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]
康沣生物-B(06922) - 2024 - 年度业绩