百济神州 2024年季度报告

☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF1934 For the quarterly period ended June 30, 2024OR BEIGENE, LTD. (Exact name of registrant as specified in its charter) *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 August 2, 2024, 1,379,529,263 ordinary shares, par value $0.0001 per share, were outstanding, of which 890,252,363 ordinary shares were held in the form of 68,480,951 American Depositary Shares, each representing 13ordinary shares, and 115,055,260 were RMB shares which are ordinary shares issued to permitted investors in Chinaand listed on the Science and Technology Innovation Board of the Shanghai Stock Exchange in Renminbi. 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 Operations26Item 3.Quantitative and Qualitative Disclosures about Market Risk39Item 4.Controls and Procedures40PART II.OTHER INFORMATION41Item 1.Legal Proceedings41Item 1A.Risk Factors41Item 2.Unregistered Sales of Equity Securities, Use of Proceeds and IssuerPurchases of Equity Securities93Item 3.Defaults Upon Senior Securities93 Item 4.Mine Safety Disclosures93Item 5.Other Information93Item 6.Exhibits93SIGNATURES96 PART I.FINANCIAL INFORMATION The accompanying notes are an integral part of these condensed consolidated financialstatements.3 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 financialstatements.6 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 oncology company discovering anddeveloping innovative treatments that are more accessible and affordable to cancer patients worldwide. The Company currently has three approved medicines that were internally discovered and developed,including BRUKINSA®(zanubrutinib), a small molecule inhibitor of Bruton’s Tyrosine Kinase (“BTK”)for the treatment of various blood cancers; TEVIMBRA®(tislelizumab), an anti-PD-1 antibody immunotherapy for the treatment of various solid tumor and blood cancers; and PARTRUVIX®(pamiparib), a selective small molecule inhibitor of PARP1 and PARP2. The Company marketsBRUKINSA in the United States (“U.S.”), the People’s Republic of China (“China” or the “PRC”), theEuropean Union (“EU”), the United Kingdom (“UK”), Canada, Australia, and additional internationalmarkets; TEVIMBRA (tislelizumab) in the U.S., EU and China; and PARTRUVIX in China. By leveragingits strong commercial capabilities, the Company has in-licensed the rights to distribute additional approvedmedicines for the China market. Supported by its global clinical deve