Full Press Release Details
HUTCHMED Reports 2023 Full Year Results and
Provides Business Updates
(102% CER) to US$838 million, with net income of US$101 million
First U.S. FDA approval of our self-developed
medicine, FRUZAQLA (fruquintinib)
Sovleplenib for ITP accepted for NDA review
in China, with Priority Review status and Breakthrough Therapy designation
& Florham Park, NJ - Wednesday, February 28, 2024: HUTCHMED (China) Limited ("HUTCHMED", the "Company"
or "we") (Nasdaq/AIM:HCM; HKEX:13), the innovative, commercial-stage biopharmaceutical company, today reports its financial
results for the year ended December 31, 2023 and provides updates on key clinical and commercial developments. HUTCHMED to host results
call and webcasts today at 7:30 a.m. EST / 12:30 p.m. GMT / 8:30 p.m. HKT in English, and at 8:30 a.m. HKT
in Chinese (Putonghua) on Thursday, February 29, 2024.
All amounts are expressed in U.S. dollars unless
Strategic: global vision, commitment to
patients and path to self-sustainability
Pipeline: fruquintinib global and China
expansion, sovleplenib China NDA3 review, savolitinib NSCLC4 enrolled
Outlook and financial: expecting strong
product revenue growth and reduced expenses; substantial cash
2023 FULL YEAR RESULTS & BUSINESS UPDATES
To, Executive Chairman of HUTCHMED, said, "We have made significant progress throughout 2023. We executed against
our commitment to bring our innovative medicines to patients worldwide with the U.S. FDA approval of FRUZAQLA in
November 2023, while remaining dedicated to becoming a self-sustaining business. The Takeda partnership, which is one of the biggest
small-molecule overseas licensing deals in the history of China biotech, strengthened our cash position by $435 million. Takeda
delivered a successful U.S. launch within 48 hours of approval, and has subsequently seen strong early patient uptake."
"We will continue to deliver on our strategy
in 2024. We will stay focused on our target of becoming sustainable through our balanced strategy of growing sales of our novel medicines
in China, and advancing our medicines overseas with our partners. This, when combined with our other goals on pipeline progression and
further business development, means that while the global macroeconomic environment remains uncertain. HUTCHMED is positioned to thrive
and continue to deliver innovative medicines to ever more patients around the world."
Chief Executive Officer and Chief Scientific Officer of HUTCHMED, said, "HUTCHMED delivered impressive financial results
in 2023, with revenue up 97% to $838 million. This, alongside our significantly strengthened cash balance of $886 million, will enable
us to continue advancing our pipeline and successfully executing our strategy."
"2023 was an important year for
HUTCHMED, particularly for fruquintinib, for which we filed market authorization applications in the U.S., EU and Japan, based on
the successful FRESCO-2 study. Following the U.S. FDA approval for third-line patients with advanced CRC, we continue to work together with Takeda continue to
pursue additional launches in new markets worldwide. In China, we also filed an NDA for second-line gastric cancer based on the
"Another milestone was the successful
ESLIM-01 registration study in China in ITP patients for sovleplenib, our first potential novel medicine in immunological diseases.
The NDA was accepted and granted priority review by the NMPA in January 2024. There are over 250,000 new and existing adult ITP
patients in China.20 The treatment options are limited to steroids and TPO/TPO-RAs21, representing an unmet
medical need that sovleplenib could help address, with its new mechanism of action and favorable safety profile. Syk inhibition has
the potential to target other major diseases such as rheumatoid arthritis. We are also planning to initiate clinical development of
sovleplenib outside China in 2024."
"For savolitinib, we completed the confirmatory
trial in NSCLC patients with MET22 exon 14 skipping alterations. An NDA submission is expected in the first quarter of 2024,
with potential to expand the label indication to include first-line patients in China. Outside China, we will continue our work with
AstraZeneca on the pivotal global savolitinib lung cancer trial SAVANNAH, which, subject to favorable data, can support a filing to the
U.S. FDA for approval. This study completed enrollment with a potential NDA submission towards the end of 2024 in EGFR23 mutant
NSCLC patients who progressed on TAGRISSO treatment, which received U.S. FDA Fast Track designation in January 2023.
We believe the convenient dosing, targeted efficacy and safety profile of savolitinib as an oral medicine in combination with TAGRISSO ,
the leading oral third-generation EGFR TKI24, should position it well in a competitive market and address the unmet needs
of MET+ NSCLC patients."
"Our China commercialization efforts progressed
well, as we successfully renewed NRDL25 coverage for both fruquintinib and surufatinib without further price reduction. Their
in-market sales saw strong growth in 2023. Over the next two years, we plan to continue growth in China through expanded
indications and the launch of new products together with revenue from FRUZAQLA overseas commercialization."
I. COMMERCIAL OPERATIONS
increased 97% (102% at CER) to $838.0 million in 2023 (2022: $426.4m), driven by the Takeda partnership, our strong
commercial progress in China, and growth in third-party distribution sales, resulting in a net income of $101 million for 2023.
consolidated revenue were up 223% (228% at CER) to $528.6 million (2022: $163.8m); towards the high end of our guidance
driven by recognition of $280.0 million in partnering revenue for the upfront payment, $32.0 million for U.S. FDA approval milestone
payments from Takeda, and our strong product sales growth resulting from in-market sales up 28% (35% at CER) to $213.6 million (2022:
| $'millions | In-market Sales* | Consolidated Revenue** | |||||||||||||||
| 2023 | 2022 | % | (CER) | 2023 | 2022 | % | (CER) | ||||||||||
| ELUNATE | $ 107.5 | $ 93.5 | +15% | (+22%) | $ 83.2 | $ 69.9 | +19% | (+26%) | |||||||||
| FRUZAQLA | $ 15.1 | - | - | - | $ 7.2 | - | - | - | |||||||||
| SULANDA | $ 43.9 | $ 32.3 | +36% | (+43%) | $ 43.9 | $ 32.3 | +36% | (+43%) | |||||||||
| ORPATHYS | $ 46.1 | $ 41.2 | +12% | (+19%) | $ 28.9 | $ 22.3 | +30% | (+37%) | |||||||||
| TAZVERIK | $ 1.0 | $ 0.1 | >700% | - | $ 1.0 | $ 0.1 | >700% | - | |||||||||
| Products Revenue | $ 213.6 | $ 167.1 | +28% | (+35%) | $ 164.2 | $ 124.6 | +32% | (+39%) | |||||||||
| Other R&D services income | $ 52.4 | $ 24.2 | +116% | (+119 %) | |||||||||||||
| Upfront and milestone income | $ 312.0 | $ 15.0 | |||||||||||||||
| Total Oncology/Immunology | $ 528.6 | $ 163.8 | +223% | (+228 %) | |||||||||||||
| Other Ventures | $ 309.4 | $ 262.6 | +18% | (+24%) | |||||||||||||
| Total revenue | $ 838.0 | $ 426.4 | +97% | (+102 %) |
FRUZAQLA and ORPATHYS , mainly represents total sales to third parties as provided by Lilly26,
Takeda and AstraZeneca, respectively.
represents drug product supply, commercial service fees and royalties paid by Lilly, to HUTCHMED, and sales to other third parties
invoiced by HUTCHMED; for FRUZAQLA , represents drug product supply and royalties paid by Takeda; for ORPATHYS ,
represents drug product supply and royalties paid by AstraZeneca and sales to other third parties invoiced by HUTCHMED; for SULANDA
and TAZVERIK , represents the Company's sales of the products to third parties.
II. REGULATORY UPDATES
III. LATE-STAGE CLINICAL DEVELOPMENT ACTIVITIES
(ORPATHYS in China), a highly selective oral inhibitor of MET being developed broadly across MET-driven
patient populations in lung, gastric and papillary renal cell carcinomas
Potential upcoming clinical and regulatory milestones
(ELUNATE in China, FRUZAQLA in the U.S.), a highly selective oral inhibitor of VEGFR27
1/2/3 designed to have enhanced selectivity that limits off-target kinase activity, allowing for high drug exposure, sustained target
inhibition, and flexibility for the potential use as part of a combination therapy
Potential upcoming clinical and regulatory milestones
(SULANDA in China), an oral inhibitor of VEGFR, FGFR34 and CSF-1R35 designed to
inhibit tumor angiogenesis and promote immune response against tumor cells via tumor associated macrophage regulation
(HMPL-523), an investigative and highly selective oral inhibitor of Syk, an important component of the Fc receptor and
B-cell receptor signaling pathway
Potential upcoming clinical milestones for sovleplenib:
(TAZVERIK in Macau and the China Hainan Pilot Zone), a first-in-class, oral inhibitor of EZH2 licensed
Potential upcoming clinical and regulatory milestones
a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3
(HMPL-689), an investigative and highly selective oral inhibitor of PI3K 41 designed to address the
gastrointestinal and hepatotoxicity associated with currently approved and clinical-stage PI3K inhibitors
IV. COLLABORATION UPDATES
Closed Exclusive Worldwide License to Takeda
for Fruquintinib Outside China
Further clinical progress by Inmagene42
with two candidates discovered by HUTCHMED
Other Ventures include our profitable prescription
drug marketing and distribution platforms
HUTCHMED is committed to progressively embedding
sustainability into all aspects of our operations and creating long-term value for our stakeholders. In 2023, we continued to make progress,
These efforts will continue to guide HUTCHMED
towards a more sustainable future. The 2023 Sustainability Report will be published alongside our 2023 Annual Report in April 2024 and