Hong Kong, Shanghai, & Florham Park, NJ: Monday, March 29, 2021: Hutchison China MediTech Limited (“HUTCHMED”) (Nasdaq/AIM: HCM) announces that on March 26, 2021, it granted conditional awards (“LTIP Awards”) under the Long Term Incentive Plan adopted by HUTCHMED in 2015 (“LTIP”) and share options under the Share Option Scheme adopted by HUTCHMED in 2015 as refreshed in April 2020 (the “Share Option Scheme”).
1. Performance-related LTIP Award for the HUTCHMED Financial Year 2021 (“Performance LTIP”) – award based on a maximum cash amount, which amount is determined by the achievement of performance targets for the financial year ending 31 December 2021. The performance targets will be determined by the Remuneration Committee of HUTCHMED based on the strategic objectives of HUTCHMED.
The Shares, to be purchased by the Trustee following determination of the cash amount based on actual achievement of performance targets, will then be held by the Trustee until the underlying LTIP Awards are vested. Vesting will occur two business days after the date of announcement of the annual results of HUTCHMED for the financial year ending December 31, 2023. Vesting will also depend upon the continued employment of the award holder with the HUTCHMED group and will otherwise be at the discretion of the Board of Directors of HUTCHMED.
HUTCHMED has granted the following LTIP Awards for the Performance LTIP to the following PDMRs:
| Award Holder | Maximum amount for the Performance LTIP | |
| Mr Christian Hogg (Executive Director and Chief Executive Officer) | US$1,616,538 | |
| Mr Johnny Cheng (Executive Director and Chief Financial Officer) | US$657,211 | |
| Dr Weiguo Su (Executive Director and Chief Scientific Officer) | US$1,622,123 |
An additional 585 employees of HUTCHMED and its subsidiaries have simultaneously been granted LTIP Awards under the Performance LTIP.
2. Share Option Scheme
HUTCHMED granted share options under its Share Option Scheme to 147 employees to subscribe for a total of 8,279,900 Ordinary Shares represented by 1,655,980 American Depositary Shares (“ADSs”) (each equating to five Ordinary Shares) subject to the acceptance of the grantee. Details of such share options granted prescribed are as follows:
| Date of grant | : | March 26, 2021 |
| Exercise price of share options granted | : | US$27.94 per ADS |
| Number of share options granted | : | 8,279,900 represented by 1,655,980 ADSs (five share options shall entitle the holder thereof to subscribe for one ADS) |
| Closing market price of ADSs on the date of grant | : | US$27.66 per ADS |
| Validity period of the share options | : | From March 26, 2021 to March 25, 2031 |
Among the share options granted, a total of 1,391,800 share options represented by 278,360 ADSs were granted to Mr Christian Hogg, Dr Weiguo Su and Mr Johnny Cheng (Executive Directors of the Company), being persons discharging managerial responsibility under the EU Market Abuse Regulation as follows:-
| Grantee | Number of share options granted | |
| Mr Christian Hogg (Executive Director and Chief Executive Officer) | 868,900 Ordinary Shares represented by 173,780 ADSs | |
| Mr Johnny Cheng (Executive Director and Chief Financial Officer) | 240,500 Ordinary Shares represented by 48,100 ADSs | |
| Dr Weiguo Su (Executive Director and Chief Scientific Officer) | 282,400 Ordinary Shares represented by 56,480 ADSs |
| 1 | Details of the person discharging managerial responsibilities/person closely associated | |||||||
| a) | Name | Mr Christian Hogg | ||||||
| 2 | Reason for the notification | |||||||
| a) | Position/status | Executive Director and Chief Executive Officer | ||||||
| b) | Initial notification/Amendment | Initial notification | ||||||
| 3 | Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor | |||||||
| a) | Name | Hutchison China MediTech Limited | ||||||
| b) | LEI | 2138006X34YDQ6OBYE79 | ||||||
| 4 | Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted | |||||||
| a) | Description of the financial instrument, type of instrument Identification code |
Option over American Depositary Share (each equating to five Ordinary Shares of US$0.10) Option over American Depositary Share with ADS ISIN: US44842L1035 |
||||||
| b) | Nature of the transaction |
Grant of options in respect of 868,900 Ordinary Shares represented by 173,780 ADSs under the Share Option Scheme. The share options granted are exercisable subject to a vesting schedule of 25% on each of the first, second, third and fourth anniversaries of the effective date of grant. |
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| c) | Price(s) and volume(s) |
|
||||||
| d) | Aggregated information
|
N/A | ||||||
| e) | Date of the transaction | 2021-03-26 | ||||||
| f) | Place of the transaction | Outside a trading venue | ||||||
| 1 | Details of the person discharging managerial responsibilities/person closely associated | |||||||
| a) | Name | Mr Johnny Cheng | ||||||
| 2 | Reason for the notification | |||||||
| a) | Position/status | Executive Director and Chief Financial Officer | ||||||
| b) | Initial notification/Amendment | Initial notification | ||||||
| 3 | Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor | |||||||
| a) | Name | Hutchison China MediTech Limited | ||||||
| b) | LEI | 2138006X34YDQ6OBYE79 | ||||||
| 4 | Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted | |||||||
| a) |
Description of the financial instrument, type of instrument Identification code |
Option over American Depositary Share (each equating to five Ordinary Shares of US$0.10) Option over American Depositary Share with ADS ISIN: US44842L1035 |
||||||
| b) | Nature of the transaction |
Grant of options in respect of 240,500 Ordinary Shares represented by 48,100 ADSs under the Share Option Scheme. The share options granted are exercisable subject to a vesting schedule of 25% on each of the first, second, third and fourth anniversaries of the effective date of grant. |
||||||
| c) | Price(s) and volume(s) |
|
||||||
| d) | Aggregated information
|
N/A | ||||||
| e) | Date of the transaction | 2021-03-26 | ||||||
| f) | Place of the transaction | Outside a trading venue | ||||||
| 1 | Details of the person discharging managerial responsibilities/person closely associated | |||||||
| a) | Name | Dr Weiguo Su | ||||||
| 2 | Reason for the notification | |||||||
| a) | Position/status | Executive Director and Chief Scientific Officer | ||||||
| b) | Initial notification/Amendment | Initial notification | ||||||
| 3 | Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor | |||||||
| a) | Name | Hutchison China MediTech Limited | ||||||
| b) | LEI | 2138006X34YDQ6OBYE79 | ||||||
| 4 | Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted | |||||||
| a) |
Description of the financial instrument, type of instrument Identification code |
Option over American Depositary Share (each equating to five Ordinary Shares of US$0.10) Option over American Depositary Share with ADS ISIN: US44842L1035 |
||||||
| b) | Nature of the transaction |
Grant of options in respect of 282,400 Ordinary Shares represented by 56,480 ADSs under the Share Option Scheme. The share options granted are exercisable subject to a vesting schedule of 25% on each of the first, second, third and fourth anniversaries of the effective date of grant |
||||||
| c) | Price(s) and volume(s) |
|
||||||
| d) | Aggregated information
|
N/A | ||||||
| e) | Date of the transaction | 2021-03-26 | ||||||
| f) | Place of the transaction | Outside a trading venue | ||||||
HUTCHMED (Nasdaq/AIM: HCM) is an innovative, commercial-stage, biopharmaceutical company committed, over the past twenty years, to the discovery and global development of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has advanced ten cancer drug candidates from discovery into clinical studies around the world and has an extensive commercial infrastructure in its home market of China. For more information, please visit: www.hutch-med.com.
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. Forward-looking statements involve risks and uncertainties. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this announcement, whether as a result of new information, future events or circumstances or otherwise.
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 | |
| Joseph Chi Lo, Brunswick |
+852 9850 5033 (Mobile) |
| Zhou Yi, Brunswick |
+852 9783 6894 (Mobile) HUTCHMED@brunswickgroup.com |
Nominated Advisor |
|
| Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK) Limited |
+44 (20) 7886 2500 |
— HMPL-306 is the sixth innovative oncology drug candidate discovered in house by HUTCHMED to enter into global development —
Hong Kong, Shanghai & Florham Park, NJ — Monday, March 29, 2021: Hutchison China MediTech Limited (“HUTCHMED”) (Nasdaq/AIM: HCM) has initiated two international Phase I studies of HMPL-306, its novel selective small molecule dual inhibitor of isocitrate dehydrogenase (“IDH”) 1 and 2 mutations. One trial is in patients with advanced solid tumors and one trial is in patients with hematological malignancies. Both trials have sites in the US and Europe. The first international patient was dosed on March 25, 2021, following a Phase I trial that was initiated in China in the second half of 2020. This new program is a demonstration of HUTCHMED’s accelerating and expanding global clinical development presence.
These two trials are multi-center studies to evaluate the safety, tolerability pharmacokinetics, pharmacodynamics and preliminary efficacy of HMPL‑306. The first trial is in solid tumors (including but not limited to gliomas, chondrosarcomas, or cholangiocarcinomas), while a second trial is in advanced relapsed, refractory or resistant hematological malignancies that harbor IDH1 or IDH2 mutations. The first stage of each study is a dose escalation phase where cohorts of patients will receive ascending oral doses of HMPL‑306 to determine the maximum tolerated dose and/or the recommended Phase II dose (“RP2D”). The second stage is a dose expansion phase where patients will receive HMPL‑306 to further evaluate the safety, tolerability, and clinical activity at the RP2D. Additional details may be found at clinicaltrials.gov, using identifiers NCT04762602 and NCT04764474, respectively.
The MD Anderson Cancer Center (“MDACC”) is the lead institution on both studies. The lead investigator for the hematological malignancies study is Dr. Farhad Ravandi, the Janiece and Stephen A. Lasher Professor of Medicine and Chief of Section of Developmental Therapeutics in the Department of Leukemia at The University of Texas MDACC. The lead investigator for the solid tumor study is Dr. Filip Janku, Associate Professor, Department of Investigational Cancer Therapeutics at The University of Texas MDACC.
A Phase I study of HMPL-306 is underway in China, with the first patient dosed in July 2020. Additional details of that study may be found at clinicaltrials.gov, using identifier NCT04272957.
HMPL-306 is HUTCHMED’s ninth innovative oncology drug candidate that it has discovered that has entered clinical development and the sixth to enter global clinical development. Cytoplasmic mutant IDH1 and mitochondrial mutant IDH2 have been known to switch to the other form when targeted by an inhibitor of IDH1 mutant alone or IDH2 mutant alone. By targeting both IDH1 and IDH2 mutations, HMPL-306 could potentially provide therapeutic benefits in cancer patients harboring either IDH mutation, and may address acquired resistance to IDH inhibition through isoform switching.
IDHs are critical metabolic enzymes that help to break down nutrients and generate energy for cells. When mutated, IDH creates a molecule that alters the cell’s genetic programming and prevents cells from maturing, 2-hydroxyglutarate (“2-HG”). Reduction in 2-HG levels can be used as a marker of target engagement by an IDH inhibitor. IDH1 or IDH2 mutations are common genetic alterations in various types of blood and solid tumors, including acute myeloid leukemia (“AML”) with approximately 20% of patients having mutant IDH genes, myelodysplastic syndrome (MDS), myeloproliferative neoplasms (MPNs), low-grade glioma and intrahepatic cholangiocarcinoma (“IHCC”). Mutant IDH isoform switching, either from cytoplasmic mutant IDH1 to mitochondrial mutant IDH2, or vice versa, is a mechanism of acquired resistance to IDH inhibition in AML and cholangiocarcinoma.[1],[2],[3] Currently, the U.S. Food and Drug Administration (FDA) has approved one drug for IDH1 mutation and one drug for IDH2 mutation, but no dual inhibitor targeting both IDH1 and IDH2 mutants has been approved.
In the US, it is estimated that there were approximately 20,000 new cases of AML in 2020 and the five-year relative survival rate is 28.7%.[4]
IDH mutations are present in a number of solid tumors, including malignant glioma and IHCC. In the US, the annual incidence of malignant glioma is estimated to be 20,000, 50-70% of which are glioblastoma.[5],[6] Approximately 60-80% of Grade 2 or 3 glioma and secondary glioblastoma harbor IDH mutations.[7] IHCC accounts for 10-20% of primary liver cancer, which was estimated to be diagnosed in 42,810 US patients in 2020.[8],[9] Approximately 20-30% of IHCC harbors IDH mutations.[10]
HUTCHMED (Nasdaq/AIM: HCM) is an innovative, commercial-stage, biopharmaceutical company committed, over the past twenty years, to the discovery and global development of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has advanced ten cancer drug candidates from discovery into clinical studies around the world and has extensive commercial infrastructure in its home market of China. For more information, please visit: www.hutch-med.com.
This press release 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 reflect HUTCHMED’s current expectations regarding future events, including its expectations for the initiation of clinical development of HMPL-306 and the potential benefits of HMPL-306 in patients harboring IDH mutations. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding clinical trial enrollment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria, changes to clinical protocols or regulatory requirements, unexpected adverse events or safety issues, the ability of drug candidate HMPL-306 as a monotherapy or in combinations to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval, the potential market of HMPL-306 for a targeted indication, the sufficiency of funding, and the impact of the COVID-19 pandemic on general economic, regulatory and political conditions. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
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 | |
| Joseph Chi Lo, Brunswick |
+852 9850 5033 (Mobile) |
| Zhou Yi, Brunswick |
+852 9783 6894 (Mobile) HUTCHMED@brunswickgroup.com |
Nominated Advisor |
|
| Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK) Limited |
+44 (20) 7886 2500 |
[1] Choe S et al. Blood 2019;134(Supplement_1):545. doi:10.1182/blood-2019-122671.
[2] Harding JJ et al. Isoform Switching as a Mechanism of Acquired Resistance to Mutant Isocitrate Dehydrogenase Inhibition. Cancer Discov. 2018;8(12):1540-1547. doi:10.1158/2159-8290.CD-18-0877.
[3] Delahousse J et al. Circulating oncometabolite D-2-hydroxyglutarate enantiomer is a surrogate marker of isocitrate dehydrogenase-mutated intrahepatic cholangiocarcinomas. Eur J Cancer 2018;90:83-91. doi:10.1016/j.ejca.2017.11.024.
[4] National Cancer Institute – seer.cancer.gov/statfacts/html/amyl.html.
[5] Ostrom QT, Patil N et al. CBTRUS Statistical Report: Primary Brain and Other Central Nervous System Tumors Diagnosed in the United States in 2013–2017. Neuro Oncol. 2020;22(12 Suppl 2):iv1–iv96. doi:10.1093/neuonc/noaa200.
[6] Wen P, Kesari S. Malignant Gliomas in Adults. N Engl J Med 2008;359:492-507. doi: 10.1056/NEJMra0708126.
[7] Yan H, Parsons W et al. IDH1 and IDH2 Mutations in Gliomas. N Engl J Med 2009;360:765-73. doi: 10.1056/NEJMoa0808710.
[8] Massarweh NN, El-Serag HB. Epidemiology of Hepatocellular Carcinoma and Intrahepatic Cholangiocarcinoma. Cancer Control September 2017. doi: 10.1177/1073274817729245.
[9] SEER Cancer Stat Facts: Liver and Intrahepatic Bile Duct Cancer. National Cancer Institute. seer.cancer.gov/statfacts/html/livibd.html
[10] Lowery MA, Ptashkin R et al. Comprehensive Molecular Profiling of Intrahepatic and Extrahepatic Cholangiocarcinomas: Potential Targets for Intervention. Clin Cancer Res. 2018;24(17):4154-4161. doi:10.1158/1078-0432.CCR-18-0078.
Hong Kong, Shanghai, & Florham Park, NJ: Friday, March 26, 2021: Hutchison China MediTech Limited (“HUTCHMED”) (Nasdaq/AIM: HCM) today announces that its 2020 Annual Report together with the Notice of Annual General Meeting and the Form of Proxy (“AGM Materials”) have been posted to Shareholders of HUTCHMED (“Shareholders”). The documents can be accessed from the HUTCHMED website (www.hutch-med.com).
The 2021 Annual General Meeting (“AGM”) will be held at the Conference Room, 18th Floor, Hutchison Telecom Tower, 99 Cheung Fai Road, Tsing Yi, Hong Kong on Wednesday, April 28, 2021 at 6:00 pm Hong Kong Time (11:00 am London Time; 6:00 am Eastern Time).
To safeguard the health and safety of Shareholders, HUTCHMED encourages Shareholders to: (i) attend the AGM online and vote by means of electronic facilities; or (ii) exercise their right to vote at the AGM by appointing the Chairman of the AGM as their proxy instead of attending the AGM in person. Shareholders will be able to view a live webcast of the AGM through the website of the Company at https://www.hutch-med.com/event/. Along with the AGM Materials, all registered Shareholders will also receive a letter containing log in details and information on how to access the webcast.
HUTCHMED (Nasdaq/AIM: HCM) is an innovative, commercial-stage, biopharmaceutical company committed, over the past twenty years, to the discovery and global development of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has advanced ten cancer drug candidates from discovery into clinical studies around the world and has an extensive commercial infrastructure in its home market of China. For more information, please visit: www.hutch-med.com.
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 | |
| Joseph Chi Lo, Brunswick |
+852 9850 5033 (Mobile) |
| Zhou Yi, Brunswick |
+852 9783 6894 (Mobile) HUTCHMED@brunswickgroup.com |
Nominated Advisor |
|
| Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK) Limited |
+44 (20) 7886 2500 |
| Date: Wednesday, April 28, 2021 |
| Time: 6:00 pm Hong Kong Time (11:00 am London Time) |
| Location: 18th Floor, Hutchison Telecom Tower, 99 Cheung Fai Road, Tsing Yi, Hong Kong |
– Allows focus on China and global clinical development and market launches of key Oncology/Immunology assets –
Hong Kong, Shanghai & Florham Park, NJ –– Wednesday, March 24, 2021: Hutchison China MediTech Limited (“HUTCHMED”) (Nasdaq/AIM: HCM) today announces that it has reached an agreement with GL Mountrose Investment Two Limited, a company controlled and managed by GL Capital Group (“GL Capital”), to sell its entire indirect interest in Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited (“HBYS”), a non-core and non-consolidated over-the-counter (“OTC”) drug joint venture business.
“HUTCHMED’s focus is the discovery and development of novel therapies in oncology and immunology. Over the past 20 years, we have invested in establishing one of the leading innovation-driven, global biopharmaceutical companies based in China,” said Simon To, Chairman of HUTCHMED. “The sale of our shares in HBYS, and exit from the OTC drug arena, will allow us to focus our organization and resources on our primary aim of accelerating investment in our Oncology/Immunology assets in China and beyond.”
Jeffrey Li, Founder and Chief Executive Officer of GL Capital, said, “As a long-term shareholder and supporter of HUTCHMED, GL is pleased to acquire its share in one of the best-known OTC businesses in China. This transaction is in-line with GL’s strategy of building a leadership position in the OTC drug area to serve patients’ needs for self-medication and cost containment of their overall healthcare budget.”
The aggregate amount to be received by HUTCHMED of approximately $169 million in cash represents about 22 times HBYS’ adjusted net profit attributable to HUTCHMED equity holders of $7.7 million in 2020[1]. Of the proceeds, approximately $127 million is related to its shareholding in HBYS with the approximately $42 million balance related to distributions of the previously announced land compensation and prior year undistributed profits.
A deposit of $15.9 million is payable by GL Capital immediately following signing of the agreement which will be credited against the proceeds due on closing of the transaction. The transaction is subject to regulatory approval in China and is expected to close in mid-2021.
HUTCHMED (Nasdaq/AIM: HCM) is an innovative, commercial-stage, biopharmaceutical company committed, over the past twenty years, to the discovery and global development of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has advanced ten cancer drug candidates from discovery into clinical studies around the world and has an extensive commercial infrastructure in its home market of China. For more information, please visit: www.hutch-med.com.
HBYS was established in 2005 and focuses primarily on the manufacture, marketing and distribution of proprietary OTC pharmaceutical products. HBYS is HUTCHMED’s non-consolidated joint venture with Guangzhou Baiyunshan Pharmaceutical Holdings Company Limited. HUTCHMED has a 50% interest in HBYS through a holding company in which HUTCHMED has an 80% interest.
GL Capital is a leading investment firm specializing in buyout and growth opportunities in China’s healthcare industry. The firm has over US$2 billion under management across both public and private equity, through USD and RMB-denominated funds.
Founded in 2010, GL Capital strives to be the partner-of-choice for leading healthcare companies, generate superior investment returns, and contribute to the sustainable development of China’s healthcare industry. For more information, please visit www.gl-investment.com.
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 reflect HUTCHMED’s current expectations regarding future events, including its expectations as to the anticipated amount of proceeds, the intended use of proceeds and the anticipated closing date of the proposed transaction. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the amount and timely receipt of the final land compensation, satisfaction of the conditions precedent to the consummation of the proposed transaction (including the ability of the parties to secure regulatory approvals on the terms expected, at all or in a timely manner), the ability of the parties to complete the proposed transaction and the impact of the COVID-19 pandemic on general economic, regulatory and political conditions. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this announcement, whether as a result of new information, future events or circumstances or otherwise.
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014.
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 | |
| Joseph Chi Lo, Brunswick |
+852 9850 5033 (Mobile) |
| Zhou Yi, Brunswick |
+852 9783 6894 (Mobile) HUTCHMED@brunswickgroup.com |
Nominated Advisor |
|
| Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK) Limited |
+44 (20) 7886 2500 |
[1] 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.
Hong Kong, Shanghai & Florham Park, NJ — Wednesday, March 24, 2021: Hutchison China MediTech Limited (“HUTCHMED”) (Nasdaq/AIM: HCM) has initiated a Phase Ib/II study of surufatinib in combination with BeiGene’s tislelizumab in patients with advanced solid tumors in the U.S. and Europe. The first patient was dosed on March 23, 2021. This trial is to explore potential synergistic activity of the novel, oral angio-immuno kinase inhibitor surufatinib with the anti-PD-1 antibody tislelizumab in enhancing overall antitumor activity from inhibition of angiogenesis along with stimulation of an immune response.
This is an open-label study to evaluate the safety, tolerability, pharmacokinetics and efficacy of surufatinib in combination with tislelizumab in patients with advanced solid tumors. The study consists of two parts: dose finding (Part 1) and dose expansion (Part 2). Part 1 will be conducted to determine the recommended Phase II dose (“RP2D”) and/or the maximum tolerated dose (MTD) of surufatinib in combination with tislelizumab in patients with advanced or metastatic solid tumors who have progressed on, or are intolerant to, standard therapies. Part 2 will be an open-label, multi-cohort design to evaluate the anti-tumor activity of surufatinib in combination with tislelizumab in patients with specific types of advanced or metastatic solid tumors, including neuroendocrine tumors, colorectal cancer, small cell lung cancer, gastric cancer, and soft tissue sarcoma. Patients will receive the RP2D determined in Part 1 of this study. Additional details may be found at clinicaltrials.gov, using identifier NCT04579757.
NETs form in cells that interact with the nervous system or in glands that produce hormones. They can originate in various parts of the body, most often in the gut or the lungs and can be benign or malignant. NETs are typically classified as pancreatic NET (“pNET”) or non-pancreatic NET (“epNET”). Approved targeted therapies include Sutent® (for pNET only) and Afinitor® for pNET and well-differentiated, non-functional gastrointestinal or lung NET.
According to Frost and Sullivan, there were 19,000 newly diagnosed cases of NETs in the U.S. in 2018. Importantly, NETs are associated with a relatively long duration of survival compared to other tumors. As a result, there were approximately 141,000 estimated patients living with NETs in the U.S. in 2018.
CRC is cancer that starts in either the colon or rectum. CRC is the third most common cancer worldwide, estimated to have caused more than 935,000 deaths in 2020.[1] In the U.S., an estimated 150,000 people were diagnosed with CRC and 53,000 people died from CRC in 2020.[2] In Europe, CRC is the second most common cancer, with an estimated 507,000 new cases and 240,000 deaths in 2020.2
Cancer of the lungs and bronchus were estimated to be diagnosed in over 228,000 people in the U.S. and 477,000 people in Europe during 2020.[3],[4] SCLC accounts for 10-15% of newly diagnosed lung cancer cases.[5] SCLC carries a lower five-year survival rate (6.6%) relative to lung cancer in general (20.5%).[1],[6]
GC is cancer that starts in the stomach. In the U.S., an estimated 27,000 people were diagnosed with GC during 2020, with overall expected five-year survival rate of 32%.[7] In Europe, GC was estimated to be diagnosed in 136,000 new patients and be the cause of 97,000 deaths in 2020.[2]
STS is a heterogeneous group of tumors that start in different soft tissues, such as muscles, tendons, and blood vessels. In the U.S., an estimated 13,000 people were diagnosed with STS for during 2020, with overall five-year survival rate of 65%.[8] In Europe, annual incidence of STS is estimated to be approximately 23,000.[9]
Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumor effects.
HUTCHMED currently retains all rights to surufatinib worldwide.
NETs in the U.S. and Europe: In the U.S., surufatinib was granted Fast Track Designations for development in pNET and epNET in April 2020, and Orphan Drug Designation for pNET in November 2019. A U.S. FDA NDA rolling submission was initiated in December 2020, to be followed by a marketing authorization application (MAA) submission to the European Medicines Agency (EMA) in Europe. The basis to support these filings includes the completed SANET-ep[10] and SANET-p[11] studies, along with existing data from surufatinib in U.S. epNET and pNET patients (clinicaltrials.gov identifier: NCT02549937).
epNETs in China: On December 30, 2020, surufatinib was granted drug registration approval by the National Medical Products Administration of China (“NMPA”) for the treatment of epNET. Surufatinib is marketed in China under the brand name Sulanda®. The approval was based on results from the SANET-ep study, a Phase III trial (clinicaltrials.gov identifier: NCT02588170) in patients with advanced epNETs conducted in China. The study met the pre-defined primary endpoint of progression-free survival (“PFS”) at a preplanned interim analysis. The positive results of this trial were highlighted in an oral presentation at the 2019 ESMO Congress and published in The Lancet Oncology in September 2020.[12] Median PFS was significantly longer for patients treated with surufatinib at 9.2 months, compared to 3.8 months for patients in the placebo group (HR 0.334; 95% CI: 0.223-0.499; p<0.0001). Surufatinib had an acceptable safety profile, with the most common treatment-related adverse events of grade 3 or worse being hypertension (36% of surufatinib patients vs. 13% of placebo patients), proteinuria (19% vs. 0%) and anemia (5% vs. 3%).
pNETs in China: In 2016, we initiated the SANET-p study, which is a pivotal Phase III study in patients with low- or intermediate-grade, advanced pNET in China. It was terminated early as the pre-defined primary endpoint of PFS was met (clinicaltrials.gov identifier: NCT02589821) at a preplanned interim analysis, leading to a second NDA accepted by the NMPA in September 2020. The positive results of this study were presented at the 2020 ESMO Virtual Congress and published simultaneously in The Lancet Oncology[13], demonstrating that surufatinib reduces the risk of disease progression or death by 51% in patients, with median PFS of 10.9 months compared to 3.7 months on placebo (HR 0.491; 95% CI: 0.391-0.755; p=0.0011). The safety profile of surufatinib was manageable and consistent with observations in prior studies.
Biliary tract cancer in China: In March 2019, we initiated a Phase IIb/III study comparing surufatinib with capecitabine in patients with advanced biliary tract cancer whose disease progressed on first-line chemotherapy. The primary endpoint is overall survival (OS) (clinicaltrials.gov identifier: NCT03873532).
Immunotherapy combinations: We have entered into collaboration agreements to evaluate the safety, tolerability and efficacy of surufatinib in combination with anti-PD-1 monoclonal antibodies, including with tislelizumab (BGB-A317), Tuoyi® (toripalimab) and Tyvyt® (sintilimab), which are approved as monotherapies in China.
Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.
The NMPA has granted tislelizumab full approval for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy. Tislelizumab has also received conditional approval from the NMPA for the treatment of patients with classical Hodgkin’s lymphoma (cHL) who received at least two prior therapies, and for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Full approval for these indications is contingent upon results from ongoing randomized, controlled confirmatory clinical trials.
In addition, three supplemental Biologics License Applications for tislelizumab have been accepted by the Center for Drug Evaluation (CDE) of the NMPA and are under review for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, for the second- or third-line treatment of patients with locally advanced or metastatic NSCLC who progressed on prior platinum-based chemotherapy, and for previously treated unresectable hepatocellular carcinoma.
Currently, 15 potentially registration-enabling clinical trials are being conducted in China and globally, including 12 Phase 3 trials and two pivotal Phase 2 trials.
In January 2021, BeiGene and Novartis entered into a collaboration and license agreement to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.
Tislelizumab is not approved for use outside of China.
HUTCHMED (Nasdaq/AIM: HCM) is an innovative, commercial-stage, biopharmaceutical company committed, over the past twenty years, to the discovery and global development of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has advanced ten cancer drug candidates from discovery into clinical studies around the world and has an extensive commercial infrastructure in its home market of China. For more information, please visit: www.hutch-med.com.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the clinical development of surufatinib in combination with tislelizumab, HUTCHMED’s and BeiGene’s roles and responsibilities in the collaboration, the opportunity and potential benefits of their product candidates both as monotherapies and in combination, and other information that is not historical information. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including the ability of HUTCHMED and BeiGene to develop and receive regulatory approvals for the combination therapies in the collaboration; the risk that the potential benefits of the collaboration do not materialize or do not outweigh the costs; the ability of HUTCHMED and BeiGene to demonstrate the efficacy and safety of their respective drug candidates as monotherapies or in combination; the clinical results for such drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; HUTCHMED’s and BeiGene’s ability to achieve commercial success for their marketed products and drug candidates, if approved; HUTCHMED’s and BeiGene’s ability to obtain and maintain protection of intellectual property for their respective technology and drugs; BeiGene’s and HUTCHMED’s reliance on third parties to conduct drug development, manufacturing and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and BeiGene’s and HUTCHMED’s ability to obtain additional funding for operations and to complete the development and commercialization of their drug candidates; and the impact of the COVID-19 pandemic on BeiGene’s and HUTCHMED’s clinical development, regulatory, commercial and other operations. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s or BeiGene’s filings with the U.S. Securities and Exchange Commission and, in the case of HUTCHMED, on AIM. All information in this press release is as of the date of this press release, and neither HUTCHMED nor BeiGene undertakes a duty to update such information unless required by law.
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 | |
| Joseph Chi Lo, Brunswick | +852 9850 5033 (Mobile) |
| Zhou Yi, Brunswick | +852 9783 6894 (Mobile) HUTCHMED@brunswickgroup.com |
Nominated Advisor |
|
| Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK) Limited |
+44 (20) 7886 2500 |
Hong Kong, Shanghai, & Florham Park, NJ: Wednesday, March 10, 2021: Hutchison China MediTech Limited (“HUTCHMED”) (Nasdaq/AIM: HCM) announces that following the announcement of the 2020 annual results of HUTCHMED on March 4, 2021, 2,656 American depositary shares (“ADS”) granted under the Long Term Incentive Plan (“LTIP”) on March 15, 2017 to Dr Weiguo Su were vested on March 9, 2021.
The notification set out below is provided in accordance with the requirements of the EU Market Abuse Regulation.
| 1 | Details of the person discharging managerial responsibilities/person closely associated | |||||
| a) | Name | v | ||||
| 2 | Reason for the notification | |||||
| a) | Position/status | Executive Director and Chief Scientific Officer | ||||
| b) | Initial notification/Amendment | Initial notification | ||||
| 3 | Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor | |||||
| a) | Name | Hutchison China MediTech Limited | ||||
| b) | LEI | 2138006X34YDQ6OBYE79 | ||||
| 4 | Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted | |||||
| a) | Description of the financial instrument, type of instrument Identification code |
ADS each representing five Ordinary Shares of US$0.10 ADS ISIN: US44842L1035 |
||||
| b) | Nature of the transaction | Vesting of awards granted on March 15, 2017 under HUTCHMED’s LTIP | ||||
| c) | Price(s) and volume(s) |
|
||||
| d) | Aggregated information
|
N/A | ||||
| e) | Date of the transaction | 2021-03-09 | ||||
| f) | Place of the transaction | Outside a trading venue | ||||
HUTCHMED (Nasdaq/AIM: HCM) is an innovative, commercial-stage, biopharmaceutical company committed, over the past twenty years, to the discovery and global development of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has advanced ten cancer drug candidates from discovery into clinical studies around the world and has an extensive commercial infrastructure in its home market of China. For more information, please visit: www.hutch-med.com.
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. Forward-looking statements involve risks and uncertainties. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this announcement, whether as a result of new information, future events or circumstances or otherwise.
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 | |
| Joseph Chi Lo, Brunswick | +852 9850 5033 (Mobile) jlo@brunswickgroup.com |
| Zhou Yi, Brunswick | +852 9783 6894 (Mobile) yzhou@brunswickgroup.com |
Nominated Advisor |
|
| Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK) Limited |
+44 (20) 7886 2500 |
| Announcement released: 12 noon GMT (8pm HKT / 7am EST ) |
| >> View Announcement << |
| Presentation webcast & call: 1pm GMT (9pm HKT / 8am EST) |
To participate by phone, please use one of the following numbers. Participant Access Code is “38028560#“.
| United Kingdom (Toll-Free) | 0800 026 1542 |
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| Switzerland (Toll-Free) | 0800 800 732 |
Today, we begin consolidating the two corporate identities that we have used since our inception. Hutchison China MediTech, or Chi-Med, has been used as our group identity, while Hutchison MediPharma has been the identity of our novel drug R&D operations, under which our oncology products are developed and are now being marketed.
As our pipeline of novel, highly selective cancer drugs gain approval and advance to the international stage, we feel it is important to now have a single and ubiquitous corporate identity, that logically captures the history and brand equity we have built over the past twenty years. Therefore, we have chosen to rename ourselves HUTCHMED.
HUTCHMED is a natural combination of the resonant components from our two separate identities. Our new brand retains our unique essence, whilst signaling a new chapter – one brand that helps patients around the world.
We will gradually change to this name at all levels in the company during 2021.
Our vision remains unaltered: to lead innovation in oncology and immunology drugs, meet unmet medical needs, and become a global biopharmaceutical company.
“At the heart of HUTCHMED lies a prolific in-house novel drug discovery and development engine that has produced ten clinical-stage drug candidates and a further seven late-stage preclinical assets in oncology and immunology over the past fifteen years.” said Mr. Simon To, Chairman of HUTCHMED. “Our aim is to bring these internally discovered and developed innovations to patients the world-over.”
“To support this strategic objective, we have built an oncology and immunology operation with around 1,200 personnel based mainly in our two core markets, China and the U.S. In China, supported by a robust manufacturing infrastructure, our commercial team is now delivering impressive sales results on our first two oncology drugs, ELUNATE® in metastatic colorectal cancer and the recently launched SULANDA® in neuroendocrine tumors. A New Drug Application was also submitted mid-last year for savolitinib in lung cancer and, subject to approval, it will be our third approved oncology drug and the first-in-class selective MET inhibitor on the market in China.”
“Outside China, our fast expanding international organization, led mainly from the U.S., is developing five un-partnered oncology drug candidates. In 2020, it achieved three U.S. Food and Drug Administration fast track designations and initiated the rolling submission of surufatinib, our first U.S. New Drug Application filing.”
“Over the next three years, we will continue to grow our R&D and commercial organizations globally to support the anticipated launch of our oncology drugs in China, the U.S. and Europe.”
| (Growth vs. Prior Period) | Lilly Sales Team | HUTCHMED Sales Team | ||
| 2020 | Q1-Q3 2020 | Q4 2020 | Jan-Feb 2021* | |
| ELUNATE® In-market Sales** | $33.7m (+91%) | $23.5m (+37%) | $10.2m (+2,051%) | $14.3m (+116%) |
| ELUNATE® Revenues consolidated by HUTCHMED*** | $20.0m (+85%) | $12.8m (+53%) | $7.2m (+192%) | $10.2m (+269%) |
* = Unaudited; ** = Represents total sales to third parties as provided by Lilly; *** = Represents manufacturing fees, commercial service fees and royalties paid by Lilly to HUTCHMED, and sales to other third parties invoiced by HUTCHMED.
China
United States & Europe
Surufatinib (SULANDA® in China), a small molecule inhibitor of VEGFR[17], FGFR[18] and CSF-1R[19] 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:
Potential upcoming clinical and regulatory milestones for Savolitinib:
Potential upcoming clinical and regulatory milestones for HMPL-689:
Potential upcoming clinical and regulatory milestones for HMPL-523:
Potential upcoming clinical and regulatory milestones for HMPL-306:
Potential upcoming clinical and regulatory milestones for HMPL-295:
Potential upcoming discovery milestones:
Today we announce the consolidation of the two corporate identities that we have used since our inception. Hutchison China MediTech, or Chi-Med, has been used as our group identity, while Hutchison MediPharma has been the identity of our novel drug R&D[43] operations under which our oncology products have been developed and are now being marketed. We believe now is the right time to consolidate to a single and ubiquitous corporate identity that captures the history and brand equity we have built over the past twenty years.
Therefore, we have chosen to rename ourselves HUTCHMED. The brand HUTCHMED will immediately replace Chi-Med as our abbreviated name. We plan to formally change our group company name at our Annual General Meeting in April 2021, and the names of our key subsidiary companies over the balance of 2021. Our ticker symbol, HCM, will remain unchanged on the Nasdaq Global Select Market and the AIM market of the London Stock Exchange. We have also changed our website to www.hutch-med.com. The information required pursuant to AIM Rule 26 may be found at this address.
The COVID-19 outbreak initially posed some challenges to our operations in 2020 resulting from restrictions in travel. Our teams adapted quickly and were able to minimize the effect across our businesses. We will continue to closely monitor the evolving situation.
Change in Segment Reporting:
As a consequence of our recent commercialization of both ELUNATE® and SULANDA® and the possible approval and launch of savolitinib during 2021, we have decided to change the manner in which we report segment results in our financial statements. Effective from the year ended December 31, 2020, we will report two segments, (1) Oncology/Immunology, covering all activities related to oncology/immunology including sales, marketing, manufacturing and research and development with respect to our drugs and drug candidates; and (2) Other Ventures, which includes all other HUTCHMED businesses. We have retrospectively revised prior period segment information to conform to current period presentation in the financial information contained in this announcement.
Cash, Cash Equivalents and Short-Term Investments were $435.2 million as of December 31, 2020 compared to $217.2 million as of December 31, 2019.
Revenues for the year ended December 31, 2020 was $228.0 million compared to $204.9 million in 2019.
Net Expenses for the year ended December 31, 2020 were $353.7 million compared to $310.9 million in 2019.
Net Loss attributable to HUTCHMED for the year ended December 31, 2020 was $125.7 million compared to $106.0 million in 2019.
Condensed Consolidated Balance Sheet Data
(in $’000)
| As of December 31, | ||||
| 2020 | 2019 | |||
| Assets | ||||
| Cash and cash equivalents and short term investments | 435,176 | 217,168 | ||
| Accounts receivable | 47,870 | 43,254 | ||
| Other current assets | 47,694 | 56,600 | ||
| Property, plant and equipment | 24,170 | 20,855 | ||
| Investments in equity investees | 139,505 | 98,944 | ||
| Other non-current assets | 29,703 | 28,301 | ||
| Total assets | 724,118 | 465,122 | ||
| Liabilities and shareholders’ equity | ||||
| Accounts payable | 31,612 | 23,961 | ||
| Other payables, accruals and advance receipts | 120,882 | 81,624 | ||
| Long-term bank borrowings | 26,861 | 26,818 | ||
| Other liabilities | 25,814 | 19,816 | ||
| Total liabilities | 205,169 | 152,219 | ||
| Total Company’s shareholders’ equity | 484,116 | 288,012 | ||
| Non-controlling interests | 34,833 | 24,891 | ||
| Total liabilities and shareholders’ equity | 724,118 | 465,122 | ||
Condensed Consolidated Statement of Operations Data
(in $’000, except share and per share data)
| Year Ended December 31, | |||
| 2020 | 2019 | ||
| Revenues: | |||
| Oncology/Immunology – Marketed Products | 19,953 | 10,766 | |
| Oncology/Immunology – R&D | 10,262 | 16,026 | |
| Oncology/Immunology consolidated revenues | 30,215 | 26,792 | |
| Other Ventures | 197,761 | 178,098 | |
| Total revenues | 227,976 | 204,890 | |
| Expenses: | |||
| Costs of revenues | (188,519) | (160,152) | |
| Research and development expenses | (174,776) | (138,190) | |
| Selling and general administrative expenses | (61,349) | (52,934) | |
| Total expenses | (424,644) | (351,276) | |
| Loss from Operations | (196,668) | (146,386) | |
| Other income | 6,934 | 5,281 | |
| Loss before income taxes and equity in earnings of equity investees | (189,734) | (141,105) | |
| Income tax expense | (4,829) | (3,274) | |
| Equity in earnings of equity investees, net of tax | 79,046 | 40,700 | |
| Net loss | (115,517) | (103,679) | |
| Less: Net income attributable to non-controlling interests | (10,213) | (2,345) | |
| Net loss attributable to HUTCHMED | (125,730) | (106,024) | |
| Losses per share attributable to HUTCHMED – basic and diluted | (0.18) | (0.16) | |
| Number of shares used in per share calculation – basic and diluted | 697,931,437 | 665,683,145 | |
| Losses per ADS attributable to HUTCHMED – basic and diluted | (0.90) | (0.80) | |
| Number of ADSs used in per share calculation – basic and diluted | 139,586,287 | 133,136,629 | |
All amounts are expressed in U.S. dollar currency unless otherwise stated.
We provide select Financial Guidance for 2021 below reflecting expected commercial progress on ELUNATE® and SULANDA® as well as the potential launch of savolitinib in mid-2021. While we do not provide net cash flow guidance for 2021, we do expect an increase in investment to support the many new potential registration studies we plan this year as well as the continued expansion of our organization in China, the U.S. and Europe.
To support our growth plans, we continue to actively evaluate non-core assets divestment opportunities as well as monitor market conditions for seeking further listings on other stock exchanges such as Hong Kong and Shanghai.
| 2020 Actual |
2021 Guidance |
|
| Oncology/Immunology consolidated revenues | $30.2 million | $110 – 130 million |
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 1 p.m. GMT / 8 a.m. EST / 9 p.m. HKT – Investors may participate in the call as follows: +44 20 3194 0569 (U.K.) / +1 646 722 4977 (U.S.) / +852 3027 6500 (Hong Kong), 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 “38028560#.”
—–
HUTCHMED will today file with the U.S. Securities and Exchange Commission its Annual Report on Form 20-F.
The Annual General Meeting of HUTCHMED will be held on Wednesday, April 28, 2021. Notice of the 2021 Annual General Meeting will be published and issued to shareholders in due course.
HUTCHMED (Nasdaq/AIM: HCM) is an innovative, commercial-stage, biopharmaceutical company committed, over the past twenty years, to the discovery and global development of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has a produced ten cancer drug candidates in clinical studies around the world and extensive commercial infrastructure in its home market of China. For more information, please visit: www.hutch-med.com.
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) Chi-Med@fticonsulting.com |
| Asia | |
| Joseph Chi Lo, Brunswick | +852 9850 5033 (Mobile) jlo@brunswickgroup.com |
| Zhou Yi, Brunswick | +852 9783 6894 (Mobile) yzhou@brunswickgroup.com |
Nominated Advisor |
|
| Freddy Crossley / Atholl Tweedie, 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 Hutchison China MediTech Limited and its consolidated subsidiaries and joint ventures unless otherwise stated or indicated by context.
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 impact of the COVID-19 pandemic or other health crises in China or globally; 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 and uncertainties regarding future global exchange rates. For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission and on AIM. 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.
REFERENCES AND ABBREVIATIONS