图表一：国产化时差培养箱获证 在关键设备自主可控的政策春风下，2025年7月8日，贝康医疗自主研发的国产化Geri时差培养箱正式获得江苏省药品 监督管理局颁发的二类医疗器械注册证（苏械注准20252181382），成为国内首家掌握时差培养箱全流程国产化技术 的企业，标志着我国在高端辅助生殖器械领域实现关键技术突破。这款融合AI与延时摄影技术的创新产品，不仅颠覆 了传统胚胎培养模式，更以国产化优势推动行业降本增效，为辅助生殖技术普及注入新动能。 图片来源：公司官网，格隆汇整理 时差培养箱：智能化胚胎实验室的革新方案 在生殖医学领域，胚胎培养技术正经历从粗放式向精准化的转型。传统集中培养模式需频繁开箱观察，易造成温湿度 波动，可能干扰胚胎发育。 而Geri时差培养箱通过6个独立培养舱室设计，为每个胚胎打造"五星级套房"，内置成像系统可实时记录发育动态，最 大限度减少人为干扰。其全球独有的可加湿功能，能模拟母体子宫渗透压环境，进一步优化胚胎生长条件。更核心的 突破在于智能化分析系统。设备搭载的AI算法可自动追踪胚胎形态、分裂速度等关键指标，建立多维度评估模型。相 较传统人工评估的主观性，该技术能更科学筛选优质胚胎， ...

Core Viewpoint - Suzhou Beikang Medical Co., Ltd. has reported a revenue growth of 43.8% in 2024, despite a sluggish market in the medical sector, indicating strong performance that exceeds sales expectations [1][3]. Revenue Growth and Product Development - The company specializes in third-generation IVF technology, particularly Preimplantation Genetic Testing (PGT), which enhances pregnancy success rates and reduces risks of genetic diseases [4]. - Beikang Medical has developed a comprehensive product line that includes reagents, consumables, instruments, and equipment for the assisted reproductive industry, providing a one-stop solution for medical institutions [4]. - The revenue has increased from RMB 107.3 million in 2021 to RMB 299.1 million in 2024, reflecting a compound annual growth rate of nearly 40% [5][4]. Financial Performance and Market Challenges - Despite revenue growth, the company has faced significant stock price declines, with a market capitalization drop of approximately 90% since its peak, now valued at around HKD 800 million [3][15]. - The company reported a net loss of RMB 237.2 million in 2024, a 23.1% increase in losses despite a revenue increase of over 40% [13][16]. - Sales costs have risen significantly, from RMB 116.6 million in 2023 to RMB 162.9 million in 2024, impacting profitability [16]. International Expansion and Market Potential - Beikang Medical has expanded its international presence, establishing a sales network covering over 30 countries and more than 1,000 medical institutions [11]. - The company has partnered with global fertility product suppliers, enhancing its international market reach [7]. - The assisted reproductive market in China has significant growth potential, with a current penetration rate of only 9.2%, compared to 36.0% in Europe and 33.0% in the U.S. [18].

Financial Performance - In 2024, the company achieved a revenue of RMB 299.1 million, a 44% increase compared to RMB 208.0 million in 2023[10] - Gross profit for 2024 was RMB 136.2 million, reflecting a 49% growth from RMB 91.4 million in the previous year[10] - The company reported a net loss of RMB 237.2 million for 2024, compared to a net loss of RMB 193.3 million in 2023[9] - Revenue from the embryo laboratory business reached approximately RMB 126 million, marking a 161% increase year-on-year[10] - The company recorded revenue of RMB 43.3 million from the sales of PGT-A kits for the year ending December 31, 2024, with a gross margin of 68.0%[32] - Other income decreased by 15.5% from RMB 54.2 million to RMB 45.8 million, mainly due to reduced foreign exchange gains and lower interest income[81] - Sales cost rose by 39.7% from RMB 116.6 million to RMB 162.9 million, primarily due to increased sales and the inclusion of costs from the acquisition of BMX in Singapore[79] - Gross profit increased by 49.0% from RMB 91.4 million to RMB 136.2 million, with gross margin improving from 43.9% to 45.5%[80] Product Development and Innovation - The core product GERI® incubator saw over 600% revenue growth in the Chinese market, with 42 units installed throughout the year[10] - The company has developed an intelligent sperm analyzer that utilizes AI and microfluidics to accurately assess sperm concentration, vitality, and morphology, addressing a 75% decline in sperm count in Chinese males over the past 40 years[21] - The company has established a comprehensive product pipeline that includes reagents, consumables, instruments, and equipment, making it one of the few global suppliers covering the entire assisted reproduction industry chain[17] - The company aims to develop automated, standardized, and intelligent assisted reproductive medical devices to enhance clinical success rates and improve operational efficiency[30] - The PGT-A reagent has been shown to increase clinical pregnancy rates to 72% and reduce miscarriage rates to 6.9%, addressing a significant clinical gap in third-generation IVF products in China[18] - The company has developed China's first third-generation IVF PGT-A reagent kit, achieving over 100,000 clinical sample verifications, establishing a strong technical barrier in the assisted reproductive field[68] Market Expansion and Strategic Partnerships - The company expanded its overseas sales network to cover over 1,000 medical institutions across 30 countries, with sales growth of 27% in Europe, 19% in North America, and 5% in the Asia-Pacific region[10] - The company signed a strategic cooperation agreement with Genea Biomedx Pty Ltd. to expand into the assisted reproductive market in Europe, South America, and Southeast Asia[11] - The company aims to penetrate international markets with its core products, including the PGT test kit and gene sequencer, while pursuing CE and FDA certifications for global compliance[63] - The overseas revenue share increased to 35% in 2024, supported by the establishment of production bases in Thailand and strategic partnerships in Southeast Asia and South America[75] Regulatory Approvals and Certifications - The DA5000 high-throughput gene sequencer obtained NMPA Class III registration, establishing a closed-loop ecosystem from reagent kits to data analysis[12] - The company has received Class III medical device registration for the PGT-A product in February 2020, with expected IVDR Class C CE certification by 2026[27] - The company anticipates obtaining Class III medical device registration for the PGT-M product by 2025, with IVDR Class C CE certification also expected by 2026[27] - The company has received Class II medical device registration for the BKA-210 sperm quality analyzer in October 2024, with IVDR Class A CE certification anticipated by 2025[27] Corporate Governance and Management - The company has adopted a governance code since its listing and has complied with all applicable provisions for the year ending December 31, 2024[129] - The roles of Chairman and General Manager are held by the same individual, Dr. Liang, to ensure unified leadership and effective strategic planning[129] - The company has a commitment to maintaining high standards of corporate governance to protect shareholder interests and enhance corporate value[129] - The board of directors has maintained compliance with listing rules, ensuring at least three independent non-executive directors, constituting one-third of the board[133] Research and Development - Research and development expenses rose by 4.4% from RMB 129.6 million to RMB 135.3 million, accounting for 45.2% of revenue in 2024 compared to 62.3% in 2023[85] - The company is committed to continuous innovation and clinical feedback to support industry-leading clinical outcomes in assisted reproduction[16] - The company has continuously enriched its product pipeline through self-research and acquisitions since going public[128] Employee and Operational Insights - As of December 31, 2024, the group had 497 employees, down from 586 employees as of December 31, 2023[101] - The total salary cost incurred by the group for the year ended December 31, 2024, was approximately RMB 185.5 million, an increase from RMB 153.9 million for the year ended December 31, 2023[101] - The company has established a manufacturing network across three countries, with a headquarters in Suzhou, China, covering 70,000 square meters, including four GMP-standard production workshops[54] Shareholder Engagement and Communication - The company encourages shareholders to participate in meetings and vote, ensuring their rights are protected[177] - The company emphasizes effective communication with shareholders and stakeholders through various channels, including annual reports and shareholder meetings[186] - The company encourages feedback from investors and stakeholders to improve communication and governance practices[186]

Group 1 - The company reported a revenue of RMB 299 million for the year ending December 31, 2024, representing a year-on-year growth of 43.82% [1] - The company incurred a loss attributable to shareholders of RMB 237 million [1] - Research and development expenditure amounted to RMB 135 million, reflecting a year-on-year increase of 4.39% [1] Group 2 - The company aims to provide automated, standardized, and intelligent assisted reproductive medical devices to improve success rates and operational efficiency for medical institutions [2] - The assisted reproductive technology sector is experiencing rapid development, with the company focusing on a "Live" core concept to deliver dynamic, real-time, and interconnected data experiences throughout the entire process [2] - The company has established a comprehensive product line covering the entire assisted reproduction industry chain, including reagents, consumables, instruments, and equipment, positioning itself as one of the few global suppliers with a full industry product offering [2]

Financial Performance - The total revenue for the year ended December 31, 2024, was RMB 299,109,000, representing a 43.7% increase from RMB 207,976,000 in 2023[3]. - The gross profit for the same period was RMB 136,223,000, up from RMB 91,351,000, indicating a gross margin improvement[3]. - The operating loss increased to RMB 230,965,000 from RMB 193,709,000, reflecting ongoing investment in product development and market expansion[3]. - The company reported a net loss of RMB 237,210,000 for 2024, compared to RMB 193,349,000 in 2023, highlighting challenges in achieving profitability[3]. - The company’s net assets decreased to RMB 1,141,815,000 in 2024 from RMB 1,398,106,000 in 2023, indicating a decline in financial stability[3]. - Basic and diluted loss per share for the year was RMB 0.9, compared to RMB 0.7 in 2023[48]. - Total comprehensive income for the year amounted to RMB (256,291) thousand, up from RMB (195,290) thousand, reflecting a year-over-year increase in losses of about 31.2%[50]. - The company’s total equity decreased from RMB 1,398,106 thousand in 2023 to RMB 1,141,815 thousand in 2024, representing a decline of approximately 18.4%[52]. - Total reportable segment revenue for 2024 reached RMB 350,176,000, a 55.5% increase from RMB 225,337,000 in 2023[67]. - Revenue from external customers amounted to RMB 299,109,000 in 2024, up 43.7% from RMB 207,976,000 in 2023[67]. Product Development and Innovation - The company has developed a high-throughput gene sequencer, DA500, which received national Class III medical device registration in September 2023[8]. - The PGT-A test kit, which enhances clinical pregnancy rates to 72% and reduces miscarriage rates to 6.9%, has been pivotal in the company's product offerings[7]. - The company aims to provide a comprehensive solution across five laboratory scenarios, enhancing the efficiency and success rates of assisted reproductive technologies[7]. - The company is focused on continuous innovation and clinical feedback to support leading clinical outcomes in reproductive science[4]. - The "Live Storage" facility is the first certified ultra-low temperature storage product in China, capable of storing 30,000 to 50,000 gametes, addressing the annual demand of 10 million embryos for cryopreservation[11]. - The "Live Intelligence" system integrates real-time data across reproductive centers, enhancing operational efficiency and safety, ultimately increasing pregnancy success rates[12]. - The iARMS system combines artificial intelligence and IoT, breaking traditional data silos and ensuring sample information security, significantly improving operational efficiency and customer satisfaction in reproductive centers[13]. - The company is focused on expanding its product offerings in the assisted reproductive technology sector, with several products in various stages of regulatory approval[16][17][19]. Regulatory Approvals and Certifications - The company received Class III medical device registration for its genetic laboratory in February 2020 and expects to obtain IVDR Class C CE certification by 2026[14]. - The automated workstation (BS1000) is projected to receive registration certification by 2025, with Class III medical device registration obtained in September 2023[14]. - The gene sequencer (DA5000) is anticipated to achieve IVDR Class C CE certification by 2026, with Class III medical device registration expected in September 2024[14]. - The male infertility laboratory's sperm quality analyzer (BKA-210) is expected to receive IVDR Class A CE certification by 2025, with Class II medical device registration obtained in October 2024[14]. - The company plans to obtain FDA certification for its smart liquid nitrogen tank by 2025, with Class II medical device registration achieved in November 2022[14]. - The ultra-low temperature storage device (BSG800) is projected to receive MDR IIa Class CE certification by 2026, with Class II medical device registration obtained in January 2025[14]. - The company expects to receive Class III registration for its products by 2025, with several products already commercialized since 2021[14]. - The iARMS intelligent management system is in the commercialization phase, with plans for Class III medical device registration by 2025[14]. - The company has received various regulatory approvals across multiple countries, including TGA (Australia), MHRA (UK), and TFDA (Thailand) for its products[14]. Market Expansion and Sales Growth - The company is experiencing stable and steady growth in commercialization, leveraging self-developed and acquired models to expand its customer base in both China and global markets[13]. - The introduction of new products and brand penetration is expected to unlock growth potential in both Chinese and international markets, positioning the company to rapidly establish market share[13]. - Revenue from PGT-A test kits reached RMB 43.3 million with a gross margin of 68.0% for the year ending December 31, 2024[17]. - The company has established a manufacturing network across three countries, with a headquarters in Suzhou, China, covering 70,000 square meters, including four GMP-standard production workshops[30]. - The overseas sales network now covers 30 countries and over 1,000 clinics, with overseas revenue accounting for 35% of total revenue in 2024[46]. - The company has built three international sales regions covering EMEA, APAC, and North America, with over 170 sales personnel globally[35]. - The company has over 600 reproductive center clients globally, accelerating the penetration of core products into high-end markets in Europe, the Middle East, APAC, and the Americas[37]. Research and Development - Research and development expenses for 2024 were RMB 135,259,000, a slight increase from RMB 129,566,000 in 2023[74]. - The company plans to enhance its R&D capabilities and expand its product portfolio through investments, acquisitions, and collaborations[123]. - The proprietary SDWGA technology used in PGT-A test kits has shown 100% sensitivity and specificity in clinical trials[16]. - The PGT-M test kit can reduce testing costs for patients by approximately 60% and shorten result generation time from two months to under two weeks[18]. - The PGT-SR test kit utilizes proprietary ReTSeq technology for efficient detection of chromosomal abnormalities, addressing a common cause of repeated miscarriages[19]. - The company aims to enhance the success rate of assisted reproductive technology through automated and standardized medical devices[16]. Operational Efficiency - The BKA210 intelligent sperm analyzer achieved real-time detection accuracy rates of 98.30% for morphology, 97.69% for vitality, and 93.29% for concentration, based on an AI deep learning model trained on 500,000 sperm samples[42]. - The Geri® incubator provides stable culture conditions with six independent chambers, each equipped with a 5-megapixel camera for dynamic embryo development data collection[24]. - The BCT38 smart liquid nitrogen tank is the world's first intelligent liquid nitrogen tank with medical device registration, featuring real-time temperature monitoring and automated operation logs[26]. - The company has committed to invest a total of USD 1,500,000 in the TruMed Health Innovation Fund LP, with contributions of RMB 5,578,000 as of December 31, 2024[85]. Corporate Governance and Compliance - The company has complied with all relevant laws and regulations during the reporting period, with no investigations or penalties from regulatory authorities[126]. - The audit committee, consisting of independent non-executive directors, reviewed the financial statements for the year ending December 31, 2024, ensuring compliance with accounting standards[135]. - The company will hold its annual general meeting on June 5, 2025, along with the first H-share class meeting and the first domestic and non-listed foreign share class meeting in 2025[130]. - The company has not proposed a final dividend for the year ending December 31, 2024[127].

Financial Performance - Revenue for the six months ended June 30, 2024, was RMB 124,739,000, an increase of 46% compared to RMB 85,546,000 for the same period in 2023[5] - Gross profit for the same period was RMB 57,878,000, up from RMB 33,564,000, reflecting a gross margin improvement[5] - Operating loss increased to RMB 117,643,000 from RMB 58,166,000 year-on-year, indicating higher operational costs[5] - The company reported a net loss of RMB 119,915,000 for the period, compared to a loss of RMB 62,493,000 in the prior year[5] - Revenue increased by 45.8% from RMB 855 million for the six months ended June 30, 2023, to RMB 1,247 million for the six months ended June 30, 2024, primarily due to the acquisition of Singapore BMX and strong sales growth in core products[33] - Gross profit increased by 72.3% from RMB 336 million to RMB 579 million, resulting in a gross margin improvement from 39.2% to 46.4%[35] - The company reported a total comprehensive loss of RMB 125,472,000 for the period, compared to RMB 67,685,000 in 2023, indicating a worsening financial position[81] - The net loss attributable to equity shareholders was RMB 119,912,000, compared to RMB 61,369,000 in the previous year, marking a 95.3% increase in losses[78] Assets and Liabilities - Total non-current assets as of June 30, 2024, were RMB 683,057,000, slightly up from RMB 682,921,000 at the end of 2023[6] - Current assets decreased to RMB 1,114,679,000 from RMB 1,215,166,000, showing a reduction in liquidity[6] - Net asset value as of June 30, 2024, was RMB 1,272,634,000, down from RMB 1,398,106,000 at the end of 2023[6] - Total equity attributable to shareholders was RMB 1,273,707,000, compared to RMB 1,399,176,000 previously[6] - Non-current liabilities increased to RMB 326,917,000 from RMB 304,716,000, indicating a rise in long-term obligations[6] - Current liabilities remained relatively stable at RMB 198,185,000 compared to RMB 195,265,000 at the end of 2023[6] - Total assets as of June 30, 2024, were RMB 1,599,551,000, slightly down from RMB 1,702,822,000 at the end of 2023[86] - The total equity as of June 30, 2024, was RMB 1,528,947,000, down from RMB 1,591,532,000 as of January 1, 2023, reflecting a decline of about 4%[89] Research and Development - The company aims to enhance the success rate of assisted reproduction through automated, standardized, and intelligent medical devices, contributing to improved clinical outcomes[7] - The company has established a comprehensive product pipeline covering the entire assisted reproduction industry chain, including reagents, consumables, instruments, and equipment[7] - The company plans to enhance R&D capabilities and technology acquisition, allocating 15% (HKD 284.8 million) for this purpose, with HKD 197.3 million already utilized[66] - Research and development expenses rose by 9.3% from RMB 637 million to RMB 696 million, reflecting ongoing investments in clinical trials for new products[39] - The company plans to continue its investment in research and development to enhance its product offerings in the genetic testing market[95] Market and Product Development - The PGT-A reagent can increase clinical pregnancy rates to 72% and reduce miscarriage rates to 6.9%, demonstrating significant advancements in genetic testing[7] - The company’s DA500 high-throughput gene sequencer has received national Class III medical device registration, filling a clinical gap in genetic testing for third-generation IVF[7] - The company’s innovative solutions are designed to provide a seamless data experience across various laboratory settings, enhancing operational efficiency and safety[7] - The market for embryo freezing is projected to require storage for 10 million new embryos annually in China, indicating substantial growth potential[10] - The company has participated in drafting industry guidelines for quality control of PGT-A testing reagents, leading the commercialization of third-generation IVF products[7] Operational Efficiency - The company aims to increase operational efficiency and customer satisfaction through its innovative solutions, targeting a 20-year development vision for reproductive centers[11] - The company has developed an intelligent system called "Live Intelligence" for reproductive centers, integrating AI and IoT to enhance operational efficiency and pregnancy success rates[11] - The iARMS system, which is a smart electronic medical record management system, aims to improve workflow and safety in reproductive centers, with independent module development for easier upgrades[11] - The company is experiencing stable and steady growth in commercialization, leveraging self-developed and acquired models to expand its customer base in China and globally[11] Corporate Governance and Structure - The company has adhered to all applicable corporate governance code provisions during the six months ending June 30, 2024[63] - The roles of Chairman and CEO are held by the same individual, Dr. Liang, which the board believes ensures consistent leadership and effective strategic planning[63] - No changes in the board of directors or supervisors have occurred during the reporting period[61] Employee and Management Changes - The total employee count decreased to 528 as of June 30, 2024, from 586 as of December 31, 2023[54] - The sales team was reduced to 70 members by June 30, 2024, down from 185 a year earlier, reflecting a shift in sales strategy and internal personnel changes[29] - The total remuneration for key management personnel for the six months ended June 30, 2024, was RMB 4,472,000, up 22.0% from RMB 3,667,000 in the same period of 2023[126] Capital and Financing - The company raised a net amount of HKD 1,898.7 million (approximately RMB 1,584.1 million) from its initial global offering, after deducting underwriting commissions and related expenses[65] - The company has utilized HKD 1,231.6 million of the total net proceeds, leaving HKD 467.1 million unutilized as of June 30, 2024[66] - The company raised RMB 67,293 thousand from bank loans during the six months ended June 30, 2024, compared to RMB 145,704 thousand in the same period of 2023, indicating a decrease of approximately 54%[93] - The company had secured bank loans of RMB 1.759 billion against land use rights and certain properties[52] Shareholder Information - The total issued share capital of the company as of June 30, 2024, is 273,526,000 shares[60] - The total number of H shares as of June 30, 2024, is 82,713,835 shares[60] - The company did not recommend the payment of an interim dividend for the reporting period, consistent with the previous year's interim dividend of zero[62]

Financial Performance - Revenue for the six months ended June 30, 2024, was RMB 124.739 million, representing a 46% increase from RMB 85.546 million in the same period of 2023[1] - Gross profit for the same period was RMB 57.878 million, compared to RMB 33.564 million in 2023, indicating a significant improvement in profitability[1] - The company reported a loss before tax of RMB 121.327 million for the first half of 2024, compared to a loss of RMB 58.256 million in the prior year, reflecting increased investment in R&D and market expansion[1] - The company reported a net loss of RMB 119,915 thousand for the six months ended June 30, 2024, compared to a net loss of RMB 62,493 thousand in the prior year, indicating a worsening financial performance[50] - Total comprehensive loss for the period was RMB 125,472 thousand, compared to RMB 67,685 thousand in the previous year, reflecting increased operational challenges[50] - Research and development expenses increased to RMB 69,639 thousand from RMB 63,724 thousand, highlighting ongoing investment in innovation[49] - The company's total liabilities increased to RMB 326,917 thousand from RMB 304,716 thousand, suggesting a rise in financial obligations[52] - The company's equity attributable to shareholders decreased to RMB 1,273,707 thousand from RMB 1,399,176 thousand, reflecting a decline in shareholder value[53] Product Development and Innovation - The company aims to enhance the success rate of assisted reproduction through automated, standardized, and intelligent medical devices, contributing to improved operational efficiency[2] - The PGT-A reagent has been shown to increase clinical pregnancy rates to 72% and reduce miscarriage rates to 6.9%, highlighting the effectiveness of the company's genetic testing products[3] - The new generation intelligent sperm analyzer has achieved precise detection of live sperm concentration, vitality, and morphology, addressing the limitations of traditional methods[4] - The company has developed the first automated ultra-low temperature embryo storage device capable of storing 30,000 to 50,000 gametes, positioning itself as a leader in the fertility preservation market[6] - The company has established a comprehensive product line covering the entire assisted reproduction industry chain, including reagents, consumables, instruments, and equipment[2] - The company has developed the iARMS system, which integrates AI and IoT to enhance efficiency and safety in reproductive centers, aiming to improve pregnancy success rates[7] - The company is focused on automating and standardizing assisted reproductive medical devices to improve success rates and operational efficiency for medical institutions[25] - The company has developed proprietary technologies such as SDWGA for PGT-A and MSLCap for PGT-M, enhancing sensitivity and specificity while reducing result generation time[26][28] Regulatory Approvals and Market Strategy - The PGT-M product is expected to receive regulatory approval in 2024, while PGT-SR is anticipated to gain certification in 2025[9] - The company has achieved regulatory certification for several products, including the gene sequencer (DA5000), which received certification in September 2023[10] - The company is focused on expanding its product portfolio, with multiple new products expected to receive regulatory approval between 2024 and 2026[16] - The company is actively pursuing regulatory approvals for its products, with a strategic focus on expanding its market presence in the assisted reproductive technology sector[30] - The PGT-A kit is the only non-aneuploidy product approved by the National Medical Products Administration in China, providing comprehensive chromosome screening capabilities[26] - The company plans to leverage existing channels and teams to release various advantageous products, tapping into growth potential in both Chinese and international markets[7] Operational Efficiency and Infrastructure - The company completed the relocation to its new headquarters in April 2024, with a total floor area of 71,628 square meters, including 21,503 square meters for R&D and 50,125 square meters for production[42] - The production facility is designed according to China's GMP requirements, with an annual capacity of 400,000 units, and has received ISO13485:2016 certification[42] - The company anticipates significant operational efficiency improvements and increased customer satisfaction through the implementation of the iARMS system[7] - The integration of genetic data from various laboratories is expected to streamline operations and improve data security within reproductive centers[7] - The company is committed to breaking down data silos in traditional information systems, ensuring modularity and interconnectivity in laboratory operations[7] Sales and Market Expansion - The commercialization of the company's products is currently stable and steadily growing, with a strong customer base established through self-developed and acquired models in both China and global markets[7] - The sales team has transitioned to a distributor-based model, reducing the number of sales personnel from 185 to 70, while covering over 300 assisted reproductive institutions in China[46] - The company has achieved a 20% year-on-year increase in the number of hospital cycles covered, reaching 500,000 cycles as of June 30, 2024[46] - Future strategies include expanding the sales network to cover 500 assisted reproductive centers in China and enhancing international market presence through a global sales network[48] - The company plans to expand its market presence in Southeast Asia, targeting a 25% market share by 2025[124] Research and Development - The company plans to enhance its R&D capabilities through mergers and collaborations, aiming to build a leading global R&D system[48] - The company has successfully published multiple research articles in respected journals, showcasing innovations in sperm quality detection and chromosome abnormality detection technologies[43][44] - The company is exploring potential acquisitions to enhance its product portfolio and market reach[124] - Clinical trials and commercialization of the PGT-M test kit are budgeted at HKD 189.9 million (10% of the total funds raised), with 2.64% already utilized[111] Financial Management and Investments - The group has not declared or paid any dividends during the reporting period[82] - The group has a deferred tax asset of RMB 252,000 and a deferred tax liability of RMB 33,223,000 as of June 30, 2024[71] - The company raised a net amount of HKD 1,898.7 million (approximately RMB 1,584.1 million) from its initial global offering, after deducting underwriting commissions and related expenses[108] - The planned use of the raised funds includes 20% (HKD 379.7 million) allocated for the core product PGT-A test kit, with 4.94% already utilized[110] - The company has allocated HKD 341.8 million (18%) for research and development, production, and commercialization of genetic testing equipment and instruments[112]

Financial Performance - The company's revenue for 2023 reached RMB 207,976,000, a 47.5% increase from RMB 140,901,000 in 2022[8] - Gross profit for 2023 was RMB 91,351,000, representing a 53.1% increase compared to RMB 59,528,000 in 2022[8] - The operating loss for 2023 was RMB 193,709,000, worsening from a loss of RMB 126,118,000 in 2022[8] - The company reported a net loss of RMB 193,349,000 for 2023, compared to a net loss of RMB 123,163,000 in 2022[8] - The total equity attributable to shareholders was RMB 1,399,176,000 in 2023, down from RMB 1,592,802,000 in 2022[8] - Revenue increased approximately 48% from RMB 140.9 million for the year ended December 31, 2022, to RMB 208.0 million for the year ended December 31, 2023, driven by steady growth in PGT reagent sales and other product sales[65] - Sales cost rose approximately 43% from RMB 81.4 million for the year ended December 31, 2022, to RMB 116.6 million for the year ended December 31, 2023, primarily due to the additional sales costs from the acquisition of Singapore BMX[66] - Gross profit increased approximately 53% from RMB 59.5 million for the year ended December 31, 2022, to RMB 91.4 million for the year ended December 31, 2023, with a gross margin of 43.9%[67] - Other income decreased approximately 44% from RMB 96.7 million for the year ended December 31, 2022, to RMB 54.2 million for the year ended December 31, 2023, mainly due to reduced foreign exchange gains[68] Product Development and Innovation - The company completed the acquisition of BMX, a well-known international embryo culture company, in June 2023, enhancing its product pipeline significantly[10] - In March 2023, the company launched an IoT-based automated oocyte freezing system, marking a significant advancement in reproductive technology[10] - The DA500 high-throughput gene sequencer has been approved as a Class III medical device by the NMPA, completing the product line integration with PGT reagent kits and software[14] - The company aims to focus on high-quality, large-scale delivery of assisted reproductive medical devices, promoting localized production across all product categories[14] - The company has developed the iARMS system, integrating AI and IoT to enhance operational efficiency and pregnancy success rates in reproductive centers[24] - The product pipeline includes several key items, with PGT-M expected to receive regulatory approval in 2024 and PGT-SR in 2025[27] - The DA500 gene sequencer received regulatory approval in September 2023, enhancing the company's product offerings in genetic testing[27] - The company plans to commercialize the iARMS system and Gidget® electronic management system in 2023, marking a significant step in its digital transformation[27] - The company aims to enhance the success rate of assisted reproductive technology through the development of automated and standardized medical devices[29] Market Expansion and Strategic Partnerships - The company entered into a strategic partnership with Genea, a top global reproductive medicine group, to enhance product development and market reach[11] - The company is pursuing a dual strategy of mergers and collaborations to expand its ecosystem in the assisted reproductive field[14] - The company is in a stable growth phase, leveraging self-developed and acquired products to expand its customer base in both China and global markets[25] - The company aims to enhance market penetration and sales through existing channels and teams, capitalizing on new product launches[25] - The company transitioned to a distributor-based sales model, covering over 300 reproductive institutions in China and expanding its international reach to over 600 clinical institutions across more than 20 countries[58] Research and Development - The company has a strong focus on R&D, with key personnel holding advanced degrees in biological sciences and biochemistry, enhancing its innovation capabilities[102] - The company is focused on developing innovative technologies, including a new real-time tracking algorithm for sperm quality detection, significantly improving existing testing methods[54] - R&D expenses increased approximately 8% from RMB 119.8 million for the year ended December 31, 2022, to RMB 129.6 million for the year ended December 31, 2023, accounting for 62.3% of revenue[73] Corporate Governance and Management - The company has adopted a governance code since its listing and has complied with all applicable provisions for the year ending December 31, 2023[121] - The roles of Chairman and General Manager are held by the same individual, Dr. Liang, to ensure consistent leadership and effective strategic planning[121] - The company has established a robust quality control department led by experienced professionals to ensure product excellence and compliance with industry standards[100] - The board includes independent directors with significant experience in capital management and strategic advisory roles, which will support the company's growth initiatives[102][106] - The company has established a comprehensive internal control system to ensure normal business operations, with a fully staffed internal audit department[191] Employee and Operational Metrics - The number of employees increased to 586 as of December 31, 2023, from 479 a year earlier[91] - The company reported a total employee compensation cost of approximately RMB 153.9 million for the year ending December 31, 2023, up from RMB 115.1 million in 2022, primarily due to the acquisition of Singapore BMX[91] - The company has achieved all measurable targets of its board diversity policy as of December 31, 2023, including having at least one female director and at least one director with accounting or other professional qualifications[133] Financial Position and Commitments - The company maintained a net cash position as of December 31, 2023, making the debt-to-equity ratio not applicable[90] - The total unfulfilled capital commitments as of December 31, 2023, amounted to RMB 16,884,000, a decrease from RMB 72,729,000 in 2022[88] - The company had secured bank loans of RMB 140.1 million against its land use rights and construction projects as of December 31, 2023[89] Regulatory Compliance and Reporting - The independent auditor for the fiscal year ending December 31, 2023, is KPMG, with their responsibilities outlined in the independent auditor's report[172] - The board has reviewed the effectiveness of the risk management and internal control systems, deeming them adequate and effective[166] - The company has not identified any violations of the standard code of conduct by its directors and supervisors during the reporting period[123]

Financial Performance - The company's revenue increased approximately 48% from RMB 1,409 million for the year ended December 31, 2022, to RMB 2,080 million for the year ended December 31, 2023[21]. - The sales cost rose about 43% from RMB 814 million in 2022 to RMB 1,166 million in 2023, primarily due to the additional sales costs from the acquisition of Singapore BMX[22]. - Administrative expenses increased by 30% from RMB 814 million in 2022 to RMB 1,054 million in 2023, mainly due to professional service fees related to the acquisition of Singapore BMX[25]. - The company recorded an income tax credit of RMB 30 million for the year ended December 31, 2023, compared to an income tax expense of RMB 60 million for the year ended December 31, 2022[28]. - The company reported a net loss attributable to equity shareholders of RMB 191,685,000 for the year, compared to RMB 122,664,000 in 2022, highlighting increased financial challenges[55]. - The company reported a loss attributable to equity shareholders of RMB 191.685 million for the year, compared to a loss of RMB 122.664 million in the previous year[102]. - The company reported a net loss of RMB 193.349 million for the year, compared to a loss of RMB 123.163 million in the previous year, indicating a year-over-year increase in losses of approximately 56.8%[149]. - The company reported a net loss of RMB 193.35 million for the year ended December 31, 2023, compared to a loss of RMB 123.16 million in 2022[198]. Acquisition and Expansion - The acquisition of Singapore BMX was completed in June 2023 for a total consideration of USD 40 million, with potential adjustments based on cash changes, leading to a final price of USD 40,469,728[32]. - The company completed the acquisition of 100% equity in Singapore BMX, which is now a wholly-owned subsidiary[114]. - The company completed the acquisition of Singapore BMX and its seven subsidiaries on June 21, 2023, enhancing its product offerings and market reach[95]. Workforce and Employee Costs - Employee costs accounted for 28.3% of revenue in 2023, compared to 30.4% in 2022, with total employee costs of RMB 58,825 thousand[26]. - The company has 586 employees as of December 31, 2023, up from 479 employees in the previous year, indicating growth in workforce to meet business demands[35]. Research and Development - Research and development expenses rose to RMB 129,566,000 from RMB 119,773,000, reflecting a continued investment in innovation[53]. - The company plans to utilize RMB 284.8 million (15% of total proceeds) to enhance research and development capabilities and recruit talent in gene testing over the next one to three years[39]. - The company plans to enhance its research and development capabilities through mergers and acquisitions, aiming to build a leading global R&D system[146]. Product Development and Innovation - The DA500 high-throughput gene sequencer received approval from the National Medical Products Administration as a Class III medical device, capable of producing data throughput of 10Gb-150Gb[83]. - The company has developed the world's first smart liquid nitrogen tank, which has received medical device registration, addressing issues related to embryo management[107]. - The company has developed a new sperm quality testing method, enhancing the detection level of semen quality significantly[117]. - The Geri® incubator features six independent chambers, improving embryo development stability and increasing embryo utilization rates for patients[132]. - The company has developed a full-time differential incubator with 6 independent chambers, allowing for stable embryo cultivation and real-time monitoring without opening the incubator lid[166]. - The company has achieved significant technological advancements with its Live View system, allowing users to observe embryo growth in real-time[166]. - The new generation intelligent sperm analyzer has achieved precise detection of live sperm concentration, vitality, and morphology, addressing reliability issues in current testing methods[195]. Market Strategy and Sales - The company aims to enhance its international strategy by establishing a global sales network and promoting its products in overseas markets[48]. - The company plans to expand its sales network to cover 500 assisted reproductive centers in China, which is expected to significantly increase sales scale and market share[146]. - The company has established partnerships with over 40 distributors, covering more than 300 assisted reproductive institutions in China[85]. - The company has transitioned to a sales model through distributors, with 55 sales personnel in China as of December 31, 2023, down from 168 the previous year[85]. - The company plans to utilize 20% of the proceeds from the global offering for the continued sales and marketing of the PGT-A test kit in China, with an actual amount of HKD 156.3 million already used[67]. Financial Position and Liabilities - The company's total liabilities increased to RMB 179,727 thousand as of December 31, 2023, from RMB 106,291 thousand as of December 31, 2022[17]. - The company has no contingent liabilities as of December 31, 2023, indicating a stable financial position[33]. - The total non-current assets are reported at RMB 682.921 million, while current assets stand at RMB 252.262 million, indicating a solid asset base[151]. Regulatory Approvals and Certifications - The Geri® incubator has received registrations from the National Medical Products Administration, CE, FDA, and TGA[132]. - The company has obtained multiple product registrations in the fields of in vitro diagnostic reagents, active devices, and independent software[116]. - The company achieved a significant milestone by obtaining the first "National Innovative Medical Device Special Approval" for its PGT-A reagent kit, filling a clinical gap in China's third-generation IVF market[154]. Future Plans and Investments - The company plans to invest 10% of the proceeds for acquiring new technologies and experienced R&D personnel for production facilities[68]. - The company expects to fully utilize the unallocated proceeds within the next one to three years[67]. - The company aims to build a global production base covering the entire assisted reproduction industry chain, focusing on high-quality and scalable delivery capabilities[92]. - The company aims to expand its market presence in fertility preservation globally with automated ultra-low temperature embryo storage equipment capable of storing 30,000 to 50,000 gametes[167]. - The company plans to launch several new products, including PGT-A and PGT-M testing kits, with registrations expected in 2024 and 2025 respectively[185][187].

Financial Performance - Revenue for the six months ended June 30, 2023, was RMB 85,546 thousand, an increase from RMB 68,568 thousand in the same period of 2022, representing a growth of approximately 24.7%[6] - Gross profit for the same period was RMB 33,564 thousand, compared to RMB 30,218 thousand in 2022, indicating a gross margin improvement[6] - The company reported a loss attributable to equity shareholders of RMB 61,369 thousand for the six months ended June 30, 2023, compared to a loss of RMB 21,285 thousand in 2022, reflecting a significant increase in losses[7] - The company reported a total revenue of RMB 85,546,000 for the six months ended June 30, 2023, compared to RMB 83,484,000 for the same period in 2022, indicating a year-over-year increase of about 2.5%[73] - The company reported an operating loss of RMB 58,166,000 for the first half of 2023, compared to an operating loss of RMB 31,603,000 in the prior year, indicating a significant increase in losses[154] - The company’s net income tax expense for the six months ended June 30, 2023, was RMB 4,237,000, compared to RMB 1,515,000 in the same period of 2022, indicating a significant increase in tax expenses[79] Assets and Liabilities - The company’s non-current assets increased to RMB 263,779 thousand as of June 30, 2023, up from RMB 207,113 thousand at the end of 2022, showing a growth of approximately 27.3%[13] - The net current assets decreased to RMB 1,191,326 thousand from RMB 1,413,044 thousand, indicating a decline in liquidity[28] - The total liabilities as of June 30, 2023, were RMB 436,025,000, compared to RMB 228,211,000 in the previous period, indicating a significant increase in liabilities[73] - The company’s total assets as of June 30, 2023, were RMB 1,964,972,000, compared to RMB 1,606,630,000 as of December 31, 2022, representing an increase of approximately 22.3%[73] Investments and Acquisitions - The company sold a 35% stake in Xingbo Bio for RMB 64,170,000, reducing its ownership from 51% to 16%[43] - The company completed the acquisition of Singapore BMX Group for a total consideration of USD 40,470,000 (approximately RMB 288,637,000) on June 21, 2023[105] - The company acquired a 51% stake in Xingbo Bio for RMB 85 million, completed on March 1, 2022, and recognized a put option for potential repurchase at a 10% compound annual interest rate[81] - The acquisition of Singapore BMX contributed revenue of RMB 2,062,000 and incurred a loss of RMB 2,917,000 from the acquisition date to June 30, 2023[125] Research and Development - The company is focusing on expanding its market presence and enhancing its product offerings through ongoing research and development initiatives[19] - Research and development expenses for the six months ended June 30, 2023, totaled RMB 29,945,000, up from RMB 19,835,000 for the same period in 2022, reflecting an increase of approximately 50.9%[78] - The company continues to focus on research and development in the medical sector to enhance its product offerings[146] - The company has developed a comprehensive solution for male fertility assessment, including an intelligent sperm quality analysis platform and automated testing kits[171] Product Development and Market Strategy - The company has established a comprehensive pipeline of male reproductive health products, expanding from high-end reproductive centers to hospitals and end customers[156] - The company aims to leverage its sales channel advantages and customer base to unlock growth potential in both domestic and international markets[160] - The PGT-A test kit received the first "National Innovative Medical Device Special Approval" Class III medical device registration in February 2020, filling a clinical gap in embryo testing in China[162] - The company has established partnerships with 65 localized laboratories in China, achieving over 70% market share in leading assisted reproductive centers[168] Financial Instruments and Reporting - The company has adopted new and revised international financial reporting standards, which may impact future financial reporting[22] - The company is committed to adhering to international financial reporting standards in its financial disclosures[144] - The fair value of derivative financial instruments increased to RMB 15,852 as of June 30, 2023, from RMB 14,975 at the beginning of the year[57] - The company has no potential dilutive ordinary shares, resulting in basic and diluted loss per share being the same[59] Cash Flow and Liquidity - As of June 30, 2023, cash and cash equivalents amounted to RMB 1,098,160, a decrease of 17.5% from RMB 1,332,146 as of December 31, 2022[38] - The company did not declare or pay any dividends during the reporting period[42] - The company incurred finance costs of RMB 1,692,000 for the six months ended June 30, 2023, compared to RMB 1,444,000 in the same period of 2022, reflecting an increase of about 17.2%[75] Regulatory and Compliance - The company has implemented an IoT-based intelligent frozen storage solution to enhance management efficiency and reduce operational errors[173] - The company anticipates obtaining registration certificates for several products by 2025, including gamete culture and embryo culture media, which have already received CE/FDA/TGA certifications[182] - The company expects to receive registration certificates for gametes and embryos by 2026, indicating ongoing product development and regulatory compliance efforts[183]