HUTCHMED Reports 2024 Full Year Results and Provides Business Updates

65% oncology products revenue growth drove profitable operation and supported new ATTC platform

Hong Kong, Shanghai & Florham Park, NJ - Wednesday, March 19, 2025: HUTCHMED (China) Limited ("HUTCHMED", the "Company" or "we") (HKEX: 13; Nasdaq/AIM: HCM) today reports its financial results for the year ended December 31, 2024 and provides updates on key clinical and commercial developments.

HUTCHMED to host results webcasts today at 8:00 a.m. EDT / 12:00 noon GMT / 8:00 p.m. HKT in English on Wednesday, March 19, 2025, and tomorrow at 8:30 a.m. HKT in Chinese (Putonghua) on Thursday, March 20, 2025. After registration, investors may access the live webcast via HUTCHMED's website at www.hutch-med.com/event.

All amounts are expressed in US dollars unless otherwise stated.

Global commercial progress and delivery of sustainable growth

·      FRUZAQLA^® (fruquintinib) ex-China in-market sales¹ of $290.6 million in 2024 by Takeda, sustaining momentum in its first full year driven by rapid US patient uptake, and EU and Japan launches, triggering a sales milestone from Takeda². Total oncology products in-market sales up 134% to $501.0 million.

·      Consolidated revenue from oncology products of $271.5 million, up 65%.

·      Net income of $37.7 million was achieved in 2024, with a cash balance of $836.1 million as of December 31, 2024, achieving financial self-reliance ahead of schedule.

·      Agreed partial disposal of equity in SHPL³ joint venture for $608 million.

Pipeline progress and new technology platform

·      Primary endpoint met in SACHI China Phase III interim analysis for savolitinib for EGFRm⁴ NSCLC⁵ with MET amplification, followed by swift NDA⁶ filing, acceptance and priority review granted by the NMPA⁷.

·      Positive SAVANNAH global pivotal Phase II results for savolitinib in combination with TAGRISSO^® for EGFRm NSCLC patients that progressed on TAGRISSO^® treatment with MET overexpression or amplification, achieving high, clinically meaningful and durable response rate and shared with global regulatory authorities by AstraZeneca⁸.

·      Positive FRUSICA-2 China Phase III results for fruquintinib with sintilimab in 2L⁹ RCC¹⁰.

·      Presented ESLIM-01 China Phase III data at ASH¹¹ and EHA¹², highlighting strong, sustained, and long-term durable response rates of sovleplenib for ITP¹³ patients, with the NDA under review by the NMPA. Additional data were requested by CDE¹⁴ and subsequently submitted by HUTCHMED. Review of the supplementary data is currently under review by CDE.

·      FRUSICA-1 Phase II results presented at ASCO¹⁵, leading to NMPA approval of a second indication of ELUNATE^®(fruquintinib) for EMC¹⁶ with pMMR¹⁷ status.

·      First candidates from new ATTC¹⁸ platform, starting development of a new wave of drug candidates potentially more selective and tolerable than previous generations of antibody drug conjugates.  

Dr Dan Eldar, Non-executive Chairman of HUTCHMED, said, "The successful commercialization of FRUZAQLA^® outside of China by our partner Takeda and the resulting milestones achieved during the year were pivotal in helping HUTCHMED reach its profitability goals. I am proud that, at times of uncertainty in the global environment and in the capital markets, we have successfully established an independent ability to support our valuable discovery engine and development pipeline while mitigating operational risks. We expect to continue our global growth with further sales in the US and in other regions of the world, while continuing to develop our pipeline in new and promising directions. The long-term interests of our shareholders and benefits to patients around the world will always remain our top priorities."

"At the end of 2024, we decided to dispose of our 45% equity interest in SHPL for $608 million, subject to closing conditions. I would like to take this opportunity to express my appreciation to the management team at SHPL for their contribution to its impressive growth over the last 20 years, which has delivered consistent benefits to consumers and shareholders alike. The commercial success and monetary contribution were important in supporting HUTCHMED's novel drug R&D¹⁹, helping us to weather challenges in our industry as we developed innovative medicines for patients in need. As our innovative drugs business has become more self-reliant, we believe it is time for HUTCHMED to move on to our next phase of evolution, particularly as we focus on global clinical development of our ATTCs. The proceeds from the SHPL disposal, on top of the ongoing profits of our globally commercialized portfolio, enables us to expedite the roll-out of this differentiated platform, which will be key to our long-term value creation."

Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, said, "We've had a highly successful year, delivering against our strategy, in the clinic and commercially with our transformational medicines. This has culminated in HUTCHMED reaching profitability, which has been a key focus of ours. I'd like to thank and congratulate the team for this milestone, as we turn our attention to further growth and cultivating HUTCHMED's next wave of medicines through our ATTC platform."

"Our pioneering ATTC platform turns a new page in HUTCHMED's innovative drug development story, establishing a new frontier in antibody-drug conjugates. This new portfolio of molecules is well placed to target a wide range of oncology indications with sizable market potential, including in first-line combinations. With the expertise and the financial strength to execute global clinical trials, we plan to move expeditiously into clinical development this year."

"Our commercial medicines hit new milestones and expanded clinical development, reaching more patients in need around the world. Fruquintinib is now treating colorectal cancer patients in over a dozen countries, with more to come. FRUZAQLA^® in-market sales exceeded $200 million within a year of launch, triggering the first sales milestone. In China, it was approved in second-line endometrial cancer, with average duration of treatment almost double that of fruquintinib's first indication, and a third registrational study FRUSICA-2 has read out positively in kidney cancer."

"For savolitinib, positive data from SACHI interim analysis in patients progressed on first line EGFR²⁰ TKI²¹ treatment with MET amplification led us to file a NDA in China, which was accepted and granted priority review. We are hopeful that SAVANNAH/SAFFRON trials will support bringing this innovative medicine to patients globally. With recent full approval in both first-line and second-line MET exon 14 skipping alteration lung cancer, savolitinib remains one of the best-in-class medicines. A registration-intent study in MET-amplified gastric cancer is currently enrolling in China. We look forward to potentially expanding its indication as the first medicine for MET amplified EGFRm NSCLC and gastric cancer. Our marketed medicines will continue to support the revenue and earnings growth of HUTCHMED."

"ESLIM-01 data for sovleplenib was presented at EHA and ASH, with durable response rate of 51.4% and overall response rate of 81.0%, significantly better than many different modalities of ITP medicines under development. These clinical results of sovleplenib again illustrate HUTCHMED's R&D competency in selectivity, resulting in desirable efficacy and safety. We are working closely with the NMPA and look forward to bringing this innovative medicine to patients in need. ESLIM-02 registration Phase III in warm AIHA²² patients is enrolling and on-track to read out next year. A NDA is under review in China for tazemetostat for recurrent/refractory follicular lymphoma and approval is expected by mid-2025. We look forward to being able to add sovleplenib and tazemetostat to our commercial portfolio and their contributions to HUTCHMED's continued growth."

2024 Full Year Results & Business Updates

I. COMMERCIAL OPERATIONS

Oncology product in-market sales were up 134% (136% at CER²³) to $501.0 million in 2024 (2023: $213.6m), leading to strong growth in oncology product consolidated revenue of 65% (67% at CER) to $271.5 million (2023: $164.2m).

·      FRUZAQLA^® (fruquintinib ex-China) in-market sales were $290.6 million in 2024 (2023: $15.1m) by Takeda, with strong performance reflecting rapid US patient uptake, as well as launches in over a dozen countries. Reaching $200.0 million sales triggered a $20 million milestone payment from Takeda.

·      ELUNATE^® (fruquintinib China) in-market sales increased 7% (9% at CER) to $115.0 million in 2024 (2023: $107.5m), maintaining its leading market share position in metastatic CRC²⁴ and demonstrating resilience against rising pressure from competing products and their generics. New indication for EMC was approved in December 2024.

·      SULANDA^® (surufatinib) in-market sales increased 12% (14% at CER) to $49.0 million in 2024 (2023: $43.9m), as increasing brand awareness amongst doctors and improving NET²⁵ diagnosis drives prescription growth and market share to 27% in 2024 (2023: 21%).

·      ORPATHYS^® (savolitinib) in-market sales approximated prior year (-2%, flat at CER) to $45.5 million in 2024 (2023: $46.1m), impacted by the launch and NRDL²⁶ inclusion of several competing same-class MET TKIs for 2L METex14²⁷ NSCLC. Results do not reflect full approval in 1L²⁸ setting received in January 2025.

Total Oncology/Immunology consolidated revenue was $363.4 million in 2024 (2023: $528.6m), within guidance of $300 million to $400 million.

·      Oncology product consolidated revenue (royalties, manufacturing revenue, promotion and marketing services revenue and commercial milestone) increased 65% (67% at CER) to $271.5 million (2023: $164.2m), driven by FRUZAQLA^® and exceeding guidance of 30% to 50% growth.

·      Takeda upfront, regulatory milestones and R&D services revenue were $67.0 million (2023: $345.9m), which included recognition of $48.1 million of the $450.0 million upfront and regulatory milestone payments achieved. This compared to recognition of $312.0 million in 2023.

·      Other revenue was $24.9 million (2023: $18.5m), including milestone payment of $6.0 million from AstraZeneca following NDA acceptance in China for ORPATHYS^® combined with TAGRISSO^®.

$630.2 million total consolidated revenue (2023: $838.0m) including Other Ventures of $266.8 million (2023: $309.4m).

* = FRUZAQLA^®, ELUNATE^® and ORPATHYS^® mainly represent total sales to third parties as provided by Takeda, Lilly²⁹ and AstraZeneca, respectively.

** = FRUZAQLA^® represents manufacturing revenue, royalties and commercial milestone paid by Takeda; ELUNATE^® represents manufacturing revenue, promotion and marketing services revenue and royalties paid by Lilly to HUTCHMED, and sales to other third parties invoiced by HUTCHMED; ORPATHYS^® represents manufacturing revenue and royalties paid by AstraZeneca and sales to other third parties invoiced by HUTCHMED; SULANDA^® and TAZVERIK^® represent the Company's sales of the products to third parties.

II. REGULATORY UPDATES

China

·      Savolitinib NDA accepted by the NMPA with Priority Review status and Breakthrough Therapy designation for 2L EGFRm NSCLC patients with MET amplification, in combination with TAGRISSO^® (osimertinib), in December 2024, triggering a milestone from AstraZeneca.

·      Savolitinib sNDA³⁰ approved by the NMPA for 1L and 2L (converted from conditional to full approval) METex14 NSCLC in January 2025.

·      Fruquintinib sNDA approved by the NMPA, in combination with TYVYT^® (sintilimab), for 2L EMC patients with pMMR status in December 2024.

·      Fruquintinib approved in Hong Kong for 3L³¹ CRC under the new 1+ Mechanism in January 2024, and subsequently the first innovative oncology medicine enlisted with Full Subsidy under the Special Drug category in October 2024.

·      Tazemetostat approved in Hong Kong for 3L R/R³² EZH2m³³ follicular lymphoma in May 2024.

·      Savolitinib approved in Hong Kong for METex14 NSCLC under the 1+ Mechanism in February 2025.

·      Tazemetostat NDA accepted by the NMPA with Priority Review status for 3L R/R follicular lymphoma in July 2024.

·      Fruquintinib sNDA voluntarily withdrawn for 2L gastric cancer, in combination with paclitaxel, in August 2024, in light of discussions with the NMPA and internal review of current data package.

Ex-China

·      Fruquintinib approved in the EU for CRC in June 2024, followed by first European reimbursement in Spain in December 2024, triggering a $10.0 million milestone from Takeda.

·      Fruquintinib approved in Japan for CRC in September 2024, followed by pricing approval and launch in November 2024, triggering a milestone from Takeda.

·      Fruquintinib approved in Argentina and Switzerland in August 2024, in Canada (also with reimbursement) and the United Kingdom in September 2024, in Australia and Singapore in October 2024, in Israel and the United Arab Emirates in December 2024, and in South Korea in March 2025.

III. LATE-STAGE CLINICAL DEVELOPMENT ACTIVITIES

Savolitinib (ORPATHYS^® in China), a highly selective oral inhibitor of MET

·      Positive SAVANNAH global pivotal Phase II top-line results for 2L EGFRm NSCLC patients with MET amplification or overexpression, in combination with TAGRISSO^® (osimertinib), achieving high, clinically meaningful and durable response rate (NCT03778229).

·      Primary endpoint met in SACHI China Phase III interim analysis for 2L EGFRm NSCLC patients with MET amplification (NCT05015608).

·      Presented Phase II small randomized controlled study results at AACR³⁴ for 2L EGFRm NSCLC patients with high MET amplification, in combination with TAGRISSO^® (osimertinib), showing ORR³⁵ of 63% and median PFS³⁶ of 8.2 months (NCT04606771).

·      Continued enrolling SAFFRON global Phase III study for 2L EGFRm NSCLC patients with MET amplification or overexpression (NCT05261399) supporting SAVANNAH; and SANOVO China Phase III study for 1L EGFRm NSCLC patients with MET overexpression (NCT05009836).

Potential upcoming clinical and regulatory milestones for savolitinib:

·      Presentation of SAVANNAH and SACHI data at upcoming scientific conferences.

·      Complete SACHI NMPA NDA review in late 2025.

·      Complete SAFFRON enrollment in the second half of 2025.

·      Complete enrollment and potential NDA submission for gastric cancer with MET amplification in the second half of 2025.

Fruquintinib (ELUNATE^® in China, FRUZAQLA^® outside of China), a highly selective oral inhibitor of VEGFR³⁷

·      Presented FRUSICA-1 China pivotal Phase II results at ASCO, in combination with TYVYT^® (sintilimab), for previously treated EMC with pMMR status, showing IRC³⁸-assessed confirmed ORR of 35.6%, median PFS of 9.5 months and median OS³⁹ of 21.3 months with a manageable safety profile (NCT03903705). This indication was approved by the NMPA in December 2024.

·      Presented FRESCO-2 subgroup analyses for CRC patients at ASCO, biomarker analysis at AACR and quality-of-life analysis at ASCO GI⁴⁰, showing meaningful quality-adjusted survival benefit, efficacy regardless of prior therapy or sequence as well as CEA⁴¹ potentially a predictor of efficacy (NCT04322539).

·      Published FRUTIGA China Phase III results in Nature Medicine for 2L gastric cancer, in combination with paclitaxel, and presentations at ASCO, showing statistically significant improvements in ORR and PFS, as well as OS benefits in sub-group without taking subsequent antitumor therapy (NCT03223376).

·      Positive result of FRUSICA-2 China Phase III in 2L RCC in March 2025 (NCT05522231).

Sovleplenib (HMPL-523), an investigative and highly selective oral inhibitor of Syk⁴²

·      Published ESLIM-01 China Phase III results for adult patients with primary ITP in China in The Lancet Haematology concurrently with presentations at EHA, showing durable response rate of 48.4%, tolerable safety profile and improved quality of life regardless of prior lines of therapies (NCT05029635).

·      Presented ESLIM-01 China Phase III long-term results at ASH, showing durable response rate of 51.4% and long-term durable response rate of 59.8% as well as consistent safety profile.

·      Published China Phase II results in warm AIHA in China at EHA and in The Lancet Haematology in 2025, demonstrating overall response rate of 66.7% and a favorable safety profile (NCT05535933).

·      Initiated ESLIM-02 China Phase III stage in warm AIHA (NCT05535933).

Potential upcoming clinical milestones for sovleplenib:

·      Complete ESLIM-01 NMPA NDA review around end 2025 (NCT05029635).

·      Complete enrollment of ESLIM-02 Phase III in the second half of 2025 (NCT05535933).

Surufatinib (SULANDA^® in China), an oral inhibitor of VEGFR, FGFR⁴³ and CSF-1R⁴⁴

·      Completed enrollment of Phase II part of a China Phase II/III trial for 1L metastatic PDAC⁴⁵ patients, in combination with AiRuiKa^® (camrelizumab), nab-paclitaxel and gemcitabine (NCT06361888). This study was informed in part by an investigator-initiated trial presented at ASCO GI 2024 of a similar combination.

Potential upcoming clinical milestone for surufatinib:

·      Data readout of the PDAC Phase II trial in late 2025.

Tazemetostat (TAZVERIK^® in Hainan, Macau and Hong Kong), a first-in-class, oral inhibitor of EZH2

·      Positive bridging study in 3L follicular lymphoma leading to NDA submission with Priority Review status (NCT05467943).

·      Continued enrolling SYMPHONY-1 Phase III China portion of the global study, in combination with lenalidomide and rituximab, in follicular lymphoma patients (NCT04224493).

Potential upcoming clinical milestone for tazemetostat:

·      Complete NDA review in China in mid 2025.

Fanregratinib (HMPL-453), a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3

·      Completed enrollment of registrational China pivotal Phase II for IHCC⁴⁶ with FGFR2 fusion / rearrangement in March 2025 (NCT04353375).

Ranosidenib (HMPL-306), an investigative and highly selective oral dual-inhibitor of IDH1 and IDH2⁴⁷ enzymes

·      Presented and published results from China and US/European Phase I studies at EHA and the journal Med for R/R IDH1/2m⁴⁸ AML⁴⁹ patients (NCT04272957, NCT04764474).

·      Initiated RAPHAEL China Phase III trial for 2L R/R IDH1/2m AML (NCT06387069).

Other early-stage investigational drug candidates

·      Presented pre-clinical and Phase I results at AACR, ASCO and EHA for ERK1/2⁵⁰ inhibitor HMPL-295, third-generation BTK⁵¹ inhibitor HMPL-760, Menin inhibitor HMPL-506, and anti-CD38 HMPL-A067.

·      Initiated Phase I trial for HMPL-506 in hematological malignancies in China (NCT06387082).

IV. ANTIBODY-TARGETED THERAPY CONJUGATE (ATTC) PLATFORM

New in-house created platform with multiple potential IND⁵² candidates

Our ATTC next-generation technology platform leverages over 20 years of expertise in targeted therapies with small molecules inhibitors. ATTC drug candidates enrich the next wave of clinical development with potential key advantages over traditional antibody-drug conjugates and/or small molecule medicines:

·      Better efficacy through synergistic antibody-small molecule targeted therapy combinations that will target specific mutations; overcome drug resistance and potentially support combinations with other targeted therapies, chemotherapy and immunotherapy, in early-line patient settings.

·      Improved safety and prolonged treatment given lower off-tumor or off-target toxicity than small molecules, less myelosuppression and better quality of life than cytotoxin-based conjugates.

·      Attractive pharmacokinetics tackles difficult drug targets, enabled by antibody-guided delivery to target sites which will improve bioavailability and reduce drug-drug interactions when compared to oral small molecules inhibitors.

V. COLLABORATION UPDATES

Further progress by Inmagene⁵³ with two candidates discovered by HUTCHMED

·      HUTCHMED received 7.5% shareholding interest in Inmagene following the latter's exercise of an option to exclusively develop, manufacture and commercialize IMG-007, a nondepleting anti-OX40 antibody, and IMG-004, a reversible, non-covalent, highly selective oral BTK inhibitor.

·      Inmagene and Ikena Oncology, Inc. (Nasdaq: IKNA) agreed to merge, which is expected to close in mid-2025, subject to closing conditions. HUTCHMED will have an interest in the merged company.

·      Inmagene announced positive results of a Phase IIa trial with IMG-007 for atopic dermatitis, showing Week 16 mean change in EASI⁵⁴ of 77% and EASI-75 response of 54% (NCT05984784). A Phase IIb dose-finding study with a subcutaneous formulation in moderate-to-severe atopic dermatitis is planned.  

·      Inmagene enrolled a Phase IIa trial with IMG-007 for alopecia areata (NCT06060977), and announced results of a Phase I study with IMG-004, indicating once daily dosing potential (NCT05349097).

VI. OTHER VENTURES

·      Other Ventures consolidated revenue is predominantly from the prescription drug distribution business⁵⁵ in China. It decreased by 14% (12% at CER) to $266.8 million (2023: $309.4m) primarily due to lower COVID-related prescription drug distribution sales in 2024.

·      Share of equity in earnings of SHPL, a non-consolidated joint venture, slightly decreased by 2% (increased 1% at CER) to $46.5 million (2023: $47.4m) mainly due to increased clinical trial investment for new products.

·      Consolidated net income attributable to HUTCHMED from Other Ventures decreased by 5% (2% at CER) to $47.7 million (2023: $50.3m), due to disposal of consumer products business in December 2023, lower COVID-related prescription drug distribution sales and fluctuation in net income contributed from SHPL.

SHPL Disposal: HUTCHMED entered into share purchase agreements to divest its 45.0% equity interest in SHPL for approximately $608 million in cash, retaining a 5.0% equity interest. It is estimated that HUTCHMED will record a pre-tax gain of approximately $477 million.

VII. SUSTAINABILITY

HUTCHMED is committed to progressively embedding sustainability into all aspects of its operations and creating long-term value for its stakeholders. Continued progress was made in 2024 including:

·      Sustainability goals and targets: satisfactory progress made in 11 short- to long-term goals and targets; sustainability performance continued to be incorporated into management's performance-based remuneration. To prepare for new targets setting, sustainability-related efforts were continually assessed and a target achievement roadmap focused on HUTCHMED's five sustainability pillars is being developed.

·      Enhanced climate actions: based on the 2022 climate risk assessment, HUTCHMED conducted another comprehensive assessment on the potential financial impacts of climate risks and opportunities for HUTCHMED with costs estimated under low-, mid-, and high-emission scenarios. This also prepares it for the latest climate-related disclosure requirements of the HKEX⁵⁶ and other international disclosure standards.

·      Biodiversity assessment: a biodiversity assessment was conducted to understand HUTCHMED's dependency and impact on nature. Based on the results of the assessment, a Biodiversity Policy was prepared and approved by the Board for public disclosure.

·      Supplier ESG⁵⁷ assessment: this was conducted to understand the sustainability maturity of the supplier base and pave the way for a tailored supplier engagement program in 2025.

·      Improvement on ESG ratings: MSCI ESG upgraded the rating of HUTCHMED from BBB to A. ISS ESG upgraded the rating of HUTCHMED from C to C+, which is classified as Prime. Its S&P Global ESG score continued to rise from 48 to 53, placing HUTCHMED in the 90^th percentile of the industry. Additionally, HUTCHMED achieved an A- rating and a top quartile score in the Hang Seng Corporate Sustainability Index Series rating, particularly in the areas of environment and governance.

In recognition of its marked improvement in sustainability efforts within the pharmaceutical industry, HUTCHMED was honored with multiple ESG awards in 2024. These efforts will continue to guide HUTCHMED towards a more sustainable future. The 2024 Sustainability Report will be published alongside the 2024 Annual Report in April 2025 and will include further information on sustainability initiatives and performance.

Financial Highlights

Foreign exchange impact: The RMB depreciated against the US dollar by approximately 3% during 2024 on average, which has impacted consolidated financial results as highlighted below.

Revenue for the year ended December 31, 2024 was $630.2 million compared to $838.0 million in 2023.

·      Oncology/Immunology consolidated revenue amounted to $363.4 million (2023: $528.6m):

§ FRUZAQLA^® revenue was $110.8 million, reflecting its successful launch since November 2023 comprising royalties, manufacturing revenue and commercial milestone.

§ ELUNATE^® revenue increased 4% (6% at CER) to $86.3 million (2023: $83.2m) in its sixth year since launch, comprising of manufacturing revenue, promotion and marketing services revenue and royalties, maintaining its leading market share position while weathering greater market competition.

§ SULANDA^® revenue increased 12% (14% at CER) to $49.0 million (2023: $43.9m) due to continued sales growth after NRDL renewal as brand awareness amongst doctors continues to increase, leading to greater NET patient access and market share.

§ ORPATHYS^® revenue decreased 15% (13% at CER) to $24.5 million (2023: $28.9m), due to phasing of manufacturing revenue of $10.9 million (2023: $15.1m), and royalties of $13.6 million (2023: $13.8m).

§ TAZVERIK^® revenue was $0.9 million (2023: $1.0m) mainly from sales in Hainan and Hong Kong.

§ Takeda upfront, regulatory milestones and R&D services revenue decreased to $67.0 million (2023: $345.9m, of which $280.0m was the recognized portion of the $400.0 million upfront cash payment received from Takeda in April 2023).

§ Other revenue of $24.9 million (2023: $18.5m), primarily related to milestone payment of $6.0 million from AstraZeneca and fees from AstraZeneca and Lilly for development and regulatory activities.

·      Other Ventures consolidated revenue decreased 14% (12% at CER) to $266.8 million (2023: $309.4m), primarily as a result of lower COVID-related prescription drug distribution sales in 2024. This excluded non-consolidated revenue at SHPL of $393.5 million (2023: $385.5m).

Net Expenses for 2024 were $592.5 million compared to $737.2 million in 2023, reflecting strong efforts on cost control.

·      Cost of Revenue decreased by 9% to $348.9 million (2023: $384.4m), which was mainly due to lower revenue from Other Ventures. Cost of revenue as a percentage of oncology product revenue improved (from 56% in 2023 to 34% in 2024) due to favorable product mix and economies of scale.

·      R&D Expenses reduced 30% to $212.1 million (2023: $302.0m), mainly due to restructuring of teams outside of China, with clinical and regulatory expenses in the US and Europe decreasing to $34.5 million (2023: $106.9m). China investment was $177.6 million (2023: $195.1m) which reflects both a decrease in cost for completed studies with NDAs under review and an ongoing commitment to key assets with global potential in our internal pipeline, including the development of the next-generation ATTC platform.

·      S&A⁵⁸ Expenses were $112.9 million (2023: $133.2m), which decreased primarily due to tighter controls over administrative spending $64.3 million (2023: $79.8m) and lower selling expenses $48.6 million (2023: $53.4m) as we realized efficiencies from a salesforce already scaled to support revenue growth.

·      Other Items mainly comprised of equity in earnings of SHPL, interest income and expense, FX and taxes, generated net income of $81.4 million (2023: $82.4m).

Net Income attributable to HUTCHMED for 2024 was $37.7 million compared to $100.8 million in 2023.

·      The net income attributable to HUTCHMED in 2024 was $0.04 per ordinary share / $0.22 per ADS⁵⁹, (2023: $0.12 per ordinary share / $0.59 per ADS).

Cash, Cash Equivalents and Short-Term Investments were $836.1 million as of December 31, 2024 compared to $886.3 million as of December 31, 2023.

·      Adjusted Group (non-GAAP⁶⁰) net cash flows excluding financing activities in 2024 were -$19.5 million mainly due to net income attributable to HUTCHMED of $37.7 million offset by changes in working capital of $62.2 million from partner milestones achieved and receivable at the end of 2024 and ongoing recognition of Takeda deferred revenue (2023: $206.7m due to the receipt of $435 million in upfront and milestone payments from Takeda).

·      Net cash used in financing activities in 2024 totaled $30.7 million mainly due to purchases for equity awards of $36.1 million (2023: net cash generated from financing activities of $48.7m mainly due to drawdowns of bank borrowings).  

FINANCIAL GUIDANCE

HUTCHMED provides full year 2025 guidance for Oncology/Immunology consolidated revenue of $350 million to $450 million. HUTCHMED's work in 2025 and beyond will be supported by its strong balance sheet. The Company will continue to be financially self-reliant while supporting investments to bring innovative medicines to patients globally.

Shareholders and investors should note that:

·      The Company does not provide any guarantee that the statements contained in the financial guidance will materialize or that the financial results contained therein will be achieved or are likely to be achieved; and

·      The Company has in the past revised its financial guidance and reference should be made to any announcements published by it regarding any updates to the financial guidance after the date of publication of this announcement.

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Use of Non-GAAP Financial Measures and Reconciliation - References in this announcement to adjusted Group net cash flows excluding financing activities and financial measures reported at CER are based on non-GAAP financial measures. Please see the "Use of Non-GAAP Financial Measures and Reconciliation" for further information relevant to the interpretation of these financial measures and reconciliations of these financial measures to the most comparable GAAP measures, respectively.

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FINANCIAL STATEMENTS

HUTCHMED will today file with the US Securities and Exchange Commission its Annual Report on Form 20-F.

Financial Summary

Condensed Consolidated Balance Sheets Data

Condensed Consolidated Statements of Operations Data

About HUTCHMED

HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, and the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch‑med.com or follow us on LinkedIn.

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References

Unless the context requires otherwise, references in this announcement to the "Group," the "Company," "HUTCHMED," "HUTCHMED Group," "we," "us," and "our," mean HUTCHMED (China) Limited and its subsidiaries unless otherwise stated or indicated by context.

Past Performance and Forward-Looking Statements

The performance and results of operations of the Group contained within this announcement are historical in nature, and past performance is no guarantee of future results of the Group. This announcement contains forward-looking statements within the meaning of the "safe harbor" provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by words like "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "pipeline," "could," "potential," "first-in-class," "best-in-class," "designed to," "objective," "guidance," "pursue," or similar terms, or by express or implied discussions regarding potential drug candidates, potential indications for drug candidates or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that any of our drug candidates will be approved for sale in any market, that any approvals which have been obtained will continue to remain valid and effective in the future, or that the sales of products marketed or otherwise commercialized by HUTCHMED and/or its collaboration partners (collectively, "HUTCHMED's Products") will achieve any particular revenue or net income levels. In particular, management's expectations could be affected by, among other things: unexpected regulatory actions or delays or government regulation generally; the uncertainties inherent in research and development, including the inability to meet our key study assumptions regarding enrollment rates, timing and availability of subjects meeting a study's inclusion and exclusion criteria and funding requirements, changes to clinical protocols, unexpected adverse events or safety, quality or manufacturing issues; the delay or inability of a drug candidate to meet the primary or secondary endpoint of a study; the delay or inability of a drug candidate to obtain regulatory approval in different jurisdictions or the utilization, market acceptance and commercial success of HUTCHMED's Products after obtaining regulatory approval; discovery, development and/or commercialization of competing products and drug candidates that may be superior to, or more cost effective than, HUTCHMED's Products and drug candidates; the impact of studies (whether conducted by HUTCHMED or others and whether mandated or voluntary) or recommendations and guidelines from governmental authorities and other third parties on the commercial success of HUTCHMED's Products and drug candidates in development; the ability of HUTCHMED to manufacture and manage supply chains, including various third party services, for multiple products and drug candidates; the availability and extent of reimbursement of HUTCHMED's Products from third-party payers, including private payer healthcare and insurance programs and government insurance programs; the costs of developing, producing and selling HUTCHMED's Products; the ability to obtain additional funding when needed; the ability to obtain and maintain protection of intellectual property for HUTCHMED's Products and drug candidates; the ability of HUTCHMED to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the successful disposition of its non-core business; global trends toward health care cost containment, including ongoing pricing pressures; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product liability litigation, litigation and investigations regarding sales and marketing practices, intellectual property disputes, and government investigations generally; and general economic and industry conditions, including uncertainties regarding the effects of the persistently weak economic and financial environment in many countries, uncertainties regarding future global exchange rates, uncertainties in global interest rates, and geopolitical relations, sanctions and tariffs. For further discussion of these and other risks, see HUTCHMED's filings with the US Securities and Exchange Commission, on AIM and on HKEX. HUTCHMED is providing the information in this announcement as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.

In addition, this announcement contains statistical data and estimates that HUTCHMED obtained from industry publications and reports generated by third-party market research firms. Although HUTCHMED believes that the publications, reports and surveys are reliable, HUTCHMED has not independently verified the data and cannot guarantee the accuracy or completeness of such data. You are cautioned not to give undue weight to this data. Such data involves risks and uncertainties and are subject to change based on various factors, including those discussed above.

Inside Information

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (as it forms part of retained EU law as defined in the European Union (Withdrawal) Act 2018).

Medical Information

This announcement contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

Ends

This announcement in its entirety is available at: http://www.rns-pdf.londonstockexchange.com/rns/2964B_1-2025-3-19.pdf

REFERENCES & ABBREVIATIONS

1    In-market sales = total sales to third parties provided by Eli Lilly (ELUNATE®), Takeda (FRUZAQLA®), AstraZeneca (ORPATHYS®) and HUTCHMED (ELUNATE®, SULANDA®, ORPATHYS® and TAZVERIK®).

2    Takeda = Takeda Pharmaceuticals International AG, a subsidiary of Takeda Pharmaceutical Company Limited.

3    SHPL = Shanghai Hutchison Pharmaceuticals Limited.

4    EGFRm = Epidermal growth factor receptor mutated.

5    NSCLC = Non-small cell lung cancer.

6    NDA = New Drug Application.

7    NMPA = China National Medical Products Administration.

8    AstraZeneca = AstraZeneca AB, a subsidiary of AstraZeneca plc.

9    2L = Second-line.

10  RCC = Renal cell carcinoma.

11   ASH = American Society of Hematology.

12  EHA = European Hematology Association.

13  ITP = immune thrombocytopenia purpura.

14  CDE = Centre for Drug Evaluation.

15  ASCO = American Society of Clinical Oncology.

16  EMC = Endometrial cancer.

17  pMMR = Proficient mismatch repair.

18  ATTC = antibody-targeted therapy conjugates.

19  R&D = Research and development.

20  EGFR = Epidermal growth factor receptor.

21  TKI = Tyrosine kinase inhibitor.

22  AIHA = Autoimmune hemolytic anemia.

23  CER = Constant exchange rate. We also report changes in performance at CER which is a non-GAAP measure. Please refer to "Use of Non-GAAP Financial Measures and Reconciliation" for further information relevant to the interpretation of these financial measures and reconciliations of these financial measures to the most comparable GAAP measures.

24  CRC = Colorectal cancer.

25  NET = Neuroendocrine tumor.

26  NRDL = China National Reimbursement Drug List.

27  METex14 = MET exon 14 skipping alteration.

28  1L = First-line.

29  Lilly = Eli Lilly and Company.

30  sNDA = Supplemental New Drug Application.

31  3L = Third-line.

32  R/R = Relapsed and/or refractory.

33  EZH2m = Enhancer of zeste homolog 2 mutated.

34  AACR = American Association for Cancer Research.

35  ORR = Objective response rate.

36  PFS = Progression free survival.

37  VEGFR = Vascular endothelial growth factor receptor.

38  IRC = Independent review committee.

39  OS = Overall survival.

40  ASCO GI = ASCO Gastrointestinal Cancers Symposium.

41  CEA = Carcinoembryonic antigen.

42  Syk = Spleen tyrosine kinase.

43  FGFR = Fibroblast growth factor receptor.

44  CSF-1R = Colony-stimulating factor 1 receptor.

45  PDAC = Pancreatic ductal adenocarcinoma.

46  IHCC = Intrahepatic cholangiocarcinoma.

47  IDH1 and IDH2 = Isocitrate dehydrogenase-1 and isocitrate dehydrogenase-2.

48  IDH1/2m = Isocitrate dehydrogenase-1 OR isocitrate dehydrogenase-2 mutated.

49  AML = Acute myeloid leukemia.

50  ERK = Extracellular signal-regulated kinase.

51  BTK = Bruton's tyrosine kinase.

52  IND = Investigational new drug application.

53  Inmagene = Inmagene Biopharmaceuticals.

54  EASI = Eczema area and severity index.

55  Distribution business = Shanghai Hutchison Whampoa Pharmaceuticals Sales Limited, formerly Hutchison Whampoa Sinopharm Pharmaceuticals (Shanghai) Company Limited.

56  HKEX = The Main Board of The Stock Exchange of Hong Kong Limited.

57  ESG = Environmental, Social and Governance.

58  S&A = Selling and administrative expenses.

59  ADS = American depositary share.

60  GAAP = Generally Accepted Accounting Principles.