Financial Performance - Total revenue for 2022 increased by 20% to $426.4 million, driven by the commercialization of three self-developed oncology drugs in China[14]. - Other business revenue grew by 11% to $262.6 million in 2022, with Shanghai Hengrui's non-consolidated joint venture revenue also increasing by 11% to $370.6 million[27]. - The company reported a net loss attributable to the company of $360.8 million in 2022, compared to a net loss of $194.6 million in 2021, resulting in a loss per share of $0.43[36]. - The company’s total revenue for the tumor/immunology business was $296.6 million in 2022, compared to $(306.3) million in 2021[106]. - The revenue from prescription drugs was $237.3 million in 2022, a 16% increase from $204.1 million in 2021[107]. - The company’s revenue from Shanghai Huanong Pharmaceutical was $370.6 million in 2022, an 11% increase from $332.6 million in 2021[107]. Oncology/Immunology Business - Revenue from oncology/immunology business grew by 37% (41% at constant exchange rates), aligning with financial guidance[7]. - Oncology/immunology business revenue grew by 37% to $163.8 million, with significant contributions from key products[15]. - Fruquintinib (爱优特) sales increased by 32% to $93.5 million, reflecting a growing market share, especially in second and third-tier cities[14]. - Surufatinib (苏泰达) sales surged by 178% to $32.3 million, benefiting from its inclusion in the national medical insurance catalog[14]. - Savolitinib (沃瑞沙) sales rose by 159% to $41.2 million, recognized as China's first selective MET inhibitor[14]. Clinical Trials and Drug Development - The FRESCO-2 Phase III international study for fruquintinib in treating refractory metastatic colorectal cancer achieved its primary endpoint, with rolling submission for new drug application to the US FDA initiated[7]. - Over 15 registration/registration intention studies involving six products are currently ongoing[7]. - The FRUTIGA Phase III study for fruquintinib in gastric cancer reached the PFS endpoint, with supplementary application for new indication underway[7]. - The company has advanced 13 oncology candidate drugs into clinical trials in China, with four also undergoing clinical development in the US and Europe[40]. - The company is developing six early-stage oncology candidates, including HMPL-306, a selective oral IDH1/2 dual inhibitor, and HMPL-760, a third-generation oral BTK inhibitor[23]. Strategic Partnerships and Collaborations - The company successfully entered into a licensing agreement with Takeda Pharmaceuticals, marking a significant strategic step[8]. - The collaboration with Takeda Pharmaceuticals for furmonertinib includes a potential total of up to $1.13 billion, with an initial payment of $400 million and up to $730 million in milestone payments[25]. - The company has established a partnership with Eli Lilly for the marketing and promotion of Aiyoute in China, receiving 70-80% of the production revenue, service fees, and royalties from sales[41]. Research and Development - R&D expenses increased to $386.9 million in 2022 from $299.1 million in 2021, primarily due to the expansion of innovative oncology drug development[35]. - The company plans to continue early development projects for candidates with global differentiation advantages, including sovleplenib, in the US, Europe, and Japan[11]. - The company is investing $50 million in R&D for new technologies and product development in the upcoming year[144]. Market Expansion and Future Outlook - A new strategic focus was announced in November to accelerate the establishment of a sustainable and profitable business[10]. - Future outlook includes a projected revenue growth of 15% for the next fiscal year, driven by new product launches and market expansion strategies[144]. - Plans for market expansion include entering three new international markets by the end of 2024, targeting a 20% increase in market share[144]. Financial Position and Cash Flow - As of December 31, 2022, cash and cash equivalents totaled $631 million, down from $1.011 billion in 2021[34]. - The company reported a net cash outflow from financing activities of $82.8 million in 2022, compared to a net cash inflow of $650 million in 2021[34]. - The total assets decreased to $1.029 billion as of December 31, 2022, from $1.373 billion in 2021[37]. Corporate Governance and Management - The company has seen changes in its board composition, with several directors transitioning to new roles or resigning from previous positions[155]. - The company’s board members have extensive experience in the pharmaceutical and financial sectors, enhancing its governance and strategic direction[154][156]. - The company emphasizes the importance of high-quality human resources to maintain market leadership and offers competitive salaries and benefits[1]. Sustainability and Social Responsibility - The company has established a comprehensive sustainability governance framework and set 11 sustainability goals and indicators[29]. - The board has approved a new sustainability strategy aimed at reducing carbon emissions by 40% by 2030[144]. - The group donated approximately $2.7 million to charitable organizations in the year ended December 31, 2022, compared to about $1.89 million in 2021, representing an increase of approximately 42%[176].
和黄医药(00013) - 2022 - 年度财报