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HUTCHMED Reports 2021 Full Year Results and Provides Business Updates Oncology/Immunology revenues up 296% to $119.6 million, due to ELUNATE growth and the 2021 launches of SULANDA and ORPATHYS ; Positive SAVANNAH, CALYP

Key Takeaway: Reports 2021 Full Year Results and Provides Business Updates Oncology/Immunology revenues up 296% to $119.6 million, due to ELUNATE growth and the 2021 launches of SULANDA and ORPATHYS ; Positive SAVANNAH, CALYPSO and VIKTORY studies triggered five registration studies on ORP

Full Press Release Details

Reports 2021 Full Year Results and Provides Business Updates
Oncology/Immunology revenues up 296% to $119.6
million, due to ELUNATE growth and the 2021 launches of SULANDA and ORPATHYS ;
Positive SAVANNAH, CALYPSO and VIKTORY studies
triggered five registration studies on ORPATHYS in lung cancer, kidney and gastric cancer during 2021;
development program - currently enrolling 13 registration studies on 6 assets - with enrollment on the 691 patient
FRESCO-2 global Phase III of fruquintinib now complete.
Company to Host Annual Results Call &
Webcast Today at 9 p.m. HKT / 1 p.m. GMT / 8 a.m. EST
Kong, Shanghai & Florham Park, NJ - Thursday, March 3, 2022: HUTCHMED (China) Limited ("HUTCHMED")
(Nasdaq/AIM:HCM; HKEX:13), the innovative, commercial-stage biopharmaceutical company, today reports its audited financial results for
the year ended December 31, 2021 and provides updates on key clinical and commercial developments since the start of 2022.
All amounts are expressed in U.S. dollars
unless otherwise stated.
YEAR Results & Business Updates
was an exceptional year for HUTCHMED," said Mr. Simon To, Chairman of HUTCHMED. "Commercial success on ELUNATE
and the launches of SULANDA and ORPATHYS contributed to an almost four-fold increase in consolidated
oncology/immunology revenues to $119.6 million, with momentum continuing in 2022.
took a major step forward in 2021 with its first approval and important, and as yet unpublished, data from the SAVANNAH study in
combination with TAGRISSO . We and our partner AstraZeneca1 initiated four Phase III studies and one Phase
II study, with registration potential, for ORPATHYS during 2021. These actions have triggered $40 million in milestone
payments to HUTCHMED since mid-2021. A seventh registration study, a global Phase III in NSCLC2,
the SAFFRON study, is set to initiate in mid-2022.
We are rapidly progressing our plan to expand
our oncology assets into global markets. Led by our team of over 800-personnel in discovery, development and manufacturing operations,
we have an un-equaled fifteen-year track-record of producing highly quality novel oncology/immunology drug candidates.
of our assets are now being developed outside China. In addition to the global progress of ORPATHYS , surufatinib's
U.S. NDA3 and EU MAA4
are in the later stages of regulatory review for advanced NETs; enrollment was completed for fruquintinib in a fourteen-country
global Phase III study, the FRESCO-2 study, in CRC5
which reads-out later in 2022; positive and differentiated POC data was presented for amdizalisib and sovleplenib; and our
ERK8, third generation BTK9
and CSF-1R10 inhibitors all
made good progress in early development.
With a strong track record in bringing innovative
drugs to patients through rigorous clinical trials, our seasoned clinical team is now enrolling 13 registration studies for six assets
with an additional 5 registration studies set to initiate in 2022. With over $1 billion in cash, and the intention to divest further
non-core assets, we anticipate having sufficient runway to see our plans through.
Our strategy is to launch a stream of new products
in both the China and global markets over the coming years, helping patients with unmet needs and creating value for all our stakeholders."
I. COMMERCIAL OPERATIONS
(Growth vs. Prior Period) In-market Sales* Consolidated Revenue**
2021 Jan -Feb 2022 Unaudited 2021 Jan-Feb 2022 Unaudited
ELUNATE $71.0m (111%) $21.6m (51%) $53.5m (168%) $13.5m (33%)
SULANDA $11.6m - $6.0 m (21%) $11.6m - $6.0 m (21%)
ORPATHYS $15.9m - $7.4m - $11.3m - $4.8m -
Product Sales $98.5m (192%) $35.0m (81%) $76.4m (282%) $24.3m (61%)
Other R&D 14 Service income $18.2m (77%) $3.7m (80%)
Milestone payments $25.0m - $15.0m -
Total Oncology/ Immunology $119.6m (296%) $43.0m (151%)
* = For ELUNATE and ORPATHYS , represents total sales to third parties as provided by Lilly and AstraZeneca, respectively; ** = For ELUNATE and ORPATHYS , represents manufacturing fees, commercial service fees and royalties paid by Lilly and AstraZeneca, respectively, to HUTCHMED, and sales to other third parties invoiced by HUTCHMED; For SULANDA , represents the Company's sales of the product to third parties.
II. REGULATORY ACHIEVEMENTS
United States and Europe
III. CLINICAL DEVELOPMENT
(ORPATHYS ), a highly selective oral inhibitor of MET being developed broadly across MET-driven patient
populations in lung and gastric cancer and renal cell carcinoma
Major clinical milestones for savolitinib in 2021:
Major savolitinib clinical data presentations in 2021:
Potential upcoming clinical and regulatory milestones
for savolitinib in 2022:
(SULANDA in China), an oral inhibitor of VEGFR25,
FGFR and CSF-1R designed to inhibit tumor angiogenesis and promote the body's immune response against tumor cells via tumor associated
macrophage regulation; approved and launched in China
Major clinical milestones for surufatinib in 2021:
Major surufatinib clinical data presentations in 2021:
Potential upcoming clinical and regulatory milestones
for surufatinib in 2022:
(ELUNATE in China), a highly selective oral inhibitor of VEGFR 1/2/3 designed to improve kinase selectivity
to minimize off-target toxicity and thereby improve tolerability; approved and launched in China
Major clinical milestones for fruquintinib in 2021:
Major fruquintinib clinical data presentations in 2021:
Potential upcoming clinical and regulatory milestones
for fruquintinib in 2022:
(HMPL-689), an investigative and highly selective oral inhibitor of PI3K 39
designed to address the gastrointestinal and hepatotoxicity associated with currently approved and clinical-stage PI3K
Major clinical milestones for amdizalisib in 2021:
Major amdizalisib clinical data presentation in 2021:
Potential upcoming clinical and regulatory milestones
for amdizalisib in 2022:
(HMPL-523), an investigative and highly selective oral inhibitor of Syk41,
an important component of the B-cell receptor signaling pathway, for the treatment of hematological cancers and immune diseases
Major clinical and regulatory milestones for sovleplenib
Major sovleplenib clinical data presentations in 2021:
Potential upcoming clinical milestone for sovleplenib
(TAZVERIK in the U.S. and Japan), an inhibitor of EZH2 licensed from Epizyme for which HUTCHMED
is collaborating to research, develop, manufacture and commercialize in Greater China
Potential upcoming clinical and regulatory milestones
for tazemetostat in 2022:
an investigative and highly selective oral inhibitor of FGFR 1/2/3
an investigative and highly selective oral inhibitor of IDH1/2 designed to address resistance to the currently marketed
Major clinical and regulatory milestones for HMPL-306
Potential upcoming clinical and regulatory milestones
for HMPL-306 in 2022:
an investigative and highly selective oral inhibitor of ERK
in the MAPK pathway43
with the potential to address intrinsic or acquired resistance from upstream mechanisms such as RAS-RAF-MEK
an investigative, highly selective, third-generation oral inhibitor of BTK with improved potency versus first generation
BTK inhibitors against both wild type & C481S mutant enzymes
an investigative, highly selective, and potent CSF-1R inhibitor designed to target CSF-1R driven tumors as a monotherapy
a differentiated, red blood cell sparing CD47 monoclonal antibody
Ventures include our profitable prescription drug marketing and distribution platforms covering about 290 cities and
towns in China with around 2,900 mainly manufacturing and commercial personnel.
VI. OTHER CORPORATE DEVELOPMENTS
Potential upcoming corporate developments:
VII. IMPACT OF COVID-19
COVID-19 did not impact our research, our clinical
studies or our commercial activities in any material manner in 2021. Certain regulatory inspections of our manufacturing facilities in
China by the U.S. FDA have, however, been postponed due to travel restrictions. We will continue to closely work with regulators and
monitor the evolving situation.
Last updated: Mar 3, 2022