Financial Performance - Total revenue for 2023 reached $838 million, representing a 97% increase (102% at constant exchange rates) compared to the previous year[2]. - Net income for the year was $101 million, with a significant contribution from the oncology/immunology business, which saw a 223% revenue increase to $528.6 million[6]. - The company has a strong cash position, ending 2023 with $886.3 million, up from $631 million in 2022[6]. - Total revenue for 2023 increased by 97% to $838 million, driven by collaboration with Takeda and strong commercialization in China[9]. - The oncology/immunology business revenue grew by 223% to $528.6 million, benefiting from a $280 million collaboration revenue from Takeda and strong product sales growth[10]. - The company reported a net cash flow of $206.7 million for 2023, a significant improvement from a negative $297.9 million in 2022[33]. - The company’s total assets grew to $1.28 billion in 2023, up from $1.03 billion in 2022[36]. - The net income attributable to Hutchmed per ordinary share was $0.12 in 2023, compared to a loss of $0.43 per share in 2022[38]. - The company’s cash, cash equivalents, and short-term investments increased by $255 million to $886.34 million as of December 31, 2023[39]. - The company’s net expenses for 2023 were $737.2 million, a decrease from $787.2 million in 2022[33]. Product Development and Approvals - The FDA approved the drug FRUZAQLA™ (fruquintinib) for third-line colorectal cancer, leading to a market launch by Takeda with initial sales of $915.1 million[5]. - The new drug application for sovleplenib for primary immune thrombocytopenia has been accepted in China and is under priority review[6]. - The company plans to submit a new drug application for fruquintinib in second-line gastric cancer in China, with recruitment for clinical trials completed[6]. - The successful ESLIM-01 study for Syk inhibitor in immune thrombocytopenia has led to a new drug application accepted for priority review in January 2024[8]. - The company aims to submit a new drug application for savolitinib in Q1 2024, expanding its label indications in China[8]. - The new drug application for the combination therapy of fruquintinib and paclitaxel for second-line treatment of gastric cancer was accepted in April 2023[16]. - Fruquintinib received FDA approval in November 2023 for the treatment of previously treated metastatic colorectal cancer patients[16]. - The EMA submission for the treatment of previously treated metastatic colorectal cancer is expected to be completed by mid-2024[18]. - The company plans to submit a new drug application for the treatment of primary immune thrombocytopenia in mid-2024[21]. - The company has initiated a Phase II study for gastric cancer patients with MET amplification in China[17]. Strategic Collaborations and Partnerships - The company is focused on advancing its product pipeline and strategic partnerships, evidenced by a $435 million upfront and milestone payments from Takeda[5]. - The strategic collaboration with Takeda is noted as one of the largest small molecule licensing deals in China's biopharmaceutical history, enhancing the company's cash flow[7]. - Takeda is responsible for the global development, production, and commercialization of furmonertinib outside of mainland China, Hong Kong, and Macau, with potential payments to the company of up to $1.13 billion[26]. - The company received a $400 million upfront payment from Takeda in April 2023, along with potential milestone payments totaling up to $730 million[26]. Research and Development - The company has 13 oncology candidates currently in clinical trials, supported by a team of approximately 900 scientists and staff[51]. - The company continues to maintain the same pricing for 爱优特® in the national medical insurance drug list for the new two-year agreement starting January 2024[53]. - The company has initiated three Phase III studies for Savolitinib, including the SACHI and SANOVO studies launched in 2021 and the SAFFRON global pivotal study started in 2022[65]. - The company has successfully obtained FDA approval for Furmonertinib in November 2023, marking a significant milestone in its global market strategy[63]. - The company is exploring the use of furmonertinib in various solid tumors, with approximately 90 ongoing clinical trials in China[86]. Market Performance - Market sales of ELUNATE® (furmonertinib) in China increased by 15% to $107.5 million, maintaining a leading market share[10]. - FRUZAQLA™ (furmonertinib) generated $15.1 million in market sales following its U.S. launch in November 2023[10]. - Sales of SULANDA® (surufatinib) rose by 36% to $43.9 million, reflecting increased market share two years after inclusion in the national medical insurance catalog[12]. - ORPATHYS® (savolitinib) sales grew by 12% to $46.1 million, with a 30% increase in sales in the last three quarters of 2023 compared to the same period in 2022[12]. - The market sales of innovative oncology products grew by 28% to $213.6 million in 2023, compared to $167.1 million in 2022, with a fixed exchange rate growth of 35%[52]. Operational Highlights - The company aims to establish a self-sustaining business model while navigating global economic uncertainties[7]. - The company has completed patient recruitment for a Phase II study of furmonertinib in July 2023, with plans to submit a new drug application to the National Medical Products Administration by mid-2024 if results are positive[84]. - The company has received fast track designation from the FDA for savolitinib for treating pancreatic and non-pancreatic neuroendocrine tumors, although a new drug application was not approved[89]. - The company has conducted clinical trials of savolitinib in approximately 2,900 patients, with promising data from several studies presented at ASCO and ESMO conferences in 2023[88]. Sustainability and Governance - The independent 2023 sustainability report will be published alongside the 2023 annual report in April 2024, detailing the company's sustainability measures and performance[165]. - The company has complied with all applicable provisions of the Corporate Governance Code as of December 31, 2023[168]. - The company is committed to transparency and has complied with the ethical responsibilities outlined in the professional code of conduct[183].
和黄医药(00013) - 2023 - 年度业绩