HUTCHMED(US:HCM)2024-02-27 16:00Financial Performance - Total revenue increased by 97% (102% at CER) to $838 million for 2023, with net income of $101 million[7]. - Revenue for the year ended December 31, 2023, was $838.0 million, compared to $426.4 million in 2022, representing a significant increase[22]. - Total revenue for 2023 reached $837,999,000, a significant increase of 96.5% compared to $426,409,000 in 2022[180]. - Net income attributable to HUTCHMED for 2023 was $100.8 million, compared to a net loss of $360.8 million in 2022, resulting in earnings of $0.12 per ordinary share[25]. - The company reported a total comprehensive income of $94,502,000 for 2023, compared to a comprehensive loss of $368,855,000 in 2022[182]. - The company achieved a basic earnings per share of $0.12 in 2023, recovering from a loss of $0.43 in 2022[180]. Oncology/Immunology Revenue - Oncology/Immunology consolidated revenue rose by 223% (228% at CER) to $528.6 million, driven by a $280 million upfront payment from Takeda[4]. - Oncology/Immunology consolidated revenue increased 223% to $528.6 million, driven by strong sales of ELUNATE, FRUZAQLA™, and SULANDA[23]. - The company expects full year 2024 Oncology/Immunology consolidated revenue to be between $300 million and $400 million, driven by a growth target of 30% to 50% in oncology marketed product revenue[29]. - In-market sales for ELUNATE (fruquintinib in China) increased by 15% (22% at CER) to $107.5 million[7]. - In-market sales of HUTCHMED's oncology products grew by 28% to $213.6 million in 2023, compared to $167.1 million in 2022[40]. Research and Development - Fruquintinib received U.S. FDA approval for third-line colorectal cancer (CRC) in November 2023, leading to U.S. in-market sales of $15.1 million[2]. - Fruquintinib NDA for second-line gastric cancer accepted for review in China, with expected NDA filing for endometrial cancer in early 2024[3]. - Sovleplenib NDA for primary immune thrombocytopenia (ITP) accepted in China with priority review status, supported by Phase III trial data[3]. - Savolitinib's pivotal global Phase II trial (SAVANNAH) completed enrollment, with potential NDA filing to the U.S. FDA expected by the end of 2024[3]. - The company plans to submit an NDA for savolitinib in early 2024 and complete several pivotal studies by late 2024[11][12][13]. - Tazemetostat is expected to file for NDA in late 2024 for relapsed/refractory follicular lymphoma, following successful studies[15]. Cash and Financial Position - Cash balance strengthened to $886.3 million at year-end 2023, up from $631 million in 2022, positioning the company for self-sustainability[4]. - Cash, cash equivalents, and short-term investments were $886.3 million as of December 31, 2023, up from $631.0 million in 2022[22]. - The company reported net cash generated from operating activities of $219.3 million, a significant improvement from a net cash used of $268.6 million in 2022, reflecting a net change of $487.9 million[132]. - The company reported a net cash used in investing activities of $291.1 million for 2023, compared to net cash generated of $296.6 million in 2022, indicating a net change of $587.7 million[133]. - The company had a net cash generated from financing activities of $48.7 million in 2023, a significant improvement from a net cash used of $82.8 million in 2022[134]. Cost and Expenses - Cost of revenue increased by 24% to $384.4 million, with Oncology/Immunology costs rising by 33% to $91.7 million due to increased product sales[24]. - R&D expenses reduced by 22% to $302.0 million, reflecting the completion of several large trials and a strategic focus on partnerships[24]. - Operating expenses for 2023 totaled $819.624 million, a slight decrease from $834.102 million in 2022[28]. - The Group's total staff costs for the year ended December 31, 2023, were $213.7 million, a decrease from $227.2 million in 2022[156]. Partnerships and Collaborations - Takeda partnership generated $435 million in upfront and milestone payments, enhancing the company's cash position and strategic pipeline[2]. - The company has partnered with Takeda for the development and commercialization of fruquintinib outside of China, with potential payments up to $1.13 billion, including $400 million received upon closing the agreement[76]. - HUTCHMED has received $85 million from AstraZeneca as part of a collaboration agreement for savolitinib, with potential total payments of $140 million[52]. Market and Product Developments - FRUZAQLA™ launched in the U.S. on November 8, 2023, with in-market sales reaching $15.1 million by the end of 2023, exceeding expectations for new patient starts[42]. - SULANDA's in-market sales increased by 36% to $43.9 million in 2023, compared to $32.3 million in 2022, maintaining a 21% prescription share in NET treatment[44]. - ORPATHYS sales grew by 12% to $46.1 million in 2023, with a significant increase of 104% in volume during the latter part of the year following NRDL listing[48]. - ELUNATE continues to be included in the NRDL for a new two-year term starting January 2024 at the same price as 2023[42]. Clinical Trials and Results - Savolitinib's Phase II trial for MET exon 14 skipping alterations in NSCLC showed an overall response rate (ORR) of 60.7% and a disease control rate (DCR) of 95.2%[57]. - The VIKTORY study for savolitinib in MET-driven gastric cancer reported a 50% ORR in patients with MET amplification[59]. - The SAMETA study for MET-driven PRCC is ongoing, with over 140 sites in more than 20 countries enrolling patients[62]. - The FRESCO-2 study demonstrated a statistically significant increase in overall survival (OS) and progression-free survival (PFS) in 691 patients, with a median OS of 9.3 months for fruquintinib versus 6.6 months for placebo[65]. - In the FRUTIGA study, patients receiving fruquintinib combined with paclitaxel achieved a median PFS of 5.6 months compared to 2.7 months for the control group, with a hazard ratio (HR) of 0.569 and p < 0.0001[71]. Strategic Focus and Future Plans - The company has utilized 50% of net proceeds ($292.7 million) for advancing late-stage clinical programs and expanding its product portfolio in cancer and immunological diseases[166]. - 20% of net proceeds ($117.1 million) was directed towards strengthening commercialization, clinical, regulatory, and manufacturing capabilities, as well as potential global business development and strategic acquisitions[166]. - The company plans to submit results for tazemetostat in follicular lymphoma for NDA filing in late 2024[86].