REG - Hutchmed China Ltd - 2024 Final Results and Business Updates

HUTCHMED (China)Announcement

19/03/2025 11:00

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20250319:nRSS2964Ba&default-theme=true

RNS Number : 2964B  Hutchmed (China) Limited  19 March 2025

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 (https://www.hutch-med.com/) ", 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 (https://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 sales(1) 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 Takeda(2). 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 SHPL(3) joint venture for
$608 million.

 

Pipeline progress and new technology platform

 

·      Primary endpoint met in SACHI China Phase III interim analysis
for savolitinib for EGFRm(4) NSCLC(5) with MET amplification, followed by
swift NDA(6) filing, acceptance and priority review granted by the NMPA(7).

·      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 AstraZeneca(8).

·      Positive FRUSICA-2 China Phase III results for fruquintinib with
sintilimab in 2L(9) RCC(10).

·      Presented ESLIM-01 China Phase III data at ASH(11) and EHA(12),
highlighting strong, sustained, and long-term durable response rates of
sovleplenib for ITP(13) patients, with the NDA under review by the NMPA.
Additional data were requested by CDE(14) and subsequently submitted by
HUTCHMED. Review of the supplementary data is currently under review by CDE.

·      FRUSICA-1 Phase II results presented at ASCO(15), leading to NMPA
approval of a second indication of ELUNATE(®)(fruquintinib) for EMC(16) with
pMMR(17) status.

·      First candidates from new ATTC(18) 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&D(19), 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 EGFR(20) TKI(21) 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 AIHA(22)
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 CER(23)) 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.

 

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).

 

 ($ in USD millions)  In-market Sales*                                        Consolidated Revenue**
                      2024          2023          %Δ            (CER)         2024    2023    %Δ       (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%)

* = FRUZAQLA(®), ELUNATE(®) and ORPATHYS(®) mainly represent total sales
to third parties as provided by Takeda, Lilly(29) 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 sNDA(30) 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 3L(31) 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/R(32) EZH2m(33)
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
AACR(34) for 2L EGFRm NSCLC patients with high MET amplification, in
combination with TAGRISSO(®) (osimertinib), showing ORR(35) of 63% and median
PFS(36) 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 VEGFR(37)

 

·      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).

·      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 Syk(42)

 

·      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, FGFR(43) and CSF-1R(44)

 

·      Completed enrollment of Phase II part of a China Phase II/III
trial for 1L metastatic PDAC(45) 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
IHCC(46) with FGFR2 fusion / rearrangement in March 2025 (NCT04353375).

 

Ranosidenib (HMPL-306), an investigative and highly selective oral dual-inhibitor of IDH1 and IDH2(47) enzymes

 

·      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).

 

Other early-stage investigational drug candidates

 

·      Presented pre-clinical and Phase I results at AACR, ASCO and EHA
for ERK1/2(50) inhibitor HMPL-295, third-generation BTK(51) 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 IND(52) 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 Inmagene(53) 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 EASI(54) 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 business(55) 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
HKEX(56) 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 ESG(57) 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&A(58) 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 ADS(59), (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-GAAP(60)) 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.

 

---

 

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  (1,107)                58,308
 equity investee
 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
(https://www.hutch-med.com/) or follow us on LinkedIn
(https://www.linkedin.com/company/hutchmed/) .

 

Contacts

 

 Investor Enquiries                                   +852 2121 8200 / ir@hutch-med.com (mailto:ir@hutch-med.com)

 Media Enquiries
 FTI Consulting -                                     +44 20 3727 1030 / HUTCHMED@fticonsulting.com
                                                      (mailto: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
                                                      (mailto: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.

 

 

Ends

 

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

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  FR MZGMFLLGGKZG