commercialization of the endoscopic stapler, with expected full utilization by 2023[60] Governance and Compliance - The audit committee has reviewed and confirmed that the interim financial results for the six months ended June 30, 2023, comply with relevant accounting standards and regulations[62] - The company has confirmed that all directors and supervisors complied with the standard code of conduct throughout the reporting period[58] - The company has not incurred any additional disclosure obligations under the listing rules as of June 30, 2023[66] - The company has not purchased, sold, or redeemed any of its listed securities during the reporting period[61] - The board does not recommend the distribution of an interim dividend for the reporting period[57] Shareholder Structure - Major shareholders include Ms. Li with 91,369,084 unlisted shares (38.21%) and 43,411,972 H-shares (18.16%), and Mr. Lu with 91,369,084 unlisted shares (38.21%) and 41,664,172 H-shares (17.42%) as of June 30, 2023[72] - The company has a significant concentration of ownership, with major shareholders controlling over 70% of the unlisted shares and H-shares combined[72] - The overall market position and shareholder structure indicate a diversified investment base, enhancing the company's stability and growth potential[75]

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。 Cryofocus Medtech (Shanghai) Co., Ltd. 康灃生物科技（上海）股份有限公司 （於 中 華 人 民 共 和 國 註 冊 成 立 的 股 份 有 限 公 司） （股 份 代 號：6922） 截 至2023年6月30日止六個月的中期業績公告 | --- | --- | --- | |----------|-----------------|-----------------| | | | | | 財務摘要 | | | | | 截 至 6 月 30 | 日止六個月 | | | 2023 年 | 2022 年 | | | （未 經 審 核） | （未 經 審 核） | | | 人民幣千元 | 人民幣千元 | | | | | | 收 入 | 18,914 | 10,306 | | 毛 利 | 14,638 | 7,088 | ...

Financial Performance - Revenue for the year ended December 31, 2022, was RMB 27,149,000, an increase of 21.5% from RMB 22,426,000 in 2021[5] - Gross profit for 2022 was RMB 19,362,000, up from RMB 15,545,000 in 2021, reflecting a gross margin improvement[5] - The company reported a net loss of RMB 118,316,000 for 2022, a slight improvement from a loss of RMB 126,497,000 in 2021[5] - Cash and cash equivalents increased to RMB 226,422,000 in 2022 from RMB 157,867,000 in 2021, indicating improved liquidity[5] - Revenue increased from RMB 224 million for the year ended December 31, 2021, to RMB 271 million for the year ended December 31, 2022, representing a growth of RMB 47 million or 21.1%[41] - Overall gross profit rose from RMB 155 million for the year ended December 31, 2021, to RMB 194 million for the year ended December 31, 2022, with gross margin improving from 69.3% to 71.3%[42] - Other income and gains surged from RMB 44 million for the year ended December 31, 2021, to RMB 114 million for the year ended December 31, 2022, primarily due to increased government subsidies and currency exchange gains[43] - Research and development expenses decreased from RMB 898 million for the year ended December 31, 2021, to RMB 599 million for the year ended December 31, 2022, a decline of 33.3%[45] - Administrative expenses increased from RMB 508 million for the year ended December 31, 2021, to RMB 838 million for the year ended December 31, 2022, an increase of 65.0%[45] - Cash and cash equivalents rose from RMB 1,579 million as of December 31, 2021, to RMB 2,264 million as of December 31, 2022, an increase of 43.4%[52] - Capital expenditures for the year ended December 31, 2022, amounted to RMB 70 million, down from RMB 124 million for the year ended December 31, 2021[54] - Total debt increased to RMB 11,371 million as of December 31, 2022, from RMB 9,001 million in 2021, representing a 26.3% increase[56] - Current ratio decreased to 5.8 as of December 31, 2022, down from 6.7 in 2021, indicating a decline in short-term liquidity[57] - Quick ratio also decreased to 5.3 in 2022 from 6.3 in 2021, reflecting a similar trend in liquidity[58] - The debt-to-asset ratio rose to 17.4% in 2022 compared to 15.0% in 2021, suggesting an increase in leverage[57] - Capital commitments for property and machinery amounted to RMB 2,052 million as of December 31, 2022, up from RMB 1,094 million in 2021, indicating ongoing investment plans[59] - The company plans to retain all future profits for business operations and expansion, with no dividend policy in the foreseeable future[169] Product Development and Innovation - The company received approval for the bladder cryoablation system from the National Medical Products Administration in June 2022 and commercialized it in December 2022[10] - The endoscopic stapler was approved in August 2022 and commercialized in October 2022, marking it as one of the first of its kind in China[10] - The heart cryoablation system registration application was submitted in July 2022, with expected approval in Q2 2023[10] - The company aims to leverage its established commercialization capabilities to enhance product market entry following regulatory approvals[10] - The company has 15 additional products in the pipeline, with several in various stages of clinical development, including three products expected to complete clinical trials in Q2 2023[13] - The vascular intervention cryoablation products are in Phase III trials, with commercialization expected in the second half of 2025[13] - The company is committed to ongoing research and development to enhance its product offerings and maintain its competitive edge in the market[12] - The cardiac cryoablation system is designed for the treatment of paroxysmal atrial fibrillation and is expected to receive regulatory approval in Q2 2023[18] - The Cryofocus cryoablation system, aimed at treating hypertension, is undergoing confirmatory clinical trials with anticipated regulatory approval in H2 2025[18] - The pulmonary hypertension cryoablation system is currently in preclinical research, with expected regulatory approval in H1 2026[18] - The COPD cryo-spray treatment system entered confirmatory clinical trials in March 2023, with plans to submit registration documents in H2 2025 and seek approval in H2 2026[18] - The asthma cryoablation system is in confirmatory clinical trials, with expected registration submission in H2 2025 and approval in H2 2026[21] - The malignant stricture cryoablation system is in confirmatory clinical trials, with plans to submit registration documents in Q3 2023 and seek approval in Q4 2024[22] - The benign stricture cryoablation system is in feasibility clinical trials, with expected registration submission in Q4 2024 and approval in H1 2026[23] - The lung nodule cryoablation system is in preclinical research, with anticipated registration submission in H2 2026 and approval in H2 2027[24] - The cough cryo-spray treatment system is in feasibility clinical trials, with expected registration submission in H1 2025 and approval in H2 2026[25] - The tuberculosis cryo-spray treatment system is also in feasibility clinical trials, with plans for registration submission in H2 2025 and approval in H2 2026[26] - The company aims to expand its product portfolio based on its cryoablation technology and plans to selectively expand its global business[40] Market Outlook and Strategy - The company anticipates rapid industry growth driven by economic recovery, increased public health awareness, and an aging population in China[11] - The company focuses on minimally invasive cryoablation technology, primarily targeting urological, respiratory, and gastrointestinal diseases, with a comprehensive product portfolio established since its founding in 2013[12] - The cryoablation device market in China is experiencing strong growth, driven by factors such as an aging population, increasing chronic disease prevalence, and supportive government policies[12] - The aging population and the growing patient base are expected to further drive the demand for cryoablation devices in the coming years[12] - The company anticipates continued market expansion due to technological advancements and the increasing demand for cryoablation therapies[12] - Future outlook includes expansion into new markets and the development of innovative medical technologies[74] - The company is actively pursuing mergers and acquisitions to enhance its product offerings and market presence[75] - New product development is centered around minimally invasive medical devices, targeting structural heart disease[76] Corporate Governance and Management - Liu Wei was appointed as CFO and Secretary of the Board in December 2021, with responsibilities including financial planning and investor relations[91] - Duong has over 24 years of engineering experience, previously holding positions at various companies including Parker Hannifin Corporation and Endocare Inc.[93] - Liu Yulong has over 17 years of experience in the pharmaceutical and medical device industry, previously working at Medtronic and Anhui Anke Biotechnology[95] - Zhao Kuiwen has been with the company since September 2017, serving as the Chief Technology Officer and responsible for R&D activities[97] - Qu Jihong joined the company in March 2022 as Chief Medical Officer, focusing on product applications and international market strategies[98] - The management team has extensive experience, with key members holding advanced degrees in engineering and business[77] - The company emphasizes its commitment to expanding its market presence and enhancing its product offerings through strategic initiatives[98] - The board consists of two executive directors, two non-executive directors, and four independent non-executive directors, ensuring a balanced power structure[111] - The company has adopted a code of conduct for securities trading by directors and senior management, confirming compliance since the listing date[110] - The company has established a comprehensive training program for new employees to understand its corporate culture and policies[104] - The board has ensured compliance with the corporate governance code since the listing date, maintaining effective accountability[105] - The board of directors consists of both executive and independent non-executive directors, with a term of three years, subject to re-election[115] - The company has established three committees: Audit Committee, Remuneration Committee, and Nomination Committee to oversee various aspects of the company's affairs[124] Risk Management and Compliance - The company has implemented a comprehensive risk management policy to continuously identify, assess, and monitor key risks related to its strategic objectives[151] - The board is responsible for establishing and reviewing the effectiveness of the internal control system, which includes financial, operational, and compliance controls[152] - The audit committee reviews and approves the company's risk management policies to ensure alignment with corporate objectives[148] - The company conducts annual reviews of its risk management and internal control systems, deeming them effective and adequate[151] - Regular training is provided to management and sales teams regarding compliance with the "two-invoice system" and other applicable laws[152] - The company monitors the implementation progress of the "two-invoice system" across different provinces[152] - The company has established channels for independent non-executive directors to express opinions openly and confidentially when necessary[144] - The company has implemented strict internal control measures to handle sensitive data, including desensitization and prior board approval for data transmission[154] - As of December 31, 2022, the company reported no claims or allegations related to bribery or corruption, indicating effective internal controls[157] Environmental, Social, and Governance (ESG) - The board is responsible for overseeing ESG-related matters and regularly reviews ESG risks and performance[179] - The company aims to enhance its governance structure and risk management systems continuously[180] - In 2022, the company identified 18 ESG material issues, categorizing them into 6 highly important, 9 moderately important, and 3 generally important issues, focusing on sustainable long-term development[190] - The company has established a dedicated ESG working group to coordinate and execute ESG-related matters, reporting directly to the board of directors[185] - The company has committed to social responsibility and sustainable development, focusing on innovation in cryogenic technology and life sciences[184]

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。 Cryofocus Medtech (Shanghai) Co., Ltd. 康灃生物科技（上海）股份有限公司 （於 中 華 人 民 共 和 國 註 冊 成 立 的 股 份 有 限 公 司） （股 份 代 號：6922） 截 止2022年12月31日止年度的年度業績公告 | --- | --- | --- | --- | |------------------|---------------------------|---------------------------|-----------------| | | | | | | 財務摘要 | | | | | | 截 止 2022 年 12 月 31 日 | 截 止 2021 年 12 月 31 日 | | | | 止年度 人民幣千元 | 止年度 人民幣千元 | 按年變動 | | 收 入 | 27 ...