Financial Performance - For the fiscal year ending December 31, 2024, the company reported revenue of RMB 158.8 million, primarily from licensing fees of RMB 100.9 million related to QX008N and QX004N, and RMB 55.7 million from R&D and CDMO services[6]. - The cost of sales for the same period was RMB 66.6 million, which includes costs associated with R&D services for QX004N and QX008N, as well as CDMO services[7]. - The net loss for the year was RMB 349.7 million, a 33% improvement from RMB 521.3 million in 2023[10]. - Adjusted net loss, excluding certain non-cash items, was RMB 274.2 million, down 30% from RMB 390.0 million in the previous year[10]. - Cash and cash equivalents increased to RMB 556.1 million from RMB 376.7 million in 2023[4]. - Other income increased by 15.63% from RMB 24.9 million in 2023 to RMB 28.8 million in 2024, primarily due to government subsidies and interest income[53]. - Administrative expenses decreased 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[55]. - Financial costs increased by 39.3% from RMB 16.8 million in 2023 to RMB 23.4 million in 2024, primarily due to increased bank borrowings[58]. - The company reported a total revenue of RMB 158.8 million for the year ending December 31, 2024, compared to no revenue in 2023[112]. - Gross profit for the same period was RMB 92.2 million, with a cost of sales amounting to RMB 66.6 million[112]. - The operating loss decreased to RMB 326.4 million in 2024 from RMB 504.5 million in 2023, indicating an improvement in operational efficiency[112]. - Cash used in operating activities decreased to RMB 186.1 million in 2024 from RMB 300.7 million in 2023, attributed to revenue from licensing agreements and milestone payments[66]. - Cash generated from financing activities increased significantly to RMB 351.8 million in 2024 from RMB 61.2 million in 2023, driven by proceeds from the initial public offering and increased bank loans[67]. Research and Development - 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[8]. - 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[38]. - Employee costs for R&D were RMB 66.99 million in 2024, down from RMB 92.99 million in 2023[39]. - The product pipeline includes QX002N and QX005N, with QX002N achieving primary endpoints in a Phase III trial for ankylosing spondylitis[11]. - QX001S, a treatment for psoriasis, received drug registration approval in October 2024, becoming the first biosimilar of ustekinumab in China[11]. - QX005N for adult moderate to severe atopic dermatitis (AD) achieved first patient in (FPI) in May 2024, with Phase III trial completion expected by March 2025[18]. - QX005N for adolescent AD entered Phase Ib/IIa trial with FPI achieved in June 2024[18]. - QX001S received drug registration certificate approval from the National Medical Products Administration in October 2024, branded as "Sailuxin®"[18]. - QX004N's Phase II clinical data was disclosed at the American Academy of Dermatology annual meeting in March 2025[18]. - QX013N for chronic spontaneous urticaria (CSU) completed Phase Ia trial with FPI achieved in June 2024[18]. - QX006N for systemic lupus erythematosus (SLE) is currently in Phase Ib trial[18]. - QX008N is undergoing Phase II clinical trials for chronic obstructive pulmonary disease (COPD) in China[18]. - QX005N has received IND approvals for seven indications, including adult and adolescent AD, prurigo nodularis (PN), chronic rhinosinusitis with nasal polyps (CRSwNP), CSU, asthma, and COPD[19]. - QX005N was included in the Breakthrough Therapy Designation (BTD) list in January 2024, indicating superior clinical efficacy compared to current treatment methods[20]. - The Phase III trial for QX002N 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)[24]. - The company is focused on the research and development of biotherapies for autoimmune and allergic diseases, indicating a strategic emphasis on innovation and market expansion[120]. Strategic Partnerships and Collaborations - The company has successfully developed strategic partnerships for core products, including a technology transfer agreement for QX008N with Health元 and an exclusive licensing agreement for QX004N with 翰森[12][13]. - Company entered into a collaboration agreement with China Medical East to co-develop QX005N, sharing 50% of the Phase III clinical trial costs[14]. - The collaboration with China Meheco involves sharing 50% of the Phase III clinical trial costs for QX005N, enhancing its commercialization potential[21]. - The company has entered into a cooperation agreement with East China Pharmaceutical for the joint development and commercialization of QX005N, dated July 19, 2024[158]. - The company plans to leverage strong medical resources and networks from well-known pharmaceutical companies for future commercialization of its candidate drugs[42]. Corporate Governance and Compliance - The audit committee has reviewed the financial reporting procedures and internal control systems, ensuring compliance with the corporate governance code[101]. - The company is committed to enhancing its corporate governance practices to promote business growth and ensure compliance with the latest developments[94]. - The company has a diverse and experienced board, ensuring a balance of power and authority[93]. - The board of directors has confirmed compliance with the standard code of conduct for securities trading since the listing date, with no violations reported during the reporting period[92]. Market Position and Future Plans - The company plans to strengthen its core competitive advantages and explore overseas expansion opportunities as part of its future strategy[46]. - The company plans to expand QX001S for pediatric plaque psoriasis and Crohn's disease following its approval for adult indications[27]. - The company is exploring strategic partnerships and potential acquisitions to enhance its market position and expand its product offerings[165]. - The company has established a production facility compliant with cGMP standards, with an annual production capacity of approximately 300 kg of therapeutic antibodies[41]. - The production facility includes a production line for vials with a capacity of 18,000 bottles per hour and a pre-filled syringe line with a capacity of 9,000 units per hour[41]. Financial Position and Assets - Total current assets increased to RMB 616.7 million in 2024 from RMB 418.3 million in 2023, while total liabilities rose to RMB 762.8 million from RMB 494.6 million[61]. - Non-current liabilities increased by 37% to RMB 332.7 million in 2024, primarily due to an increase in bank loans with a term of 2 to 3 years[63]. - The current ratio declined to 1.4 in 2024 from 1.7 in 2023, mainly due to increased current liabilities associated with clinical trials[72]. - The debt-to-asset ratio rose to 74.7% in 2024 from 42.5% in 2023, primarily due to increased borrowings[73]. - The company has secured additional credit financing of RMB 30.0 million post-reporting period, indicating no significant difficulties in obtaining further credit[69]. - The company’s total assets decreased, with net asset value reported at RMB 221,050 thousand in 2024 compared to RMB 300,950 thousand in 2023[116]. - The company’s total trade and other payables reached RMB 208,794 thousand in 2024, up from RMB 129,914 thousand in 2023, reflecting a growth of 60.6%[146]. Risk Management - The group faces currency risk primarily from cash balances denominated in currencies other than the functional currency, specifically HKD and USD[80]. - The group regularly monitors liquidity needs and adheres to borrowing covenants to maintain sufficient cash reserves[78]. - The group conducts impairment assessments based on expected credit loss models to ensure adequate provisions for credit losses[77]. - The group has implemented a cautious investment strategy, focusing on low-risk financial products provided by reputable banks[85]. - The group does not utilize any interest rate swaps to hedge against interest rate risks as of December 31, 2024[79]. Shareholder Information - The company has a significant shareholder structure, with Mr. Qiu holding approximately 45.71% through Shanghai Quan You Investment Management Partnership[165]. - The company has not declared or paid any dividends for the year ending December 31, 2024, consistent with 2023[152]. - The company has not conducted any share buybacks or sales since the listing date[89].
荃信生物(02509) - 2024 - 年度业绩