BeOne Medicines Ltd. 10-K/A

bgne-20231231 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K/A Amendment No. 1 (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31 , 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-37686 BEIGENE, LTD. (Exact Name of Registrant as Specified in its Charter) Cayman Islands 98-1209416 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) c/o Mourant Governance Services (Cayman) Limited 94 Solaris Avenue, Camana Bay Grand Cayman Cayman Islands KY1-1108 (Address of principal executive offices, including zip code) +1 ( 345 ) 949 4123 (Registrant’s Telephone Number, Including Area Code) Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading Symbol(s) Name of each exchange on which registered American Depositary Shares, each representing 13 Ordinary Shares, par value $0.0001 per share ONC The NASDAQ Global Select Market Ordinary Shares, par value $0.0001 per share* 06160 The Stock Exchange of Hong Kong Limited *Included in connection with the registration of the American Depositary Shares (“ADSs”) with the U.S. Securities and Exchange Commission. The ordinary shares are not listed for trading in the United States but are listed for trading on The Stock Exchange of Hong Kong Limited (“HKEx”) . Securities registered pursuant to Section 12(g) of the Act: The RMB shares are ordinary shares of the registrant issued to permitted investors in the People’s Republic of China and listed and traded on the STAR Market in Renminbi. The RMB shares are not listed for trading in the United States or on the HKEx and are not fungible with the ordinary shares listed on the HKEx or the ADSs representing the ordinary shares listed on NASDAQ, and in no event will any RMB shares be able to be converted into the ordinary shares listed on the HKEx or the ADSs listed on NASDAQ, or vice versa. Indicate by check mark if the registrant is a well‑known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☒ No ☐ Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Exchange Act. Yes ☐ No ☒ Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S‑T (§ 232.405 of this chapter) during the preceding 12 months (or for such 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, a smaller 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 transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☒ If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☒ Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b‑2 of the Exchange Act). Yes ☐ No ☒ As of June 30, 2023, the last business day of the registrant’s most recently completed second fiscal quarter, the aggregate market value of the ordinary shares, including in the form of ADSs, each representing 13 ordinary shares, held by non‑affiliates of the registrant was approximately $ 10.5 billion, based upon the closing price of the registrant’s ADSs on the NASDAQ Global Select Market on June 30, 2023. As of February 14, 2024, 1,359,513,224 ordinary shares, par value $0.0001 per share, were outstanding, of which 861,019,991 ordinary shares were held in the form of 66,232,307 ADSs, and 115,055,260 were RMB shares. DOCUMENTS INCORPORATED BY REFERENCE Portions of BeiGene, Ltd.’s Proxy Statement for its 2024 Annual General Meeting of Shareholders are incorporated by reference in the Annual Report on Form 10-K in response to Part III. EXPLANATORY NOTE BeiGene, Ltd. (the “Company”) is filing this Amendment No. 1 (this “Amendment”) to its Annual Report on Form 10-K for the year ended December 31, 2023 (“Form 10-K”), filed with the U.S. Securities and Exchange Commission (the “SEC”) on February 26, 2024, to comply with Rule 5-04 of SEC Regulation S-X. The Company has concluded that its restricted net assets of consolidated subsidiaries exceeded 25% of its consolidated net assets for the fiscal years ended December 31, 2023 and 2022. As a result, the Company is filing this Amendment to amend Item 15 of the Form 10-K to include financial statements of the parent company only as a supplemental schedule in accordance with Rule 5-04 of SEC Regulation S-X. The Reports of Independent Registered Public Accounting Firms filed as part of this 10-K/A include these parent-only financial statements. In addition, the Company’s Chief Executive Officer and Chief Financial Officer have provided new certifications dated as of the date of this filing pursuant to Rules 13a-14(a) and 13a-14(b) under the Securities Exchange Act of 1934, as amended. Except as described above, this Amendment does not amend, modify, or otherwise update any other information in the Form 10-K and does not reflect events occurring after the filing of the Form 10-K. Accordingly, this Amendment should be read in conjunction with the Form 10-K and the Company’s other filings made with the SEC subsequent to the filing of the Form 10-K. PART IV Item 15. Exhibits and Financial Statement Schedules The following documents are filed as part of this Amendment: (a) (2) Financial Information of Parent Company - Financial Statements Schedule I for the years ended December 31, 2023, 2022, and 2021. (3) The exhibits filed as part of this Amendment are set forth on the Exhibit Index immediately following the financial schedule. The Exhibit Index is incorporated herein by reference. Report of Independent Registered Public Accounting Firm To the Stockholders and the Board of Directors of BeiGene, Ltd. We have audited the consolidated financial statements of BeiGene, Ltd. (the Company) as of December 31, 2023 and 2022, and for each of the two years in the period ended December 31, 2023, and have issued our report thereon dated February 26, 2024 included elsewhere in the Form 10-K. Our audits of the consolidated financial statements included the financial statement schedule listed in Item 15 of this Form 10-K/A (the “schedule”) as of December 31, 2023 and 2022, and for each of the two years in the period ended December 31, 2023. This schedule is the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s schedule, based on our audits. In our opinion, the schedule presents fairly, in all material respects, the information set forth therein when considered in conjunction with the consolidated financial statements. /s/ Ernst & Young LLP Boston, Massachusetts January 8, 2025 Report of Independent Registered Public Accounting Firm To the Shareholders and the Board of Directors of BeiGene, Ltd. We have audited the consolidated statements of operations, comprehensive loss, cash flows and shareholders’ equity of BeiGene, Ltd. (the Company) for the year ended December 31, 2021, and the related notes (collectively referred to as the “consolidated financial statements”) and have issued our report thereon dated February 28, 2022, except for the effects on the consolidated financial statements of the correction of an error, as to which the date is February 27, 2023, included elsewhere in the Form 10-K. Our audit of the consolidated financial statements included the financial statement schedule listed in Item 15 of this Form 10-K/A (the “schedule”) for the year ended December 31, 2021. This schedule is the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s schedule, based on our audits. In our opinion, the schedule present fairly, in all material respects, the information set forth therein when considered in conjunction with the consolidated financial statements. /s/ Ernst & Young Hua Ming LLP Beijing, The People’s Republic of China January 8, 2025 Schedule I - Condensed Financial Information of Registrant BeiGene, Ltd. Financial Information of Parent Company Condensed Statements of Operations (Amounts in thousands of U.S. Dollars (“$”)) Year Ended December 31, 2023 2022 2021 $ $ $ Operating expenses Research and development 326,560 637,152 472,465 Selling, general and administrative 304,543 228,801 203,971 Total operating expenses 631,103 865,953 676,436 Loss from operations ( 631,103 ) ( 865,953 ) ( 676,436 ) Interest income (expense), net 48,982 39,585 ( 7,709 ) Other expense, net ( 297,856 ) ( 1,173,306 ) ( 773,671 ) Loss before income taxes ( 879,977 ) ( 1,999,674 ) ( 1,457,816 ) Income tax expense 1,731 4,141 — Net loss ( 881,708 ) ( 2,003,815 ) ( 1,457,816 ) BeiGene, Ltd. Financial Information of Parent Company Condensed Statements of Comprehensive Loss (Amounts in thousands of U.S. Dollars (“$”)) Year Ended December 31, 2023 2022 2021 $ $ $ Net loss ( 881,708 ) ( 2,003,815 ) ( 1,457,816 ) Other comprehensive (loss) income, net of tax of nil: Foreign currency translation adjustments ( 25,464 ) ( 90,421 ) 13,714 Pension liability adjustments, net ( 5,611 ) 365 1,865 Unrealized holding gain (loss), net 9,046 ( 5,311 ) ( 4,571 ) Comprehensive loss ( 903,737 ) ( 2,099,182 ) ( 1,446,808 ) BeiGene, Ltd. Financial Information of Parent Company Condensed Balance Sheets (Amounts in thousands of U.S. Dollars (“$”)) As of December 31, 2023 2022 $ $ Assets Current assets: Cash and cash equivalents 723,964 1,742,320 Prepaid expenses and other current assets 785,471 1,354,298 Total current assets 1,509,435 3,096,618 Loans to subsidiaries 2,030,249 2,079,810 Investment in wholly owned subsidiaries 1,207,352 229,634 Other non-current assets 69,361 75,118 Total assets 4,816,397 5,481,180 Liabilities and shareholders’ equity Current liabilities: Accrued expenses and other payables 197,289 619,485 Indebtedness to subsidiaries 362,917 — Short-term debt 547,215 297,868 Total current liabilities 1,107,421 917,353 Other long-term liabilities 171,649 180,472 Total liabilities 1,279,070 1,097,825 Total shareholders’ equity 3,537,327 4,383,355 Total liabilities and shareholders’ equity 4,816,397 5,481,180 BeiGene, Ltd. Financial Information of Parent Company Condensed Statements of Cash Flows (Amounts in thousands of U.S. Dollars (“$”)) Year Ended December 31, 2023 2022 2021 $ $ $ Cash flows from operating activities: Net loss ( 881,708 ) ( 2,003,815 ) ( 1,457,816 ) Adjustments to reconcile net loss to net cash used in operating activities: Acquired in-process research and development 15,000 — 75,000 Amortization of research and development cost share liability ( 55,294 ) ( 96,402 ) ( 112,486 ) Unrealized losses in subsidiaries 237,351 932,071 871,365 Other items, net ( 374,370 ) ( 596,496 ) ( 256,514 ) Changes in operating assets and liabilities: Prepaid expenses and other current assets 30,519 6,671 ( 20,079 ) Accrued expenses and other payables ( 140,126 ) 875,826 236,738 Net cash used in operating activities ( 1,168,628 ) ( 882,145 ) ( 663,792 ) Cash flows from investing activities: Purchases of short-term investments ( 2,075 ) ( 1,485 ) ( 1,943,930 ) Proceeds from sale or maturity of short-term investments 552,000 1,487,028 2,758,381 Purchase of in-process research and development ( 15,000 ) ( 75,000 ) — Investment in subsidiaries ( 883,328 ) ( 2,675,908 ) ( 113,000 ) Other investing activities 188,656 79,004 ( 191,113 ) Net cash (used in) provided by investing activities ( 159,747 ) ( 1,186,361 ) 510,338 Cash flows from financing activities: Proceeds from public offering, net of cost — — 3,442,616 Proceeds from short-term loans 547,842 296,188 246,347 Repayment of short-term loans ( 293,002 ) ( 247,460 ) ( 245,459 ) Proceeds from option exercises and employee share purchase plan 55,712 46,965 92,762 Net cash provided by financing activities 310,552 95,693 3,536,266 Net (decrease) increase in cash, cash equivalents, and restricted cash ( 1,017,823 ) ( 1,972,813 ) 3,382,812 Cash, cash equivalents, and restricted cash, beginning of year 1,742,371 3,715,184 332,372 Cash, cash equivalents, and restricted cash, end of year 724,548 1,742,371 3,715,184 Notes 1. Schedule I has been provided pursuant to the requirements of Rules 12-04(a) and 5-04(c) of Regulation S-X (the “Rules”), which require condensed financial information as to the financial position, changes in financial position and results of operations of a parent company as of the same dates and for the same periods for which audited consolidated financial statements have been presented when the restricted net assets of consolidated subsidiaries exceed 25 percent of consolidated net assets as of the end of the most recently completed fiscal year. 2. The condensed financial information has been prepared using the same accounting policies as set out in the consolidated financial statements. For purposes of this condensed financial information, BeiGene, Ltd. (the “Parent Company”)’s investments in its wholly owned and majority owned subsidiaries are recorded under the equity method of accounting in accordance with ASC 323. 3. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted as allowed under the Rules. These footnote disclosures provide certain supplemental information relating to the operations of the Company and, as such, these statements should be read in conjunction with the notes to the consolidated financial statements in the Form 10-K. 4. As of December 31, 2023, the Parent Company had a remaining capital commitment of $ 8,850 on an equity investment which is expected to be paid from time to time over the investment period. The Parent Company has unconditionally guaranteed the payment and performance of the obligations of BeiGene Switzerland GmbH in accordance with the terms of the global strategic oncology collaboration with Amgen Inc. No amounts have been recognized related to this guarantee. The Parent Company has no other material contingencies, long-term obligations or guarantees not already disclosed in its consolidated financial statements in the Form 10-K. 5. The following table summarizes the Parent Company’s short-term debt obligations as of December 31, 2023 and 2022: Lender Line of Credit Term Maturity Date Interest Rate As of December 31, 2023 2022 $ RMB $ RMB China Merchants Bank $ 380,000 1 -year December 25, 2024 1 300,000 2,129,321 — — China Minsheng Bank $ 150,000 1 -year December 19, 2024 7.3 % 150,000 1,064,660 — — China Minsheng Bank $ 200,000 1 -year October 9, 2023 4.3 % — — 150,000 1,034,554 Shanghai Pudong Development Bank $ 50,000 1 -year February 25, 2023 2.2 % — — 50,000 344,851 HSBC Bank RMB 340,000 1 -year May 3, 2024 2 47,903 340,000 — — Shanghai Pudong Development Bank RMB 700,000 1 -year November 21, 2024 2.9 % 49,312 350,000 — — China Industrial Bank RMB 675,000 1 -year September 18, 2023 2.4 % — — 97,868 675,000 Total short-term debt 547,215 3,883,981 297,868 2,054,405 1. The outstanding borrowings bear floating interest rates benchmarking the Secured Overnight Financing Rate (“SOFR”). The loan interest rate was 7.2 % as of December 31, 2023. 2. The outstanding borrowings bear floating interest rates benchmarking Hong Kong interbank market rate for RMB. The loan interest rate was 4.5 % as of December 31, 2023. Table of Contents Exhibit Index Exhibit No. Exhibit Description Filed/ Furnished Herewith Incorporated by Reference Herein from Form or Schedule Filing Date SEC File/ Reg. Number 23.1 Consent of Ernst & Young LLP X 23.2 Consent of Ernst & Young Hua Ming LLP X 31.1 Certification of Principal Executive Officer pursuant to Rule 13a‑14(a) and Rule 15d‑14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes‑Oxley Act of 2002 X 31.2 Certification of Principal Financial Officer pursuant to Rule 13a‑14(a) and Rule 15d‑14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes‑Oxley Act of 2002 X 32.1* Certification of Principal Executive Officer and Principle Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes‑Oxley Act of 2002 X 101.INS Inline XBRL Instance Document - the instance document does not appear in the interactive data file because its XBRL tags are embedded within the Inline XBRL document 101.SCH Inline XBRL Taxonomy Extension Schema Document X 101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document X 101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document X 101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document X 101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document X 104 Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101.*) X * Furnished herewith. Table of Contents SIGNATURES Pursuant to the requirements of the Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this Amendment to be signed on its behalf by the undersigned, thereunto duly authorized. BEIGENE, LTD. Date: January 8, 2025 By: /s/ JOHN V. OYLER John V. Oyler Chief Executive Officer and Chairman (Principal Executive Officer)