HUTCHMED (China) Limited (“HUTCHMED”, the “Company” or “we”)
(Nasdaq/AIM:HCM; HKEX:13) today reports its financial results for
the six months ended June 30, 2024 and provides updates on key
clinical and commercial developments.
HUTCHMED to host results webcasts today
at 8:00 a.m. EDT / 1:00 p.m. BST /
8:00 p.m. HKT in English, and at 8:30 a.m. HKT in
Chinese (Putonghua) on Thursday, August 1, 2024.
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.
Continued revenue momentum with
substantial cash balance to support growth
- Reiterate
full year 2024 guidance for Oncology/Immunology consolidated
revenue of $300 to $400 million, with $168.7 million in the first
half of 2024, driven by 59% (64% at
CER1) oncology product revenue
growth.
-
FRUZAQLA® US in-market
sales2 of $130.5 million in the
first half of 2024 – demonstrating strong demand and
commercial traction since launch in November 2023.
- Net income
of $25.8 million in the first half of 2024. Cash
balance of $802.5 million as of June 30, 2024, as we
continued to prioritize key R&D3 projects and enhance
commercial efficiency.
Globalization of fruquintinib continues,
broader pipeline makes strong progress
- Preparation
for EU launch of FRUZAQLA®
underway led by partner Takeda4 after
European Commission approval in June 2024 – Filings in
over a dozen jurisdictions supported by FRESCO-2.
- HUTCHMED
preparing for China launch of sovleplenib for
ITP5 – potentially its
first hematology medicine, after the NDA6 was
accepted and granted Priority Review status in January 2024.
- Potential
US NDA filing for savolitinib for NSCLC7 at year
end, based on SAVANNAH trial readout.
- NDAs
accepted to expand use of ORPATHYS®
and ELUNATE®, and for
TAZVERIK® in China – for
treatment-naïve METex148 NSCLC, endometrial cancer and follicular
lymphoma, respectively.
- Key
late-stage registration trials initiated with 15 ongoing/under
review – across six drug candidates: ESLIM-02 for
sovleplenib in warm AIHA9, RAPHAEL for HMPL-306 in AML10, and for
surufatinib in PDAC11.
- Growing
hematology portfolio with new programs targeting Menin and
CD38, joining the existing portfolio of inhibitors and antibodies
targeting Syk12, EZH213, IDH14, BTK15 and CD47.
Dr Dan Eldar, Non-executive Chairman of
HUTCHMED, said, “HUTCHMED has delivered strong performance
in the first half of this year. The team has made significant
progress implementing our strategy in discovering and developing
novel, effective medicines; conducting clinical trials in our home
market and in the global markets; and rapidly advancing regulatory
and commercial goals. I am very pleased with the ongoing success of
our partnership with Takeda and with the growing ability of the
Company to provide health benefits to patients overseas. We have
grown our revenues from the US during this period and we expect to
see revenue growth from many other countries in the coming months.
We are also capitalizing on our proven track record of bringing new
medicines and additional indications for our marketed medicines to
China, with several potential NDA approvals for the next few
years.”
“I would like to take this opportunity to
express my appreciation to Mr Simon To, my predecessor, who has
recently retired. Mr To has stood at the cradle of HUTCHMED and has
made a very significant contribution to grow the Company and turn
it into a global innovative player, discovering, developing and
commercializing therapies for the treatment of cancer and
immunological diseases, improving the quality of life of patients
around the world. I look forward to guiding the Company along its
next phase of growth, which is full of potential and promise.”
2024 INTERIM RESULTS & BUSINESS UPDATES
Dr Weiguo Su, Chief Executive Officer
and Chief Scientific Officer of HUTCHMED, said, “The
HUTCHMED team has been working tirelessly to continue the
outstanding clinical and regulatory momentum that we have had in
recent years, whilst importantly driving the commercial success of
our approved products. I would like to extend my thanks to everyone
for their hard work and commitment. Our oncology product
revenue has grown 59% compared to the first half of 2023
and we are progressing a more focused R&D pipeline that has
considerable potential for value creation. This year we initiated
three key late-stage studies across our pipeline and are excited to
be running over a dozen such studies that could support future drug
approvals.”
“The partnership strategy that we adopted for
globalizing our medicines is allowing us to simultaneously fuel our
in-house R&D engine, drive sales in our home market, and bring
our medicines to patients in new geographies. Takeda’s impressive
initial sales of FRUZAQLA® demonstrates both the quality of our
medicines and their potential across the globe and our strategy of
working with partners outside of our home market.”
“We expect to advance our registration trials in
the second half of the year. Around year end, we anticipate the
potential approval of sovleplenib in China and potential NDA filing
of savolitinib in the US. We will continue to progress towards
becoming a self-sustaining biopharma business.”
I. COMMERCIAL OPERATIONS
Oncology in-market sales were up 140%
(145% at CER) to $243.3 million (H1-23: $101.3m), which
led to strong growth in consolidated oncology product revenue of
59% (64% at CER) to $127.8 million (H1-23: $80.1m), and mainly
comprised of the following:
-
FRUZAQLA® (fruquintinib
ex-China) in-market sales were $130.5 million (H1-23:
nil), which was launched in the US in November 2023. Its strong
performance was due to rapid US patient uptake, as well as
fulfilling sales channel inventory requirements;
-
ELUNATE® (fruquintinib
China) in-market sales increased 8% (13% at CER) to $61.0
million (H1-23: $56.3m), in line with CRC16 market growth,
maintaining our leading market share position while weathering
greater market competition;
-
SULANDA® (surufatinib)
in-market sales increased 12% (17% at CER) to $25.4
million (H1-23: $22.6m), as doctors’ awareness continues
to increase, leading to greater NET patient access and market
share; and
-
ORPATHYS® (savolitinib)
in-market sales increased 18% (22% at CER) to $25.9
million (H1-23: $22.0m), as it benefited from improved
testing and diagnosis for METex14 NSCLC and also ongoing growth
momentum in the second year on the NRDL17.
Oncology/Immunology consolidated revenue
comprised of consolidated oncology product revenue, which included
product revenue, commercial service fees and royalties, as well as
R&D income from our collaboration partners, mainly as
follows:
- Takeda
upfront, milestones and R&D services revenue were $33.8
million (H1-23: $269.1m), which included recognition of
$19.4 million of the $435.0 million upfront and milestone payments
already received from Takeda in cash during 2023. This compared to
recognition of $258.7 million in the first half of 2023.
As a result, total Oncology/Immunology
consolidated revenue was $168.7 million (H1-23: $359.2m).
Including Other Ventures revenue, total revenue was $305.7 million
(H1-23: $532.9m).
|
(Unaudited, $ in millions) |
In-market Sales* |
Consolidated Revenue** |
|
|
H1 2024 |
H1 2023 |
%Δ |
(CER) |
H1 2024 |
H1 2023 |
%Δ |
(CER) |
|
FRUZAQLA® |
$130.5 |
|
— |
— |
|
|
$42.8 |
|
— |
— |
|
|
| ELUNATE® |
$61.0 |
$56.3 |
+8 |
% |
(+13%) |
$46.0 |
$42.0 |
+9 |
% |
(+14%) |
| SULANDA® |
$25.4 |
$22.6 |
+12 |
% |
(+17%) |
$25.4 |
$22.6 |
+12 |
% |
(+17%) |
| ORPATHYS® |
$25.9 |
$22.0 |
+18 |
% |
(+22%) |
$13.1 |
$15.1 |
-14 |
% |
(-10%) |
|
TAZVERIK® |
$0.5 |
$0.4 |
+40 |
% |
(+46%) |
$0.5 |
$0.4 |
+40 |
% |
(+46%) |
|
Oncology Products |
$243.3 |
$101.3 |
+140 |
% |
(+145%) |
$127.8 |
$80.1 |
+59 |
% |
(+64%) |
| Takeda upfront,
milestone and R&D services |
|
|
$33.8 |
$269.1 |
-87 |
% |
(-87%) |
| Other R&D
services |
|
|
$7.1 |
$10.0 |
-29 |
% |
(-27%) |
|
Total Oncology/Immunology |
|
|
$168.7 |
$359.2 |
-53 |
% |
(-52%) |
| Other
Ventures |
|
|
$137.0 |
$173.7 |
-21 |
% |
(-18%) |
|
Total Revenue |
|
|
$305.7 |
$532.9 |
-43 |
% |
(-41%) |
* = For FRUZAQLA®, ELUNATE® and
ORPATHYS®, mainly represented total sales to third parties as
provided by Takeda, Lilly18 and AstraZeneca,
respectively.** = For FRUZAQLA®, represented drug product
supply and royalties paid by Takeda; for ELUNATE®, represented
drug product supply, commercial service fees and royalties paid by
Lilly to HUTCHMED, and sales to other third parties invoiced by
HUTCHMED; for ORPATHYS®, represented drug product supply and
royalties paid by AstraZeneca and sales to other third parties
invoiced by HUTCHMED; for SULANDA® and TAZVERIK®, represented the
Company’s sales of the products to third parties.
II. REGULATORY UPDATES
China
- Savolitinib
sNDA19 accepted by
NMPA20 for first-line
and second-line METex14 NSCLC in 2024;
-
Fruquintinib approved in Hong Kong for third-line
CRC in January 2024;
-
Fruquintinib sNDA accepted by NMPA with Priority Review for
second-line endometrial cancer in early 2024;
-
Tazemetostat approved in Hong Kong for
R/R21 follicular
lymphoma in May 2024; and
-
Tazemetostat NDA accepted by NMPA with Priority Review for
R/R follicular lymphoma in July 2024.
Ex-China
-
Fruquintinib approved in the EU in June 2024,
following positive opinion received from the EMA22 Committee for
Medicinal Products for Human Use for previously-treated metastatic
CRC in April 2024.
III. LATE-STAGE CLINICAL DEVELOPMENT
ACTIVITIES
Savolitinib
(ORPATHYS® in China), a
highly selective oral inhibitor of MET23
- Completed
enrollment of SAVANNAH (NCT03778229), a Fast
Track-designated pivotal global Phase II study for NSCLC patients
who have progressed following TAGRISSO® due to MET amplification or
overexpression, which may file in the US for accelerated approval.
A small parallel study (NCT04606771) in this patient population
presented data at AACR24 also demonstrated higher clinical activity
with the combination therapy, with safety consistent with the known
profiles of each treatment; and
- Continued
enrolling SAFFRON (NCT05261399), a global, pivotal Phase
III study in this patient population of the TAGRISSO® combination
supporting SAVANNAH; SACHI (NCT05015608), a
similar pivotal Phase III study for patients in China that
progressed on EGFR25 inhibitor treatment, and
SANOVO (NCT05009836), a pivotal Phase III study
for first-line patients in China with EGFR mutation & MET
overexpression.
Potential upcoming clinical and regulatory milestones for
savolitinib:
- Complete
enrollment of SACHI in late 2024; and
- File
FDA26 NDA on SAVANNAH,
subject to positive results, around year end 2024.
Fruquintinib
(ELUNATE® in China,
FRUZAQLA® outside of
China), a highly selective oral inhibitor of VEGFR27 1/2/3
designed to have enhanced selectivity that limits off-target kinase
activity
- Presented
results of FRUSICA-1, the registration Phase II study
combined with sintilimab for patients with endometrial cancer with
pMMR28 status, which showed meaningful efficacy improvements
regardless of prior bevacizumab treatment and a manageable toxicity
profile (NCT03903705);
- Presented
FRESCO-2 subgroup analyses at ASCO29, biomarker
analysis at AACR and quality-of-life
analysis at ASCO GI30 (NCT04322539). Analyses
showed that the treatment was effective regardless of prior therapy
or sequence, that CEA31 response may be an early predictor of
improved efficacy, and that it demonstrated clinically meaningful
quality-adjusted survival benefit in patients with
previously-treated CRC; and
- Published
in Nature Medicine the results of
FRUTIGA, the study combined with paclitaxel for gastric
cancer patients in China, concurrently with ASCO and following
initial presentation at ASCO Plenary (NCT03223376). PFS32, ORR33
and DCR34 showed statistically significant improvements, and
although OS35 improvement was not statistically significant
overall, it was statistically significant in a pre-specified
analysis excluding patients taking subsequent antitumor
therapy.
Potential upcoming clinical and regulatory milestones for
fruquintinib:
- Complete
PMDA36 NDA review for previously-treated
metastatic CRC in late-2024; and
- Announce
top-line results from the FRUSICA-2 Phase II/III registration trial
in clear cell RCC37 around year end if
the requisite number of PFS events is reached (NCT05522231).
Sovleplenib (HMPL-523), an
investigative and highly selective oral inhibitor of Syk, an
important component of the Fc receptor and B-cell receptor
signaling pathways
- Published
ESLIM-01 (NCT05029635) results in adult patients with
primary ITP in China in Lancet Haematology
concurrently with presentations at
EHA38. In addition to
demonstrating a clinically meaningful early and sustained durable
response of 48.4% and a tolerable safety profile, it significantly
improved quality of life and showed consistent clinical benefits
regardless of prior lines of therapies, prior TPO/TPO-RA39 exposure
or treatment types;
- Published
results of the Phase II proof-of-concept stage of a study in
patients with warm AIHA in China at EHA, demonstrating a
favorable safety profile and encouraging hemoglobin benefits;
and
- Initiated
ESLIM-02, the Phase III stage of the
study, as a result of this positive data (NCT05535933).
Potential upcoming clinical milestones for sovleplenib:
- Initiate a
dose-finding study in ITP in the US/EU in mid-2024
(NCT06291415); and
- Complete
ESLIM-01 NMPA NDA review around year end.
Surufatinib
(SULANDA® in China), an
oral inhibitor of VEGFR, FGFR40 and CSF-1R41 designed to inhibit
tumor angiogenesis and promote immune response against tumor cells
via tumor associated macrophage regulation
- Initiated a
Phase II/III trial for treatment-naïve metastatic PDAC in
China, in combination with PD-142 antibody 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. This highly aggressive form
of cancer has an estimated 511,000 people diagnosed annually
worldwide.
Tazemetostat
(TAZVERIK® in Hainan, Macau and
Hong Kong), a first-in-class, oral inhibitor of EZH2
- Potential
to complete China NDA review for R/R follicular lymphoma
in mid-2025.
HMPL-453, a novel, highly
selective and potent inhibitor targeting FGFR 1, 2 and 3
- Continued
enrolling the registrational Phase II trial for IHCC43
with FGFR 2 fusion (NCT04353375).
HMPL-306, an investigative and
highly selective oral dual-inhibitor of IDH1 and IDH2 enzymes,
which have been implicated as drivers of certain hematological
malignancies, gliomas and solid tumors
- Presented
results from China and US/European Phase I studies at EHA,
showing it as an effective treatment for IDH1 and/or IDH2-mutated
R/R AML (NCT04272957, NCT04764474); and
- Initiated
RAPHAEL Phase III Trial for IDH1- and/or IDH2-mutated R/R
AML in China (NCT06387069).
Other early-stage investigational drug
candidates
- Presented
preclinical and Phase I results at AACR, ASCO and EHA for
ERK1/244 inhibitor HMPL-295, third-generation BTK inhibitor
HMPL-760, Menin inhibitor HMPL-506, and CD38 ADC45 HMPL-A067;
and
- Initiated
Phase I trial for HMPL-506 for hematological malignancies
in China (NCT06387082).
IV. COLLABORATION UPDATES
Further clinical progress by
Inmagene46 with two candidates
discovered by HUTCHMED
- Received
approximately 7.5% of shares (fully diluted) in Inmagene
following exercise of its option for an exclusive license to
further develop, manufacture and commercialize IMG-007, a
nondepleting anti-OX40 antibody, and IMG-004, a reversible,
non-covalent, highly selective oral BTK inhibitor;
- Inmagene
announced positive interim results from a Phase IIa trial of
IMG-007 for atopic dermatitis. Treatment led to rapid,
marked, and durable improvement of skin signs in patients with
atopic dermatitis, while remaining well-tolerated overall. Final
results are anticipated later in the third quarter of 2024.
Inmagene also completed enrollment of a Phase IIa trial for
alopecia areata; and
- Inmagene
announced positive topline results of a multiple ascending dose
study with IMG-004, indicating once daily dosing
potential. It was well tolerated, without reports of liver
enzyme elevation or bleeding events, across once daily doses ranges
for 10 days. Preliminary modeling and data support 50mg once daily
as a potential therapeutic dose and further development as a
differentiated treatment for BTK-mediated immunological
diseases.
V. OTHER VENTURES
- Other Ventures
revenue is predominantly from our prescription drug distribution
operation in China. Consolidated revenue decreased by 21% (18% at
CER) to $137.0 million (H1-23: $173.7m) primarily as a result of
lower COVID-related prescription drug distribution sales in
2024.
- SHPL47, a
non-consolidated joint venture, saw revenue decrease by 4% (flat at
CER) to $225.2 million (H1-23: $235.3m) mainly due to pricing
reduction in a few higher-priced provinces to standardize the
pricing structure of MUSKARDIA® in preparation for potential
national implementation of volume-based procurement.
- Consolidated net
income attributable to HUTCHMED from our Other Ventures decreased
by 8% (4% at CER) to $34.1 million (H1-23: $37.2m), which was
primarily due to decrease on the net income contributed from SHPL
of $33.8 million (H1-23: $35.1m) as a result of price reduction
impact from volume-based procurement, as well as increase in
R&D spending.
- We continue to
explore opportunities to monetize the underlying value of our SHPL
joint venture including various divestment and collaboration
alternatives.
VI. SUSTAINABILITY
HUTCHMED is committed to progressively embedding
sustainability into all aspects of our operations and creating
long-term value for our stakeholders. In April 2024, we published
our 2023 Sustainability Report, which highlighted progress made in
our 11 goals and targets; our enhanced climate actions including
Scope 3 emissions screening and measurement and engaging with
suppliers; our enhanced data quality; our strengthened alignment of
our five most relevant and material sustainability pillars; and our
enhanced disclosure and sector specific disclosure standards ahead
of requirement.
Wider recognition of HUTCHMED’s efforts have been
reflected in steady improvements in major local and international
sustainability ratings including from Hang Seng, ISS, MSCI, S&P
Global, Sustainalytics and Wind. Recently, HUTCHMED scored 49 for
S&P Global ESG48 Ratings, significantly higher than the
industry average of 31. HUTCHMED also received the Best ESG(E) at
the Hong Kong Investor Relations Association’s 10th Investor
Relations Awards, two awards at Bloomberg Businessweek’s ESG
Leading Enterprises event, five awards from Metro Finance’s GBA ESG
Achievement Awards, and was listed amongst the Top 20 Chinese
Pharmaceutical Listed Companies in ESG Competitiveness by
Healthcare Executive.
In 2024, we continue our efforts on the above
areas and further strengthening our climate action by conducting a
more comprehensive climate risk assessment to quantify the impact
of climate risks in our major operations; incorporate
sustainability into our corporate culture; and considering future
goals and targets.
FINANCIAL HIGHLIGHTS
Foreign exchange impact: The
RMB depreciated against the US dollar on average by approximately
4% during the first half of 2024, which has impacted our
consolidated financial results as highlighted below.
Cash, Cash Equivalents and Short-Term
Investments were $802.5 million as of June 30, 2024 compared to
$886.3 million as of December 31, 2023.
- Adjusted Group
(non-GAAP49) net cash flows excluding financing activities in the
first half of 2024 were ‑$51.3 million (H1-23: $219.3m), mainly due
to $39.8 million net cash used in operating activities and $10.1
million of capital expenditure; and
- Net cash used in
financing activities in the first half of 2024 totaled $32.6
million due to purchases for equity awards of $36.1 million (H1-23:
net cash generated from financing activities of $5.8m).
Revenue for the six months ended June
30, 2024 was $305.7 million compared to $532.9 million in the six
months ended June 30, 2023.
-
Oncology/Immunology consolidated
revenue amounted to $168.7 million (H1-23:
$359.2m) from:
-
FRUZAQLA® revenue was
$42.8 million, reflecting its successful US launch since
early November 2023, comprising royalties and manufacturing
revenue;
-
ELUNATE® revenue
increased 9% (14% at CER) to $46.0 million (H1-23: $42.0m)
in its sixth year since launch, comprising of manufacturing
revenue, promotion and marketing service revenue and royalties,
which is in line with CRC market growth, maintaining our leading
market share position while weathering greater market
competition;
-
SULANDA® revenue
increased 12% (17% at CER) to $25.4 million (H1-23:
$22.6m) continued sales growth after NRDL renewal as doctors’
awareness continues to increase, leading to greater NET patient
access and market share;
-
ORPATHYS® revenue
decreased 14% (10% at CER) to $13.1 million (H1-23:
$15.1m), due to a reduction in manufacturing revenue to $5.3
million (H1-23: $8.5m), offset by an increase in royalties to $7.8
million (H1-23: $6.6m) reflecting strong in-market sales growth of
18% (22% at CER);
-
TAZVERIK® revenue was
$0.5 million (H1-23: $0.4m) mainly from sales in the
Hainan Pilot Zone50;
- Takeda
upfront, milestones and R&D services revenue decreased to $33.8
million (H1-23: $269.1m, of which $258.7m was the
recognized portion of the $400 million upfront cash payment
received from Takeda in April 2023); and
- Other
R&D services revenue of $7.1 million (H1-23: $10.0m),
primarily related to fees from AstraZeneca and Lilly for the
management of development and regulatory activities.
- Other
Ventures consolidated revenue decreased 21% (18% at CER) to $137.0
million (H1-23: $173.7m), primarily as a result of lower
COVID-related prescription drug distribution sales in 2024. This
excluded non‑consolidated revenue at SHPL of $225.2 million (H1-23:
$235.3m).
Net Expenses for the six months ended
June 30, 2024 were $279.9 million compared to $364.3 million in the
six months ended June 30, 2023, reflecting our strong efforts on
cost control.
- Cost of
Revenue decreased by 14% to $180.1 million (H1-23:
$208.3m), which was the net result of a reduction in cost of
revenue from our Other Ventures, offset by the increase in product
sales of our marketed products and the cost of promotion and
marketing services for ELUNATE® resulting from the increased sales
force;
- R&D
Expenses reduced 34% to $95.3 million (H1-23: $144.6m),
mainly due to the strategic prioritization of our pipeline,
particularly outside China. Clinical and regulatory expenses in the
US and Europe were $14.9 million (H1-23: $55.6m), while R&D
expenses in China were $80.4 million (H1-23: $89.0m);
-
S&A51
Expenses were $57.8 million (H1-23: $68.3m), which
decreased primarily due to tighter control over our spending, while
utilizing existing infrastructure to support further revenue
growth; and
- Other
Items mainly comprised of equity in earnings of SHPL,
interest income and expense, FX and taxes, generated net income of
$53.3 million (H1-23: $56.9m), which decreased primarily due to
lower foreign currency exchange gains recognized in the
period.
Net Income attributable to HUTCHMED for
the six months ended June 30, 2024 was $25.8 million compared to
$168.6 million for the six months ended June 30, 2023.
- The net income
attributable to HUTCHMED for the six months ended June 30, 2024 was
$0.03 per ordinary share / $0.15 per ADS52, (H1-23: $0.20 per
ordinary share / $1.00 per ADS).
FINANCIAL GUIDANCE
We reiterate full year 2024 guidance for
Oncology/Immunology consolidated revenue is $300 million to $400
million, driven by 30% to 50% growth target in oncology marketed
product revenue. HUTCHMED’s work in 2024 and beyond will be
supported by its strong balance sheet. The Company is thus well
placed to deliver against its target to become a self-sustaining
business and its goal to bring its innovative medicines to patients
globally through its own sales network in China markets and through
partners worldwide.
Shareholders and investors should note that:
- we do 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
- we have in the past revised our
financial guidance and reference should be made to any
announcements published by us 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 SUMMARY
Condensed Consolidated Balance Sheets
Data
|
(in $’000) |
As ofJune 30, 2024 |
|
As ofDecember 31, 2023 |
| Assets |
(Unaudited) |
|
|
|
Cash and cash equivalents and short-term investments |
802,453 |
|
886,336 |
|
Accounts receivable |
156,916 |
|
116,894 |
|
Other current assets |
88,891 |
|
93,609 |
|
Property, plant and equipment |
94,815 |
|
99,727 |
|
Investment in an equity investee |
80,519 |
|
48,411 |
|
Other non-current assets |
37,274 |
|
34,796 |
| Total
assets |
1,260,868 |
|
1,279,773 |
| Liabilities and
shareholders’ equity |
|
|
|
|
Accounts payable |
43,398 |
|
36,327 |
|
Other payables, accruals and advance receipts |
249,218 |
|
271,399 |
|
Deferred revenue |
108,777 |
|
127,119 |
|
Bank borrowings |
82,100 |
|
79,344 |
|
Other liabilities |
25,357 |
|
22,197 |
| Total
liabilities |
508,850 |
|
536,386 |
| Company’s shareholders’
equity |
740,084 |
|
730,541 |
| Non-controlling interests |
11,934 |
|
12,846 |
| Total liabilities and
shareholders’ equity |
1,260,868 |
|
1,279,773 |
Condensed Consolidated Statements of
Operations Data
| (Unaudited, in $’000, except
share and per share data) |
Six months ended June 30, |
| |
2024 |
|
2023 |
| Revenue: |
|
|
|
|
Oncology/Immunology – Marketed Products |
127,796 |
|
|
80,149 |
|
|
Oncology/Immunology – R&D |
40,841 |
|
|
279,034 |
|
|
Oncology/Immunology consolidated revenue |
168,637 |
|
|
359,183 |
|
|
Other Ventures |
137,044 |
|
|
173,691 |
|
|
Total revenue |
305,681 |
|
|
532,874 |
|
|
|
|
|
|
| Operating
expenses: |
|
|
|
|
Cost of revenue |
(180,135 |
) |
|
(208,324 |
) |
|
Research and development expenses |
(95,256 |
) |
|
(144,633 |
) |
|
Selling and administrative expenses |
(57,811 |
) |
|
(68,263 |
) |
|
Total operating expenses |
(333,202 |
) |
|
(421,220 |
) |
|
|
|
|
|
|
|
(27,521 |
) |
|
111,654 |
|
|
Other income, net |
22,765 |
|
|
25,434 |
|
| (Loss)/income before
income taxes and equity in earnings of an
equity investee |
(4,756 |
) |
|
137,088 |
|
|
Income tax expense |
(2,886 |
) |
|
(2,730 |
) |
|
Equity in earnings of an equity investee, net of tax |
33,807 |
|
|
35,110 |
|
| Net
income |
26,165 |
|
|
169,468 |
|
| Less: Net income attributable
to non-controlling interests |
(364 |
) |
|
(917 |
) |
| Net income
attributable to HUTCHMED |
25,801 |
|
|
168,551 |
|
|
|
|
|
|
| Earnings per share
attributable to HUTCHMED (US$ per share) |
|
|
|
|
– basic |
0.03 |
|
|
0.20 |
|
|
– diluted |
0.03 |
|
|
0.19 |
|
| Number of shares used in per
share calculation |
|
|
|
|
– basic |
856,030,704 |
|
|
846,928,863 |
|
|
– diluted |
872,534,466 |
|
|
866,990,610 |
|
|
|
|
|
|
| Earnings per ADS
attributable to HUTCHMED (US$ per ADS) |
|
|
|
|
– basic |
0.15 |
|
|
1.00 |
|
|
– diluted |
0.15 |
|
|
0.97 |
|
| Number of ADSs used in per
share calculation |
|
|
|
|
– basic |
171,206,141 |
|
|
169,385,773 |
|
|
– diluted |
174,506,893 |
|
|
173,398,122 |
|
|
|
|
|
|
|
|
About HUTCHMED
HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) is an
innovative, commercial-stage, biopharmaceutical company. It is
committed to the discovery, global development and
commercialization of targeted therapies and immunotherapies for the
treatment of cancer and immunological diseases. It has
approximately 5,000 personnel across all its companies, at the
center of which is a team of about 1,800 in oncology/immunology.
Since inception it has focused on bringing cancer drug candidates
from in-house discovery to patients around the world, with its
first three oncology medicines marketed in China, the first of
which is also marketed in the US. 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 |
|
| Ben Atwell / Alex Shaw,
FTI Consulting |
+44 20 3727 1030 /
+44 7771 913 902 (Mobile) /
+44 7779 545 055 (Mobile) /
HUTCHMED@fticonsulting.com |
| Zhou Yi, Brunswick |
+852 9783 6894 (Mobile) /
HUTCHMED@brunswickgroup.com |
| |
|
| Nominated
Advisor |
|
| Atholl Tweedie / Freddy Crossley
/ Rupert Dearden, Panmure Liberum |
+44 (20) 7886 2500 |
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, including, among others, the risk that HUTCHMED’s ADSs
could be barred from trading in the United States as a result of
the Holding Foreign Companies Accountable Act and the rules
promulgated thereunder; 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
inability of a drug candidate to meet the primary or secondary
endpoint of a study; the 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 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 of HUTCHMED to meet
any of its financial projections or guidance and changes to the
assumptions underlying those projections or guidance; 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 and
uncertainties regarding the impact of pandemics and disease
outbreaks. For further discussion of these and other risks, see
HUTCHMED’s filings with the US Securities and Exchange Commission,
on AIM and on HKEX53. 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/584882e0-cb55-4c65-8b21-f088947ccfee
_________________
|
REFERENCES & ABBREVIATIONS |
|
1 |
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” below for
further information relevant to the interpretation of these
financial measures and reconciliations of these financial
measures to the most comparable GAAP measures. |
| 2 |
In-market sales = total sales to
third parties provided by Eli Lilly (ELUNATE®), Takeda (FRUZAQLA®),
AstraZeneca (ORPATHYS®) and HUTCHMED (ELUNATE®, SULANDA®,
ORPATHYS® and TAZVERIK®). |
| 3 |
R&D = Research and
development. |
| 4 |
Takeda = Takeda Pharmaceuticals
International AG, a subsidiary of Takeda Pharmaceutical Company
Limited. |
| 5 |
ITP = immune thrombocytopenia
purpura. |
| 6 |
NDA = New Drug Application. |
| 7 |
NSCLC = Non-small cell lung
cancer. |
| 8 |
METex14 = MET exon 14 skipping
alterations. |
| 9 |
AIHA = Autoimmune hemolytic
anemia. |
| 10 |
AML = Acute myeloid
leukemia. |
| 11 |
PDAC = Pancreatic ductal
adenocarcinoma. |
| 12 |
Syk = Spleen tyrosine
kinase. |
| 13 |
EZH2 = Enhancer of zeste homolog
2. |
| 14 |
IDH = Isocitrate
dehydrogenase. |
| 15 |
BTK = Bruton’s tyrosine
kinase. |
| 16 |
CRC = Colorectal cancer. |
| 17 |
NRDL = China National
Reimbursement Drug List. |
| 18 |
Lilly = Eli Lilly and
Company. |
| 19 |
sNDA = Supplemental New Drug
Application. |
| 20 |
NMPA = China National Medical
Products Administration. |
| 21 |
R/R = Relapsed and/or
refractory. |
| 22 |
EMA = European Medicines
Agency. |
| 23 |
MET = Mesenchymal epithelial
transition factor. |
| 24 |
AACR = American Association for
Cancer Research Annual Meeting. |
| 25 |
EGFR = Epidermal growth factor
receptor. |
| 26 |
FDA = Food and Drug
Administration. |
| 27 |
VEGFR = Vascular endothelial
growth factor receptor. |
| 28 |
pMMR = Proficient mismatch
repair. |
| 29 |
ASCO = American Society of
Clinical Oncology Annual Meeting. |
| 30 |
ASCO GI = ASCO Gastrointestinal
Cancers Symposium. |
| 31 |
CEA = Carcinoembryonic
antigen. |
| 32 |
PFS = Progression free
survival. |
| 33 |
ORR = Objective response
rate. |
| 34 |
DCR = Disease control rate. |
| 35 |
OS = Overall survival. |
| 36 |
PMDA = Pharmaceuticals and
Medical Devices Agency. |
| 37 |
RCC = Renal cell carcinoma. |
| 38 |
EHA = European Hematology
Association. |
| 39 |
TPO/TPO-RA = Thrombopoietin
and/or thrombopoietin receptor agonists. |
| 40 |
FGFR = Fibroblast growth factor
receptor. |
| 41 |
CSF-1R = Colony-stimulating
factor 1 receptor. |
| 42 |
PD-1 = Programmed cell death
protein-1. |
| 43 |
IHCC = Intrahepatic
cholangiocarcinoma. |
| 44 |
ERK = Extracellular
signal-regulated kinase. |
| 45 |
ADC = Antibody-drug
conjugate. |
| 46 |
Inmagene = Inmagene
Biopharmaceuticals. |
| 47 |
SHPL = Shanghai Hutchison
Pharmaceuticals Limited. |
| 48 |
ESG = Environmental, Social and
Governance. |
| 49 |
GAAP = Generally Accepted
Accounting Principles. |
| 50 |
Hainan Pilot Zone = Hainan Boao
Lecheng International Medical Tourism Pilot Zone. |
| 51 |
S&A= Selling and
administrative expenses. |
| 52 |
ADS = American depositary
share. |
| 53 |
HKEX = The Main Board of The
Stock Exchange of Hong Kong Limited. |
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