Press Release
London: Thursday, March 28, 2019: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) will share further data on the savolitinib development programs in lung cancer at the American Association of Cancer Research (AACR) Annual Meeting in Atlanta, Georgia, USA, March 31 to April 3, 2019.
Preliminary efficacy and safety results will be presented from the China Phase II study of savolitinib monotherapy in non-small cell lung cancer (“NSCLC”) patients with MET Exon 14 skipping mutations who have failed prior systemic therapy, or are unable to receive chemotherapy (abstract #CT031, clinicaltrials.gov identifier NCT02897479).
In addition, several abstracts will be presented from the TATTON Phase Ib/II trial of savolitinib in combination with Tagrisso® (osimertinib) in patients with epidermal growth factor receptor (“EGFR”) mutation-positive NSCLC and MET-amplification who have progressed following treatment with an EGFR tyrosine kinase inhibitor (“EGFR-TKI”) (clinicaltrials.gov identifier NCT02143466). One presentation will focus on patients who had progressed on a first- or second-generation EGFR-TKI and had not previously received a third-generation EGFR-TKI (abstract #CT032). Another presentation will focus on patients whose disease further progressed despite prior treatment with a third-generation EGFR-TKI (abstract #CT033). These presentations are complemented by a poster presentation on detection methods for identifying MET-driven EGFR-TKI resistance in the TATTON trial (abstract #4897/20).
TATTON preliminary results were presented at the World Conference on Lung Cancer (WCLC) in Yokohama, Japan, in October 2017.[1] The TATTON trial supports SAVANNAH, an ongoing Phase II clinical trial exploring the combination of savolitinib and Tagrisso® to overcome MET-driven EGFR-TKI resistance following treatment with Tagrisso® (clinicaltrials.gov identifier NCT03778229).
Further details of the presentations are as follows:
Session: | Can the Challenge of NSCLC Resistance Be MET or Will We Not MEK It? |
Session Type: | Clinical Trials Plenary Session |
Session # & Link: | CTPL02 |
Date & Time: | Sunday, March 31: 3:00 PM-5:15 PM |
Location: | Marcus Auditorium, Building A, Georgia World Congress Center |
1st Presentation Title: | Preliminary efficacy and safety results of savolitinib treating patients with pulmonary sarcomatoid carcinoma (PSC) and other types of non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations |
Lead Author: | Shun Lu, Professor at Shanghai Chest Hospital, Jiao Tong University |
Abstract # & Link: | CT031 – abstract available after 3:00 PM EST on Friday, March 29, 2019 |
Time: | 3:05 PM-3:30 PM |
2nd Presentation Title: | TATTON Phase Ib expansion cohort: Osimertinib plus savolitinib for patients (pts) with EGFR-mutant, MET-amplified NSCLC after progression on prior first/second-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) |
Lead Author: | Helena A. Yu, Medical Oncologist at Memorial Sloan Kettering Cancer Center |
Abstract # & Link: | CT032 – abstract only available at time of presentation |
Time: | 3:40 PM-3:55 PM |
3rd Presentation Title: | TATTON Phase Ib expansion cohort: Osimertinib plus savolitinib for patients (pts) with EGFR-mutant, MET-amplified NSCLC after progression on prior third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) |
Lead Author: | Lecia V. Sequist, Associate Professor of Medicine at Harvard Medical School and the Director of the Center for Innovation in Early Cancer Detection at Massachusetts General Hospital |
Abstract # & Link: | CT033 – abstract only available at time of presentation |
Time: | 3:55 PM-4:15 PM |
Session: | Novel Strategies for Biomarker Identification and Use in Cancer 3 |
Poster Title: | Detection of MET-mediated EGFR tyrosine kinase inhibitor (TKI) resistance in advanced non-small cell lung cancer (NSCLC): biomarker analysis of the TATTON study |
Lead Author: | Ryan J. Hartmaier, AstraZeneca |
Abstract # & Link: | 4897 / 20 – abstract now available |
Date & Time: | April 3, 2019, 8:00 AM – 12:00 PM |
Location: | Section 19, Building B, Georgia World Congress Center |
Savolitinib is a potential first-in-class inhibitor of c-MET, an enzyme which has been shown to function abnormally in many types of solid tumors. Chi-Med designed savolitinib to be a potent and highly selective oral inhibitor, which, through chemical structure modification, addresses human metabolite-related renal toxicity, the primary issue that halted development of several other selective c-MET inhibitors. In clinical studies to date, involving over 900 patients, savolitinib has shown promising signs of clinical efficacy in patients with c-MET gene alterations in multiple tumor types with an acceptable safety profile. Chi-Med is currently testing savolitinib in partnership with AstraZeneca in Phase Ib/II studies, in multiple solid tumor indications, both as a monotherapy and in combinations.
Chi-Med (AIM/Nasdaq: HCM) is an innovative biopharmaceutical company which researches, develops, manufactures and markets pharmaceutical products. Its Innovation Platform, Hutchison MediPharma, has about 420 scientists and staff focusing on discovering, developing and commercializing targeted therapies and immunotherapies in oncology and autoimmune diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world. Chi-Med’s Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products, covering an extensive network of hospitals across China.
Dual-listed on the AIM market of the London Stock Exchange and the Nasdaq Global Select Market, Chi-Med is headquartered in Hong Kong and majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 1). For more information, please visit: www.chi-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 Chi-Med’s current expectations regarding future events, including its expectations for the clinical development of savolitinib, plans to initiate clinical studies for savolitinib, its expectations as to whether such studies 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 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 savolitinib 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 savolitinib for a targeted indication and the sufficiency of funding. In addition, as certain studies rely on the use of Tagrisso®, Iressa® and Imfinzi® as combination therapeutics with savolitinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of Tagrisso®, Iressa® 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 Chi-Med’s filings with the U.S. Securities and Exchange Commission and on AIM. Chi-Med 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] Ahn M-J, et al. TATTON Phase Ib Expansion Cohort: Osimertinib Plus Savolitinib for Patients with EGFR-mutant MET-amplified NSCLC After Progression on Prior EGFR-TKI. Abstract #8985. Presented at the World Lung Cancer Congress (WCLC) 2017, Yokohama, Japan, 15-18 October 2017.
Location: 4th Floor, Hutchison House, 5 Hester Road, Battersea, London SW11 4AN, UK |
Time: 11am |
Conrad Hotel, Hong Kong
Morgan Stanley Office, Hong Kong
London: Monday, March 25, 2019: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) announces that following the publication of the 2018 annual report of Chi-Med on March 21 2019, the following awards granted under the Long Term Incentive Plan (“LTIP”) on October 19, 2015 to Mr Christian Hogg, Mr Johnny Cheng and Dr Weiguo Su were vested on March 22, 2019:-
Award Holders |
Number of American depositary shares (“ADS”) |
|
Person Discharging Managerial Responsibilities | ||
Mr Christian Hogg (Executive Director and Chief Executive Officer) |
8,234 |
|
Mr Johnny Cheng (Executive Director and Chief Financial Officer) |
2,540 |
|
Dr Weiguo Su (Executive Director and Chief Scientific Officer) |
3,008 |
|
Total |
13,782 |
The notifications set out below are 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 | 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 |
ADS each representing one half of one Ordinary Share of US$1.00ADS ISIN: US44842L1035 |
||||
b) | Nature of the transaction | Vesting of awards granted on October 19, 2015 under Chi-Med’s LTIP | ||||
c) | Price(s) and volume(s) |
|
||||
d) | Aggregated information
|
N/A | ||||
e) | Date of the transaction | 2019-03-22 | ||||
f) | Place of the transaction | Nasdaq Stock Market |
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 |
ADS each representing one half of one Ordinary Share of US$1.00ADS ISIN: US44842L1035 |
||||
b) | Nature of the transaction | Vesting of awards granted on October 19, 2015 under Chi-Med’s LTIP | ||||
c) | Price(s) and volume(s) |
|
||||
d) | Aggregated information
|
N/A | ||||
e) | Date of the transaction | 2019-03-22 | ||||
f) | Place of the transaction | Nasdaq Stock Market |
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 |
ADS each representing one half of one Ordinary Share of US$1.00ADS ISIN: US44842L1035 |
||||
b) | Nature of the transaction | Vesting of awards granted on October 19, 2015 under Chi-Med’s LTIP | ||||
c) | Price(s) and volume(s) |
|
||||
d) | Aggregated information
|
N/A | ||||
e) | Date of the transaction | 2019-03-22 | ||||
f) | Place of the transaction | Nasdaq Stock Market |
Chi-Med (AIM/Nasdaq: HCM) is an innovative biopharmaceutical company which researches, develops, manufactures and markets pharmaceutical products. Its Innovation Platform, Hutchison MediPharma, has about 420 scientists and staff focusing on discovering, developing and commercializing targeted therapies and immunotherapies in oncology and autoimmune diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world. Chi-Med’s Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products, covering an extensive network of hospitals across China.
Dual-listed on the AIM market of the London Stock Exchange and the Nasdaq Global Select Market, Chi-Med is headquartered in Hong Kong and majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 1). For more information, please visit: www.chi-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 Chi-Med’s filings with the U.S. Securities and Exchange Commission and on AIM. Chi-Med 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.
Corporate Information
2018 Key Highlights
Highlights
Chairman’s Statement
Financial Review
Operations Review
Biographical Details Of Directors
Report of the Directors
Corporate Governance Report
Form 20-F (Including Financial Statements)
Information For Shareholders
London: Thursday, March 21, 2019: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) today announces that its 2018 Annual Report together with the Notice of Annual General Meeting and the Form of Proxy have been posted to shareholders. The documents can be accessed from the website of Chi-Med (www.chi-med.com).
About Chi-Med
Chi-Med (AIM/Nasdaq: HCM) is an innovative biopharmaceutical company which researches, develops, manufactures and markets pharmaceutical products. Its Innovation Platform, Hutchison MediPharma, has about 420 scientists and staff focusing on discovering, developing and commercializing targeted therapies and immunotherapies in oncology and autoimmune diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world. Chi-Med’s Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products, covering an extensive network of hospitals across China.
Dual-listed on the AIM market of the London Stock Exchange and the Nasdaq Global Select Market, Chi-Med is headquartered in Hong Kong and majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 1). For more information, please visit: www.chi-med.com.
London: Monday, March 11, 2019: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) today published the Form 20-F for the financial year ended December 31, 2018. This is available for viewing at http://www.rns-pdf.londonstockexchange.com/rns/4831S_1-2019-3-11.pdf and also on the website of the Company at www.chi-med.com.
Chi-Med (AIM/Nasdaq: HCM) is an innovative biopharmaceutical company which researches, develops, manufactures and markets pharmaceutical products. Its Innovation Platform, Hutchison MediPharma, has about 420 scientists and staff focusing on discovering, developing and commercializing targeted therapies and immunotherapies in oncology and autoimmune diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world. Chi-Med’s Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products, covering an extensive network of hospitals across China.
Dual-listed on the AIM market of the London Stock Exchange and the Nasdaq Global Select Market, Chi-Med is headquartered in Hong Kong and majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 1). For more information, please visit: www.chi-med.com.
London: Monday, March 11, 2019: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) today announces its audited financial results for the year ended December 31, 2018 and provides updates on key clinical programs.
Video webcast presentation at 9:00 a.m. GMT and additional conference call at 9:00 a.m. EDT.
(1) China Phase II in mesenchymal epithelial transition receptor (“MET”) exon 14 mutation/deletion non-small cell lung cancer (“NSCLC”); and
(2) Global Tagrisso®/savolitinib combination Phase II in MET-positive Tagrisso® refractory NSCLC.
“With the launch of Elunate® underway and doing well, and with its financial prospects enhanced by the recent Lilly amendment, we are focused on our broader late-stage clinical development program with multiple important opportunities being pursued in parallel,” said Simon To, Chairman, Chi-Med. “We took a big step in 2018 to expand our U.S. development capability in order that we can take full advantage of the global potential of our assets. We also entered the immuno oncology arena through multiple development collaborations combining PD-1 antibodies with our highly selective small molecules. The increased investment in all these activities is partially offset by robust income from our commercial operation in China, which also serves as a very powerful platform for future product launches.”
“Looking ahead, we target multiple NDAs in the coming two or three years, covering savolitinib, surufatinib and fruquintinib, as well as registration studies with our hematological cancer assets. We believe that these activities will address a broad range of unmet medical needs and benefit a large number of patients.”
The items below are selected financial data for the year ended December 31, 2018. All dollars are expressed in US dollar currency unless otherwise stated. For more details, please refer to “Financial Review”, “Operations Review” and “Audited Consolidated Financial Statements” below.
OVERALL GROUP: in-line with our most recent guidance
INNOVATION PLATFORM: increased investment in R&D driven by expansion of our operations and progress on our clinical development pipeline
COMMERCIAL PLATFORM: continued solid net income growth amid shift in revenue model and over-the-counter (“OTC”) logistics divestment
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U.K. Analysts Meeting and Webcast Scheduled Today at 9:00 a.m. GMT (5:00 p.m. HKT) – at Citigate Dewe Rogerson, 3 London Wall Buildings, London, EC2M 5SY, U.K. Investors may participate in the call at +44 20 3003 2666 (800 900 476 toll free in Hong Kong), or access a live video webcast of the call via Chi-Med’s website at www.chi-med.com/investors/event-information/.
U.S. Conference Call Scheduled Today at 9:00 a.m. EDT – to participate in the call from the U.S., please dial 1 866 966 5335.
Additional dial-in numbers are also available at Chi-Med’s website. For both calls please use conference ID “Chi-Med.”
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The points below summarize some of the pipeline development highlights during 2018 and to-date in 2019. For more details, please refer to “Operations Review – Innovation Platform” below.
FRUQUINTINIB – Highly selective tyrosine kinase inhibitor (“TKI”) of vascular endothelial growth factor receptor (“VEGFR”) 1/2/3 – focus on maximizing commercial potential of our first approved drug:
SAVOLITINIB – Highly selective TKI of MET:
SURUFATINIB (HMPL-012 or sulfatinib) – unique angio-immuno kinase inhibitor of VEGFR, fibroblast growth factor receptor (“FGFR”) 1, and colony stimulating factor-1 receptor (“CSF-1R”):
Further progress in early/proof-of-concept clinical trials, including:
Expansion of U.S. and international operations, and recruitment of key personnel: established new office in New Jersey to support our multiple unpartnered compounds through proof-of-concept and registration trials outside of Asia.
The points below summarize some of the operational and financial highlights of our Commercial Platform during 2018. For more details, please refer to “Operations Review — Commercial Platform” below.
Large-scale, high-performance drug marketing and distribution platform covering ~320 cities/towns in China with approximately 3,400 sales personnel. Targeting multiple indications with several household-name brands:
We provide streamlined Financial Guidance for 2019.
The ramp-up of manufacturing and royalty revenues from Lilly on Elunate® is expected to significantly benefit the Company’s financial results in years to come, with a gradual start in 2019 – the product’s first full year on the market. On the broader Innovation Platform, we plan to continue to increase our investment in R&D particularly on clinical development of our main assets in the U.S. and Europe as well as in China (as discussed in the “Product pipeline progress” section below).
On the Commercial Platform, we expect to continue to generate cash flow directly through our subsidiaries and via dividends from our joint ventures. Two government reforms, the Two-Invoice System and the 4+7 Quality Consistency Evaluation (“QCE”) System, could narrow growth rates this year before having a positive mid- to long-term impact for Chi-Med (both reforms are discussed in detail the “Commercial Platform,” section below).
2019 Guidance | |
Research & Development Expenses | $(160) – (200) million |
Adjusted (non-GAAP) Group Net Cash Flow excluding financing activities | $(120) – (150) million |
2019 U.S. dollar guidance takes into account the weakening of the RMB, which is down 5% relative to the first half average last year due to global macroeconomic factors.
Use of Non-GAAP Financial Measures – References in this announcement to adjusted R&D expenses, adjusted consolidated net income attributable to Chi-Med from our Commercial Platform, adjusted consolidated operating profit from our Commercial Platform, adjusted consolidated net income attributable to Chi-Med from our Prescription Drugs business, adjusted revenues of HBYS and non-consolidated joint ventures, adjusted service fees for Seroquel®, adjusted Group net cash flows and adjusted Group net cash flows excluding financing activities 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.
Chi-Med will today file with the U.S. Securities and Exchange Commission its Annual Report on Form 20-F.
The Annual General Meeting of Chi-Med will be held at 4th Floor, Hutchison House, 5 Hester Road, Battersea, London SW11 4AN on Wednesday, April 24, 2019 at 11:00 a.m.
Chi-Med (AIM/Nasdaq: HCM) is an innovative biopharmaceutical company which researches, develops, manufactures and markets pharmaceutical products. Its Innovation Platform, Hutchison MediPharma, has about 420 scientists and staff focusing on discovering, developing and commercializing targeted therapies and immunotherapies in oncology and autoimmune diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world. Chi-Med’s Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products, covering an extensive network of hospitals across China.
Dual-listed on the AIM market of the London Stock Exchange and the Nasdaq Global Select Market, Chi-Med is headquartered in Hong Kong and majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 1). For more information, please visit: www.chi-med.com.
Mark Lee, Senior Vice President, Corporate Finance & Development
+852 2121 8200
Annie Cheng, Vice President, Corporate Finance & Development
+1 (973) 567 3786
David Dible, Citigate Dewe Rogerson
+44 7967 566 919 (Mobile)
david.dible@citigatedewerogerson.com
Xuan Yang, Solebury Trout
+1 (415) 971 9412 (Mobile)
UK & Europe – Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
Americas – Brad Miles, Solebury Trout
+1 (917) 570 7340 (Mobile)
Hong Kong & Asia ex-China – Joseph Chi Lo, Brunswick
+852 9850 5033 (Mobile)
Hong Kong & Asia ex-China – Zhou Yi, Brunswick
+852 9783 6894 (Mobile)
Mainland China – Sam Shen, Edelman
+86 1367 179 1029 (Mobile)
Richard Gray / Atholl Tweedie, Panmure Gordon (UK) Limited
+44 (20) 7886 2500
Unless the context requires otherwise, references in this announcement to the “Group,” the “Company,” “Chi-Med,” “Chi-Med 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,” “believe,” “first-in-class,” “best-in-class,” “designed to,” “objective,” “guidance,” “pursue,” or similar terms, or by express or implied discussions regarding potential drug candidates, potential indications for drug candidates or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that any of our drug candidates will be approved for sale in any market, or that any approvals which are obtained will be obtained at any particular time, or that any such drug candidates will achieve any particular revenue or net income levels. In particular, management’s expectations could be affected by, among other things: unexpected regulatory actions or delays or government regulation generally; the uncertainties inherent in research and development, including the inability to meet our key study assumptions regarding enrollment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria and funding requirements, changes to clinical protocols, unexpected adverse events or safety, quality or manufacturing issues; the inability of a drug candidate to meet the primary or secondary endpoint of a study; the inability of a drug candidate to obtain regulatory approval in different jurisdictions or gain commercial acceptance after obtaining regulatory approval; global trends toward health care cost containment, including ongoing pricing pressures; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product liability litigation, litigation and investigations regarding sales and marketing practices, intellectual property disputes, and government investigations generally; and general economic and industry conditions, including uncertainties regarding the effects of the persistently weak economic and financial environment in many countries and uncertainties regarding future global exchange rates. For further discussion of these and other risks, see Chi-Med’s filings with the U.S. Securities and Exchange Commission and on AIM. Chi-Med 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 Chi-Med obtained from industry publications and reports generated by third-party market research firms. Although Chi-Med believes that the publications, reports and surveys are reliable, Chi-Med 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.
The content above is a copy of the first section of the announcement. For the remainder, including Financial Review, Operations Review, Non-GAAP Financial Measures and Reconciliation, and Consolidated Financial Statements, please download the Full Announcement.
Announcement released: 7am BST (3pm HKT / 3am EDT) |
>> See announcement here |
Presentation webcast & call: 9am BST (5pm HKT / 5am EDT) |
>> Click here for the webcast |
US conference call: 9am EDT (1pm BST/9pm HKT) |
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