NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”), except for number of shares and per share data)
(Unaudited)
1. Description of Business, Basis of Presentation and Consolidation and Significant Accounting Policies
Description of business
BeiGene, Ltd. (the “Company”, “BeiGene”, “it”, “its”) is a global oncology company discovering and developing 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 markets BRUKINSA in the United States (“U.S.”), the People’s Republic of China (“China” or the “PRC”), the European Union (“EU”), the United Kingdom (“UK”), Canada, Australia, and additional international markets; TEVIMBRA (tislelizumab) in the U.S., EU and China; and PARTRUVIX in China. By leveraging its strong commercial capabilities, the Company has in-licensed the rights to distribute additional approved medicines for the 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. (“Amgen”) and Beijing Novartis Pharma Co., Ltd. (“Novartis”) to develop and commercialize innovative medicines.
Basis of presentation and consolidation
The accompanying condensed consolidated balance sheet as of September 30, 2024, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2024 and 2023, the condensed consolidated statements of cash flows for the nine months ended September 30, 2024 and 2023, and the condensed consolidated statements of shareholders’ equity for the three and nine months ended September 30, 2024 and 2023, and the related footnote disclosures are unaudited. The accompanying unaudited interim condensed financial statements were prepared in accordance with U.S. generally accepted accounting principles (“GAAP”), including guidance with respect to interim financial information and in conformity with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for annual financial statements. These financial statements should be read in conjunction with the consolidated financial statements and related footnotes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 (the “Annual Report”).
The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all normal recurring adjustments, necessary to present a fair statement of the results for the interim periods presented. Results of operations for the three and nine months ended September 30, 2024 are not necessarily indicative of the results expected for the full fiscal year or for any future annual or interim period.
The unaudited interim condensed consolidated financial statements include the financial statements of the Company and its subsidiaries. All significant intercompany transactions and balances between the Company and its subsidiaries are eliminated upon consolidation.
Use of estimates
The preparation of the consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the period. Areas where management uses subjective judgment include, but are not limited to, estimating the useful lives of long-lived assets, estimating variable consideration in product sales and collaboration revenue arrangements, identifying separate accounting units and determining the standalone selling price of each performance obligation in the Company’s revenue arrangements, assessing the impairment of long-lived assets, valuation and recognition of share-based compensation expenses, realizability of deferred tax assets, estimating uncertain tax positions, valuation of inventory, estimating the allowance for credit losses, determining defined benefit pension plan obligations, measurement of right-of-use assets and lease liabilities and the fair value of financial instruments. Management bases the estimates on historical experience, known trends and various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities and reported amounts of revenues and expenses. Actual results could differ from these estimates.
Recent accounting pronouncements
New accounting standards which have not yet been adopted
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which amended ASC 280. This update requires disclosure of incremental segment information on an annual and interim basis. This update is effective for annual periods beginning after December 15, 2023, and interim periods within annual periods beginning after December 15, 2024. Early adoption is permitted. This guidance should be applied retrospectively to all prior periods presented in the financial statements. The Company operates in one segment: pharmaceutical products. Its chief operating decision maker is the Chief Executive Officer, who makes operating decisions, assesses performance, and allocates resources on a consolidated basis. Single reportable segment entities are required to comply with all ASC 280 disclosure requirements. The Company will disclose descriptive information as required under ASC 280 and reference the consolidated financial statements in the segment and geographic information footnote for annual periods beginning January 1, 2024 and interim periods beginning January 1, 2025.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This update requires that public entities on an annual basis, (1) in the rate reconciliation, disclose specific categories and provide additional information for reconciling items that meet a quantitative threshold; (2) about income taxes paid, disclose the amount of income taxes paid (net of refunds received) disaggregated by federal, state, and foreign taxes and by individual jurisdiction in which income taxes paid (net of refunds received) is equal to or greater than 5 percent of total income taxes paid (net of refunds received); and (3) disclose income (or loss) from continuing operations before income tax expense (or benefit) disaggregated between domestic and foreign and income tax expense (or benefit) disaggregated by federal, state, and foreign. This update is effective for annual periods beginning after December 15, 2024. Early adoption is permitted. This guidance should be applied on a prospective basis. Retrospective application is permitted. The Company is currently evaluating the impact on its financial statements of adopting this guidance.
Significant accounting policies
For a more complete discussion of the Company’s significant accounting policies and other information, the unaudited interim condensed consolidated financial statements and notes thereto should be read in conjunction with the consolidated financial statements included in the Company’s Annual Report for the year ended December 31, 2023.
There have been no material changes to the Company’s significant accounting policies as of and for the nine months ended September 30, 2024, as compared to the significant accounting policies described in the Annual Report.
2. Fair Value Measurements
The Company measures certain financial assets and liabilities at fair value. Fair value is determined based upon the exit price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants, as determined by either the principal market or the most advantageous market. Inputs used in the valuation techniques to derive fair values are classified based on a three-level hierarchy, as follows:
Level 1 – Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets.
Level 2 – Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities; quoted prices in markets with insufficient volume or infrequent transactions (less active markets); or model-derived valuations in which all significant inputs are observable or can be derived principally from or corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the asset or liability.
The Company considers an active market to be one in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis, and considers an inactive market to be one in which there are infrequent or few transactions for the asset or liability, the prices are not current, or price quotations vary substantially either over time or among market makers.
The following tables present the Company’s financial assets and liabilities measured and recorded at fair value on a recurring basis using the above input categories as of September 30, 2024 and December 31, 2023:
| | | | | | | | | | | | | | | | | | | | |
| | Quoted Price in Active Market for Identical Assets | | Significant Other Observable Inputs | | Significant Unobservable Inputs |
As of September 30, 2024 | | (Level 1) | | (Level 2) | | (Level 3) |
| | $ | | $ | | $ |
Cash equivalents | | | | | | |
Money market funds | | 966,088 | | | — | | | — | |
| | | | | | |
| | | | | | |
Prepaid expenses and other current assets: | | | | | | |
Convertible debt instrument | | — | | | — | | | 3,170 | |
Other non-current assets (Note 4): | | | | | | |
Equity securities with readily determinable fair values | | 1,889 | | | 160 | | | — | |
Convertible debt instrument | | — | | | — | | | 4,995 | |
Total | | 967,977 | | | 160 | | | 8,165 | |
| | | | | | | | | | | | | | | | | | | | |
| | Quoted Price in Active Market for Identical Assets | | Significant Other Observable Inputs | | Significant Unobservable Inputs |
As of December 31, 2023 | | (Level 1) | | (Level 2) | | (Level 3) |
| | $ | | $ | | $ |
Cash equivalents | | | | | | |
| | | | | | |
Money market funds | | 1,052,149 | | | — | | | — | |
| | | | | | |
| | | | | | |
Prepaid expenses and other current assets: | | | | | | |
U.S. Treasury securities | | 2,600 | | | — | | | — | |
Convertible debt instrument | | — | | | — | | | 4,668 | |
Other non-current assets (Note 4): | | | | | | |
Equity securities with readily determinable fair values | | 3,046 | | | 542 | | | — | |
Convertible debt instrument | | — | | | — | | | 4,215 | |
Total | | 1,057,795 | | | 542 | | | 8,883 | |
The Company’s cash equivalents are highly liquid investments with original maturities of 3 months or less. The Company’s investments in available-for-sale debt securities include U.S. Treasury securities. The Company determines the fair value of cash equivalents and available-for-sale debt securities using a market approach based on quoted prices in active markets.
The Company’s equity securities carried at fair value consist of holdings in common stock and warrants to purchase additional shares of common stock of Leap Therapeutics, Inc. (“Leap”), a publicly-traded biotechnology company. The common stock investment is measured and carried at fair value and classified as a Level 1 investment. The warrants to purchase additional shares of common stock are measured using the Black-Scholes option-pricing valuation model and classified as a Level 2 investment. Refer to Note 4, Restricted Cash and Investments for details of the determination of the carrying amount of private equity investments without readily determinable fair values and equity method investments.
The Company holds convertible notes issued by private biotech companies. The Company elected the fair value option method of accounting for the convertible notes. Accordingly, the convertible notes are remeasured at fair value on a recurring basis using Level 3 inputs, with any changes in the fair value option recorded in other income, net. The Company recorded losses on fair value adjustment of $1,802 and $1,664 for the three and nine months ended September 30, 2024, respectively.
As of September 30, 2024 and December 31, 2023, the Company held time deposits of $15,000 and $42,852 that were classified as cash equivalents, respectively. As of September 30, 2024 and December 31, 2023, the fair values of cash and cash equivalents, restricted cash, accounts receivable, accounts payable, and short-term debt approximated their carrying values due to their short-term nature. Long-term bank loans approximate their fair value due to the fact that the related interest rates approximate the rates currently offered by financial institutions for similar debt instrument of comparable maturities.
3. Collaborative and Licensing Arrangements
The Company has entered into collaborative arrangements for the research and development, manufacture and/or commercialization of medicines and drug candidates. To date, these collaborative arrangements have included out-licenses of and options to out-license internally developed products and drug candidates to other parties, in-licenses of products and drug candidates from other parties, and profit- and cost-sharing arrangements. These arrangements may include non-refundable upfront payments, contingent obligations for potential development, regulatory and commercial performance milestone payments, cost-sharing and reimbursement arrangements, royalty payments, and profit sharing. For detailed descriptions of each arrangement, see the Company’s Form 10-K for the year ended December 31, 2023 filed with the U.S. Securities and Exchange Commission on February 26, 2024.
Out-Licensing Arrangements
For the three and nine months ended September 30, 2024, the Company’s collaboration revenue consisted primarily of revenue generated under the Novartis broad markets agreement. For the three and nine months ended September 30, 2023, the Company’s collaboration revenue primarily consisted of the recognition of previously deferred revenue from its former collaboration agreements with Novartis for tislelizumab and ociperlimab.
The following table summarizes total collaboration revenue recognized for the three and nine months ended September 30, 2024 and 2023:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended | | Nine Months Ended |
| | September 30, | | September 30, |
| | 2024 | | 2023 | | 2024 | | 2023 |
Revenue from Collaborators | | $ | | $ | | $ | | $ |
| | | | | | | | |
Research and development service revenue | | — | | 59,052 | | | — | | | 79,432 | |
Right to access intellectual property revenue | | — | | 51,978 | | | — | | | 104,475 | |
Material rights revenue | | — | | 71,980 | | | — | | | 71,980 | |
Other | | 8,152 | | 3,008 | | | 20,906 | | 9,157 | |
Total | | 8,152 | | 186,018 | | | 20,906 | | 265,044 | |
Novartis
Tislelizumab Collaboration and License
In September 2023, the Company and Novartis agreed to mutually terminate the tislelizumab collaboration and license agreement. Pursuant to the termination agreement, the Company regained full, global rights to develop, manufacture and commercialize tislelizumab with no royalty payments due to Novartis. Novartis may continue its ongoing clinical trials and has the ability to conduct future combination trials with tislelizumab subject to BeiGene’s approval. BeiGene agreed to provide Novartis with ongoing clinical supply of tislelizumab to support its clinical trials. Pursuant to the termination agreement, Novartis agreed to provide transition services to the Company to enable key aspects of the tislelizumab development and commercialization plan to proceed without disruption, including manufacturing, regulatory, safety and clinical support. Upon termination of the agreement in September 2023, there were no further performance obligations, and the remaining deferred revenue balance associated with the tislelizumab R&D services was recognized in full.
Ociperlimab Option, Collaboration and License Agreement and China Broad Market Development Agreement
In July 2023, the Company and Novartis mutually agreed to terminate the ociperlimab option, collaboration and license agreement. Pursuant to the termination agreement, the Company regained full, global rights to develop, manufacture and commercialize ociperlimab. Upon termination the Company had no further performance obligations under the collaboration, and all remaining deferred revenue balances were recognized in full. The China broad markets agreement remains in place.
The following table summarizes collaboration revenue recognized in connection with the China broad markets agreement for the three and nine months ended September 30, 2024 and the terminated ociperlimab option, collaboration and license agreement for the three and nine months ended September 30, 2023:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended | | Nine Months Ended |
| | September 30, | | September 30, |
| | 2024 | | 2023 | | 2024 | | 2023 |
| | $ | | $ | | $ | | $ |
| | | | | | | | |
Research and development service revenue | | — | | 3,569 | | | — | | | 7,153 | |
Right to access intellectual property revenue | | — | | 51,978 | | | — | | | 104,475 | |
Material rights revenue | | — | | 71,980 | | | | | 71,980 | |
China broad markets agreement | | 5,154 | | 2,954 | | | 13,655 | | | 5,590 | |
Total | | 5,154 | | 130,481 | | | 13,655 | | | 189,198 | |
In-Licensing Arrangements - Commercial
Amgen
During the three and nine months ended September 30, 2024 and 2023, the Company recorded the following amounts related to its collaboration arrangement with Amgen. For a detailed description of the arrangement and related rights and obligation, see the Company’s Form 10-K for the year ended December 31, 2023 filed on February 26, 2024.
Amounts recorded related to the Company’s portion of the co-development funding on the pipeline assets for the three and nine months ended September 30, 2024 and 2023 were as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended | | Nine Months Ended |
| | September 30, | | September 30, |
| | 2024 | | 2023 | | 2024 | | 2023 |
| | $ | | $ | | $ | | $ |
Research and development expense | | 17,015 | | | 16,321 | | | 52,981 | | | 39,595 | |
Amortization of research and development cost share liability | | 16,575 | | | 15,900 | | | 51,614 | | | 38,569 | |
Total amount due to Amgen for BeiGene’s portion of the development funding | | 33,590 | | | 32,221 | | | 104,595 | | | 78,164 | |
| | | | | | | | |
| | | | | | | | As of |
| | | | | | | | September 30, 2024 |
| | | | | | | | $ |
Remaining portion of development funding cap | | | | | | 379,057 | |
As of September 30, 2024 and December 31, 2023, the research and development cost share liability recorded in the Company’s balance sheet was as follows:
| | | | | | | | | | | | | | | | |
| As of | | | |
| September 30, | | December 31, | | | |
| 2024 | | 2023 | | | | | |
| $ | | $ | | | | | |
Research and development cost share liability, current portion | 104,067 | | | 68,004 | | | | | | |
Research and development cost share liability, non-current portion | 82,985 | | | 170,662 | | | | | | |
Total research and development cost share liability | 187,052 | | | 238,666 | | | | | | |
The total reimbursement paid under the commercial profit-sharing agreement for product sales is classified in the income statement for the three and nine months ended September 30, 2024 and 2023 as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended | | Nine Months Ended |
| | September 30, | | September 30, |
| | 2024 | | 2023 | | 2024 | | 2023 |
| | $ | | $ | | $ | | $ |
Cost of sales - product | | 10,278 | | | 3,159 | | | 28,437 | | | 4,343 | |
Research and development | | (269) | | | 431 | | | (1,413) | | | 1,743 | |
Selling, general and administrative | | (21,641) | | | (14,679) | | | (60,894) | | | (44,067) | |
Total | | (11,632) | | | (11,089) | | | (33,870) | | | (37,981) | |
The Company purchases commercial inventory from Amgen to distribute in China. Inventory purchases amounted to $43,061 and $152,940 during the three and nine months ended September 30, 2024, respectively, and $18,746 and $58,023 during the three and nine months ended September 30, 2023, respectively. Net amounts payable to Amgen was $89,482 and $55,474 as of September 30, 2024 and December 31, 2023, respectively.
In-Licensing Arrangements - Development
The Company has in-licensed the rights to develop, manufacture and, if approved, commercialize multiple development stage drug candidates globally or in specific territories. These arrangements typically include non-refundable upfront payments, contingent obligations for potential development, regulatory and commercial performance milestone payments, cost-sharing arrangements, royalty payments, and profit sharing.
Upfront and milestone payments incurred under these arrangements for the three and nine months ended September 30, 2024 and 2023 are set forth below. All upfront and development milestones were expensed to research and development expense. All regulatory and commercial milestones were capitalized as intangible assets and are being amortized over the remainder of the respective product patent or term of the commercialization agreements.
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | Three Months Ended | | Nine Months Ended |
| | | September 30, | | September 30, |
| | | 2024 | | 2023 | | 2024 | | 2023 |
Payments due to collaboration partners | Classification | | $ | | $ | | $ | | $ |
Upfront payments | Research and development expense | | — | | | 15,000 | | | 27 | | | 15,000 | |
Development milestones incurred | Research and development expense | | 5,000 | | | — | | | 51,500 | | | — | |
Regulatory and commercial milestone payments | Intangible asset | | — | | | 9,379 | | | — | | | 18,612 | |
Total | | | 5,000 | | | 24,379 | | | 51,527 | | | 33,612 | |
4. Restricted Cash and Investments
Restricted Cash
The Company’s restricted cash primarily consists of RMB-denominated cash deposits held in designated bank accounts for collateral for letters of credit. The Company classifies restricted cash as current or non-current based on the term of the restriction. Restricted cash as of September 30, 2024 and December 31, 2023 was as follows:
| | | | | | | | | | | | | | |
| | As of |
| | September 30, | | December 31, |
| | 2024 | | 2023 |
| | $ | | $ |
Short-term restricted cash | | 9,284 | | | 11,473 | |
Long-term restricted cash | | 2,211 | | | 2,711 | |
Total | | 11,495 | | | 14,184 | |
In addition to the restricted cash balances above, the Company is required by the PRC securities law to use the proceeds from its offering on the STAR Market of the Shanghai Stock Exchange (the “STAR Offering”) in strict compliance with the planned uses as disclosed in the PRC prospectus as well as those disclosed in the Company’s proceeds management policy approved by the board of directors. As of September 30, 2024, the Company had cash remaining related to the STAR Offering proceeds of $787,147.
Investments in Equity Securities
The following table summarizes the Company’s investments in equity securities:
| | | | | | | | | | | | | | |
| | As of |
| | September 30, | | December 31, |
| | 2024 | | 2023 |
| | $ | | $ |
Equity securities with readily determinable fair values 1 | | | | |
Fair value of Leap common stock | | 1,889 | | | 3,046 | |
Fair value of Leap warrants | | 160 | | | 542 | |
Equity securities without readily determinable fair values | | | | |
Pi Health, Inc. 2 | | 40,798 | | | — | |
Other | | 55,159 | | | 55,860 | |
Equity-method investments | | 35,233 | | | 25,981 | |
Total | | 133,239 | | | 85,429 | |
1 Represents common stock and warrants to purchase additional shares of common stock of Leap Therapeutics, Inc. (“Leap”). The Company measures the investment in the common stock and warrants at fair value, with changes in fair value recorded to other income, net.
2 In the first quarter of 2024, the Company divested the net assets comprising substantially all of its Pi Health business with a carrying value of $38,063. The consideration received for the divestiture consisted of preferred stock in a newly formed entity, Pi Health, Inc., with a fair value of $40,798 and cash consideration of $1,000. The transaction resulted in a pre-tax gain of $3,735 recorded within other income, net during the nine months ended September 30, 2024. The Company will account for its investment prospectively as a private equity security without a readily determinable fair value and the divestiture is not treated as a discontinued operation in the Statement of Operations and therefore the historical results of operations of the Pi Health business will remain in the Company’s continuing operations.
The following table summarizes unrealized (losses) gains related to investments in equity securities recorded in other income, net for the three and nine months ended September 30, 2024 and 2023:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended | | Nine Months Ended |
| | September 30, | | September 30, |
| | 2024 | | 2023 | | 2024 | | 2023 |
| | $ | | $ | | $ | | $ |
| | | | | | | | |
Equity securities with readily determinable fair values | | 494 | | | (2,291) | | | (1,539) | | | (2,927) | |
Equity securities without readily determinable fair values | | — | | | (5,522) | | | (797) | | | (4,441) | |
Equity-method investments | | (2,936) | | | (2,675) | | | (7,809) | | | (5,299) | |
5. Inventories, Net
The Company’s inventories, net consisted of the following:
| | | | | | | | | | | | | | |
| | As of |
| | September 30, | | December 31, |
| | 2024 | | 2023 |
| | $ | | $ |
Raw materials | | 147,297 | | | 148,772 | |
Work in process | | 61,985 | | | 39,098 | |
Finished goods | | 222,394 | | | 228,252 | |
Total inventories, net | | 431,676 | | | 416,122 | |
6. Property, Plant and Equipment, Net
Property, plant and equipment, net are recorded at cost and consisted of the following:
| | | | | | | | | | | | | | |
| | As of |
| | September 30, | | December 31, |
| | 2024 | | 2023 |
| | $ | | $ |
Land | | 65,485 | | | 65,485 | |
Building | | 608,004 | | | 231,656 | |
Manufacturing equipment | | 249,371 | | | 186,856 | |
Laboratory equipment | | 236,085 | | | 205,349 | |
Leasehold improvement | | 60,728 | | | 60,124 | |
Software, electronics and office equipment | | 83,814 | | | 83,281 | |
Property, plant and equipment, at cost | | 1,303,487 | | | 832,751 | |
Less: accumulated depreciation | | (366,165) | | | (249,212) | |
Construction in progress | | 625,643 | | | 740,615 | |
Property, plant and equipment, net | | 1,562,965 | | | 1,324,154 | |
The Company has made a significant investment in its newly opened manufacturing and R&D center in Hopewell, New Jersey. In the three months ended September 30, 2024, $256,570 of assets were placed into service. As of September 30, 2024, the Company had construction in progress of $473,833 related to the Hopewell facility, the majority of which will be put into service in the first quarter of 2025.
In March 2024, the Company acquired a land use right and the facility currently being constructed on the land for $75,986. The Company plans to complete the construction of the facility and build a research and development center on the land. Based on the relative fair values of the land use right and construction in progress, $29,721 of the total purchase price was allocated to the land use right and $46,265 was allocated to the construction in progress. In May 2024, the Company acquired additional construction in progress in connection with the properties for $23,443. As of September 30, 2024, title of the land use right was being transitioned to the Company. As such, the purchase price allocated to the land use right was recorded as a long-term prepaid as of September 30, 2024 and will be transferred to operating lease right-of-use asset upon the closing of the transaction.
Depreciation expense was $70,028 and $117,892 for the three and nine months ended September 30, 2024, respectively, and $19,242 and $59,574 for the three and nine months ended September 30, 2023, respectively. Included within depreciation expense for the three and nine months ended September 30, 2024 is $41,808 of accelerated depreciation expense resulting from the move of production to more efficient, larger scale equipment for tislelizumab.
7. Intangible Assets
Intangible assets as of September 30, 2024 and December 31, 2023 are summarized as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | As of |
| | September 30, 2024 | | December 31, 2023 |
| | Gross | | | | | | Gross | | | | |
| | carrying | | Accumulated | | Intangible | | carrying | | Accumulated | | Intangible |
| | amount | | amortization | | assets, net | | amount | | amortization | | assets, net |
| | $ | | $ | | $ | | $ | | $ | | $ |
Finite-lived intangible assets: | | | | | | | | | | | | |
Developed products | | 64,811 | | | (11,465) | | | 53,346 | | | 64,274 | | | (7,807) | | | 56,467 | |
Other | | 8,987 | | | (8,394) | | | 593 | | | 8,987 | | | (8,316) | | | 671 | |
Total finite-lived intangible assets | | 73,798 | | | (19,859) | | | 53,939 | | | 73,261 | | | (16,123) | | | 57,138 | |
Developed products represent post-approval milestone payments under license and commercialization agreements. The Company is amortizing the developed products over the remainder of the respective product patent or the term of the commercialization agreements.
Amortization expense for developed products is included in cost of sales - product in the accompanying consolidated statements of operations. Amortization expense for other intangible assets is included in selling, general and administrative expense in the accompanying consolidated statements of operations.
The weighted-average life for each finite-lived intangible assets is approximately 12 years. Amortization expense was as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended | | Nine Months Ended |
| | September 30, | | September 30, |
| | 2024 | | 2023 | | 2024 | | 2023 |
| | $ | | $ | | $ | | $ |
Amortization expense - Cost of sales - product | | 1,186 | | | 981 | | | 3,546 | | | 2,620 | |
Amortization expense - Selling, general and administrative | | 78 | | | 1,287 | | | 78 | | | 1,662 | |
Total | | 1,264 | | | 2,268 | | | 3,624 | | | 4,282 | |
Estimated amortization expense for each of the five succeeding years and thereafter, as of September 30, 2024 is as follows:
| | | | | | | | | | | | | | | | | | | | |
Year Ending December 31, | | Cost of Sales - Product | | Selling, General and Administrative | | Total |
| | $ | | $ | | $ |
2024 (remainder of year) | | 1,204 | | | 17 | | | 1,221 | |
2025 | | 4,812 | | | 67 | | | 4,879 | |
2026 | | 4,812 | | | 67 | | | 4,879 | |
2027 | | 4,812 | | | 67 | | | 4,879 | |
2028 | | 4,812 | | | 67 | | | 4,879 | |
2029 and thereafter | | 32,894 | | | 308 | | | 33,202 | |
Total | | 53,346 | | | 593 | | | 53,939 | |
8. Income Taxes
Income tax expense was $23,046 and $45,255 for the three and nine months ended September 30, 2024, respectively, and $13,925 and $39,091 for the three and nine months ended September 30, 2023, respectively. The income tax expense for the three and nine months ended September 30, 2024 and 2023 was primarily attributable to current U.S. tax expense determined after other special tax deductions and research and development tax credits, current Switzerland tax expense based on year to date earnings, and current China tax expense due to certain non-deductible expenses.
On a quarterly basis, the Company evaluates the realizability of deferred tax assets by jurisdiction and assesses the need for a valuation allowance. In assessing the realizability of deferred tax assets, the Company considers historical profitability, evaluation of scheduled reversals of deferred tax liabilities, projected future taxable income and tax-planning strategies. Valuation allowances have been provided on deferred tax assets where, based on all available evidence, it was considered more likely than not that some portion or all of the recorded deferred tax assets will not be realized in future periods. After consideration of all positive and negative evidence, as of September 30, 2024, the Company will maintain a full valuation allowance against its net deferred tax assets.
As of September 30, 2024, the Company had gross unrecognized tax benefits of $17,592. The Company does not anticipate that the amount of existing unrecognized tax benefits will significantly change within the next 12 months. The Company’s reserve for uncertain tax positions increased by $1,788 and $3,328 in the three and nine months ended September 30, 2024 primarily due to U.S. federal and state tax credits and incentives.
9. Supplemental Balance Sheet Information
Prepaid expenses and other current assets consist of the following:
| | | | | | | | | | | | | | |
| | As of |
| | September 30, | | December 31, |
| | 2024 | | 2023 |
| | $ | | $ |
Prepaid research and development costs | | 60,227 | | | 60,476 | |
Prepaid taxes | | 25,048 | | | 37,320 | |
Other receivables | | 33,967 | | | 37,859 | |
Prepaid manufacturing cost | | 28,849 | | | 42,066 | |
Prepaid general and administrative expenses | | 16,183 | | | 14,619 | |
Short-term restricted cash | | 9,284 | | | 11,473 | |
Deposits | | 7,860 | | | 26,753 | |
Prepaid insurance | | 6,180 | | | 8,872 | |
Other current assets | | 21,482 | | | 18,027 | |
Total | | 209,080 | | | 257,465 | |
Other non-current assets consist of the following: | | | | | | | | | | | | | | |
| | As of |
| | September 30, | | December 31, |
| | 2024 | | 2023 |
| | $ | | $ |
| | | | |
Prepayment of property and equipment 1 | | 35,963 | | | 4,144 | |
Prepaid supply cost | | 12,779 | | | 18,122 | |
Rental deposits and other | | 9,180 | | | 8,195 | |
Prepaid VAT | | 2,807 | | | 2,546 | |
Long-term restricted cash | | 2,211 | | | 2,711 | |
Long-term investments (Note 4) | | 138,234 | | | 89,644 | |
Total | | 201,174 | | | 125,362 | |
1 Includes payment for acquired land use right that was in the process of being transitioned to the Company as of September 30, 2024 (See Note 6).
Accrued expenses and other payables consist of the following:
| | | | | | | | | | | | | | |
| | As of |
| | September 30, | | December 31, |
| | 2024 | | 2023 |
| | $ | | $ |
Revenue rebates and returns related | | 213,747 | | | 139,936 | |
Compensation related | | 211,856 | | | 217,803 | |
External research and development activities related | | 112,077 | | | 162,969 | |
Commercial activities | | 80,810 | | | 87,572 | |
Individual income tax and other taxes | | 34,550 | | | 30,083 | |
Accrued general and administrative expenses | | 30,830 | | | 36,203 | |
Other | | 33,473 | | | 19,165 | |
Total | | 717,343 | | | 693,731 | |
Other long-term liabilities consist of the following:
| | | | | | | | | | | | | | |
| | As of |
| | September 30, | | December 31, |
| | 2024 | | 2023 |
| | $ | | $ |
Deferred government grant income | | 32,429 | | | 34,204 | |
Pension liability | | 13,022 | | | 14,995 | |
Asset retirement obligation | | 1,140 | | | 1,127 | |
Other | | 3,977 | | | 484 | |
Total | | 50,568 | | | 50,810 | |
10. Debt
The following table summarizes the Company’s short-term and long-term debt obligations as of September 30, 2024 and December 31, 2023:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Lender | | Line of Credit | | Term | | Maturity Date | | Interest Rate | | As of |
September 30, 2024 | | December 31, 2023 |
| | | | | | | | | | $ | | RMB | | $ | | RMB |
China Construction Bank | | RMB580,000 | | 9-year | | June 11, 2027 | | 1 | | 15,675 | | | 110,000 | | | 14,089 | | | 100,000 | |
China Merchants Bank | | RMB350,000 | | 9-year | | January 20, 2029 | | 2 | | 8,957 | | | 62,857 | | | 8,856 | | | 62,857 | |
China Merchants Bank | | RMB378,000 | | 9-year | | November 8, 2029 | | 3 | | 7,783 | | | 54,620 | | | 5,636 | | | 40,000 | |
China Merchants Bank | | $380,000 | | 1-year | | 4 | | 380,000 | | | 2,666,667 | | | 300,000 | | | 2,129,321 | |
China Minsheng Bank | | $150,000 | | 1-year | | December 19, 2024 | | 7.3% | | 150,000 | | | 1,052,632 | | | 150,000 | | | 1,064,660 | |
China Industrial Bank | | RMB 675,000 | | 364-day | | March 27, 2025 | | 5 | | 96,188 | | | 675,000 | | | — | | | — | |
China Merchants Bank | | RMB 400,000 | | 1-year | | June 5, 2025 | | 3.0% | | 57,000 | | | 400,000 | | | 56,356 | | | 400,000 | |
HSBC Bank | | RMB 340,000 | | 1-year | | May 5, 2025 | | 6 | | 48,450 | | | 340,000 | | | 47,903 | | | 340,000 | |
China Industrial Bank | | RMB 200,000 | | 1-year | | May 29, 2024 | | — | | — | | | — | | | 28,177 | | | 200,000 | |
Shanghai Pudong Development Bank | | RMB 700,000 | | 1-year | | 7 | | 2.9% | | 99,750 | | | 700,000 | | | 49,312 | | | 350,000 | |
Other short-term debt 8 | | | | | | | | | | — | | | — | | | 28,037 | | | 199,000 | |
Total short-term debt | | 863,803 | | | 6,061,776 | | | 688,366 | | | 4,885,838 | |
| | | | | | | | | | | | | | | | |
China Construction Bank | | RMB580,000 | | 9-year | | June 11, 2027 | | 1 | | 51,300 | | | 360,000 | | | 59,174 | | | 420,000 | |
China Merchants Bank | | RMB350,000 | | 9-year | | January 20, 2029 | | 2 | | 31,350 | | | 220,000 | | | 37,638 | | | 267,143 | |
China Merchants Bank | | RMB378,000 | | 9-year | | November 8, 2029 | | 3 | | 36,463 | | | 255,880 | | | 42,337 | | | 300,500 | |
China CITIC Bank | | RMB480,000 | | 10-year | | July 28, 2032 | | 9 | | 68,400 | | | 480,000 | | | 58,469 | | | 415,000 | |
Total long-term bank loans | | 187,513 | | | 1,315,880 | | | 197,618 | | | 1,402,643 | |
1The outstanding borrowings bear floating interest rates benchmarking RMB loan interest rates of financial institutions in the PRC. The loan interest rate was 4.2% as of September 30, 2024. The loan is secured by BeiGene Guangzhou Factory’s property ownership certificate and fixed assets. The Company repaid $6,886 (RMB50,000) during the nine months ended September 30, 2024.
2The outstanding borrowings bear floating interest rates benchmarking against prevailing interest rates of certain PRC financial institutions. The loan interest rate was 3.7% as of September 30, 2024. The loan is secured by Guangzhou Factory’s second land use right and certain fixed assets in the second phase of the Guangzhou manufacturing facility’s build out. The Company repaid $6,526 (RMB47,143) during the nine months ended September 30, 2024.
3The outstanding borrowings bear floating interest rates benchmarking RMB loan interest rates of financial institutions in the PRC. The loan interest rate was 3.8% as of September 30, 2024. The loan is secured by fixed assets placed into service upon completion of the third phase of the Guangzhou manufacturing facility’s build out. The Company repaid $4,169 (RMB30,000) during the nine months ended September 30, 2024.
4The outstanding borrowings bear floating interest rates benchmarking the secured overnight financing rate. The loan interest rate was 6.7% as of September 30, 2024. $300,000 of the borrowings matures on December 25, 2024, and $80,000 matures on January 27, 2025.
5The outstanding borrowings bear floating interest rates benchmarking RMB loan interest rates of financial institutions in the PRC. The loan interest rate was 2.6% as of September 30, 2024.
6The outstanding borrowings bear floating interest rates benchmarking Hong Kong interbank market rate for RMB. The loan interest rate was 5.7% as of September 30, 2024.
7$49,875 (RMB350,000) of the outstanding borrowings matures on November 21, 2024 and March 19, 2025, respectively.
8During the two years ended December 31, 2023, the Company entered into short-term working capital loans with China Industrial Bank and China Merchants Bank to borrow up to RMB875,000 in aggregate. The Company repaid $27,476 (RMB199,000) during the nine months ended September 30, 2024.
9In July 2022, the Company entered into a 10-year bank loan agreement with China CITIC Bank to borrow up to RMB480,000 at a floating interest rate benchmarked against prevailing interest rates of certain PRC financial institutions. The Company drew down $9,053 (RMB65,000) during the nine months ended September 30, 2024. The weighted average loan interest rate was 3.7% as of September 30, 2024. The loan is secured by BeiGene Suzhou Co., Ltd.’s property ownership certificate of the small molecule manufacturing campus in Suzhou, China.
The Company has numerous financial and non-financial covenants on its debt obligations with various banks and other lenders. Some of these covenants include cross-default provisions that could require acceleration of repayment of loans in the event of default. However, the Company’s debt is primarily short-term in nature. Any acceleration would be a matter of months but may impact the Company’s ability to refinance debt obligations if an event of default occurs. As of September 30, 2024, the Company was in compliance with all covenants of its material debt agreements.
Interest Expense
Interest expense recognized for the three and nine months ended September 30, 2024 was $14,312 and $39,949, respectively, among which, $8,176 and $25,697 was capitalized, respectively. Interest expense recognized for the three and nine months ended September 30, 2023 was $6,630 and $16,095, respectively, among which, $11,632 and $12,404 was capitalized, respectively.
11. Product Revenue
The Company’s product revenue is primarily derived from the sale of its internally developed products BRUKINSA in the U.S., Europe, China, and other regions, and tislelizumab in China; XGEVA®, BLINCYTO® and KYPROLIS® in China under a license from Amgen; and POBEVCY® in China under a license from Bio-Thera.
The table below presents the Company’s net product revenue for the three and nine months ended September 30, 2024 and 2023.
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended | | Nine Months Ended |
| | September 30, | | September 30, |
| | 2024 | | 2023 | | 2024 | | 2023 |
| | $ | | $ | | $ | | $ |
Product revenue – gross | | 1,245,589 | | | 731,515 | | | 3,357,208 | | | 1,908,448 | |
Less: Rebates and sales returns | | (252,142) | | | (136,225) | | | (695,697) | | | (349,122) | |
Product revenue – net | | 993,447 | | | 595,290 | | | 2,661,511 | | | 1,559,326 | |
The following table disaggregates net product revenue by product for the three and nine months ended September 30, 2024 and 2023:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended | | Nine Months Ended |
| | September 30, | | September 30, |
| | 2024 | | 2023 | | 2024 | | 2023 |
| | $ | | $ | | $ | | $ |
BRUKINSA® | | 690,278 | | | 357,695 | | | 1,816,192 | | | 877,353 | |
Tislelizumab | | 163,351 | | | 144,352 | | | 467,038 | | | 408,666 | |
XGEVA® | | 63,445 | | | 24,456 | | | 161,880 | | | 68,621 | |
BLINCYTO® | | 20,215 | | | 14,870 | | | 53,712 | | | 40,394 | |
KYPROLIS® | | 17,972 | | | 11,101 | | | 48,019 | | | 27,096 | |
POBEVCY® | | 12,193 | | | 14,130 | | | 40,398 | | | 41,894 | |
REVLIMID® | | 11,103 | | | 14,960 | | | 32,469 | | | 59,965 | |
Other | | 14,890 | | | 13,726 | | | 41,803 | | | 35,337 | |
Total product revenue – net | | 993,447 | | | 595,290 | | | 2,661,511 | | | 1,559,326 | |
The following table presents the roll-forward of accrued revenue rebates and returns for the nine months ended September 30, 2024 and 2023:
| | | | | | | | | | | | | | |
| | Nine Months Ended |
| | September 30, |
| | 2024 | | 2023 |
| | $ | | $ |
Balance at beginning of the period | | 139,936 | | | 41,817 | |
Accrual | | 695,697 | | | 349,122 | |
Payments | | (621,886) | | | (278,683) | |
Balance at end of the period | | 213,747 | | | 112,256 | |
12. (Loss) Earnings Per Share
The following table reconciles the numerator and denominator in the computations of basic and diluted (loss) earnings per share:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended | | Nine Months Ended |
| | September 30, | | September 30, |
| | 2024 | | 2023 | | 2024 | | 2023 |
| | $ | | $ | | $ | | $ |
Numerator: | | | | | | | | |
Net (loss) income | | (121,350) | | | 215,413 | | | (492,905) | | | (514,155) | |
| | | | | | | | |
Denominator: | | | | | | | | |
Weighted-average shares outstanding—basic | | 1,376,751,873 | | | 1,360,716,279 | | | 1,361,216,763 | | | 1,358,392,470 | |
Effect of dilutive securities: | | | | | | | | |
Stock options, restricted stock units and ESPP shares | | — | | | 29,615,554 | | | — | | | — | |
Weighted-average shares outstanding—diluted | | 1,376,751,873 | | | 1,390,331,833 | | | 1,361,216,763 | | | 1,358,392,470 | |
| | | | | | | | |
(Loss) earnings per share | | | | | | | | |
Basic | | (0.09) | | | 0.16 | | | (0.36) | | | (0.38) | |
Diluted | | (0.09) | | | 0.15 | | | (0.36) | | | (0.38) | |
For the three and nine months ended September 30, 2024 and the nine months ended September 30, 2023, the computation of basic loss per share using the two-class method was not applicable as the Company was in a net loss position, and the effects of all share options, restricted shares, restricted share units and ESPP shares were excluded from the calculation of diluted loss per share, as their effect would have been anti-dilutive.
For the three months ended September 30, 2023, diluted earnings per share was computed using the weighted-average number of ordinary shares and the effect of potentially dilutive shares outstanding during the periods. Potentially dilutive shares consist of stock options, restricted stock units and ESPP shares. The dilutive effect of outstanding stock options, restricted stock units and ESPP shares is reflected in diluted net earnings per share by application of the treasury stock method.
13. Share-Based Compensation Expense
Share Option and Incentive Plan
During the nine months ended September 30, 2024, the Company granted options for 9,035,663 ordinary shares, restricted share units for 45,696,365 ordinary shares, and performance share units for 2,405,949 ordinary shares under the Company’s share option and incentive plan. As of September 30, 2024, options, restricted share units, and performance share units for ordinary shares outstanding totaled 65,461,567, 85,279,987, and 2,162,082, respectively. As of September 30, 2024, share-based awards to acquire 82,344,989 ordinary shares were available for future grant under the Company’s share option and incentive plan.
Employee Share Purchase Plan
The Company’s employee share purchase plan (the “ESPP”) allows eligible employees to purchase the Company’s ordinary shares (including in the form of ADSs) at the end of each offering period, which will generally be six months, at a 15% discount to the market price of the Company’s ADSs at the beginning or the end of each offering period, whichever is lower, using funds deducted from their payroll during the offering period. Eligible employees are able to authorize payroll deductions of up to 10% of their eligible earnings, subject to applicable limitations.
As of September 30, 2024, 4,953,682 ordinary shares were available for future issuance under the ESPP.
The following tables summarizes the shares issued under the ESPP:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | Market Price1 | | Purchase Price2 | | |
Issuance Date | | Number of Ordinary Shares Issued | | ADS | | Ordinary | | ADS | | Ordinary | | Proceeds |
August 31, 2024 | | 1,035,996 | | | $ | 165.02 | | | $ | 12.69 | | | $ | 140.27 | | | $ | 10.78 | | | $ | 11,178 | |
February 29, 2024 | | 1,021,397 | | | $ | 165.65 | | | $ | 12.74 | | | $ | 140.80 | | | $ | 10.83 | | | $ | 11,063 | |
August 31, 2023 | | 794,144 | | | $ | 207.55 | | | $ | 15.97 | | | $ | 176.42 | | | $ | 13.57 | | | $ | 10,777 | |
February 28, 2023 | | 930,582 | | | $ | 171.10 | | | $ | 13.16 | | | $ | 145.44 | | | $ | 11.19 | | | $ | 10,414 | |
1 The market price is the lower of the closing price on the Nasdaq Stock Market on the issuance date or the offering date, in accordance with the terms of the ESPP.
2 The purchase price is the price which was discounted from the applicable market price, in accordance with the terms of the ESPP.
Share-Based Compensation Expense
The following table summarizes total share-based compensation expense recognized for the three and nine months ended September 30, 2024 and 2023:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended | | Nine Months Ended |
| | September 30, | | September 30, |
| | 2024 | | 2023 | | 2024 | | 2023 |
| | $ | | $ | | $ | | $ |
Research and development | | 47,670 | | | 44,150 | | | 141,121 | | | 124,126 | |
Selling, general and administrative | | 66,933 | | | 51,969 | | | 192,890 | | | 150,710 | |
Total | | 114,603 | | | 96,119 | | | 334,011 | | | 274,836 | |
14. Accumulated Other Comprehensive Loss
The movement of accumulated other comprehensive loss was as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | Unrealized | | | | |
| | Foreign Currency | | Gains/(Losses) on | | Pension | | |
| | Translation | | Available-for-Sale | | Liability | | |
| | Adjustments | | Securities | | Adjustments | | Total |
| | $ | | $ | | $ | | $ |
Balance as of December 31, 2023 | | (87,987) | | | 35 | | | (11,494) | | | (99,446) | |
Other comprehensive income (loss) before reclassifications | | 15,348 | | | (35) | | | — | | | 15,313 | |
Amounts reclassified from accumulated other comprehensive loss | | — | | | — | | | 608 | | | 608 | |
Net-current period other comprehensive income (loss) | | 15,348 | | | (35) | | | 608 | | | 15,921 | |
Balance as of September 30, 2024 | | (72,639) | | | — | | | (10,886) | | | (83,525) | |
15. Shareholders’ Equity
BMS Settlement
On August 1, 2023, the Company entered into a Settlement and Termination Agreement (the “Settlement Agreement”) with BMS-Celgene and certain of its affiliates relating to the termination of the parties’ ongoing contractual relationships, the previously-disclosed ongoing arbitration proceeding concerning ABRAXANE® (the “Arbitration”), the License and Supply Agreement (“LSA”), the Amended and Restated Quality Agreement (the “QA”), and the Share Subscription Agreement (the “SSA”), entered into by the parties in 2017 and 2018. Pursuant to the Settlement Agreement, the parties agreed to mutually dismiss the Arbitration and BMS-Celgene and its affiliates agreed to transfer 23,273,108 ordinary shares of the Company originally purchased in 2017, in each case subject to and in accordance with the terms and conditions of the Settlement Agreement. In consideration for the shares being returned, the Company agreed to drop its claims pursuant to the Settlement Agreement. Furthermore, the parties agreed to terminate the LSA and QA on December 31, 2023, subject to the Company’s right to continue selling all inventory of REVLIMID and VIDAZA until sold out or December 31, 2024, whichever is earlier. The Settlement Agreement provides for a settlement and release by each party of claims arising from or relating to the Arbitration, the LSA, the QA and the SSA, as well as other disputes and potential disputes between the parties, in each case subject to and in accordance with the terms and conditions of the Agreement. The receipt of the shares occurred on August 15, 2023. The Company recorded a noncash gain upon receipt of $362,917, which represents the fair value on the day the shares were received. The gain was recorded within other income, net in the consolidated statements of operations. The shares were constructively retired as of December 31, 2023. The Company recorded the amount of the cancelled shares in excess of par to additional paid-in capital.
16. Restricted Net Assets
The Company’s ability to pay dividends may depend on the Company receiving distributions of funds from its PRC subsidiaries. Relevant PRC statutory laws and regulations permit payments of dividends by the Company’s PRC subsidiaries only out of the subsidiary’s retained earnings, if any, as determined in accordance with PRC accounting standards and regulations. The results of operations reflected in the condensed consolidated financial statements prepared in accordance with GAAP differ from those reflected in the statutory financial statements of the Company’s PRC subsidiaries.
In accordance with the company law of the PRC, a domestic enterprise is required to provide statutory reserves of at least 10% of its annual after-tax profit until such reserve has reached 50% of its respective registered capital based on the enterprise’s PRC statutory accounts. A domestic enterprise is also required to provide discretionary surplus reserve, at the discretion of the board of directors, from the profits determined in accordance with the enterprise’s PRC statutory accounts. The aforementioned reserves can only be used for specific purposes and are not distributable as cash dividends. The Company’s PRC subsidiaries were established as domestic enterprises and therefore are subject to the above-mentioned restrictions on distributable profits.
As a result of these PRC laws and regulations, including the requirement to make annual appropriations of at least 10% of after-tax income and set aside as general reserve fund prior to payment of dividends, the Company’s PRC subsidiaries are restricted in their ability to transfer a portion of their net assets to the Company.
Foreign exchange and other regulations in the PRC may further restrict the Company’s PRC subsidiaries from transferring funds to the Company in the form of dividends, loans and advances. As of September 30, 2024 and December 31, 2023, the net cash of the Company’s PRC subsidiaries amounted to $1,391,444 and $1,837,790, respectively.
17. Commitments and Contingencies
Purchase Commitments
As of September 30, 2024, the Company had non-cancellable purchase commitments amounting to $155,852, of which $29,955 related to minimum purchase requirements for supply purchased from contract manufacturing organizations and $125,897 related to binding purchase obligations of inventory from Amgen. The Company does not have any minimum purchase requirements for inventory from Amgen.
Capital Commitments
The Company had capital commitments amounting to $66,151 for the acquisition of property, plant and equipment as of September 30, 2024, related to various facilities across the globe, including the manufacturing and clinical R&D campus in Hopewell, New Jersey.
Co-Development Funding Commitment
Under the Amgen Collaboration Agreement, the Company is responsible for co-funding global development costs for the Amgen oncology pipeline assets up to a total cap of $1,250,000. The Company is funding its portion of the co-development costs by contributing cash and development services. As of September 30, 2024, the Company’s remaining co-development funding commitment was $379,057.
Funding Commitment
The Company had committed capital related to two equity-method investments in the amount of $15,056. As of September 30, 2024, the remaining capital commitment was $8,156 and is expected to be paid from time to time over the investment period.
18. Segment and Geographic Information
The Company operates in one segment: pharmaceutical products. Its chief operating decision maker is the Chief Executive Officer, who makes operating decisions, assesses performance and allocates resources on a consolidated basis.
The Company’s long-lived assets are primarily located in the U.S. and the PRC.
Net product revenues by geographic area are based upon the location of the customer, and net collaboration revenue is recorded in the jurisdiction in which the related income is expected to be sourced from.
Total revenues by geographic area are presented as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended | | Nine Months Ended |
| | September 30, | | September 30, |
| | 2024 | | 2023 | | 2024 | | 2023 |
| | $ | | $ | | $ | | $ |
U.S. - total revenue | | 505,462 | | | 398,229 | | | 1,338,348 | | | 815,059 | |
Product revenue | | 503,745 | | | 270,084 | | | 1,334,566 | | | 632,391 | |
Collaboration revenue | | 1,717 | | | 128,145 | | | 3,782 | | | 182,668 | |
| | | | | | | | |
China - total revenue | | 375,993 | | | 287,935 | | | 1,048,439 | | | 831,399 | |
Product revenue | | 370,295 | | | |