HUTCHMED Reports 2024 Full Year Results and Provides Business Updates
HUTCHMED reported strong financial results for 2024, achieving profitability with a net income of $37.7 million and a cash balance of $836.1 million. The company's oncology products saw significant growth, with total in-market sales up 134% to $501.0 million and consolidated revenue increasing 65% to $271.5 million.
FRUZAQLA® (fruquintinib) demonstrated impressive performance with ex-China in-market sales of $290.6 million in its first full year, driven by US patient uptake and launches in EU and Japan. The company reached a significant milestone by agreeing to a partial disposal of equity in SHPL joint venture for $608 million.
Key pipeline developments included positive results from multiple clinical trials: SACHI Phase III for savolitinib in NSCLC, SAVANNAH global pivotal Phase II for savolitinib with TAGRISSO®, and FRUSICA-2 Phase III for fruquintinib. The company also introduced its new ATTC platform for developing next-generation antibody drug conjugates.
HUTCHMED ha riportato risultati finanziari solidi per il 2024, raggiungendo la redditività con un utile netto di 37,7 milioni di dollari e un saldo di cassa di 836,1 milioni di dollari. I prodotti oncologici dell'azienda hanno registrato una crescita significativa, con le vendite totali sul mercato aumentate del 134% a 501,0 milioni di dollari e il fatturato consolidato aumentato del 65% a 271,5 milioni di dollari.
FRUZAQLA® (fruquintinib) ha dimostrato prestazioni impressionanti con vendite sul mercato ex-Cina di 290,6 milioni di dollari nel suo primo anno completo, trainate dall'adozione da parte dei pazienti negli Stati Uniti e dai lanci nell'UE e in Giappone. L'azienda ha raggiunto un traguardo significativo concordando una cessione parziale di partecipazioni nella joint venture SHPL per 608 milioni di dollari.
Sviluppi chiave nel pipeline hanno incluso risultati positivi da molteplici studi clinici: SACHI Fase III per savolitinib nel NSCLC, SAVANNAH Fase II globale cruciale per savolitinib con TAGRISSO®, e FRUSICA-2 Fase III per fruquintinib. L'azienda ha anche introdotto la sua nuova piattaforma ATTC per lo sviluppo di coniugati di farmaci ad anticorpi di nuova generazione.
HUTCHMED informó resultados financieros sólidos para 2024, logrando rentabilidad con un ingreso neto de 37,7 millones de dólares y un saldo de efectivo de 836,1 millones de dólares. Los productos oncológicos de la compañía vieron un crecimiento significativo, con ventas totales en el mercado que aumentaron un 134% a 501,0 millones de dólares y los ingresos consolidados aumentando un 65% a 271,5 millones de dólares.
FRUZAQLA® (fruquintinib) demostró un rendimiento impresionante con ventas en el mercado fuera de China de 290,6 millones de dólares en su primer año completo, impulsadas por la adopción de pacientes en EE. UU. y lanzamientos en la UE y Japón. La empresa alcanzó un hito significativo al acordar una disposición parcial de acciones en la empresa conjunta SHPL por 608 millones de dólares.
Los desarrollos clave en la cartera incluyeron resultados positivos de múltiples ensayos clínicos: SACHI Fase III para savolitinib en NSCLC, SAVANNAH Fase II global decisiva para savolitinib con TAGRISSO®, y FRUSICA-2 Fase III para fruquintinib. La compañía también presentó su nueva plataforma ATTC para desarrollar conjugados de fármacos a base de anticuerpos de nueva generación.
HUTCHMED는 2024년 강력한 재무 결과를 보고하며, 3,770만 달러의 순이익과 8억 3,610만 달러의 현금 잔고로 수익성을 달성했습니다. 회사의 종양학 제품은 상당한 성장을 보였으며, 시장 내 총 매출은 134% 증가하여 5억 1,010만 달러에 달하고, 통합 수익은 65% 증가하여 2억 7,150만 달러에 이르렀습니다.
FRUZAQLA® (fruquintinib)는 첫 해에 중국 외 시장에서 2억 9,060만 달러의 매출을 기록하며 인상적인 성과를 보였으며, 이는 미국 환자 수요와 EU 및 일본에서의 출시로 인해 촉진되었습니다. 회사는 SHPL 합작 투자에서 6억 8백만 달러에 대한 부분적 지분 처분에 합의함으로써 중요한 이정표를 도달했습니다.
주요 파이프라인 개발에는 여러 임상 시험에서의 긍정적인 결과가 포함되었습니다: SACHI 3상에서 NSCLC에 대한 savolitinib, SAVANNAH TAGRISSO®와 함께하는 savolitinib에 대한 글로벌 중추 2상, FRUSICA-2 3상에서 fruquintinib에 대한 결과가 포함됩니다. 회사는 또한 차세대 항체 약물 접합체를 개발하기 위한 새로운 ATTC 플랫폼을 도입했습니다.
HUTCHMED a annoncé des résultats financiers solides pour 2024, atteignant la rentabilité avec un revenu net de 37,7 millions de dollars et un solde de trésorerie de 836,1 millions de dollars. Les produits oncolytiques de l'entreprise ont connu une croissance significative, avec des ventes totales sur le marché augmentant de 134 % pour atteindre 501,0 millions de dollars et un chiffre d'affaires consolidé en hausse de 65 % à 271,5 millions de dollars.
FRUZAQLA® (fruquintinib) a montré une performance impressionnante avec des ventes sur le marché hors de Chine atteignant 290,6 millions de dollars lors de sa première année complète, soutenues par l'adoption par les patients aux États-Unis et les lancements en Europe et au Japon. L'entreprise a atteint une étape importante en convenant d'une cession partielle d'actions dans la coentreprise SHPL pour 608 millions de dollars.
Les développements clés de la pipeline comprenaient des résultats positifs de plusieurs essais cliniques : SACHI Phase III pour savolitinib dans le NSCLC, SAVANNAH Phase II mondiale décisive pour savolitinib avec TAGRISSO®, et FRUSICA-2 Phase III pour fruquintinib. L'entreprise a également introduit sa nouvelle plateforme ATTC pour le développement de conjugués de médicaments à base d'anticorps de nouvelle génération.
HUTCHMED berichtete über starke finanzielle Ergebnisse für 2024 und erzielte eine Rentabilität mit einem Nettoergebnis von 37,7 Millionen Dollar und einem Barguthaben von 836,1 Millionen Dollar. Die Onkologieprodukte des Unternehmens verzeichneten ein signifikantes Wachstum, mit einem Anstieg der Gesamtverkäufe auf dem Markt um 134 % auf 501,0 Millionen Dollar und einem Anstieg des konsolidierten Umsatzes um 65 % auf 271,5 Millionen Dollar.
FRUZAQLA® (fruquintinib) zeigte eine beeindruckende Leistung mit einem Umsatz von 290,6 Millionen Dollar auf dem Markt außerhalb Chinas im ersten vollen Jahr, angetrieben durch die Akzeptanz von Patienten in den USA und Markteinführungen in der EU und Japan. Das Unternehmen erreichte einen bedeutenden Meilenstein, indem es einer teilweisen Veräußerung von Eigenkapital an dem Joint Venture SHPL für 608 Millionen Dollar zustimmte.
Wichtige Entwicklungen in der Pipeline umfassten positive Ergebnisse aus mehreren klinischen Studien: SACHI Phase III für savolitinib bei NSCLC, SAVANNAH globale entscheidende Phase II für savolitinib mit TAGRISSO® und FRUSICA-2 Phase III für fruquintinib. Das Unternehmen stellte auch seine neue ATTC-Plattform zur Entwicklung von Antikörper-Wirkstoff-Konjugaten der nächsten Generation vor.
- Achieved profitability with $37.7 million net income in 2024
- Oncology product sales grew 134% to $501.0 million
- FRUZAQLA® ex-China sales reached $290.6 million in first full year
- Secured $608 million from SHPL joint venture partial disposal
- Strong cash position of $836.1 million as of December 2024
- Voluntary withdrawal of fruquintinib sNDA for 2L gastric cancer
- ORPATHYS® (savolitinib) sales declined 2% due to competing MET TKIs
- Total consolidated revenue decreased to $630.2 million from $838.0 million in 2023
Insights
HUTCHMED's 2024 results showcase impressive commercial execution with 65% growth in oncology products revenue driving the company to profitability ahead of schedule. Total oncology in-market sales surged 134% to
The company achieved net income of
Product-specific performance shows strong momentum: FRUZAQLA® external sales exceeded
The transformation to profitability, global commercial expansion, and R&D progress create a sustainable business model with multiple growth drivers. With the balance sheet strength to support pipeline advancement—particularly the novel ATTC platform—HUTCHMED has successfully reduced operational risk while positioning for continued momentum in 2025.
HUTCHMED's 2024 results demonstrate remarkable clinical and regulatory progress across their portfolio. The standout achievement is fruquintinib's global expansion with approvals in the EU, Japan, and over a dozen countries, validating HUTCHMED's scientific approach and commercial partnership with Takeda. The rapid US uptake of FRUZAQLA® affirms fruquintinib's differentiated clinical profile among VEGFR inhibitors.
The company's pipeline momentum is equally impressive. The positive SAVANNAH data for savolitinib in combination with osimertinib in 2L EGFRm NSCLC with MET amplification/overexpression represents a significant advancement addressing a critical treatment resistance mechanism. The NMPA's priority review and breakthrough designation underscores this combination's potential to address a major unmet need in precision oncology.
The ESLIM-01 data for sovleplenib in ITP is particularly noteworthy, with durable response rates of 51.4% and overall response rates of 81.0% exceeding many competing therapies. This validates HUTCHMED's focus on selectivity to optimize efficacy while maintaining favorable safety profiles.
The introduction of the ATTC platform signals HUTCHMED's evolution into antibody-drug conjugates, potentially addressing the limitations of current ADCs through improved selectivity and tolerability. With candidates advancing toward clinical development this year, this platform could create substantial value beyond their current small molecule portfolio.
With multiple late-stage assets nearing approval in 2025 including sovleplenib for ITP and tazemetostat for follicular lymphoma, plus expanded indications for current products, HUTCHMED's commercial portfolio is poised for continued diversification and growth.
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., March 19, 2025 (GLOBE NEWSWIRE) -- 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 up134% to$501.0 million . - Consolidated revenue from oncology products of
$271.5 million , up65% . - 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
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
“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
2024 FULL YEAR RESULTS & BUSINESS UPDATES
I. COMMERCIAL OPERATIONS
Oncology product in-market sales were up
- 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 to27% 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
- 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 of30% to50% 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$6.0 million from AstraZeneca following NDA acceptance in China for ORPATHYS® combined with TAGRISSO®.
($ in USD millions) | In-market Sales* | Consolidated Revenue** | ||||||||||||
2024 | 2023 | %Δ | (CER) | 2024 | 2023 | %Δ | (CER) | |||||||
FRUZAQLA® | +1,825 | % | (+1, | +1,450 | % | (+1, | ||||||||
ELUNATE® | +7 | % | (+ | +4 | % | (+ | ||||||||
SULANDA® | +12 | % | (+ | +12 | % | (+ | ||||||||
ORPATHYS® | -2 | % | (+ | -15 | % | (- | ||||||||
TAZVERIK® | -8 | % | (- | -8 | % | (- | ||||||||
Oncology Products | $501.0 | $213.6 | +134 | % | (+ | $271.5 | $164.2 | +65 | % | (+ | ||||
Takeda upfront, regulatory milestones and R&D services | -81 | % | (- | |||||||||||
Other revenue (R&D services and licensing) | +34 | % | (+ | |||||||||||
Total Oncology/Immunology | $363.4 | $528.6 | -31 | % | (- | |||||||||
Other Ventures | -14 | % | (- | |||||||||||
Total Revenue | $630.2 | $838.0 | -25 | % | (- |
* = 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 of59.8% 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. 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 of54% (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% (increased1% 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
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 90th 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
Revenue for the year ended December 31, 2024 was
- 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.
- FRUZAQLA® revenue was
- 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
- 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 (from56% in 2023 to34% 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
- 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
- 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
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.
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.
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
(in $’000) | As of December 31, | ||
2024 | 2023 | ||
Assets | |||
Cash and cash equivalents and short-term investments | 836,110 | 886,336 | |
Accounts receivable | 155,537 | 116,894 | |
Other current assets | 74,908 | 93,609 | |
Property, plant and equipment | 92,498 | 99,727 | |
Investment in an equity investee | 77,765 | 48,411 | |
Other non-current assets | 37,378 | 34,796 | |
Total assets | 1,274,196 | 1,279,773 | |
Liabilities and shareholders’ equity | |||
Accounts payable | 42,521 | 36,327 | |
Other payables, accruals and advance receipts | 256,124 | 271,399 | |
Deferred revenue | 98,503 | 127,119 | |
Bank borrowings | 82,806 | 79,344 | |
Other liabilities | 22,389 | 22,197 | |
Total liabilities | 502,343 | 536,386 | |
Company’s shareholders’ equity | 759,929 | 730,541 | |
Non-controlling interests | 11,924 | 12,846 | |
Total liabilities and shareholders’ equity | 1,274,196 | 1,279,773 |
Condensed Consolidated Statements of Operations Data
(in $’000, except share and per share data) | Year Ended December 31, | ||||
2024 | 2023 | ||||
Revenue: | |||||
Oncology/Immunology – Marketed Products | 271,534 | 164,165 | |||
Oncology/Immunology – R&D | 91,831 | 364,451 | |||
Oncology/Immunology Consolidated Revenue | 363,365 | 528,616 | |||
Other Ventures | 266,836 | 309,383 | |||
Total revenue | 630,201 | 837,999 | |||
Operating expenses: | |||||
Cost of revenue | (348,884 | ) | (384,447 | ) | |
Research and development expenses | (212,109 | ) | (302,001 | ) | |
Selling and administrative expenses | (112,913 | ) | (133,176 | ) | |
Total operating expenses | (673,906 | ) | (819,624 | ) | |
Other income, net | 42,598 | 39,933 | |||
(Loss)/income before income taxes and equity in earnings of an equity investee | (1,107 | ) | 58,308 | ||
Income tax expense | (7,192 | ) | (4,509 | ) | |
Equity in earnings of an equity investee, net of tax | 46,469 | 47,295 | |||
Net income | 38,170 | 101,094 | |||
Less: Net income attributable to non-controlling interests | (441 | ) | (314 | ) | |
Net income attributable to HUTCHMED | 37,729 | 100,780 | |||
Earnings per share attributable to HUTCHMED (US$ per share) | |||||
– basic | 0.04 | 0.12 | |||
– diluted | 0.04 | 0.12 | |||
Number of shares used in per share calculation | |||||
– basic | 855,351,683 | 849,654,296 | |||
– diluted | 872,829,129 | 869,196,348 | |||
Earnings per ADS attributable to HUTCHMED (US$ per ADS) | |||||
– basic | 0.22 | 0.59 | |||
– diluted | 0.22 | 0.58 | |||
Number of ADSs used in per share calculation | |||||
– basic | 171,070,337 | 169,930,859 | |||
– diluted | 174,565,826 | 173,839,270 | |||
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.
Contacts
Investor Enquiries | +852 2121 8200 / ir@hutch-med.com |
Media Enquiries | |
FTI Consulting – | +44 20 3727 1030 / HUTCHMED@fticonsulting.com |
Ben Atwell / Alex Shaw | +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) |
Brunswick – Zhou Yi | +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com |
Panmure Liberum | Nominated Advisor and Joint Broker |
Atholl Tweedie / Freddy Crossley / Rupert Dearden | +44 20 7886 2500 |
HSBC | Joint Broker |
Simon Alexander / Alina Vaskina / Arnav Kapoor | +44 20 7991 8888 |
Cavendish | Joint Broker |
Geoff Nash / Nigel Birks | +44 20 7220 0500 |
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.
This announcement in its entirety is available at:
http://ml.globenewswire.com/Resource/Download/3b541e3e-0c05-4065-810b-72732d8ea41b
_______________________
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. |
