Full Press Release Details
Reports 2024 Full Year Results and Provides Business Updates
oncology products revenue growth drove profitable operation and supported new ATTC platform
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.
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.
amounts are expressed in US dollars unless otherwise stated.
commercial progress and delivery of sustainable growth
progress and new technology platform
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."
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."
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
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."
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."
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."
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."
Full Year Results & Business Updates
COMMERCIAL OPERATIONS
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 CRC 24 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 NET 25 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 NRDL 26 inclusion of several competing same-class MET TKIs for 2L METex14 27 NSCLC. Results do not reflect full approval in 1L 28 setting received in January 2025. |
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 . |
million total consolidated revenue (2023: $838.0m) including Other Ventures of
$266.8 million (2023: $309.4m).
| ($ in USD millions) | In-market Sales* | Consolidated Revenue** | ||||||||||||||||||||||||||
| 2024 | 2023 | % | (CER) | 2024 | 2023 | % | (CER) | |||||||||||||||||||||
| FRUZAQLA | $ 290.6 | $ 15.1 | +1,825% | (+1,825%) | $ 110.8 | $ 7.2 | +1,450% | (+1,450%) | ||||||||||||||||||||
| ELUNATE | $ 115.0 | $ 107.5 | +7% | (+9%) | $ 86.3 | $ 83.2 | +4% | (+6%) | ||||||||||||||||||||
| SULANDA | $ 49.0 | $ 43.9 | +12% | (+14%) | $ 49.0 | $ 43.9 | +12% | (+14%) | ||||||||||||||||||||
| ORPATHYS | $ 45.5 | $ 46.1 | -2% | (+0%) | $ 24.5 | $ 28.9 | -15% | (-13%) | ||||||||||||||||||||
| TAZVERIK | $ 0.9 | $ 1.0 | -8% | (-7%) | $ 0.9 | $ 1.0 | -8% | (-7%) | ||||||||||||||||||||
| Oncology Products | $ 501.0 | $ 213.6 | +134% | (+136%) | $271.5 | $164.2 | +65% | (+67%) | ||||||||||||||||||||
| Takeda upfront, regulatory milestones and R&D services | $ 67.0 | $ 345.9 | -81% | (-81%) | ||||||||||||||||||||||||
| Other revenue (R&D services and licensing) | $ 24.9 | $ 18.5 | +34% | (+36%) | ||||||||||||||||||||||||
| Total Oncology/Immunology | $363.4 | $528.6 | -31% | (-31%) | ||||||||||||||||||||||||
| Other Ventures | $266.8 | $ 309.4 | -14% | (-12%) | ||||||||||||||||||||||||
| Total Revenue | $ 630.2 | $838.0 | -25% | (-24%) |
ELUNATE and ORPATHYS mainly represent total sales to third parties as provided by Takeda, Lilly29
and AstraZeneca, respectively.
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.
LATE-STAGE CLINICAL DEVELOPMENT ACTIVITIES
(ORPATHYS in China), a highly selective
oral inhibitor of MET
upcoming clinical and regulatory milestones for savolitinib:
(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 IRC 38 -assessed confirmed ORR of 35.6%, median PFS of 9.5 months and median OS 39 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 GI 40 , showing meaningful quality-adjusted survival benefit, efficacy regardless of prior therapy or sequence as well as CEA 41 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). |
(HMPL-523), an investigative and highly selective oral
| 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). |
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). |
(SULANDA in China), an oral inhibitor
of VEGFR, FGFR43 and CSF-1R44
upcoming clinical milestone for surufatinib:
(TAZVERIK in Hainan, Macau and Hong Kong),
a first-in-class, oral inhibitor of EZH2
upcoming clinical milestone for tazemetostat:
(HMPL-453), a novel, highly selective and potent inhibitor
targeting FGFR 1, 2 and 3
(HMPL-306), an investigative and highly selective oral
dual-inhibitor of IDH1 and IDH247
| Presented and published results from China and US/European Phase I studies at EHA and the journal Med for R/R IDH1/2m 48 AML 49 patients (NCT04272957, NCT04764474). | |
| Initiated RAPHAEL China Phase III trial for 2L R/R IDH1/2m AML (NCT06387069). |
early-stage investigational drug candidates
ANTIBODY-TARGETED THERAPY CONJUGATE (ATTC) PLATFORM
in-house created platform with multiple potential IND52 candidates
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:
COLLABORATION UPDATES