Sobi to streamline nirsevimab contractual arrangements

USA - English

• USA - English

Nirsevimab economics simplified through a new royalty agreement with Sanofi and the termination of the participation agreement with AstraZeneca

Alignment will provide Sobi benefit through simplification, only revenue recognition and greater flexibility

STOCKHOLM, April 9, 2023 /PRNewswire/ -- Sobi® today announced a streamlining and simplification of the contractual economics for nirsevimab. In January 2019, Sobi completed the acquisition of Synagis® (palivizumab) from AstraZeneca in the US as well as the right to AstraZeneca's full share of US profits and losses for nirsevimab. Synagis is a medicine used to help prevent a serious lung disease caused by respiratory syncytial virus (RSV) in children. Nirsevimab is under regulatory review in the US and recently approved in the EU for the prevention of RSV lower respiratory tract disease in new-borns and infants.

New royalty agreement with Sanofi

Through a new royalty agreement with Sanofi, Sobi will receive a quarterly royalty on net sales of nirsevimab in the US. Royalty rates will start at 25 per cent at launch, which is anticipated in 2023, continue in 2024 and increase each year from 2025 to 2028 in a tiered fashion to a range of 30 to 35 per cent of net sales. Beyond 2028, the royalty rates will remain at these levels.

As part of the new royalty agreement with Sanofi, Sobi will pay Sanofi USD 66 million as reimbursement of prior costs for research & development of nirsevimab in the US with Sobi owing no further payments.

Termination of participation agreement with AstraZeneca

Through a separate agreement with AstraZeneca, Sobi terminated the participation agreement related to nirsevimab that was entered into at the end of 2018 and closed in January 2019. This termination removes Sobi's right to AstraZeneca's full share of US profits and losses for nirsevimab, including US development and commercialisation costs and the obligation to pay future milestones and royalties to AstraZeneca. Sobi will pay AstraZeneca USD 15 million as an upfront final consideration with Sobi owing no further payments. For more information about the participation agreement, please refer to Note 2, Revenue from profit-sharing arrangement, page 53 or Note 4, Profit-sharing arrangement, page 63 of the Annual and sustainability report 2022.

Financial considerations

The outlook for 2023 provided by Sobi on 9 February 2023 excluded any elements of Sobi's right to the full share of US profits and losses for nirsevimab.

About Synagis

Synagis® (palivizumab) is an RSV F protein inhibitor monoclonal antibody immunisation indicated for the prevention of serious lower respiratory tract infection caused by RSV in infants and young children at high risk of RSV disease.

About nirsevimab

Nirsevimab, formerly MEDI8897, is a single dose long-acting antibody, developed and commercialised in partnership by AstraZeneca and Sanofi. It is designed to protect infants entering or during their first RSV season and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

Sobi

Sobi® is a specialised international biopharmaceutical company transforming the lives of people with rare and debilitating diseases. Providing reliable access to innovative medicines in the areas of haematology, immunology and specialty care, Sobi has approximately 1,600 employees across Europe, North America, the Middle East, Asia and Australia. In 2022, revenue amounted to SEK 18.8 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com, LinkedIn and YouTube.

Contacts

For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here.

This information is information that Sobi is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, on 9 April 2023 at 18:00 CEST.

Thomas Kudsk Larsen
Head of Communication and Investor Relations

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SOURCE Swedish Orphan Biovitrum AB