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Revenue recognition
 9 Months Ended
Sep. 30, 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 September 30, 2023 and 2022, net product sales outside of the United States were $76.6 million and $79.4 million, respectively, consisting of sales of Translarna, Tegsedi, Waylivra, and Upstaza. Translarna net revenues made up $69.0 million and $76.6 million of the net product sales outside of the United States for the three months ended September 30, 2023 and 2022, respectively. During the three months ended September 30, 2023, and 2022, net product sales in the United States were $67.4 million and $54.8 million, respectively, consisting solely of sales of Emflaza. During the three months ended September 30, 2023, one country, the United States, accounted for at least 10% of the Company’s net product sales, representing $67.4 million of the net product sales. During the three months ended September 30, 2022, two countries, the United States and Russia, accounted for at least 10% of the Company’s net product sales, representing $54.8 million and $28.3 million of the net product sales, respectively. For the three months ended September 30, 2023 and 2022, the Company had a total of three and two distributors, respectively, that each accounted for over 10% of the Company’s net product sales.

During the nine months ended September 30, 2023 and 2022, net product sales outside of the United States were $318.5 million and $247.6 million, respectively, consisting of Translarna, Tegsedi, Waylivra, and Upstaza. Translarna net revenues made up $280.6 million and $232.9 million of the net product sales outside of the United States for the nine months ended September 30, 2023 and 2022, respectively. For the nine months ended September 30, 2023 and 2022, net product sales in the United States were $187.7 million and $160.1 million, respectively, consisting solely of Emflaza. During the nine months ended September 30, 2023, three countries, the United States, Russia, and Brazil, accounted for at least 10% of the Company’s net product sales, representing $187.7 million, $69.0 million, and $52.5 million of net product sales, respectively. During the nine months ended September 30, 2022, two countries, the United States and Russia, accounted for at least 10% of the Company’s net product sales, representing $160.1 million and $57.1 million of net product sales, respectively. For the nine months ended September 30, 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 September 30, 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 September 30, 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 September 30, 2023, the Company did not recognize collaboration revenue related to the SMA License Agreement with Roche. For the three months ended September 30, 2022, the Company recognized $50.0 million of collaboration revenue related to the SMA License Agreement. For the nine months ended September 30, 2023, the amounts recognized for the collaboration revenue related to the SMA License Agreement with Roche were immaterial. For the nine months ended September 30, 2022, the Company recognized $50.0 million of collaboration revenue related

to the SMA License Agreement. In September 2022, the Company recognized a sales milestone of $50.0 million for the achievement of $750.0 million in worldwide annual net sales from Evrysdi.

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 and nine months ended September 30, 2023, the Company has recognized $50.2 million and $117.9 million of royalty revenue related to Evrysdi, respectively. For the three and nine months ended September 30, 2022, the Company has recognized $32.9 million and $73.6 million of royalty revenue, respectively, related to Evrysdi.

Manufacturing Revenue

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For the three and nine months ended September 30, 2023, the Company recognized $2.4 million and $6.7 million of manufacturing revenue, respectively, related to the production of plasmid DNA and AAV vectors for gene therapy applications for external customers. No manufacturing revenue was recognized for the three and nine months ended September 30, 2022. The Company has not made significant changes to the judgments made in applying ASC Topic 606 for the three and nine months ended September 30, 2023 and 2022.

As of September 30, 2023 and December 31, 2022, the Company has a contract liabilities balance of $1.2 million and $1.4 million, respectively, related to the production of plasmid DNA and AAV vectors for gene therapy applications for external customers, which is recorded within deferred revenue on the consolidated balance sheet. For the three-month period ended September 30, 2023, the Company did not recognize any revenue related to the amount included in the contract liability balance at the beginning of the period. For the nine-month period ended September 30, 2023, the Company recognized $1.4 million related to the amounts included in the contract liability balance at the beginning of the period.

As of September 30, 2023, the Company has contract assets of $1.4 million related to plasmid DNA and AAV production for external customers, which is recorded within prepaid expenses and other current assets on the consolidated balance sheet. The Company did not have any contract assets for the period ending December 31, 2022.

Remaining performance obligations

As of September 30, 2023 and December 31, 2022, the Company has remaining performance obligations of $1.2 million and $1.4 million, respectively, related to the production of plasmid DNA and AAV vectors for gene therapy applications for external customers. 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.