XML 31 R19.htm IDEA: XBRL DOCUMENT v3.22.1
Revenue recognition
3 Months Ended
Mar. 31, 2022
Revenue from Contract with Customer [Abstract]  
Revenue recognition

11.        Revenue recognition

Net product sales

The Company views its operations and manages its business in one operating segment.

During the three months ended March 31, 2022 and 2021, net product sales in the United States were $48.6 million and $43.5 million, respectively, consisting solely of Emflaza, and net product sales outside of the United States were $81.2 million and $47.8 million, respectively, consisting of Translarna, Tegsedi, and Waylivra. Translarna net revenues made up $79.2 million and $46.5 million of the net product sales outside of the United States for the three months ended March 31, 2022 and 2021, respectively. For the three months ended March 31, 2022 and 2021, the Company had a total of two and two distributors, respectively, that each accounted for over 10% of the Company’s net product sales.

As of March 31, 2022 and December 31, 2021, the Company did not have any contract liabilities or assets. For the three month period ended March 31, 2022, the Company did not recognize any revenue related to the amounts included in the contract liability balance at the beginning of the period. For the three month period ended March 31, 2021, the Company recognized $2.1 million of revenue, related to the amounts included in the contract liability balance at the beginning of the period. The Company has not made significant changes to the judgments made in applying ASC Topic 606 for the three month periods ending March 31, 2022 and 2021.

Remaining performance obligations

Remaining performance obligations represent the transaction price for goods the Company has yet to provide. As of March 31, 2022 and December 31, 2021 the Company does not have any remaining performance obligations relating to Translarna net product revenue.

Collaboration and Royalty revenue

In November 2011, the Company and the SMA Foundation entered into the SMA License Agreement with Roche. Under the terms of the SMA License Agreement, Roche acquired an exclusive worldwide license to the Company’s SMA program.

Under the SMA License 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 specified sales events, and up to double digit royalties on worldwide annual net sales of a commercial product.

The SMA program currently has one approved product, Evrysdi, which was approved in August 2020 by the FDA for the treatment of SMA in adults and children two months and older.  As of March 31, 2022, the Company does not have any remaining research and development event milestones that can be received. The remaining potential sales milestones that can be received is $300.0 million.

For the three months ended March 31, 2022 and 2021, the Company recognized $0.0 million and $20.0 million, respectively, related to the SMA License Agreement with Roche. 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 for the three months ended March 31, 2021.

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 three months ended March 31, 2022, the Company has recognized $18.9 million of royalty revenue, related to Evrysdi. For the three months ended March 31, 2021, the Company has recognized $6.7 million of royalty revenue related to Evrysdi.