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Collaborative and Licensing Arrangements | 12 Months Ended
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Dec. 31, 2024
Research and Development [Abstract] |
Collaborative and Licensing Arrangements | Collaborative and Licensing Arrangements The Company enters into collaborative arrangements for the research and development, manufacture and/or commercialization of drug products 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. Out-Licensing Arrangements During the three years ended December 31, 2024, the Company’s collaboration revenue related to its out-licensing collaborative agreements has consisted of research and development services revenue and right to access intellectual property revenue from its former collaboration agreements with Novartis for tislelizumab and ociperlimab. Other collaboration revenue consists primarily of revenue under the Novartis broad markets agreement and, beginning in 2024, royalty revenue under the Amgen collaboration agreement. The following table summarizes total collaboration revenue recognized for the years ended December 31, 2024, 2023 and 2022:
| Year Ended December 31,
| 2024 |  | 2023 |  | 2022
Revenue from Collaborators | $ |  | $ |  | $
Research and development service revenue | — |  |  | 79,431 |  |  | 46,822 |
Right to access intellectual property revenue | — |  |  | 104,477 |  |  | 104,994 |
Material rights revenue | — |  |  | 71,980 |  |  | — |
Other | 30,695 |  |  | 13,039 |  |  | 9,493 |
Total | 30,695 |  |  | 268,927 |  |  | 161,309 |
Novartis Tislelizumab Collaboration and License In January 2021, the Company entered into a collaboration and license agreement with Novartis, granting Novartis rights to develop, manufacture and commercialize tislelizumab in North America, Europe, and Japan (the “Novartis Territory”). The Company and Novartis agreed to jointly develop tislelizumab in these licensed countries, with Novartis responsible for regulatory submissions after a transition period and for commercialization upon regulatory approvals. In addition, both companies had the ability to conduct clinical trials globally to explore combinations of tislelizumab with other cancer treatments, and the Company has an option to co-detail the product in North America, funded in part by Novartis. Under the agreement the Company received an upfront cash payment of $650,000 from Novartis. A portion of the transaction price was allocated to the R&D services to be performed under the agreement and deferred and was being recognized as collaboration revenue as the R&D services were performed using a percentage-of-completion method. In September 2023, the Company and Novartis agreed to mutually terminate the collaboration and license agreement, effective immediately. 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. The following table summarizes collaboration revenue recognized in connection with the tislelizumab collaboration and license agreement for the years ended December 31, 2024, 2023 and 2022:
| Year Ended December 31,
| 2024 |  | 2023 |  | 2022
| $ |  | $ |  | $
Research and development service revenue | — |  |  | 72,278 |  |  | 39,655 |
Other 1 | 2,113 |  |  | 5,067 |  |  | 9,493 |
Total | 2,113 |  |  | 77,345 |  |  | 49,148 |
1 Represents revenue recognized on sale of tislelizumab clinical supply to Novartis in conjunction with the collaboration. Ociperlimab Option, Collaboration and License Agreement and China Broad Market Development Agreement In December 2021, the Company expanded its collaboration with Novartis by entering into an option, collaboration and license agreement with Novartis to develop, manufacture and commercialize the Company’s investigational TIGIT inhibitor ociperlimab in the Novartis Territory. In addition, the Company and Novartis entered into an agreement granting the Company rights to market, promote and detail five approved Novartis oncology products, TAFINLAR® (dabrafenib), MEKINIST® (trametinib), VOTRIENT® (pazopanib), AFINITOR® (everolimus), and ZYKADIA® (ceritinib), across designated regions of China referred to as “broad markets.” In the first quarter of 2022, the Company initiated marketing and promotion of these five products. Under the terms of the option, collaboration and license agreement, the Company received an upfront cash payment of $300,000. At inception, a portion of the upfront cash payment was deferred related to performance obligations to be satisfied at a later point in time or over time. In July 2023, the Company and Novartis mutually agreed to terminate the ociperlimab option, collaboration and license agreement, effective immediately. 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 ociperlimab option, collaboration and license agreement for the years ended December 31, 2024, 2023 and 2022:
| Year Ended December 31,
| 2024 |  | 2023 |  | 2022
| $ |  | $ |  | $
Research and development service revenue | — |  |  | 7,153 |  |  | 7,167 |
Right to access intellectual property revenue | — |  |  | 104,477 |  |  | 104,994 |
Material rights revenue | — |  |  | 71,980 |  |  | — |
Other 2 | 18,259 |  |  | 8,859 |  |  | — |
Total | 18,259 |  |  | 192,469 |  |  | 112,161 |
2 Represents revenue generated under the broad markets marketing and promotion agreement in conjunction with the collaboration. In-Licensing Arrangements - Commercial Amgen In October 2019, the Company entered into a global strategic oncology collaboration with Amgen (“Amgen Collaboration Agreement”) for the commercialization and development in China, excluding Hong Kong, Taiwan and Macau, of Amgen’s XGEVA®, KYPROLIS®, and BLINCYTO®, and the joint global development of a portfolio of oncology assets in Amgen’s pipeline, with BeiGene responsible for development and commercialization in China. The agreement became effective on January 2, 2020, following approval by the Company’s shareholders and satisfaction of other closing conditions. Under the agreement, the Company is responsible for the commercialization of XGEVA, KYPROLIS and BLINCYTO in China for five or seven years. Amgen is responsible for manufacturing the products globally and supplying the products to the Company at an agreed upon price. The Company and Amgen share equally in the China commercial profits and losses during the commercialization period. Following the commercialization period, the Company has the right to retain one product and is entitled to receive royalties on sales in China for an additional five years on the products not retained. Amgen and the Company are also jointly developing a portfolio of Amgen oncology pipeline assets under the collaboration. The Company is responsible for conducting clinical development activities in China and co-funding global development costs by contributing cash and development services up to a total cap of $1,250,000. Amgen is responsible for all development, regulatory and commercial activities outside of China. For each pipeline asset that is approved in China, the Company will receive commercial rights for seven years from approval. The Company has the right to retain approximately one out of every three approved pipeline assets, other than LUMAKRAS (sotorasib) (“AMG 510”), Amgen’s KRAS G12C inhibitor, for commercialization in China. The Company and Amgen will share equally in the China commercial profits and losses during the commercialization period. The Company is entitled to receive royalties from sales in China for pipeline assets returned to Amgen for five years after the seven-year commercialization period. The Company is also entitled to receive royalties from global sales of each product outside of China (with the exception of AMG 510). On April 20, 2022, the parties entered into the First Amendment to Amgen Collaboration Agreement, which amends certain terms and conditions relating to the financial responsibilities of the parties in connections with the development and commercialization of certain Amgen proprietary products for the treatment of oncology-related diseases and conditions. In connection with the Company’s ongoing assessment of the Amgen Collaboration Agreement cost-share contributions, the Company determined that further investment in the development of LUMAKRAS was no longer commercially viable for BeiGene. As a result, in February 2023, the Company and Amgen entered into the Second Amendment to the Amgen Collaboration Agreement to (i) stop sharing costs with Amgen for the further development of LUMAKRAS during the period starting January 1, 2023 and ending August 31, 2023; and (ii) cooperate in good faith to prepare a transition plan with the termination of LUMAKRAS from the Amgen Collaboration Agreement. The Amgen Collaboration Agreement is within the scope of ASC 808, as both parties are active participants and are exposed to the risks and rewards dependent on the commercial success of the activities performed under the agreement. The Company is the principal for product sales to customers in China during the commercialization period and will recognize 100% of net product revenue on these sales. Amounts due to Amgen for its portion of net product sales will be recorded as cost of sales. Cost reimbursements due to or from Amgen under the profit share will be recognized as incurred and recorded to cost of sales; selling, general and administrative expense; or research and development expense, based on the underlying nature of the related activity subject to reimbursement. Costs incurred for the Company’s portion of the global co-development funding are recorded to research and development expense as incurred. In connection with the Amgen Collaboration Agreement, a Share Purchase Agreement (“SPA”) was entered into by the parties on October 31, 2019. On January 2, 2020, the closing date of the transaction, Amgen purchased 15,895,001 of the Company’s ADSs for $174.85 per ADS, representing a 20.5% ownership stake in the Company. Per the SPA, the cash proceeds shall be used as necessary to fund the Company’s development obligations under the Amgen Collaboration Agreement. Pursuant to the SPA, Amgen also received the right to designate one member of the Company’s board of directors, and Anthony Hooper joined the Company’s board of directors as the Amgen designee in January 2020. Amgen relinquished its right to appoint a designated director to the Company’s board of directors in January 2023. In determining the fair value of the common stock at closing, the Company considered the closing price of the common stock on the closing date of the transaction and included a lack of marketability discount because the shares are subject to certain restrictions. The fair value of the shares on the closing date was determined to be $132.74 per ADS, or $2,109,902 in the aggregate. The Company determined that the premium paid by Amgen on the share purchase represents a cost share liability due to the Company’s co-development obligations. The fair value of the cost share liability on the closing date was determined to be $601,857 based on the Company’s discounted estimated future cash flows related to the pipeline assets. The estimation of future cash flows involved management assumptions of revenue growth rates and probability of technical and regulatory success of the pipeline assets. The total cash proceeds of $2,779,241 were allocated based on the relative fair value method, with $2,162,407 recorded to equity and $616,834 recorded as a research and development cost share liability. The cost share liability is being amortized proportionately as the Company contributes cash and development services to its total co-development funding cap. Amounts recorded related to the Company’s portion of the co-development funding on the pipeline assets for the years ended December 31, 2024, 2023 and 2022 were as follows:
| Year Ended December 31,
| 2024 |  | 2023 |  | 2022
| $ |  | $ |  | $
BeiGene’s portion of the development funding | 148,391 |  |  | 108,608 |  |  | 195,357 |
Less: Amortization of research and development cost share liability | 73,226 |  |  | 55,294 |  |  | 96,402 |
Research and development expense | 75,165 |  |  | 53,314 |  |  | 98,955 |
|  |  |  |  | As of December 31, 2024
Remaining portion of development funding cap |  |  |  |  | 335,261 |
As of December 31, 2024 and 2023, the research and development cost share liability recorded in the Company’s balance sheet was as follows:
| As of December 31,
| 2024 |  | 2023
| $ |  | $
Research and development cost share liability, current portion | 111,154 |  |  | 68,004 |
Research and development cost share liability, non-current portion | 54,286 |  |  | 170,662 |
Total research and development cost share liability | 165,440 |  |  | 238,666 |
The net reimbursement paid under the commercial profit-sharing agreement for in-line product sales is classified in the consolidated statements of operations for the three years ended December 31, 2024 as follows:
| Year Ended December 31,
| 2024 |  | 2023 |  | 2022
| $ |  | $ |  | $
Cost of sales - product | 37,150 |  |  | 8,358 |  |  | 5,898 |
Selling, general and administrative | (83,674) |  |  | (60,917) |  |  | (54,865) |
Research and development | (2,438) |  |  | 1,688 |  |  | (1,216) |
Total | (48,962) |  |  | (50,871) |  |  | (50,183) |
The Company purchases commercial inventory from Amgen to distribute in China. Total inventory purchases amounted to $247,655, $108,691 and $71,720, respectively, during the year ended December 31, 2024, 2023 and 2022. Net amounts payable to Amgen as of December 31, 2024 and 2023 were $116,563 and $55,474, 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 made under these arrangements for the years ended December 31, 2024, 2023 and 2022 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 the term of the commercialization agreements.
|  | Year Ended December 31,
|  | 2024 |  | 2023 |  | 2022
Payments due to collaboration partners | Classification | $ |  | $ |  | $
Upfront payments | Research and development expense | 60,027 |  |  | 46,800 |  |  | 68,665 |
Development milestone payments | Research and development expense | 54,000 |  |  | — |  |  | 5,500 |
Regulatory and commercial milestone payments | Intangible asset | — |  |  | 24,365 |  |  | — |
Total |  | 114,027 |  |  | 71,165 |  |  | 74,165 |
The Company has entered into a number of in-licensing collaborative arrangements during the years ended December 31, 2024, 2023 and 2022. A summary of amounts incurred under these arrangements is included above. The Company may be required to pay additional amounts upon the achievement of various development and commercial milestones under these agreements. The Company may also incur significant research and development costs if the related product candidate were to advance to late-stage clinical trials. In addition, if any products related to these collaborations are approved for sale, the Company may be required to pay significant milestones upon approval and milestones and/or royalties on future sales. The payment of these amounts, however, is contingent upon the occurrence of various future events, which have a high degree of uncertainty of occurrence.

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- Definition The entire disclosure for collaborative arrangements in which the entity is a participant, including a) information about the nature and purpose of such arrangements; b) its rights and obligations thereunder; c) the accounting policy for collaborative arrangements; and d) the income statement classification and amounts attributable to transactions arising from the collaborative arrangement between participants. + References Reference 1: http://www.xbrl.org/2003/role/disclosureRef -Name Accounting Standards Codification -Section 50 -Paragraph 1 -Subparagraph (a) -SubTopic 10 -Topic 808 -Publisher FASB -URI https://asc.fasb.org/1943274/2147479402/808-10-50-1 Reference 2: http://www.xbrl.org/2003/role/disclosureRef -Name Accounting Standards Codification -Section 50 -Paragraph 1 -Subparagraph (b) -SubTopic 10 -Topic 808 -Publisher FASB -URI https://asc.fasb.org/1943274/2147479402/808-10-50-1 Reference 3: http://www.xbrl.org/2003/role/disclosureRef -Name Accounting Standards Codification -Topic 808 -Publisher FASB -URI https://asc.fasb.org/808/tableOfContent + Details
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