Hong Kong, Shanghai & Florham Park, NJ — Thursday, March 31, 2022: HUTCHMED (China) Limited (“HUTCHMED” or the “Company”) (Nasdaq/AIM:HCM; SEHK:13) provides an update on its status under the Holding Foreign Companies Accountable Act (the “Act”), following the Company’s initial announcement on March 11, 2022.
On March 30, 2022, as expected following its adoption of implementing rules pursuant to the Act, the U.S. Securities and Exchange Commission (the “SEC”) added HUTCHMED to its conclusive list of issuers identified under the Act. The Company was provisionally named as a Commission-Identified Issuer on March 8, 2022, following the filing of its annual report on Form 20-F with the SEC on March 3, 2022. The SEC has estimated that 273 registrants might be identified under the Act as part of its review of registrants in calendar year 2020. We anticipate that other similarly situated U.S.-listed companies with operations in Hong Kong and other parts of China will be added once they file their annual reports with the SEC.
As the Company continues to monitor market developments and evaluate all strategic options, with the appropriate counsel and guidance, it would like to note that this update has no impact on business operations.
HUTCHMED understands that the motivation behind the Act is to ensure appropriate transparency and disclosure so that investors are able to make informed investment decisions. This we fully support and have been committed to ever since our initial listing in London in 2006. As always, we will continue complying with relevant laws and regulations in all the jurisdictions we are listed. Furthermore, we are working to maintain communication with the China Securities Regulatory Commission (CSRC) to understand if there are further updates on their discussions with the US authorities regarding how China-based companies may be able to meet the requirements of the Act. We will continue to evaluate all options to remain listed in the US, including assessing the merits of appointing an auditor outside of China if and when the contribution of our international business to the Group exceeds our China business.
The Company’s American depositary shares, each of which represents five ordinary shares, continue to trade uninterrupted on the Nasdaq Global Select Market. Its ordinary shares are admitted for trading on the AIM market. In addition, on June 30, 2021, the Company completed a primary listing of its ordinary shares on the Main Board of The Stock Exchange of Hong Kong Limited (“HKEX”) under the stock code “13”. The shares listed on HKEX and AIM are fully fungible with the shares represented by the Company’s American depositary shares.
The Act is part of a continued regulatory focus in the United States on access to audit and other information currently protected by national law, in particular China’s, and the preparation of such list is provided for in the Act and the SEC’s implementing rules. The Act requires the SEC to prohibit the securities of any issuer which is required to file periodic reports under the U.S. Securities Exchange Act of 1934, which includes the Company, from being traded on any of the U.S. securities exchanges, including the Nasdaq Stock Market, or on any over-the-counter market if the auditor of such issuer’s financial statements is not subject to inspection by the U.S. Public Company Accounting Oversight Board (“PCAOB”) for three consecutive years, beginning in 2021. Under the current terms of the Act, the Company’s American depositary shares will be delisted from the Nasdaq Stock Market in early 2024, unless the Act is amended to exclude the Company or the PCAOB is able to conduct a full inspection of the Company’s auditor during the required timeframe. In addition, legislation is being considered in the United States to shorten the number of non-inspection years from three years to two.
HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has more than 4,600 personnel across all its companies, at the center of which is a team of about 1,500 in oncology/immunology. Since inception it has advanced 12 cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved and marketed in China. For more information, please visit: www.hutch‑med.com or follow us on LinkedIn.
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. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, unexpected regulatory actions or delays or government regulation generally, including, among others, the risk that HUTCHMED’s American depositary shares could be barred from trading in the United States as a result of the Holding Foreign Companies Accountable Act and the rules promulgated thereunder and the risk that such Act could be amended to shorten the number of non-inspection years from three years to two years; the risk that the prices of the Company’s securities could be adversely affected if they cease to trade on any particular market or are subject to trading interruptions or if investors must take steps to migrate their shares from Nasdaq to the AIM market or HKEX in order to trade such securities; 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. 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, on AIM and with HKEX. 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 – Zhou Yi, Brunswick |
+852 9783 6894 (Mobile) HUTCHMED@brunswickgroup.com |
Nominated Advisor |
|
| Atholl Tweedie / Freddy Crossley, Panmure Gordon (UK) Limited |
+44 (20) 7886 2500 |
| Date: Wednesday, April 27, 2022 |
| 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 |
Hong Kong, Shanghai, & Florham Park, NJ — Wednesday, March 23, 2022: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX:13) today announces that its 2021 Annual Report together with the Notice of Annual General Meeting and the Form of Proxy (“AGM Materials”) will be posted to shareholders on March 24, 2022 who have elected to receive the AGM Materials in printed form. The documents can also be accessed from the HUTCHMED website (www.hutch-med.com).
The 2022 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 27, 2022 at 6:00 pm Hong Kong Time (11:00 am London 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. Shareholders will be able to view a live webcast of the AGM through the website of the Company at www.hutch-med.com/event/. All registered shareholders will also receive a letter containing log in details and information on how to access the webcast.
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has more than 4,600 personnel across all its companies, at the center of which is a team of about 1,500 in oncology/immunology. Since inception it has advanced 12 cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved and marketed in China. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.
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 |
Hong Kong, Shanghai & Florham Park, NJ — Friday, March 11, 2022: HUTCHMED (China) Limited (“HUTCHMED” or the “Company”) (Nasdaq/AIM: HCM; SEHK:13) would like to provide an update on its status under the Holding Foreign Companies Accountable Act (the “Act”).
On March 8, 2022, as expected in its implementation of the Act, the U.S. Securities and Exchange Commission (the “SEC”) provisionally named the Company as a Commission-Identified Issuer, following the Company’s filing of its annual report on Form 20-F with the SEC on March 3, 2022. The SEC estimated that 273 registrants might be identified under the Act as part of its review of registrants in calendar year 2020. We anticipate that other similarly situated U.S.-listed companies with operations in Hong Kong and other parts of China will be added once they file their annual reports with the SEC.
The Act is part of a continued regulatory focus in the United States on access to audit and other information currently protected by national law, in particular China’s, and the preparation of such list is provided for in the Act and the SEC’s implementing rules. The Act requires the SEC to prohibit the securities of any “covered issuer,” including the Company, from being traded on any of the U.S. securities exchanges, including the Nasdaq Stock Market, if the auditor of the covered issuer’s financial statements is not subject to inspection by the U.S. Public Company Accounting Oversight Board (“PCAOB”) for three consecutive years, beginning in 2021. Under the current terms of the Act, the Company’s American depositary shares will be delisted from the Nasdaq Stock Market in early 2024, unless the Act is amended to exclude the Company or the PCAOB is able to conduct a full inspection of the Company’s auditor during the required timeframe. In addition, legislation is being considered in the United States to shorten the number of non-inspection years from three years to two.
The Company’s American depositary shares, each of which represents five ordinary shares, trade on the Nasdaq Global Select Market and its ordinary shares are admitted for trading on the AIM market. In addition, on June 30, 2021, the Company completed a primary listing of its ordinary shares on the Main Board of The Stock Exchange of Hong Kong Limited (“HKEX”) under the stock code “0013”. The shares listed on HKEX and AIM are fully fungible with the shares represented by the Company’s American depositary shares.
The Company will continue to monitor market developments and evaluate all strategic options.
HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has more than 4,600 personnel across all its companies, at the center of which is a team of about 1,500 in oncology/immunology. Since inception it has advanced 12 cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved and marketed in China. For more information, please visit: www.hutch‑med.com or follow us on LinkedIn.
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. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, unexpected regulatory actions or delays or government regulation generally, including, among others, the risk that HUTCHMED’s American depositary shares could be barred from trading in the United States as a result of the Holding Foreign Companies Accountable Act and the rules promulgated thereunder and the risk that such Act could be amended to shorten the number of non-inspection years from three years to two years; the risk that the prices of the Company’s securities could be adversely affected if they cease to trade on any particular market or are subject to trading interruptions or if investors must take steps to migrate their shares from Nasdaq to the AIM market or HKEX in order to trade such securities; 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. 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, on AIM and with HKEX. 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 – Zhou Yi, Brunswick |
+852 9783 6894 (Mobile) HUTCHMED@brunswickgroup.com |
Nominated Advisor |
|
| Atholl Tweedie / Freddy Crossley, Panmure Gordon (UK) Limited |
+44 (20) 7886 2500 |
Hong Kong, Shanghai & Florham Park, NJ — Wednesday, March 9, 2022: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; SEHK:13) announces that following the announcement of the 2021 annual results of HUTCHMED on March 3, 2022, the following awards granted under the Long Term Incentive Plan (“LTIP”) on March 15, 2017 and April 20, 2020 to Dr Weiguo Su and Mr Johnny Cheng were vested on March 8, 2022:-
| Award Holders | Number of American depositary shares (“ADS”) |
|
| Person Discharging Managerial Responsibilities | ||
| Dr Weiguo Su (Executive Director, Chief Executive Officer and Chief Scientific Officer) | 18,770 | |
| Mr Johnny Cheng (Executive Director and Chief Financial Officer) | 4,198 | |
| Total | 22,968 |
The notifications set out below are provided in accordance with the requirements of the EU Market Abuse Regulation.
(a) Dr Weiguo Su
| 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, Chief Executive Officer 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 | HUTCHMED (China) 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 | (i) Vesting of awards granted on March 15, 2017 under HUTCHMED’s LTIP (ii) Vesting of awards granted on April 20, 2020 under HUTCHMED’s LTIP |
|||||||||
| c) | Price(s) and volume(s) |
|
|||||||||
| d) | Aggregated information
|
N/A | |||||||||
| e) | Date of the transaction | 2022-03-08 | |||||||||
| f) | Place of the transaction | Outside a trading venue | |||||||||
(b) Mr Johnny Cheng
| 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 | HUTCHMED (China) 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 April 20, 2020 under HUTCHMED’s LTIP | ||||
| c) | Price(s) and volume(s) |
|
||||
| d) | Aggregated information
|
N/A | ||||
| e) | Date of the transaction | 2022-03-08 | ||||
| f) | Place of the transaction | Outside a trading venue | ||||
HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has more than 4,600 personnel across all its companies, at the center of which is a team of about 1,500 in oncology/immunology. Since inception it has advanced 12 cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved and marketed in China. For more information, please visit: www.hutch‑med.com or follow us on LinkedIn.
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 |
Hong Kong, Shanghai & Florham Park, NJ — Monday, March 7, 2022: (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has received a US$15 million milestone payment from AstraZeneca PLC (“AstraZeneca”) (LSE/STO/Nasdaq:AZN).
This milestone has been triggered by the initiation of start-up activities for SAFFRON, the first global Phase III study for ORPATHYS® in combination with TAGRISSO® in epidermal growth factor receptor (“EGFR”)-mutated non-small cell lung cancer (“NSCLC”) patients with mesenchymal epithelial transition receptor (“MET”) driven tumors following progression after TAGRISSO®. SAFFRON, which is expected to commence enrolling patients in mid-2022, follows important lessons learned from the SAVANNAH study, which is targeted to be presented at an upcoming scientific conference in the second half of 2022.
To date, AstraZeneca has now paid HUTCHMED US$85 million of the total US$140 million in upfront payments, development and first-sale milestones due under the license and collaboration agreement between HUTCHMED and AstraZeneca.
Lung cancer is the leading cause of cancer death among men and women, accounting for about one-fifth of all cancer deaths.[1] More than a third of the world’s lung cancer patients are in China.[2] Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC.[3] The majority of NSCLC patients are diagnosed with advanced disease while approximately 25-30% present with resectable disease at diagnosis.[4],[5] For patients with resectable tumors, the majority of patients eventually develop recurrence despite complete tumor resection and adjuvant chemotherapy.[6]
Approximately 10-25% of NSCLC patients in the U.S. and Europe, and 30-40% of patients in Asia have EGFR-mutated NSCLC.[7],[8],[9] These patients are particularly sensitive to treatment with an EGFR tyrosine kinase inhibitor (“TKI”) which blocks the cell-signaling pathways that drive the growth of tumor cells.[10]
MET is a tyrosine kinase receptor.[11] Aberration of MET (amplification or overexpression) is present in both treatment naïve patients as well as being one of the primary mechanisms of acquired resistance to EGFR TKIs for metastatic EGFR-mutated NSCLC.[12],[13] Approximately 2-3% of NSCLC patients have tumors with MET exon 14 skipping alterations, a targetable mutation in the MET gene.[14]
Savolitinib is an oral, potent, and highly selective MET TKI that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations) or gene amplification.
Savolitinib is marketed in China under the brand name ORPATHYS® for the treatment of patients with NSCLC with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy. It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers, as a single treatment and in combination with other medicines.
In 2011, following its discovery and initial development by HUTCHMED, AstraZeneca and HUTCHMED entered a global licensing and collaboration agreement to jointly develop and commercialize savolitinib. Under the current terms of the agreement, a US$15 million milestone payment is triggered by the initiation of start-up activities for the SAFFRON study. Joint development of savolitinib in China is led by HUTCHMED, while AstraZeneca leads development outside of China. HUTCHMED is responsible for the marketing authorization, manufacturing and supply of savolitinib in China. AstraZeneca is responsible for the commercialization of savolitinib in China and worldwide. Sales of savolitinib are recognized by AstraZeneca.
Phase II study of savolitinib monotherapy in MET Exon 14 skipping alteration NSCLC (NCT02897479) – The conditional approval in China for MET Exon 14 skipping alteration NSCLC was based on the results of a Phase II study that were published in The Lancet Respiratory Medicine[15]. At a median follow up of 17.6 months, savolitinib demonstrated an objective response rate (“ORR”) of 42.9% (95% confidence interval [CI] 31.1-55.3) and median progression-free survival (“PFS”) of 6.8 months (95% CI 4.2-9.6) in the overall trial population. Disease control rate (“DCR”) in the overall trial population was 82.9% (95% CI 72.0-90.8). The safety and tolerability profile of savolitinib was consistent with previous trials, and no new safety signals were identified. Continued approval is contingent upon the successful completion of a confirmatory trial in this patient population (NCT04923945).
Based on results of the TATTON and SAVANNAH studies below, several Phase III studies of savolitinib in combination with TAGRISSO® have been initiated, including SACHI, and SANOVO and SAFFRON.
SACHI Phase III study of savolitinib in combination with TAGRISSO® in patients who have progressed following EGFR TKI treatment due to MET amplification (NCT05015608) – Initiated in the second half of 2021, this is a randomized, open-label study in China in EGFR mutation positive NSCLC patients with MET amplified tumors following progression after treatment with any EGFR TKI.
SANOVO Phase III study of savolitinib in combination with TAGRISSO® in treatment-naïve patients with EGFR mutant positive NSCLC with MET overexpression (NCT05009836) – Initiated in the second half of 2021, this is a randomized, blinded study in China in untreated, unresectable or metastatic patients with EGFR mutation positive NSCLC with MET positive tumors.
TATTON Phase Ib/II studies of savolitinib in combination with TAGRISSO® in patients who have progressed following EGFR TKI treatment due to MET amplification (NCT02143466) – This global exploratory study in over 220 EGFR mutation positive NSCLC patients with MET amplified tumors following progression after treatment with any EGFR TKI. Results were published in Lancet Oncology[16] and final analysis was presented at the World Conference on Lung Cancer[17]. Three cohorts with patients treated following progression on first- or second-generation EGFR TKI demonstrated an ORR of 64.7-66.7% and a median PFS of 9.0-11.1 months. The cohort of patients treated following progression on a third-generation EGFR TKI demonstrated an ORR of 33.3% (95% CI 22.4-45.7), with a median PFS of 5.5 months (95% CI 4.1-7.7). The combination demonstrated encouraging anti-tumor activity and an acceptable risk-benefit profile.
SAVANNAH Phase II study of savolitinib in combination with TAGRISSO® in patients who have progressed following TAGRISSO® due to MET amplification or overexpression (NCT03778229) – This is a single-arm, open-label, global study in EGFR mutated NSCLC patients with MET amplified/overexpressed tumors following progression after treatment with TAGRISSO®, an EGFR TKI owned by AstraZeneca. We plan to submit results for presentation at an upcoming scientific conference.
SAMETA Phase III study in combination with IMFINZI® PD-L1 inhibitor in MET-driven, unresectable and locally advanced or metastatic papillary renal cell carcinoma (“RCC”) (NCT05043090) – Based on the encouraging results of the SAVOIR monotherapy and CALYPSO combination therapy studies below, we initiated SAMETA, a global Phase III, open-label, randomized, controlled study of savolitinib plus IMFINZI® versus sunitinib monotherapy versus IMFINZI® monotherapy in patients with MET-driven, unresectable and locally advanced or metastatic papillary RCC.
SAVOIR randomized, controlled study of savolitinib monotherapy in MET-driven PRCC (NCT03091192) – Data from 60 patients in this global study of savolitinib monotherapy compared with sunitinib monotherapy in MET-driven papillary RCC was presented at the ASCO 2020 Program and published simultaneously in JAMA Oncology[18]. Savolitinib demonstrated encouraging activity, including an ORR of 27% versus 7% for sunitinib, with no savolitinib responding patients experiencing disease progression at data cut-off, and an encouraging OS hazard ratio of 0.51 (95% CI: 0.21–1.17; p=0.110) with median not reached at data cut-off.
CALYPSO study of savolitinib in combination with IMFINZI® PD-L1 inhibitor in RCC (NCT02819596) – This investigator initiated open-label Phase I/II study of savolitinib in combination with IMFINZI®, a PD-L1 antibody owned by AstraZeneca, evaluated the safety and efficacy of the savolitinib/IMFINZI® combination in patients with RCC. An analysis of 41 papillary RCC patients was presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting[19], showing a confirmed response rate in 8 out of the 14 MET-driven patients, or 57%, with a median DoR of 9.4 months, median PFS of 10.5 months and median OS of 27.4 months. No new safety signals were seen.
Phase II study of savolitinib monotherapy in advanced or metastatic MET amplified gastric cancer (“GC”) or adenocarcinoma of the gastroesophageal junction (“GEJ”) (NCT04923932) – This is an open-label, two-cohort, multi-center study to evaluate the efficacy, safety and PK of savolitinib in locally advanced or metastatic GC or GEJ patients whose disease progressed after at least one line of standard therapy.
This trial follows multiple Phase II studies that have been conducted in Asia to study savolitinib in MET-driven GC patients, including VIKTORY[xx]. VIKTORY is an investigator-initiated Phase II umbrella study in GC in South Korea in which a total of 715 patients were successfully sequenced into molecular-driven patient groups, including those with MET amplified GC. Patients whose tumors harbor MET amplification were treated with savolitinib monotherapy, reporting an ORR of 50% (10/20, 95% CI: 28.0, 71.9).
Savolitinib opportunities are also continuing to be explored in multiple other MET-driven tumor settings via investigator-initiated studies including colorectal cancer.
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has more than 4,600 personnel across all its companies, at the center of which is a team of over 1,500 in oncology/immunology. Since inception it has advanced 12 cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved and marketed. For more information, please visit: www.hutch‑med.com or follow us on LinkedIn.
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 regarding the therapeutic potential of savolitinib for the treatment of patients with NSCLC, the further clinical development of savolitinib in this and other indications, its expectations as to whether clinical studies of savolitinib would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the sufficiency of its data to support New Drug Application approval of savolitinib for the treatment of patients with NSCLC in China, its potential to gain expeditious approvals for savolitinib in other jurisdictions such as E.U. or Japan, the safety profile of savolitinib, the potential for savolitinib to become a new standard of care for NSCLC patients, its ability to implement and complete its further clinical development plans for savolitinib, its potential commercial launch in the U.S., E.U., Japan, China and other jurisdictions, the timing of these events, and the impact of the COVID-19 pandemic on general economic, regulatory and political conditions. In addition, as certain studies rely on the use of TAGRISSO® and IMFINZI® as combination therapeutics with savolitinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of TAGRISSO® and IMFINZI®. 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, on AIM and with The Stock Exchange of Hong Kong Limited. 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.
[1] World Health Organization. International Agency for Research on Cancer. Lung Fact Sheet. Available at gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf. Accessed June 2021.
[2] World Health Organization. International Agency for Research on Cancer. Globocan China Fact Sheet 2020. Available at gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf. Accessed June 2021.
[3] LUNGevity Foundation. Types of Lung Cancer. Available at lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer. Accessed June 2021.
[4] Cagle PT, Allen TC, Olsen RJ. Lung Cancer Biomarkers: Present Status and Future Developments. Arch Pathol Lab Med. 2013;137(9):1191-1198. doi: 10.5858/arpa.2013-0319-CR.
[5] Le Chevalier T, et al. Adjuvant Chemotherapy for Resectable Non-Small Cell Lung Cancer: Where is it Going? Ann Oncol. 2010;21:vii196-vii198. doi: 10.1093/annonc/mdq376.
[6] Pignon J, et al. Lung Adjuvant Cisplatin Evaluation: A Pooled Analysis by the LACE Collaborative Group. J Clin Oncol. 2008;26:3552-3559. doi: 10.1200/jco.2007.13.9030.
[7] Zhang YL, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget. 2016;7(48):78985-78993. doi: 10.18632/oncotarget.12587.
[8] Keedy V.L., et al. American Society of Clinical Oncology Provisional Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for Patients with Advanced Non-Small Cell Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor Therapy. J Clin Oncol. 2011:29;2121-27. doi: 10.1200/JCO.2010.31.8923.
[9] Ellison G, et al. EGFR Mutation Testing in Lung Cancer: a Review of Available Methods and Their Use for Analysis of Tumour Tissue and Cytology Samples. J Clin Pathol. 2013:66;79-89. doi: 10.1136/jclinpath-2012-201194.
[10] Cross DA, et al. AZD9291, an Irreversible EGFR TKI, Overcomes T790M-Mediated Resistance to EGFR Inhibitors in Lung Cancer. Cancer Discov. 2014;4(9):1046-1061. doi: 10.1158/2159-8290.CD-14-0337.
[11] Organ SL, Tsao MS. An overview of the c-MET signaling pathway. Ther Adv Med Oncol 2011; 3(1 Suppl):S7-S19. doi: 10.1177/1758834011422556.
[12] Ramalingham SS, et al. Mechanisms of acquired resistance to first-line osimertinib: Preliminary data from the phase III FLAURA study. Ann Oncol. 2018; 29, SUPPLEMENT 8, VIII740. doi: 10.1093/annonc/mdy424.063.
[13] Sterlacci W, et al. MET overexpression and gene amplification: prevalence, clinico-pathological characteristics and prognostic significance in a large cohort of patients with surgically resected NSCLC. Virchows Arch. 2017;471(1):49-55. doi:10.1007/s00428-017-2131-1.
[14] Vuong HG, et al. Clinicopathological implications of MET exon 14 mutations in non-small cell lung cancer – A systematic review and meta-analysis. Lung Cancer 2018; 123: 76-82. doi: 10.1016/j.lungcan.2018.07.006.
[15] Lu S, et al. Once-daily savolitinib in Chinese patients with pulmonary sarcomatoid carcinomas and other non-small-cell lung cancers harbouring MET exon 14 skipping alterations: a multicentre, single-arm, open-label, phase 2 study. Lancet Respir Med. 2021 Jun 21:S2213-2600(21)00084-9. doi: 10.1016/S2213-2600(21)00084-9.
[16] Sequist LV, et al. Osimertinib plus savolitinib in patients with EGFR mutation-positive, MET-amplified, non-small-cell lung cancer after progression on EGFR tyrosine kinase inhibitors: interim results from a multicentre, open-label, phase 1b study. Lancet Oncol. 2020;21(3):373-386. doi:10.1016/S1470-2045(19)30785-5.
[17] Han JY, et al. Osimertinib + savolitinib in patients with EGFRm MET-amplified/overexpressed NSCLC: Phase Ib TATTON Parts B and D final analysis. WCLC January 2021 #FP14.03. doi: 10.1016/j.jtho.2021.01.146.
[18] Choueiri TK, et al. Efficacy of Savolitinib vs Sunitinib in Patients With MET-Driven Papillary Renal Cell Carcinoma: The SAVOIR Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 Aug 1;6(8):1247-1255. doi: 10.1001/jamaoncol.2020.2218.
[19] Suarez C, et al. Clinical activity of durvalumab and savolitinib in MET-driven, metastatic papillary renal cancer. J Clin Oncol 39, no. 15_suppl (May 20, 2021) 4511-4511. doi: 10.1200/JCO.2021.39.15_suppl.4511.
[20] Lee J, et al. Tumor Genomic Profiling Guides Patients with Metastatic Gastric Cancer to Targeted Treatment: The VIKTORY Umbrella Trial. Cancer Discov. 2019;9(10):1388-1405. doi: 10.1158/2159-8290.CD-19-0442.
| 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 |
Hong Kong, Shanghai & Florham Park, NJ – Thursday, March 3, 2022: (“HUTCHMED” or the “Company”) (Nasdaq/AIM:HCM; HKEX:13) today announces:
Dr. Su has been selected and appointed to his additional role as the CEO, as part of the Company’s ongoing succession planning. Since joining the Company in 2005, Dr. Su has been responsible for the establishment of all aspects of the oncology/immunology innovation platform which led to the in-house discovery of 12 novel oncology drug candidates of the Company, the first three of which have achieved approval and successful commercial launch. When assuming the new position, Dr. Su will combine the crucial research and development function of the Company for which he has been responsible, with the lead executive role as the CEO.
Prior to HUTCHMED, Dr. Su, aged 64, spent fifteen years in the U.S. Research and Development organization of Pfizer, Inc. and before that, seven years completing his PhD and Post-Doctoral Fellowship in Chemistry at Harvard University under the guidance of Nobel Laureate, Professor E. J. Corey. Dr. Su received a Bachelor of Science degree in Chemistry from Fudan University in Shanghai.
In March 2017, Dr. Su was granted the prestigious award by the China Pharmaceutical Innovation and Research Development Association (PhIRDA) as one of the Most Influential Drug R&D Leaders in China.
While Dr. Su will remain as the CSO for the time being, as part of the ongoing succession planning of the Company, Dr Su, the Nomination Committee and the Board will identify appropriate candidates to take up the leadership of its research and development function.
Mr. Christian Hogg, retiring CEO of HUTCHMED, said “After over 34 years away, and 27 years in China, I have taken the decision to return home to Europe to focus on, and be close to, my important family responsibilities. I am glad to see the Board’s new appointment of Dr. Weiguo Su, one of the industry’s most respected leaders, and a person who I believe, with the support of our board and deeply experienced senior management team, will take HUTCHMED to greater heights. I would like to thank all HUTCHMED colleagues and stakeholders for the support they have given me and I look forward to their continued success.”
Mr. Simon To, Chairman of HUTCHMED said, “Christian was the first employee of HUTCHMED twenty-two years ago and he has worked tirelessly to build the Company from its very beginning into the truly globally facing biopharmaceutical company it is today. Christian will remain as a strategic advisor to the Company, with an emphasis on organizational development, relations with our partners, global commercialization strategy and investor relations matters.”
Mr. To continued, “On behalf of the Board, I would like to congratulate Dr. Su on his appointment to CEO of HUTCHMED, and wish him great success in this well-deserved appointment. I would also like to extend our deepest appreciation to Christian for his contributions and wish him the best in his retirement.”
The change to the position of CEO will take effect on March 4, 2022. Also effective from the same date, Mr. Hogg will cease to be a member of the Sustainability Committee and the Technical Committee of the Company.
Mr. Hogg has confirmed that he has no disagreement with the Board, and that there are no other matters that need to be brought to the attention of the shareholders of the Company in connection with his retirement.
Dr. Su does not have any relationship with any other Directors, senior management, substantial or controlling shareholders of the Company. As at the date of this announcement, Dr. Su had a personal interest in 6,833,580 ordinary shares in the Company (“Shares”), representing approximately 0.79% of the number of Shares in issue, within the meaning of Part XV of the Securities and Futures Ordinance. The term of Dr. Su’s service as an Executive Director of the Company is subject to retirement by rotation and re-election at the annual general meeting of the Company. The director’s fees of Dr. Su as an Executive Director and a member of the Technical Committee of the Company under his appointment letter are US$70,000 and US$5,000 per annum respectively. The emoluments specified in the service agreement appointing Dr. Su as CEO and CSO of the Company are US$1,959,300 per annum in salary and cash bonus. There will also be equity compensation of up to US$4,440,700 per annum, including performance based and non-performance based portions. Such emoluments are determined by reference to the performance and profitability of the Company as well as his personal performance, remuneration benchmark in the industry and the prevailing market conditions. Such amounts are subject to review from time to time and proration for an incomplete year of service.
There are no other matters concerning Dr. Su that are required to be brought to the attention of the shareholders, nor is there other information that is required to be disclosed pursuant to the requirements of Rule 13.51(2) of the Rules Governing the Listing of Securities on the Stock Exchange of Hong Kong Limited and Rule 17 of the AIM Rules for Companies.
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has more than 4,600 personnel across all its companies, at the center of which is a team of over 1,500 in oncology/immunology. Since inception it has advanced 12 cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved and marketed. For more information, please visit: www.hutch‑med.com or follow us on LinkedIn.
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. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, the risk that current or future appointees to HUTCHMED’s board of directors are not effective in their respective positions, the difficulty in locating and recruiting suitable candidates for its board of directors and the management difficulties which may arise from changes in HUTCHMED’s board of directors. 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, on AIM and with The Stock Exchange of Hong Kong Limited. 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 (as it forms part of retained EU law as defined in the European Union (Withdrawal) Act 2018).
| 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 |
Oncology/Immunology revenues up 296% to $119.6 million, due to ELUNATE® growth and the 2021 launches of SULANDA® and ORPATHYS®;
Positive SAVANNAH, CALYPSO and VIKTORY studies triggered five registration studies on ORPATHYS® in lung cancer, kidney and gastric cancer during 2021;
Broad late-stage development program – currently enrolling 13 registration studies on 6 assets – with enrollment on the 691 patient FRESCO-2 global Phase III of fruquintinib now complete.
Company to Host Annual Results Call & Webcast Today
at 9 p.m. HKT / 1 p.m. GMT / 8 a.m. EST
Hong Kong, Shanghai & Florham Park, NJ — Thursday, March 3, 2022: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13), the innovative, commercial-stage biopharmaceutical company, today reports its audited financial results for the year ended December 31, 2021 and provides updates on key clinical and commercial developments since the start of 2022.
All amounts are expressed in U.S. dollars unless otherwise stated.
“2021 was an exceptional year for HUTCHMED,” said Mr. Simon To, Chairman of HUTCHMED. “Commercial success on ELUNATE® and the launches of SULANDA® and ORPATHYS® contributed to an almost four-fold increase in consolidated oncology/immunology revenues to $119.6 million, with momentum continuing in 2022.
ORPATHYS® took a major step forward in 2021 with its first approval and important, and as yet unpublished, data from the SAVANNAH study in combination with TAGRISSO®. We and our partner AstraZeneca[1] initiated four Phase III studies and one Phase II study, with registration potential, for ORPATHYS® during 2021. These actions have triggered $40 million in milestone payments to HUTCHMED since mid-2021. A seventh registration study, a global Phase III in NSCLC[2], the SAFFRON study, is set to initiate in mid-2022.
We are rapidly progressing our plan to expand our oncology assets into global markets. Led by our team of over 800-personnel in discovery, development and manufacturing operations, we have an un-equaled fifteen-year track-record of producing highly quality novel oncology/immunology drug candidates.
Seven of our assets are now being developed outside China. In addition to the global progress of ORPATHYS®, surufatinib’s U.S. NDA[3] and EU MAA[4] are in the later stages of regulatory review for advanced NETs; enrollment was completed for fruquintinib in a fourteen-country global Phase III study, the FRESCO-2 study, in CRC[5] which reads-out later in 2022; positive and differentiated POC data was presented for amdizalisib and sovleplenib; and our FGFR[6], IDH1/2[7], ERK[8], third generation BTK[9] and CSF-1R[10] inhibitors all made good progress in early development.
With a strong track record in bringing innovative drugs to patients through rigorous clinical trials, our seasoned clinical team is now enrolling 13 registration studies for six assets with an additional 5 registration studies set to initiate in 2022. With over $1 billion in cash, and the intention to divest further non-core assets, we anticipate having sufficient runway to see our plans through.
Our strategy is to launch a stream of new products in both the China and global markets over the coming years, helping patients with unmet needs and creating value for all our stakeholders.”
| (Growth vs. Prior Period) | In-market Sales* | Consolidated Revenue** | ||||||
| 2021 | Jan-Feb 2022 Unaudited |
2021 | Jan-Feb 2022 Unaudited |
|||||
| ELUNATE® | $71.0m | (111%) | $21.6m | (51%) | $53.5m | (168%) | $13.5m | (33%) |
| SULANDA® | $11.6m | – | $6.0m | (21%) | $11.6m | – | $6.0m | (21%) |
| ORPATHYS® | $15.9m | – | $7.4m | – | $11.3m | – | $4.8m | – |
| Product Sales | $98.5m | (192%) | $35.0m | (81%) | $76.4m | (282%) | $24.3m | (61%) |
| Other R&D[14] Service income | $18.2m | (77%) | $3.7m | (80%) | ||||
| Milestone payments | $25.0m | – | $15.0m | – | ||||
| Total Oncology/ Immunology | $119.6m | (296%) | $43.0m | (151%) | ||||
| * = For ELUNATE® and ORPATHYS®, represents total sales to third parties as provided by Lilly and AstraZeneca, respectively; ** = For ELUNATE® and ORPATHYS®, represents manufacturing fees, commercial service fees and royalties paid by Lilly and AstraZeneca, respectively, to HUTCHMED, and sales to other third parties invoiced by HUTCHMED; For SULANDA®, represents the Company’s sales of the product to third parties. |
||||||||
Savolitinib (ORPATHYS®), a highly selective oral inhibitor of MET being developed broadly across MET-driven patient populations in lung and gastric cancer and renal cell carcinoma
Major clinical milestones for savolitinib in 2021:
Major savolitinib clinical data presentations in 2021:
Potential upcoming clinical and regulatory milestones for savolitinib in 2022:
Surufatinib (SULANDA® in China), an oral inhibitor of VEGFR[25], FGFR and CSF-1R 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
Major clinical milestones for surufatinib in 2021:
Major surufatinib clinical data presentations in 2021:
Potential upcoming clinical and regulatory milestones for surufatinib in 2022:
Fruquintinib (ELUNATE® in China), a highly selective oral 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
Major clinical milestones for fruquintinib in 2021:
Major fruquintinib clinical data presentations in 2021:
Potential upcoming clinical and regulatory milestones for fruquintinib in 2022:
Amdizalisib (HMPL-689), an investigative and highly selective oral inhibitor of PI3Kδ[39] designed to address the gastrointestinal and hepatotoxicity associated with currently approved and clinical-stage PI3Kδ inhibitors
Major clinical milestones for amdizalisib in 2021:
Major amdizalisib clinical data presentation in 2021:
Potential upcoming clinical and regulatory milestones for amdizalisib in 2022:
Sovleplenib (HMPL-523), an investigative and highly selective oral inhibitor of Syk[41], an important component of the B-cell receptor signaling pathway, for the treatment of hematological cancers and immune diseases
Major clinical and regulatory milestones for sovleplenib in 2021:
Major sovleplenib clinical data presentations in 2021:
Potential upcoming clinical milestone for sovleplenib in 2022:
Tazemetostat (TAZVERIK® in the U.S. and Japan), an inhibitor of EZH2 licensed from Epizyme for which HUTCHMED is collaborating to research, develop, manufacture and commercialize in Greater China
Potential upcoming clinical and regulatory milestones for tazemetostat in 2022:
HMPL-453, an investigative and highly selective oral inhibitor of FGFR 1/2/3
HMPL-306, an investigative and highly selective oral inhibitor of IDH1/2 designed to address resistance to the currently marketed IDH inhibitors
Major clinical and regulatory milestones for HMPL-306 in 2021:
Potential upcoming clinical and regulatory milestones for HMPL-306 in 2022:
HMPL-295, an investigative and highly selective oral inhibitor of ERK in the MAPK pathway [43] 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 oral inhibitor of BTK with improved potency versus first generation BTK inhibitors against both wild type & C481S mutant enzymes
HMPL-653, an investigative, highly selective, and potent CSF-1R inhibitor designed to target CSF-1R driven tumors as a monotherapy or in combinations
HMPL-A83, a differentiated, red blood cell sparing CD47 monoclonal antibody
Other Ventures include our profitable prescription drug marketing and distribution platforms covering about 290 cities and towns in China with around 2,900 mainly manufacturing and commercial personnel.
Potential upcoming corporate developments:
COVID-19 did not impact our research, our clinical studies or our commercial activities in any material manner in 2021. Certain regulatory inspections of our manufacturing facilities in China by the U.S. FDA have, however, been postponed due to travel restrictions. We will continue to closely work with regulators and monitor the evolving situation.
VIII. SUSTAINABILITY
As an innovative, commercial-stage biopharmaceutical company, HUTCHMED embraces sustainability at the core of how we operate. Over the past two decades, we worked hard to strengthen healthcare systems by providing quality and accessible drugs. As the world is gradually adapting to the changes brought about by COVID-19, the pandemic has highlighted the importance of building sustainability and environmental, social and governance factors into business strategy. HUTCHMED has embarked on our sustainability journey in 2020 by publishing our inaugural ESG report to demonstrate our efforts, and establishing a board level Sustainability Committee in 2021 to support the Board of Directors in fulfilling their responsibilities. We plan to publish our second sustainability report for 2021 at the end of May 2022.
Going forward, HUTCHMED will be working with our stakeholders to embrace sustainable business practices and develop a sustainability strategy that will help focus our efforts on areas which are most relevant to our business. Through a materiality assessment exercise for 2021, priority areas include: Business ethics; Drug research-related topics; Drug development; Commercial operations responsibilities; Environmental topics; and Management of our people. Over the course of 2022, we will continue to engage our stakeholders to identify areas for improvement to building a more sustainable and responsible future.
Cash, Cash Equivalents and Short-Term Investments were $1,011.7 million as of December 31, 2021 compared to $435.2 million as of December 31, 2020.
Revenues for the year ended December 31, 2021 were $356.1 million compared to $228.0 million in 2020.
ELUNATE® revenues increased 168% to $53.5 million (2020: $20.0m) in manufacturing revenues, promotion and marketing service revenues and royalties, as our in-house sales team increased in-market sales 111% to $71.0 million (2020: $33.7m), as provided by Lilly[51];
SULANDA® sales revenues of $11.6 million since mid-January 2021 launch, initially approved to treat patients with advanced extra-pancreatic (non-pancreatic) NET and subsequently also approved to treat patients with pancreatic NET in June 2021;
ORPATHYS® revenue of $36.3 million since mid-July 2021 launch, which was comprised of a $25.0 million first sale milestone payment and $11.3 million in manufacturing revenues and royalties. AstraZeneca reported $15.9 million in-market sales (2020: nil) of ORPATHYS® in 2021; and
Other R&D service fee revenues of $18.2 million (2020: $10.2m), which were primarily fees from AstraZeneca and Lilly for the management of development activities in China.
Net Expenses for the year ended December 31, 2021 were $550.7 million compared to $353.7 million in 2020.
Net Loss attributable to HUTCHMED for the year ended December 31, 2021 was $194.6 million compared to $125.7 million in 2020.
Condensed Consolidated Balance Sheet Data
(in $’000)
|
As of December 31, |
||||
| 2021 | 2020 | |||
| Assets | ||||
| Cash and cash equivalents and short-term investments | 1,011,700 | 435,176 | ||
| Accounts receivable | 83,580 | 47,870 | ||
| Other current assets | 116,796 | 47,694 | ||
| Property, plant and equipment | 41,275 | 24,170 | ||
| Investments in equity investees | 76,479 | 139,505 | ||
| Other non-current assets | 42,831 | 29,703 | ||
| Total assets | 1,372,661 | 724,118 | ||
| Liabilities and shareholders’ equity | ||||
| Accounts payable | 41,177 | 31,612 | ||
| Other payables, accruals and advance receipts | 210,839 | 121,283 | ||
| Bank borrowings | 26,905 | 26,861 | ||
| Other liabilities | 54,226 | 25,413 | ||
| Total liabilities | 333,147 | 205,169 | ||
| Company’s shareholders’ equity | 986,893 | 484,116 | ||
| Non-controlling interests | 52,621 | 34,833 | ||
| Total liabilities and shareholders’ equity | 1,372,661 | 724,118 | ||
Condensed Consolidated Statement of Operations Data
(in $’000, except share and per share data)
| Year Ended December 31, | ||||
| 2021 | 2020 | |||
| Revenues: | ||||
| Oncology/Immunology – Marketed Products | 76,429 | 19,953 | ||
| Oncology/Immunology – R&D | 43,181 | 10,262 | ||
| Oncology/Immunology consolidated revenues | 119,610 | 30,215 | ||
| Other Ventures | 236,518 | 197,761 | ||
| Total revenues | 356,128 | 227,976 | ||
| Expenses: | ||||
| Costs of revenues | (258,234) | (188,519) | ||
| Research and development expenses | (299,086) | (174,776) | ||
| Selling and general administrative expenses | (127,125) | (61,349) | ||
| Total expenses | (684,445) | (424,644) | ||
|
Loss from Operations |
(328,317) | (196,668) | ||
| Gain on divestment of an equity investee | 121,310 | – | ||
| Other (expense)/income | (8,733) | 6,934 | ||
| Loss before income taxes and equity in earnings of equity investees | (215,740) | (189,734) | ||
| Income tax expense | (11,918) | (4,829) | ||
| Equity in earnings of equity investees, net of tax | 60,617 | 79,046 | ||
| Net loss | (167,041) | (115,517) | ||
| Less: Net income attributable to non-controlling interests | (27,607) | (10,213) | ||
| Net loss attributable to HUTCHMED | (194,648) | (125,730) | ||
|
Losses per share attributable to HUTCHMED – basic and diluted (US$ per share) |
(0.25) | (0.18) | ||
| Number of shares used in per share calculation – basic and diluted | 792,684,524 | 697,931,437 | ||
|
Losses per ADS attributable to HUTCHMED – basic and diluted (US$ per ADS) |
(1.23) | (0.90) | ||
| Number of ADSs used in per share calculation – basic and diluted | 158,536,905 | 139,586,287 | ||
All amounts are expressed in U.S. dollars unless otherwise stated.
We provide financial guidance for 2022 below reflecting expected revenue growth of ELUNATE®, SULANDA® and ORPATHYS® in China. We intend to update guidance to include ex-China consolidated revenues, upon the occurrence of surufatinib U.S. and EU approval (if granted) and to reflect any developments in the non-core market out-licensing of our products.
While we are not providing net cash flow guidance for 2022, we do expect an increase in investment to support global clinical and organizational expansion. To support our cash needs, we continue to engage in active discussions regarding the potential divestment of non-core assets, such as SHPL, as well as evaluate equity capital markets action, such as a potential future listing on the STAR Market of the Shanghai Stock Exchange.
| 2021 Actual |
2022 Guidance |
||
| Oncology/Immunology consolidated revenues | $119.6 million | $160 – 190 million | |
Shareholders and investors should note that:
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 9 p.m. HKT / 1 p.m. GMT / 8 a.m. EST – 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 “19304872#.”
—–
HUTCHMED will today file with the U.S. Securities and Exchange Commission its Annual Report on Form 20-F.
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has more than 4,600 personnel across all its companies, at the center of which is a team of over 1,500 in oncology/immunology. Since inception it has advanced 12 cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved and marketed in China. For more information, please visit: www.hutch‑med.com or follow us on LinkedIn.
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.
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, including, among others, the risk that HUTCHMED’s ADSs could be barred from trading in the United States as a result of the Holding Foreign Companies Accountable Act and the rules promulgated thereunder; 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).
——
[1] AstraZeneca = AstraZeneca PLC and its wholly owned subsidiary, AstraZeneca AB (publ).
[2] NSCLC = Non-small cell lung cancer.
[3] NDA = New Drug Application.
[4] MAA = Marketing Authorisation Application.
[5] CRC = Colorectal cancer.
[6] FGFR = Fibroblast growth factor receptor.
[7] IDH = Isocitrate dehydrogenase.
[8] ERK = Extracellular signal-regulated kinase.
[9] BTK = Bruton’s tyrosine kinase.
[10] CSF-1R = Colony stimulating factor-1 receptor.
[11] In-market sales = total sales to third parties provided by Eli Lilly (ELUNATE®), AstraZeneca (ORPATHYS®) and HUTCHMED (SULANDA®).
[12] MET = Mesenchymal epithelial transition receptor.
[13] NRDL = National Reimbursement Drug List.
[14] R&D = Research and development.
[15] NMPA = National Medical Products Administration.
[16] ITP = Immune thrombocytopenia purpura.
[17] FDA = Food and Drug Administration.
[18] PDUFA = Prescription Drug User Fee Act.
[19] EMA = European Medicines Agency.
[20] EOP2 = End of Phase 2.
[21] EGFR = Epidermal growth factor receptor.
[22] TKI = Tyrosine kinase inhibitor.
[23] ASCO = American Society of Clinical Oncology.
[24] WCLC = World Conference on Lung Cancer.
[25] VEGFR = Vascular endothelial growth factor receptor.
[26] NEC = Neuroendocrine carcinoma.
[27] Junshi = Shanghai Junshi Biosciences Co., Ltd.
[28] PMDA = Japanese Pharmaceuticals and Medical Devices Agency.
[29] BeiGene = BeiGene, Ltd.
[30] PD-1 = Programmed Cell Death Protein-1.
[31] ESMO IO = European Society for Medical Oncology Immuno-Oncology Congress.
[32] CgA = Chromogranin A.
[33] BTC = Biliary tract cancer.
[34] HCC = Hepatocellular carcinoma.
[35] RCC = Renal cell cancer.
[36] CSCO = Chinese Society of Clinical Oncology Annual Meeting.
[37] Genor = Genor Biopharma Co. Ltd.
[38] OS = Overall survival.
[39] PI3Kδ = Phosphoinositide 3-kinase delta.
[40] RP2D = Recommended Phase II dose.
[41] Syk = Spleen tyrosine kinase.
[42] ASH 2021 = the 63rd ASH Annual Meeting and Exposition in December 2021.
[43] MAPK pathway = RAS-RAF-MEK-ERK signaling cascade.
[44] We also report changes in performance at constant exchange rate (“CER”) which is a non-GAAP measure. Please refer to “Use of Non-GAAP Financial Measures and Reconciliation” below for further information relevant to the interpretation of these financial measures and reconciliations of these financial measures to the most comparable GAAP measures.
[45] SHPL = Shanghai Hutchison Pharmaceuticals Limited.
[46] HBYS = Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited.
[47] HKEX = The Stock Exchange of Hong Kong Limited.
[48] Inmagene = Inmagene Biopharmaceuticals.
[49] Hutchison Sinopharm = Hutchison Whampoa Sinopharm Pharmaceuticals (Shanghai) Company Limited.
[50] GAAP = Generally Accepted Accounting Principles.
[51] Lilly = Eli Lilly and Company.
[52] SG&A Expenses = selling, general and administrative expenses.
[53] ADS = American depositary share.
| Date: March 3 , 2022 (Thursday) |
| Announcement released: 7am EST / 12 noon GMT / 8pm HKT |
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— First homegrown innovative medicine approved in Macau based on China clinical data —
Hong Kong, Shanghai & Florham Park, NJ –– Tuesday, March 1, 2022: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has received approval to market fruquintinib (ELUNATE® in China), a selective and potent oral inhibitor of vascular endothelial growth factor receptors (“VEGFR”) 1, 2 and 3, in the Macau Special Administrative Region.
The approval follows the latest update to the provisions on new drug importation which allows drugs that have been approved in one or more specified jurisdictions to be authorized for use in Macau. Prior to the update, regulations required approval from at least two other jurisdictions. Fruquintinib was approved in Mainland China by the National Medical Products Administration (“NMPA”) in September 2018 for the treatment of metastatic colorectal cancer (“CRC”). ELUNATE® will become the first homegrown innovative oncology drug to be marketed in Macau based on its approval by the NMPA.
Dr. Karen Atkin, Chief Operating Officer of HUTCHMED, said, “With the rapid pace of innovation in China’s biotech sector in recent years, more homegrown innovative drugs are being developed and launched in China. We are encouraged by the Macau government’s policy for registration of novel therapies, such as ELUNATE®, based on China clinical trial data. We now look forward to patients in Macau having full access to ELUNATE® in the coming months.”
Fruquintinib is a highly selective and potent oral inhibitor of VEGFR-1, -2 and -3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. The generally favorable tolerability in patients treated to date, along with fruquintinib’s low potential for drug-drug interactions based on preclinical assessment, suggests that it may also be highly suitable for combinations with other anti-cancer therapies.
Metastatic CRC in China: Fruquintinib was approved for marketing by the China NMPA in September 2018 and commercially launched in China in late November 2018 under the brand name ELUNATE®. It was included in the China National Reimbursement Drug List (NRDL) in January 2020. ELUNATE® is indicated for the treatment of patients with metastatic CRC who have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan, including those who have previously received anti-VEGF therapy and/or anti-EGFR therapy (RAS wild type). Results of the FRESCO study[1], a Phase III pivotal registration trial of fruquintinib in 416 patients with metastatic CRC in China, were published in The Journal of the American Medical Association, JAMA, in June 2018 (clinicaltrials.gov identifier: NCT02314819).
The safety and efficacy of fruquintinib for the following investigational uses have not been established and there is no guarantee that it will receive health authority approval or become commercially available in any country for the uses being investigated:
Metastatic CRC in the U.S., Europe, and Japan: The U.S. Food and Drug Administration (“FDA”) granted Fast Track Designation for the development of fruquintinib for the treatment of patients with metastatic CRC in June 2020. A Phase III registration study of fruquintinib for the treatment of patients with metastatic CRC, FRESCO-2, is currently underway in the U.S., Europe, Japan and Australia. Additional details of the study may be found at clinicaltrials.gov, using identifier NCT04322539. The U.S. FDA has acknowledged that the totality of the fruquintinib clinical data, including the FRESCO-2 study (if positive), the prior positive Phase III FRESCO study demonstrating improvement in overall survival that led to fruquintinib approval for metastatic CRC in China in 2018, and additional completed and ongoing supporting studies in metastatic CRC, could potentially support a New Drug Application (NDA) for the treatment of patients with advanced metastatic CRC (third-line and above). The FRESCO-2 study design was also reviewed and endorsed by The European Medicines Agency (EMA) and Japanese Pharmaceuticals and Medical Devices Agency (PMDA).
Gastric Cancer (“GC”) in China: In October 2017, HUTCHMED initiated the FRUTIGA study, a randomized, double-blind, Phase III trial evaluating the efficacy and safety of fruquintinib combined with paclitaxel for second-line treatment of advanced gastric or esophagogastric junction (“GEJ”) adenocarcinoma. The trial is designed to enroll patients who did not respond to first-line standard chemotherapy. Subjects receive either fruquintinib combined with paclitaxel or placebo combined with paclitaxel. Patients are randomized at a 1:1 ratio and stratified according to factors such as stomach vs. GEJ tumor type and performance status. The primary efficacy endpoint is overall survival (OS). Secondary efficacy endpoints include progression-free survival (as defined by RECIST 1.1), objective response rate, disease control rate, duration of response, and quality-of-life score (EORTC QLQ-C30, version 3.0). Biomarkers related to the antitumor activity of fruquintinib will also be explored (clinicaltrials.gov identifier: NCT03223376). In June 2020, HUTCHMED completed a planned interim data review. Based on the preset criteria, the Independent Data Monitoring Committee (IDMC) recommended that the trial continue.
Immunotherapy combinations: HUTCHMED has entered into collaboration agreements to evaluate the safety, tolerability and efficacy of fruquintinib in combination with PD-1 monoclonal antibodies, including with tislelizumab (BGB-A317, developed by BeiGene, Ltd) and sintilimab (IBI308, developed by Innovent Biologics, Inc. and marketed as TYVYT® in China).
HUTCHMED (Nasdaq/AIM: HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has more than 4,600 personnel across all its companies, at the center of which is a team of over 1,500 in oncology/immunology. Since inception it has advanced 12 cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved and marketed in China. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.
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 regarding the therapeutic potential of fruquintinib for the treatment of patients with advanced CRC and the further clinical development of fruquintinib in this and other indications. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the sufficiency of clinical data to support New Drug Application approval of fruquintinib for the treatment of patients with advanced CRC in the U.S., Europe, Japan, Australia or other jurisdictions, its potential to gain expeditious approvals from regulatory authorities, the safety profile of fruquintinib, HUTCHMED’s ability to fund, implement and complete its further clinical development and commercialization plans for fruquintinib, the timing of these events, and the impact of the COVID-19 pandemic on general economic, regulatory and political conditions. In addition, as certain studies rely on the use of other drug products such as paclitaxel, tislelizumab and sintilimab as combination therapeutics with fruquintinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of these therapeutics. 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, on AIM and on The Stock Exchange of Hong Kong Limited. 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.
[1] Li J, Qin S, Xu RH, et al. Effect of Fruquintinib vs Placebo on Overall Survival in Patients With Previously Treated Metastatic Colorectal Cancer: The FRESCO Randomized Clinical Trial. JAMA. 2018;319(24):2486-2496. doi:10.1001/jama.2018.7855.、
Investor Enquiries |
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| Mark Lee, Senior Vice President | +852 2121 8200 |
| Annie Cheng, Vice President | +1 (973) 567 3786 |
Media Enquiries |
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| 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 |
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| Atholl Tweedie / Freddy Crossley, Panmure Gordon (UK) Limited |
+44 (20) 7886 2500 |