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Revenue recognition
 3 Months Ended
Mar. 31, 2023
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, 2023 and 2022, net product sales outside of the United States were $133.0 million and $81.2 million, respectively, consisting of sales of Translarna, Tegsedi, Waylivra, and Upstaza. Translarna net revenues made up $115.1 million and $79.2 million of the net product sales outside of the United States for the three months ended March 31, 2023 and 2022, respectively. During the three months ended March 31, 2023, and 2022, net product sales in the United States were $54.6 million and $48.6 million, respectively, consisting solely of sales of Emflaza. During the three months ended March 31, 2023, three countries, the United States, Russia, and Brazil, accounted for at least 10% of the Company’s net product sales, representing $54.6 million, $44.6 million, and $25.9 million of the net product sales, respectively. During the three months ended March 31, 2022, two countries, the United States and Brazil, accounted for at least 10% of the Company’s net product sales, representing $48.6 million and $25.8 million of the net product sales, respectively. For the three months ended March 31, 2023 and 2022, 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, 2023 and December 31, 2022, the Company does not have a contract liabilities balance related to net product sales, and has not made significant changes to the judgments made in applying ASC Topic 606.

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, 2023, 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 $250.0 million.

For the three months ended March 31, 2023 and 2022, the amounts recognized for the collaboration revenue related to the SMA License Agreement with Roche were immaterial.

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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, 2023 and 2022, the Company has recognized $30.8 and $18.9 million of royalty revenue related to Evrysdi, respectively.

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Manufacturing Revenue

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For the three months ended March 31, 2023, the Company recognized $2.0 million of manufacturing revenue related to the production of plasmid DNA and AAV vectors for gene therapy applications for external customers. No manufacturing revenue was recognized in the three months ended March 31, 2022. The Company has not made significant changes to the judgments made in applying ASC Topic 606 for the three months ended March 31, 2023 and 2022.

As of March 31, 2023 and December 31, 2022, the Company has a contract liabilities balance of $0.2 million and $1.4 million, respectively, relating to the production of plasmid DNA and AAV vectors for gene therapy applications for external customers. The Company did not have any contract assets for periods ended March 31, 2023 and December 31 2022. For three months ended March 31, 2023, the Company recognized $1.4 million of revenue related to the amounts included in the contract liability balance at the beginning of the period. For the three months ended March 31, 2022, the Company did not recognize any revenues related to the contract liability balance at the beginning of the period.

Remaining performance obligations

Remaining performance obligations represent the transaction price for goods the Company has yet to provide. As of March 31, 2023 and December 31, 2022, the aggregate amount of transaction price allocated to remaining performance obligations related to plasmid DNA and AAV vector production for external customers is $0.2 million and $1.4 million, respectively. The Company expects to recognize revenue over the next one year, as the specific timing for satisfying the performance obligations is contingent upon a number of factors, including customers’ needs and schedules.

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