Revenue recognition |
12 Months Ended |
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Dec. 31, 2021 | |
Revenue from Contract with Customer [Abstract] | |
Revenue recognition | 13. Revenue recognition Net product sales The Company views its operations and manages its business in one operating segment. During the years ended December 31, 2021, 2020 and 2019, net product sales in the United States were $187.3 million, $139.0 million, and $101.0 million, respectively, consisting solely of sales of Emflaza, and net product sales outside of the United States were $241.6 million, $194.4 million, and $190.3 million respectively, consisting of sales of Translarna, Tegsedi, and Waylivra. Translarna net product revenues made up $236.0 million, $191.9 million, and $190.0 million of the net product sales outside the United States for the years ended December 31, 2021, 2020, and 2019, respectively. For the years ended December 31, 2021, 2020, and 2019, two of the Company’s distributors each accounted for over 10% of the Company’s net product sales. As of December 31, 2021, the Company does not have a contract liabilities balance. As of December 31, 2020, the Company’s contract liabilities balance was $4.2 million. The Company did not have any contract assets for the years ended December 31, 2021 and 2020. During the years ended December 31, 2021 and 2020, the Company recognized revenues of $4.0 million and $8.1 million, respectively, related to amounts included in contract liability balance at the beginning of each period. The Company has not made significant changes to the judgments made in applying ASC Topic 606 for the years ended December 31, 2021 and 2020. Remaining performance obligations Remaining performance obligations represent the transaction price for goods the Company has yet to provide. As of December 31, 2021, the Company does not have any remaining performance obligations relating to Translarna net product revenue. As of December 31, 2020, the aggregate amount of transaction price allocated to remaining performance relating to Translarna net product revenue was $4.2 million.Collaboration revenue and Royalty revenue In November 2011, the Company and the Spinal Muscular Atrophy Foundation (“SMA Foundation”) entered into a licensing and collaboration agreement with F. Hoffman-La Roche Ltd and Hoffman- La Roche Inc. (collectively, “Roche”). Under the terms of the SMA License Agreement, Roche acquired an exclusive worldwide license to the Company’s SMA program. Under the agreement, the Company is eligible to receive additional payments from Roche if specified events are achieved with respect to each licensed product, including up to $135.0 million in research and development event milestones, up to $325.0 million in sales milestones upon achievement of certain sales events, and up to double digit royalties on worldwide annual net sales of a commercial product. In November 2019, the Company announced the filing of an NDA in the United States, which triggered a $15.0 million payment to the Company from Roche. Under ASC Topic 606, the acceptance of the NDA filing by the FDA resolved the uncertainty of whether the milestone was probable of being achieved, and the Company recorded it as collaboration revenue for the year ended December 31, 2019. The SMA program currently has one approved product, Evrysdi™ (risdiplam), which was approved in August 2020 by the FDA for the treatment of SMA in adults and children two months and older. The first commercial sale of Evrysdi in the United States was made in August 2020. This event triggered a $20.0 million milestone payment to the Company from Roche. In August 2020, the EMA accepted the MAA filed by Roche for Evrysdi for the treatment of SMA, which triggered a $15.0 million milestone payment to the Company from Roche. In October 2020, Chugai, a subsidiary of Roche, filed an NDA in Japan for Evrysdi for the treatment of SMA, which triggered a $7.5 million milestone payment to the Company from Roche. Under ASC Topic 606, the acceptance of the NDA filing resolved the uncertainty of whether the milestone was probable of being achieved. The Company recorded the three milestone payments as collaboration revenue for the year ended December 31, 2020. The first commercial sale of Evrysdi in the EU was made in March 2021. This event triggered a $20.0 million milestone payment to the Company from Roche. The first commercial sale in Japan was made in August 2021, which was the final research and development milestone received by the Company. This event triggered a $10.0 million payment to the Company from Roche. As of December 31, 2021, the Company does not have any remaining research and development milestones that can be received. In December 2021, the Company recorded its first sales milestone of $25.0 million for the achievement of $500.0 million in worldwide annual net sales from Evrysdi, which is recorded on the balance sheet within prepaid expenses and other current assets as of December 31, 2021. The remaining potential sales milestones as of December 31, 2021 is $300.0 million upon achievement of certain sales events. For the years ended December 31, 2021, 2020, and 2019, the Company recognized revenue related to the licensing and collaboration agreement with Roche of $55.0 million, $42.6 million, and $15.2 million, respectively. In addition to research and development and sales milestones, the Company is eligible to receive up to double-digit royalties on worldwide annual net sales of a commercial product under the SMA License Agreement. For the year ended December 31, 2021, the Company has recognized $54.6 million of royalty revenue related to Evrysdi. For the year ended December 31, 2020, the Company has recognized $4.8 million of royalty revenue related to Evrysdi. No royalty revenue was recognized in the years prior, as the first commercial sale of Evrysdi occurred in August 2020. |