Financial Performance - Total revenue for the year ended December 31, 2021, was RMB 4,260.9 million, an increase of 74.1% compared to RMB 2,446.7 million for the year ended December 31, 2020[11]. - Product revenue reached RMB 4,001.1 million, growing 69.0% from RMB 2,367.5 million in the previous year, driven by strong sales of the leading PD-1 product, Sintilimab[11]. - The company reported a loss of RMB 3,138.1 million for the year ended December 31, 2021, an increase of 214.3% compared to a loss of RMB 998.4 million for the year ended December 31, 2020, primarily due to ongoing R&D investments and increased share-based compensation expenses[13]. - Revenue from customer contracts for the year ended December 31, 2021, was RMB 4,269.7 million, an increase from RMB 3,843.8 million in 2020, representing a growth of approximately 11.1%[43]. - Gross profit for the year ended December 31, 2021, was RMB 3,696.7 million, up from RMB 3,456.1 million in 2020, indicating a growth of 7.0%[43]. - The company reported a loss before tax of RMB 3,051.0 million for the year ended December 31, 2021, compared to a loss of RMB 858.7 million in 2020, representing a significant increase in losses[43]. Product Development and Pipeline - The company has established a competitive product pipeline consisting of 32 clinical-stage products, including 7 approved products, 1 product under NMPA review, 5 in Phase III or pivotal studies, and 19 in Phase I or II clinical stages[8]. - The company has 29 innovative high-value pipelines, including six commercialized products and 23 in various clinical stages, with plans to submit at least three NDAs in 2022[15]. - The company plans to launch at least 10 commercialized products in the next two years and aims for at least 15 by 2025[9]. - The company has successfully advanced seven new drugs into the CMC stage in 2021, with plans to enter first-in-human clinical trials starting in 2022[23]. - The company aims to submit New Drug Applications (NDA) for at least three new products in 2022, including IBI-310 (CTLA-4), IBI-306 (PCSK-9), and IBI-326 (BCMA CAR-T)[22]. Research and Development - R&D expenses rose to RMB 2,116.0 million, an increase of RMB 398.2 million from RMB 1,717.8 million in the previous year, focusing on late-stage clinical trials and new drug development[11]. - The company has over 80 projects in the preclinical drug discovery phase, providing a diverse foundation for long-term sustainable growth in the market[21]. - The company has received FDA approval for IND for eight molecules, with several global products expected to report more data in 2022, including IBI-188 (CD47) and IBI-110 (LAG-3)[23]. - The company is focusing on developing new therapies for autoimmune diseases and metabolic disorders, showcasing a diverse therapeutic portfolio[25]. Strategic Collaborations - The company has formed strategic collaborations with international partners such as Eli Lilly, Adimab, Incyte, and MD Anderson Cancer Center to enhance its development capabilities[3]. - The company deepened its strategic collaboration with Eli Lilly in March 2022, gaining exclusive commercialization rights for certain oncology products in mainland China[19]. - The company has established a strategic collaboration with Eli Lilly to deepen cooperation in the oncology field, gaining exclusive commercialization rights for several products in mainland China[30]. Market Expansion and Sales - The commercialization team has over 2,700 experienced marketing and sales professionals, covering approximately 5,100 hospitals and 1,100 pharmacies across more than 320 cities as of December 31, 2021[27]. - The company is expanding its market presence in China, Hong Kong, Macau, and Taiwan, which are key regions for commercialization[25]. - The company anticipates receiving regulatory decisions from NMPA in 2022 for three sNDAs related to DABOSHU (sintilimab injection) for 1L ESCC, 1L GC, and EGFR-mutated non-squamous NSCLC post-EGFR-TKI treatment[28]. Financial Position and Cash Flow - The company maintains a solid financial position with approximately RMB 14 billion in cash, positioning itself favorably amid market fluctuations[10]. - As of December 31, 2021, the company's cash and short-term financial assets amounted to approximately $1,415.1 million, ensuring a solid financial position for strategic focus[13]. - The company raised approximately HKD 4.7 billion through a share placement in January 2021, enhancing its financial stability[13]. - The company’s cash and cash equivalents increased from RMB 8,121.1 million as of December 31, 2020, to RMB 9,021.9 million as of December 31, 2021, primarily due to the issuance of new shares raising approximately RMB 3,893.3 million[55]. Corporate Governance and Compliance - The company has established an audit committee, remuneration committee, nomination committee, and strategic committee to oversee various aspects of its operations[120]. - The board believes it has appropriately maintained a balance of diversity among its members without setting measurable targets[123]. - The company is committed to high levels of corporate governance and compliance with applicable laws and regulations[129]. - The company has implemented appropriate insurance for directors and senior personnel to cover legal liabilities arising from business operations[120]. Social Responsibility and Employee Welfare - The company is committed to fulfilling social responsibilities and enhancing employee welfare, aiming for sustainable growth[62]. - The group made charitable donations of approximately RMB 204.6 million for the year ended December 31, 2021, compared to RMB 72.9 million in 2020, representing an increase of 180%[67]. - The total number of employees increased to 5,568 as of December 31, 2021, up from 3,279 in 2020[63].
信达生物(01801) - 2021 - 年度财报