Oncology/Immunology revenues up 296% to
Positive SAVANNAH, CALYPSO and VIKTORY studies triggered five registration studies on ORPATHYS® in lung cancer, kidney and gastric cancer during 2021;
Broad late-stage 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
All amounts are expressed in
2021 FULL YEAR RESULTS & BUSINESS UPDATES
“2021 was an exceptional year for HUTCHMED,” said Mr. Simon To, Chairman of
ORPATHYS® took a major step forward in 2021 with its first approval and important, and as yet unpublished, data from the SAVANNAH study in combination with TAGRISSO®.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
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
Seven of our assets are now being developed outside
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
Our strategy is to launch a stream of new products in both the
I. COMMERCIAL OPERATIONS
- Total revenues increased 56% to
$356.1 million in 2021 (2020:$228.0m ), driven by commercial progress on our three in-house developed oncology drugs ELUNATE®, SULANDA® and ORPATHYS®; - Full year 2021 Oncology/Immunology consolidated revenues of
$119.6 million , up 296% (2020:$30.2m ), and in line with 2021 guidance of$110-130 million ; - Continuing expansion of in-house oncology commercial organization in
China , which at the end of 2021 numbered about 630 personnel (end 2020: ~390) covering over 2,500 oncology hospitals and over 29,000 oncology physicians; - ELUNATE® (fruquintinib in
China ) in-market sales11 increased 111% to$71.0 million (2020:$33.7m ), reflecting a full year ofHUTCHMED management of all on-the-ground medical detailing, promotion and local and regional marketing activities inChina ; - SULANDA® (surufatinib in
China ) launched for both extra-pancreatic NET and pancreatic NET with in-market sales in 2021 of$11.6 million (2020: nil). An encouraging start in the self-pay market and positioned well for national reimbursement which started inJanuary 2022 ; - ORPATHYS® (savolitinib in
China ) launched in mid-2021 through AstraZeneca’s extensive oncology commercial organization, with in-market sales of$15.9 million (2020: nil). Rapid initial self-pay uptake due to being the first-in-class selective MET12 inhibitor inChina ; - Successful management of the NRDL13 process to expand access to our key products in
January 2022 . Concluded ELUNATE® NRDL renewal and first time NRDL inclusion of SULANDA®; and U.S. commercial team continued to build for the potential surufatinibU.S. approval in 2022. The team, more than 30 personnel, is fully engaged on all aspects of launch readiness including supply chain, market access, marketing, sales and commercial operations.
(Growth vs. Prior Period) | In-market Sales* | Consolidated Revenue** | |||||||||||
2021 | Jan- Unaudited | 2021 | Jan- Unaudited | ||||||||||
ELUNATE® | (111%) | (51%) | (168%) | (33%) | |||||||||
SULANDA® | – | (21%) | – | (21%) | |||||||||
ORPATHYS® | – | – | – | – | |||||||||
Product Sales | (192%) | (81%) | (282%) | (61%) | |||||||||
Other R&D14 Service income | (77%) | (80%) | |||||||||||
Milestone payments | – | – | |||||||||||
Total Oncology/ Immunology | (296%) | (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 |
II. REGULATORY ACHIEVEMENTS
- Received China NMPA15 NDA approval for ORPATHYS® (savolitinib) as a treatment for patients with MET exon 14 skipping alteration NSCLC in
June 2021 , making savolitinib the first-in-class selective MET inhibitor inChina . - Received second China NMPA NDA approval for SULANDA® (surufatinib) in
June 2021 as a treatment for patients with advanced pancreatic NET; - A
$25 million milestone payment was made to us by AstraZeneca inJuly 2021 upon first sale of ORPATHYS® inChina ; - Received Breakthrough Therapy Designation in
China for amdizalisib (HMPL-689) inSeptember 2021 for the treatment of relapsed or refractory follicular lymphoma; and - Received Breakthrough Therapy Designation in
China for sovleplenib (HMPL-523) inJanuary 2022 for the treatment of ITP16.
- Surufatinib
U.S. FDA17 NDA process update:- Completed submission of
U.S. FDA NDA for surufatinib, which was accepted inJune 2021 , for the treatment of both pancreatic and extra-pancreatic NET; U.S. FDA NDA review, as well as the clinical site inspections and pre-approval inspections of our manufacturing facilities, are ongoing, several inspections have been completed with others pending subject to COVID-19 travel restrictions and security requirements for foreign visitors; and- The PDUFA18 goal date is
April 30, 2022 and mid- and late-cycle review meetings with the FDA have completed. Timing of completion of the NDA review is subject to FDA scheduling limitations.
- Completed submission of
- Surufatinib EMA19 MAA process update:
- Fully submitted
EMA MAA for surufatinib, which was validated and accepted in July 2021, for the treatment of both pancreatic and non-pancreatic NET; and - Completed the 120-day assessment, and now entering the later stages of MAA review.
- Fully submitted
- Savolitinib: conducted
U.S. FDA EOP220 meeting for SAVANNAH study of savolitinib plus TAGRISSO® in EGFR21 TKI22 refractory NSCLC.- Continued evaluation of SAVANNAH study for potential accelerated approval use; and
- Completed clinical trial applications in
U.S. , EU andJapan for the SAFFRON study, a global pivotal Phase III study of savolitinib and TAGRISSO® in patients with NSCLC who have progressed following TAGRISSO® treatment due to MET amplification.
III. CLINICAL DEVELOPMENT ACTIVITIES
Savolitinib (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:
- Initiated SAMETA, a global Phase III pivotal study of the savolitinib plus IMFINZI® combination in MET-driven, unresectable and locally advanced or metastatic PRCC in
October 2021 (NCT05043090); - Initiated SANOVO, a pivotal Phase III study in
China for the savolitinib plus TAGRISSO® combination in treatment naïve patients with EGFR mutant NSCLC with MET aberration inSeptember 2021 (NCT05009836); - Initiated SACHI, a pivotal Phase III study in
China for the savolitinib plus TAGRISSO® combination in patients with EGFR mutant NSCLC who have progressed following EGFR TKI treatment due to MET amplification inNovember 2021 (NCT05015608); - Initiated Phase II study with potential for registration (NCT04923932) for savolitinib in metastatic gastric cancer with MET amplification in
China in mid-2021; - Initiated a confirmatory China Phase IIIb post-approval study (NCT04923945) of savolitinib monotherapy in MET exon 14 skipping alteration patients in mid-2021; and
- A further
$15 million milestone payment, to us by AstraZeneca, was triggered inFebruary 2022 upon initiation of start-up activities for SAFFRON.
Major savolitinib clinical data presentations in 2021:
- Presented CALYPSO Phase II study data in MET-driven PRCC patients (NCT02819596) for savolitinib in combination with IMFINZI® at the 2021 ASCO23 Annual Meeting;
- Published in The Lancet Respiratory Medicine updated data from the Phase II study in patients with MET exon 14 skipping alteration NSCLC (NCT02897479); and
- Presented final Phase II data at WCLC24 2020 for the TATTON study (NCT02143466) in NSCLC patients with MET amplification who had progressed after prior treatment with EGFR inhibitors.
Potential upcoming clinical and regulatory milestones for savolitinib in 2022:
- Submit for presentation the SAVANNAH Phase II study (NCT03778229) for the savolitinib plus TAGRISSO® combination in NSCLC patients harboring EGFR mutation and MET amplification or overexpression at a scientific conference in the second half of 2022; and
- Commence enrollment in SAFFRON, a global, pivotal Phase III study for the savolitinib plus TAGRISSO® combination in mid-2022 (NCT05261399).
Surufatinib (SULANDA® in
Major clinical milestones for surufatinib in 2021:
- Initiated the SURTORI-01 Phase III trial in NEC26 patients in
China , the first pivotal study combining SULANDA® and TUOYI®, Junshi’s27 anti-PD-1 antibody, inSeptember 2021 (NCT05015621); - Initiated a bridging study in NET patients in
Japan inSeptember 2021 (NCT05077384) based on dialogue with the Japanese PMDA28; and - Initiated an international Phase Ib/II study of surufatinib combined with tislelizumab (NCT04579757), BeiGene’s29 PD-130 antibody, in the
U.S. andEurope inMarch 2021 .
Major surufatinib clinical data presentations in 2021:
- Presented NEC cohort data from the China Phase II study of surufatinib plus TUOYI® (NCT04169672) at the 2021 ASCO and ESMO IO31 2021 annual meetings;
- Presented data from the gastric and gastroesophageal junction cancers cohort of the China Phase II study of surufatinib plus TUOYI® (NCT04169672) at the 2021 ASCO and ESMO IO 2021 annual meetings;
- Presented data from two additional cohorts of the China Phase II study of surufatinib plus TUOYI® (NCT04169672) at the ESMO IO 2021 for esophageal and small cell lung cancer;
- Presented updated results from
U.S. Phase Ib monotherapy NET cohorts (NCT02549937) in heavily pretreated patients with NET at the 2021 ASCO Annual Meeting; - Presented a subgroup analysis by Ki-67 and baseline CgA32 of the Phase III monotherapy study in pancreatic NET (SANET-p) (NCT02589821) at the 2021 ASCO Annual Meeting; and
- Presented Phase II data for surufatinib monotherapy in BTC33 patients (NCT02966821) at the 2021 ASCO Annual Meeting in
U.S. patients after first-line chemotherapy.
Potential upcoming clinical and regulatory milestones for surufatinib in 2022:
- Submit for presentation data from the Phase Ib/II combination study with tislelizumab at a scientific conference in the second half of 2022;
- Submit for presentation further Phase II data for the TUOYI® combination study for biliary tract, thyroid cancer, non-small cell lung cancer, endometrial cancer and sarcoma cohorts at a scientific conference in the second half of 2022, and
- Plan to initiate SURTORI-02, a Phase III study of surufatinib in combination with TUOYI® in esophageal cancer in
China in the second half of 2022.
Fruquintinib (ELUNATE® in
Major clinical milestones for fruquintinib in 2021:
- Completed enrollment in the FRESCO-2 global Phase III registration study (NCT04322539) in refractory metastatic CRC in late 2021, with 691 patients recruited in 15 months, across 14 countries including
U.S. , EU,Japan andAustralia , ahead of schedule; - Initiated registration-intent Phase II study in endometrial cancer for fruquintinib in combination with TYVYT® (NCT03903705) following discussion with the NMPA;
- Initiated a Phase II study in
China andKorea for fruquintinib in combination with tislelizumab (NCT04716634) with advanced or metastatic, unresectable gastric cancer, CRC or NSCLC; - Initiated a Phase Ib/II study in the
U.S. for fruquintinib in combination with tislelizumab (NCT04577963) in patients with triple negative breast or endometrial cancer and metastatic CRC; and - Completed enrollment in four cohorts of the Phase II study of fruquintinib combined with TYVYT® (NCT03903705), in CRC, endometrial cancer, HCC34 and RCC35 in
China .
Major fruquintinib clinical data presentations in 2021:
- Presented preliminary endometrial cancer, HCC and RCC cohorts data from the Phase Ib/II studies of fruquintinib combined with TYVYT® at CSCO36 2021 (NCT03903705);
- Presented preliminary CRC cohorts data from the Phase Ib/II studies of fruquintinib combined with TYVYT® and of fruquintinib combined with geptanolimab, Genor’s37 PD-1 antibody, at the 2021 ASCO Annual Meeting (NCT04179084 and NCT03977090, respectively); and
- Presented Phase Ib
U.S. monotherapy data in two different cohorts of patients with refractory metastatic CRC (NCT03251378) at the 2022 ASCO Gastrointestinal Cancers Symposium.
Potential upcoming clinical and regulatory milestones for fruquintinib in 2022:
- Complete enrollment of the FRUTIGA China Phase III registration study (NCT03223376) in advanced gastric cancer in 2022, which is expected to enroll about 700 patients in
China ; - Report outcome of the FRESCO-2 trial (NCT04322539) in the second half of 2022 when the event-driven primary endpoint, OS38, is reached;
- If FRESCO-2 is positive,
HUTCHMED plans to initiate a simultaneous submission program to apply for fruquintinib marketing authorization with theU.S. FDA, the EMA and the PMDA; and - Plan to initiate Phase III studies of fruquintinib plus TYVYT® combination in HCC, RCC and endometrial cancer in
China .
Amdizalisib (HMPL-689), an investigative and highly selective oral inhibitor of PI3Kδ39 designed to address the gastrointestinal and hepatotoxicity associated with currently approved and clinical-stage PI3Kδ inhibitors
Major clinical milestones for amdizalisib in 2021:
- Initiated two Phase II studies with potential for registration in
China for the treatment of patients with follicular lymphoma and patients with marginal zone lymphoma inApril 2021 ; and - Initiated dose expansion portion of the Phase I/Ib study in the
U.S. andEurope (NCT03786926) in the second half of 2021 in multiple types of non-Hodgkin’s lymphoma.
Major amdizalisib clinical data presentation in 2021:
- Presented initial dose expansion data at ESMO in
September 2021 at the RP2D40, in patients with multiple types of non-Hodgkin’s lymphoma inChina .
Potential upcoming clinical and regulatory milestones for amdizalisib in 2022:
- Initiate additional Phase II studies with potential for registration intent in
China in additional relapsed/refractory non-Hodgkin’s lymphoma indications in the second half of 2022; - Initiate studies in combination with other anti-cancer therapies in
China in early 2022; and - Complete recruitment of patients for Phase II studies with potential for registration intent in
China for the treatment of follicular lymphoma and marginal zone lymphoma in late 2022.
Sovleplenib (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 in 2021:
- Initiated the ESLIM-01 Phase III pivotal study in ITP (NCT03951623) in
China inOctober 2021 ; and - Initiated dose expansion portion of the international Phase I study in the second half of 2021 in multiple non-Hodgkin’s lymphoma indications.
Major sovleplenib clinical data presentations in 2021:
- Presented initial Phase Ib ITP study (NCT03951623) in
China at ASH 202142; and - Presented initial data from the dose escalation portion of the international Phase I study (NCT03779113) in lymphoma patients in the
U.S. andEurope at ASH 2021.
Potential upcoming clinical milestone for sovleplenib in 2022:
- Complete
U.S. IND and initiate Phase I study in theU.S. in patients with ITP.
Tazemetostat (TAZVERIK® in the
Potential upcoming clinical and regulatory milestones for tazemetostat in 2022:
- Initiate a bridging study in follicular lymphoma in
China for conditional registration based onU.S. approvals; - Initiate the
China portion of the global SYMPHONY-1 Phase III trial (NCT04224493) of tazemetostat combined with lenalidomide and rituximab in patients with relapsed or refractory follicular lymphoma after at least one prior line of therapy; - Initiate Phase II combination studies with other
HUTCHMED assets; and - Engage with NMPA on potential path for regulatory approval for the treatment of patients with epithelioid sarcoma, a rare disease for which TAZVERIK® has FDA approval.
HMPL-453, an investigative and highly selective oral inhibitor of FGFR 1/2/3
- Initiated combination studies with other anti-cancer therapies, including chemotherapies and/or PD-1 antibodies, in
China inJanuary 2022 (NCT05173142).
HMPL-306, an investigative and highly selective oral inhibitor of IDH1/2 designed to address resistance to the currently marketed IDH inhibitors
Major clinical and regulatory milestones for HMPL-306 in 2021:
- Initiated Phase I dose escalation study in
China in hematological malignancies; - Initiated dose escalation portion of a Phase I study (NCT04764474) in the
U.S. andEurope in patients with hematological malignancies with an IDH1 and/or IDH2 mutation in early 2021; and - Initiated dose escalation portion of a Phase I study (NCT04762602) in the
U.S. andEurope in patients with solid tumors with an IDH1 and/or IDH2 mutation in early 2021.
Potential upcoming clinical and regulatory milestones for HMPL-306 in 2022:
- Submit for presentation data from the dose escalation portion of the Phase I study (NCT04272957) in
China at a scientific conference in mid-2022; and - Initiate dose expansion portion of the Phase I study in
China in mid-2022; and - Initiate dose expansion portion of the Phase I studies in the
U.S. andEurope in mid-2022.
HMPL-295, 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
- Initiated Phase I trial (NCT04908046) in patients with advanced solid tumors in
China inJuly 2021 .
HMPL-760, 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
- Initiated Phase I trials in
China (NCT05190068) and theU.S. (NCT05176691) in patients with advanced hematological malignancies inJanuary 2022 .
HMPL-653, an investigative, highly selective, and potent CSF-1R inhibitor designed to target CSF-1R driven tumors as a monotherapy or in combinations
- Initiated Phase I trial in
China (NCT05190068) in patients with advanced malignant solid tumors and tenosynovial giant cell tumors inJanuary 2022 .
HMPL-A83, a differentiated, red blood cell sparing CD47 monoclonal antibody
- Completed IND submission for HMPL-A83 in
China in early 2022.
IV. MANUFACTURING
- Commercial scale-up and launches of SULANDA® and ORPATHYS®, alongside ongoing supply of ELUNATE®;
- Completed all relevant amdizalisib and sovleplenib manufacturing process studies, in preparation for potential NDA submissions; and
- Rapid progress in building our new flagship
Shanghai manufacturing facility, designed to increase our novel drug product manufacturing capacity by over five-fold. Small molecule and large molecule equipment installation is planned for late 2022, with GMP compliance targeted for late 2023.
V. OTHER VENTURES
Other Ventures include our profitable prescription drug marketing and distribution platforms covering about 290 cities and towns in
- Other Ventures delivered encouraging growth with consolidated revenues up 20% (13% at CER44) to
$236.5 million (2020:$197.8m ). This does not include revenues from our non-consolidated joint venture SHPL45, which also grew by 20% (12% at CER) to$332.6 million (2020:$276.4m ); - Consolidated net income attributable to
HUTCHMED from ourOther Ventures grew by 24% (16% at CER) to$54.4 million (2020:$44.0m ), excluding one-time gains; and - One-time gains totaled
$88.5 million (2020:$28.8m ), including$82.9 million (2020: nil) from the divestment of HBYS46 and$5.6 million (2020:$28.8m ) from land compensation, before withholding tax.
VI. OTHER CORPORATE DEVELOPMENTS
- Completed listing on the Main
Board of HKEX 47, raising net proceeds of approximately$585 million ; - Completed divestment of interest in HBYS, a non-core and non-consolidated over-the-counter drug joint venture business for
$159.1 million in cash, representing about 22 times HBYS’s adjusted net profit attributable toHUTCHMED equity holders in 2020 with an additional$46.4 million related to declared dividends expected to be collected in 2022; - Entered into a collaboration with Epizyme in
August 2021 to research, develop, manufacture and commercialize inGreater China its drug TAZVERIK®, an EZH2 inhibitor approved by theU.S. FDA for the treatment of certain patients with epithelioid sarcoma and follicular lymphoma; - Changed our group company name/corporate identity to
HUTCHMED inApril 2021 , unifying the names of the majority of our key subsidiaries; - Announced a strategic partnership with Inmagene48 in
January 2021 to further develop four novel preclinical drug candidates discovered byHUTCHMED for the potential treatment of multiple immunological diseases; and - Arbitral award in favor of Hutchison Sinopharm49 in connection with the termination of its distribution rights for SEROQUEL® in mainland
China byLuye Pharma Hong Kong Ltd. In 2021, the Hong Kong International Arbitration Centre made a final award in favor of Hutchison Sinopharm againstLuye Pharma Hong Kong Ltd. in the amount ofRMB253.2 million ($39.6 million ), plus costs and interest. Payment of the award is expected in 2022.
Potential upcoming corporate developments:
- Divestment of further non-core operations, we continue to look for opportunities to divest non-core businesses, including SHPL, to better focus on the development and global commercialization of our innovation-driven assets; and
- Large molecule advancement, we continue to evaluate opportunities which might accelerate our capabilities in the large molecule arena.
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
VIII. SUSTAINABILITY
As an innovative, commercial-stage biopharmaceutical company,
Going forward,
FULL YEAR 2021 FINANCIAL RESULTS
Cash, Cash Equivalents and Short-Term Investments were
Adjusted Group (non-GAAP50) net cash flows excluding financing activities were -$73.5 million (2020: -$78.4m ), with the net decrease mainly due to$159.1 million in proceeds from the divestment of HBYS, which offset the increasing Oncology/Immunology R&D spending and lower dividends received from our non-consolidated joint ventures totaling$49.9 million (2020:$86.7m ); and- Net cash generated from financing activities totaled
$650.0 million (2020:$296.4m ) mainly resulting from the global offering of shares and listing on the HKEX inJune 2021 and a private placement inApril 2021 to a fund affiliated with Baring Private Equity Asia.
Revenues for the year ended
- Oncology/Immunology consolidated revenues increased 296% (287% at CER) to
$119.6 million (2020:$30.2m ) resulting from:
ELUNATE® revenues increased 168% to$53.5 million (2020:$20.0m ) in manufacturing revenues, promotion and marketing service revenues and royalties, as our in-house sales team increased in-market sales 111% to$71.0 million (2020:$33.7m ), as provided by Lilly51;
SULANDA® sales revenues of$11.6 million sincemid-January 2021 launch, initially approved to treat patients with advanced extra-pancreatic (non-pancreatic) NET and subsequently also approved to treat patients with pancreatic NET inJune 2021 ;
ORPATHYS® revenue of$36.3 million sincemid-July 2021 launch, which was comprised of a$25.0 million first sale milestone payment and$11.3 million in manufacturing revenues and royalties. AstraZeneca reported$15.9 million in-market sales (2020: nil) of ORPATHYS® in 2021; and
Other R&D service fee revenues of$18.2 million (2020:$10.2m ), which were primarily fees from AstraZeneca and Lilly for the management of development activities inChina .
- Other Ventures consolidated revenues increased 20% (13% at CER) to
$236.5 million (2020:$197.8m ), mainly due to continued sales growth of third-party prescription drug products.
Net Expenses for the year ended
- Cost of Revenues were
$258.2 million (2020:$188.5m ), the majority of which were the cost of third-party prescription drug products marketed through our profitableOther Ventures , as well as full year costs associated with ELUNATE®, including the provision of promotion and marketing services to Lilly which commenced inOctober 2020 , and the costs for SULANDA® and ORPATHYS® which commenced commercial sales in 2021; - R&D Expenses were
$299.1 million (2020:$174.8m ), which increased mainly as a result of an expansion in the active development of eleven novel oncology drug candidates. Our rapidly scaling international clinical and regulatory operations in theU.S. andEurope incurred expenses of$140.1 million (2020:$63.3m ), while R&D expenses inChina were$159.0 million (2020:$111.5m ); - SG&A Expenses52 were
$127.1 million (2020:$61.3m ), which increased primarily due to higher staff costs and share-based compensation expense to support rapidly expanding operations. This included the build-up of a large-scale national oncology commercial infrastructure inChina and commercial launch readiness in theU.S. to support our oncology products; and - Other Items generated net income of
$133.7 million (2020:$70.9m ), which increased primarily due to a one-off gain on the divestment of HBYS attributable to the Group of$82.9 million (comprised of a gain of$121.3 million offset in part by related taxes of$14.4 million and amounts attributable to a non-controlling interest of$24.0 million ), offset in part by lower one-time land compensation of$5.6 million (2020:$28.8m ) recognized for HBYS.
Net Loss attributable to
- As a result, the net loss attributable to
HUTCHMED in 2021 was$0.25 per ordinary share /$1.23 per ADS53, compared to net loss attributable toHUTCHMED of$0.18 per ordinary share /$0.90 per ADS, in 2020.
FINANCIAL SUMMARY
Condensed Consolidated Balance Sheet Data
(in $’000)
As of | ||||
2021 | 2020 | |||
Assets | ||||
Cash and cash equivalents and short-term investments | 1,011,700 | 435,176 | ||
Accounts receivable | 83,580 | 47,870 | ||
Other current assets | 116,796 | 47,694 | ||
Property, plant and equipment | 41,275 | 24,170 | ||
Investments in equity investees | 76,479 | 139,505 | ||
Other non-current assets | 42,831 | 29,703 | ||
Total assets | 1,372,661 | 724,118 | ||
Liabilities and shareholders’ equity | ||||
Accounts payable | 41,177 | 31,612 | ||
Other payables, accruals and advance receipts | 210,839 | 121,283 | ||
Bank borrowings | 26,905 | 26,861 | ||
Other liabilities | 54,226 | 25,413 | ||
Total liabilities | 333,147 | 205,169 | ||
Company’s shareholders’ equity | 986,893 | 484,116 | ||
Non-controlling interests | 52,621 | 34,833 | ||
Total liabilities and shareholders’ equity | 1,372,661 | 724,118 | ||
Condensed Consolidated Statement of Operations Data
(in $’000, except share and per share data)
Year Ended | ||||||
2021 | 2020 | |||||
Revenues: | ||||||
Oncology/Immunology – Marketed Products | 76,429 | 19,953 | ||||
Oncology/Immunology – R&D | 43,181 | 10,262 | ||||
Oncology/Immunology consolidated revenues | 119,610 | 30,215 | ||||
Other Ventures | 236,518 | 197,761 | ||||
Total revenues | 356,128 | 227,976 | ||||
Expenses: | ||||||
Costs of revenues | (258,234 | ) | (188,519 | ) | ||
Research and development expenses | (299,086 | ) | (174,776 | ) | ||
Selling and general administrative expenses | (127,125 | ) | (61,349 | ) | ||
Total expenses | (684,445 | ) | (424,644 | ) | ||
Loss from Operations | (328,317 | ) | (196,668 | ) | ||
Gain on divestment of an equity investee | 121,310 | – | ||||
Other (expense)/income | (8,733 | ) | 6,934 | |||
Loss before income taxes and equity in earnings of equity investees | (215,740 | ) | (189,734 | ) | ||
Income tax expense | (11,918 | ) | (4,829 | ) | ||
Equity in earnings of equity investees, net of tax | 60,617 | 79,046 | ||||
Net loss | (167,041 | ) | (115,517 | ) | ||
Less: Net income attributable to non-controlling interests | (27,607 | ) | (10,213 | ) | ||
Net loss attributable to | (194,648 | ) | (125,730 | ) | ||
Losses per share attributable to | (0.25 | ) | (0.18 | ) | ||
Number of shares used in per share calculation - basic and diluted | 792,684,524 | 697,931,437 | ||||
Losses per ADS attributable to | (1.23 | ) | (0.90 | ) | ||
Number of ADSs used in per share calculation - basic and diluted | 158,536,905 | 139,586,287 |
All amounts are expressed in
FINANCIAL GUIDANCE
We provide financial guidance for 2022 below reflecting expected revenue growth of ELUNATE®, SULANDA® and ORPATHYS® in
While we are not providing net cash flow guidance for 2022, we do expect an increase in investment to support global clinical and organizational expansion. To support our cash needs, we continue to engage in active discussions regarding the potential divestment of non-core assets, such as SHPL, as well as evaluate equity capital markets action, such as a potential future listing on the STAR Market of the
2021 Actual | 2022 Guidance | |
Oncology/Immunology consolidated revenues |
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” below for further information relevant to the interpretation of these financial measures and reconciliations of these financial measures to the most comparable GAAP measures, respectively.
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Conference Call and Audio Webcast Presentation scheduled today at
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FINANCIAL STATEMENTS
About
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References
Unless the context requires otherwise, references in this announcement to the “Group,” the “Company,” “HUTCHMED,” “HUTCHMED Group,” “we,” “us,” and “our,” mean
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
In addition, this announcement contains statistical data and estimates that
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
REFERENCES & ABBREVIATIONS | |
1 | AstraZeneca = AstraZeneca PLC and its wholly owned subsidiary, |
2 | NSCLC = Non-small cell lung cancer. |
3 | NDA = New Drug Application. |
4 | MAA = Marketing Authorisation Application. |
5 | CRC = Colorectal cancer. |
6 | FGFR = Fibroblast growth factor receptor. |
7 | IDH = Isocitrate dehydrogenase. |
8 | ERK = Extracellular signal-regulated kinase. |
9 | BTK = Bruton’s tyrosine kinase. |
10 | CSF-1R = Colony stimulating factor-1 receptor. |
11 | In-market sales = total sales to third parties provided by Eli Lilly (ELUNATE®), AstraZeneca (ORPATHYS®) and |
12 | MET = Mesenchymal epithelial transition receptor. |
13 | NRDL = National Reimbursement Drug List. |
14 | R&D = Research and development. |
15 | NMPA = |
16 | ITP = Immune thrombocytopenia purpura. |
17 | FDA = |
18 | PDUFA = Prescription Drug User Fee Act. |
19 | EMA = |
20 | EOP2 = End of Phase 2. |
21 | EGFR = Epidermal growth factor receptor. |
22 | TKI = Tyrosine kinase inhibitor. |
23 | ASCO = |
24 | WCLC = |
25 | VEGFR = Vascular endothelial growth factor receptor. |
26 | NEC = Neuroendocrine carcinoma. |
27 | Junshi = Shanghai Junshi Biosciences Co., Ltd. |
28 | PMDA = |
29 | BeiGene = BeiGene, Ltd. |
30 | PD-1 = Programmed Cell Death Protein-1. |
31 | ESMO IO = |
32 | CgA = Chromogranin A. |
33 | BTC = Biliary tract cancer. |
34 | HCC = Hepatocellular carcinoma. |
35 | RCC = Renal cell cancer. |
36 | CSCO = |
37 | Genor = |
38 | OS = Overall survival. |
39 | PI3Kδ = Phosphoinositide 3-kinase delta. |
40 | RP2D = Recommended Phase II dose. |
41 | Syk = Spleen tyrosine kinase. |
42 | ASH 2021 = the 63rd ASH Annual Meeting and Exposition in |
43 | MAPK pathway = RAS-RAF-MEK-ERK signaling cascade. |
44 | We also report changes in performance at constant exchange rate (“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. |
45 | SHPL = |
46 | HBYS = |
47 | HKEX = |
48 | Inmagene = Inmagene Biopharmaceuticals. |
49 | Hutchison Sinopharm = |
50 | GAAP = Generally Accepted Accounting Principles. |
51 | Lilly = Eli Lilly and Company. |
52 | SG&A Expenses = selling, general and administrative expenses. |
53 | ADS = American depositary share. |
54 | EGFRm+ = Epidermal growth factor receptor mutation positive. |
55 | ORR = Objective response rate. |
56 | DCR = Disease control rate. |
57 | NEN = Neuroendocrine neoplasms. |
58 | SCLC = Small cell lung cancer. |
59 | DoR = Duration of response. |
60 | TRAE = Treatment related adverse event. |
61 | TN = Triple negative. |
62 | HR+ = Hormone receptor positive. |
63 | Her2- = Human epidermal growth factor receptor 2 negative. |
64 | SXBX = She |
65 | HBYS’ adjusted net profit attributable to |
66 | HSBC = The Hong kong and |
67 | HIBOR = Hong Kong Interbank Offered Rate. |
68 | Deutsche Bank AG = Deutsche Bank AG, |
69 | PBOC = People’s |
This announcement in its entirety is available at: http://ml.globenewswire.com/Resource/Download/4c5a3183-e214-4ce3-b8e6-219970db6113
Source:
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