Financial Performance - Jiangsu Qunxin Biopharmaceutical Co., Ltd. achieved a revenue of approximately RMB 158.8 million in 2024, marking a significant increase compared to 2023[14]. - The company reported a net loss of RMB 349.7 million for the year, an improvement from a loss of RMB 521.3 million in 2023, indicating a reduction in losses by approximately 32.9%[14]. - Cash and cash equivalents increased by 47.6% to RMB 556.1 million, up from RMB 376.7 million in 2023, reflecting a strong liquidity position[14]. - The adjusted net loss under non-IFRS measures was RMB 274.2 million, down from RMB 390.0 million in 2023, indicating improved operational efficiency[14]. - For the fiscal year ending December 31, 2024, the company's revenue was RMB 158.8 million, primarily from licensing fees of RMB 100.9 million from QX008N and QX004N, and RMB 55.7 million from R&D and CDMO services[15]. - The company's CDMO service revenue increased from RMB 12.1 million in 2023 to RMB 23.8 million in 2024, reflecting a growth of RMB 11.7 million[15]. - The cost of sales for the fiscal year ending December 31, 2024, was RMB 66.6 million, which includes costs associated with R&D services for QX004N and QX008N, as well as CDMO services[16]. - The company achieved a gross profit of RMB 92.2 million for the fiscal year ending December 31, 2024, with a gross margin reflecting strong R&D capabilities[55]. - The company's total employee costs, including director remuneration, amounted to approximately RMB 168.8 million for the year ending December 31, 2024, a decrease from RMB 222.4 million for the previous year[51]. - Administrative expenses decreased significantly from RMB 164.6 million in 2023 to RMB 115.9 million in 2024, mainly due to a reduction in equity-settled share payment expenses[61]. - Other income increased by 15.63% from RMB 24.9 million in 2023 to RMB 28.8 million in 2024, driven by government subsidies and interest income[59]. - Financial costs rose by 39.3% to RMB 23.4 million in 2024, attributed to increased bank borrowings to meet operational needs[63]. - The company recorded a net loss of RMB 349.7 million for the year ending December 31, 2024, an improvement of 33% compared to a net loss of RMB 521.3 million in 2023[64]. - The company has generated significant operating losses since its inception and expects to continue incurring losses for the foreseeable future[164]. Research and Development - The company’s R&D expenses decreased to RMB 334.3 million from RMB 364.4 million in the previous year, showing a focus on cost management[14]. - R&D expenses decreased by 8.3% from RMB 364.4 million in 2023 to RMB 334.3 million in 2024, mainly due to reclassification of clinical costs and a reduction in equity-settled share payment expenses[17]. - The total R&D costs for the year ended December 31, 2024, amounted to approximately RMB 334.3 million, a decrease from RMB 364.4 million in 2023[46][47]. - The company has achieved 20 IND approvals over the past 9 years, with 19 from the National Medical Products Administration and 1 from the FDA[45]. - QX002N for AS is progressing to Phase III clinical trial, with primary endpoint data expected in February 2025[27]. - QX005N for adult moderate-to-severe AD and PN has initiated Phase III trials, with first patient in (FPI) achieved in May 2024[27]. - QX001S received drug registration certificate from the National Medical Products Administration in October 2024, branded as "Sailuxin®"[27]. - QX004N completed Phase II primary endpoint data readout in August 2024, with further clinical trial plans announced[27]. - QX006N for SLE completed Phase Ib clinical trial as of the last feasible date[27]. - QX005N has received IND approvals for seven indications, including adult and adolescent moderate-to-severe AD, PN, and asthma[28]. - QX013N for CSU achieved the last patient in (LPI) for Phase I clinical trial in September 2024[27]. - The company has established a collaboration agreement with East China Pharmaceutical for the development and commercialization of QX001S in China[27]. - QX008N is under development for COPD in China, with Health元 leading the clinical trials[27]. - The company retains exclusive rights for QX001S outside of China, while collaborating with East China Pharmaceutical for its commercialization[27]. - QX005N was included in the Breakthrough Therapy Designation (BTD) list in January 2024, indicating superior clinical efficacy compared to current treatments[29]. - The Phase II clinical trial for QX005N in treating CRSwNP was completed in February 2025, with a collaboration agreement established with China Meheco in July 2024 for joint development[30]. - The Phase III clinical trial for QX002N in treating AS enrolled 641 patients, with a 40.4% ASAS40 response rate in the treatment group compared to 18.9% in the placebo group (P<0.0001)[32]. - QX001S, a biosimilar to ustekinumab, was approved in October 2024, with global sales of Stelara® reaching $10.361 billion in 2024[34]. - China Meheco submitted a BLA for QX001S in July 2023, which was approved in October 2024, and additional applications for pediatric indications are underway[35]. - QX004N showed a 76.9% improvement in PASI scores after 16 weeks of treatment in the Phase II trial, indicating strong efficacy[37]. - QX008N completed its Phase Ib clinical trial for moderate to severe asthma in January 2025, with a licensing agreement signed with Health元 for development in specific regions[39]. - QX013N received clinical trial approval from the National Medical Products Administration for the treatment of CSU on May 9, 2024, marking it as the first c-kit targeted candidate biologic in China[40]. - QX006N, an IFNAR1 targeted monoclonal antibody for SLE, successfully completed its Ib phase clinical trial in October 2024[43]. Strategic Collaborations and Partnerships - Strategic collaborations with major pharmaceutical companies were established to enhance clinical research and commercialization potential, including partnerships for QX008N and QX004N[9]. - The company entered into a strategic collaboration with Health Yuan for the development and commercialization of QX008N, receiving an upfront payment of RMB 75.0 million[20]. - A collaboration agreement was established with Han Sen (Shanghai) for QX004N, which includes potential milestone payments of up to RMB 1,032.0 million[21]. - The company will share the costs of the Phase III clinical trial for QX005N with China Medical East on a 50/50 basis, enhancing its commercialization potential[22]. - The company has a strategic focus on product licensing and mergers and acquisitions, as highlighted by Mr. Yu's previous role in business development at Heplisav-B[113]. - The company aims to enhance its market presence through strategic partnerships and collaborations in the biopharmaceutical sector[117]. Market and Operational Strategies - Future strategies will focus on maintaining clinical progress of existing products and expanding into domestic and international markets for innovative drugs[11]. - The company plans to strengthen its core competitive advantages by expanding its pipeline and seeking overseas opportunities[52][53]. - The company aims to enhance production efficiency and capacity utilization while continuing to recruit and develop talent[53]. - The company has a mission to address the vast unmet medical needs in the autoimmune and allergic disease market through its innovative therapies[157]. - The company has a strong focus on expanding its market presence and enhancing its product development capabilities[157]. - The company is positioned for future growth with a focus on innovation and market expansion, supported by its experienced leadership team[123]. Governance and Management - The board currently consists of three executive directors, two non-executive directors, and three independent non-executive directors[155]. - The independent directors are tasked with providing oversight and strategic guidance, ensuring the company's governance aligns with best practices[121][126]. - The management team emphasizes the importance of financial reporting and analysis in driving business decisions and strategies[110]. - The company is committed to ensuring no actual conflicts of interest exist between its directors and stakeholders[116]. - The company has a diverse board with members experienced in finance, investment management, and biopharmaceuticals, enhancing its strategic oversight[136]. - The management team has a diverse background in pharmaceuticals, biotechnology, and clinical research, contributing to strategic growth[142]. Risks and Compliance - The company faces significant risks related to its financial condition, drug development, clinical trials, and regulatory approvals, with no guarantee of successfully commercializing its core products[163]. - The company is committed to maintaining compliance with environmental protection and occupational health and safety regulations in China[166]. - The group regularly monitors liquidity needs and adheres to borrowing covenants to maintain sufficient cash reserves[87]. - The group conducts impairment assessments based on expected credit loss models to ensure adequate provisions for credit losses[86]. Employee and Operational Metrics - As of December 31, 2024, the company employed 339 staff members, all located in China, and is focused on providing a safe working environment[171]. - The internal R&D team consists of 125 members, with approximately 59% holding master's degrees or higher in relevant fields[45]. - The production facility has passed GMP compliance inspection by the National Medical Products Administration in November 2024, ensuring adherence to quality standards[48]. - The production facility has a therapeutic antibody production capacity of approximately 300 kg per year, with specific production lines for vials and pre-filled syringes[48]. Financial Position and Investments - Current assets increased from RMB 418.3 million in 2023 to RMB 616.7 million in 2024, reflecting a significant growth in liquidity[66]. - Trade and other receivables surged by 95.8% from RMB 26.5 million in 2023 to RMB 51.8 million in 2024, driven by increased receivables from licensing agreements[71]. - Non-current liabilities rose by 37.0% from RMB 242.9 million in 2023 to RMB 332.7 million in 2024, mainly due to an increase in bank loans with a term of 2 to 3 years[69]. - The company's operating cash flow improved, with net cash used in operating activities decreasing from RMB 300.7 million in 2023 to RMB 186.1 million in 2024[76]. - Financing activities generated net cash of RMB 351.8 million in 2024, a significant increase from RMB 61.2 million in 2023, largely due to IPO proceeds and increased bank borrowings[77]. - The current ratio decreased from 1.7 in 2023 to 1.4 in 2024, attributed to rising current liabilities associated with ongoing clinical trials[82]. - The debt-to-asset ratio increased from 42.5% in 2023 to 74.7% in 2024, primarily due to higher bank borrowings[83]. - The company has an unused credit line of RMB 161.7 million available for working capital as of December 31, 2024[75]. - The group has implemented a cautious investment strategy, focusing on low-risk financial products provided by reputable banks[96].
荃信生物(02509) - 2024 - 年度财报