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2019 Annual Report 年度報告 Contents CStone Pharmaceuticals 基石藥業 (Incorporated in the Cayman Islands with limited liability) ( 於開曼群島註冊成立的有限公司 ) Stock Code 股份代號 : 2616 2019 Annual Report 年度報告 Contents Pages Pages CORPORATE INFORMATION 2 CONSOLIDATED STATEMENT OF PROFIT OR LOSS AND FINANCIAL HIGHLIGHTS 3 OTHER COMPREHENSIVE INCOME 77 BUSINESS HIGHLIGHTS 5 CONSOLIDATED STATEMENT OF FINANCIAL POSITION 79 CHAIRMAN’S STATEMENT 7 CONSOLIDATED STATEMENT OF MANAGEMENT DISCUSSION AND ANALYSIS 9 CHANGES IN EQUITY 81 DIRECTORS AND SENIOR MANAGEMENT 22 CONSOLIDATED STATEMENT OF CASH FLOWS 83 REPORT OF THE DIRECTORS 32 NOTES TO THE CONSOLIDATED CORPORATE GOVERNANCE REPORT 58 FINANCIAL STATEMENTS 85 INDEPENDENT AUDITOR’S REPORT 72 DEFINITIONS 159 Corporate Information BOARD OF DIRECTORS PRINCIPAL PLACE OF BUSINESS IN HONG KONG Executive Director 40th Floor, Sunlight Tower No. 248 Queen’s Road East Dr. Frank Ningjun Jiang Wanchai (Chairman and Chief Executive Officer) Hong Kong Non-executive Directors PRINCIPAL SHARE REGISTRAR Dr. Wei Li Walkers Corporate Limited Mr. Qun Zhao Cayman Corporate Centre Mr. Yanling Cao 27 Hospital Road Mr. Guobin Zhang George Town Dr. Lian Yong Chen Grand Cayman KY1-9008 Cayman Islands Independent Non-executive Directors HONG KONG SHARE REGISTRAR Dr. Paul Herbert Chew Mr. Ting Yuk Anthony Wu Computershare Hong Kong Investor Services Limited Mr. Hongbin Sun Shops 1712–1716 17th Floor Hopewell Centre AUDIT COMMITTEE 183 Queen’s Road East Wanchai Mr. Hongbin Sun (Chairman) Hong Kong Dr. Paul Herbert Chew Mr. Ting Yuk Anthony Wu HONG KONG LEGAL ADVISER COMPENSATION COMMITTEE Davis Polk & Wardwell 18/F, The Hong Kong Club Building Mr. Ting Yuk Anthony Wu (Chairman) 3A Chater Road Dr. Wei Li Hong Kong Dr. Paul Herbert Chew COMPLIANCE ADVISOR NOMINATION COMMITTEE Somerley Capital Limited Dr. Frank Ningjun Jiang (Chairman) 20/F China Building Mr. Yanling Cao 29 Queen’s Road Central Dr. Paul Herbert Chew Hong Kong Mr. Ting Yuk Anthony Wu Mr. Hongbin Sun PRINCIPAL BANKERS STRATEGY COMMITTEE Bank of China (Hong Kong) Limited, Hong Kong Bank of China Tower Dr. Frank Ningjun Jiang (Chairman) 1 Garden Road Dr. Lian Yong Chen Central, Hong Kong Dr. Paul Herbert Chew China Construction Bank AUTHORIZED REPRESENTATIVES Industrial Park of Suzhou Branch Dr. Frank Ningjun Jiang No.1133 Dong Huan Road Ms. Yeung Ching Man Suzhou PRC COMPANY SECRETARY AUDITOR Ms. Yeung Ching Man Deloitte Touche Tohmatsu REGISTERED OFFICE Registered Public Interest Entity Auditors 35/F One Pacific Place The offices of Vistra (Cayman) Limited 88 Queensway Admiralty P.O. Box 31119, Grand Pavilion Hong Kong Hibiscus Way 802 West Bay Road STOCK CODE Grand Cayman KY1-1205 2616 Cayman Islands HEAD OFFICE AND PRINCIPAL PLACE OF COMPANY WEBSITE BUSINESS IN CHINA www.cstonepharma.com 1000 Zhangheng Road KEY DATE Building 25 Pudong New District Annual General Meeting Shanghai, 201203 June 23, 2020 PRC 2 CSTONE PHARMACEUTICALS Financial Highlights NON-INTERNATIONAL FINANCIAL REPORTING STANDARDS (“NON-IFRS”) MEASURES: The research and development expenses excluding the share-based payment expenses increased by RMB461.8 million from RMB726.9 million for the year ended December 31, 2018 to RMB1,188.7 million for the year ended December 31, 2019, primarily attributable to additional trials which increased clinical development costs. The administrative expenses excluding the share-based payment expenses increased by RMB58.3 million from RMB79.3 million for the year ended December 31, 2018 to RMB137.6 million for the year ended December 31, 2019, primarily attributable to increase in employee costs. The loss excluding the effect of the fair value changes of the conversion feature of preferred shares and share-based payment expenses increased by RMB468.7 million from RMB672.6 million for the year ended December 31, 2018 to RMB1,141.3 million for the year ended December 31, 2019, primarily due to increase in research and development expenses and administrative expenses, partially offset by increase in interest income. International Financial Reporting Standards (“IFRS”) Numbers: • Other income increased by RMB63.5 million from RMB20.5 million for the year ended December 31, 2018 to RMB84.0 million for the year ended December 31, 2019, primarily attributable to increase in interest income from bank deposits and time deposits. • Other gains and losses decreased by RMB104.6 million from losses of RMB742.0 million for the year ended December 31, 2018 to losses of RMB637.4 million for the year ended December 31, 2019, primarily attributable to a narrowed loss on fair value changes of derivative financial liabilities, which was a non-cash, one-time adjustment upon the Listing as required under the IFRS. • Research and development expenses increased by RMB545.4 million from RMB850.2 million for the year ended December 31, 2018 to RMB1,395.6 million for the year ended December 31, 2019, primarily attributable to additional trials which increased clinical development costs. • Administrative expenses increased by RMB150.5 million from RMB191.0 million for the year ended December 31, 2018 to RMB341.5 million for the year ended December 31, 2019, primarily attributable to increase in employee costs. • As a result of the above factors, the loss for the year increased by RMB515.3 million from RMB1,793.1 million for the year ended December 31, 2018 to RMB2,308.4 million for the year ended December 31, 2019, primarily due to increase in research and development expenses and administrative expenses, partially offset by increase in interest income. ANNUAL REPORT 2019 3 Financial Highlights As at December 31/year ended December 31 2019 2018 2017 2016 RMB’000 RMB’000 RMB’000 RMB’000 Non-IFRS measures Research and development expenses excluding the share-based payment expenses (1,188,743) (726,930) (196,497) (242,187) Administrative expenses excluding the share-based payment expenses (137,640) (79,296) (28,191) (10,616) Loss for the year excluding the non-IFRS adjustments (1,141,263) (672,598) (234,526) (237,470) IFRS measures Other income 83,962 20,497 13,954 187 Other gains and losses (637,365) (741,979) (103,665) 9,185 Research and development expenses (1,395,624) (850,197) (213,441) (247,121) Administrative expenses (341,476) (190,991) (39,335) (15,050) Listing expenses (17,638) (30,459) – – Finance costs (303) – (60) (240) Loss for the year (2,308,444) (1,793,129) (342,547) (253,039) Loss per share Basic and diluted (RMB Yuan) (2.39) (2.79) (0.67) (0.89) Cash and cash equivalents and time deposits 2,725,867 1,462,552 83,390 59,539 Total assets 2,950,645 1,632,118 564,280 826,139 Total liabilities 469,063 1,116,787 113,228 59,184 Total equity 2,481,582 515,331 451,052 766,955 4 CSTONE PHARMACEUTICALS Business Highlights On February 26, 2019, the Company was successfully listed on the Stock Exchange. Over the past year, significant advancement has been made with respect to our product pipeline and business operations: LATE-STAGE ASSETS: • CS1001 (PD-L1 antibody) – In 2019, we have made notable progress to advance our lead IO asset CS1001 in the clinic, qualifying it as a promising anti-PD-L1 with unique advantage and significant differentiation. Data presented at three major congresses (Chinese Society of Clinical Oncology (“CSCO”), European Society for Medical Oncology (“ESMO”), and The American Society of Hematology (“ASH”)) have demonstrated that CS1001 is safe and efficacious in multiple solid tumors and lymphomas, including esophageal, gastric, cholangiocarcinoma/gall bladder, and microsatellite instability-high (“MSI-H”)/mismatch repair deficient (“dMMR”) cancer, as well as natural killer T-cell lymphoma (“NKTL”). Its outstanding activity in esophageal cancer and NKTL in particular reveals the potential of CS1001 as a best-in-class drug candidate. Based on these proof-of-concept data, we have initiated two additional registrational trials of CS1001 in China for patients with advanced gastric cancer and esophageal cancer, and dosed the first patient in April 2019 and December 2019, respectively. Together with the four initiated in 2018 (Stage III non-small cell lung cancer (“NSCLC”), stage IV NSCLC, NKTL and classical Hodgkin lymphoma (“cHL”)), we are currently conducting six registrational trials for CS1001. We expect top-line results of the Phase III trial of CS1001 in combination with standard-of-care chemotherapies in patients with first-line Stage IV squamous or non- squamous NSCLC to be available in the second half of 2020. Furthermore, we plan to consult with CDE on our cHL and NKTL regulatory strategy and expect to submit an NDA in China for cHL and potentially also NKTL in the second half of 2020. • CS1003 (PD-1 antibody) – Preliminary data of the Phase Ia study of CS1003 monotherapy were presented at the CSCO 2019 annual meeting, which showed that CS1003 was safe and tolerable. Anti- tumor activity of CS1003 was observed in multiple tumor types. We have initiated a global Phase III trial of CS1003 in combination with LENVIMA® (lenvatinib), a standard-of-care tyrosine kinase inhibitor (“TKI”) in patients with advanced HCC and dosed the first patient in December 2019. • Ivosidenib (CS3010) – In May 2019, an NDA for the isocitrate dehydrogenase-1 inhibitor TIBSOVO® (ivosidenib) has been submitted to the Taiwan Food and Drug Administration (“TFDA”) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (“R/R AML”) containing an isocitrate dehydrogenase-1 mutation (“IDH1m”); marketing approval is expected in 2020. Two registrational trials in IDH1m AML are ongoing in China: one in IDH1m R/R AML, anticipating trial completion in 2020 and NDA submission in China by the first half of 2021; and another in newly diagnosed IDH1m AML patients who are not eligible for intensive therapy. • Avapritinib (CS3007) – On January 9, 2020, the KIT/PDGFRA inhibitor AYVAKITTM (avapritinib) received U.S. FDA approval for the treatment of adults with unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations.
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