Financial Performance - Total revenue for 2022 reached RMB 21,603,000, compared to RMB 2,150,000 in 2021, representing a significant increase[5] - Gross profit for 2022 was RMB 6,562,000, up from RMB 919,000 in 2021[5] - The company reported a pre-tax loss of RMB 1,146,284,000 for 2022, compared to a loss of RMB 584,507,000 in 2021[5] - The total equity decreased to RMB 1,407,878,000 in 2022 from RMB 2,390,152,000 in 2021[6] - The company recorded revenue of RMB 21.6 million, representing a 904.8% increase compared to RMB 2.2 million in the previous year[26] - The company recorded operating revenue of RMB 216 million for the year ended December 31, 2022, representing a growth of 904.8% compared to RMB 22 million for the year ended December 31, 2021, primarily due to rapid revenue growth from its flagship product, Dragonfly Eye[65] - Other net income for the year ended December 31, 2022, was RMB 421 million, compared to RMB 247 million for the year ended December 31, 2021, primarily from interest income and government subsidies[72] - The company recorded a net loss of RMB 27 million from financial instruments measured at fair value for the year ended December 31, 2022, compared to a net gain of RMB 455 million for the year ended December 31, 2021[73] - The adjusted net loss for the year ended December 31, 2022, was RMB 1,009.4 million, compared to RMB 452.8 million in 2021, reflecting an increase of 122%[77] Assets and Liabilities - Total assets decreased to RMB 1,930,125,000 in 2022 from RMB 2,791,884,000 in 2021[6] - Non-current assets increased to RMB 831,303,000 in 2022 from RMB 697,658,000 in 2021[6] - Cash and cash equivalents decreased from RMB 19,408 million as of December 31, 2021, to RMB 7,480 million as of December 31, 2022, primarily due to ongoing R&D and marketing activities[85] - The total interest-bearing borrowings as of December 31, 2022, were RMB 331 million, compared to zero as of December 31, 2021[89] - The net current asset value as of December 31, 2022, was RMB 7,735 million, down from RMB 18,598 million as of December 31, 2021, mainly due to continued expenditures in R&D, clinical registration, and commercialization activities[90] Product Development and Innovation - The company has developed multiple products across five major surgical specialties, including laparoscopic, orthopedic, and vascular surgery[8] - Three flagship products have received market approval through expedited channels[8] - The company aims to build a global medical robot innovation platform to enhance surgical capabilities[9] - The company is focusing on integrating new technologies such as artificial intelligence and 5G into its products to enhance their capabilities[22] - The company is committed to continuous R&D for the next generation of products, aiming to optimize the operational experience for surgeons and elevate Chinese laparoscopic technology to an international level[38] - The company is focused on the development of five core underlying technologies for surgical robots, ensuring continuous innovation and product development capabilities[52] Market Position and Strategy - The company is positioned as the only surgical robot company covering five major high-growth surgical specialties globally[11] - The global surgical robot market is projected to reach $28.51 billion by 2025, with a compound annual growth rate (CAGR) of 27.1% from 2021 to 2025[19] - The Chinese surgical robot market is expected to reach RMB 17.47 billion by 2025, with a CAGR of 42.9% from 2021 to 2025[19] - The company aims to continue exploring breakthroughs in surgical robot technology and its applications in remote surgery, enhancing healthcare quality in grassroots medical institutions[15] - The company plans to expand its product portfolio and establish a multi-specialty surgical robot platform to meet the growing demand for minimally invasive surgeries[60] - A global strategy is being pursued to build an innovative platform for medical robot solutions, integrating resources to enhance overseas commercialization and supply chain capabilities[62] Clinical Applications and Partnerships - The company established partnerships with nearly 100 hospitals, conducting around 2,000 clinical validations and doctor training surgeries, demonstrating the safety and effectiveness of its products[13] - Over 600 robot-assisted surgeries have been completed across nearly 30 hospitals in over ten provinces, demonstrating TUMAI's clinical application maturity and stability[34] - The company has established over 40 clinical application and training centers nationwide, enhancing the recognition and reputation of its innovative products[13] - The company has established over 30 clinical application and training centers nationwide for TUMAI, enhancing its recognition among hospitals and surgeons[33] Regulatory Approvals and Certifications - Tumai became the first four-arm laparoscopic surgical robot developed by a Chinese company to receive NMPA approval, while Honghu was the first domestic surgical robot to obtain NMPA, FDA, and CE certifications[14] - The Honghu product received certifications in China, the US, and Europe, successfully completing its first total knee replacement surgery in the US, laying a solid foundation for future overseas sales[12] - The "Honghu" orthopedic surgical robot received NMPA registration in April 2022 and obtained FDA 510(k) certification and EU CE certification in July and December 2022, respectively, becoming the first domestic surgical robot approved in China, the US, and the EU[40] Research and Development Expenses - Research and development costs rose by 92.5% to RMB 756 million for the year ended December 31, 2022, compared to RMB 393 million for the year ended December 31, 2021, driven by an increase in R&D personnel and related expenses[68] - The company reported R&D expenses of RMB 755.8 million for the fiscal year ending December 31, 2022, which significantly contributed to a major net loss[143] Management and Governance - The company emphasizes the importance of internal control and risk management through a supervisory board consisting of three members[114] - The company has expanded its management team with experienced professionals to strengthen its operational capabilities[122] - The company is actively involved in the development of new medical technologies and products, enhancing its market position[121] Shareholder Information - Major shareholders hold significant stakes in the company, with Shanghai Moku holding approximately 52.60% of H shares, translating to 500,731,007 shares[177] - The company has no distributable reserves as of December 31, 2022, consistent with the previous year[157] - The company maintains compliance with the relevant regulations regarding shareholdings and interests[175] Environmental Responsibility - The company is committed to environmental responsibility and integrates environmental factors into its operational strategies[138] - The company has a focus on creating environmentally sustainable business practices[138]

Financial Performance - The company reported a revenue of RMB 21,603 million for the year ended December 31, 2022, representing a significant increase of 904.8% compared to RMB 2,150 million in 2021[2] - Gross profit for the year was RMB 6,562 million, up from RMB 919 million in the previous year[2] - The company incurred a loss before tax of RMB (1,146,284) million, compared to a loss of RMB (584,507) million in 2021[3] - The net loss attributable to equity shareholders was RMB (1,139,806) million, compared to RMB (582,921) million in the prior year[3] - Basic and diluted loss per share was RMB (1.19), an increase from RMB (0.63) in 2021[2] - The company reported other comprehensive income of RMB 9,580 million for the year, compared to a loss of RMB (3,953) million in 2021[5] - The company recorded operating revenue of RMB 216 million for the year ended December 31, 2022, representing a growth of 904.8% compared to RMB 22 million for the year ended December 31, 2021, primarily driven by rapid revenue growth from its flagship product, Dragonfly Eye[61] - The adjusted net loss for the year ended December 31, 2022, was RMB 1,009.4 million, compared to RMB 452.8 million in 2021, reflecting an increase of 122%[72] Assets and Liabilities - The company’s total assets decreased to RMB 1,604,811 million as of December 31, 2022, from RMB 2,557,415 million in 2021[6] - Current liabilities increased to RMB 325,314 million from RMB 234,469 million in the previous year[6] - The company’s cash and cash equivalents decreased significantly to RMB 747,962 million from RMB 1,940,825 million in 2021[6] - Non-current assets increased to RMB 831,303 million from RMB 697,658 million in the previous year[6] - The total interest-bearing borrowings as of December 31, 2022, were RMB 33.1 million, compared to zero as of December 31, 2021, resulting in a net debt-to-equity ratio of 2.4%[79] - The net current asset value as of December 31, 2022, was RMB 773.5 million, down from RMB 1,859.8 million as of December 31, 2021, primarily due to continued expenditures on R&D, clinical registration, and commercialization activities[80] Revenue Sources and Customer Base - In 2022, the revenue from medical device sales was RMB 21,603,000, a significant increase from RMB 2,150,000 in 2021, representing a growth of approximately 908%[11] - As of December 31, 2022, the total expected revenue from existing customer contracts was RMB 1,828,000,000, compared to RMB 102,000,000 in 2021, indicating a substantial increase of about 1696%[12] - The company had two customers contributing over 10% of total revenue in 2022, down from three customers in 2021, indicating a slight diversification in customer base[12] - The geographical revenue for 2022 was entirely from customers in China, with no revenue reported from other countries[14] Research and Development - Research and development costs increased to RMB 755,802,000 in 2022 from RMB 392,649,000 in 2021, representing an increase of approximately 92.5%[19] - The company applied for a total of 948 patents globally as of December 31, 2022, with 263 patents granted, including 190 in China and 73 overseas, reflecting a strong focus on innovation in clinical applications and AI technology[56] - The company emphasizes the importance of its innovative research and development projects, which are steadily advancing key milestones[34] Product Development and Market Expansion - The core product, TUMAI, achieved its first sale during the reporting period, marking the first domestically produced laparoscopic surgical robot to be commercialized[32] - The flagship product, Dragonfly Eye, experienced significant growth in installation volume and sales during its first complete sales year[32] - The company is expanding into gynecology, thoracic surgery, and general surgery, with a projected revenue of HKD 100.96 million for these segments[82] - The company is developing next-generation imaging products, with expected revenue of HKD 201.91 million[82] - The company is enhancing its manufacturing capabilities and supply chain management, with a revenue target of HKD 168.26 million[83] Technological Advancements - The company successfully completed the world's longest distance 5G remote robotic surgery and the first robotic-assisted 5G hepatobiliary surgery in China[32] - The integration of 5G technology has enabled the successful completion of two ultra-remote urological surgeries, showcasing the company's technological capabilities in remote surgical applications[39] - The company has developed a 5G remote surgery technology, successfully completing two ultra-remote urological surgeries across nearly 5,000 kilometers[50] Strategic Initiatives and Future Outlook - The company plans to continue advancing its globalization strategy by building a comprehensive platform for medical robot solutions and recruiting talent globally[60] - The company aims to improve operational efficiency, targeting a 5% reduction in costs over the next fiscal year[99] - The management highlighted the importance of maintaining shareholder value through consistent performance and strategic initiatives[99] Corporate Governance - The company has complied with all applicable corporate governance codes during the reporting period[86] - The audit committee consists of three independent non-executive directors, responsible for providing independent opinions on financial reporting and internal controls[87] Miscellaneous - The company did not declare any dividends for the year ended December 31, 2022, consistent with the previous year[28] - There were no significant investments, acquisitions, or disposals of subsidiaries, associates, or joint ventures during the reporting period[90]

Financial Performance - Revenue for the first half of 2022 was RMB 1,048,000, compared to no revenue reported in the same period of 2021[38] - Gross profit for the first half of 2022 was RMB 691,000, with a significant increase from the previous year[38] - The company reported a pre-tax loss of RMB 463,501, compared to a pre-tax loss of RMB 242,560 in the first half of 2021[38] - The total operating loss for the period was RMB 439,820,000, compared to a loss of RMB 231,412,000 for the same period in 2021, indicating a significant increase in losses[141] - The net loss attributable to equity shareholders was RMB 459,052,000, compared to RMB 241,965,000 in the previous year, reflecting a year-over-year increase of approximately 90%[141] - The total comprehensive loss for the period was RMB 468,445,000, compared to RMB 243,988,000 for the same period in 2021[142] - Research and development expenses amounted to RMB 336,411,000, significantly higher than RMB 160,072,000 in the previous year, indicating a focus on innovation[141] - The company incurred financing costs of RMB 5,558,000, up from RMB 705,000 in the previous year, suggesting increased borrowing or financial activity[141] Assets and Liabilities - The total assets as of June 30, 2022, were RMB 2,538,470, a decrease from RMB 2,791,884 as of December 31, 2021[39] - Cash and cash equivalents decreased from RMB 1,940.8 million as of December 31, 2021, to RMB 1,477.0 million as of June 30, 2022, due to ongoing R&D and marketing activities[94] - The net current assets of the group were RMB 1,338.3 million as of June 30, 2022, down from RMB 1,859.8 million as of December 31, 2021[98] - Total liabilities increased to RMB 381,779 thousand from RMB 234,469 thousand, marking a significant rise of approximately 62.8% year-over-year[143] - The company's total equity attributable to shareholders decreased to RMB 1,991,763 thousand from RMB 2,393,142 thousand, a drop of approximately 16.8% year-over-year[144] Product Development and Approvals - The company’s flagship product, TUMAI, received NMPA approval, becoming the first four-arm laparoscopic surgical robot developed by a Chinese company[42] - The HONGHU product also received NMPA approval, marking it as the first orthopedic surgical robot with independent intellectual property rights approved in China[42] - The HONGHU product obtained FDA 510(k) certification in July 2022, becoming the first Chinese surgical robot to receive such certification[42] - The company completed the first human clinical trial of the bronchoscopic surgical robot during the reporting period[42] - Three flagship products, Tumai, Dragonfly Eye, and Honghu, have received NMPA approval, with Honghu also obtaining FDA 510(k) certification in July 2022[51] Market and Growth Strategy - The global surgical robot market is projected to grow from $3.6 billion in 2016 to $12.3 billion in 2021, and is expected to reach $40.7 billion by 2027[47] - The Chinese surgical robot market is expected to grow from $600 million in 2021 to $4.8 billion by 2027, increasing its global market share from approximately 5% to about 12%[47] - The company has begun commercial promotion in the U.S. market following FDA certification for its product, with the establishment of its first training center in the U.S.[44] - The company is actively expanding its product pipeline, with ongoing clinical trials for Tumai in various complex surgical applications, including gynecological and oncological surgeries[55] Research and Development - The company has established two R&D centers in Shanghai and Shenzhen, and is expanding its global presence with centers in Singapore and the USA, employing over 600 R&D professionals[66] - The company is focused on advancing five core underlying technologies for surgical robots, leveraging big data, AI, and 5G communications to enhance surgical precision and safety[64] - The company has committed to ongoing research and development in robotic surgical technologies, aiming to expand its product offerings and market reach[182] Corporate Governance and Shareholder Information - The company aims to achieve a high level of corporate governance, which is crucial for development and protecting shareholder interests, and has complied with all applicable code provisions during the reporting period[128] - Major shareholders include Shanghai Mokuo with 500,731,007 H-shares, representing approximately 52.60% of the relevant class of shares and 52.24% of the total issued shares[109] - The company proposed to issue up to 116,062,930 A-shares and apply for listing on the Shanghai Stock Exchange's Sci-Tech Innovation Board[115] Challenges and Risks - In the first half of 2022, the company faced significant challenges in R&D, clinical trials, and supply chain due to the recurring COVID-19 pandemic in China, leading to delays in the promotion of large medical equipment in various regions[49] - The company emphasizes the importance of cautious investment decisions due to uncertainties in the commercialization of its core products[57]

Financial Performance - Total revenue for the year ended December 31, 2021, was RMB 2,150,000, representing a significant increase compared to previous years[7] - Gross profit for the same period was RMB 919,000, indicating a positive trend in profitability[7] - The company reported a pre-tax loss of RMB 584,507,000, which is an increase from RMB 209,290,000 in 2020[7] - The total equity as of December 31, 2021, was RMB 2,390,152,000, a significant increase from RMB 1,441,452,000 in 2020[8] - The company recorded revenue of RMB 2.2 million in 2021, primarily from the sales of its flagship product, DFVision® three-dimensional electronic laparoscope[20] - The company reported a significant net loss of RMB 584.5 million for the fiscal year ending December 31, 2021, attributed to high R&D expenditures[98] - Employee costs increased to RMB 285.8 million in 2021 from RMB 76.9 million in 2020, due to an increase in the number of employees to 898[55] - Administrative expenses increased by 299.8% from RMB 26.9 million in the year ended December 31, 2020, to RMB 107.5 million in the year ended December 31, 2021[45] - R&D costs rose by 190.0% from RMB 135.4 million in the year ended December 31, 2020, to RMB 392.6 million in the year ended December 31, 2021, primarily due to the progress of clinical trials and product development[46] Asset Growth - Total assets as of December 31, 2021, reached RMB 2,791,884,000, up from RMB 1,704,354,000 in 2020, reflecting strong asset growth[8] - Non-current assets increased to RMB 697,658,000 from RMB 189,304,000 in 2020, showcasing substantial investment in long-term resources[8] - Cash and cash equivalents increased from RMB 1,497.3 million as of December 31, 2020, to RMB 1,940.8 million as of December 31, 2021, primarily due to net proceeds of approximately RMB 1,375.4 million from the IPO in November 2021[56] - As of December 31, 2021, the net current assets amounted to RMB 1,859.8 million, up from RMB 1,286.1 million as of December 31, 2020, mainly attributed to the net proceeds from the IPO[61] Product Development and Innovation - The company has developed a comprehensive surgical robot technology platform, covering five major areas including laparoscopic and orthopedic surgery[10] - The company is focused on developing innovative robotic surgical solutions to extend and reshape lives, aligning with its mission[11] - The company has initiated multiple clinical trials for various products, including the bronchoscopic surgical robot and the R-ONE vascular intervention robot, which are in different stages of development[14] - The company is committed to continuous innovation and aims to enhance its product offerings and accelerate product iterations to meet the evolving needs of minimally invasive surgery[16] - The company is focusing on the development of five core underlying technologies for surgical robots, leveraging advancements in big data, artificial intelligence, human-computer interaction, and 5G communication to drive innovation in minimally invasive surgery[29] Market Presence and Strategy - The company aims to build a global medical robot solution innovation platform, enhancing its market presence[11] - The surgical robot market in China is still in its early stages with low penetration rates, indicating significant potential for future growth[16] - The company successfully listed on the Hong Kong Stock Exchange in 2021, marking a significant milestone in its development history[13] - The company aims to expand its product portfolio and establish a multi-specialty surgical robot platform to meet the demand for minimally invasive surgeries[39] - The company will accelerate commercialization and enhance market penetration by establishing more training centers for surgical robots[40] Clinical Trials and Approvals - Three flagship products have received approval from the National Medical Products Administration (NMPA), with two already on the market and one in the registration phase[10] - The core product, TUMAI, received NMPA approval in January 2022, becoming the first domestically produced four-arm laparoscopic surgical robot system approved for market[13] - The company completed the registration clinical trial for its Honghu robot in July 2021, aiming to become the first domestically produced surgical robot to receive FDA certification[14] - The TUMAI® single-arm laparoscopic surgical robot completed its first human trial for single-port laparoscopic cholecystectomy in December 2021, marking a significant breakthrough in minimally invasive surgery[24] Corporate Governance - The company is committed to maintaining high standards of corporate governance and compliance with regulatory requirements[78] - The board consists of seven members, including one executive director, three non-executive directors, and three independent non-executive directors as of December 31, 2021[169] - The company has adopted the principles of the Corporate Governance Code as the basis for its governance practices since its listing date[166] - The company provides formal training for newly appointed directors to ensure understanding of its operations and regulatory responsibilities[173] - The company has implemented written guidelines for employees regarding securities trading to prevent insider trading[180] Shareholder Information - The company reported significant shareholdings, with Dr. He holding 621,906,912 shares (65.33%) and Mr. Yuan holding 557,001,874 shares (58.51%) as of December 31, 2021[114] - Major shareholder Shanghai Mucai holds 500,731,007 H shares, indicating a significant stake in the company[124] - The company’s equity distribution reflects a strong concentration among a few major shareholders, which may impact governance and decision-making[124] - The company has disclosed its equity interests in accordance with the Securities and Futures Ordinance, ensuring transparency[122] Future Plans and Utilization of IPO Proceeds - The company plans to utilize the net proceeds from the IPO for various purposes, including ongoing R&D activities and market expansion, with significant allocations planned for 2023[63] - A total of RMB 588.91 million (35.0%) is allocated for ongoing R&D activities related to the company's surgical robots, expected to be utilized by the first half of 2023[63] - RMB 201.912 million (12%) is designated for product improvements based on clinical feedback, with expected utilization by the first half of 2023[63] - RMB 353.346 million (21%) is allocated for the commercialization of orthopedic surgical robots, anticipated to be utilized by the first half of 2023[64] Workforce and Employment - The company employed 898 staff as of December 31, 2021, up from 312 staff a year earlier, indicating a substantial increase in workforce[100] - The company has a workforce of 898 employees as of December 31, 2021, with a significant portion holding master's degrees or higher[36] - Employee costs rose significantly to RMB 190.0 million in 2021 from RMB 61.1 million in 2020, reflecting an increase in R&D personnel[93]