Sanofi's ALTUVIIIO approved by the US FDA

Published: 28-Feb-2023

"This positive event triggers impairment reversal, positively impacting 2022 IFRS net income"

Sanofi has announced the filing of its Form 20-F with the US Securities and Exchange Commission (SEC) and its “Document d’Enregistrement Universel” containing its Annual Financial Report with the French market regulator Autorité des marchés financiers (AMF).

On February 22, 2023, the US Food and Drug Administration (FDA) approved ALTUVIIIO. This confirms the significant increase of value of the asset. That decision, which occurred prior to the filing of the French Document d’enregistrement universel and of the Annual Report on Form 20-F, resulted in an adjustment to IFRS net income for the year ended December 31, 2022 as presented in the Sanofi press release issued on February 3, 2023. 

The adjustment consisted of the reversal of €2,154 million of impairment losses against the intangible assets associated with the Eloctate franchise, in accordance with IAS 36 (Impairment of Assets); the assets had been partially written down in 2019. The adjustment is presented within the line item Impairment of intangible assets in the consolidated income statement; the net impact after tax is a gain of €1,651 million. Cash flows are not impacted by the adjustment. Following the adjustment, for the year ended December 31, 2022, IFRS net income amounts to €8,371 million (versus €6,720 million as per the press release of February 3, 2023); earnings per share (IFRS EPS) amounts to €6.69 (versus €5.37 as per the press release of February 3, 2023); and total equity amounts to €75,152 million (versus €73,512 million as per the press release of February 3, 2023).

Business net income (a non-IFRS financial measure) for the year ended December 31, 2022 is unchanged, as is the amount of the dividend proposed by the Board of Directors held on February 2, 2023.

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