Financial Performance - Total revenue for 2023 reached 838million,representinga97101 million, with a significant contribution from the oncology/immunology business, which saw a 223% revenue increase to 528.6million[6].−Thecompanyhasastrongcashposition,ending2023with886.3 million, up from 631millionin2022[6].−Totalrevenuefor2023increasedby97838 million, driven by collaboration with Takeda and strong commercialization in China[9]. - The oncology/immunology business revenue grew by 223% to 528.6million,benefitingfroma280 million collaboration revenue from Takeda and strong product sales growth[10]. - The company reported a net cash flow of 206.7millionfor2023,asignificantimprovementfromanegative297.9 million in 2022[33]. - The company’s total assets grew to 1.28billionin2023,upfrom1.03 billion in 2022[36]. - The net income attributable to Hutchmed per ordinary share was 0.12in2023,comparedtoalossof0.43 per share in 2022[38]. - The company’s cash, cash equivalents, and short-term investments increased by 255millionto886.34 million as of December 31, 2023[39]. - The company’s net expenses for 2023 were 737.2million,adecreasefrom787.2 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 915.1million[5].−ThenewdrugapplicationforsovleplenibforprimaryimmunethrombocytopeniahasbeenacceptedinChinaandisunderpriorityreview[6].−Thecompanyplanstosubmitanewdrugapplicationforfruquintinibinsecond−linegastriccancerinChina,withrecruitmentforclinicaltrialscompleted[6].−ThesuccessfulESLIM−01studyforSykinhibitorinimmunethrombocytopeniahasledtoanewdrugapplicationacceptedforpriorityreviewinJanuary2024[8].−ThecompanyaimstosubmitanewdrugapplicationforsavolitinibinQ12024,expandingitslabelindicationsinChina[8].−Thenewdrugapplicationforthecombinationtherapyoffruquintinibandpaclitaxelforsecond−linetreatmentofgastriccancerwasacceptedinApril2023[16].−FruquintinibreceivedFDAapprovalinNovember2023forthetreatmentofpreviouslytreatedmetastaticcolorectalcancerpatients[16].−TheEMAsubmissionforthetreatmentofpreviouslytreatedmetastaticcolorectalcancerisexpectedtobecompletedbymid−2024[18].−Thecompanyplanstosubmitanewdrugapplicationforthetreatmentofprimaryimmunethrombocytopeniainmid−2024[21].−ThecompanyhasinitiatedaPhaseIIstudyforgastriccancerpatientswithMETamplificationinChina[17].StrategicCollaborationsandPartnerships−Thecompanyisfocusedonadvancingitsproductpipelineandstrategicpartnerships,evidencedbya435 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 1.13billion[26].−Thecompanyreceiveda400 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 107.5million,maintainingaleadingmarketshare[10].−FRUZAQLA™(furmonertinib)generated15.1 million in market sales following its U.S. launch in November 2023[10]. - Sales of SULANDA® (surufatinib) rose by 36% to 43.9million,reflectingincreasedmarketsharetwoyearsafterinclusioninthenationalmedicalinsurancecatalog[12].−ORPATHYSR◯(savolitinib)salesgrewby1246.1 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 213.6millionin2023,comparedto167.1 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].
