Financial Performance - Total revenue for the year ended December 31, 2022, was RMB 4,556.4 million, an increase of 6.7% compared to RMB 4,269.7 million for the year ended December 31, 2021[3]. - The net loss for the year was RMB 2,461.8 million, an increase of RMB 433.4 million from RMB 2,028.4 million in the previous year, mainly due to sustained R&D investments[4]. - The adjusted net loss for the year was RMB 2,461.8 million, compared to RMB 2,028.4 million in the previous year, reflecting the impact of ongoing investments[4]. - The company recorded a net loss of RMB 2,179.3 million for the year ended December 31, 2022, compared to a net loss of RMB 2,728.8 million in 2021, reflecting an improvement of approximately 20.2%[46]. - The basic and diluted loss per share for 2022 was RMB 1.46, compared to RMB 1.88 in 2021, indicating an improvement in loss per share[82]. Revenue Breakdown - Product revenue reached RMB 4,139.1 million, a growth of 3.4% from RMB 4,001.1 million in the previous year, driven by rapid sales growth and new product contributions[5]. - Pharmaceutical product sales accounted for RMB 4,139.1 million in revenue for the year ended December 31, 2022, up from RMB 4,001.1 million in 2021, indicating a growth of about 3.5%[90]. - Total revenue from external customers in China was RMB 4,132,539,000 in 2022, compared to RMB 3,967,517,000 in 2021, reflecting a growth of about 4.2%[96]. Research and Development - Research and development expenses increased to RMB 2,664.7 million from RMB 2,118.7 million, reflecting ongoing investment in clinical trials and pipeline development[3]. - Research and development expenses increased to RMB 2,871.2 million in 2022 from RMB 2,322.5 million in 2021, marking a rise of about 23.7%[46]. - The company has established a pipeline of over 30 innovative drug candidates, including more than 20 oncology and 10 non-oncology products, with 8 commercialized products[19]. - The company is advancing multiple innovative molecules with differentiated clinical potential, including IBI-363 (PD-1/IL-2) and IBI-311 (IGF-1R) for long-term pipeline growth[10]. Product Development and Approvals - New drug approvals included the launch of 希冉擇® (Remosiruab) and 睿妥® (Sepmetinib), targeting specific cancer treatments, which will support broader patient solutions[5]. - The NMPA approved two new indications for Daborhuzhu® (sindilizumab injection), making it the first PD-1 inhibitor in China for first-line treatment of five major cancers, including ESCC and GC[6]. - The NMPA accepted three new drug applications (NDA) for innovative candidates, including IBI-306 for primary hypercholesterolemia and mixed dyslipidemia, and IBI-326 for relapsed/refractory multiple myeloma[7]. - IBI-362 (mazdutide), a dual agonist for GLP-1R and GCGR, showed strong weight loss and blood sugar reduction effects in Phase 2 studies, with Phase 3 trials for obesity starting in November 2022[8]. Strategic Partnerships and Collaborations - The company established a strategic partnership with Eli Lilly in March 2022, obtaining exclusive commercialization rights for two drugs in mainland China and priority negotiation rights for a potential future drug[11]. - In August 2022, the company entered a strategic collaboration with Sanofi to accelerate the development and market access of innovative oncology drugs, including a €300 million initial strategic equity investment from Sanofi[12]. - The company has initiated a strategic collaboration with LG Chem for Tigulixostat, which is currently undergoing a Phase 3 clinical trial initiated in Q4 2022[44]. Operational Efficiency and Management - Sales and marketing expenses were RMB 2,578.4 million, representing 56.6% of total revenue, compared to 59.6% in the previous year, indicating improved operational efficiency[3]. - The company aims to implement a more sustainable and healthier business management model to enhance operational efficiency and support long-term growth[5]. - The company aims to focus on fine management to expand product scale and improve operational efficiency while developing innovative drugs[16]. Market Expansion and Future Plans - The company is actively exploring new drug development and market expansion strategies, including potential mergers and acquisitions to strengthen its market position[23]. - The company aims to enhance global quality and innovation standards while creating sustainable value for patients, employees, society, and shareholders[23]. - The company plans to gradually utilize the remaining proceeds from the placements based on market conditions and operational needs[80]. Financial Position and Assets - As of December 31, 2022, the company had cash and short-term financial assets of approximately RMB 9.166 billion, equivalent to over $1.3 billion, bolstered by the strategic investment from Sanofi[23]. - Total current assets as of December 31, 2022, were RMB 11,506.7 million, slightly down from RMB 11,550.8 million in 2021[59]. - The company had unused long-term bank loan facilities of approximately RMB 2,291.2 million as of December 31, 2022[61]. Governance and Compliance - The company has complied with all applicable provisions of the Corporate Governance Code for the year ended December 31, 2022, except for the separation of the roles of Chairman and CEO[70]. - The company established an audit committee consisting of four independent non-executive directors, with the chair being Ms. Xu Yiyin[74]. - The company has established a nomination committee, a remuneration committee, and a strategic committee in addition to the audit committee[75].
信达生物(01801) - 2022 - 年度业绩