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Collaboration arrangements and concentration of credit risk | 12 Months Ended
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Dec. 31, 2022
Collaboration arrangements and concentration of credit risk |
Collaboration arrangements and concentration of credit risk | 4. Collaboration arrangements and concentration of credit risk ​ CSL Behring collaboration ​ On the Signing Date, uniQure biopharma B.V., a wholly-owned subsidiary of uniQure N.V., entered into the CSL Behring Agreement with CSL Behring, pursuant to which CSL Behring received exclusive global rights to the Product. On May 6, 2021, a day after the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, the CSL Behring Agreement became fully effective (“Closing”). ​ The Company concluded that CSL Behring is a customer in accordance with Topic 606. The Company identified two material performance obligations related to the CSL Behring Agreement:
| (i) | License Sale; and |
| (ii) | Manufacturing Development. |
These performance obligations are considered distinct from one another, as CSL Behring can benefit from the identified service either on its own or together with other resources that are readily available to CSL Behring, and as the performance obligations are separately identifiable from other performance obligations in the CSL Behring Agreement. The Company continued to develop the Product between the Signing Date and Closing and performed certain reimbursable activities to fulfill the transfer of the global rights (“Additional Covenants” and together with the License the “License Sale”). The Additional Covenants are not considered distinct from the performance obligation to sell the license to CSL Behring as CSL Behring could not benefit from the Additional Covenants on their own, or have these activities be performed with readily available resources. License Sale The Company determined that the fixed upfront payment of $450.0 million and the $12.4 million that the Company received in May 2021 in relation to the Additional Covenants should be allocated to the License Sale. In addition, the Company concluded that variable milestone payments, sales milestone payments and royalties should be allocated to the License Sale performance obligation as well. The Company determined that the License Sale was completed on May 6, 2021, when it transferred the license and CSL Behring assumed full responsibility for the development and commercialization of the Product. At Closing, the Company evaluated the amounts of potential payments and the likelihood that the payments will be received. The Company utilized the most likely amount method to estimate the variable consideration to be included in the transaction price. Since the Company cannot control the achievement of regulatory and first commercial sales milestones, the Company concluded that the potential payments were constrained as of Closing. The Company determined that it would recognize revenue related to these payments only to the extent that it becomes probable that no significant reversal of recognized cumulative revenue will occur thereafter. The Company determined that achievement of a total of $55.0 million of milestone payments related to the submissions of a biologics license application (“BLA”) and market authorization application (“MAA”) was probable as of February 25, 2022, the time of filing the 2021 financial statements, and hence recorded these as license revenue in the year ended December 31, 2021. In March and April 2022, the global regulatory submissions were submitted and the Company received the $55.0 million owed to it from CSL Behring. The Company recorded $100.0 million in variable milestone revenue related to a first sale of HEMGENIX™ in the U.S. during the year ended December 31, 2022 as the Company considers the occurrence of this event to be probable following the November 2022 BLA approval of HEMGENIX™. Despite the approval of the MAA for HEMGENIX™ by the Europeans Medicines Agency (“EMA”) in February 2023, the Company did not record the $75.0 million variable milestone payment related to a first sale of HEMGENIX™ in the one of five major European countries, namely France, Germany, Italy, Spain, and the United Kingdom, as license revenue in the year ended December 31, 2022. The Company considers that the milestone is only owed if achieved prior to July 2, 2023, which is contingent on factors outside the Company’s control and thus the Company determined that occurrence was not probable as of December 31, 2022. The Company is also eligible to receive up to $1.3 billion in additional payments based on the achievement of commercial milestones. The CSL Behring Agreement also provides that the Company will be eligible to receive tiered double-digit royalties in a range of up to a low-twenties percent of net sales of the Product based on sales thresholds. The Company will include payments related to sales milestones in the transaction price when their achievement becomes probable, and it will include royalties on the sale of Product once these have been earned. ​ The Company recognized $100.0 million and $517.4 million of revenues related to the License Sale in the years ended December 31, 2022 and December 31, 2021, respectively (nil in 2020). ​ The Company records expenses related to its existing license and other agreements as well as its financial advisor for a high single digit percentage of any such revenue recognized associated to meeting a milestone. Manufacturing Development ​ The Company determined that the $50.0 million variable milestone payment related to Manufacturing Development should be allocated to the Manufacturing Development performance obligation. The Company concluded that this milestone payment represents the stand-alone selling price (“SSP”) of the services based on the estimated cost of providing the services including a reasonable margin. Manufacturing Development includes providing information regarding a next generation manufacturing process of the Product to CSL Behring. CSL Behring did not request such services during the year ended December 31, 2022. The variable consideration will be reduced if the Company does not complete the development by pre-agreed dates following BLA, respectively MAA approval. The Company utilized the most likely amount method to estimate the variable consideration to be included in the transaction price. As of December 31, 2022, the Company has not recognized any revenue related to the Manufacturing Development milestone. Contract manufacturing ​ On the Signing Date, the Company and CSL Behring entered into a development and commercial supply agreement, pursuant to which, among other things, the Company will supply the Product to CSL Behring at an agreed-upon price commensurate with the SSP. The Company will be responsible for supplying development and commercial Product until such time that these capabilities may be transferred to CSL Behring or a designated contract manufacturing organization. On September 6, 2022, CSL Behring notified the Company of its intent to transfer manufacturing technology related to the Product in the coming years to a third-party contract manufacturer designated by CSL Behring. CSL Behring also requested that the Company continue to serve as a manufacturer of the Product after the Company completes the technology transfer to a third party. The Company and CSL Behring are in the process of negotiating the terms of the transfer of manufacturing responsibility pursuant to the CSL Behring Agreement. The Company generated $1.7 million contract manufacturing revenue from sales to CSL Behring. The Company recognizes contract manufacturing revenue when CSL Behring obtains control of the Product. The Company incurred $2.1 million of cost in relation to its contract manufacturing activities during the year ended December 31, 2022. Collaboration services ​ Following Closing, the Company was facilitating the completion of the HOPE-B clinical trial on behalf of CSL Behring until CSL Behring took over the execution of the clinical trials in December 2022. Activities related to on-demand development services as well as activities related to the completing the HOPE-B clinical trial are reimbursed by CSL Behring at an agreed full-time-employee rate (“FTE-rate”) and CSL Behring also reimburses agreed third-party expenses incurred in relation to performing these activities. The Company concluded that these rights at Closing do not represent material rights. The Company recognized $3.0 million of collaboration revenue in the year ended December 31, 2022, compared to $2.4 million and nil in the same periods in 2021 and 2020. Accounts receivable and contract asset As of December 31, 2022, the Company recorded accounts receivable of $2.2 million from CSL Behring related to collaboration services as well as a contract asset of $100.0 million expected to be received from CSL Behring following the first sale of HEMGENIX™ in the U.S in 2023. As of December 31, 2021, the Company recorded accounts receivable of $2.9 million from CSL Behring related to collaboration services as well as a contract asset of $55.0 million associated with milestone payments due upon CSL Behring’s global regulatory submissions for HEMGENIX™. Bristol-Myers Squibb collaboration ​ 2015 agreement ​ In May 2015, the Company entered into the BMS CLA and various related agreements with BMS, which the Company collectively refers to as the BMS CLA, which provided BMS with exclusive access to the Company’s gene therapy technology platform for the research, development and commercialization of therapeutics aimed at multiple Collaboration Targets. The initial four-year research term under the collaboration terminated on May 21, 2019. ​ 2020 amendment ​ On December 1, 2020, the Company and BMS entered into the amended BMS CLA. Under the amended BMS CLA, BMS was limited to four Collaboration Targets. For a period of one-year from the effective date of the amended BMS CLA, BMS was able to replace up to two of the four active Collaboration Targets with two new targets in the field of cardiovascular disease. The Company continued to be eligible to receive research, development, and regulatory milestone payments of up to $217.0 million for each Collaboration Target, if defined milestones had been achieved. ​ Since the December 2020 amendment, BMS no longer was entitled to designate a fifth to tenth Collaboration Targets and as such the Company’s remaining obligations under the amended BMS CLA were substantially reduced. The Company also no longer was entitled to receive up to an aggregate $16.5 million in target designation payments for the research, development and regulatory milestone payments associated with the fifth to tenth Collaboration Targets. ​ For as long as any of the four Collaboration Targets were being advanced, BMS might have placed a purchase order to be supplied with research, clinical and commercial supplies. ​ The amended BMS CLA did not extend the initial four-year research term that expired in May 2019. BMS could place purchase orders to be provided with limited services primarily related to analytical and development efforts in respect of the four Collaboration Targets. BMS could have requested such services for a period not to exceed the earlier of (i) the completion of all activities under a Research Plan and (ii) November 30, 2023. BMS continued to reimburse the Company for these services. ​ 2022 Termination ​ On November 21, 2022, the Company received written notice that BMS is terminating the BMS CLA as amended effective February 21, 2023. ​ Services to BMS were rendered by the Dutch operating entity. Total collaboration and license revenue generated with BMS are as follows (presented as revenue from a related party up until the effective date of the amended BMS CLA and presented as revenue after the effective date): ​
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
​ | Years ended December 31,
​ | 2022 | ​ | ​ | 2021 | ​ | ​ | 2020
​ | ​ | (in thousands)
Bristol Myers Squibb | $ | 1,752 | ​ | $ | 4,176 | ​ | $ | 37,514
​ | $ | 1,752 | ​ | $ | 4,176 | ​ | $ | 37,514
​ ​ Amounts owed by BMS in relation to the Collaboration and License Revenue are as follows (presented as “Accounts receivables” as of December 31, 2022 and 2021: ​
​ | ​ | ​ | ​ | ​ | ​ | ​
​ | ​ | December 31, | ​ | December 31,
​ |  | 2022 |  | 2021
​ | ​ | (in thousands)
Bristol Myers Squibb | ​ | $ | 136 | ​ | $ | 914
Total | ​ | $ | 136 | ​ | $ | 914
​ ​ License Revenue ​ The Company recognized no License Revenue for the year ended December 31, 2022 (December 31, 2021: nil million, December 31, 2020: $33.0 million). In 2015 the Company received $75.1 million of payments that it allocated to License Revenue. The Company recognized License Revenue over the expected performance period based on its measure of progress towards the completion of certain activities related to its services. The Company did not identify any new distinct performance obligations and determined the amended BMS CLA did not represent a separate contract in accordance with ASC 606. The Company evaluated the effect the modification had on its measure of progress towards the completion of its performance obligation related to License Revenue and determined that its remaining performance obligation under the amended BMS CLA was immaterial and recognized the remaining balance of unrecognized License Revenue as of November 30, 2020 of $27.8 million in profit and loss during the year ended December 31, 2020 as License Revenue from a related party. The Company included variable consideration related to any research, development, and regulatory milestone payments, in the transaction price once it considered it probable that including these payments in the transaction price would not result in the reversal of cumulative revenue recognized. Due to the significant uncertainty surrounding the development of gene-therapy product candidates and the dependence on BMS’s performance and decisions, the Company with the exception of a $4.4 million research milestone payment received and recorded as License Revenue in December 2020 did not consider this probable as of December 31, 2021. No variable consideration became due prior to the termination of the amended BMS CLA on February 21, 2023. Under the amended BMS CLA, the Company would have recognized License Revenue related to product sales by BMS from any of the Collaboration Targets when the sales would have occurred. The Company was eligible to receive net sales-based milestone payments and tiered mid-single to low double-digit royalties on product sales. ​ Collaboration Revenue ​ The Company recognized collaboration revenues associated with Collaboration Target-specific pre-clinical analytical development and process development activities that were reimbursable by BMS under the BMS CLA and the amended BMS CLA as well as other related agreements. Collaboration Revenue related to these contracted services was recognized when performance obligations were satisfied. ​ The Company generated $1.8 million collaboration revenue for the year ended December 31, 2022 (December 31, 2021: $4.2 million; December 31, 2020: $0.2 million). ​

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