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 company reported a net loss attributable to shareholders of RMB 2,179,270,000 for the year ended December 31, 2022, compared to a net loss of RMB 2,728,755,000 in 2021, indicating an improvement in financial performance[98]. - The company reported a loss before tax of RMB 2,170.5 million for 2022, an improvement from a loss of RMB 2,641.7 million in 2021[46]. - The gross profit for 2022 was RMB 3,625.4 million, compared to RMB 3,764.4 million in 2021, reflecting a decrease of approximately 3.7%[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 2022, up from RMB 4,001.1 million in 2021, indicating a growth of about 3.5%[48]. - Licensing fee income increased significantly to RMB 417.1 million in 2022 from RMB 268.7 million in 2021, reflecting a growth of approximately 55.3%[48]. - The total revenue from licensing fees increased significantly to RMB 20,304,000 in 2022 from RMB 8,863,000 in 2021, marking an increase of approximately 129.5%[90]. Research and Development - Research and development expenses increased to RMB 2,664.7 million, up RMB 546.0 million from RMB 2,118.7 million in the previous year, reflecting ongoing investment in clinical trials and pipeline development[3]. - Research and development expenses rose from RMB 2,322.5 million in 2021 to RMB 2,871.2 million in 2022, an increase of 23.6%[52]. - The company has established a strong pipeline with over 30 innovative drug candidates, including more than 20 oncology and 10 non-oncology products[19]. - The company is focusing on chronic disease areas such as cardiovascular and metabolic diseases, with several high-potential products advancing towards clinical trials[20]. Product Development and Approvals - New drug approvals included the launch of 希冉擇® (Remosiruab) for advanced gastric cancer and liver cancer, and 睿妥® (Sepantritinib) for specific types of lung and thyroid cancers[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 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 Eli Lilly in the oncology field, enhancing its international strategic cooperation model[23]. Operational Efficiency - 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 sales expense ratio for 2022 was 62.6%, down from 65.5% in 2021, with a notable decrease to 56.9% in the second half of 2022 compared to 68.5% in the first half[18]. - The company aims to focus on fine management to expand product scale and enhance operational efficiency while developing innovative drugs[16]. Financial Health 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, compared to RMB 11,550.8 million in 2021, a slight decrease of 0.4%[59]. - The company had unused long-term bank loan financing of approximately RMB 2,291.2 million as of December 31, 2022[61]. - The company’s cash and cash equivalents stood at RMB 9,162.8 million as of December 31, 2022, compared to RMB 8,377.1 million in 2021[83]. Corporate Governance - The group has adhered to the corporate governance code and has not separated the roles of the chairman and CEO, believing it enhances decision-making efficiency[71]. - The company established an audit committee consisting of four independent non-executive directors, with the chair being Ms. Xu Yiyin[74]. - The board of directors includes a diverse group of members, ensuring a range of perspectives in decision-making[103].
信达生物(01801) - 2022 - 年度业绩