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View Annual Report CORPORATE INFORMATION BOARD OF DIRECTORS REMUNERATION COMMITTEE Paul CARTER (Chairman)* Executive Directors Graeme JACK # Simon TO, BSc, ACGI, MBA Simon TO Chairman TECHNICAL COMMITTEE Christian HOGG, BSc, MBA Chief Executive Officer Karen FERRANTE (Chairman) Paul CARTER Johnny CHENG, BEc, CA Christian HOGG Chief Financial Officer Tony MOK Weiguo SU, BSc, PhD Weiguo SU Chief Scientific Officer Simon TO Non-executive Directors COMPANY SECRETARY Edith SHIH Dan ELDAR, BA, MA, MA, PhD Edith SHIH, BSE, MA, MA, EdM, Solicitor, FCIS, FCS(PE) NOMINATED ADVISER Independent Non-executive Directors Panmure Gordon (UK) Limited Paul CARTER, BA, FCMA CORPORATE BROKERS Senior Independent Director Panmure Gordon (UK) Limited Karen FERRANTE, MD, BSc HSBC Bank plc Graeme JACK, BCom, CA (ANZ), FHKICPA Tony MOK, BMSc, MD, FRCPC, FHKCP, FHKAM, FRCP, FASCO AUDITOR PricewaterhouseCoopers AUDIT COMMITTEE Graeme JACK (Chairman) Paul CARTER Karen FERRANTE *Appointed as Chairman of Remuneration Committee on 28 September 2018 #Resigned as Chairman of Remuneration Committee on 28 September 2018 CONTENTS Corporate Information 2018 Key Highlights 4 Financial Highlights 5 Operating Highlights 6 Chairman’s Statement 10 Financial Review 11 Operations Review 13 Innovation Platform 13 Commercial Platform 27 Biographical Details of Directors 34 Report of the Directors 38 Corporate Governance Report 44 Form 20-F (with certain items or sub-items highlighted below) Introduction 3 Risk Factors 11 History and Development of the Company 56 Our Organizational Structure 57 Business Overview 58 Operating and Financial Review and Prospects 157 Directors, Senior Management and Employees 194 Major Shareholders and Related Party Transactions 209 Consolidated Financial Statements F-1 to F-132 Information for Shareholders BUILDING A GLOBAL SCIENCE-FOCUSED BIOPHARMA COMPANY FROM A POWERFUL BASE IN CHINA 2 GLOBAL INNOVATION • 5 clinical drug candidates in US/EU development • Building global clinical development footprint • World-class >420 person scientific team CHINA ONCOLOGY • Major market potential driven by regulatory reforms and high unmet medical need in oncology • Elunate® (Fruquintinib capsules) first ever home-grown cancer drug launched in China[1] • 8 oncology assets in China development EXISTING CHINA BUSINESS • Cash generative China Commercial Platform • Platform for future innovative drug launches [1] Believed to be the first ever China-discovered novel oncology drug to receive full NDA approval in China. Hutchison China MediTech Limited 2018 Annual Report 3 2018 KEY HIGHLIGHTS FRUQUINTINIB HEMATOLOGICAL (ELUNATE®) MALIGNANCIES • Received New Drug Application (“NDA”) • Expanded Phase I/Ib dataset in Australia and approval for fruquintinib and launched in China in lymphoma for HMPL-523 targeting late November 2018 for colorectal cancer spleen tyrosine kinase (“Syk”) and HMPL-689 (“CRC”), the first ever China-discovered novel targeting phosphoinositide 3-kinase delta oncology drug to receive full NDA approval in (“PI3Kδ”). Cleared U.S. Investigational New China; and Drug (“IND”) applications on both assets with U.S. and E.U. clinical development set to start • Completed an agreement with Eli Lilly and in H1 2019. Company (“Lilly”) to amend the original 2013 license and collaboration agreement for fruquintinib enabling both parties to maximize its long-term commercial potential in China. IMMUNOTHERAPY SAVOLITINIB COMBINATIONS • Initiated two studies with potential for • Signed four co-development collaborations registration in lung cancer: for fruquintinib and surufatinib in combination with various programmed cell death protein-1 1. China Phase II in mesenchymal epithelial (“PD-1”) monoclonal antibodies. 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® GLOBAL CLINICAL refractory NSCLC. DEVELOPMENT • Presented Phase II data of Imfinzi®/savolitinib • Expansion of U.S. and international clinical and combination in papillary renal cell carcinoma regulatory operations firmly underway with five (“PRCC”), a tolerable combination with Chi-Med drug candidates either in or about to immature but encouraging efficacy. start global clinical development. 4 FINANCIAL HIGHLIGHTS The items below are selected financial INNOVATION COMMERCIAL data for the year ended December 31, 2018. All dollars are expressed in US dollar PLATFORM PLATFORM currency unless otherwise stated. Increased investment in R&D driven by Continued solid net income growth amid For more details, please refer to “Financial expansion of our operations and progress shift in revenue model and over-the-counter Review”, “Operations Review” and “Audited on our clinical development pipeline (“OTC”) logistics divestment Consolidated Financial Statements” in this annual report. • Consolidated revenue was $41.2 million • Total consolidated sales fell 16% to $172.9 million (2017: $36.0m) mainly from service fee (2017: $205.2m) because of the payments from AstraZeneca AB (publ) implementation of the Two-Invoice System OVERALL GROUP (“AstraZeneca”), Lilly and Nutrition Science in China, a new government policy that led In-line with our most recent guidance Partners Limited (“NSP”), our 50/50 joint to a shift in our revenue recognition for venture with Nestlé Health Science S.A., and certain third-party drugs from gross sales • Group revenue of $214.1 million $13.5 m in milestone payments from Lilly consolidation to a fee-for-service revenue (2017: $241.2m). following fruquintinib approval. Following model. This new Two-Invoice System policy fruquintinib’s launch, under the brand name did not affect our total consolidated net • Net loss attributable to Chi‑Med of Elunate®, we recorded revenue of $3.3m and income in 2018. $74.8 million (2017: net loss $26.7m). royalty income of $0.3m during the last five weeks of 2018. • Total sales of non‑consolidated joint • Adjusted Group net cash flow (non‑GAAP) ventures, on an as adjusted (non‑GAAP) was ‑$57.3 million in 2018. Cash from our • R&D expenses on an as adjusted (non‑GAAP) basis excluding the effects of the divestment Commercial Platform, as well as payments basis increased to $142.2 million of certain non‑core operations, up 13% received from our multi-national partners, (2017: $88.0m), primarily driven by the to $491.5 million (2017: $433.3m) driven offset more than half of our research and progress in the development of our eight by strong growth across major product development (“R&D”) expenses. clinical drug candidates, five of which are now categories. in development outside China; investment • Cash resources of $420.3 million at Group in the establishment of small molecule • Total consolidated net income from our level as of December 31, 2018 ($479.6m as manufacturing operations in China; and Commercial Platform attributable to Chi‑Med of December 31, 2017), including cash and expansion of U.S. and international clinical and up 10% to $41.4 million (2017: $37.5m), on an cash equivalents, short-term investments and regulatory operations. as adjusted (non-GAAP) basis excluding one- unutilized bank facilities. time gains in 2017. • Net loss from our Innovation Platform attributable to Chi‑Med of $102.4 million (2017: net loss of $51.9m). Hutchison China MediTech Limited 2018 Annual Report 5 OPERATING HIGHLIGHTS • Two further analyses of FRESCO data in which fruquintinib demonstrated tolerable INNOVATION presented at the annual meeting of the safety and strong anti-tumor efficacy in NSCLC, PLATFORM American Society of Clinical Oncology meeting all secondary endpoints, however it did (“ASCO”) in June 2018: (1) a subgroup not achieve its primary overall survival (“OS”) The points below summarize some of the analysis by prior anti-VEGF or anti-epidermal endpoint; pipeline development highlights during 2018 and growth factor receptor (“EGFR”) target to-date in 2019. For more details, please refer therapy showed that fruquintinib had clinically Global clinical development: Chi-Med retains to “Operations Review – Innovation meaningful benefits regardless of prior all rights to fruquintinib outside of China. In Platform” in this annual report. targeted therapy (PTT) without observed 2018, the U.S. recommended Phase II dose for cumulative toxicity; and (2) an ad-hoc analysis fruquintinib was determined to be the same FRUQUINTINIB – Highly selective tyrosine of quality-adjusted time without symptoms as the dose in China. Planning is ongoing for a kinase inhibitor (“TKI”) of vascular or toxicity (“Q-TWiST”) showed relative Phase II/III registration study in CRC in the U.S. / endothelial growth factor receptor (“VEGFR”) improvement of Q-TWiST with fruquintinib, Europe in addition to multiple exploratory 1/2/3 – focus on maximizing commercial representing a potentially clinically important studies of fruquintinib in the U.S.; and potential of our first approved drug: quality-of-life benefit for patients; PD‑1 collaborations: in late 2018 we entered FRESCO China Phase III in third‑line CRC: 2018 Lilly Amendment: an important into collaboration agreements with Innovent potentially best-in-class in terms of both efficacy amendment to the original 2013 agreement that Biologics (Suzhou) Co. Ltd. (“Innovent”) globally and safety. we believe secures the long-term commercial and Genor Biopharma Co. Ltd. (“Genor”) in China potential fruquintinib. Chi-Med will pay the full to explore fruquintinib in combination with their • China NDA – approval and launch: received cost
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