Full Press Release Details
HUTCHMED Reports 2021 Interim Results and Provides Business Updates
ELUNATE in-market sales1 rose 186%, reflecting impact of in-house sales force
Received 1st approval in China for ORPATHYS and 2nd 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, Shanghai & Florham Park, NJ Wednesday, July 28, 2021: 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
II. REGULATORY ACHIEVEMENTS
United States & Europe
III. CLINICAL DEVELOPMENT ACTIVITIES
Surufatinib (SULANDA in China), a small molecule inhibitor of VEGFR22, FGF23 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
Potential upcoming clinical and regulatory milestones for surufatinib:
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
Potential upcoming clinical and regulatory milestones for fruquintinib:
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
Potential upcoming clinical and regulatory milestones for savolitinib:
HMPL-689, an investigative and highly selective small molecule inhibitor of PI3K 42 designed to address the gastrointestinal and hepatotoxicity associated with currently approved and clinical-stage PI3K inhibitors
Potential upcoming clinical and regulatory milestones for HMPL-689:
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
Potential upcoming clinical and regulatory milestones for HMPL-523:
HMPL-453, an investigative and highly selective small molecule inhibitor of FGFR 1/2/3
Potential upcoming clinical and regulatory milestones for HMPL-453:
HMPL-306, an investigative and highly selective small molecule inhibitor of IDH1/2 designed to address resistance to the currently marketed IDH inhibitors
Potential upcoming clinical and regulatory milestones for HMPL-306:
HMPL-295, an investigative and highly selective small molecule inhibitor of ERK in the MAPK pathway49 with the potential to address intrinsic or acquired resistance from upstream mechanisms such as RAS-RAF-MEK
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:
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
Potential upcoming discovery milestones:
V. OTHER CORPORATE DEVELOPMENTS
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.
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.
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.
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.
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.
Condensed Consolidated Balance Sheet Data
| 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.
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 | 2021 Current | Adjustments vs. | |||||||
| Actual | Guidance | 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.
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#.
| 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 |
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.
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).
We discover, develop, manufacture and market targeted therapies and immunotherapies for the treatment of cancer and immunological diseases through a fully integrated team of approximately 720 scientists and staff (December 31, 2020: >600), and an in-house oncology commercial organization of about 540 staff (December 31, 2020: ~390).
Currently, we have eleven self-discovered oncology drug candidates in clinical trials in China, with six also in clinical development in the U.S. and Europe. Our first three drug candidates, fruquintinib, surufatinib and savolitinib, have all been approved and launched in China.
MARKETED PRODUCT SALES
Fruquintinib (ELUNATE in China)
In the first half of 2021, ELUNATE in-market sales increased 186% to $40.1 million (H1-20: $14.0m), as provided by Lilly. ELUNATE revenues consolidated by HUTCHMED increased 244% to $29.8 million (H1-20: $8.6m).
HUTCHMED took over development and execution responsibilities for all on-the-ground medical detailing, promotion and local and regional marketing activities for ELUNATE in China from Lilly in October 2020. We estimate, for our approved indication in third-line metastatic CRC, there is an approximate incidence of 83,000 new patients per year in China.
During the first half of 2021, we conducted about 5,000 educational/scientific events involving approximately 70,000 healthcare professionals ( HCPs ). We increased medical sales coverage to over 2,500 cancer hospitals and secured hospital pharmacy listings for ELUNATE in over 400 hospitals, in both cases more than double the level of October 2020 when HUTCHMED took over from Lilly. We estimate that during the first half of 2021 approximately 9,000 patients were treated with ELUNATE .
We have confirmed a total of about 20 investigator-initiated studies, which target to explore ELUNATE use in CRC, gastric cancer, NSCLC, pancreatic cancer, and several other indications. We believe that these studies combined with our promotion and marketing activities are rapidly raising awareness of ELUNATE in China.
Surufatinib (SULANDA in China)
SULANDA was first launched for the treatment of advanced NETs for tumors originating outside of the pancreas in mid-January 2021 and for those originating in the pancreas in late June 2021. Total sales in the first half of 2021 were $8.0 million (H1-20: nil).
During the first half of 2021, we introduced SULANDA through a campaign of local, regional and national launch events involving approximately 12,000 HCPs. We have utilized means-tested early access and patient access programs to enable SULANDA use by over 2,000 patients during the first half of 2021. We estimate, there is an approximate incidence of 34,000 new advanced NET patients per year in China.
We view this initial progress as encouraging and, over the balance of 2021, we expect to decide our long term pricing strategy for SULANDA either by submitting for inclusion in the 2022 NRDL or by continuing to price at current levels and expanding our early access and patient access programs.
We have also confirmed a total of over 30 investigator-initiated studies in a broad range of exploratory solid tumor indications all of which are expected to gradually expand awareness of SULANDA in China.
Savolitinib (ORPATHYS )
On June 22, 2021, ORPATHYS became the first-in-class selective MET inhibitor to be approved in China. Our partner, AstraZeneca, then launched ORPATHYS in mid-July 2021, less than three weeks after its conditional approval by the NMPA for patients with MET exon 14 skipping alteration NSCLC.
More than a third of the world's lung cancer patients are in China and, among those with NSCLC, approximately 2-3% have tumors with MET exon 14 skipping alterations, representing an approximate incidence of 13,000 new patients per year in China. Importantly also, MET plays a role in multiple other solid tumors, with an estimated total incidence of 120,000 new patients per year in China.
In the second half of 2021, HUTCHMED will begin to consolidate revenues from ORPATHYS , starting with a $25 million non-creditable and non-refundable first sale milestone payment from AstraZeneca and then ongoing manufacturing fees in addition to royalties of 30% of ORPATHYS sales in China.
As a result of its approval prior to the mid-2021 cut off, ORPATHYS will be eligible for potential inclusion in the 2022 NDRL, subject to negotiation and agreement with the relevant regulatory authorities.
RESEARCH & DEVELOPMENT
Savolitinib (ORPATHYS )
Savolitinib is an oral, potent, and highly selective small molecule inhibitor of MET. In global partnership with AstraZeneca, savolitinib has been studied in NSCLC, PRCC and gastric cancer in about 1,200 clinical trial patients to date, both as a monotherapy and in combinations.
Savolitinib Lung cancer:
MET plays an important role in NSCLC. The table below shows a summary of the clinical studies for savolitinib in lung cancer patients.
| Treatment | Name, Line, Patient Focus | Sites | Phase | Status/Plan | NCT # | ||||||
| Savolitinib monotherapy | MET exon 14 skipping alteration | China | II Registration | Approved and launched | NCT02897479 | ||||||
| Savolitinib + TAGRISSO | SAVANNAH: 2L/3L EGFRm+ 62 ; TAGRISSO refractory; MET+ | Global | II Registration-intent | Ongoing. Data support progressing into Phase III, expected in H2 2021 | NCT03778229 | ||||||
| Savolitinib + TAGRISSO | 2L/3L EGFRm+; TAGRISSO refractory; MET+ | Global | III | In planning. Intend to initiate in H2 2021 | N/A | ||||||
| Savolitinib + TAGRISSO | SACHI: 2L EGFR TKI refractory NSCLC; MET+ | China | III | In planning. Intend to initiate in H2 2021 | N/A | ||||||
| Savolitinib + TAGRISSO | SANOVO: Na ve patients with EGFRm & MET+ | China | III | In planning. Intend to initiate in H2 2021 | N/A |
NMPA NDA Approval in MET exon 14 skipping alterations NSCLC (NCT02897479) In June 2021, savolitinib was approved by the NMPA based on positive results from a Phase II trial conducted in China in patients with NSCLC with MET exon 14 skipping alterations, including patients with the more aggressive pulmonary sarcomatoid carcinoma subtype. Savolitinib demonstrated effective anti-tumor activity based on an independent review of ORR and DCR. The approval is conditional upon successful completion of a confirmatory study in this patient population (NCT04923945), which is expected to enroll approximately 160 patients from approximately 40 sites. In July 2021, the first commercial sales in China occurred.
EGFR TKI-resistance in NSCLC MET-amplification is a major mechanism for acquired resistance to both first-generation EGFR TKIs, such as IRESSA and TARCEVA , as well as third-generation EGFR TKIs like TAGRISSO . As many as 30% of EGFR mutation positive NSCLC patients develop MET amplification driven resistance to EGFR TKIs. Savolitinib has been studied extensively in these patients in the TATTON and SAVANNAH studies.
SAVANNAH Phase II study of combination with TAGRISSO in patients who have progressed following TAGRISSO due to MET amplification or overexpression (NCT03778229) The SAVANNAH study is a global single-arm, open-label study that has now fully enrolled the savolitinib 300mg QD63 cohort, and is currently enrolling two additional cohorts of savolitinib 300mg BID64 and 600mg QD. The study will also determine optimal design of the planned global Phase III study regarding optimal biomarker strategy and dosage regimen. Enrollment is expected to be completed in mid-2021 and planning for the global Phase III study is now underway.
In-Planning SACHI China Phase III study of combination with TAGRISSO in 2L EGFR TKI refractory, MET amplified NSCLC patients We intend to initiate a Phase III study in China targeting EGFR TKI refractory second-line NSCLC patients in the second half of 2021.
In-Planning SANOVO China Phase III study of combination with TAGRISSO in EGFR mutant and MET positive NSCLC patients We intend to initiate a Phase III study in China targeting treatment na ve patients who are both EGFR mutation and MET aberrant in the second half of 2021.
Savolitinib Kidney cancer:
MET is a clear genetic driver in RCC. The table below shows a summary of the clinical studies for savolitinib in kidney cancer patients.
| Treatment | Name, Line, Patient Focus | Sites | Phase | Status/Plan | NCT # | ||||||
| Savolitinib + IMFINZI | SAMETA: MET-driven, unresectable and locally advanced or metastatic PRCC | Global | III | In planning. Expected to begin enrollment in H2 2021 | N/A | ||||||
| Savolitinib + IMFINZI | CALYPSO: PRCC | U.K./Spain | II | Data update at ASCO 2021 | NCT02819596 | ||||||
| Savolitinib + IMFINZI | CALYPSO: Clear cell RCC; VEGFR TKI refractory | U.K./Spain | II | Ongoing | NCT02819596 |