Revenue Growth - Total revenue for the first half of 2022 increased by 28% to $202 million, driven by the commercialization of three self-developed oncology drugs[10]. - Oncology/immunology business revenue grew by 113% to $91.1 million compared to $42.9 million in the first half of 2021[10]. - The sales of ELUNATE® (fruquintinib) in the first half of 2022 reached $50.4 million, a 26% increase from $40.1 million in the same period last year[10]. - Sales of SULANDA® (surufatinib) amounted to $13.6 million in the first half of 2022, up from $8 million in the first half of 2021[10]. - ORPATHYS® (savolitinib) generated sales of $23.3 million in the first half of 2022, marking its first revenue since its launch in late 2021[10]. - The combined revenue from tumor/immunology business was $9,110 million, reflecting a 113% increase from $4,290 million year-over-year[11]. - The sales of Aiyoute® reached $5,040 million, up 26% from $4,010 million in the first half of 2021[11]. - The sales of Sutai Da® increased by 69% to $1,360 million from $800 million in the same period last year[11]. - Revenue from the oncology/immunology business for marketed products was $63.517 million, up from $37.795 million in 2021, representing a 68.2% increase[31]. Clinical Trials and Research Development - The company is advancing multiple key early-stage studies and ongoing late-stage clinical trials, including the SAVANNAH study, which is expected to report encouraging data in August[8]. - The company initiated the SAFFRON global Phase III study for the combination therapy of Saiwo Tini and Tagrisso®[15]. - The FRESCO-2 global Phase III study is set to announce top-line results after reaching the predefined number of OS events, involving 691 patients across 14 countries[16]. - The company plans to submit the marketing application for Aiyoute® to the FDA, EMA, and PMDA in the second half of 2022[16]. - The company has advanced 13 oncology candidates into clinical trials in China, with seven also undergoing clinical development in the US and Europe[34]. - The ongoing global phase III SAFFRON study is currently recruiting patients, focusing on the efficacy of Savolitinib in combination with other therapies[41]. - The company has initiated a Phase I clinical trial for HMPL-760 in China for advanced hematological malignancies[18]. - The company has started a Phase I clinical trial for HMPL-295 in China for advanced solid tumors[18]. - The company has launched a Phase I clinical trial for HMPL-653 in China for advanced malignant solid tumors and tenosynovial giant cell tumors[18]. Financial Performance - The net loss attributable to the company for the first half of 2022 was $162.9 million, compared to a net loss of $102.4 million for the same period in 2021[28]. - The company reported a net cash outflow from operating activities of $110.9 million for the first half of 2022, compared to a cash outflow of $63.1 million in the first half of 2021[27]. - The company reported a 3% decrease in comprehensive income from other businesses to $110.9 million in the first half of 2022, compared to $114.5 million in the same period of 2021[22]. - The company reported a total comprehensive loss of $(167,047) thousand for the six months ended June 30, 2022, compared to $(98,256) thousand in 2021, an increase of 69.9%[169]. - The net cash used in operating activities was $(89.9) million for the six months ended June 30, 2022, compared to $(71.3) million in the same period of 2021[101]. - The company reported a net loss of approximately $5,000 for other joint ventures in the first half of 2022, compared to a net profit of $79,000 in the same period of 2021[189]. Regulatory Approvals and Milestones - The company received approval for Aiyoute® and Sutai Da® in Macau, marking a significant regulatory milestone[12]. - The FDA requested a new international multi-center clinical trial for Sovantib, indicating the need for more representative data for the U.S. patient population[13]. - The company received fast track designation from the FDA for fuquintinib, indicating potential expedited review for market approval[61]. - The company plans to conduct a Phase II clinical trial for severe COVID-19 patients, targeting approximately 80 patients to assess the treatment's effectiveness[76]. Market Expansion and Strategic Initiatives - The company expanded its commercial team in China to approximately 820 employees, covering about 3,000 oncology hospitals and 30,000 oncologists[10]. - The company remains optimistic about future growth opportunities, particularly with the expected revenue increase from ORPATHYS®, SULANDA®, and ELUNATE® in the Chinese market[9]. - The company is constructing a new flagship production facility in Shanghai, aiming to increase production capacity for innovative drug products by over five times, with equipment installation planned for completion by the end of 2022[21]. - The company is exploring the potential for accelerated approval in the U.S. based on the results from the SAVANNAH study[42]. Corporate Governance and Sustainability - The company has established a sustainability committee at the board level to support its sustainability initiatives and has published its second sustainability report in May 2022[124]. - The company emphasizes the importance of high-quality human resources to maintain market leadership and offers competitive salaries and benefits[123]. - The company has complied with all provisions of the Corporate Governance Code as set out in Appendix 14 of the Hong Kong Listing Rules for the six months ended June 30, 2022[126]. - The company is committed to continuous improvement of governance standards and practices across its operations[161].
和黄医药(00013) - 2022 - 中期财报