HUTCHMED Reports 2021 Interim Results and Provides Business Updates

Rhea-AI Summary

HUTCHMED reported significant growth in its interim financial results for H1 2021, with total revenues up by 47% to $157.4 million. Sales for ELUNATE® surged 186% to $40.1 million, while SULANDA® generated $8.0 million since its January launch. The company received its first approval in China for ORPATHYS® and accepted applications for surufatinib in the U.S. and E.U. HUTCHMED raised $615 million through an additional listing on HKEX, bolstering its cash resources to approximately $1.2 billion.

Positive

• Total revenues increased 47% to $157.4 million in H1 2021.
• In-market sales of ELUNATE® rose 186% to $40.1 million.
• SULANDA® generated $8.0 million in sales since its launch.
• Raised $615 million from an additional listing on HKEX.
• Cash and cash equivalents increased to $950.4 million as of June 30, 2021.

Negative

• Net loss attributable to HUTCHMED increased to $102.4 million from $49.7 million in H1 2020.
• R&D expenses rose to $123.1 million, up from $74.0 million in H1 2020.

ELUNATE^® in-market sales¹ rose 186%, reflecting impact of in-house sales force

Received 1^st approval in China for ORPATHYS^® and 2^nd approval in China for SULANDA^®

U.S. and E.U. applications for surufatinib both accepted

Raised $615m² gross proceeds from additional listing on HKEX³

Company to Host Interim Results Call & Webcast Today at 8 p.m. HKT / 1 p.m. BST / 8 a.m. EDT

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., July 28, 2021 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13), the innovative, commercial-stage biopharmaceutical company, today reports its unaudited financial results for the six months ended June 30, 2021 and provides updates on key clinical and commercial developments since the start of the year.

All amounts are expressed in U.S. dollar currency unless otherwise stated.

2021 INTERIM RESULTS & BUSINESS UPDATES

“HUTCHMED’s progress has been truly exceptional,” said Mr. Simon To, Chairman of HUTCHMED. “Our novel drug discovery and development engine keeps powering ahead. Not only have we secured our third and fourth oncology drug NDA⁴ approvals in China, but also our first U.S. FDA⁵ and EMA⁶ applications for market approval have been accepted.”

“Ten registrational studies are set to start this year on our five lead global assets. These are based on exciting data from proof-of-concept studies of both monotherapies and immunotherapy/TKI⁷ combinations. In addition, our early-stage portfolio is also progressing with our IDH1/2⁸, ERK⁹ and third generation BTK¹⁰ inhibitors all starting development this year.”

“In parallel, our commercial oncology operations are rapidly progressing.”

“In China, our oncology team is now about 540 people on the ground marketing ELUNATE^® and SULANDA^®, recording in-market sales¹¹ of $48.1 million in the first half of 2021. In the U.S., our oncology commercial team is building to support potential launches of surufatinib in 2022 and fruquintinib in 2023. On ORPATHYS^®, our partner AstraZeneca¹² will leverage its great commercial capabilities in lung cancer to market this important first-in-class drug.”

“On the corporate-level we took several important steps during the first half to support our global plans. We changed our name to HUTCHMED, consolidating several legacy group and operating names into a single ubiquitous global corporate identity. We also built a balance of about $1.2 billion in cash and resources through our homecoming IPO¹³ on HKEX as well as through divestment of our non-core OTC¹⁴ drug business.”

“Over the next three years, we will continue to rapidly build our global R&D¹⁵ and commercial organizations, supporting the anticipated global launches of our oncology drugs.”

I. COMMERCIAL OPERATIONS

• Total revenues increased 47% to $157.4 million in the first half of 2021 (H1-20: $106.8m);
• Oncology/Immunology consolidated revenues increased 161% to $42.9 million (H1-20: $16.4m). Our China oncology commercial organization expanded to about 540 personnel (end 2020: ~390) covering over 2,500 oncology hospitals and over 29,000 oncology physicians;
• ELUNATE^® (fruquintinib in China) in-market sales increased 186% to $40.1 million (H1-20: $14.0m), reflecting enhanced detailing, promotion and local & regional marketing in China through our organization;
• SULANDA^® (surufatinib in China) launched for both extra-pancreatic NET¹⁶ (mid-January 2021) and pancreatic NET (June 2021), with sales of $8.0 million (H1-20: nil);
• ORPATHYS^® (savolitinib) launched in July 2021, just three weeks after approval, through AstraZeneca’s extensive, market-leading oncology commercial organization. HUTCHMED will receive a fixed royalty of 30% on all sales in China; and
• U.S. commercial organization continued to build for the potential surufatinib U.S. approval in the first half of 2022. The team is fully engaged on all aspects of launch readiness including supply chain, market access, marketing, sales and commercial operations.

II. REGULATORY ACHIEVEMENTS

China

• Received China NMPA¹⁷ NDA approval for ORPATHYS^® (savolitinib) as a treatment for patients with MET¹⁸ exon 14 skipping alteration NSCLC¹⁹ in June 2021, making savolitinib the first-in-class selective MET inhibitor in China; and
• Received second China NMPA NDA approval for SULANDA^® in June 2021 as a treatment for patients with advanced pancreatic NET.

United States & Europe

• Completed submission of U.S. FDA NDA for surufatinib, which was accepted in June 2021, for the treatment of both pancreatic and extra-pancreatic NET. The assigned PDUFA²⁰ goal date is April 30, 2022; and
• Fully submitted EMA MAA²¹ for surufatinib, which was validated and accepted in July 2021, for the treatment of both pancreatic and non-pancreatic NET.

III. CLINICAL DEVELOPMENT ACTIVITIES

Surufatinib (SULANDA^® in China), a small molecule inhibitor of VEGFR²², FGFR²³ and CSF-1R²⁴ 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

• Initiated an international Phase Ib/II study of surufatinib combined with tislelizumab (NCT04579757), BeiGene’s²⁵ PD-1²⁶ antibody, in the U.S. and Europe, in March 2021;
• Presented NEC²⁷ cohort preliminary data from the China Phase II study of surufatinib plus TUOYI^®, Junshi’s²⁸ anti-PD-1 antibody, (NCT04169672) at the 2021 ASCO²⁹ Annual Meeting. The combination demonstrated good preliminary efficacy and manageable tolerability. There are currently no standard second-line treatments available to NEC patients;
• Presented preliminary data from the gastric and gastroesophageal junction cancers cohort of the China Phase II study of surufatinib plus TUOYI^® (NCT04169672) at the 2021 ASCO Annual Meeting, which also demonstrated good preliminary efficacy and manageable tolerability in this patient population. Registration design for gastric cancer is under discussion;
• Completed enrollment of a further four China Phase II cohorts for surufatinib plus TUOYI^® (NCT04169672) including biliary tract, esophageal, small cell lung cancers and sarcoma, with further thyroid, NSCLC and endometrial cancer cohorts continuing to enroll;
• Presented updated results from U.S. Phase Ib monotherapy NET cohorts (NCT02549937) at the 2021 ASCO Annual Meeting. In heavily pretreated patients with NET, surufatinib demonstrated encouraging efficacy in patients refractory or intolerant to AFINITOR^® and SUTENT^®, with a manageable safety profile consistent with the completed Phase III trials SANET‑p and SANET‑ep;
• Presented a subgroup analysis by Ki-67 and baseline CgA³⁰ of the Phase III monotherapy study in pancreatic NET (SANET-p) (NCT02589821) at the 2021 ASCO Annual Meeting. SANET-p had shown that surufatinib demonstrated statistically significant and clinically meaningful improvement in PFS³¹, and this exploratory analysis showed that surufatinib demonstrated benefit irrespective of Ki-67 expression levels or baseline CgA; and
• Presented Phase II data for surufatinib monotherapy in BTC³² patients (NCT02966821) at the 2021 ASCO Annual Meeting in U.S. patients after first-line chemotherapy. This data highlights surufatinib’s potential in BTC.   Emerging data from our Phase II cohort of the surufatinib combination plus TUOYI^®, however, means we will prioritize development of the combination over the monotherapy.

Potential upcoming clinical and regulatory milestones for surufatinib:

• Initiate the first Phase III pivotal study for the SULANDA^® plus TUOYI^® combination in late 2021, in NEC patients in China;
• Submit for presentation further Phase II data for the SULANDA^® plus TUOYI^® combination in select indications in the second half of 2021, such as potentially biliary tract, esophageal, small cell lung cancers and sarcoma and updated NET/NEC cohort data; and
• Initiate pivotal study in NET patients in Japan in late 2021.

Fruquintinib (ELUNATE^® in China), a highly selective small molecule 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

• Completed enrollment in four cohorts of the Phase II study of fruquintinib combined with TYVYT^® (NCT03903705), Innovent’s³³ PD-1 antibody – in CRC³⁴, HCC³⁵, endometrial cancer and RCC³⁶. Also initiated additional cohorts in gastric cancer, cervical cancer and NSCLC;
• 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). Both combination studies showed encouraging, durable benefit in advanced CRC patients with manageable safety profiles. A registration strategy for CRC is under discussion, as well as for additional indications; and
• Initiated a Phase II study in China and Korea for fruquintinib in combination with tislelizumab (NCT04716634, led by BeiGene) with advanced or metastatic, unresectable gastric cancer, CRC or NSCLC.

Potential upcoming clinical and regulatory milestones for fruquintinib:

• Submit Phase Ib U.S. monotherapy expansion data in metastatic CRC (NCT03251378) in the second half of 2021 for publication in early 2022;
• Submit for presentation additional cohorts’ data from the studies of fruquintinib combined with an anti-PD-1 antibody in the second half of 2021, such as HCC, endometrial cancer and RCC;
• Initiate a Phase Ib/II study in the U.S. for fruquintinib in combination with tislelizumab (NCT04577963) in patients with advanced, refractory triple negative breast cancer in the second half of 2021;
• Initiate a registrational study in China of fruquintinib combined with an anti-PD-1 antibody in endometrial cancer patients, in the second half of 2021, the first of several potential pivotal studies with this combination;
• Complete enrollment of the FRESCO-2 global Phase III registration study (NCT04322539) in refractory metastatic CRC in late 2021, which is expected to enroll over 680 patients from over 150 sites in 14 countries; and
• Complete enrollment of the FRUTIGA China Phase III registration study (NCT03223376) in advanced gastric cancer in late 2021, which is expected to enroll approximately 700 patients from approximately 35 sites in China.

Savolitinib (ORPATHYS^®), a highly selective small molecule inhibitor of MET being developed broadly across MET-driven patient populations in lung and gastric cancer and renal cell carcinoma

• Presented CALYPSO Phase II study data in MET-driven patients (NCT02819596) for savolitinib in combination with IMFINZI^®, AstraZeneca’s PD-L1³⁸ antibody at the 2021 ASCO Annual Meeting. In MET-driven PRCC³⁹ patients, the combination demonstrated encouraging synergy in efficacy and tolerability in line with single agent safety profiles;
• Published in The Lancet Respiratory Medicine updated data from the Phase II study (NCT02897479), which were the results reviewed by the NMPA when it approved savolitinib for the treatment of patients with MET exon 14 skipping alteration NSCLC;
• Presented final Phase II data for TATTON (NCT02143466) at WCLC⁴⁰ 2020 (held in January 2021), a global exploratory study in NSCLC aiming to recruit patients with MET amplification who had progressed after prior treatment with EGFR⁴¹ inhibitors. TATTON clearly confirmed the importance of the savolitinib plus TAGRISSO^® combination; and
• Initiated Phase II study with potential for registration (NCT04923932) for savolitinib in metastatic gastric cancer in China in mid-2021.

Potential upcoming clinical and regulatory milestones for savolitinib:

• Initiate a confirmatory China Phase IIIb post-approval study (NCT04923945) of savolitinib monotherapy in MET exon 14 skipping alteration patients in mid-2021 following its market launch, which is expected to enroll approximately 160 patients from approximately 40 sites;
• Initiate SAMETA, a global Phase III pivotal study of the savolitinib plus IMFINZI^® combination in MET-driven, unresectable and locally advanced or metastatic PRCC, based on the encouraging results of SAVOIR and CALYPSO studies, in the second half of 2021;
• Initiate SANOVO, a pivotal Phase III study in China for the savolitinib plus TAGRISSO^® combination in treatment naïve patients with EGFR mutant positive NSCLC with MET aberration in the second half of 2021;
• Initiate SACHI, a pivotal Phase III study in China for the savolitinib plus TAGRISSO^® combination in patients with NSCLC who have progressed following EGFR TKI treatment due to MET amplification in the second half of 2021; and
• Conclude the SAVANNAH Phase II study (NCT03778229) for the savolitinib plus TAGRISSO^® combination in NSCLC patients harboring EGFR mutation and MET amplification or overexpression. SAVANNAH will inform final regulatory, biomarker and dose regimen strategy for the initiation of global Phase III development in late 2021.

HMPL-689, an investigative and highly selective small molecule inhibitor of PI3Kδ⁴² designed to address the gastrointestinal and hepatotoxicity associated with currently approved and clinical-stage PI3Kδ inhibitors

• Initiated Phase II studies with potential for registration intent in China for the treatment of patients with follicular lymphoma and patients with marginal zone lymphoma in April 2021.

Potential upcoming clinical and regulatory milestones for HMPL-689:

• Complete Phase Ib dose expansion study (NCT03128164) and submit interim data for presentation in the second half of 2021. Over 95 patients have enrolled at the RP2D⁴³ in six non-Hodgkin’s lymphoma sub-type cohorts;
• Complete Phase I dose escalation in the U.S. and Europe (NCT03786926) in mid-2021 and initiate Phase Ib expansion studies in multiple non-Hodgkin’s lymphoma indications;
• Complete U.S. FDA regulatory discussions in the second half of 2021 followed by the initiation of registration intent studies in indolent non-Hodgkin’s lymphoma by the end of 2021;
• Initiate additional Phase II studies with potential for registration intent in China in additional relapsed/refractory non-Hodgkin’s lymphoma indications in late 2021 or early 2022; and
• Initiate studies in combination with other anti-cancer therapies in China in early 2022.

HMPL-523, an investigative and highly selective small molecule inhibitor of Syk⁴⁴, an important component of the B-cell receptor signaling pathway, for the treatment of hematological cancers and immune disease

• Completed Phase Ib ITP⁴⁵ dose expansion study (NCT03951623) in China with all patients having completed eight weeks treatment.

Potential upcoming clinical and regulatory milestones for HMPL-523:

• Initiate dose expansion of the Phase I study (NCT03779113) in the U.S. and Europe, following completion of dose escalation, in the second half of 2021;
• Initiate a Phase III study in ITP in China in late 2021, after engagement with the CDE⁴⁶;
• Initiate a Phase II study in AIHA⁴⁷ in China in late 2021; and
• Submit for presentation Phase Ib study preliminary data in ITP (NCT03951623) in late 2021.

HMPL-453, an investigative and highly selective small molecule inhibitor of FGFR 1/2/3

Potential upcoming clinical and regulatory milestones for HMPL-453:

• Initiate studies in combination with other anti-cancer therapies in China in late 2021 or early 2022, based on the response to the late June 2021 submission of an IND⁴⁸ to the NMPA.

HMPL-306, an investigative and highly selective small molecule inhibitor of IDH1/2 designed to address resistance to the currently marketed IDH inhibitors

• Initiated dose escalation portion of a Phase I study (NCT04764474) in the U.S. in patients with relapsed or refractory hematological malignancies with an IDH1 and/or IDH2 mutation in the first half of 2021; and
• Initiated dose escalation portion of a Phase I study (NCT04762602) in the U.S. in patients with solid tumors with an IDH1 and/or IDH2 mutation in the first half of 2021.

Potential upcoming clinical and regulatory milestones for HMPL-306:

• Initiate dose expansion portion of the Phase I studies in China and the U.S. (NCT04272957, NCT04762602 and NCT04764474) in patients with relapsed or refractory hematological malignancies or solid tumors with an IDH1 and/or IDH2 mutation, after full enrollment of the dose escalation cohorts in late 2021 or early 2022.

HMPL-295, an investigative and highly selective small molecule inhibitor of ERK in the MAPK pathway ⁴⁹ 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 in July 2021.

HMPL-760, an investigative, highly selective, third-generation small molecule inhibitor of BTK with improved potency versus first generation BTK inhibitors against both wild type & C481S mutant enzymes

Potential upcoming clinical and regulatory milestones for HMPL-760:

• Initiate Phase I trial in the U.S. in patients with advanced hematological malignancies in late 2021, based on the IND submission in late June 2021 to the U.S. FDA to begin clinical trials; and
• Initiate Phase I trial in China in patients with advanced hematological malignancies in late 2021 or early 2022, based on the IND submission in late June 2021 to the China NMPA.

Discovery, our in-house scientific team has been responsible for the discovery of all eleven of our clinical drug candidates including our three approved oncology drugs ELUNATE^®, SULANDA^® and ORPATHYS^®

• Completed preclinical IND-enabling activities and submitted two INDs for HMPL-760 to the U.S. FDA and China NMPA.

Potential upcoming discovery milestones:

• IND-enabling toxicity studies are underway for two additional in-house discovered oncology drug candidates, a potent and selective small molecule CSF-1R inhibitor (HMPL-653) and a CD47 antibody (HMPL-A83). If the outcomes of these studies are positive, we will follow with IND submissions in China and the U.S. in late 2021 and early 2022.

IV. MANUFACTURING

• Rapid progress being made in building our new flagship Shanghai manufacturing facility, since breaking ground in December 2020. This facility is designed to increase our novel drug product manufacturing capacity by over five-fold and is on-track to commence production in 2024. In the first half of 2021 we obtained all necessary approvals and permits; completed vendor selection process for both the primary construction and specific equipment; completed site preparation and pilings; and initiated construction of the central utility building.

V. OTHER CORPORATE DEVELOPMENTS

• Completed listing of ordinary shares and primary offering of 119,600,000 new ordinary shares⁵⁰ on the Main Board of HKEX (the “Global Offering”), raising net proceeds of approximately $585 million, to advance our late-stage clinical programs as well as our pipeline of clinical-stage and preclinical drug candidates, further strengthening our oncology commercialization, clinical, regulatory and manufacturing capabilities and enabling funding of potential global business development and strategic acquisition opportunities and for general corporate purposes;
• Announced a divestment agreement to sell our entire indirect interest in HBYS⁵¹, a non-core and non-consolidated over-the-counter drug joint venture business, to GL Capital⁵² with the aggregate amount attributable to HUTCHMED of approximately $169 million in cash. This cash amount represents about 22 times HBYS’s adjusted net profit attributable to HUTCHMED equity holders of $7.7 million in 2020⁵³. The transaction is subject to regulatory approval in China and is expected to close in the second half of 2021;
• Changed our group company name to HUTCHMED in April 2021, and the names of several of our key subsidiaries. All remaining key subsidiaries’ names will change over the balance of 2021; and
• Announced a strategic partnership with Inmagene⁵⁴ in January 2021 to further develop four novel preclinical drug candidates discovered by HUTCHMED for the potential treatment of multiple immunological diseases.

VI. IMPACT OF COVID-19

COVID-19 has not impacted our clinical studies in any material manner to date in 2021. We will continue to closely monitor the evolving situation.

INTERIM 2021 FINANCIAL RESULTS

Cash, Cash Equivalents and Short-Term Investments were $950.4 million as of June 30, 2021 compared to $435.2 million as of December 31, 2020.

• Adjusted Group (non-GAAP⁵⁵) net cash flows excluding financing activities in H1 2021 were -$63.1 million (H1-20: -$32.5m) mainly due to Oncology/Immunology R&D spending and partially offset by dividends received from our non-consolidated joint ventures totaling $42.1 million (H1-20: $35.3m); and
• Net cash generated from financing activities in H1 2021 totaled $578.3 million (H1-20: $96.3m) mainly resulting from the Global Offering in June 2021 and a private placement in April 2021 to a fund affiliated with BPEA⁵⁶.
• Not included above is a further approximately $250 million from: $77 million in net proceeds in July 2021 from the exercise of the over-allotment option of the Global Offering; the $25 million milestone payment from AstraZeneca triggered by first commercial sales of ORPATHYS^® in July 2021; and the approximately $150 million in remaining net proceeds receivable under our agreed divestment of HBYS to GL Capital.

Revenues for the six months ended June 30, 2021 were $157.4 million compared to $106.8 million in the six months ended June 30, 2020.

• Oncology/Immunology consolidated revenues increased 161% (152% at CER⁵⁷) to $42.9 million (H1-20: $16.4m) comprised of:
  
  ELUNATE^® revenues increased 244% to $29.8 million (H1-20: $8.6m) in manufacturing revenues, promotion and marketing service revenues and royalties, as our in-house sales team increased in-market sales 186% to $40.1 million (H1-20: $14.0m), as provided by Lilly⁵⁸;
  
  SULANDA^® sales revenues of $8.0 million since mid-January launch, initially to treat patients with advanced extra-pancreatic (non-pancreatic) NET, then also to treat patients with pancreatic NET in June 2021; and
  
  R&D service fee revenues of $5.1 million (H1-20: $7.8m) primarily from AstraZeneca and Lilly.
  
  ORPATHYS^® $25 million payment and fixed royalty of 30% on all China sales from AstraZeneca not included, as the milestone payment was recently triggered by its first sales in China in July 2021. AstraZeneca has launched ORPATHYS^® across China through its extensive, market-leading oncology commercial organization.

• Other Ventures consolidated revenues increased 27% (18% at CER) to $114.5 million (H1-20: $90.4m) mainly due to continued sales growth of third-party prescription drug products.

Net Expenses for the six months ended June 30, 2021 were $259.8 million compared to $156.5 million in the six months ended June 30, 2020.

• Cost of Revenues were $123.2 million (H1-20: $83.6m), the majority of which were the cost of third-party prescription drug products marketed through our profitable Other Ventures, as well as costs associated with promotion and marketing services to Lilly which commenced in October 2020;
• R&D Expenses were $123.1 million (H1-20: $74.0m) mainly as a result of an expansion in the development of our eleven novel oncology drug candidates. With six now in global development, our rapidly scaling international clinical and regulatory operations in the U.S. and Europe incurred expenses of $59.3 million (H1-20: $19.9m) while R&D expenses in China were $63.8 million (H1-20: $54.1m);
• SG&A⁵⁹ Expenses were $54.8 million (H1-20: $27.4m) primarily due to increases in staff costs and share-based compensation to support expanding operations. This included the build-up of a large-scale national oncology commercial infrastructure in China to support our oncology products; and
• Other Items⁶⁰ generated net income of $41.3 million (H1-20: $28.5m) resulting primarily from an increase in our share of equity in the earnings from equity investees under our Other Ventures in China which delivered solid underlying net income growth of 19% (9% at CER) in the first half of 2021 and also benefited from a one-time land compensation of $5.1 million (H1-20: nil).

Net Loss attributable to HUTCHMED for the six months ended June 30, 2021 was $102.4 million compared to $49.7 million in the six months ended June 30, 2020.

• As a result, the net loss attributable to HUTCHMED in the first half of 2021 was $0.14 per ordinary share / $0.70 per ADS⁶¹ compared to net loss attributable to HUTCHMED of $0.07 per ordinary share / $0.35 per ADS, in the six months ended June 30, 2020.

FINANCIAL SUMMARY

Condensed Consolidated Balance Sheet Data
(in $’000)

		As of June 30,		As of December 31,
		2021		2020
		(Unaudited)
Assets
Cash and cash equivalents and short-term investments		950,448		435,176
Accounts receivable		58,878		47,870
Other current assets		81,848		47,694
Property, plant and equipment		29,168		24,170
Investments in equity investees		118,316		139,505
Other non-current assets		34,231		29,703
Total assets		1,272,889		724,118
Liabilities and shareholders’ equity
Accounts payable		28,513		31,612
Other payables, accruals and advance receipts		181,610		120,882
Bank borrowings		26,883		26,861
Other liabilities		22,188		25,814
Total liabilities		259,194		205,169
Total Company’s shareholders’ equity		984,795		484,116
Non-controlling interests		28,900		34,833
Total liabilities and shareholders’ equity		1,272,889		724,118

Condensed Consolidated Statement of Operations Data
(Unaudited, in $’000, except share and per share data)

	Six Months Ended June 30,
	2021			2020
Revenues:
Oncology/Immunology – Marketed Products	37,795			8,645
Oncology/Immunology – R&D	5,056			7,747
Oncology/Immunology consolidated revenues	42,851			16,392
Other Ventures	114,511			90,373
Total revenues	157,362			106,765
Expenses:
Costs of revenues	(123,249	)		(83,572	)
Research and development expenses	(123,050	)		(73,974	)
Selling and general administrative expenses	(54,797	)		(27,384	)
Total expenses	(301,096	)		(184,930	)
Loss from Operations	(143,734	)		(78,165	)
Other income	3,287			1,585
Loss before income taxes and equity in earnings of equity investees	(140,447	)		(76,580	)
Income tax expense	(1,859	)		(2,032	)
Equity in earnings of equity investees, net of tax	42,966			30,366
Net loss	(99,340	)		(48,246	)
Less: Net income attributable to non-controlling interests	(3,057	)		(1,448	)
Net loss attributable to HUTCHMED	(102,397	)		(49,694	)
Losses per share attributable to HUTCHMED - basic and diluted	(0.14	)		(0.07	)
Number of shares used in per share calculation - basic and diluted	729,239,181			685,285,841
Losses per ADS attributable to HUTCHMED - basic and diluted	(0.70	)		(0.35	)
Number of ADSs used in per share calculation - basic and diluted	145,847,836			137,057,168

All amounts are expressed in U.S. dollar currency unless otherwise stated.

FINANCIAL GUIDANCE

During the first half of 2021, we performed as expected with commercial progress on ELUNATE^®, SULANDA^® and now ORPATHYS^®. While results are encouraging, we leave guidance unchanged.   

	H1 2021 Actual	2021 Current Guidance	Adjustments vs. Previous Guidance
Oncology/Immunology consolidated revenues	$42.9 million	$110 – 130 million	nil

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 8 p.m. HKT / 1 p.m. BST / 8 a.m. EDT – Investors may participate in the call as follows: +852 3027 6500 (Hong Kong) / +44 20 3194 0569 (U.K.) / +1 646 722 4977 (U.S.), or access a live audio webcast of the call via HUTCHMED’s website at www.hutch-med.com/event/.

Additional dial-in numbers are also available at HUTCHMED's website. Please use participant access code “45675713#.”

About HUTCHMED

HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development & commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. A dedicated organization of over 1,300 personnel. has advanced eleven cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved and launched. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.

Contacts

Investor Enquiries
Mark Lee, Senior Vice President	+852 2121 8200
Annie Cheng, Vice President	+1 (973) 567 3786
Media Enquiries
Americas – Brad Miles, Solebury Trout	+1 (917) 570 7340 (Mobile) bmiles@troutgroup.com
Europe – Ben Atwell / Alex Shaw, FTI Consulting	+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) HUTCHMED@fticonsulting.com
Asia – Zhou Yi, Brunswick	+852 9783 6894 (Mobile) HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie / Freddy Crossley, Panmure Gordon (UK) Limited	+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 consolidated subsidiaries and joint ventures 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 U.S. 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,” “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, or that any approvals which are obtained will be obtained at any particular time, or that any such drug candidates 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; 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 gain commercial acceptance after obtaining regulatory approval; 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 the COVID-19 pandemic. For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission, on AIM and on HKEX. 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).

 

REFERENCES AND ABBREVIATIONS
1	ELUNATE® In-market sales = total sales to third parties provided by Eli Lilly.
2	Gross proceeds of $534.7 million raised through the sale of new ordinary shares on June 30, 2021, and additional gross proceeds of $80.2 million raised via the sale of additional new ordinary shares from the full exercise of the over-allotment option on July 15, 2021.
3	HKEX = The Stock Exchange of Hong Kong Limited.
4	NDA = New Drug Application.
5	FDA = Food and Drug Administration.
6	EMA = European Medicines Agency.
7	TKI = Tyrosine kinase inhibitor.
8	IDH = Isocitrate dehydrogenase.
9	ERK = Extracellular signal-regulated kinase.
10	BTK = Bruton’s tyrosine kinase.
11	In-market sales = total sales to third parties provided by Eli Lilly (ELUNATE®) and HUTCHMED (SULANDA®).
12	AstraZeneca = AstraZeneca PLC and its wholly owned subsidiary, AstraZeneca AB (publ).
13	IPO = Initial public offering.
14	OTC = Over the counter.
15	R&D = Research and development.
16	NET = Neuroendocrine tumors.
17	NMPA = National Medical Products Administration.
18	MET = Mesenchymal epithelial transition receptor.
19	NSCLC = Non-small cell lung cancer.
20	PDUFA = Prescription Drug User Fee Act.
21	MAA = Marketing Authorisation Application.
22	VEGFR = Vascular endothelial growth factor receptor.
23	FGFR = Fibroblast growth factor receptor.
24	CSF-1R = Colony stimulating factor-1 receptor.
25	BeiGene = BeiGene, Ltd.
26	PD-1 = Programmed Cell Death Protein-1.
27	NEC = Neuroendocrine carcinoma.
28	Junshi = Shanghai Junshi Biosciences Co., Ltd.
29	ASCO = American Society of Clinical Oncology.
30	CgA = Chromogranin A.
31	PFS = Progression-free survival.
32	BTC = Biliary tract cancer.
33	Innovent = Innovent Biologics, Inc.
34	CRC = Colorectal cancer.
35	HCC = Hepatocellular carcinoma.
36	RCC = Renal cell cancer.
37	Genor = Genor Biopharma Co. Ltd.
38	PD-L1 = Programmed death-ligand 1.
39	PRCC = Papillary renal cell carcinoma.
40	WCLC = World Conference on Lung Cancer.
41	EGFR = Epidermal growth factor receptor.
42	PI3Kδ = Phosphoinositide 3-kinase delta.
43	RP2D = Recommended Phase II dose.
44	Syk = Spleen tyrosine kinase.
45	ITP = Immune thrombocytopenia purpura.
46	CDE = Center for Drug Evaluation.
47	AIHA = Autoimmune hemolytic anemia.
48	IND = Investigational New Drug application.
49	MAPK pathway = RAS-RAF-MEK-ERK signaling cascade.
50	119,600,000 new ordinary shares represented by 104,000,000 new ordinary shares issued on June 30, 2021 (raising net proceeds of ~$508 million) and additional 15,600,000 new ordinary shares from the full exercise of the over-allotment option on July 15, 2021 (raising net proceeds of $77 million).
51	HBYS = Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited.
52	GL Capital = GL Mountrose Investment Two Limited, a company controlled and managed by GL Capital Group.
53	HBYS’ adjusted net profit attributable to HUTCHMED equity holders (after 20% non-controlling interest) in 2020 of $7.7 million is a non-GAAP measure which is 40% of HBYS’ 2020 net profit of $91.3 million less $72.0 million gain on land compensation, net of tax.
54	Inmagene = Inmagene Biopharmaceuticals.
55	GAAP = Generally Accepted Accounting Principles.
56	BPEA = Baring Private Equity Asia.
57	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.
58	Lilly = Eli Lilly and Company.
59	SG&A = Selling, general and administrative.
60	Other items = Includes other income, net of other expenses, income tax expense, equity in earnings of equity investees, net of tax and net income attributable to non-controlling interests.
61	ADS = American depositary share.

This announcement in its entirety is available at: http://ml.globenewswire.com/Resource/Download/495fc1d8-ba3e-4ecb-9e98-565edce2f91f 

FAQ

What are HUTCHMED's key financial figures for H1 2021?

HUTCHMED reported total revenues of $157.4 million, a 47% increase from H1 2020.

How much did HUTCHMED raise from its HKEX listing?

HUTCHMED raised $615 million in gross proceeds from an additional listing on HKEX.

What was the performance of ELUNATE® in H1 2021?

ELUNATE® sales increased by 186% to $40.1 million.

What approvals did HUTCHMED receive in China recently?

HUTCHMED received its first approval for ORPATHYS® and second approval for SULANDA® in China.

What was HUTCHMED's net loss in H1 2021?

The net loss attributable to HUTCHMED was $102.4 million, compared to $49.7 million in H1 2020.