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].
贝康医疗-B(02170) - 2024 - 年度业绩