Collaborative Arrangements | Collaborative 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 internally-developed drug candidates to other parties, in-licenses of drug products and drug candidates from other parties, and profit and cost sharing arrangements. Amgen On October 31, 2019, the Company entered into a global strategic oncology collaboration with Amgen (the "Amgen Collaboration Agreement") for the commercialization and development in China, excluding Hong Kong, Taiwan and Macao, 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. On January 2, 2020, following approval by the Company's shareholders and satisfaction of other closing conditions, the agreement became effective. 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 of the products globally and will supply the products to the Company at an agreed upon price. The Company and Amgen will 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. XGEVA was approved in China in 2019 for patients with giant cell tumor of the bone and a supplemental new drug application has been filed for prevention of skeletal-related events in cancer patients with bone metastases. Additionally, new drug applications have been filed in China for KYPROLIS as a treatment for patients with multiple myeloma and BLINCYTO a as a treatment for adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL). Amgen and the Company are also jointly developing a portfolio of Amgen oncology pipeline assets under the collaboration. In April 2020, two Amgen oncology pipeline assets were removed from the collaboration due to portfolio prioritization, and the parties expect that the development plan for the assets in the portfolio will continue to evolve over time. 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 AMG 510, 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). 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 collaboration, 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. 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 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 cash proceeds received from the Amgen collaboration for the three months ended March 31, 2020 were as follows: Three Months Ended March 31, 2020 $ Fair value of equity issued to Amgen 2,162,407 Fair value of research and development cost share liability 616,834 Total cash proceeds 2,779,241 Amounts recorded related to the Company's portion of the co-development funding on the pipeline assets for the three months ended March 31, 2020 were as follows: Three Months Ended March 31, 2020 $ Research and development expense 28,366 Amortization of research and development cost share liability 27,634 Total amount due to Amgen for BeiGene's portion of the development funding 56,000 Total amount of development funding payable in cash 56,000 Total amount of development funding paid with development services — Remaining portion of development funding cap at March 31, 2020 1,194,000 At March 31, 2020 , the research and development cost share liability recorded in the Company's balance sheet was as follows: As of March 31, 2020 $ Research and development cost share liability, current portion 128,672 Research and development cost share liability, non-current portion 460,528 Total research and development cost share liability 589,200 There were no product sales or commercial profit share payments related to the Amgen collaboration during the three months ended March 31, 2020 . Celgene Corporation, a Bristol Myers Squibb company ("BMS") On July 5, 2017, the Company entered into a license agreement with Celgene Corporation, now BMS, pursuant to which the Company granted to the BMS parties an exclusive right to develop and commercialize the Company’s investigational PD-1 inhibitor, tislelizumab, in all fields of treatment, other than hematology, in the United States, Europe, Japan and the rest of world other than Asia (the “PD-1 License Agreement”). The Company entered into a mutual agreement with BMS to terminate the Amended and Restated PD-1 License Agreement effective June 14, 2019 in advance of the acquisition of Celgene by BMS. The following table summarizes total collaboration revenue recognized related to the BMS collaboration for the three months ended March 31, 2020 and 2019 : Three Months Ended March 31, 2020 2019 $ $ Reimbursement of research and development costs — 18,174 Research and development service revenue — 2,238 Total — 20,412 For the three months ended March 31, 2019 , the Company recognized collaboration revenue of $20,412 related to its former collaboration with BMS. The Company recognized $18,174 of research and development reimbursement revenue for the three months ended March 31, 2019 for the clinical trials that Celgene had opted into. The $2,238 of research and development services revenue for the three months ended March 31, 2019 , reflected the recognition of upfront consideration that was allocated to research and development services at the time of the collaboration and was recognized over the term of the respective clinical studies for the specified indications. In-Licensing Arrangements The Company has in-licensed the rights to develop, manufacture and, if approved, commercialize multiple development stage drug candidates and drug products 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 development milestones paid under these arrangements for the three months ended March 31, 2020 and 2019 are set forth below. All upfront and development milestones were expensed to research and development expense. There have been no regulatory or commercial milestones paid under these arrangements to date. Three Months Ended March 31, 2020 2019 Research and development payments to Collaboration Partners $ $ Upfront payments 43,000 10,000 Milestone payments 5,000 — Total 48,000 10,000 EUSA Pharma On January 13, 2020, the Company entered into an exclusive development and commercialization agreement with EUSA Pharma ("EUSA") for the orphan biologic products SYLVANT ® (siltuximab) and QARZIBA ® (dinutuximab beta) in China. Under the terms of the agreement, EUSA granted the Company exclusive rights to SYLVANT in greater China and to QARZIBA in mainland China. Under the agreement, the Company will fund and undertake all clinical development and regulatory submissions in the territories, and will commercialize both products once approved. EUSA received a $40,000 upfront payment and will be eligible to receive payments upon the achievement of regulatory and commercial milestones up to a total of $160,000 . EUSA will also be eligible to receive tiered royalties on future product sales. The upfront payment was expensed to research and development expense during the three months ended March 31, 2020 in accordance with the Company's acquired in-process research and development expense policy. Other In addition to the collaborations discussed above, the Company has entered into additional collaborative arrangements during the three months ended March 31, 2020 and 2019 . The Company may be required to pay additional amounts upon the achievement of various development, regulatory and commercial milestones under these agreements. The Company may also incur significant research and development costs if the related product candidates 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 milestones and 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. |