百济神州 2023年季度报告

☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF1934 *Included in connection with the registration of the American Depositary Shares with the Securities and ExchangeCommission. The ordinary shares are not listed for trading in the United States but are listed for trading on The StockExchange of Hong Kong Limited. As of July 31, 2023, 1,376,270,056 ordinary shares, par value $0.0001 per share, were outstanding, of which871,565,851 ordinary shares were held in the form of 67,043,527 American Depositary Shares, each representing 13ordinary shares, and 115,055,260 were RMB shares. Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of theSecurities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant wasrequired to file such reports); and (2) has been subject to such filing requirements for the past 90days.Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to besubmitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or forsuch shorter period that the registrant was required to submit such files).Yes☒No☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, asmaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,”“accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. Large accelerated filer☒Accelerated filer☐Non-accelerated filer☐Smaller reporting company☐Emerging growth company☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transitionperiod for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of theExchange Act.☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).Yes☐No☒ Table of Contents BeiGene, Ltd.Quarterly Report on Form 10-QTABLE OF CONTENTS Page PART I.FINANCIAL INFORMATION3Item 1.Financial Statements3Item 2.Management’s Discussion and Analysis of Financial Condition and Resultsof Operations31Item 3.Quantitative and Qualitative Disclosures about Market Risk48Item 4.Controls and Procedures49PART II.OTHER INFORMATION51Item 1.Legal Proceedings51Item 1A.Risk Factors51Item 2.Unregistered Sales of Equity Securities and Use of Proceeds110Item 3.Defaults Upon Senior Securities110 Item 4.Mine Safety Disclosures110Item 5.Other Information110Item 6.Exhibits111SIGNATURES114 PART I.FINANCIAL INFORMATION BEIGENE, LTD.CONDENSED CONSOLIDATED BALANCE SHEETS(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)As ofJune 30,December 31,Note20232022$$(unaudited)(audited) Table of Contents The accompanying notes are an integral part of these condensed consolidated financialstatements.4 The accompanying notes are an integral part of these condensed consolidated financialstatements.5 Table of Contents BEIGENE, LTD.CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS(Amounts in thousands of U.S. Dollars (“$”))(Unaudited) The accompanying notes are an integral part of these condensed consolidated financial statements.7 Table of Contents BEIGENE, LTD. NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”), except for number of sharesand per share data) (Unaudited) 1. Description of Business, Basis of Presentation and Consolidation and Significant AccountingPolicies Description of business BeiGene, Ltd. (the “Company”, “BeiGene”, “it”, “its”) is a global biotechnology company that isdiscovering and developing innovative oncology treatments that are more accessible and affordable tocancer patients worldwide. The Company currently has three approved medicines that were internally discovered and developed,including BRUKINSA®, a small molecule inhibitor of Bruton’s Tyrosine Kinase for the treatment ofvarious blood cancers; tislelizumab, an anti-PD-1 antibody immunotherapy for the treatment of varioussolid tumor and blood cancers; and pamiparib, a selective small molecule inhibitor of PARP1 and PARP2.The Company has obtained approvals to market BRUKINSA in the United States, the People's Republic ofChina (“China” or the “PRC”), the European Union, the United Kingdom, Canada, Australia and additionalinternational markets, and tislelizumab and pamiparib in China. By leveraging its strong commercialcapabilities, the Company has in-licensed the rights to distribute an additional 14 approved medicines forthe China market. Supported by its global clinical development and commercial capabilities, the Company has entered into collaborations with world-leading biopharmaceutical companies such as Amgen Inc.(