Full Press Release Details
HUTCHMED Reports 2022 Full Year Results
and Provides Business Updates
Landmark licensing deal with Takeda
for fruquintinib outside of China, bringing HUTCHMED up to US$1.13 billion, plus royalties, and demonstrating execution of the new
Record Full Year 2022 oncology/immunology
revenues driven by significant increase in China in-market sales of ELUNATE , SULANDA and ORPATHYS
alongside clinical and strategic progress
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 - Tuesday, February 28, 2023: 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, 2022 and provides updates on key clinical and commercial
All amounts are expressed in U.S. dollars
unless otherwise stated.
| Announced a strategy update, including a prioritization of late-stage assets and a new global partnership approach to bring innovative medicines to patients outside of China | ||
| Signed a landmark licensing agreement with Takeda 1 to license fruquintinib outside of China for a potential total of up to $1.13 billion, plus royalties on net sales, demonstrating this strategy in action | ||
| Focus on driving near-term value creation and establishing a profitable, sustainable business over the long term |
| FRESCO-2 Phase III data for fruquintinib in refractory metastatic CRC 2 , our first global multi-regional clinical trial and presented at ESMO 3 , met the primary end point of overall survival with a 34% reduction in risk of death | ||
| Started rolling submission of NDA 4 to U.S. FDA 5 for fruquintinib for the treatment of refractory CRC | ||
| Statistically significant PFS 6 benefit in fruquintinib FRUTIGA Phase III in China with supplemental NDA in preparation | ||
| Global SAVANNAH Phase II data for savolitinib showed 52% response rate and 9.6 months duration of response in high MET 7 2L+ NSCLC 8 patients with no prior chemotherapy | ||
| ORPATHYS (savolitinib) to be included in NRDL 9 effective March 1, 2023 | ||
| Over 15 registration/registration-intent studies ongoing with six products |
| Oncology/Immunology revenues up 37% (41% CER 10 ) to $163.8 million and in line with guidance | ||
| ELUNATE , SULANDA and ORPATHYS combined in-market sales 11 up 70% | ||
| Substantial cash balance, plus $400 million upfront payment from Takeda at closing, will position HUTCHMED well on the path to a sustainable business |
2022 Full Year Results & Business
"I am proud of the progress that we at
HUTCHMED have made during 2022," said Mr Simon To, Chairman of HUTCHMED. "This work is already bearing fruit, as indicated
not only by the increase in revenues, but also the positive clinical and regulatory progress we have made with fruquintinib - culminating
in the successful, post-period licensing agreement with Takeda, marking a significant delivery against the Company's strategy.
This out-licensing ensures we remain true to the overall goal of our business of safeguarding access to our innovative medicines to patients
globally. Further, our partnerships provide significant financial momentum while we focus on revenue growth from increased product sales
"This strategy of revenue growth and strategic
partnerships places us well on the path to a sustainable business. It is this path which will allow us to continue our expansion, as
demonstrated by HUTCHMED's continued delivery in China where our oncology commercial team has reached about 900 people to support
greater access to our medicines; our ongoing development of savolitinib, which became our third product on the NRDL; and the continued
ability of our business to develop medicines towards global markets. It is through this ability that we expect to see multiple New Drug
Applications being made not only in China but with key regulators around the world as we look to extend our ability to bring potentially
life changing medicines to patients around the world."
"2022 has been a key turning point for
HUTCHMED, but I believe it will enable us to truly reach our goal of becoming a global biopharmaceutical company."
Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, said, "2022 was a pivotal year for HUTCHMED.
Challenged by difficult market conditions, the team worked incredibly hard to position HUTCHMED for success today as well as for a promising
future. In November, we announced a new strategy that focuses on accelerating our path to a sustainable and profitable business, which
involves a reprioritization of pipeline assets and a partnership approach for bringing our innovative medicines more efficiently to patients
outside of China. We believe that this new strategy has unlocked greater value in the Company and we are already seeing a positive impact
from this approach."
early 2023 we announced a significant licensing deal with Takeda for the global development, commercialization and manufacturing of fruquintinib,
outside of China. We are pleased to have attracted such a strong partner and to place fruquintinib in the hands of a company with the
scale, expertise, resources and commitment to maximize its success globally, as we believe we are already doing in China. The expected
proceeds from the deal notably extends our cash runway, and the additional bandwidth allows us to continue to pursue value-driving opportunities
from our internal pipeline while supporting our commercial growth in China. The Takeda deal perfectly exemplifies our global partnership
approach and showcases our commitment to fulfilling our promises, swiftly and effectively."
"This approach goes hand in hand with the
strategic prioritization of our pipeline. This includes focusing our development efforts on late-stage assets through clinical development
and towards patients. Ultimately, this is how we will accelerate our path to a sustainable business over the long term. As part of our
pipeline prioritization, we have reduced some funding to select international clinical programs and we look to further develop of some
of these programs through partnerships. Specifically, these changes affect amdizalisib, HMPL-306 and HMPL-760 international clinical
programs. We will continue the surufatinib clinical program in Japan where a bridging study is fully recruited. Going forward, HUTCHMED
still intends to continue to run early phase development programs for select drug candidates in the U.S., EU and Japan including sovleplenib
where we believe our compounds are differentiated from a global perspective. This does not impact our commitment to patients, which,
if anything, has intensified as we sharpen our focus on a smaller set of programs that we believe have the most immediate patient impact.
I am proud of what the team has achieved this
year amidst very difficult times for the sector, and feel very positive about our outlook."
I. COMMERCIAL OPERATIONS
| Total revenues increased 20% (24% CER) to $426.4 million in 2022 (2021: $356.1m), driven by commercial progress on our three in-house developed oncology drugs in China; | ||
| Oncology/Immunology consolidated revenues up 37% (41% CER) to $163.8 million (2021: $119.6m); | ||
| ELUNATE (fruquintinib) in-market sales in 2022 increased 32% to $93.5 million (2021: $71.0m), reflecting its expanding lead in market share, particularly in tier 2 and 3 cities; | ||
| SULANDA (surufatinib) in-market sales in 2022 increased 178% to $32.3 million (2021: $11.6m), reflecting its first time NRDL inclusion which started in January 2022; | ||
| ORPATHYS (savolitinib) in-market sales in 2022 increased 159% to $41.2 million (2021: $15.9m) following its launch in the second half of 2021 through AstraZeneca's 12 extensive oncology commercial organization. Rapid initial self-pay uptake due to being the first-in-class selective MET inhibitor in China, expect continued uptake to be supported by NRDL inclusion starting March 1, 2023; | ||
| TAZVERIK (tazemetostat) successfully launched in Hainan province in China in June 2022; and | ||
| Successful management of commercial operations to expand coverage of oncology hospitals and physicians despite challenges of pandemic-related lockdowns in the first half of 2022. |
| $'millions | In-market Sales* | Consolidated Revenues** | ||||
| 2022 | 2021 | % Change | 2022 | 2021 | % Change | |
| ELUNATE | $93.5 | $71.0 | +32% | $69.9 | $53.5 | +31% |
| SULANDA | $32.3 | $11.6 | +178% | $32.3 | $11.6 | +178% |
| ORPATHYS | $41.2 | $15.9 | +159% | $22.3 | $11.3 | +97% |
| TAZVERIK | $0.1 | - | - | $0.1 | - | - |
| Product Sales | $167.1 | $98.5 | +70% | $124.6 | $76.4 | +63% |
| Other R&D 13 services income | $24.2 | $18.2 | +33% | |||
| Milestone payment | $15.0 | $25.0 | -40% | |||
| Total Oncology/ Immunology | $163.8 | $119.6 | +37% | |||
| * = For ELUNATE and ORPATHYS , represents total sales to third parties as provided by Lilly 14 and AstraZeneca, respectively; and ELUNATE sales to other third parties as invoiced by HUTCHMED. ** = For ELUNATE , represents manufacturing fees, commercial service fees and royalties paid by Lilly, to HUTCHMED, and sales to other third parties invoiced by HUTCHMED; for ORPATHYS represents manufacturing fees and royalties paid by AstraZeneca; for SULANDA and TAZVERIK , represents the Company's sales of the products to third parties. |
II. REGULATORY UPDATES
| Received Breakthrough Therapy Designation in China for sovleplenib (HMPL-523) in January 2022 for the treatment of ITP 15 ; | ||
| Received approval for TAZVERIK in the Hainan Boao Lecheng International Medical Tourism Pilot Zone in May 2022 for the treatment of certain patients with epithelioid sarcoma or follicular lymphoma; and | ||
| Received Macau approvals for ELUNATE and SULANDA , the first drugs approved in the territory based on China NMPA 16 approval, following regulatory updates in Macau. |
| Fruquintinib submissions to the EMA 17 and the Japanese PMDA 18 to follow the completion of the US NDA submission; all expected to be completed in 2023; | ||
| Savolitinib granted Fast Track Designation by the FDA for the combination treatment with TAGRISSO of NSCLC patients harboring MET overexpression and/or amplification following progression on TAGRISSO ; and | ||
| Surufatinib U.S. NDA and EMA MAA 19 withdrawn: |
| o | A Complete Response Letter regarding the US NDA (CRL) was issued in April 2022 by the U.S. FDA, citing the requirement of a multi-regional clinical trial in a more representative patient population. Following the Letter, the U.S. NDA was withdrawn in January 2023; the MAA was withdrawn in August 2022, following interactions with EMA reviewers which suggested that there is a low probability of a positive opinion; | |
| o | In Japan, the bridging study is continuing and a pre-NDA PMDA consultation is targeted for the first half of 2023; and | |
| o | Pandemic-related issues concerning inspection access contributed to FDA and EMA actions. |
III. CLINICAL DEVELOPMENT
(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
| Presentation of SAVANNAH global Phase II study data showing improved response rates with increasing levels of MET aberration for the TAGRISSO combination (NCT03778229) in NSCLC patients harboring EGFR 20 mutation and MET amplification or overexpression at WCLC 21 2022 . Overall results demonstrated strong ORR 22 , DoR 23 and PFS among patients with higher MET levels, particularly among those with no prior chemotherapy; | ||
| Aligned with FDA for the pivotal Phase II study for accelerated approval of the TAGRISSO combination for NSCLC MET patients following progression on TAGRISSO , and began enrolling; | ||
| Initiated SAFFRON, a global, pivotal Phase III study of the TAGRISSO combination (NCT05261399), which triggered a $15 million milestone payment. Enrolled patients will have MET levels consistent with the higher MET level patient groups in SAVANNAH and have had no prior chemotherapy; | ||
| Enrolling SACHI, a pivotal Phase III study of the TAGRISSO combination in China for NSCLC patients with MET amplification following progression on EGFR inhibitor treatment (NCT05015608); | ||
| Enrolling SANOVO, a pivotal Phase III study of the TAGRISSO combination in China in NSCLC patients harboring EGFR mutation and MET overexpression, comparing the combination with TAGRISSO monotherapy (NCT05009836); | ||
| Presented final Phase II OS 24 in patients with MET exon 14 skipping alteration NSCLC at ELCC 25 2022 (NCT02897479); | ||
| Enrolling the confirmatory China Phase IIIb study in MET exon 14 skipping altered NSCLC in both first-line and second-line and above patients (NCT04923945); | ||
| Enrolling SAMETA, a global Phase III study in MET-driven PRCC 26 of the IMFINZI combination comparing to sunitinib (NCT05043090); | ||
| Enrolled a China Phase II study in gastric cancer patients who have failed at least one line of systemic treatment (NCT04923932); and | ||
| Initiated SOUND, a China Phase II study of the IMFINZI combination in EGFR wild-type NSCLC patients with MET alterations (NCT05374603). |
Potential upcoming clinical and regulatory milestones
| Convert the gastric cancer Phase II study to a registration trial , following discussion with NMPA in the first half of 2023; and | ||
| Complete enrollment of SAVANNAH pivotal Phase II study . |
(ELUNATE in China), a highly selective oral inhibitor of VEGFR27
1/2/3 designed to improve kinase selectivity to minimize off-target toxicity and thereby
improve tolerability; approved and launched in China
| Presented positive results of the global Phase III FRESCO-2 registration trial (NCT04322539) in 691 refractory metastatic CRC patients, recruited from 14 countries including U.S., EU, Japan and Australia at ESMO in September 2022. Treatment with fruquintinib resulted in a statistically significant and clinically meaningful increase in the primary endpoint of OS and the key secondary endpoint of PFS compared to placebo; | ||
| Presented preliminary data from the U.S. Phase Ib monotherapy study of fruquintinib in patients with refractory metastatic CRC (NCT03251378) at 2022 ASCO GI 28 ; and | ||
| Reported top-line results of the FRUTIGA China Phase III registration study (NCT03223376) in 703 advanced gastric cancer patients. The study met one of the primary endpoints of statistically significant improvement in PFS, which is clinically meaningful. The other primary endpoint of OS was not statistically significant. There were statistically significant improvements in secondary endpoints including ORR and DCR 29 , and improved DoR; and | ||
| Initiated China Phase III study of combination with PD-1 30 inhibitor sintilimab in RCC 31 (NCT05522231). |
Potential upcoming clinical and regulatory milestones
| Submit a supplementary NDA to the NMPA for fruquintinib in combination with paclitaxel in the treatment of advanced gastric cancer in H1 2023, supported by results of the FRUTIGA study; | ||
| Complete recruitment of a Phase II registration enabling study for endometrial cancer of fruquintinib in combination with PD-1 inhibitor sintilimab around mid-2023 (NCT03903705); | ||
| Submit FRUTIGA results for presentation at a scientific conference; | ||
| Submit for presentation further Phase II data of fruquintinib with PD-1 inhibitors ; and | ||
| Publication of FRESCO-2 results in a peer-reviewed scientific journal. |
(SULANDA in China), an oral inhibitor of VEGFR, FGFR32
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
| Presented a pooled analysis of safety data from the SANET-p and SANET-ep studies at the 2022 ASCO 34 annual meetings; and | ||
| Presented data from the Phase Ib/II global tislelizumab combination study at NANETS 35 2022. |
Potential upcoming clinical and regulatory milestones
(HMPL-523), an investigative and highly selective oral inhibitor of Syk36,
an important component of the Fc receptor and B-cell receptor signaling pathway
Potential upcoming clinical milestones for sovleplenib:
| Report top-line results from ESLIM-01 China Phase III in the second half of 2023; and | ||
| Complete Phase II Proof-of-Concept study in warm AIHA 37 in China and decide on whether to proceed into Phase III. |
(HMPL-689), an investigative and highly selective oral inhibitor of PI3K 38
designed to address the gastrointestinal and hepatotoxicity associated with currently
approved and clinical-stage PI3K inhibitors
| Completed recruitment of patients for China registration Phase II study for the treatment of follicular lymphoma (with Breakthrough Therapy Designation) in February 2023 (NCT04849351); and | ||
| Initiated China combination trial with tazemetostat in February 2023 (NCT05713110). |
Potential upcoming clinical and regulatory milestones
(TAZVERIK in the U.S., Japan and the Hainan Pilot Zone), a first-in-class,
oral inhibitor of EZH2 licensed from Ipsen39
subsidiary Epizyme40
| Initiated a China bridging study in follicular lymphoma in July 2022 for conditional registration based on U.S. approvals (NCT05467943); | ||
| Ipsen presented updated data from the Phase Ib portion of the global SYMPHONY-1 Phase III trial at ASH (NCT04224493) of tazemetostat combined with lenalidomide and rituximab (R²) in patients with relapsed or refractory follicular lymphoma after at least one prior line of therapy; and | ||
| Initiated the China portion of the global SYMPHONY-1 Phase III trial in September 2022. |
investigational drug candidates
addition to the six drug candidates being developed in over 15 registration studies above, HUTCHMED is developing six further oncology
candidates in early stage clinical trials. These are HMPL-306, a highly selective oral inhibitor of IDH1/241
designed to address resistance to currently marketed IDH inhibitors; HMPL-760, a highly selective, third-generation oral inhibitor
of BTK42 with improved potency versus first
generation BTK inhibitors against both wild type & C481S mutant enzymes; HMPL-453, a highly selective oral inhibitor of FGFR
1/2/3; HMPL-295, a highly selective oral inhibitor of ERK43